Regulatory Authority
Regulatory Authority
Scope of Assessment
Regulatory Fees
Ethics Committee
Ethics Committee
Scope of Review
Ethics Committee Fees
Authorizing Body
Clinical Trial Lifecycle
Submission Process
Submission Content
Timeline of Review
Trial Initiation
Safety Reporting
Progress Reporting
Sponsorship
Definition of Sponsor
Trial Authorization
Insurance
Compensation
Quality, Data & Records Management
Site/Investigator Selection
Informed Consent
Documentation Requirements
Required Elements
Compensation Disclosure
Participant Rights
Special Circumstances/Emergencies
Vulnerable Populations
Children/Minors
Pregnant Women, Fetuses & Neonates
Prisoners
Mentally Impaired
Investigational Products
Definition of Investigational Product
Manufacturing & Import
IMP/IND Quality Requirements
Labeling & Packaging
Product Management
Specimens
Definition of Specimen
Import & Export
Consent for Specimens
Tanzania
QUICK FACTS
Clinical trial application languageUnspecified
Parallel regulatory and ethical review permittedYes
Clinical trial registration requiredYes
In-country sponsor presence/representation requiredNo
Age of minorsUnder 18
Specimens export allowedUnspecified
Regulatory Authority > Regulatory Authority
Back to Top
Email section Share    Print section Print
Last content review/update: May 02, 2017. Submit updates or comments.
SUMMARY

Overview
As per the TFDCA, the Tanzania Food and Drugs Authority (TFDA) is the regulatory authority responsible for clinical trial approvals, oversight, and inspections in Tanzania. The TFDA grants permission for clinical trials to be conducted in Tanzania in accordance with the TFDCA and the TFDCA-CTC.

The TFDA is a regulatory body under the Ministry of Health and Social Welfare (MOHSW), which grants it authority to ensure the quality, safety, and effectiveness of food, drugs (including herbal drugs), cosmetics, and medical devices in Tanzania.

The agency has a Ministerial Advisory Board, which consists of:

  • The MOHSW Permanent Secretary who serves as Chairman
  • Up to 12 Minister-appointed members
  • The Director General who serves as Secretary to the board

The TFDA Director General oversees the following directorates:

  • Directorate of Medicines and Complementary Products
  • Directorate of Food Safety
  • Directorate of Laboratory Services
  • Directorate of Business Support

The Directorate of Medicines and Complementary Products is responsible for ensuring that all medicines, cosmetics, and medical devices are evaluated for quality, safety, and effectiveness prior to approval or use; for controlling clinical trials; and for monitoring and evaluating adverse drug reactions.

The TFDA website (see Additional Resource (B)) specifies that the TFDA’s Clinical Trial and Pharmacovigilance Department (CTPV) conducts reviews of the following:

  • New applications for clinical trial approvals
  • Amendments to clinical trial protocols and informed consent documents
  • Serious adverse event reports
  • Requests for Clinical Trial Certificate (CTC) extension

Contact Information
Tanzania Food and Drugs Authority
P.O. Box 77150
Dar Es Salaam, Tanzania

Phone: 255 22 2450512 / 2450751 / 2452108
Fax: 255 22 2450793
Directorate of Medicines and Complementary Products Email: dmc@tfda.or.tz

ADDITIONAL RESOURCES

(A) (Website) Tanzania Food and Drugs Authority (TFDA) – Organization (Current as of October 26, 2016)
Tanzania Food and Drugs Authority, United Republic of Tanzania

(B) (Website) Tanzania Food and Drugs Authority (TFDA) – Clinical Trials Control (Current as of October 26, 2016)
Tanzania Food and Drugs Authority, United Republic of Tanzania

(C) (Document) Tanzania Food and Drugs Authority (TFDA) – Frequently Asked Questions (Date Unavailable)
Tanzania Food and Drugs Authority, United Republic of Tanzania

Relevant Section: 1. Current TFDA Organization Structure

(D) (Document) Ten Years of Regulating Food, Medicines, Cosmetics and Medical Devices: Milestones Attained 2003 - 2013 (Date Unavailable)
Tanzania Food and Drugs Authority, United Republic of Tanzania

Relevant Sections: Chapters Two and Four

(E) (Website) Tanzania Food and Drugs Authority (TFDA) – General Frequently Asked Questions (Current as of October 26, 2016)
Tanzania Food and Drugs Authority, United Republic of Tanzania

REQUIREMENTS

(1) (Legislation) The Tanzania Food, Drugs and Cosmetics Act, 2003 (TFDCA) (2003)
Parliament, United Republic of Tanzania

Relevant Sections: Part II (a)(4, 5, 8, 9, 10, and 11) and Part IV (c)

(2) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Part II (3-4) and Second Schedule (Declaration of Investigator)

Regulatory Authority > Scope of Assessment
Back to Top
Email section Share    Print section Print
Last content review/update: May 02, 2017. Submit updates or comments.
SUMMARY

Overview
As indicated in the TFDCA and the TFDCA-CTC, the Tanzania Food and Drugs Authority (TFDA) is responsible for reviewing, evaluating, and approving clinical trial applications in Tanzania. The scope of the TFDA’s assessment includes all clinical trials (Phases I-IV). As delineated in the TFDCA, the TFDCA-CTC, and the G-AppConductCT, the TFDA’s approval of a clinical trial application is dependent upon obtaining proof of national ethics committee (EC) approval. According to the G-AppConductCT, the TFDA and national EC reviews may be conducted in parallel. However, the TFDA application must include a copy of the national EC's acknowledgement of receipt for the study protocol. In addition, the TFDA's approval will only be finalized once EC approval by the national EC is obtained.

Clinical Trial Review Process
As set forth in the TFDCA, the TFDCA-CTC, and G-AppConductCT, the TFDA coordinates the clinical trial application process. Upon receipt of a clinical trial application, the TFDA initially screens the application for completeness. If complete, the TFDA officer acknowledges receipt of the application by returning a signed copy of the cover sheet to the applicant (see Appendix 1 of the G-AppConductCT). According to Additional Resource (A), the application is then evaluated by the TFDA’s Clinical Trial and Pharmacovigilance Department (CTPV) within the Directorate of Medicines and Cosmetics. The TFDCA states that the TFDA Director General must issue a Clinical Trial Certificate to authorize the trial to be conducted. (See the Clinical Trial Lifecycle topic, Submission Content subtopic for submission requirements.)

ADDITIONAL RESOURCES

(A) (Website) Tanzania Food and Drugs Authority (TFDA) – Clinical Trials Control (Current as of October 26, 2016)
Tanzania Food and Drugs Authority, United Republic of Tanzania

REQUIREMENTS

(1) (Legislation) The Tanzania Food, Drugs and Cosmetics Act, 2003 (TFDCA) (2003)
Parliament, United Republic of Tanzania

Relevant Section: Part IV (c)

(2) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Part II (3-5) and First and Second Schedules

(3) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (2nd Edition) (February 2009)
Tanzania National Drug Authority, Ministry of Health, United Republic of Tanzania

Relevant Sections: Definition of Terms, 1, and Appendices 1-2

Regulatory Authority > Regulatory Fees
Back to Top
Email section Share    Print section Print
Last content review/update: April 26, 2017. Submit updates or comments.
SUMMARY

Overview
As per the G-AppConductCT and TFDCAFees2015, applicants are responsible for paying a processing fee to submit a clinical trial application. The TFDCAFees2015 indicates that the Tanzania Food and Drugs Authority (TFDA) levies the following processing fees:

  • $3,000 USD for submitting a clinical trial application
  • Double the cost of registration and analysis fee for fast track clinical trial applications
  • $300 USD for amendments for major changes in clinical trials
  • $300 USD for amendments for minor changes in clinical trials

See TFDAFees2015 for a complete list of TFDA fees and charges.

Instructions for Payment of Clinical Trial Application Fee
The G-AppConductCT states that the fee must be paid directly to the TFDA or by bank draft electronic transfer to the order of the TFDA.

Foreign applicants should send payments to:
Account Number: 100380013    
Bank: Citibank, Tanzania Ltd.
Bank physical address: Dar Es Salaam – Head Office Peugeot House, 36 Upanga Road, P.O. Box 71625, Dar Es Salaam, Tanzania
Swift Code: CITITZTZ

Local applicants should make payments by banker’s draft electronic transfer or send payments to:
Account Number: 6503900110
Bank: National Microfinance Bank
Bank physical address: Kariakoo Branch

Applicants are responsible for all bank charges when payment is made by bank transfer.

Tanzania Commission for Science and Technology  (COSTECH) Registration Fee
As delineated in Additional Resource (A), the COSTECH charges an application fee of $50 USD (to be paid in travelers checks or cash, and deposited into the COSTECH bank account) to register a research proposal. Bank account number information is not provided on the COSTECH website.

If the application is approved, COSTECH requires the researcher to pay a research fee of $300 USD. Permits are issued for a period of one year, and can be renewed for a similar period, provided that COSTECH receives satisfactory progress reports for the previous periods. After the researcher obtains his/her research permit, he/she is required to apply for a class C residence permit from the Tanzanian Immigration Department.

ADDITIONAL RESOURCES

(A) (Website) Tanzania Commission for Science and Technology (COSTECH) – Research Clearance (Current as of October 26, 2016)
Tanzania Commission for Science and Technology, United Republic of Tanzania

(B) (Website) Global Health Technologies Coalition - Tanzania: Drugs (Last Updated September 23, 2014)
Global Health Technologies Coalition, Washington, DC

(C) (Document) National Health Research Ethics Committee Client Services Charter (April 2014)
National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

REQUIREMENTS

(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (2nd Edition) (February 2009)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Definition of Terms, 1, and Appendix 1

(2) (Regulation) The Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations (TFDCAFees2015) (October 23, 2015)
Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Section: First Schedule

Ethics Committee > Ethics Committee
Back to Top
Email section Share    Print section Print
Last content review/update: October 26, 2016. Submit updates or comments.
SUMMARY

Overview
Clinical trials require national ethics committee (EC) approval for each trial site. The National Institute for Medical Research (NIMR) is the governmental body responsible for EC oversight, and for the promotion and coordination of research in Tanzania. As per Additional Resource (D), institutional ECs are not allowed to approve research of a clinical trial nature or those trials conducted with foreign collaborators.

As delineated in the G-TMRCC and Additional Resources (A), (B), (C), and (D), the Medical Research Coordination Committee (MRCC) serves as the NIMR’s national health research coordinating body, and is responsible for supervising health research in Tanzania. The MRCC, in turn, delegates the registration, review, approval, and monitoring of research to the National Health Research Ethics Review Sub-Committee (NatHREC). The NatHREC focuses on the ethical issues surrounding submitted research proposals, and is responsible for safeguarding the dignity, rights, safety, and well-being of research participants. All clinical trial protocols to be conducted in Tanzania are reviewed by a specialized nine-member subcommittee, the Clinical Trials Sub-Committee, that meets monthly and reports to the NatHREC.

As per Additional Resources (C) and (D), applicants for research that is not a clinical trial or involve a foreign collaborator must obtain NatHREC’s approval and institutional EC approval from the host institution where the proposed research will be conducted. If an institutionally based EC is not available, approval should still be obtained from the NatHREC. In addition, foreign researchers are required to obtain a Research Clearance and Research Permit from the Tanzania Commission for Science and Technology (COSTECH) (see Additional Resource (E)). After the researcher obtains his/her research permit, he/she is also required to apply for a class C residence permit from the Tanzanian Immigration Department.
See the Clinical Trial Lifecycle topic, Submission Content subtopic for detailed submission requirements.

NatHREC Composition
As per the G-TMRCC and Additional Resources (A) and (B), the NatHREC is composed of 15 members and includes physicians, lawyers, biomedical scientists, bioethicists, molecular biologists, sociologists/anthropologists, and representatives from faith-based organizations. The current list of NatHREC members may be accessed at Additional Resource (C).

NatHREC members are appointed by their respective institutions based on knowledge, qualifications, and experience in reviewing and evaluating the scientific, medical, and ethical aspects of research protocols. Committee members must include at least one (1) health scientist, one (1) non-health scientist, one (1) community representative, and one (1) member that ensures gender equity. The chairperson is to be non-affiliated with the NIMR, and the Secretary is to be affiliated with the NIMR.

Institutional EC Composition
As per the G-EthicsHR, the composition and qualification requirements for the institutionally based ECs vary by host institution. A committee consisting of up to 12 members is considered to be appropriate. See sections 1.2.1 for detailed information on composition requirements, and Additional Resource (F) for links to specific institutions.

Terms of Reference, Review Procedures, and Meeting Schedule
The G-TMRCC and Additional Resource (A) state that the NatHREC must operate within written standard operating procedures (SOPs), including a process to be followed for conducting reviews. The SOPs should include information on NatHREC composition, meeting schedules, frequency of reviews, requirements for initial and ongoing evaluation of the research study, and requirements for notifying the investigator and the institution of results related to the study’s initial and ongoing evaluation.

Committee members should agree to disclose their names, occupations, and affiliations, and to sign the confidentiality and conflict of interest agreements. The appointment of committee members is valid for four (4) years, and a member may be renewed for up to two (2) consecutive terms.

The majority of committee members must be involved in the review and approval process. Additional Resource (A) also states that, for all active study files, the NatHREC must send the closed or completed study files to an off-site storage facility and store them for at least 15 years after the study's conclusion. For all prematurely terminated studies, the relevant records (referred to as "inactive files") must be retained for at least three (3) years after the study’s conclusion, and made available to the regulatory authorities upon request.

For detailed NatHREC procedures and information on other administrative processes, see Additional Resources (A) and (C).

ADDITIONAL RESOURCES

(A) (Guidance) Standard Operating Procedures for the National Health Research Ethics Review Committee (2007)
National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Tanzania Health Research Ethics Forum, SOPs #01, #2, #3, #6, #20, and #23

(B) (Website) The National Institute for Medical Research – Structure (Current as of October 26, 2016)
National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

(C) (Website) The National Institute for Medical Research – Health Research Ethics (Current as of October 26, 2016)
National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

(D) (Document) National Health Research Ethics Committee Client Services Charter (April 2014)
National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

(E) (Website) Tanzania Commission for Science and Technology (COSTECH) – Research Clearance (Current as of January 21, 2016)
Tanzania Commission for Science and Technology, United Republic of Tanzania

(F) (Website) Health Research Web – Tanzania – Regulation and Ethics Review of Research (Current as of October 26, 2016)
Health Research Web, Council on Health Research for Development

REQUIREMENTS

(1) (Guidance) The Medical Research Coordinating Committee’s (TMRCC) Ethical Guidelines (G-TMRCC) (Date Unavailable)
Medical Research Coordinating Committee, National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

(2) (Guidance) Guidelines on Ethics for Health Research in Tanzania (G-EthicsHR) (2nd Edition) (2009)
Tanzania National Health Research Forum, National Health Research Ethics Committee, National Institute for Medical Research, United Republic of Tanzania

Relevant Sections: 1.2.1, 1.2.7.5, and 1.2.7.6

Ethics Committee > Scope of Review
Back to Top
Email section Share    Print section Print
Last content review/update: May 02, 2017. Submit updates or comments.
SUMMARY

Overview
According to the G-TMRCC, the G-EthicsHR, and Additional Resources (A) and (B), the primary scope of information assessed by the National Health Research Ethics Review Sub-Committee (NatHREC) and the institutional ethics committees (ECs) relate to maintaining and protecting the dignity and rights of research participants and ensuring  their safety throughout their participation in a clinical trial. The NatHREC and the institutional ECs must also pay special attention to reviewing informed consent and to protecting the welfare of certain classes of participants deemed to be vulnerable. (See Informed Consent topic, and the subtopics of Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses & Neonates; Prisoners; and Mentally Impaired for additional information about these populations).

Both the NatHREC and the institutional ECs are also responsible for ensuring an independent, timely, and competent review of all ethical aspects of the clinical trial protocol. The ECs must act in the interests of the potential research participants and the communities involved, evaluating the possible risks and expected benefits to participants, confirming the suitability of the investigator(s), facilities, and methods, and verifying the adequacy of confidentiality and privacy safeguards. See the G-EthicsHR, and Additional Resources (A) and (B) for detailed ethical review guidelines.

Role in Clinical Trial Approval Process
As per the G-AppConductCT, the TFDCA, the TFDCA-CTC, and Additional Resource (B), the Tanzania Food and Drugs Authority (TFDA) and the NatHREC must approve a clinical trial application prior to the sponsor, the contract research organization (CRO), or the principal investigator (PI) initiating the clinical trial. As per Additional Resource (A), institutional ECs are not allowed to approve research of a clinical trial nature or those trials conducted with foreign collaborators.

As indicated in Additional Resources (A) and (C), all ethical clearance certificates are valid for 12 months after which PIs are required to apply for renewal/extension.  Three (3) copies of the clearance certificate will be issued (for the PI(s) and the Regional  and District Medical Officers). The NatHREC will process research extension requests within a week of receiving completed application documents.  

As delineated in Additional Resource (B), investigators must submit all documents for EC review and approval at least three (3) months prior to the study’s commencement. Moreover, foreign researchers are required to obtain a Research Clearance and Research Permit from the Tanzania Commission for Science and Technology (COSTECH) (see Additional Resource (D)). Additional Resource (B) also states that the NatHREC must review and approve any protocol amendments prior to those changes being implemented.  See the Clinical Trial Lifecycle topic, Submission Content subtopic for detailed ethics submission requirements.

As indicated in Additional Resource (B), the EC is required to conduct a continuing review of the approved research study. However, if the NatHREC has not conducted a follow-up review and approval of the study by the expiration date provided in the initial TFDA approval letter, EC approval is deemed to have expired and all research activities should stop.

ADDITIONAL RESOURCES

(A) (Document) National Health Research Ethics Committee Client Service Charter (April 2014)
National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

(B) (Guidance) Standard Operating Procedures for the National Health Research Ethics Review Committee (2007)
National Institute for Medical Research, Ministry of Health, United Republic of Tanzania

Relevant Sections: Tanzania Health Research Ethics Forum, SOPs # 01, #5, #10, and #7

(C) (Website) The National Institute for Medical Research – Health Research Ethics (Current as of October 26, 2016)
National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

(D) (Website) Tanzania Commission for Science and Technology (COSTECH) – Research Clearance (Current as of October 26, 2016)
Tanzania Commission for Science and Technology, United Republic of Tanzania

(E) (Website) Health Research Web – Tanzania – Regulation and Ethics Review of Research (Current as of October 26, 2016)
Health Research Web, Council on Health Research for Development

REQUIREMENTS

(1) (Guidance) The Medical Research Coordinating Committee’s (TMRCC) Ethical Guidelines (G-TMRCC) (Date Unavailable)
Medical Research Coordinating Committee, National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

(2) (Guidance) Guidelines on Ethics for Health Research in Tanzania (G-EthicsHR) (2nd Edition) (2009)
Tanzania National Health Research Forum, National Health Research Ethics Committee, National Institute for Medical Research, United Republic of Tanzania

Relevant Section: 1.2.5

(3) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (2nd Edition) (February 2009)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Definition of Terms, 1, and Appendices 1-2

(4) (Legislation) The Tanzania Food, Drugs and Cosmetics Act, 2003 (TFDCA) (2003)
Parliament, United Republic of Tanzania

Relevant Section: Part IV (c)

(5) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Part II (3-4) and First and Second Schedules

Ethics Committee > Ethics Committee Fees
Back to Top
Email section Share    Print section Print
Last content review/update: October 26, 2016. Submit updates or comments.
SUMMARY

Overview
According to the G-TMRCC and Additional Resource (A), the National Health Research Ethics Review Sub-Committee (NatHREC) requires the sponsor, the contract research organization, or the principal investigator (PI) to pay a nonrefundable fee to submit a clinical trial research protocol for ethical review and approval.

Additional Resource (A) specifies the following fees per clinical trial research proposal:

  • International researchers - $2,000 USD
  • Tanzanian researchers – 2,000,000 TShs (approximately $900 USD)
  • International students – $750 USD
  • Tanzanian students – 1,000,000 TShs (approximately $450 USD)

Additional Resource (B) provides the following banking instructions for ethics application and registration fee payments:

Foreign applications:
NBC SAMORA Avenue Branch
A/C No. 012105009961 (For USD)
Swift Code: NLCBTZTX
Recipient: NIMR

Domestic Applications:
NBC SAMORA Avenue Branch
A/C No. 012103015635 (For TSHS)
Recipient: NIMR

The PI must always be listed in the bank deposit slip. The PI should also submit the original bank deposit slip (for receipt) and attach a copy of the slip to the proposal on submission.

Institutionally based ethics committees (ECs) may independently decide whether to charge fees for a protocol review.

ADDITIONAL RESOURCES

(A) (Document) National Health Research Ethics Committee Client Service Charter (April 2014)
National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

(B) (Document) National Health Ethics Review Committee (NatHREC) Bank Details (Current as of October 26, 2016)
National Health Ethics Review Committee, National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

(C) (Website) The National Institute for Medical Research – Health Research Ethics (Current as of October 26, 2016)
National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

(D) (Website) Tanzania Commission for Science and Technology (COSTECH) – Research Clearance (Current as of October 26, 2016)
Tanzania Commission for Science and Technology, United Republic of Tanzania

(E) (Website) Health Research Web – Tanzania – Regulation and Ethics Review of Research (Current as of October 26, 2016)
Health Research Web, Council on Health Research for Development

REQUIREMENTS

(1) (Guidance) The Medical Research Coordinating Committee’s (TMRCC) Ethical Guidelines (G-TMRCC) (Date Unavailable)
Medical Research Coordinating Committee, National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

Ethics Committee > Authorizing Body
Back to Top
Email section Share    Print section Print
Last content review/update: October 26, 2016. Submit updates or comments.
SUMMARY

Overview
As mandated by the Parliament Act No. 23 of 1979, the National Institute for Medical Research (NIMR) is the central body responsible for oversight, and for the promotion and coordination of research in Tanzania. (This act is not currently available online.) The NIMR is a semi-autonomous organization under the Ministry of Health and Social Welfare (MOHSW). The G-TMRCC, and Additional Resources (A), (B), (C), and (D) state that the NIMR’s Medical Research Coordination Committee (MRCC) serves as the national health research coordinating body, and is responsible for supervising health research in Tanzania. The MRCC, as the NIMR’s clearance body, delegates the registration, review, approval, and monitoring of research to the National Health Research Ethics Review Sub-Committee (NatHREC). The NatHREC focuses on the ethical issues surrounding submitted research proposals. All clinical trial protocols to be conducted in Tanzania are also reviewed by a specialized nine-member subcommittee, the Clinical Trials Sub-Committee, that meets monthly and reports to the NatHREC.

MRCC Composition
As delineated in the G-TMRCC, the MRCC is composed of eight (8) members including the following:

  • Director General NIMR, Chairman
  • Director, Research Coordination and Promotion, NIMR, Secretary
  • Director General, Tanzania Commission for Science and Technology (COSTECH), Member
  • Medical Association of Tanzania Member
  • Muhimbili University College of Health Science (MUCHS), Member
  • Director, Preventive Services (Ministry of Health and Social Welfare (MOHSW), Member
  • Head, Health Systems Research Unit (MoH) Member
  • University of Dar es Salaam (UDSM), Member

For detailed information on the MRCC’s responsibilities, see the G-TMRCC.

NatHREC Composition
As delineated in the G-TMRCC and Additional Resource (A), the NatHREC consists of 15 members who collectively have the qualifications and experience to review and evaluate the medical, scientific, and ethical aspects of research protocols. The committee is composed of both scientists and non-scientists with varying backgrounds. Committee members must include at least one (1) health scientist, one (1) non-health scientist, one (1) community representative, and one (1) member that ensure gender equity. The NatHREC is represented by the following organizations:

  • NIMR
  • COSTECH
  • MUCHS
  • Christian Social Services Commission (CSSC)
  • The Muslim Council of Tanzania (BAKWATA)
  • Economic and Social Research Foundation (ESRF)
  • Tanzania Gender Networking Programme (TGNP)
  • Legal and Human Rights Centre (LHRC)
  • University of Dar es Salaam (UDSM)
  • MOHSW
  • Ministry of Education (MoE)

For detailed information on the NatHREC responsibilities, see the G-TMRCC, the G-EthicsHR, and Additional Resource (A).

Auditing
As per Additional Resource (A), every unit in the NatHREC office must be prepared and available to answer questions during evaluation, audit, or inspection visits by regulatory authorities. See SOP #22 of Additional Resource (A) for detailed inspection requirements.

No information is available on registration and accreditation responsibilities by the NatHREC.

ADDITIONAL RESOURCES

(A) (Guidance) Standard Operating Procedures for the National Health Research Ethics Review Committee (2007)
National Institute for Medical Research, Ministry of Health, United Republic of Tanzania

Relevant Sections: SOPs # 01 and #22

(B) (Website) The National Institute for Medical Research – Structure (Current as of October 26, 2016)
National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

(C) (Website) The National Institute for Medical Research – Health Research Ethics (Current as of October 26, 2016)
National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

(D) (Document) National Health Research Ethics Committee Client Service Charter (April 2014)
National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

(E) (Website) Tanzania Commission for Science and Technology (COSTECH) – Research Clearance (Current as of October 26, 2016)
Tanzania Commission for Science and Technology, United Republic of Tanzania

(F) (Website) Health Research Web – Tanzania – Regulation and Ethics Review of Research (Current as of October 26, 2016)
Health Research Web, Council on Health Research for Development

REQUIREMENTS

(1) (Guidance) The Medical Research Coordinating Committee’s (TMRCC) Ethical Guidelines (G-TMRCC) (Date Unavailable)
Medical Research Coordinating Committee, National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

(2) (Guidance) Guidelines on Ethics for Health Research in Tanzania (G-EthicsHR) (2nd Edition) (2009)
Tanzania National Health Research Forum, National Health Research Ethics Committee, National Institute for Medical Research, United Republic of Tanzania

Relevant Sections: 1.2.7.5 and 1.2.7.6

(3) (Legislation) The Parliament Act No. 23 of 1979 (not available online) (1979)
Parliament, United Republic of Tanzania

Clinical Trial Lifecycle > Submission Process
Back to Top
Email section Share    Print section Print
Last content review/update: May 02, 2017. Submit updates or comments.
SUMMARY

Overview
According to the G-AppConductCT, the TFDCA, the TFDCA-CTC, and Additional Resource (A), the Tanzania Food and Drugs Authority (TFDA) requires the sponsor, his/her designated contract research organization (CRO), or the investigator to obtain TFDA approval as well as ethics committee (EC) approval by the National Health Research Ethics Review Sub-Committee (NatHREC). As per Additional Resource (C), institutional ECs are not allowed to approve research of a clinical trial nature or those trials conducted with foreign collaborators. As delineated in the G-AppConductCT and the TFDCA, the TFDA’s approval of a clinical trial application is dependent upon obtaining proof of NattHREC approval.

Foreign researchers must also register his/her research proposal with the Tanzania Commission for Science and Technology (COSTECH), and obtain a Research Clearance and Research  permit prior to initiating a study (see Additional Resource (B)). After the researcher obtains his/her research permit, he/she is also required to apply for a class C residence permit from the Tanzanian Immigration Department.

Delivery Address for Clinical Trial Application
Director General
Tanzania Food and Drugs Authority
EPI-Mabibo-Ubungo External
Off Mandela Road
P.O. Box 77150
Dar Es Salaam, Tanzania

Assembly and Number of Copies
As per the G-AppConductCT, applicants must submit both paper and electronic copies. The paper documents should be arranged in spring file folders, and the electronic documents should be in Word format, Bookman Old Style, font 11. The number of copies to be submitted is not specified in the G-AppConductCT. Appendix 1 of the G-AppConductCT provides the Clinical Trial Application Form template.

The G-TMRCC specifies that the NatHREC within the National Institute of Medical Research (NIMR) requires all applicants to complete the Application Form for Ethics Approval (see Additional Resource (D)) to obtain ethics approval.
    
Clinical Trial Application Language Requirements
While there is no specified language requirement for documents submitted to the TFDA, English appears to be the preferred language. The NatHREC Checklist for Ethical Clearance Application Submission (see Additional Resource (E)) requires informed consent/assent forms, data collection tools, and written information provided to participants to be in English and Kiswahili. However, the G-AppConductCT only states that informed consent documents be written in Kiswahili.

ADDITIONAL RESOURCES

(A) (Website) The National Institute of Medical Research – Health Research Ethics (Current as of October 26, 2016)
National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

(B) (Website) Tanzania Commission for Science and Technology (COSTECH) – Research Clearance (Current as of October 26, 2016)
Tanzania Commission for Science and Technology, United Republic of Tanzania

(C) (Document) National Health Research Ethics Committee Client Services Charter (April 2014)
National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

(D) (Form) Application Form for Ethics Approval (Version 1) (2010)
National Health Research Ethics Review Sub-Committee, Medical Research Coordinating Committee, National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

(E) (Checklist) Checklist Ethical Clearance Application Submission (June 2014)
National Health Research Ethics Review Sub-Committee, Medical Research Coordinating Committee, National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

REQUIREMENTS

(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (2nd Edition) (February 2009)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Definition of Terms, 1, and Appendix 1

(2) (Legislation) The Tanzania Food, Drugs and Cosmetics Act, 2003 (TFDCA) (2003)
Parliament, United Republic of Tanzania

Relevant Section: Part IV (c)

(3) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Part II (3-4) and Second Schedule (Declaration of Investigator)

(4) (Guidance) The Medical Research Coordinating Committee’s (TMRCC) Ethical Guidelines (G-TMRCC) (Date Unavailable)
Medical Research Coordinating Committee, National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

Clinical Trial Lifecycle > Submission Content
Back to Top
Email section Share    Print section Print
Last content review/update: April 26, 2017. Submit updates or comments.
SUMMARY

Overview
In accordance with the G-AppConductCT, the TFDCA, the TFDCA-CTC, and Additional Resource (A), the sponsor, the contract research organization (CRO), or the principal investigator (PI) must apply to the Tanzania Food and Drugs Authority (TFDA) and to the National Institute of Medical Research (NIMR)’s National Health Research Ethics Review Sub-Committee (NatHREC) to conduct a drug-related clinical trial.

TFDA Requirements
As per the G-AppConductCT and the TFDCA-CTC, the following documentation must be submitted to the TFDA:

  • Cover letter
  • Application form (See Appendix 1  of the G-AppConductCT and First Schedule of the TFDCA-CTC)
  • General investigational plan
  • Capacity building plans (including plans for staff training and updates)
  • Protocol (including case report form copies or descriptions, informed consent forms (ICFs), and information to be given to participants)
  • Investigator’s Brochure (IB) or prescribing information data sheet
  • Sponsor, investigator(s), and monitor(s) declarations
  • Sponsor and PI financial declaration
  • Certified copy of insurance of research participants
  • Ethics clearance certificate or a copy of NatHREC acknowledgement of protocol submission from the National Health Research Ethics Review Sub-Committee (NatHREC) or any approved medical research institute
  • Investigator(s) Curriculum Vitae(s) (CVs)
  • Investigational medicinal product dossier
  • Application fees

NatHREC Requirements
As per the G-TMRCC and the NatHREC Checklist for Ethical Clearance Application Submission (see Additional Resource (E)), the NatHREC requires applicants to submit the following documentation for ethics approval:

  • Application Form for Ethical Approval (see Additional Resource (D))
  • Cover letter signed by PI or co-PI
  • Commitment letter from affiliated institution and/or local government officials
  • Four copies of the protocol
  • ICFs/Assent Forms in English and Kiswahili
  • EC approval certificate from affiliating institution(s), where applicable
  • Data collection tools in English and Kiswahili
  • Elaborated recruitment procedure
  • Written information to be provided to participants in English and Kiswahili
  • Research team CVs
  • Evidence of payment of application and registration fees (Bank slip)
  • Completed Data Transfer Agreement and/or Material Transfer Agreement, where applicable
  • IBs and Case Report Forms (CRFs)
  • Proof of insurance coverage
  • List of Data Safety Monitoring Board members (with at least one Tanzanian)

Refer to Additional Resources (C), (D), and (E) for detailed submission requirements.

Clinical Protocol
As delineated in the G-TMRCC and Additional Resource (C) the clinical protocol should include the following elements:

  • Summary
  • Introduction and literature review
  • Statement of the problem
  • Rationale
  • Objectives
  • Methodology (including data collection instruments)
  • Study staff CVs and list of references
  • Budget and budget justification
  • Ethical considerations
  • Study limitations
  • Dissemination of research results
  • Approval from foreign and/or local ECs
  • ICFs/Assent Forms in English and Kiswahili
  • Research tools, questionnaires, and tables
  • IBs
  • Letter of Intent of Insurance
  • Any supporting documents

COSTECH Requirements
As delineated in Additional Resources (A) and (B), a foreign researcher who intends to commence research in Tanzania is also required to register his/her research proposal with the Tanzania Commission for Science and Technology (COSTECH) to obtain a research permit prior to initiating a study. Applicants must complete the COSTECH’s Application for Research Clearance (see Additional Resource (B)). As per Additional Resource (B), the form should be submitted along with the following:

  • Application fee (See the Regulatory Authority topic, Regulatory Fees subtopic for detailed fee information)
  • Completed CV form (see Additional Resource (B))
  • Three passport size photos
  • A letter from local contact/collaborator (academic/research institution or host institution)
  • Comprehensive research proposal

See Additional Resource (B) for detailed application requirements.

ADDITIONAL RESOURCES

(A) (Website) The National Institute for Medical Research – Health Research Ethics (Current as of October 26, 2016)
National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

(B) (Website) Tanzania Commission for Science and Technology (COSTECH) – Research Clearance (Current as of October 26, 2016)
Tanzania Commission for Science and Technology, United Republic of Tanzania

(C) (Document) National Health Research Ethics Committee Client Service Charter (April 2014)
National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

(D) (Form) Application Form for Ethics Approval (Version 1) (2010)
National Health Research Ethics Review Sub-Committee, Medical Research Coordinating Committee, National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

(E) (Checklist) Checklist Ethical Clearance Application Submission (June 2014)
National Health Research Ethics Review Sub-Committee, Medical Research Coordinating Committee, National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

REQUIREMENTS

(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (2nd Edition) (February 2009)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Definition of Terms, 1, and Appendix 1

(2) (Legislation) The Tanzania Food, Drugs and Cosmetics Act, 2003 (TFDCA) (2003)
Parliament, United Republic of Tanzania

Relevant Section: Part IV (c)

(3) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Part II (3-4) and First - Fourth Schedules

(4) (Guidance) The Medical Research Coordinating Committee’s (TMRCC) Ethical Guidelines (G-TMRCC) (Date Unavailable)
Medical Research Coordinating Committee, National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania


Clinical Trial Lifecycle > Timeline of Review
Back to Top
Email section Share    Print section Print
Last content review/update: April 26, 2017. Submit updates or comments.
SUMMARY

Overview
Based on the G-AppConductCT, the TFDCA, the TFDCA-CTC, and Additional Resource (A), the Tanzania Food and Drugs Authority’s (TFDA) approval of a clinical trial application is dependent upon obtaining proof of ethical approval by the National Institute of Medical Research (NIMR)’s National Health Research Ethics Review Sub-Committee (NatHREC). According to the G-AppConductCT, the TFDA and NatHREC reviews may be conducted in parallel. However, the TFDA application must include a copy of the NatHREC's acknowledgement of receipt for the study protocol. In addition, the TFDA's approval will only be finalized once NatHREC approval is obtained.

TFDA Approval
According to the G-AppConductCT, the TFDA review process takes three (3) months following receipt of the submission. The outcome of the application will be communicated to the applicant within this period.

As set forth in the G-AppConductCT, the TFDCA, and the TFDCA-CTC, the TFDA coordinates the clinical trial application process. Upon receipt of a clinical trial application, the TFDA initially screens the application for completeness. If complete, the TFDA officer acknowledges receipt of the application by returning a signed copy of the cover sheet to the applicant (see Appendix 1 of the G-AppConductCT or First Schedule of the TFDCA-CTC). According to Additional Resource (A), the application is then evaluated by the TFDA’s Clinical Trial and Pharmacovigilance Department (CTPV) within the Directorate of Medicines and Cosmetics. The TFDCA states that the TFDA Director General must issue a Clinical Trial Certificate to authorize the trial to be conducted.

NatHREC Approval
Additional Resource (C) states that the NatHREC review and ethical clearance process takes six (6) to eight (8) weeks from the date of receiving a complete initial or revised submission. The expedited NatHREC review process is completed within four (4) weeks following receipt of the completed applications.

As set forth in the G-TMRCC and Additional Resources (B) and (C), the NatHREC meets once a month to evaluate application submissions. Additional Resources (B) and (C) state that the NatHREC Secretary is responsible for receiving and processing new protocol submissions, and for ensuring that the Application Assessment Form (Form #02) (Additional Resource (D)) is properly completed and all of the protocol elements are included. If the application is complete, the Secretariat forwards the proposal to the NIMR Registry section for registration. Registered proposals are returned to the Secretariat office again within one (1) day of receiving the documents from the NIMR Registry section. The proposal is then registered into NatHREC's Register and Electronic database and a step-by-step review process is begun. Applicants will receive acknowledgement of proposal acceptance for review with three (3) working days following the NatHREC's receipt of the proposal documents from the NIMR Registry section.

Per Additional Resources (B) and (C), the proposal is sent to three (3) reviewers for evaluation within four (4) working days after receiving the registered proposal from the NIMR Registry. Reviewers are required to provide comments within 14 days following proposal receipt. The reviewer(s) comments are discussed and decided upon in NatHREC's monthly meeting, and a decision is sent to the principal investigator (PI) within three (3) working days following the committee meeting. The PI is required to respond to the committee's comments and resubmit the proposal, if necessary, within one (1) month for ordinary proposals, and within 12 weeks for clinical trial proposals. The PI may also request an extension to respond to the comments. After receiving the PI's comments, the committee will make a decision on ethical approval during the next monthly meeting. An approved proposal is recommended to the NIMR’s Medical Research Coordination Committee (MRCC) for ethical clearance. Investigators who fail to respond to NatHREC comments within three (3) months are removed from the register. Ethical clearance certificates are issued and signed by the MRCC Chairman (Director General, NIMR), and the Chief Medical Officer, Ministry of Health and Social Welfare (MOHSW).

Institutional EC Approval
According to Additional Resource (B), the institutional EC review may occur prior to the proposal review by the NatHREC as the application to NatHREC requires an EC approval certificate from affiliating institution(s), where applicable. The ethical review and approval timeline varies by institution. See the specific institutions listed at Additional Resource (C) for detailed requirements.

COSTECH Approval
As per Additional Resources (A) and (F), foreign applicants are required to obtain a research clearance/research permit from the Tanzania Commission for Science and Technology (COSTECH) (see Additional Resource (F)). The COSTECH website does not specify an official timeline for the research clearance/research permit application review and approval process.

ADDITIONAL RESOURCES

(A) (Website) The National Institute for Medical Research – Health Research Ethics (Current as of October 26, 2016)
National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

(B) (Guidance) Standard Operating Procedures for the National Health Research Ethics Review Committee (2007)
National Institute for Medical Research, Ministry of Health, United Republic of Tanzania

Relevant Sections: SOPs #4, #5, and #7

(C) (Document) National Health Research Ethics Committee Client Services Charter (April 2014)
National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

(D) (Form) Application Form for Ethics Approval (Version 1) (2010)
National Institute for Medical Research, Ministry of Health, United Republic of Tanzania

(E) (Website) Health Research Web – Tanzania – Regulation and Ethics Review of Research (Current as of October 26 2016)
Health Research Web, Council on Health Research for Development

(F) (Website) Tanzania Commission for Science and Technology (COSTECH) – Research Clearance (Current as of October 26, 2016)
Tanzania Commission for Science and Technology, United Republic of Tanzania

REQUIREMENTS

(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (2nd Edition) (February 2009)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Definition of Terms, 1, and Appendix 1

(2) (Legislation) The Tanzania Food, Drugs and Cosmetics Act, 2003 (TFDCA) (2003)
Parliament, United Republic of Tanzania

Relevant Section: Part IV (c)

(3) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Part II (3-4) and First and Second Schedules

(4) (Guidance) The Medical Research Coordinating Committee’s (TMRCC) Ethical Guidelines (G-TMRCC) (Date Unavailable)
Medical Research Coordinating Committee, National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

Clinical Trial Lifecycle > Trial Initiation
Back to Top
Email section Share    Print section Print
Last content review/update: May 02, 2017. Submit updates or comments.
SUMMARY

Overview
In accordance with the G-AppConductCT, the TFDCA, the TFDCA-CTC, and Additional Resource (A), a clinical trial can only commence after an applicant receives permission from the Tanzania Food and Drugs Authority (TFDA) and approval from the National Institute of Medical Research (NIMR)’s National Health Research Ethics Review Sub-Committee (NatHREC). The applicant must also register his/her research proposal with the Tanzania Commission for Science and Technology (COSTECH), and obtain a research permit prior to initiating a study (see Additional Resource (B)). No waiting period is required following the applicant’s receipt of these approvals.
 
In addition, as per the G-AppConductCT, the TFDCA, the TFDCA-CTC, and the G-ImptExptPharm, the sponsor or the principal investigator (PI) is required to obtain an import license for the shipment of an investigational product to be used in the trial. (See the Investigational Products topic, Manufacturing & Import subtopic for additional information).

As stated in the G-AppConductCT, all investigators must possess appropriate qualifications, training, and experience. The trials should be conducted in compliance with the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs). All investigators as well as the trial monitor must have had formal training in Good Clinical and Laboratory Practices (GCLP), and submit proof that a GCLP course was attended within the past three (3) years.

Additionally, per the TFDCA-CTC, the PI must have the following minimum qualifications and experience:

  • University degree in medicine, pharmacy, pharmacology, toxicology, biochemistry, veterinary, dentistry, or related fields
  • Practical experience within relevant professional area
  • Previous relevant experience as a co-investigator in at least two (2) trials
  • Tanzanian resident, and
  • In good standing with a professional organization

Clinical Trial Agreement
Prior to the trial’s commencement, the G-AppConductCT specifies that the protocol must be dated and signed by the investigator, the host institution, and the sponsor, and can function as a contract. In addition, as per the G-CTInsurance, a clinical trial agreement must be signed by the Chief Executive of the host institution, the sponsor, and the PI.

EC Confirmation of Review and Approval
The G-AppConductCT, the TFDCA, the TFDCA-CTC, and Additional Resource (A) mandate that the sponsor, the contract research organization (CRO), or the PI receive written confirmation of the NatHREC’s review and approval of the protocol prior to the trial’s commencement.

As delineated in Additional Resource (E), investigators must submit all documents for EC review and approval at least three (3) months prior to the study’s commencement. (See Ethics Committee topic, Scope of Review subtopic and Clinical Trial Lifecycle topic, Submission Content subtopic for additional details on the EC review process).

Tanzanian Clinical Trials Registry
As per the TFDCA-CTC, all clinical trials taking place in Tanzania must be registered with the Tanzania Clinical Trials Registry (TzCTR) (Additional Resource (G)). An applicant must submit detailed clinical trial information to the TzCTR not later than 21 days after the first participant is enrolled in the trial. See the TFDCA-CTC for complete registry submission requirements.

Data and Safety Monitoring Board (DSMB)
As delineated in Additional Resource (E), in larger studies or trials, the NatHREC may require that a Data and Safety Monitoring Board (DSMB) be formed to keep the committee up-to-date on the balance between risks and benefits. Per Additional Resource (F), for clinical trials that involve a DSMB, the principal investigator must submit a list of DSMB members, including at least one (1) Tanzanian, to the NIMR. The G-AppConductCT also specifies that detailed board information must be provided. See Section 9 of the G-AppConductCT for detailed requirements. In addition, per the G-ReptSafetyData, the sponsor must also ensure that the DSMB’s interim safety data analyses are submitted to the TFDA.

ADDITIONAL RESOURCES

(A) (Website) The National Institute for Medical Research – Health Research Ethics (Current as of October 26, 2016)
National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

(B) (Website) Tanzania Commission for Science and Technology (COSTECH) – Research Clearance (Current as of October 26, 2016)
Tanzania Commission for Science and Technology, United Republic of Tanzania

(C) (Document) National Health Research Ethics Committee Client Services Charter (April 2014)
National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

(D) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation, Geneva, Switzerland

(E) (Guidance) Standard Operating Procedures for the National Health Research Ethics Review Committee (2007)
National Institute for Medical Research, Ministry of Health, United Republic of Tanzania

Relevant Section: SOP #11

(F) (Checklist) Checklist for Ethical Clearance Application Submission (June 2014)
National Health Research Ethics Review Sub-Committee, Medical Research Coordinating Committee, National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

(G) (Website) Tanzania Clinical Trials Registry (Current as of October 26, 2016)
Tanzania Food and Drugs Authority, United Republic of Tanzania

(H) (Website) Reporting and Monitoring of Adverse Drug Reactions (Current as of October 26, 2016)
Tanzania Food and Drugs Authority, United Republic of Tanzania

REQUIREMENTS

(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (2nd Edition) (February 2009)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Definition of Terms, 1, 2, 9, and Appendix 1

(2) (Legislation) The Tanzania Food, Drugs, and Cosmetics Act, 2003 (TFDCA) (2003)
Parliament, United Republic of Tanzania

Relevant Section: Part IV (c)

(3) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Part II (3-4), Part III, Part VI, and Second Schedule

(4) (Guidance) Guidelines for Importation and Exportation of Pharmaceutical Products and Raw Materials (G-ImptExptPharm) (2nd Edition) (July 2011)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Section: 1.5

(5) (Guidance) Guidelines for Reporting of Safety Data in Clinical Trials (G-ReptSafetyData) (1st Draft) (May 2011)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Definition of Terms and 1.0

(6) (Guidance) Guidelines for Insurance and Indemnity of Clinical Trials in Tanzania (G-CTInsurance) (1st Edition) (December 2010)
Tanzania National Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Section: 4.5

Clinical Trial Lifecycle > Safety Reporting
Back to Top
Email section Share    Print section Print
Last content review/update: April 26, 2017. Submit updates or comments.
SUMMARY

Overview
In accordance with the G-ReptSafetyData, the G-AppConductCT, and the TFDCA-CTC, the following definitions provide a basis for a common understanding of Tanzania’s safety reporting requirements:

  • Adverse Event (AE) – Any adverse medical occurrence in a research participant to whom a drug product was administered, and which does not necessarily bear a causal relationship to the treatment
  • Adverse Drug Reaction (ADR) – All noxious and unintended responses to a medicinal product related to any dose
  • Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (SADR) – Any untoward medical occurrence that at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect
  • Suspected Unexpected Serious Adverse Reaction (SUSAR) (also referred to as Unexpected ADR) – A serious adverse reaction where the nature and severity of the event is not consistent with the medicinal product


Reporting Requirements for AEs/ADRs and SUSARs

Investigator Responsibilities

As stated in the G-ReptSafetyData and the G-AppConductCT, the investigator is responsible for reporting all AEs/ADRs, SAEs/SADRs, and SUSARs to the sponsor using the case report form (CRF)/reporting form and the SAE/SADR Reporting Form approved in the protocol, or, the Council for International Organizations of Medical Sciences’ (CIOMS) form. See section 3.0 of the G-ReptSafetyData for key data elements to include on the form.

The TFDCA-CTC states that the PI must immediately report to the TFDA any SAE/SADR that occurs to a participant at a trial site where he/she is responsible for the conduct of the trial. The report may be made orally or in writing, and must be followed up with a written report in 14 days. Also, the PI must report AEs that the protocol identifies as critical to safety evaluations. The reports must identify each participant by a number assigned to that participant in accordance with the protocol.

The TFDCA-CTC further states the PI or sponsor must record and report SUSARs that are fatal or life-threatening to the TFDA within seven (7) days and other SUSARS within 15 days.

Sponsor Responsibilities
The G-ReptSafetyData states that the sponsor is responsible for the assessment and reporting of SAEs/SADRs and SUSARs to the TFDA. In addition, the sponsor must retain detailed records of safety information reported by the investigator(s), and ensure that all reports required by the TFDA are submitted on time. In addition, the sponsor must report all SAEs and SUSARs occurring from trial sites outside the country to the TFDA.

The G-ReptSafetyData requires that fatal or life-threatening SAEs/SADRs or SUSARs must be immediately reported to the TFDA by telephone, fax, or email followed by a complete report within seven (7) additional calendar days. All deaths during the study, including the post treatment follow-up period, and deaths that resulted from a process that began during the study, should be reported.

Per the G-ReptSafetyData, all other SAEs and SUSARs that are not fatal or life-threatening must be filed as soon as possible but no later than 14 calendar days after first knowledge by the sponsor. Please note that the TFDCA-CTC states that non-life-threatening SUSARs should be reported in 15 days.

See the G-ReptSafetyData and the TFDCA-CTC for detailed reporting requirements.

Form Completion & Delivery Requirements
As per the G-ReptSafetyData and the G-AppConductCT, all SAEs/SADRs and SUSARs must be reported on the protocol approved case report form (CRF)/reporting form, or, the Council for International Organizations of Medical Sciences’ (CIOMS) form. The form must be submitted to the TFDA office by courier, mail, or email (as an attachment) to info@tfda.or.tz or by fax. See Appendix 9 of the G-AppConductCT and Appendix 1 of the G-ReptSafetyData for the reporting forms.

Data and Safety Monitoring Board (DSMB)
As delineated in the TFDCA-CTC and Additional Resource (D), in larger studies or trials, the NatHREC may requires that a Data and Safety Monitoring Board (DSMB) be formed to keep the committee up-to-date on the balance between risks and benefits. The TFDCA-CTC states that the DSMB requirement may depend on trial design and scientific background, risk and benefit assessment, or, any other reasons determined by NatHREC.

The sponsor must also ensure that the DSMB’s interim safety data analyses are submitted to the Tanzania Food and Drugs Authority (TFDA).

ADDITIONAL RESOURCES

(A) (Form) Suspect Adverse Reaction Report Form (CIOMS Form I) (Current as of October 26, 2016)
Council for International Organizations of Medical Sciences, Geneva

(B) (Checklist) Checklist Ethical Clearance Application Submission (June 2014)
National Health Research Ethics Review Sub-Committee, Medical Research Coordinating Committee, National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

(C) (Document) National Health Research Ethics Committee Client Service Charter (April 2014)
National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

(D) (Guidance) Standard Operating Procedures for the National Health Research Ethics Review Committee (2007)
National Institute for Medical Research, Ministry of Health, United Republic of Tanzania

Relevant Section: SOP #11

(E) (Website) Reporting and Monitoring of Adverse Drug Reactions (Current as of October 26, 2016)
Tanzania Food and Drugs Authority, United Republic of Tanzania

REQUIREMENTS

(1) (Guidance) Guidelines for Reporting of Safety Data in Clinical Trials (G-ReptSafetyData) (1st Draft) (May 2011)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Section: Foreword, Responsibility, Definition of Terms, 1.0, 2.0, 3.0, and Appendix 1

(2) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (2nd Edition) (February 2009)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Definition of Terms, 8, 9, and Appendix 9

(3) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Parts I, V, and VIII

Clinical Trial Lifecycle > Progress Reporting
Back to Top
Email section Share    Print section Print
Last content review/update: April 26, 2017. Submit updates or comments.
SUMMARY

Overview
In accordance with the G-AppConductCT and the TFDCA-CTC, the principal investigator (PI) and the sponsor share responsibility for submitting progress reports on the status of a clinical trial and for submitting a final study report.

Interim/Progress Reports
As delineated in the G-AppConductCT, the sponsor or the PI must submit progress reports to the Tanzania Food and Drugs Authority (TFDA) on a six-month basis from the date of the clinical trial’s commencement. The TFDCA-CTC states that progress reports should be submitted annually, or more frequently, as required by the TFDA.

According to Additional Resources (A) and (B), the investigator must submit written progress reports every six (6) months to the National Health Research Ethics Review Sub-Committee (NatHREC) for all ongoing approved health research activities in Tanzania.

Annual Report
In addition to the six (6) month progress report, per Additional Resource (A), the investigator must also submit an annual report to the NatHREC in order to obtain extended approval for the study.

Final Report
The G-AppConductCT requires the sponsor or the PI to submit a closing report to the TFDA within 60 days of the trial’s completion. This report should be followed by a final study report within six (6) months after trial closure unless otherwise justified. The structure and content of the final report should comply with the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs).

In addition, per Additional Resource (A), the PI is required to submit a final report to the NatHREC once the last participant has completed all visits and all adverse experiences have been brought to appropriate resolution. All committee members will review the final report and a decision regarding further actions that are required by the PI will be reached during the monthly meeting. The NatHREC Secretariat will notify the PI of the decision reached by the committee. If no action is required, the study shall be considered closed, the final report will be signed by the chairperson or the designee, a letter of acknowledgement will be sent to the PI, and the entire study protocol and the final report will be archived.

ADDITIONAL RESOURCES

(A) (Guidance) Standard Operating Procedures for the National Health Research Ethics Review Committee (2007)
National Institute for Medical Research, Ministry of Health, United Republic of Tanzania

Relevant Section: SOPs #15 and #26

(B) (Document) National Health Research Ethics Committee Client Service Charter (April 2014)
National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

(C) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation, Geneva, Switzerland

REQUIREMENTS

(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (2nd Edition) (February 2009)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: 10 and 11

(2) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Section: Part IV

Sponsorship > Definition of Sponsor
Back to Top
Email section Share    Print section Print
Last content review/update: October 26, 2016. Submit updates or comments.
SUMMARY

Overview
As per the G-AppConductCT and the TFDCA-CTC, a sponsor is defined as an individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.

In accordance with the G-AppConductCT and the TFDCA-CTC, the Tanzanian government also permits a sponsor to authorize a contract research organization (CRO) to perform one or more of a sponsor’s trial-related duties and functions.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (2nd Edition) (February 2009)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Section: Definition of Terms

(2) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Section: Part I (2)

 

Sponsorship > Trial Authorization
Back to Top
Email section Share    Print section Print
Last content review/update: May 02, 2017. Submit updates or comments.
SUMMARY

Overview
In accordance with the G-AppConductCT, the TFDCA-CTC, the TFDCA, and Additional Resource (A), the sponsor, the contract research organization (CRO), or the principal investigator (PI) is responsible for submitting a clinical trial application to the Tanzania Food and Drugs Authority (TFDA) to obtain approval to conduct a study.

To complete the clinical trial application package, the sponsor, the CRO, or the PI must use the TFDA’s clinical trial application form provided in Appendix 1 of the G-AppConductCT and the First Schedule of the TFDCA-CTC. In addition to the completed application, the sponsor, the CRO, or the PI must also provide the following:

  • Clinical protocol
  • Ethics clearance or a copy of acknowledgement of protocol submission from the National Health Research Ethics Review Sub-Committee (NatHREC) or any approved medical research institute
  • Informed consent form
  • Investigator’s brochure
  • Sponsor, investigator(s), and monitor(s) declarations
  • Sponsor and PI financial declaration
  • Certified copy of insurance for research participants
  • Investigational medicinal product dossier

See the Clinical Trial Lifecycle topic, Submission Content subtopic for detailed submission requirements.

The applicant must also register his/her research proposal with the Tanzania Commission for Science and Technology (COSTECH), and obtain a research permit prior to initiating a study.

ADDITIONAL RESOURCES

(A) (Website) Tanzania Commission for Science and Technology (COSTECH) – About Us (Current as of October 26, 2016)
Tanzania Commission for Science and Technology, United Republic of Tanzania

REQUIREMENTS

(1) (Legislation) The Tanzania Food, Drugs, and Cosmetics Act, 2003 (TFDCA) (2003)
Parliament, United Republic of Tanzania

Relevant Section: Part IV (c)

(2) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (2nd Edition) (February 2009)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Definition of Terms, 1, Appendix 1

(3) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Part II (3-4) and First - Fourth Schedules

Sponsorship > Insurance
Back to Top
Email section Share    Print section Print
Last content review/update: April 26, 2017. Submit updates or comments.
SUMMARY

Overview
As set forth in the G-AppConductCT, the G-CTInsurance, and the TFDCA-CTC, the sponsor or his/her designated contract research organization (CRO) is responsible for providing insurance coverage for any unforeseen injury to research participants. Before a clinical trial begins, the sponsor should also provide insurance and indemnify the investigator and the institution against claims arising from malpractice or negligence, and provide a copy of a valid insurance certificate from a recognized insurer in the clinical trial application submission. Additionally, per the TFDCA-CTC, the insurance policy should be obtained from an insurance company registered in Tanzania. The G-CTInsurance and Appendix 1 of the G-AppConductCT states that the National Health Research Ethics Review Sub-Committee (NatHREC) and the institutionally-based ethics committee (EC) also require a copy of the insurance as part of its submission review process. Furthermore, per the TFDCA-CTC, for investigator-initiated trials, proof of current malpractice insurance that covers clinical trials must be provided to the Tanzania Food and Drugs Authority (TFDA). (See the Clinical Trial Lifecycle topic, Submission Content subtopic for additional submission requirements.)

Indemnity Agreement and Clinical Trial Insurance Policy
As per G-CTInsurance and the TFDCA-CTC, the sponsor or his/her designated CRO must sign an indemnity agreement with the host institution and the investigator(s) to cover any risks related to a research participant being injured by an investigational product, or from any procedure necessary as part of the protocol. The indemnity must be signed by the sponsor and the institution’s chief executive officer. See Appendix 1 of the G-CTInsurance for a sample agreement. Per the TFDCA-CTC, the sponsor must also indemnify the investigator against claims arising from the trial, except for claims that arise from malpractice or negligence.

The G-CTInsurance states that the insurance policy must meet the following requirements:

  • Cover the conduct of the relevant clinical trial in Tanzania
  • Provide a policy registered by the Tanzanian Insurance Regulatory Authority (TIRA)
  • Contain insurance coverage for an amount sufficient to meet  the indemnification requirements applicable to the EC-specified level of risk
  • Cover claims made by research participants during the trial as well as those made after the trial is completed

See the Sponsorship topic, Compensation subtopic and Informed Consent topic, Compensation Disclosure subtopic for specific details related to sponsorship compensation obligations.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (2nd Edition) (February 2009)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: 1, 3, and Appendix 1

(2) (Guidance) Guidelines for Insurance and Indemnity of Clinical Trials in Tanzania (G-CTInsurance) (1st Edition) (December 2010)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Section: Introduction and Background, 1, 2, and Appendix 1

(3) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Part II (4), Part IV (11-12), Part IX and First Schedule

Sponsorship > Compensation
Back to Top
Email section Share    Print section Print
Last content review/update: April 26, 2017. Submit updates or comments.
SUMMARY

Overview
As specified in the G-CTInsurance, the sponsor or his/her designated contract research organization (CRO) is responsible for providing compensation to research participants and/or their legal heirs in the event of trial-related injuries or death. The sponsor must also ensure that participants who suffer any trial-related injuries are provided with free medical treatment for such injuries.

As per the TFDCA-CTC and the G-AppConductCT, participants may also be compensated for travel and incidental expenses incurred while participating in the trial. (See Informed Consent topic, Compensation Disclosure subtopic for more information on participant compensation rights that must be described during the informed consent process).

Payment Procedures and Requirements
The G-CTInsurance indicates that the sponsor should provide financial compensation and medical treatment as per the recommendations of the ethics committee (EC) and ultimately the Tanzania Food and Drugs Authority (TFDA).

As per the G-CTInsurance, the amount of compensation paid should be appropriate to the nature, severity, and persistence of the injury. Compensation should be abated, or in certain circumstances excluded, in light of the following factors (which will depend on the risk level the participant can reasonably be expected to accept):

  • The seriousness of the disease being treated
  • The degree of probability that adverse reactions will occur and any warning given
  • The risks and benefits of the established treatments relative to those known or suspected of the trial medicines
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Guidelines for Insurance and Indemnity of Clinical Trials in Tanzania (G-CTInsurance) (1st Edition) (December 2010)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Section: Introduction and Background, 1, Appendix II

(2) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Section: First Schedule (Part 6)

(3) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (2nd Edition) (February 2009)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Definition of Terms, 1, 3.4, and Appendix 1

Sponsorship > Quality, Data & Records Management
Back to Top
Email section Share    Print section Print
Last content review/update: April 26, 2017. Submit updates or comments.
SUMMARY

Overview
As stated in the G-AppConductCT and the TFDCA-CTC, the Tanzanian government complies with the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) requirement that the sponsor implement and maintain quality assurance (QA) and quality control (QC) systems with written standard operating procedures (SOPs) to ensure that trials are conducted and data are generated, recorded, and reported in compliance with the protocol.

The sponsor must also obtain the investigator(s)’ and the institution(s)’ agreement to:

  • conduct the trial in compliance with the ICH-GCPs, applicable regulatory requirement(s), and the protocol agreed to by the sponsor and approved by the ethics committee (EC)
  • comply with data recording and reporting procedures
  • permit monitoring, auditing, and inspection
  • retain essential documents until the sponsor informs them that they are no longer needed

Also, per the TFDCA-CTC, the sponsor must ensure that all agreements made with the principal investigator (PI) and any other parties involved in a clinical trial are in writing, as part of the protocol or in a separate agreement.

Electronic Data Processing System
As per ICH-GCPs, when using electronic trial data processing systems, the sponsor must ensure that the electronic data processing system conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistency of intended performance, and that he/she maintains SOPs for using these systems.

Record Management
As set forth in the TFDCA-CTC and the ICH-GCPs, all sponsor-specific essential documents used in the trial should be retained for at least two (2) years after formal discontinuation of the trial or the last approval of a marketing application. The TFDCA-CTC states that the investigator and the sponsor must retain all trial-related records, documents and information at the trial site for a period not less than 20 years following the trial’s completion. See the TFDCA-CTC for detailed record retention requirements. The sponsor should inform the investigator(s) and the institution(s) in writing when trial-related records are no longer needed.

Audit Requirements
As part of its QA system, the G-AppConductCT and the ICH-GCPs note that the sponsor should perform a clinical trial audit. The sponsor should appoint auditors to review the clinical trial, ensure that the auditors are qualified by training and experience, and document their qualifications. The sponsor must also ensure that the audit is conducted in accordance with his/her own SOPs, the auditor observations are documented, and data are available as needed for the Tanzania Food and Drugs Authority (TFDA). No specific timeframe is provided for the audit process.

Premature Study Termination/Suspension
The TFDCA-CTC and the G-AppConductCT state that if a trial is prematurely terminated or suspended, the PI or the sponsor must inform the TFDA no later than 15 days after the date of the termination, and explain the reason(s) for the termination and its impact on the proposed or ongoing clinical trials. The sponsor or PI must also inform all co-investigators of the termination, the reasons for the termination, and advise them in writing of potential health risks to research participants. For each discontinued clinical trial site, the sponsor must stop the use or importation of the investigational product (IP) from the date of the trial’s discontinuation and take all reasonable measures to ensure the recovery of all unused quantities of the IP.

Multicenter Studies
As delineated in the ICH-GCPs, in the event of a multicenter clinical trial, the sponsor must ensure that:

  • All investigators conduct the trial in strict compliance with the protocol agreed to by the sponsor, and, if required, by the TFDA, and given ethics committee approval
  • The case report forms (CRFs) are designed to capture the required data at all multicenter trial sites
  • Investigator responsibilities are documented prior to the start of the trial
  • All investigators are given instructions on following the protocol, complying with a uniform set of standards to assess clinical and laboratory findings, and completing the CRFs
  • Communication between investigators is facilitated

The TFDCA-CTC and the G-AppConductCT also states that in the case of multicenter studies where the PI is foreign, the appointed national PI must be a resident and assume full responsibilities for all local clinical trial sites.

ADDITIONAL RESOURCES

(A) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation
Geneva, Switzerland

Relevant Sections: 5.1, 5.5, 5.6, 5.19, and 5.23

REQUIREMENTS

(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (2nd Edition) (February 2009)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Foreword, Definition of Terms, 2.2, 3, 11, and Appendix 1

(2) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Part IV (8, 10, 11, 15, and 16)

Sponsorship > Site/Investigator Selection
Back to Top
Email section Share    Print section Print
Last content review/update: April 26, 2017. Submit updates or comments.
SUMMARY

Overview
The Tanzanian government complies with the requirements delineated in the G-AppConductCT and the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) for conducting clinical trials. As set forth in the ICH-GCPs, the sponsor is responsible for selecting the investigator(s) and the institution(s) for the clinical trial, and for ensuring that the investigator(s) are qualified by training and experience. Additionally, the sponsor must define and allocate all study related duties and responsibilities to the relevant parties participating in the study. As delineated in the ICH-GCPs and the G-AppConductCT, prior to entering into an agreement with the investigator(s) and the institution(s) to conduct a study, the sponsor should provide the investigator(s) with the protocol and an investigator’s brochure.

Data and Safety Monitoring Board (DSMB)
As delineated in the TFDCA-CTC and Additional Resource (C), in larger studies or trials, the National Health Research Ethics Review Sub-Committee (NatHREC) may require that a Data and Safety Monitoring Board (DSMB) be formed to keep the committee up-to-date on the balance between risks and benefits. The TFDCA-CTC states that the DSMB requirement may depend on trial design and scientific background, risk and benefit assessment, or any other reasons determined by NatHREC.

Per Additional Resource (C), for clinical trials that require a DSMB, the principal investigator (PI) must submit a list of DSMB members, including at least one (1) Tanzanian, to the National Institute for Medical Research (NIMR). Additionally, the TFDCA-CTC requires the following information:

  • Trial objectives and terms of reference
  • Member composition, qualifications, specific roles, and relationship to the investigators and study
  • How meetings will be organized

The G-AppConductCT also specifies that detailed board information must be provided. See Section 9 of the G-AppConductCT and Part VIII of the TFDCA-CTC for detailed requirements. In addition, per the G-ReptSafetyData, the sponsor must also ensure that the DSMB’s interim safety data analyses are submitted to the Tanzania Food and Drugs Authority (TFDA).

ADDITIONAL RESOURCES

(A) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation
Geneva, Switzerland

Relevant Sections: 5.6 and 5.7

(B) (Website) The National Institute for Medical Research – Health Research Ethics (Current as of October 26, 2016)
National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

(C) (Checklist) Checklist Ethical Clearance Application Submission (June 2014)
National Health Research Ethics Review Sub-Committee, Medical Research Coordinating Committee, National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

(D) (Guidance) Standard Operating Procedures for the National Health Research Ethics Review Committee (2007)
National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Tanzania Health Research Ethics Forum and SOP # 01

(E) (Website) Reporting and Monitoring of Adverse Drug Reactions (Current as of October 26, 2016)
Tanzania Food and Drugs Authority, United Republic of Tanzania

REQUIREMENTS

(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (2nd Edition) (February 2009)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Foreword, 1.5, 2.3, 2.4, and 9

(2) (Guidance) The Medical Research Coordinating Committee’s (TMRCC) Ethical Guidelines (G-TMRCC) (Date Unavailable)
Medical Research Coordinating Committee, National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

(3) (Guidance) Guidelines for Reporting of Safety Data for Clinical Trials (G-ReptSafetyData) (1st Draft) (May 2011)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Definition of Terms and 1.0

(4) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Section: Part VIII

Informed Consent > Documentation Requirements
Back to Top
Email section Share    Print section Print
Last content review/update: April 26, 2017. Submit updates or comments.
SUMMARY

Overview
In all Tanzanian clinical trials, a freely given informed consent must be obtained from each participant in accordance with the requirements set forth in the G-AppConductCT, the G-EthicsHR, and the TFDCA-CTC. As per the G-AppConductCT and the G-EthicsHR, the informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by the National Health Research Ethics Review Sub-Committee (NatHREC), and provided to the Tanzania Food and Drugs Authority (TFDA) for approval with the clinical trial application. (See the Informed Consent topic, ICF Requirements/Elements subtopic for details on what should be included in the form.)

The G-AppConductCT and the G-EthicsHR state that the investigator, or his/her designated representative, must provide detailed research study information to the participant and/or his/her legal representative(s) or guardian(s). The G-AppConductCT and the G-EthicsHR also specify that the oral and written information concerning the trial, including the ICF, should be easy to understand and presented without coercion or unduly influencing a potential participant to enroll in the clinical trial. The participant, and his/her legal representative(s) or guardian(s), should also be given adequate time to consider whether to participate.

Re-Consent
According to G-AppConductCT, any change in the ICF due to a protocol modification or an alteration in treatment modality, procedures, or site visits, should be approved by the NatHREC and the TFDA prior to implementing any changes. The participant and/or his/her legal representative(s) or guardian(s) should also be informed in a timely manner if new information becomes available that may be relevant to the participant’s willingness to continue participation in the trial. The communication of this information should be documented.

Language Requirements
As stated in the G-AppConductCT, the ICF content should be presented in Kiswahili, and all information to be given to participants, both oral and written, must be in Kiswahili. The consent form and the accompanying information must be in Kiswahili.

Documentation Copies
The G-AppConductCT states that the participant and/or the participant’s legal representative(s) or guardian(s), and the person who conducted the informed consent discussion must sign and date the ICF. Where the participant is illiterate, and/or his/her legal representative(s) or guardian(s) is illiterate, verbal consent should be obtained in the presence of and countersigned by an impartial witness.

Before participating in the study, the participant should receive a copy of the signed and dated ICF, and any other written information provided during the informed consent process. The participant and/or his legal representative(s) or guardian(s) should also receive a copy of any updates to the signed and dated ICF, and copies of any amendments to the written information orginally provided.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (2nd Edition) (February 2009)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Definition of Terms, 1.5, 3.12, and 5

(2) (Guidance) Guidelines on Ethics for Health Research in Tanzania (G-EthicsHR) (2nd Edition) (2009)
Tanzania National Health Research Forum, National Health Research Ethics Committee, National Institute for Medical Research, United Republic of Tanzania

Relevant Sections: 3.1, 3.2, and 3.3
 
(3) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Section: Part IV (8)

Informed Consent > Required Elements
Back to Top
Email section Share    Print section Print
Last content review/update: April 26, 2017. Submit updates or comments.
SUMMARY

Overview
As delineated in the G-AppConductCT, the TFDCA, the G-TMRCC, the TFDCA-CTC, the G-EthicsHR, and Additional Resource (A), prior to beginning a clinical trial, the sponsor or the principal investigator (PI) is required to obtain ethics committee (EC) approval from the National Institute for Medical Research (NIMR)’s National Health Research Ethics Review Sub-Committee (NatHREC) for the written informed consent form (ICF) and any other information being provided to the research participant and/or his/her legal representative(s) or guardian(s).

The G-AppConductCT and the G-EthicsHR state that information about the research study should be clearly presented in both written and oral form.

No Coercion
As per the G-AppConductCT, none of the oral and written information concerning the research study, including the written ICF, should contain any language that causes the participant and/or his/her legal representative(s) and/or guardian(s) to waive or to appear to waive his/her legal rights, or that releases or appears to release the investigator(s), the institution, the sponsor, or their representatives from their liabilities for any negligence.

ICF Required Elements
Based on the G-AppConductCT and the G-EthicsHR, the ICF should include the following statements or descriptions, as applicable:

  • The study purpose, procedures, and duration
  • Approximate number of participants involved in the trial
  • Experimental aspects of the study
  • The participant’s responsibilities in participating in the trial
  • Any expected risks or discomforts to the participant, and when applicable, to an embryo, fetus, or nursing infant
  • Disclosure of alternate procedures or treatments available to participants
  • Clinical trial treatment schedule(s) and the probability for random assignment to each treatment
  • Any benefits or prorated payment to the participant or others reasonably expected from the research; if no benefit is expected, the participant should be made aware of this
  • Compensation and/or treatment available for the participant in the case of trial-related injury
  • That participation is voluntary, and that the participant can withdraw from the study at any time without penalty or loss of benefits, including medical treatment, to which the participant is otherwise entitled
  • The extent to which confidentiality of records identifying the participant will be maintained, and the possibility of record access by the Tanzania Food and Drugs Authority (TFDA)
  • That the participant and/or his/her legal representative(s) or guardian(s) will be notified in a timely manner if significant new findings develop during the course of the study which may affect the participant's willingness to continue
  • Individuals to contact for further information regarding the trial, the rights of trial participants, and whom to contact in the event of trial-related injury
  • Foreseeable circumstances under which the investigator(s) may remove the participant without his/her consent
  • The consequences of a participant’s decision to withdraw from the research, and procedures for orderly withdrawal by the participant
  • That the participant and/or his/her legal representative(s) or guardian(s) will be notified in a timely manner if significant new findings develop during the course of the study which may affect the participant's willingness to continue
  • Any additional costs to the participant that may result from participation in the research

See the Informed Consent topic, Compensation Disclosure subtopic and Vulnerable Populations subtopic and the Specimens topic, Consent for Specimens subtopic for further information.

ADDITIONAL RESOURCES

(A) (Guidance) Standard Operating Procedures for the National Health Research Ethics Review Committee (2007)
National Institute for Medical Research, Ministry of Health, United Republic of Tanzania

Relevant Sections: Introduction, SOPs #01 and #7

(B) (Website) The National Institute for Medical Research – Health Research Ethics (Current as of October 26, 2016)
National Institute of Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

REQUIREMENTS

(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (2nd Edition) (February 2009)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Section: Definition of Terms, 1, 5, and Appendices 1 and 2

(2) (Legislation) The Tanzania Food, Drugs, and Cosmetics Act, 2003 (TFDCA) (2003)
Parliament, United Republic of Tanzania

Relevant Section: Part IV (c)

(3) (Guidance) The Medical Research Coordinating Committee’s (TMRCC) Ethical Guidelines (G-TMRCC) (Date Unavailable)
Medical Research Coordinating Committee, National Institute of Medical Research, Ministry of Health, United Republic of Tanzania

(4) (Guidance)  Guidelines on Ethics for Health Research in Tanzania (G-EthicsHR) (2nd Edition) (2009)
Tanzania National Health Research Forum, National Health Research Ethics Committee, National Institute for Medical Research, United Republic of Tanzania

Relevant Sections: 3.4 and 3.5

(5) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Part II (3-4) and First and Second Schedules

Informed Consent > Compensation Disclosure
Back to Top
Email section Share    Print section Print
Last content review/update: October 26, 2016. Submit updates or comments.
SUMMARY

Overview
In accordance with the G-AppConductCT, the informed consent form (ICF) should contain a statement describing the compensation or medical treatment a participant can receive for participating in a clinical trial. (See the Informed Consent topic, Required Elements subtopic for additional details on what should be included in the ICF, and the Sponsorship topic, Compensation subtopic for information on sponsor requirements.)

Compensation for Participation in Research
As stated in the G-AppConductCT, the ICF should contain a statement with a description of the nature, form, and extent of compensation for study participation. The ICF should also inform the participants if they will need to pay for any expenses in order to participate in the trial.

Compensation for Injury
As per the G-AppConductCT and the G-CTInsurance, the ICF should include a statement advising the participant that compensation and medical treatment is available in the event of any trial-related injury. If applicable, this should include a statement regarding compensation for any potential injury received by a child in utero through the mother’s participation in a research study.

In addition, the G-EthicsHR states that according to the Tanzanian InsuranceAct, insurance coverage should be provided to protect participants who may develop an illness due to participating in a trial. The Act requires the following:

  • All clinical trial proposals must provide statements on how participants will be compensated in the event of adverse effects
  • The name(s) of insurance companies or brokers must be provided in the proposal
  • The terms and mode of compensation must be clearly stated in the proposal

(See the Informed Consent topic, Required Elements subtopic for additional details on what should be included in the ICF, and see the Sponsorship topic, Compensation subtopic for participant compensation rights).

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Guidelines for Insurance and Indemnity of Clinical Trials in Tanzania (G-CTInsurance) (1st Edition) (December 2010)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Section: Foreword, Introduction and Background, 1, 3, and 4

(2) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (2nd Edition) (February 2009)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: 1, 3, 5, and Appendix 1

(3) (Legislation) The Insurance Act, 2009 (InsuranceAct) (2009)
Tanzanian Insurance Regulatory Authority, United Republic of Tanzania

Relevant Section: Part A (IV)

(4) (Guidance) Guidelines on Ethics for Health Research in Tanzania (G-EthicsHR) (2nd Edition) (2009)
Tanzania National Health Research Forum, National Health Research Ethics Committee, National Institute for Medical Research, United Republic of Tanzania

Relevant Sections: 7.3

Informed Consent > Participant Rights
Back to Top
Email section Share    Print section Print
Last content review/update: October 26, 2016. Submit updates or comments.
SUMMARY

Overview
As stated in the G-AppConductCT and the G-EthicsHR, the Tanzanian government complies with the ethical principles set forth in the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) and the Declaration of Helsinki which promote respect for all human beings and safeguard the rights of research participants. A participant’s rights must also be clearly addressed in the informed consent form (ICF) and during the informed consent process. (See the Informed Consent topic, and the subtopics of ICF Requirements/Elements and Vulnerable Populations for additional information regarding requirements for participant rights.)

The Right to Participate, Abstain, or Withdraw
As set forth in the G-AppConductCT and the G-EthicsHR, the participant or his/her legal representative(s) or guardian(s) should be informed that participation is voluntary, that he/she may withdraw from the research study at any time, and that refusal to participate will not involve any penalty or loss of benefits to which the participant is otherwise entitled.

The Right to Information
As delineated in the G-AppConductCT and the G-EthicsHR, a potential research participant and/or his/her legal representative(s) or guardian(s) has the right to be informed about the nature and purpose of the research study, its anticipated duration, study procedures, any potential benefits or risks, any compensation for participation or injury/treatment, and any significant new information regarding the research study. (See the Informed Consent topic, Required Elements subtopic for more detailed information regarding participant rights.)

The Right to Privacy and Confidentiality
As per the G-AppConductCT and the G-EthicsHR, all participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right.

The Right of Inquiry/Appeal
The G-AppConductCT states that the research participant and/or his/her legal representative(s) or guardian(s) should be provided with contact information for the sponsor and the investigator(s) to address trial-related inquiries. (See the Informed Consent topic, Required Elements subtopic for more detailed information regarding participant rights.)

The Right to Safety and Welfare
As specified in the G-AppConductCT and the TFDCA-CTC, the Tanzanian government complies with the ICH-GCPs principles that state a research participant’s right to safety and the protection of his/her health and welfare must take precedence over the interests of science and society.

ADDITIONAL RESOURCES

(A) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation, Geneva, Switzerland

REQUIREMENTS

(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (2nd Edition) (February 2009)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Definition of Terms, 5, Appendix 10, and Appendix 11

(2) (Guidance) Guidelines on Ethics for Health Research in Tanzania (G-EthicsHR) (2nd Edition) (2009)
Tanzania National Health Research Forum, National Health Research Ethics Committee, National Institute for Medical Research, United Republic of Tanzania

Relevant Sections: 1.1, 3.1, 3.4, 3.5, 4, and Appendix One (1 (f))

(3) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Section: Part IV (8)

Informed Consent > Special Circumstances/Emergencies
Back to Top
Email section Share    Print section Print
Last content review/update: April 26, 2017. Submit updates or comments.
SUMMARY

Overview
The G-AppConductCT and the G-EthicsHR make provisions to protect the rights of a research participant during the informed consent (IC) process when the procedure is complicated by special circumstances. Special circumstances may include medical emergencies or when a participant is mentally incapacitated.

Medical Emergencies
As per the G-AppConductCT, in an emergency, if the signed informed consent form (ICF) cannot be obtained from the research participant, the consent of his/her legal representative(s) or guardian(s) should be obtained. If prior consent from the participant or his/her legal representative(s) or guardian(s) cannot be obtained, participant enrollment should require measures described in the protocol and/or elsewhere. Tanzania Food and Drugs Authority (TFDA) approval should also be obtained in order to protect the participant’s rights, safety, and well-being and to ensure compliance with the National Health Research Ethics Review Sub-Committee (NatHREC) and TFDA requirements. The participant or his/her legal representative(s) or guardian(s) should provide consent as soon as possible.

In addition, per the G-EthicsHR, in rare cases, such as an emergency, exception from IC requirements may be considered by an institutional ethics committee (EC). In this case, the institutional EC may approve a trial without requiring participant IC be obtained provided that:

  • The participant(s) are in a life-threatening situation, available treatments are unproven or unsatisfactory, and collecting valid scientific evidence is necessary to determine the safety and effectiveness of the particular intervention
  • The participant will not be able to give IC as a result of a medical condition, the intervention under investigation must be administered before consent from the legal representative(s) or guardian(s) is feasible, and, there is no reasonable way to identify prospectively the participant likely to become eligible to participate in the trial
  • Participation in the trial holds direct benefits for the participant
  • The trial could not be reasonably carried out without the waiver
  • The proposed trial activity plan defines the length of the potential therapeutic window based on scientific evidence, and the investigator is committed to attempting to contact a legal representative(s) or guardian(s) for consent within this prescribed window rather than proceeding without consent
  • The institutional EC has reviewed and approved the IC procedures and approved the use of these procedures/documents for use with participant(s) or their legal representative(s) or guardian(s) where feasible, and, for use when providing an opportunity for a family member to object to the participant’s involvement in the trial

Please refer to section 3.17 of the G-EthicsHR for detailed requirements to be complied with during emergency situations.

Waiver of Consent
As delineated by the G-EthicsHR, although voluntary IC is always a requirement for every research proposal, this obligation can be waived by the NatHREC and an institutional EC. These general requirements may be lifted in circumstances where before the use of the investigational product (IP), both the investigator and the practicing physician, who is not otherwise participating in the trial, certify in writing the following:

  • The participant is facing a life-threatening situation necessitating the use of the IP
  • IC cannot be obtained from the participant due to an inability to communicate with or obtain legally effective consent from the participant
  • Time is insufficient to obtain consent from the legal representative(s) or guardian(s)
  • No available approved alternative or generally recognized therapy exists that provides an equal or greater likelihood of saving the participant’s life

If the investigator determines that immediate use of the IP is required to preserve the participant’s life, and he/she does not have the time to obtain an independent determination by the NatHREC or the institutional EC, the investigator must submit written documentation within five (5) working days to both an independent physician, who is not participating in the trial for review and evaluation, and to the institutional EC for review.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (2nd Edition) (February 2009)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Section: 5.14

(2) (Guidance) Guidelines on Ethics for Health Research in Tanzania (G-EthicsHR) (2nd Edition) (2009)
Tanzania National Health Research Forum, National Health Research Ethics Committee, National Institute for Medical Research, United Republic of Tanzania

Relevant Sections: 3.9, 3.15, 3.16, and 3.17

Informed Consent > Vulnerable Populations
Back to Top
Email section Share    Print section Print
Last content review/update: October 26, 2016. Submit updates or comments.
SUMMARY

Overview
As per the G-AppConductCT and the G-EthicsHR, in all Tanzanian clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process. The G-AppConductCT and the G-EthicsHR characterize vulnerable populations as those who are incapable of protecting their own interests due to a lack of autonomy, intelligence, education, resources, strength, or other necessary attributes. They are also described as those whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy should they refuse to participate. These participants may include children, persons with mental disabilities, persons with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, prisoners, detainees, refugees, members of a group with a hierarchical structure, such as students, subordinate hospital and laboratory personnel, pharmaceutical industry employees, members of the armed forces, and persons kept in detention.

As per the G-EthicsHR, trials involving vulnerable persons must
meet the following requirements:

  • Critical review by an ethics committee
  • Expose the participants to no or minimal risk
  • Is not contradictory to the participant’s interests
  • Must be impossible to carry out research in participants with the capacity to consent
  • Must be designed to have maximum benefit to others in this category of participants

See the Informed Consent topic, and the subtopics of Children/Minors; Pregnant Women, Fetuses & Neonates; Prisoners; and Mentally Impaired for additional information about these vulnerable populations.

Information on the other vulnerable populations specified in the G-EthicsHR is provided below.

The Elderly
As per the G-EthicsHR, it is important to exercise special care when involving the elderly who have been in the hospital or in a residential home for a long time because they may be more dependent on others for their care. Independent but caring observer(s) for the elderly must be fully informed about the study, and must ensure that the elderly participant understands the intended research activities prior to consent.

Students
The G-EthicsHR states that students involved with research studies are a vulnerable group, especially when the institution where they attend is conducting the research. Students should be permitted to withdraw from the study at any time without undue consequences. Students should also not be subject to any form of coercion, pressure, or financial inducement other than that proposed as a fee for participation.

Research Involving the Community
The G-EthicsHR specifies that in circumstances where it is unfeasible to obtain individual participant informed consent, a community may choose to have a representative who will provide consent where a study is planned to take place. The representative should be selected in a manner that conforms to the community’s traditions and culture. The authenticity of the community approval may also need to be established. An individual’s refusal to participate in a trial must be respected regardless of the community’s consent.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (2nd Edition) (February 2009)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Definition of Terms and Appendix 11

(2) (Guidance) Guidelines on Ethics for Health Research in Tanzania (G-EthicsHR) (2nd Edition) (2009)
Tanzania National Health Research Forum, National Health Research Ethics Committee, National Institute for Medical Research, United Republic of Tanzania

Relevant Sections: Definitions, 3.7, 3.10, 3.13, 3.14, 6.7, and 6.8

Informed Consent > Children/Minors
Back to Top
Email section Share    Print section Print
Last content review/update: October 26, 2016. Submit updates or comments.
SUMMARY

Overview
The G-CTPaediatric states that a child is a person less than 18 years of age. As per the G-CTPaediatric, the G-AppConductCT, and the G-EthicsHR, when the research participant is a child, the informed consent form (ICF) must be signed by the child’s legal representative(s) and/or guardian(s).

The G-CTPaediatric and the G-EthicsHR state that a study may only be conducted on children with a legal representative and/or guardian if the following conditions are fulfilled:

  • The approval/favorable opinion is obtained from the National Institute for Medical Research (NIMR)’s National Health Research Ethics Review Sub-Committee (NatHREC)
  • The trial objectives cannot be met by selecting other participants who can give informed consent personally
  • The foreseeable risks to the participants are low, or if the risk is greater than minimal, the trial presents the prospect of direct benefit to pediatric participants, or will yield generalizable knowledge about a pediatric disorder or condition
  • The negative impact on the participants’ well-being is minimal
  • The procedures should be first tested on consenting adults prior to being carried out in children
  • The trial is not prohibited by law

Assent Requirements
When the NatHREC determines that the child is capable of providing assent, the committee must verify that adequate provisions are made for soliciting the assent of the child based on his/her age, maturity, and psychological state.

The NatHREC may determine that a child’s assent is unnecessary based on the following:

  • His/her limited capacity to comprehend is so limited that he/she cannot be reasonably consulted
  • The procedure will have a direct benefit to his/her health and well-being, and is available only by participating in the trial

Even if the NatHREC determines that a child is capable of assent, the committee may still waive the assent requirement if:

  • The trial involves no more than minimal risk
  • The waiver will not adversely affect the research participant’s rights and welfare
  • The trial could not be conducted without the waiver

All pediatric participants, however, should be informed to the fullest extent possible about the study in language and terms that they are easily able to understand. In addition, when appropriate, the pediatric participants will be provided with additional information after participating in the trial.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Draft Guidance) Guidance on the Conduct of Clinical Trials in Paediatric Population in Tanzania (G-CTPaediatric) (November 2011)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: 5 and 7

(2) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (2nd Edition) (February 2009)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Section: Appendix 11

(3) (Guidance) Guidelines on Ethics for Health Research in Tanzania (G-EthicsHR) (2nd Edition) (2009)
Tanzania National Health Research Forum, National Health Research Ethics Committee, National Institute for Medical Research, United Republic of Tanzania

Relevant Sections: Definitions, 1.2.6, 3.8, and Appendix One (1 (k))

Informed Consent > Pregnant Women, Fetuses & Neonates
Back to Top
Email section Share    Print section Print
Last content review/update: October 26, 2016. Submit updates or comments.
SUMMARY

Overview
As per the G-EthicsHR, any research studies involving pregnant, women who may become pregnant, or fetuses, requires additional safeguards to ensure the research conforms to appropriate ethical standards and upholds societal values. The following conditions are required for the research to take place:

  • Should only be carried out if the pregnancy plays an essential role in the propose of the research
  • Appropriate studies on animals and non-pregnant women have been completed
  • The risk to the fetus is primarily due to interventions or procedures that have the greatest potential to directly benefit the woman or the fetus; or, if there is no such prospect of benefit, the risk to the fetus is not greater than minimal, and the purpose of the research is to develop important biomedical knowledge which cannot be obtained by any other means
  • Any risk is the least possible for achieving the research objectives
  • Each individual providing consent is fully informed about the reasonably foreseeable impact of the research on the fetus or neonate
  • No inducements, monetary or otherwise, should be offered to terminate a pregnancy
  • Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy
  • Individuals engaged in the research will have part in determining the viability of a neonate

For all studies involving pregnant women, fetuses in utero, and fetuses ex utero, the mother and father must be both legally competent and have been fully informed of the possible impact on the fetus, and have given their informed consent to proceed. However, the father’s consent will not be required if the purpose of the study is primarily to meet the mother’s health needs, the father’s identity or whereabouts are unknown, the father is not reasonably available, or the pregnancy resulted from rape or incest.

See section 3.11 of the G-EthicsHR for additional details on pregnant women and fetuses.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Guidelines on Ethics for Health Research in Tanzania (G-EthicsHR) (2nd Edition) (2009)
Tanzania National Health Research Forum, National Health Research Ethics Committee, National Institute for Medical Research, United Republic of Tanzania

Relevant Section: 3.11

Informed Consent > Prisoners
Back to Top
Email section Share    Print section Print
Last content review/update: October 26, 2016. Submit updates or comments.
SUMMARY

Overview
According to the G-EthicsHR, prisoners are considered vulnerable because incarceration could affect their ability to make a voluntary decision regarding participation in research. A research study involving prisoners should ensure that:

  • The research results will benefit the study population in the same category
  • The prisoners must be assured that they will not be subject to undue pressure or coercion in their decision to participate, and that their willingness or refusal to participate will not impact any decisions regarding their release or further detention
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Guidelines on Ethics for Health Research in Tanzania (G-EthicsHR) (2nd Edition) (2009)
Tanzania National Health Research Forum, National Health Research Ethics Committee, National Institute for Medical Research, United Republic of Tanzania

Relevant Sections: Definitions and 3.12

Informed Consent > Mentally Impaired
Back to Top
Email section Share    Print section Print
Last content review/update: October 26, 2016. Submit updates or comments.
SUMMARY

Overview
According to the G-EthicsHR, the ethics committee must approve the participation of research participants who are incompetent, or mentally incapable of giving consent, and sufficient justification must be provided for involving this population in a study.

A research study may involve mentally impaired persons or those with learning disabilities under the following conditions:

  • The study carries no or minimal risk
  • The research may potentially benefit this category of participants and is in their best interests
  • The research may potentially benefit others in the same category
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Guidelines on Ethics for Health Research in Tanzania (G-EthicsHR) (2nd Edition) (2009)
Tanzania National Health Research Forum, National Health Research Ethics Committee, National Institute for Medical Research, United Republic of Tanzania

Relevant Section: 3.9

Investigational Products > Definition of Investigational Product
Back to Top
Email section Share    Print section Print
Last content review/update: October 26, 2016. Submit updates or comments.
SUMMARY

Overview
As delineated in the G-AppConductCT, an investigational product is referred to as an investigational medicinal product in Tanzania, and it is defined as a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial. This includes a product with a marketing authorization when it is used or assembled (formulated or packaged) in a different way from the approved form, when used for an unapproved indication, or when used to gain further information about an approved use.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (2nd Edition) (February 2009)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Section: Definition of Terms

Investigational Products > Manufacturing & Import
Back to Top
Email section Share    Print section Print
Last content review/update: April 26, 2017. Submit updates or comments.
SUMMARY

Overview
According to the G-AppConductCT, the TFDCA, the G-ImptExptPharm, and the TFDCA-CTC, the Tanzania Food and Drugs Authority (TFDA) is responsible for authorizing the manufacture of investigational products (IPs) in Tanzania. The TFDA will approve the manufacture of an IP after the clinical trial application has been approved.

The TFDA is also responsible for authorizing the import of IPs. As per the TFDCA, and the G-ImptExptPharm, the sponsor or the principal investigator (PI) may apply for an import license once the clinical trial application has been approved by the TFDA. The import license application should be accompanied by the clinical trial approval letter issued by the TFDA. The sponsor must complete the cover sheet contained in Annex 1 of the G-ImptExptPharm for the importation and release of IPs.

As delineated in the G-ImptExptPharm, the import permit is valid for six (6) months, not transferable, and issued to cover only one (1) shipment. In the case of partial shipments, only two (2) shipments may be allowed based on the initial import permit. See the G-ImptExptPharm for detailed import application requirements.

In addition, as per the G-AppConductCT and the G-ImptExptPharm, the TFDA requires the manufacturer to provide the following upon arrival at the ports of entry:

  • A Certificate of Analysis for each batch of IPs
  • An import permit
  • An original proforma invoice
  • An airway bill or bill of lading
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (2nd Edition) (February 2009)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Section: 1

(2) (Legislation) The Tanzania Food, Drugs, and Cosmetics Act, 2003 (TFDCA) (2003)
Parliament, United Republic of Tanzania

Relevant Section: Part IV (c)

(3) (Guidance) Guidelines for Importation and Exportation of Pharmaceutical Products and Raw Materials (G-ImptExptPharm) (2nd Edition) (July 2011)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: 1.3, 1.5, 1.6, and Annex I

(4) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Section: Part IV

Investigational Products > IMP/IND Quality Requirements
Back to Top
Email section Share    Print section Print
Last content review/update: April 26, 2017. Submit updates or comments.
SUMMARY

Overview
In accordance with the G-AppConductCT and the TFDCA-CTC, the Tanzanian government follows the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs), and requires the sponsor or his/her designated contract research organization (CRO) to provide investigators with an Investigator’s Brochure (IB). The G-AppConductCT and the ICH-GCPs specify that the IB must contain all of the relevant information on the investigational product(s) (IPs) obtained through the earlier research phases, including preclinical, toxicological, safety, efficacy, and adverse event data. Per the TFDCA-CTC, the sponsor should also update the IB as significant new information becomes available and maintain records of each change.

IB Content Requirements
The ICH-GCPs require the IB to provide coverage of the following areas:

  • Physical, chemical, and pharmaceutical properties and formulation parameters
  • Non-clinical studies (pharmacology, pharmacokinetics, toxicology, and metabolism profiles)
  • Effects of IP in humans (pharmacology, pharmacokinetics, metabolism, and pharmacodynamics; safety and efficacy; regulatory and post marketing experiences)
  • Summary of data and guidance for the investigator(s)
  • Bibliography

See Section 7 of the ICH-GCPs for detailed content guidelines.

The sponsor is also accountable for supplying the IP, including the comparator(s) and placebo, if applicable. As specified in the G-AppConductCT, the G-ImptExptPharm, and the TFDCA-CTC, the sponsor must ensure that the products are manufactured in accordance with the current codes of Good Manufacturing Practice (GMP). (See Investigational Products topic, Product Management subtopic for additional information on IP supply, storage, and handling requirements).

Certificate of Analysis and Drug Manufacturing Certificate Requirements
As stated in the Manufacturing & Import subtopic, the Tanzania Food and Drugs Authority (TFDA) requires the manufacturer to provide the following upon arrival at the ports of entry:

  • A Certificate of Analysis for each batch of IPs
  • An import permit
  • An original proforma invoice
  • An Airway bill or bill of lading

The G-ImptExptPharm states that for each IP to be imported, the proforma invoice should include the product name or code; the supplier/manufacturer name; batch number; quantity; expiration date; date of issue; and supplier signature and stamp.

ADDITIONAL RESOURCES

(A) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation, Geneva, Switzerland

Relevant Sections: 5.13 and 5.14

REQUIREMENTS

(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (2nd Edition) (February 2009)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Section: 1

(2) (Legislation) The Tanzania Food, Drugs, and Cosmetics Act, 2003 (TFDCA) (2003)
Parliament, United Republic of Tanzania

Relevant Section: Part IV (c)

(3) (Guidance) Guidelines for Importation and Exportation of Pharmaceutical Products and Raw Materials (G-ImptExptPharm) (2nd Edition) (July 2011)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: 1.3, 1.5, 1.6, and Annex I

(4) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Part  IV (8 and 11) and First and Second Schedules

Investigational Products > Labeling & Packaging
Back to Top
Email section Share    Print section Print
Last content review/update: October 26, 2016. Submit updates or comments.
SUMMARY

Overview
Investigational product (IP) labeling in Tanzania must comply with the requirements set forth in the G-AppConductCT, the G-ImptExptPharm, and the TFDCA-CTC. The G-ImptExptPharm and the TFDCA-CTC state that for an investigational product (IP) to be used in a clinical trial, it must be properly labeled in English or Kiswahili language or both, and the information printed on the labels must be indelible, engraved, or embossed on a primary and secondary container.

As set forth in the G-AppConductCT, the G-ImptExptPharm, and the TFDCA-CTC, the following information must be included on the label:

  • Statement indicating that the product is for “clinical trial purpose only”
  • Name, number, or identifying mark
  • Recommended storage conditions
  • Sponsor name and address
  • Protocol code or identification
  • Trade or brand name where appropriate
  • International Non-Proprietary Name (INN, Generic name)
  • Active ingredient quantities listed in the formulation
  • Manufacture and expiration dates
  • Batch or lot number
  • Storage conditions
  • Manufacturer name and address
  • Product registration number issued by the TFDA included in the outer and inner packaging, where applicable
  • Enclosed and accompanying literature must be in English or Kiswahili
  • Active pharmaceutical ingredient specification (BP, USP, etc.)

According to the TFDCA-CTC, where applicable, investigational medicinal products shall be labeled in the manner that protects the blinding. Also, re-labelling of any remaining investigational medicinal product from previously manufactured batches shall be performed in accordance with established written procedures and Good Manufacturing Practice principles.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (2nd Edition) (February 2009)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Section: 6.9

(2) (Guidance) Guidelines for Importation and Exportation of Pharmaceutical Products and Raw Materials (G-ImptExptPharm) (2nd Edition) (July 2011)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Section: 1.2.6

(3) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Part VII

Investigational Products > Product Management
Back to Top
Email section Share    Print section Print
Last content review/update: April 26, 2017. Submit updates or comments.
SUMMARY

Overview
In accordance with the G-AppConductCT and the TFDCA-CTC, the sponsor or his/her designated contract research organization (CRO) is responsible for providing the investigators with an Investigator’s Brochure (IB). The IB must contain all of the relevant information on the investigational product(s) (IPs) obtained through the earlier research phases, including preclinical, toxicological, safety, efficacy, and adverse events data. The G-AppConductCT also states that the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) provides more detailed information, and may be followed when preparing the IB. As per the TFDCA-CTC, the sponsor or his/her CRO should also update the IB as significant new information becomes available and maintain records of each change.

Investigational Product Supply, Storage, and Handling Requirements
As defined in the G-AppConductCT, the sponsor, his/her designated CRO, or the PI must also supply the investigator(s)/institution(s) with the IPs, including the comparator(s) and placebo, if applicable. The sponsor, his/her designated CRO, or the principal investigator (PI) should not supply either party with the IP(s) until he/she obtains approval from the Tanzania Food and Drugs Authority (TFDA) and the National Institute for Medical Research (NIMR)’s National Health Research Ethics Review Sub-Committee (NatHREC).

The G-AppConductCT, the G-ImptExptPharm , and the TFDCA-CTC, specify that the sponsor, his/her designated CRO, or the PI must ensure the following:

  • IP product quality and stability over the period of use
  • IP manufactured according to any applicable Good Manufacturing Practices (GMPs)
  • Proper coding, packaging, and labeling of the IP(s)
  • Records maintained for document shipment of the IP(s)
  • Acceptable IP handling and storage conditions and shelf-life

Refer to the G-AppConductCT, the G-ImptExptPharm, and the TFDCA-CTC, for detailed sponsor-related IP requirements.

Record Requirements
As set forth in the G-AppConductCT, which complies with the IP recordkeeping requirements delineated in the ICH-GCPs, the sponsor must ensure maintenance of the following:

  • Records documenting IP(s) handling, storage, shipment, receipt, disposition, return, and destruction
  • A system for retrieving IPs and documenting this retrieval
  • A system to dispose of unused IP(s) and corresponding documentation
  • Sufficient quantities of the IP(s) used in the trial to reconfirm specifications, should this become necessary, and maintenance of records of batch samples analyses and characteristics

As per the TFDCA-CTC and the ICH-GCPs, the sponsor should inform the investigator(s) and institution(s) in writing of the need for record retention and should notify the investigator(s) and institution(s) in writing when the trial related records are no longer needed. All sponsor-specific essential documents used in the trial should be retained for at least two (2) years after formal discontinuation of the trial, or the last approval of a marketing application. The TFDCA-CTC states that the investigator and the sponsor must retain all trial-related records, documents and information at the trial site for a period not less than 20 years following the trial’s completion. See the TFDCA-CTC for detailed record retention requirements.

ADDITIONAL RESOURCES

(A) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation
Geneva, Switzerland

Relevant Sections: 5.5, 5.12, and 5.14

REQUIREMENTS

(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (2nd Edition) (February 2009)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Definition of Terms, 1, 6, Appendix 1, and Appendix 10

(2) (Legislation) The Tanzania Food, Drugs, and Cosmetics Act, 2003 (TFDCA) (2003)
Parliament, United Republic of Tanzania

Relevant Section: Part IV (c)

(3) (Guidance) Guidelines for Importation and Exportation of Pharmaceutical Products and Raw Materials (G-ImptExptPharm) (2nd Edition) (July 2011)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: 1.3, 1.5, Annex I, and Annex III

(4) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Sections: Part IV and First and Second Schedules

Specimens > Definition of Specimen
Back to Top
Email section Share    Print section Print
Last content review/update: October 26, 2016. Submit updates or comments.
SUMMARY

Overview
In Tanzania, specimens are biological materials for medical research to be transferred between researchers/organizations for research use only (see Additional Resources (A) and (B)).

ADDITIONAL RESOURCES

(A) (Form) Material Transfer Agreement for Researchers/Organizations (For Research Use Only) (Date Unavailable)
National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Section: Article I (1.1)

(B) (Form) Application Form for Ethics Approval (Version 1) (2010)
National Health Research Ethics Review Sub-Committee, Medical Research Coordinating Committee, National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

REQUIREMENTS

No applicable regulatory requirements

Specimens > Import & Export
Back to Top
Email section Share    Print section Print
Last content review/update: October 26, 2016. Submit updates or comments.
SUMMARY

Overview
As delineated in Additional Resource (A), the principal investigator (PI) is required to obtain approval for material transfers from the National Institute for Medical Research (NIMR)’s Medical Research Coordination Committee (MRCC). The National Health Research Ethics Review Sub-Committee (NatHREC) is responsible for the review and approval of all issues pertaining to the transfer of biological research materials on the MRCC’s behalf.

NatHREC Material Transfer Requirements
According to Additional Resource (A), for Material Transfer Agreements (MTAs), the NatHREC requires that the source provider be a Tanzanian. The provider must present an MTA that is signed and stamped by the source and recipient institutions/authorities, and that provides the specific details surrounding the materials to be transferred (see Additional Resource (B) for MTA form to be completed). The NatHREC will receive and review the MTA request and approve it within five (5) working days. Per Additional Resource (B), although the NatHREC reviews and approves the MTA request, the MRCC Chairman must ultimately authorize the form.

In addition to completing the MTA form, the PI must also complete the MRCC’s Application for Ethics Approval form (Additional Resource (C)). The form requires the PI to state whether blood and/or any other biological materials will be involved in the study, and, if the study involves the shipment of biological samples outside Tanzania. If applicable, procedures to be used to process, store and test the biological samples (e.g., blood, genital swabs, urine, etc.) must also be described.

Material Transfer Import Requirements
At this time no information is available on requirements to import materials to Tanzania from clinical trials being conducted outside of the country.

ADDITIONAL RESOURCES

(A) (Document) National Health Research Ethics Committee Client Service Charter (April 2014)
National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

(B) (Form) Material Transfer Agreement for Researchers/Organizations (For Research Use Only) (Date Unavailable)
National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Section: Article I (1.1)

(C) (Form) Application Form for Ethics Approval (Version 1) (2010)
National Health Research Ethics Review Sub-Committee, Medical Research Coordinating Committee, National Institute for Medical Research, Ministry of Health and Social Welfare, United Republic of Tanzania

REQUIREMENTS

No applicable regulatory requirements

Specimens > Consent for Specimens
Back to Top
Email section Share    Print section Print
Last content review/update: October 26, 2016. Submit updates or comments.
SUMMARY

Overview
In accordance with the G-AppConductCT, prior to collecting, storing, or using a research participant’s biological specimen(s), informed consent must be obtained, including for any proposed archiving of specimens for future research.
(See the Informed Consent topic, Required Elements and Participant Rights subtopics for additional information on informed consent).

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (2nd Edition) (February 2009)
Tanzania Food and Drugs Authority, Ministry of Health and Social Welfare, United Republic of Tanzania

Relevant Section: 3.12

Please help us understand our users better by providing your organizational affiliation.
Thank you for providing your affiliation information.
OMB #: 0925-0668
Expiration Date: 2/28/2019