0A4F4F9BD490A749D5437F821CF06DF1
Standard Operating Procedures for the National Health Research Ethics Committee
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Criminal Convictions
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p.000062: during pregnancy resulted in an adverse outcome in the child. Examples: Vaginal cancer in female off
p.000062: spring from diethylstilbestrol during pregnancy, malformation in the offspring caused by thalidomide.
p.000062: Requires Intervention to Prevent Permanent Impairment or Damage-Report if suspect that the use of a
p.000062: medical product may result in a condition, which required medical or surgical intervention to
p.000062: preclude permanent impairment or damage to a patient. Examples: Acetaminophen overdose-induced
p.000062: hepatotoxicity requiring treatment with acetylcysteine to prevent permanent damage burns from radiation
p.000062: equipment requiring drug therapy, breakage of a screw requiring replacement of hardware to prevent
p.000062: malunion of a fractured long bone.
p.000062: Detailed, written instructions, in a certain format, describe activities and action undertaken by an
p.000062: organization to achieve uniformity of the performance of a specific function.
p.000062: Study site Is an organization, a unit that is responsible for carrying a research in a given
p.000062: locality.
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p.000062: Vulnerable Participants
p.000062: A vulnerable category of participants includes children, prisoners, pregnant women, handicapped or mentally disabled
p.000062: persons, and economically or educationally disadvantaged persons, who are likely to be vulnerable to coercion or
p.000062: undue influence.
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p.000063: APPENDIX II: FORMS/TOOLS
p.000063:
p.000063: FORM 01:
p.000063: CONFIDENTIALITY AND CONFLICT OF INTEREST DECLARATION FORM FOR MEMBERS OF THE NATIONAL HEALTH RESEARCH
p.000063: ETHICS REVIEW COMMITTEE
p.000063:
p.000063: ………… Meeting of National Health Research Ethics Review Committee/Clinical Trials Sub-committee
p.000063:
p.000063: Confidentiality:
p.000063:
p.000063: I agree to consider all discussions and / or
p.000063: statements made in this meeting as confidential information. I declare to safeguard confidentiality during and
p.000063: after the meeting. I also declare to consider any documents, materials or information provided to me in
p.000063: the course of the meeting, or in conducting activities of this committee after the meeting, as confidential materials,
p.000063: never to be divulged to any person without any prior written permission of the Chairperson of the
p.000063: committee.
p.000063:
p.000063: Conflict of Interest
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p.000072: registered in Tanzania?
p.000072:
p.000072: c) If this trial involves testing a new drug, vaccine or medical device, please attach the
p.000072: investigator brochure?
p.000072:
p.000072: If there is no investigator brochure, please explain the reason.
p.000072:
p.000072: d) What will be offered to the control arm?
p.000072:
p.000072: e) Please confirm that TFDA approval will be processed before data collection begins.
p.000072:
p.000072: f) Is there a Data Monitoring & Safety Committee in place? YES/NO
p.000072:
p.000072: If NO, please explain reasons
p.000072:
p.000072: g) If the intervention to be tested is found to be effective, describe plans to make it
p.000072: available to the participants and other people after the end of the trial.
p.000072:
p.000072: h) Have you obtained a certificate insurance cover for study participants locally (a cover
p.000072:
p.000072:
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p.000073: from insurance company based in Tanzania)? YES/NO If YES please attach
p.000073:
p.000073: If NO please describe how this will be obtained
p.000073:
p.000073: 25. Is the study going to involve vulnerable population? YES/NO
p.000073: (Vulnerable population include: pregnant women, human foetuses, neonates, children, prisoners, hospitalized patients,
p.000073: mentally ill persons etc)
p.000073:
p.000073: If YES, describe steps which will be taken to ensure protection of human subjects
p.000073:
p.000073: 26. Please give details of the funder.
p.000073:
p.000073:
p.000073: 27. Please give details of research sponsor. This is not necessarily the funding body. The sponsor is
p.000073: responsible for the initiation and management of the study. All clinical trials should have an identified
p.000073: sponsor.
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p.000074:
p.000074: FORM 4: RESEARCH PROPOSAL ASSESSMENT FORM
p.000074:
p.000074: NATIONAL INSTITUTE FOR MEDICAL RESEARCH
p.000074:
p.000074: Telephone 255 22 2 121400
p.000074: Telex 41919 NIMR TZ P.O. Box
p.009653: 9653
p.009653: Telegrams MEDSEARCH Dar es Salaam
p.009653: Telefax 255 22 2 12120020
p.009653: Tanzania
p.009653: Email: headquaters@nimr.or.tz
p.009653: [DATE]
p.009653: Our Ref No. [####] Your Ref. [####]
p.009653:
p.009653: [Name of Reviewer] [Address]
p.009653:
p.009653: Dear [Name of Reviewer]
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Political / political affiliation
Searching for indicator party:
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p.000064: delegate of any organization or private interest. Your fundamental duty is to independently review both
p.000064: scientific and ethical aspects of research protocols involving human subjects and make a
p.000064: determination and the best possible objective recommendations, based on the merits of the submissions you review.
p.000064:
p.000064: The National Ethics Review Committee aims to meet the highest ethical standards in order to merit the trust and
p.000064: confidence of the communities’ protection of rights and wellbeing of human subjects. As a member of
p.000064: the National Ethics Review Committee you are expected to meet the same high standards of ethical behaviour as you
p.000064: carry out your mandate.
p.000064:
p.000064: This Agreement, encompasses any information deemed confidential or proprietary provided to the Undersigned in
p.000064: conjunction with duties as a member of the National Ethics Review Committee. Any written information provided
p.000064: to the undersigned that is of a confidential, proprietary or privileged nature shall be
p.000064: identified accordingly.
p.000064:
p.000064: As such, the undersigned agrees to hold all confidential or proprietary trade secrets (“information”) in trust or
p.000064: confidence and agrees that it shall be used only for contemplated purposes; shall not be used for any other
p.000064: purpose or disclosed to any third party. Written confidential information provided for review shall not be
p.000064: copied or retained, and all confidential information (and any copies and notes thereof) shall remain the
p.000064: sole property of the National Ethics Review committee.
p.000064:
p.000064: The Undersigned agrees not to disclose or utilize, directly or indirectly, any confidential or
p.000064: proprietary information belonging to a third party in fulfilling this agreement. Furthermore, the undersigned
p.000064: confirms that his/her performance of this agreement is consistent with the institute’s policies and any contractual
p.000064: obligations they may have to third parties.
p.000064:
p.000064:
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p.000065: 65
p.000065:
p.000065: CONFLICT OF INTEREST
p.000065:
p.000065: It is a policy of the National Ethics Review Committee that no member may participate in the review or
p.000065: approval for activities in which that member has a conflict of interest except to provide information as
p.000065: requested by the National Ethics Review Committee.
p.000065:
p.000065: You shall immediately disclose to the Chairperson of the National Ethics Review Committee any actual or
p.000065: potential conflicts of interest that you may have in relation to any particular proposal submitted for review by
p.000065: the Committee and to abstain from any participation in discussions or recommendations in respect
p.000065: of such proposals.
p.000065:
p.000065: If an applicant submitting a protocol believes that an Ethics Review Committee member has a potential
p.000065: conflict, the investigator may request in writing or by telephone to the Chairperson that the member be
p.000065: excluded from the review of the protocol.
p.000065:
p.000065: Members will notify the Chairman any conflict of interest that they may have with any application and if so will not
p.000065: participate in evaluation of the proposal of interest.
p.000065:
p.000065: A member or members who may have a conflict of interest may not be counted toward a quorum and may not
p.000065: vote.
p.000065: All members of the National Ethics Review Committee will sign a Confidentiality and Conflict of Interest
p.000065: declaration form at the beginning of every meeting that they will attend. The form will define elements of Conflict of
p.000065: Interest.
p.000065:
p.000065: Confidentiality and non-disclosure
p.000065: In the course of your activities as a member of the National Ethics Review Committee, you may
p.000065: be provided with confidential information and documentation (referred to as the “Confidential Information”).
p.000065: You agree to take reasonable measures to protect the Confidential Information: subject to applicable
p.000065: legislation,
p.000065:
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p.000066: including the Access to Information Act, not to disclose confidential information to any person; not to use
p.000066: confidential information for any purpose outside the committee, and for any purpose outside the Committee’s
p.000066: mandate, and in particular, in a manner which would result in a benefit to yourself or any third party, and to return
p.000066: all confidential information (including any minutes or notes you have made as part of your committee duties) to
p.000066: the Chairperson upon termination of your functions as a committee member.
p.000066:
p.000066: Please sign and date this agreement, if the undersigned agrees with the terms and conditions set forth above. The
p.000066: original shall be kept in file in the custody of the regularly compliance office. A copy shall be provided
p.000066: for your records.
p.000066:
p.000066: I (name) ……………………………… Address…………………………………………...
p.000066: ……………………………………………………………………………………………….. Have read and accept the aforementioned terms and conditions as explained in
p.000066: this agreement.
p.000066:
p.000066: ……………………………………… …………………………………….. Undersigned Signature
p.000066: Date
p.000066:
p.000066: ……………………………………… ……………………………………. Compliance Officer
p.000066: Date
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p.000067: 67
p.000067:
p.000067: FORM 2: CHECKLIST ETHICAL CLEARANCE APPLICATION SUBMISSION
p.000067:
p.000067: 1. NEW PROPOSAL AND AMENDMENT
p.000067:
p.000067: Required Documents: Five (5) hard copies of all documents Attached with
p.000067: application?
p.000067: 1. National Health Research Ethics Committee (NatHREC) Application Form □
p.000067: 2. Cover letter with Institution logo signed by PI or CO-PI □
p.000067: 3. Commitment letter from affiliated institution and/or local government
p.000067: officials
p.000067: □
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Political / vulnerable
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p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006: Terms of reference
p.000006: The Committee operates within specified Standard Operating Procedure (SOPs), which are detailed, written
p.000006: instructions presented in a format that describes all activities and actions to be undertaken by an organization
p.000006: for achieving uniformity of the performance of specific functions. The aim of the SOPs and
p.000006: their accompanying checklists and forms is to simplify the organization and documentation of
p.000006: operation, whilst maintaining high standard of performance. They facilitate and support ethical review by
p.000006: improving the standard and uniformity of the decision-making and assure and gain the confidence of the public in the
p.000006: working of NatHREC. The SOPs promote transparency and efficiency in communication and operations of NatHREC.
p.000006:
p.000006: The following are terms of reference under which the Committee operates:
p.000006:
p.000006: 1. Review health research proposals submitted to it within a reasonable time and document its views in writing to
p.000006: the applicant(s), clearly identifying the study, the documents reviewed and the dates for the following:
p.000006: 1.1 Approval for commencement of the study
p.000006: 1.2 Modifications required prior to its approval
p.000006: 1.3 Disapproval
p.000006: 1.4 Termination/suspension of any prior approval
p.000006:
p.000006: 2. Safeguard the dignity, rights, safety and wellbeing of study participants and communities. Special
p.000006: attention shall be paid to studies that may include vulnerable participants.
p.000006:
p.000006: 3. The Committee may ask the Principal Investigator (s) to provide additional information on
p.000006: any aspect of the study, including physical presentation/personal communication
p.000006: regarding the research proposal to the full committee; however, the researcher/investigator shall not participate
p.000006: in the deliberations of the Committee or in the voting of the Committee on any issue.
p.000006:
p.000006:
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p.000007:
p.000007: 4. Obtain the following documents from Principal Investigator(s):
p.000007: i. Application form
p.000007: ii. Summary of Proposal
p.000007: iii. Study proposal(s) and/or amendment(s)
p.000007: iv. Written Informed consent forms and consent form updates that the Principal Investigator(s)
p.000007: proposes for use in the study
p.000007: v. Participant recruitment procedures
p.000007: vi. Written information to be provided to participants
p.000007: vii. In case of a clinical trial, the investigator’s brochure should be provided
p.000007: viii. For clinical trials there should be a document of intent of insurance from an insurance company
p.000007: ix. Institutional Review Board certificate of applicant’s institution
p.000007: x. Institutional Review Board certificate of collaborating foreign institution where
p.000007: applicable
p.000007: xi. IRB certificate and/or commitment letter of collaborating local institutions
p.000007: xii. Research budget and its justification
p.000007: xiii. Curriculum vitae (CVs) and composition of the research team
p.000007:
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p.000024: conflicts of interest shall also be examined. In case of investigators from outside Tanzania, the proposal will be
p.000024: examined to ensure that it includes a local investigator who has sufficient capacity to carry out the study.
p.000024:
p.000024: 4. Study Participation
p.000024: Under this item the assessment shall be done with a view of evaluating voluntary, non-coercive recruitment of
p.000024: participation. The following aspects shall be assessed to see if they have been adequately considered in the proposal:
p.000024: i. Procedures for obtaining informed consent
p.000024:
p.000024:
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p.000025:
p.000025: ii. Contents of the patient information sheet
p.000025: iii. Contents and language of the informed consent document
p.000025: iv. Translation of the informed consent document to the local language
p.000025: v. Language used is plain and easy to understand by the general public
p.000025: vi. Contact persons with address and phone numbers
p.000025: vii. Privacy and confidentiality
p.000025: viii. Risks -physical/mental/social
p.000025: ix. Benefits -to participants and to others
p.000025: x. Compensation -reasonable/ unreasonable
p.000025: xi. Involvement of vulnerable participants
p.000025: xii. Provisions for medical/psychosocial support
p.000025: xiii. Treatment for study related injuries
p.000025: xiv. Use of biological materials
p.000025: xv. Matters related to insurance of research participants and
p.000025: sponsor/researcher indemnity
p.000025:
p.000025: 5. Examination of Local Institutions and community Involvement
p.000025: Ethical research conduct involving human participation requires community consultation and involvement
p.000025: of local researchers and institutions in the study design, analysis and publication of the results. It
p.000025: also requires contribution to development of local capacity for research and treatment and benefit to
p.000025: local communities and availability of study results. The proposal shall be examined to assess adequate
p.000025: consideration of these aspects.
p.000025:
p.000025: 6. Decision by the Committee members
p.000025: The guidance, advice and decision reached by the Committee members shall be summarized in the Reviewers
p.000025: Guide. The summary shall include proposal title and date of review, checklist of documents reviewed, and
p.000025: decision reached by the Committee for example approved/approved with stipulation/recommended for resubmission
p.000025: after revision or rejected. Recommendations and/or suggestions, if
p.000025:
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p.000026: any including reasons for disapproving a study (if so) shall be part of the summary. The summary shall also include a
p.000026: list of members participating in a review meeting.
p.000026:
p.000026: 7. Appeal procedures
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p.000027: assessment for the study
p.000027: iv. Changes to study documentation such as participant information sheets, consent forms,
p.000027: questionnaires, letters of invitation, letters to other clinicians/scientists, information sheets for relatives or
p.000027: caregivers
p.000027: v. Change in the use of biological samples
p.000027: vi. A change of sponsor(s) or sponsor’s legal representative
p.000027: vii. Appointment of a new PI or key collaborator
p.000027: viii. A change to the responsibility and liability insurance coverage for the study
p.000027:
p.000028: 28
p.000028:
p.000028: ix. Appointment of a new PI at a research site
p.000028: x. A significant change to the definition of a research site
p.000028: xi. A change to the definition of the end of the study
p.000028: xii. Any other significant change to the protocol or the terms of the original application
p.000028: 3. Major: whatever procedural changes alter the risk which participants are exposed to, or the potential benefit,
p.000028: constitutes a major amendment. Examples include:
p.000028: i. A change in the primary purpose or objective of the research, such as introduction of additional genetic
p.000028: studies.
p.000028: ii. A substantial change in research methodology
p.000028: iii. Introduction of new classes of investigations or other interventions (rather than simply re-scheduling or
p.000028: modifying those already approved)
p.000028: iv. Recruitment of a new type of participant (especially if these would be regarded as being from vulnerable
p.000028: groups)
p.000028:
p.000028: Detailed instruction
p.000028: 1. The PI shall prepare the amendment package and submit to the Secretariat.
p.000028:
p.000028: 2. Upon receipt of the amendment package, the Secretariat shall follow the receiving procedures in
p.000028: Submission of Research Protocol (SOP# 06) and Procedure for Maintaining Confidentiality of NatHREC
p.000028: Documents (SOP# 02).
p.000028:
p.000028: 3. A request for amendment of a previously approved proposal shall describe the requested amendment, provide the
p.000028: rationale for the amendment, and describe the impact, if any, of the amendment on the proposal’s risk: benefit profile.
p.000028:
p.000028: 4. The Secretariat shall check the amendment submission for completeness, including an amended
p.000028: version of the proposal and related documents. Changes or modifications in the amended version
p.000028: shall be underlined or highlighted.
p.000028:
p.000029: 29
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p.000029: 5. The Secretariat shall then:
p.000029: a. Inform the Chairperson of the committee verbally and in writing
p.000029: b. Keep “Sent” and “Received” mails related to the notification of the Chairperson in the proposal file
p.000029: under the correspondence section
p.000029: c. Send the request for amendment memorandum together with the proposal and related documents to
p.000029: the Chairperson within one working day of receipt of the Secretariat and include a
p.000029: recommendation for expedited or full review.
p.000029:
p.000029: 6. After review of the materials, the Chairperson shall determine whether the proposal requires
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p.000036: monitoring by a Data and Safety Monitoring Board (DSMB). DSMB’s may be critical for studies intended to save lives,
p.000036: prevent serious disease progression, or reduce the risk of a major adverse health outcome. DSMBs are particularly
p.000036: important in studies where interim data analysis is required to ensure the safety of research participants.
p.000036:
p.000036: The primary responsibility of a DSMB is to safeguard human subjects by analysing accumulating data relevant to the
p.000036: risks and benefits on a regular basis. Especially in long-term trials, the DSMB reviews data periodically to
p.000036: assess effectiveness and toxicity, and to decide if and when the data are sufficiently favourable to one
p.000036: treatment that the study should be discontinued. The DSMB shall also decide whether adverse events are
p.000036: serious enough to warrant termination of the study.
p.000036:
p.000036: NatHREC considers DSMBs to be relevant in the following kinds of studies:
p.000036: i. Controlled studies with mortality and/or severe morbidity as a primary or secondary end-point.
p.000036: ii. Randomized controlled studies focused on evaluating clinical efficacy and safety of a new intervention.
p.000036: iii. Early studies of a high-risk intervention.
p.000036: iv. Studies in the early phases of a novel intervention with very limited information on clinical safety.
p.000036: v. Studies where the design or expected data accrual is complex, particularly studies that take long
p.000036: duration.
p.000036: vi. Studies carried out in emergency situations.
p.000036: vii. Studies which involve vulnerable populations.
p.000036:
p.000036:
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p.000037:
p.000037: For clinical trials conducted only in Tanzania, the DSMB must include representation from Tanzania. For multi-country
p.000037: clinical trials, the DSMB should include regional representation, preferably Tanzanian, on its roster.
p.000037: For Studies with DSMBs, the most recent report from the DSMB should be submitted to the NatHREC as an information item.
p.000037:
p.000037:
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p.000037: SOP 14: INQUIRIES FROM RESEARCH PARTICIPANTS, COMMUNITY MEMBERS OR ANY PERSON INTERESTED IN THE STUDY
p.000037: The NatHREC shall consider its prime responsibility by assuming the protection of the rights and welfare of human
p.000037: subjects in research approved by the Committee. This SOP applies to all requests concerning the rights
p.000037: and well-being of the participants in the studies approved by the NatHREC. This procedure shall provide guidelines
p.000037: for dealing with and accommodating requests by participants regarding their rights as participants in any
p.000037: approved clinical research studies. It is the responsibility of all Staff and Committee members acting on
p.000037: behalf of the Committee to facilitate subjects/patients' requests within the scope of their responsibilities.
p.000037:
p.000037: Informed Consent documents reviewed by the Committee may routinely contain the statement, "Questions regarding the
p.000037: rights of a subject/patient” may be addressed to the Chairperson, address and/or phone number. On some occasions the
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p.000062: quality of life. Examples: Cerebrovascular accident due to drug-induced hypercoagulability; toxicity, peripheral
p.000062: neuropathy.
p.000062: Congenital Anomaly - Report if there is suspicions that exposure to a medical product prior to conception or
p.000062: during pregnancy resulted in an adverse outcome in the child. Examples: Vaginal cancer in female off
p.000062: spring from diethylstilbestrol during pregnancy, malformation in the offspring caused by thalidomide.
p.000062: Requires Intervention to Prevent Permanent Impairment or Damage-Report if suspect that the use of a
p.000062: medical product may result in a condition, which required medical or surgical intervention to
p.000062: preclude permanent impairment or damage to a patient. Examples: Acetaminophen overdose-induced
p.000062: hepatotoxicity requiring treatment with acetylcysteine to prevent permanent damage burns from radiation
p.000062: equipment requiring drug therapy, breakage of a screw requiring replacement of hardware to prevent
p.000062: malunion of a fractured long bone.
p.000062: Detailed, written instructions, in a certain format, describe activities and action undertaken by an
p.000062: organization to achieve uniformity of the performance of a specific function.
p.000062: Study site Is an organization, a unit that is responsible for carrying a research in a given
p.000062: locality.
p.000062:
p.000062: Vulnerable Participants
p.000062: A vulnerable category of participants includes children, prisoners, pregnant women, handicapped or mentally disabled
p.000062: persons, and economically or educationally disadvantaged persons, who are likely to be vulnerable to coercion or
p.000062: undue influence.
p.000062:
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p.000063: 63
p.000063:
p.000063: APPENDIX II: FORMS/TOOLS
p.000063:
p.000063: FORM 01:
p.000063: CONFIDENTIALITY AND CONFLICT OF INTEREST DECLARATION FORM FOR MEMBERS OF THE NATIONAL HEALTH RESEARCH
p.000063: ETHICS REVIEW COMMITTEE
p.000063:
p.000063: ………… Meeting of National Health Research Ethics Review Committee/Clinical Trials Sub-committee
p.000063:
p.000063: Confidentiality:
p.000063:
p.000063: I agree to consider all discussions and / or
p.000063: statements made in this meeting as confidential information. I declare to safeguard confidentiality during and
p.000063: after the meeting. I also declare to consider any documents, materials or information provided to me in
p.000063: the course of the meeting, or in conducting activities of this committee after the meeting, as confidential materials,
p.000063: never to be divulged to any person without any prior written permission of the Chairperson of the
p.000063: committee.
p.000063:
p.000063: Conflict of Interest
p.000063: I declare that I have no/I have a conflict of interest in relation to the following/none of the proposals tabled for
p.000063: discussion in this meeting.
p.000063:
p.000063: Conflict of Interest: (Write down)
p.000063: …………………………………………………………………………………………………..
p.000063: ………………………………………………………………………………………………….. Proposal for which I have a Conflict of Interest
p.000063: Proposal title:
p.000063: ……………………………………………………………………………………………….…
p.000063: ………………………………………………………………………………………………….
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p.000072: study, i.e.; office space, equipped laboratories.
p.000072:
p.000072: 24 If this is a clinical/intervention trial of a medicine, device, biologic/vaccine, or any other
p.000072: form of treatment or intervention, please respond to the following questions:
p.000072:
p.000072: a) Does the trial comply with Good Clinical Practice (GCP)?
p.000072:
p.000072: b) Does this trial involve testing a new drug, vaccine or medical device which is not
p.000072: registered in Tanzania?
p.000072:
p.000072: c) If this trial involves testing a new drug, vaccine or medical device, please attach the
p.000072: investigator brochure?
p.000072:
p.000072: If there is no investigator brochure, please explain the reason.
p.000072:
p.000072: d) What will be offered to the control arm?
p.000072:
p.000072: e) Please confirm that TFDA approval will be processed before data collection begins.
p.000072:
p.000072: f) Is there a Data Monitoring & Safety Committee in place? YES/NO
p.000072:
p.000072: If NO, please explain reasons
p.000072:
p.000072: g) If the intervention to be tested is found to be effective, describe plans to make it
p.000072: available to the participants and other people after the end of the trial.
p.000072:
p.000072: h) Have you obtained a certificate insurance cover for study participants locally (a cover
p.000072:
p.000072:
p.000073: 73
p.000073:
p.000073: from insurance company based in Tanzania)? YES/NO If YES please attach
p.000073:
p.000073: If NO please describe how this will be obtained
p.000073:
p.000073: 25. Is the study going to involve vulnerable population? YES/NO
p.000073: (Vulnerable population include: pregnant women, human foetuses, neonates, children, prisoners, hospitalized patients,
p.000073: mentally ill persons etc)
p.000073:
p.000073: If YES, describe steps which will be taken to ensure protection of human subjects
p.000073:
p.000073: 26. Please give details of the funder.
p.000073:
p.000073:
p.000073: 27. Please give details of research sponsor. This is not necessarily the funding body. The sponsor is
p.000073: responsible for the initiation and management of the study. All clinical trials should have an identified
p.000073: sponsor.
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
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p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
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p.000073:
p.000073:
p.000074: 74
p.000074:
p.000074: FORM 4: RESEARCH PROPOSAL ASSESSMENT FORM
p.000074:
p.000074: NATIONAL INSTITUTE FOR MEDICAL RESEARCH
p.000074:
p.000074: Telephone 255 22 2 121400
p.000074: Telex 41919 NIMR TZ P.O. Box
...
Searching for indicator vulnerability:
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p.000033: 33
p.000033:
p.000033: SOP 12: CONTINUING REVIEW
p.000033:
p.000033: The purpose of continuing review is to review progress of the entire study, not just changes made so as to ensure
p.000033: continued protection of rights and welfare of research participants. The Chairperson and Committee members
p.000033: are responsible for determining whether the research is reviewed annually, or more frequently
p.000033: appropriate to the degree of risk. The Committee is also responsible for determining whether an independent data
p.000033: and safety monitoring board is required. The investigator of the research is responsible for
p.000033: keeping the Committee informed of significant findings that affect the risk/benefit ratio and thus the
p.000033: need for more frequent review. The investigator is also responsible for following the continuing review
p.000033: procedures and deadlines.
p.000033:
p.000033: Determination of Frequency of Continuing Review
p.000033: 1. At a research activity’s initial review, the Committee shall determine:
p.000033: i. How often it shall re-evaluate the research project. All research shall be reviewed at intervals
p.000033: appropriate to the degree of risk, but not less than once per year.
p.000033: ii. The factors to be considered in setting the frequency of review should include the nature of the
p.000033: study, the degree of risk involved, and the vulnerability of the study subject population.
p.000033: iii. Whether these studies need verification from sources other than the investigator that no
p.000033: material changes in the research have occurred.
p.000033:
p.000033: 2. The investigator shall utilize the Continuing Review Form (Form 05) to complete the review
p.000033: report and shall include all required elements, including the following:
p.000033: i. Number and demographics of participants enrolled
p.000033: ii. Changes in principal or Co-investigator(s)
p.000033: iii. A summary description of subject experiences
p.000033:
p.000033:
p.000034: 34
p.000034:
p.000034: iv. Any serious adverse events experienced
p.000034: v. Numbers of and reasons for withdrawals from the research
p.000034: vi. The research results obtained thus far
p.000034: vii. A current risk-benefit assessment based on study results and
p.000034: viii. Any new information since the Committee's last review.
p.000034:
p.000034: 3. If the investigator/researcher cannot provide any of the required information, s/he shall provide justification
p.000034: for the delay in the report, and a timetable for provision of the information. The investigator/researcher shall
p.000034: also submit a copy of the consent documents and procedures currently in use. Studies that expire must be suspended
p.000034: until NatHREC approval is obtained.
p.000034:
p.000034: 4. The investigator/researcher shall submit hard copies of the continuing review report, with original
p.000034: signature. Five copies are sufficient for research that qualifies for expedited continuing review, and
...
Health / Cognitive Impairment
Searching for indicator impaired:
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p.000076:
p.000076: FORM 05: PARTICIPANT’S INQUIRY FORM
p.000076:
p.000076:
p.000076: Date Received Requested from:
p.000076: Telephone call:
p.000076:
p.000076: Fax: ...………………...............…… Of ................…………………………......
p.000076: Date: ……………………...................
p.000076:
p.000076: Mailed letter Ref: …………………………………. Of …………………….
p.000076: Date: ……………....................................
p.000076:
p.000076: Email of: …………………………………….......................................................
p.000076: Date: …………………………………….......
p.000076: Other methods (Specify):
p.000076:
p.000076: Name of participant:
p.000076:
p.000076: Address:
p.000076:
p.000076: Title of the protocol being participated in Starting date of participation: What is requested:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076: Action taken
p.000076:
p.000076:
p.000076:
p.000076:
p.000076: Outcome
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076: ………………………………… ………………………………………
p.000076: Name of receiving officer Signature
p.000076:
p.000077: 77
p.000077:
p.000077: FORM 06: ANNUAL CONTINUING REVIEW APPLICATION/ASSESSMENT
p.000077:
p.000077: Protocol title:
p.000077:
p.000077:
p.000077: Certificate approval no. Principal Investigator:
p.000077: Action requested: Review for new subject accrual to continue [ ]
p.000077: Review for enrolled participants follow-up only [ ] Review for termination of study
p.000077: [ ]
p.000077:
p.000077:
p.000077: Have there been any amendments since last review?
p.000077: Yes [ ] Comment:
p.000077:
p.000077:
p.000077: No [ ] Comment:
p.000077:
p.000077:
p.000077: Impaired participants None [ ] Physically [ ] Mentally [ ] Both [ ]
p.000077: Others (Specify):
p.000077:
p.000077:
p.000077:
p.000077:
p.000077: Have there been any changes in the participant population, recruitment or selection criteria since
p.000077: the last review?
p.000077: Have there been any changes in the informed consent process or documentation since
p.000077: the last review?
p.000077: Has any information appeared in the literature or evolved from this or similar research that
p.000077: might affect the committee’s evaluation of the risk/benefit analysis of human
p.000077: subjects involved in this protocol?
p.000077: Have any participants withdrawn for this study since the last approval?
p.000077: No [ ] Yes [ ] Explain:
p.000077:
p.000077:
p.000077: No [ ] Yes [ ] Explain:
p.000077:
p.000077:
p.000077: Yes [ ] Comment:
p.000077:
p.000077:
p.000077: No [ ] Comment:
p.000077:
p.000077:
p.000077:
p.000077: No [ ] Yes [ ] Explain:
p.000077:
p.000077: Summary of protocol Actual ceiling set by the NatHREC
p.000077:
p.000078: 78
p.000078:
p.000078: participants New participants accrued since last review Total participants accrued since
p.000078: protocol began
p.000078:
p.000078:
p.000078: Have any unexpected complications or side effects been noted since last review?
...
Searching for indicator impairment:
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p.000061: incapacity or that maybe consistence with development of a congenital anomaly.
p.000061: The adverse event is SERIOUS and should be reported when the
p.000061:
p.000061:
p.000062: 62
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062: Standard Operating Procedures (SOPs)
p.000062: patient outcome is:
p.000062: Death - Report if the patient's death is suspected as being a direct outcome of the adverse event.
p.000062: Life- Threatening - Report if the patient was at substantial risk of dying at the time of the adverse event or it is
p.000062: suspected that the use or continued use of the product would result in the patient's death. Examples: Pacemaker
p.000062: failure; gastrointestinal haemorrhage; bone marrow suppression; infusion pump failure which permits uncontrolled free
p.000062: flow resulting in excessive drug dosing.
p.000062: Hospitalization - (initial or prolonged)-Report if admission to the hospital or prolongation of a hospital stay results
p.000062: because of the adverse event. Examples. Anaphylaxis pseudomembranous colitis or bleeding causing or prolonging
p.000062: hospitalisation.
p.000062: Disability - Report if the adverse event resulted in a significant, persistent, or permanent change,
p.000062: impairment, damage or disruption in the patient's body function/structure, physical activities or
p.000062: quality of life. Examples: Cerebrovascular accident due to drug-induced hypercoagulability; toxicity, peripheral
p.000062: neuropathy.
p.000062: Congenital Anomaly - Report if there is suspicions that exposure to a medical product prior to conception or
p.000062: during pregnancy resulted in an adverse outcome in the child. Examples: Vaginal cancer in female off
p.000062: spring from diethylstilbestrol during pregnancy, malformation in the offspring caused by thalidomide.
p.000062: Requires Intervention to Prevent Permanent Impairment or Damage-Report if suspect that the use of a
p.000062: medical product may result in a condition, which required medical or surgical intervention to
p.000062: preclude permanent impairment or damage to a patient. Examples: Acetaminophen overdose-induced
p.000062: hepatotoxicity requiring treatment with acetylcysteine to prevent permanent damage burns from radiation
p.000062: equipment requiring drug therapy, breakage of a screw requiring replacement of hardware to prevent
p.000062: malunion of a fractured long bone.
p.000062: Detailed, written instructions, in a certain format, describe activities and action undertaken by an
p.000062: organization to achieve uniformity of the performance of a specific function.
p.000062: Study site Is an organization, a unit that is responsible for carrying a research in a given
p.000062: locality.
p.000062:
p.000062: Vulnerable Participants
p.000062: A vulnerable category of participants includes children, prisoners, pregnant women, handicapped or mentally disabled
p.000062: persons, and economically or educationally disadvantaged persons, who are likely to be vulnerable to coercion or
p.000062: undue influence.
p.000062:
p.000062:
p.000062:
p.000062:
p.000063: 63
p.000063:
p.000063: APPENDIX II: FORMS/TOOLS
p.000063:
p.000063: FORM 01:
...
Health / Drug Usage
Searching for indicator drug:
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p.000088: Procedures. Their valuable contribution will be cherished for many years to come.
p.000088:
p.000088: Julius Massaga PhD
p.000088: SECRETARY
p.000088: NATIONAL HEALTH RESEARCH ETHICS COMMITTEE
p.000088: iv
p.000088:
p.000088: ABBREVIATIONS
p.000088:
p.000088: CIOMS Council for International Organization of Medical Sciences CV
p.000088: Curriculum Vitae
p.000088: DSMB Data and Safety Monitoring Board
p.000088:
p.000088: ICH International Conference on Harmonization
p.000088:
p.000088: IRB Institutional Review Board
p.000088:
p.000088: IREC Institutional Review Ethics Committee MOHSW Ministry of Health and
p.000088: Social Welfare MRCC Medical Research Coordinating Committee NatHREC National
p.000088: Health Research Ethics Committee NIMR National Institute for Medical Research
p.000088: NSR Non-Significant Risk Device
p.000088:
p.000088: PI Principal Investigator
p.000088:
p.000088: RTI Research Triangle Institute International
p.000088:
p.000088: SAE Serious Adverse Events
p.000088:
p.000088: SOPs Standard Operating Procedures
p.000088:
p.000088: TANHER FORUM Tanzania National Health Research Forum TFDA Tanzania Food and Drug Authority
p.000088: UN United Nations
p.000088:
p.000088: WHO World Health Organization
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088: v
p.000088:
p.000088: FOREWORD
p.000088: It is with great pleasure that we have established the Standard Operating procedures (SOPs) for the National Health
p.000088: Research Ethics Committee (NatHREC), a Sub- Committee of the Medical Research Coordinating Committee
p.000088: of the National Institute for Medical Research (NIMR), Tanzania.
p.000088:
p.000088: The SOPs, by definition are detailed written instructions to achieve uniformity and maintain standards in the
p.000088: performance of a specific function. In this particular case, these instructions have detailed procedures
p.000088: guiding the establishment of Institutional Health Research Review Committees or Boards (IRBs) and
p.000088: their basic functions. The document outlines procedures for structuring and administering IRBs, and
p.000088: reviewing as well as monitoring research during the phase of implementation.
p.000088:
p.000088: NatHREC followed these SOPs since 2007 but with time it was realized that certain procedures outlined in the SOPs 2007
p.000088: required modification to ensure their practical implementation. This, coupled with the fact that it was always
p.000088: envisaged the SOPs would be a dynamic document that would be reviewed when the need arises the NatHREC
p.000088: decided to review the SOP in 2014
p.000088:
p.000088: As a dynamic and living document, the SOPs will be reviewed from time to time in the future and NIMR will
...
p.000038: involving risks to subjects or others as well as ethics complaints. In addition, the Committee is
p.000038: authorized to offer mediation under appropriate circumstances. The Committee shall also make sure that researchers
p.000038: are
p.000038:
p.000039: 39
p.000039:
p.000039: aware of the policies and procedures concerning reporting and continuing review requirements. The
p.000039: Secretariat shall be responsible for the screening and assessment of the reports and seeing whether they require a
p.000039: review of the full Committee, the Chairperson, or other qualified Committee members or experts.
p.000039:
p.000039: Detailed instruction
p.000039: 1. Before each Board Committee
p.000039: The Secretariat shall review the reporter's assessment to determine whether the report requires review
p.000039: by full Committee, the Chairperson or other qualified Committee member(s). Criteria of the review shall
p.000039: be as follows:
p.000039:
p.000039: i. If assessment of adverse experience is unknown or unlikely, the report shall be forwarded to the
p.000039: Chairperson for review and determination if full Committee should review the report at the following convened
p.000039: meeting.
p.000039: ii. If assessment of adverse experience is possibly caused by, or probably caused by the investigational
p.000039: product or intervention, the report shall be added to the agenda of the next convened or ad hoc meeting
p.000039: depending upon the severity of the event.
p.000039: iii. If an adverse experience/investigational new drug or product safety report that has
p.000039: previously been seen by the full Committee is being resubmitted by another investigator in the same
p.000039: study (as part of a multi- Centre study), this notification shall not require full Committee review. Rather, the
p.000039: Chairperson will determine the course of action.
p.000039:
p.000039: 2. During the Committee meeting
p.000039: After reading and reviewing the report, the Chairperson or designee shall entertain discussion on the report
p.000039: and similar adverse experiences or advisories. If appropriate to the discussions, the Chairperson may call
p.000039: for a consensus on whether to:
p.000039: i. Request an amendment to the proposal or consent
p.000039:
p.000039:
p.000040: 40
p.000040:
p.000040: ii. Request further information
p.000040: iii. Suspend or terminate the study
p.000040: iv. Take no action at the present time
p.000040:
p.000040: 3. The Secretariat shall notify the investigator in writing of any required actions. The Committee’s decision
p.000040: shall be noted in the minutes.
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040: SOP 16: ALLEGATIONS OF NON–COMPLIANCE AND NON- AUTHORIZED RESEARCH
p.000040:
p.000040: The purpose of this SOP is to provide instructions for maintaining records that identify
p.000040: investigators/institutes who fail to comply with National/International guidelines for the conduct of human
p.000040: research or who fail to correspond to the NatHREC requests. This SOP applies to all research projects
p.000040: approved by the NatHREC as well as non-authorized researches. The Secretariat is responsible for
p.000040: maintaining documentation of alleged non-compliance.
p.000040:
...
p.000060: Expedited review A review process in which one or more experienced NatHREC members review and
p.000060: approve research on behalf of the NatHREC. Only activities that meet the criteria for expedited review (see SOP #11)
p.000060: may be reviewed using the expedited review procedures.
p.000060:
p.000060: External researchers/ collaborators
p.000060: These are non-Tanzanians that are participating in a research in the country.
p.000060: Final Report An obligatory review of study activities presented as a written report to
p.000060: the Committee after the last subject has completed all visits and all adverse experiences have
p.000060: been brought to appropriate resolution.
p.000060: Health Health is a state of complete physical, mental and social well-being and not
p.000060: merely the absence of disease or infirmity.
p.000060:
p.000060: Independent Consultant
p.000060: An expert who gives advice, comments and suggestions to the NatHREC with no affiliation to the
p.000060: institutes or investigators proposing the research proposals.
p.000060: Inspection The act by a regulatory authorities of conducting an official review of documents,
p.000060: facilities, records, and any other resources that are deemed by the authorities to be related to the clinical
p.000060: trial and that may be located at the site of the trial, at the sponsor's and/or contract research
p.000060: organizations (CRO) facilities, Office of Ethics Committees, or at other establishments deemed appropriate by the
p.000060: regulatory authorities.
p.000060:
p.000060: Investigational New Drug
p.000060:
p.000060:
p.000060: Investigator’s Brochure
p.000060: Investigational new drug means a new drug, antibiotic drug, or biological drug that is used in a clinical
p.000060: investigation. The term also includes a biological product that is used in vitro for diagnostic purposes.
p.000060: The terms "investigational drug" and "investigational new drug" are deemed to be synonymous for purposes of this
p.000060: part. Is a document containing a summary of the clinical and non- clinical data relating to an investigational
p.000060: medicinal product which are relevant to the study of the product in human subjects
p.000060: Medical Device A medical device is any health care product that does not achieve any of its intended
p.000060: purposes by chemical action or by being metabolized. Medical devices include items such as diagnostic test kids,
p.000060: crutches, electrodes, prescribed beds, pacemakers, arterial
p.000060:
p.000061: 61
p.000061:
p.000061: grafts, intraocular lenses, and orthopaedic pins. Medical devices also include diagnostic aids such as
p.000061: reagents and test kids for in vitro diagnosis of disease and other conditions, for example,
p.000061: pregnancy.
p.000061: Minutes The official record of events, activities, and actions taken by the
p.000061: convened NatHREC.
p.000061: Monitoring visit Oversight visits to study sites by the NatHREC or its
p.000061: representatives to assess the conduct of NatHREC-approved research.
p.000061:
p.000061: National Research Ethics Committee (NatHREC)
p.000061: A national independent ethics review committee that is housed within the NIMR structure. The NatHREC is
p.000061: a subcommittee to the MRCC.
p.000061: Nutrient Supplements Substances, which may or may not be regulated that are necessary for the body's nutritional and
p.000061: metabolic processes.
p.000061: Participants’ rights Recognition of the inherent dignity and of the equal and inalienable
...
p.000061: to answer the question, and present an answer to the question.
p.000061: Research Participant Is a patient, service user, or any healthy person who is taking part in the study
p.000061:
p.000061: Serious Adverse Event (SAE)
p.000061: Is untoward occurrence that results in death, is life-threatening, and requires hospitalization or
p.000061: prolongation of existing hospitalization, results in persistent or significant disability or
p.000061: incapacity or that maybe consistence with development of a congenital anomaly.
p.000061: The adverse event is SERIOUS and should be reported when the
p.000061:
p.000061:
p.000062: 62
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062: Standard Operating Procedures (SOPs)
p.000062: patient outcome is:
p.000062: Death - Report if the patient's death is suspected as being a direct outcome of the adverse event.
p.000062: Life- Threatening - Report if the patient was at substantial risk of dying at the time of the adverse event or it is
p.000062: suspected that the use or continued use of the product would result in the patient's death. Examples: Pacemaker
p.000062: failure; gastrointestinal haemorrhage; bone marrow suppression; infusion pump failure which permits uncontrolled free
p.000062: flow resulting in excessive drug dosing.
p.000062: Hospitalization - (initial or prolonged)-Report if admission to the hospital or prolongation of a hospital stay results
p.000062: because of the adverse event. Examples. Anaphylaxis pseudomembranous colitis or bleeding causing or prolonging
p.000062: hospitalisation.
p.000062: Disability - Report if the adverse event resulted in a significant, persistent, or permanent change,
p.000062: impairment, damage or disruption in the patient's body function/structure, physical activities or
p.000062: quality of life. Examples: Cerebrovascular accident due to drug-induced hypercoagulability; toxicity, peripheral
p.000062: neuropathy.
p.000062: Congenital Anomaly - Report if there is suspicions that exposure to a medical product prior to conception or
p.000062: during pregnancy resulted in an adverse outcome in the child. Examples: Vaginal cancer in female off
p.000062: spring from diethylstilbestrol during pregnancy, malformation in the offspring caused by thalidomide.
p.000062: Requires Intervention to Prevent Permanent Impairment or Damage-Report if suspect that the use of a
p.000062: medical product may result in a condition, which required medical or surgical intervention to
p.000062: preclude permanent impairment or damage to a patient. Examples: Acetaminophen overdose-induced
p.000062: hepatotoxicity requiring treatment with acetylcysteine to prevent permanent damage burns from radiation
p.000062: equipment requiring drug therapy, breakage of a screw requiring replacement of hardware to prevent
p.000062: malunion of a fractured long bone.
p.000062: Detailed, written instructions, in a certain format, describe activities and action undertaken by an
p.000062: organization to achieve uniformity of the performance of a specific function.
p.000062: Study site Is an organization, a unit that is responsible for carrying a research in a given
p.000062: locality.
p.000062:
p.000062: Vulnerable Participants
p.000062: A vulnerable category of participants includes children, prisoners, pregnant women, handicapped or mentally disabled
p.000062: persons, and economically or educationally disadvantaged persons, who are likely to be vulnerable to coercion or
p.000062: undue influence.
p.000062:
p.000062:
p.000062:
p.000062:
p.000063: 63
p.000063:
p.000063: APPENDIX II: FORMS/TOOLS
p.000063:
p.000063: FORM 01:
p.000063: CONFIDENTIALITY AND CONFLICT OF INTEREST DECLARATION FORM FOR MEMBERS OF THE NATIONAL HEALTH RESEARCH
p.000063: ETHICS REVIEW COMMITTEE
p.000063:
...
p.000071:
p.000071:
p.000072: 72
p.000072:
p.000072: during the consent process.
p.000072:
p.000072:
p.000072: 18 Describe how you are going to assess comprehension of the information provided during the
p.000072: consent process.
p.000072:
p.000072: 19 Will payments be made to participants? (These should usually not be for more thantravelling
p.000072: expenses and/or loss of earnings and must not be coercive or represent an undue inducement to take part) NO.
p.000072: If YES give details and justification.
p.000072:
p.000072: 20 State theexperience of the PI and co-investigators in the study in the field concerned, and their role
p.000072: will be on the project.
p.000072:
p.000072:
p.000072: 21 Please describe how project staff (PI and other staff) will be trained on the protection of study
p.000072: participants in research. In case already trained attach certificate.
p.000072:
p.000072: 22 When applicable, state what medical supervision is available to the participants
p.000072:
p.000072: 23 Describe the facilities available to support the successful conduct of the proposed research
p.000072: study, i.e.; office space, equipped laboratories.
p.000072:
p.000072: 24 If this is a clinical/intervention trial of a medicine, device, biologic/vaccine, or any other
p.000072: form of treatment or intervention, please respond to the following questions:
p.000072:
p.000072: a) Does the trial comply with Good Clinical Practice (GCP)?
p.000072:
p.000072: b) Does this trial involve testing a new drug, vaccine or medical device which is not
p.000072: registered in Tanzania?
p.000072:
p.000072: c) If this trial involves testing a new drug, vaccine or medical device, please attach the
p.000072: investigator brochure?
p.000072:
p.000072: If there is no investigator brochure, please explain the reason.
p.000072:
p.000072: d) What will be offered to the control arm?
p.000072:
p.000072: e) Please confirm that TFDA approval will be processed before data collection begins.
p.000072:
p.000072: f) Is there a Data Monitoring & Safety Committee in place? YES/NO
p.000072:
p.000072: If NO, please explain reasons
p.000072:
p.000072: g) If the intervention to be tested is found to be effective, describe plans to make it
p.000072: available to the participants and other people after the end of the trial.
p.000072:
p.000072: h) Have you obtained a certificate insurance cover for study participants locally (a cover
p.000072:
p.000072:
p.000073: 73
p.000073:
p.000073: from insurance company based in Tanzania)? YES/NO If YES please attach
p.000073:
p.000073: If NO please describe how this will be obtained
p.000073:
p.000073: 25. Is the study going to involve vulnerable population? YES/NO
p.000073: (Vulnerable population include: pregnant women, human foetuses, neonates, children, prisoners, hospitalized patients,
p.000073: mentally ill persons etc)
...
p.000077: Others (Specify):
p.000077:
p.000077:
p.000077:
p.000077:
p.000077: Have there been any changes in the participant population, recruitment or selection criteria since
p.000077: the last review?
p.000077: Have there been any changes in the informed consent process or documentation since
p.000077: the last review?
p.000077: Has any information appeared in the literature or evolved from this or similar research that
p.000077: might affect the committee’s evaluation of the risk/benefit analysis of human
p.000077: subjects involved in this protocol?
p.000077: Have any participants withdrawn for this study since the last approval?
p.000077: No [ ] Yes [ ] Explain:
p.000077:
p.000077:
p.000077: No [ ] Yes [ ] Explain:
p.000077:
p.000077:
p.000077: Yes [ ] Comment:
p.000077:
p.000077:
p.000077: No [ ] Comment:
p.000077:
p.000077:
p.000077:
p.000077: No [ ] Yes [ ] Explain:
p.000077:
p.000077: Summary of protocol Actual ceiling set by the NatHREC
p.000077:
p.000078: 78
p.000078:
p.000078: participants New participants accrued since last review Total participants accrued since
p.000078: protocol began
p.000078:
p.000078:
p.000078: Have any unexpected complications or side effects been noted since last review?
p.000078: Investigational new drug/device
p.000078: Have any investigators been added or deleted since the last review?
p.000078: Changes in medical advisory/investigation?
p.000078:
p.000078: Have any investigators developed an equity or consultative relationship with a source
p.000078: related to this protocol which might be considered a conflict of interest?
p.000078: Signature
p.000078:
p.000078:
p.000078: Committee Comment/decision
p.000078: Yes [ ] Comment:
p.000078:
p.000078:
p.000078: No [ ] Comment:
p.000078:
p.000078: No [ ]
p.000078: Yes [ ] Comment:
p.000078: No [ ]
p.000078: Yes [ ] Comment:
p.000078: No [ ]
p.000078:
p.000078: Yes [ ] (Append a statement of disclosure)
p.000078:
p.000078:
p.000078:
p.000078:
p.000078: Principal Investigator ………………………………....................
p.000078:
p.000078: Date …………………..........
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078: Approvals Chairperson, NatHREC………………………………….….......
p.000078:
p.000078: Date…………….................
p.000078:
p.000078: Completion Secretary, NatHREC ……………………………….....................
p.000078:
p.000078: Date ……………...................
p.000078:
p.000079: 79
p.000079:
p.000079: FORM 07: CHECKLIST FOR AUDITING AND INSPECTION
p.000079:
p.000079:
p.000079: Type of Audit Internal Audit [ ] External Audit [ ]
p.000079: The Date(s) which the audit/inspection has been agreed for:
p.000079: Shall an interpreter be
p.000079:
p.000079: required? If Yes what arrangement has been made?
p.000079: Review the SOPs and note details of any omissions or deviations, with reasons
...
Searching for indicator influence:
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p.000007: viii. For clinical trials there should be a document of intent of insurance from an insurance company
p.000007: ix. Institutional Review Board certificate of applicant’s institution
p.000007: x. Institutional Review Board certificate of collaborating foreign institution where
p.000007: applicable
p.000007: xi. IRB certificate and/or commitment letter of collaborating local institutions
p.000007: xii. Research budget and its justification
p.000007: xiii. Curriculum vitae (CVs) and composition of the research team
p.000007:
p.000007: 5. Consider the suitability of the investigator(s) for the proposed study by considering
p.000007: relevant qualification, training and experience, as documented by current curriculum vitae and/or by any other relevant
p.000007: documentation:
p.000007: a) May request more information than is given when additional information would assist
p.000007: NatHREC in taking a decision on the proposal or provide protection of the rights, safety and/or well-being of
p.000007: participants researchers.
p.000007: b) Review both the amount and type of benefit to participants to ensure that such benefits do not
p.000007: present problems of coercion or undue influence on the study participants.
p.000007:
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: c) Concerns itself strictly on the scientific and ethical merits of submitted proposals for approval;
p.000008: executing the tasks free from bias or influence and not involving itself in the day to day administration,
p.000008: policy and other Institutional issues.
p.000008: d) Assists investigator(s) in the submission process. In this regard, the following items shall
p.000008: be made available to them by the Committee Secretariat:
p.000008: i. Proposal submission forms and all relevant guidelines as stipulated in this Standard Operating Procedures
p.000008: (SOPs)
p.000008: ii. Meeting Almanac
p.000008: iii. Checklist
p.000008:
p.000008: 6. The Committee members and consultant reviewers shall be provided by the Committee Secretariat with all
p.000008: relevant SOPs to guide them in the review process of the proposals given to them.
p.000008:
p.000008: Ethical review basis
p.000008: 1. The Committee recognizes that the proposals it approves may also be approved by institutional review
p.000008: committees/community committees prior to submission to this Committee or their implementation in specific localities.
p.000008: 2. In evaluating proposed health research, the Committee is aware of the diversity of laws, cultures and
p.000008: practices governing research and medical practices in various communities in Tanzania.
p.000008: 3. It attempts to inform itself where possible of requirements and conditions of the various localities where
p.000008: proposed health research is being considered.
p.000008: 4. The Committee seeks to be informed, as appropriate, by institutional review boards and researchers of
p.000008: the outcome of the research it has approved through progress reports.
p.000008: 5. The Committee is guided in its work by the ethical principles expressed in the
p.000008: Declaration of Helsinki, the International Ethical Guidelines for Biomedical Research
p.000008:
p.000008:
p.000008:
p.000008:
p.000009: 9
p.000009:
...
p.000010: i. Protracted illness of a member, which does not permit him/her to participate in the
p.000010: deliberations of the Committee.
p.000010: ii. Persistent absenteeism of a member without reasonable cause
p.000010: iii. Voluntary withdrawal by a member.
p.000010: iv. Ethical misconduct (s)
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: SOP 02. CONFIDENTIALITY OF PROCEEDINGS
p.000011:
p.000011: 1. Members do not sit on the NatHREC meeting in any specific representative capacity (institutions,
p.000011: associations, departments) and must be able to discuss freely the applications submitted to them.
p.000011: 2. The NatHREC meetings must be completely confidential.
p.000011: 3. Any breaches of confidentiality by members will result in termination of their membership.
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: SOP 03: CONFLICT OF INTEREST AGREEMENT
p.000011:
p.000011: The WHO Declaration of Interests for WHO Experts defines a conflict of interest as follows: “A conflict of interest
p.000011: means that the expert or his/her partner (“partner” includes a spouse or other person with whom s/he has a
p.000011: similar close personal relationship), or the administrative unit with which the expert has an employment
p.000011: relationship, has a financial or other interest that could unduly influence the expert’s position with respect to the
p.000011: subject matter being considered. An apparent conflict of interest exists when an interest would not necessarily
p.000011: influence the expert but could result in the expert’s objectivity being questioned by others. A potential conflict of
p.000011: interest exists with an interest which any reasonable person could be uncertain whether or not should be
p.000011: reported”.
p.000011:
p.000011: The purpose of this procedure is to provide a form of Conflict of Interest Agreement, who should read, keep in mind and
p.000011: sign it, when and where to sign and how the signed document be kept. This SOP covers the Agreement on both
p.000011: Confidentiality and Conflict of Interest, concerning activities and information of NatHREC.
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000012: 12
p.000012:
p.000012: It is the responsibility of all newly appointed Committee members and Consultant reviewers to read, understand,
p.000012: accept and sign the agreement stated on the Confidentiality/Conflict of Interest form (Form 01) before
p.000012: beginning their tasks on conducting activities with NatHREC to protect the rights of the participants.
p.000012:
p.000012: Detailed instructions
p.000012:
p.000012: 1. Newly appointed members or consultant reviewers shall:
p.000012: i. Obtain two copies of the Agreement Form (Form 01) from the Secretariat.
p.000012: ii. Read through the context of the form very carefully and fill in their names and their address in the
p.000012: blanks.
p.000012: iii. Ask questions, if any and the Secretariat shall explain or clarify the context.
p.000012: iv. Sign and date both copies at the undersigned signature and give the forms back to a Secretariat.
p.000012: v. Keeps a copy as their records (Secretariat and Members).
p.000012:
p.000012:
...
p.000059: some time.
p.000059: Appointing Authority The body responsible for the establishment and support of NatHREC, in this case is the
p.000059: MRCC-NIMR
p.000059: Audit A systematic and independent examination of research trial approval
p.000059: activities and documents to determine whether the review and approval activities were conducted and
p.000059: data were recorded and accurately reported according to the SOPs, GCP, Declaration of Helsinki and applicable
p.000059: regulatory requirements
p.000059: Chairperson A member of the Committee presiding over a meeting.
p.000059: Clients As a national review Committee, NATREC considers investigators, investigational
p.000059: sites, sponsors or sponsor representatives as its clients or customers. Clients requesting the services of
p.000059: NATREC are asked to accept and abide by the procedures set forth in SOPs.
p.000059: Committee Members Individuals serving as regular and alternate members on the NatHREC’s
p.000059: operations. This Committee is constituted in accordance with the NatHREC membership requirements set
p.000059: forth in SOP # 01.
p.000059: Confidentiality Prevention of disclosure, to other than authorized individuals, of Committee
p.000059: information and documents
p.000059: Conflict of Interest A situation in which a person, such as a public official, an
p.000059: employee, or a professional, has a private or personal interest
p.000059:
p.000059:
p.000060: 60
p.000060:
p.000060: sufficient to appear to influence the objective exercise of his or her official duties. There are three key
p.000060: elements in this definition: financial interest; official duties; professional interest. A conflict of interest
p.000060: occurs when:
p.000060: (i) An individual's private interest differs from his or her professional obligations to the
p.000060: institute.
p.000060: (ii) Professional actions or decisions occur that an independent observer might reasonably question.
p.000060: (iii) A conflict depends upon situation and not on the character or actions of the individual.
p.000060: (iv) Potential conflicts of interest must be disclosed and managed as per policy.
p.000060: Expedited review A review process in which one or more experienced NatHREC members review and
p.000060: approve research on behalf of the NatHREC. Only activities that meet the criteria for expedited review (see SOP #11)
p.000060: may be reviewed using the expedited review procedures.
p.000060:
p.000060: External researchers/ collaborators
p.000060: These are non-Tanzanians that are participating in a research in the country.
p.000060: Final Report An obligatory review of study activities presented as a written report to
p.000060: the Committee after the last subject has completed all visits and all adverse experiences have
p.000060: been brought to appropriate resolution.
p.000060: Health Health is a state of complete physical, mental and social well-being and not
p.000060: merely the absence of disease or infirmity.
p.000060:
p.000060: Independent Consultant
p.000060: An expert who gives advice, comments and suggestions to the NatHREC with no affiliation to the
p.000060: institutes or investigators proposing the research proposals.
...
p.000071:
p.000071: If YES, please describe why are samples being taken outside the country
p.000071:
p.000071: 11 Would local scientist(s)(Tanzanian) be involved in sample analysis? YES/NO
p.000071:
p.000071: If YES describe her/his involvement, and if NOT please explain what are the strategies for technology transfer
p.000071:
p.000071: 12 Specify data management procedures and methods to be used during data analysis.
p.000071:
p.000071: 13 If data will be taken overseas, please describe why are being taken outside the country Please note that
p.000071: before data are take outside Tanzania, clearance is required by completing a Data Transfer Management
p.000071: Agreement Form
p.000071:
p.000071: 14 Describe the potential risks, discomfort, distress or hazards that research participants may be exposed
p.000071: to (these may be physical, biological and/or psychological). What precautions will be taken to reduce risks and
p.000071: ensure participants’ safety?
p.000071:
p.000071: 15 Describe potential benefits for the participants and the population where they come from. Are there
p.000071: direct benefits for the people of Tanzania and/or other countries?
p.000071:
p.000071: 16 Specify how confidentiality of the study participants and data collected will be maintained.
p.000071:
p.000071: 17 State the manner in which consent will be obtained and documented in writing. Provide copies
p.000071: of the informed consent forms and other relevant documents in English and Kiswahili. Describe steps to be taken
p.000071: to minimize coercion/undue influence
p.000071:
p.000071:
p.000072: 72
p.000072:
p.000072: during the consent process.
p.000072:
p.000072:
p.000072: 18 Describe how you are going to assess comprehension of the information provided during the
p.000072: consent process.
p.000072:
p.000072: 19 Will payments be made to participants? (These should usually not be for more thantravelling
p.000072: expenses and/or loss of earnings and must not be coercive or represent an undue inducement to take part) NO.
p.000072: If YES give details and justification.
p.000072:
p.000072: 20 State theexperience of the PI and co-investigators in the study in the field concerned, and their role
p.000072: will be on the project.
p.000072:
p.000072:
p.000072: 21 Please describe how project staff (PI and other staff) will be trained on the protection of study
p.000072: participants in research. In case already trained attach certificate.
p.000072:
p.000072: 22 When applicable, state what medical supervision is available to the participants
p.000072:
p.000072: 23 Describe the facilities available to support the successful conduct of the proposed research
p.000072: study, i.e.; office space, equipped laboratories.
p.000072:
p.000072: 24 If this is a clinical/intervention trial of a medicine, device, biologic/vaccine, or any other
p.000072: form of treatment or intervention, please respond to the following questions:
p.000072:
p.000072: a) Does the trial comply with Good Clinical Practice (GCP)?
p.000072:
...
Health / Mentally Disabled
Searching for indicator disabled:
(return to top)
p.000062: Requires Intervention to Prevent Permanent Impairment or Damage-Report if suspect that the use of a
p.000062: medical product may result in a condition, which required medical or surgical intervention to
p.000062: preclude permanent impairment or damage to a patient. Examples: Acetaminophen overdose-induced
p.000062: hepatotoxicity requiring treatment with acetylcysteine to prevent permanent damage burns from radiation
p.000062: equipment requiring drug therapy, breakage of a screw requiring replacement of hardware to prevent
p.000062: malunion of a fractured long bone.
p.000062: Detailed, written instructions, in a certain format, describe activities and action undertaken by an
p.000062: organization to achieve uniformity of the performance of a specific function.
p.000062: Study site Is an organization, a unit that is responsible for carrying a research in a given
p.000062: locality.
p.000062:
p.000062: Vulnerable Participants
p.000062: A vulnerable category of participants includes children, prisoners, pregnant women, handicapped or mentally disabled
p.000062: persons, and economically or educationally disadvantaged persons, who are likely to be vulnerable to coercion or
p.000062: undue influence.
p.000062:
p.000062:
p.000062:
p.000062:
p.000063: 63
p.000063:
p.000063: APPENDIX II: FORMS/TOOLS
p.000063:
p.000063: FORM 01:
p.000063: CONFIDENTIALITY AND CONFLICT OF INTEREST DECLARATION FORM FOR MEMBERS OF THE NATIONAL HEALTH RESEARCH
p.000063: ETHICS REVIEW COMMITTEE
p.000063:
p.000063: ………… Meeting of National Health Research Ethics Review Committee/Clinical Trials Sub-committee
p.000063:
p.000063: Confidentiality:
p.000063:
p.000063: I agree to consider all discussions and / or
p.000063: statements made in this meeting as confidential information. I declare to safeguard confidentiality during and
p.000063: after the meeting. I also declare to consider any documents, materials or information provided to me in
p.000063: the course of the meeting, or in conducting activities of this committee after the meeting, as confidential materials,
p.000063: never to be divulged to any person without any prior written permission of the Chairperson of the
p.000063: committee.
p.000063:
p.000063: Conflict of Interest
p.000063: I declare that I have no/I have a conflict of interest in relation to the following/none of the proposals tabled for
p.000063: discussion in this meeting.
p.000063:
p.000063: Conflict of Interest: (Write down)
p.000063: …………………………………………………………………………………………………..
...
Searching for indicator mentally:
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p.000062: spring from diethylstilbestrol during pregnancy, malformation in the offspring caused by thalidomide.
p.000062: Requires Intervention to Prevent Permanent Impairment or Damage-Report if suspect that the use of a
p.000062: medical product may result in a condition, which required medical or surgical intervention to
p.000062: preclude permanent impairment or damage to a patient. Examples: Acetaminophen overdose-induced
p.000062: hepatotoxicity requiring treatment with acetylcysteine to prevent permanent damage burns from radiation
p.000062: equipment requiring drug therapy, breakage of a screw requiring replacement of hardware to prevent
p.000062: malunion of a fractured long bone.
p.000062: Detailed, written instructions, in a certain format, describe activities and action undertaken by an
p.000062: organization to achieve uniformity of the performance of a specific function.
p.000062: Study site Is an organization, a unit that is responsible for carrying a research in a given
p.000062: locality.
p.000062:
p.000062: Vulnerable Participants
p.000062: A vulnerable category of participants includes children, prisoners, pregnant women, handicapped or mentally disabled
p.000062: persons, and economically or educationally disadvantaged persons, who are likely to be vulnerable to coercion or
p.000062: undue influence.
p.000062:
p.000062:
p.000062:
p.000062:
p.000063: 63
p.000063:
p.000063: APPENDIX II: FORMS/TOOLS
p.000063:
p.000063: FORM 01:
p.000063: CONFIDENTIALITY AND CONFLICT OF INTEREST DECLARATION FORM FOR MEMBERS OF THE NATIONAL HEALTH RESEARCH
p.000063: ETHICS REVIEW COMMITTEE
p.000063:
p.000063: ………… Meeting of National Health Research Ethics Review Committee/Clinical Trials Sub-committee
p.000063:
p.000063: Confidentiality:
p.000063:
p.000063: I agree to consider all discussions and / or
p.000063: statements made in this meeting as confidential information. I declare to safeguard confidentiality during and
p.000063: after the meeting. I also declare to consider any documents, materials or information provided to me in
p.000063: the course of the meeting, or in conducting activities of this committee after the meeting, as confidential materials,
p.000063: never to be divulged to any person without any prior written permission of the Chairperson of the
p.000063: committee.
p.000063:
p.000063: Conflict of Interest
p.000063: I declare that I have no/I have a conflict of interest in relation to the following/none of the proposals tabled for
p.000063: discussion in this meeting.
p.000063:
p.000063: Conflict of Interest: (Write down)
...
p.000072: investigator brochure?
p.000072:
p.000072: If there is no investigator brochure, please explain the reason.
p.000072:
p.000072: d) What will be offered to the control arm?
p.000072:
p.000072: e) Please confirm that TFDA approval will be processed before data collection begins.
p.000072:
p.000072: f) Is there a Data Monitoring & Safety Committee in place? YES/NO
p.000072:
p.000072: If NO, please explain reasons
p.000072:
p.000072: g) If the intervention to be tested is found to be effective, describe plans to make it
p.000072: available to the participants and other people after the end of the trial.
p.000072:
p.000072: h) Have you obtained a certificate insurance cover for study participants locally (a cover
p.000072:
p.000072:
p.000073: 73
p.000073:
p.000073: from insurance company based in Tanzania)? YES/NO If YES please attach
p.000073:
p.000073: If NO please describe how this will be obtained
p.000073:
p.000073: 25. Is the study going to involve vulnerable population? YES/NO
p.000073: (Vulnerable population include: pregnant women, human foetuses, neonates, children, prisoners, hospitalized patients,
p.000073: mentally ill persons etc)
p.000073:
p.000073: If YES, describe steps which will be taken to ensure protection of human subjects
p.000073:
p.000073: 26. Please give details of the funder.
p.000073:
p.000073:
p.000073: 27. Please give details of research sponsor. This is not necessarily the funding body. The sponsor is
p.000073: responsible for the initiation and management of the study. All clinical trials should have an identified
p.000073: sponsor.
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000074: 74
p.000074:
p.000074: FORM 4: RESEARCH PROPOSAL ASSESSMENT FORM
p.000074:
p.000074: NATIONAL INSTITUTE FOR MEDICAL RESEARCH
p.000074:
p.000074: Telephone 255 22 2 121400
p.000074: Telex 41919 NIMR TZ P.O. Box
p.009653: 9653
p.009653: Telegrams MEDSEARCH Dar es Salaam
p.009653: Telefax 255 22 2 12120020
p.009653: Tanzania
p.009653: Email: headquaters@nimr.or.tz
p.009653: [DATE]
p.009653: Our Ref No. [####] Your Ref. [####]
p.009653:
p.009653: [Name of Reviewer] [Address]
p.009653:
p.009653: Dear [Name of Reviewer]
p.009653: REQUEST TO ASSESS A HEALTH RESEARCH PROPOSAL
p.009653:
p.009653: [SUMMARY OF REQUEST FOR REVIEW]
p.009653:
...
p.000076: Date: ……………………...................
p.000076:
p.000076: Mailed letter Ref: …………………………………. Of …………………….
p.000076: Date: ……………....................................
p.000076:
p.000076: Email of: …………………………………….......................................................
p.000076: Date: …………………………………….......
p.000076: Other methods (Specify):
p.000076:
p.000076: Name of participant:
p.000076:
p.000076: Address:
p.000076:
p.000076: Title of the protocol being participated in Starting date of participation: What is requested:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076: Action taken
p.000076:
p.000076:
p.000076:
p.000076:
p.000076: Outcome
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076: ………………………………… ………………………………………
p.000076: Name of receiving officer Signature
p.000076:
p.000077: 77
p.000077:
p.000077: FORM 06: ANNUAL CONTINUING REVIEW APPLICATION/ASSESSMENT
p.000077:
p.000077: Protocol title:
p.000077:
p.000077:
p.000077: Certificate approval no. Principal Investigator:
p.000077: Action requested: Review for new subject accrual to continue [ ]
p.000077: Review for enrolled participants follow-up only [ ] Review for termination of study
p.000077: [ ]
p.000077:
p.000077:
p.000077: Have there been any amendments since last review?
p.000077: Yes [ ] Comment:
p.000077:
p.000077:
p.000077: No [ ] Comment:
p.000077:
p.000077:
p.000077: Impaired participants None [ ] Physically [ ] Mentally [ ] Both [ ]
p.000077: Others (Specify):
p.000077:
p.000077:
p.000077:
p.000077:
p.000077: Have there been any changes in the participant population, recruitment or selection criteria since
p.000077: the last review?
p.000077: Have there been any changes in the informed consent process or documentation since
p.000077: the last review?
p.000077: Has any information appeared in the literature or evolved from this or similar research that
p.000077: might affect the committee’s evaluation of the risk/benefit analysis of human
p.000077: subjects involved in this protocol?
p.000077: Have any participants withdrawn for this study since the last approval?
p.000077: No [ ] Yes [ ] Explain:
p.000077:
p.000077:
p.000077: No [ ] Yes [ ] Explain:
p.000077:
p.000077:
p.000077: Yes [ ] Comment:
p.000077:
p.000077:
p.000077: No [ ] Comment:
p.000077:
p.000077:
p.000077:
p.000077: No [ ] Yes [ ] Explain:
p.000077:
p.000077: Summary of protocol Actual ceiling set by the NatHREC
p.000077:
p.000078: 78
p.000078:
p.000078: participants New participants accrued since last review Total participants accrued since
p.000078: protocol began
p.000078:
p.000078:
p.000078: Have any unexpected complications or side effects been noted since last review?
p.000078: Investigational new drug/device
p.000078: Have any investigators been added or deleted since the last review?
...
Searching for indicator disability:
(return to top)
p.000061: The investigator/researcher with overall responsibility for the research. In a multi-site study, in a country, there
p.000061: should be one overall PI to be answerable, with other CO –PI’s as the case may be.
p.000061: Project Manager Individual responsible for coordinating an investigational study. This person may
p.000061: also be referred to as a Site Coordinator. Serve as the primary point of contact for the NatHREC.
p.000061:
p.000061: Proposal Deviation/ Violation
p.000061: Any instance in which the NatHREC-approved proposal has not been followed.
p.000061: Protocol A document that describes the objectives, design, methodology, statistical
p.000061: considerations (or other methods of data analysis) and organisation of a research study.
p.000061: Quorum Attendance at any convened meeting of the board where at least half of
p.000061: the regular (or alternate) members, including at least one physician and one layperson, is maintained
p.000061: throughout the discussions and voting portions of the meeting.
p.000061: Research Research is a systematic process of steps used to collect and analyze
p.000061: information to increase understanding of a topic or issue". It consists of three steps: Pose a question, collect data
p.000061: to answer the question, and present an answer to the question.
p.000061: Research Participant Is a patient, service user, or any healthy person who is taking part in the study
p.000061:
p.000061: Serious Adverse Event (SAE)
p.000061: Is untoward occurrence that results in death, is life-threatening, and requires hospitalization or
p.000061: prolongation of existing hospitalization, results in persistent or significant disability or
p.000061: incapacity or that maybe consistence with development of a congenital anomaly.
p.000061: The adverse event is SERIOUS and should be reported when the
p.000061:
p.000061:
p.000062: 62
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062: Standard Operating Procedures (SOPs)
p.000062: patient outcome is:
p.000062: Death - Report if the patient's death is suspected as being a direct outcome of the adverse event.
p.000062: Life- Threatening - Report if the patient was at substantial risk of dying at the time of the adverse event or it is
p.000062: suspected that the use or continued use of the product would result in the patient's death. Examples: Pacemaker
p.000062: failure; gastrointestinal haemorrhage; bone marrow suppression; infusion pump failure which permits uncontrolled free
p.000062: flow resulting in excessive drug dosing.
p.000062: Hospitalization - (initial or prolonged)-Report if admission to the hospital or prolongation of a hospital stay results
p.000062: because of the adverse event. Examples. Anaphylaxis pseudomembranous colitis or bleeding causing or prolonging
p.000062: hospitalisation.
p.000062: Disability - Report if the adverse event resulted in a significant, persistent, or permanent change,
p.000062: impairment, damage or disruption in the patient's body function/structure, physical activities or
p.000062: quality of life. Examples: Cerebrovascular accident due to drug-induced hypercoagulability; toxicity, peripheral
p.000062: neuropathy.
p.000062: Congenital Anomaly - Report if there is suspicions that exposure to a medical product prior to conception or
p.000062: during pregnancy resulted in an adverse outcome in the child. Examples: Vaginal cancer in female off
p.000062: spring from diethylstilbestrol during pregnancy, malformation in the offspring caused by thalidomide.
p.000062: Requires Intervention to Prevent Permanent Impairment or Damage-Report if suspect that the use of a
p.000062: medical product may result in a condition, which required medical or surgical intervention to
p.000062: preclude permanent impairment or damage to a patient. Examples: Acetaminophen overdose-induced
p.000062: hepatotoxicity requiring treatment with acetylcysteine to prevent permanent damage burns from radiation
p.000062: equipment requiring drug therapy, breakage of a screw requiring replacement of hardware to prevent
p.000062: malunion of a fractured long bone.
p.000062: Detailed, written instructions, in a certain format, describe activities and action undertaken by an
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.000060: medicinal product which are relevant to the study of the product in human subjects
p.000060: Medical Device A medical device is any health care product that does not achieve any of its intended
p.000060: purposes by chemical action or by being metabolized. Medical devices include items such as diagnostic test kids,
p.000060: crutches, electrodes, prescribed beds, pacemakers, arterial
p.000060:
p.000061: 61
p.000061:
p.000061: grafts, intraocular lenses, and orthopaedic pins. Medical devices also include diagnostic aids such as
p.000061: reagents and test kids for in vitro diagnosis of disease and other conditions, for example,
p.000061: pregnancy.
p.000061: Minutes The official record of events, activities, and actions taken by the
p.000061: convened NatHREC.
p.000061: Monitoring visit Oversight visits to study sites by the NatHREC or its
p.000061: representatives to assess the conduct of NatHREC-approved research.
p.000061:
p.000061: National Research Ethics Committee (NatHREC)
p.000061: A national independent ethics review committee that is housed within the NIMR structure. The NatHREC is
p.000061: a subcommittee to the MRCC.
p.000061: Nutrient Supplements Substances, which may or may not be regulated that are necessary for the body's nutritional and
p.000061: metabolic processes.
p.000061: Participants’ rights Recognition of the inherent dignity and of the equal and inalienable
p.000061: rights of all members of the human family is the foundation of freedom, justice and peace in the
p.000061: world. It is essential that Human Rights should be protected by the rule of law.
p.000061:
p.000061: Principal Investigator (PI)
p.000061: The investigator/researcher with overall responsibility for the research. In a multi-site study, in a country, there
p.000061: should be one overall PI to be answerable, with other CO –PI’s as the case may be.
p.000061: Project Manager Individual responsible for coordinating an investigational study. This person may
p.000061: also be referred to as a Site Coordinator. Serve as the primary point of contact for the NatHREC.
p.000061:
p.000061: Proposal Deviation/ Violation
p.000061: Any instance in which the NatHREC-approved proposal has not been followed.
p.000061: Protocol A document that describes the objectives, design, methodology, statistical
p.000061: considerations (or other methods of data analysis) and organisation of a research study.
p.000061: Quorum Attendance at any convened meeting of the board where at least half of
p.000061: the regular (or alternate) members, including at least one physician and one layperson, is maintained
p.000061: throughout the discussions and voting portions of the meeting.
p.000061: Research Research is a systematic process of steps used to collect and analyze
p.000061: information to increase understanding of a topic or issue". It consists of three steps: Pose a question, collect data
p.000061: to answer the question, and present an answer to the question.
p.000061: Research Participant Is a patient, service user, or any healthy person who is taking part in the study
p.000061:
p.000061: Serious Adverse Event (SAE)
...
Health / Physically Disabled
Searching for indicator illness:
(return to top)
p.000009:
p.000009: Condition of Appointment
p.000009: 1. Willingness to publicize their identity, name, profession and affiliation to the Committee.
p.000009: 2. Willingness to sign a confidentiality agreement at the start of the term and abide by the
p.000009: confidentiality agreement regarding meeting deliberations, applications, proposal submissions, information
p.000009: on research participants and related matters which they have had the privilege to have as a result of being members
p.000009: of the Committee. The confidentiality protects the privacy and confidentiality of all parties whose
p.000009: information may be disclosed to the Committee in the course of its work.
p.000009: 3. Willingness to disclose any conflict of interest– financial, professional, or otherwise – in a project
p.000009: or proposal under consideration.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: 4. Any member who has any vested interest in a proposal submitted to the Committee for review may
p.000010: provide the NatHREC with information about the proposal, but shall not participate in the deliberations on the
p.000010: proposal.
p.000010:
p.000010: Resignation, Disqualification, Replacement of Members
p.000010: 1. Members may resign their position by submitting a letter of resignation to the Chairperson.
p.000010: 2. Members may also be disqualified from continuance should the appointing authority provide written
p.000010: reasons to the NatHREC members and there is unanimous agreement.
p.000010: 3. NatHREC shall request for a replacement of any member under the following circumstances:
p.000010: i. Protracted illness of a member, which does not permit him/her to participate in the
p.000010: deliberations of the Committee.
p.000010: ii. Persistent absenteeism of a member without reasonable cause
p.000010: iii. Voluntary withdrawal by a member.
p.000010: iv. Ethical misconduct (s)
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: SOP 02. CONFIDENTIALITY OF PROCEEDINGS
p.000011:
p.000011: 1. Members do not sit on the NatHREC meeting in any specific representative capacity (institutions,
p.000011: associations, departments) and must be able to discuss freely the applications submitted to them.
p.000011: 2. The NatHREC meetings must be completely confidential.
p.000011: 3. Any breaches of confidentiality by members will result in termination of their membership.
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: SOP 03: CONFLICT OF INTEREST AGREEMENT
p.000011:
p.000011: The WHO Declaration of Interests for WHO Experts defines a conflict of interest as follows: “A conflict of interest
p.000011: means that the expert or his/her partner (“partner” includes a spouse or other person with whom s/he has a
p.000011: similar close personal relationship), or the administrative unit with which the expert has an employment
p.000011: relationship, has a financial or other interest that could unduly influence the expert’s position with respect to the
...
Searching for indicator physically:
(return to top)
p.000076: Telephone call:
p.000076:
p.000076: Fax: ...………………...............…… Of ................…………………………......
p.000076: Date: ……………………...................
p.000076:
p.000076: Mailed letter Ref: …………………………………. Of …………………….
p.000076: Date: ……………....................................
p.000076:
p.000076: Email of: …………………………………….......................................................
p.000076: Date: …………………………………….......
p.000076: Other methods (Specify):
p.000076:
p.000076: Name of participant:
p.000076:
p.000076: Address:
p.000076:
p.000076: Title of the protocol being participated in Starting date of participation: What is requested:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076: Action taken
p.000076:
p.000076:
p.000076:
p.000076:
p.000076: Outcome
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076: ………………………………… ………………………………………
p.000076: Name of receiving officer Signature
p.000076:
p.000077: 77
p.000077:
p.000077: FORM 06: ANNUAL CONTINUING REVIEW APPLICATION/ASSESSMENT
p.000077:
p.000077: Protocol title:
p.000077:
p.000077:
p.000077: Certificate approval no. Principal Investigator:
p.000077: Action requested: Review for new subject accrual to continue [ ]
p.000077: Review for enrolled participants follow-up only [ ] Review for termination of study
p.000077: [ ]
p.000077:
p.000077:
p.000077: Have there been any amendments since last review?
p.000077: Yes [ ] Comment:
p.000077:
p.000077:
p.000077: No [ ] Comment:
p.000077:
p.000077:
p.000077: Impaired participants None [ ] Physically [ ] Mentally [ ] Both [ ]
p.000077: Others (Specify):
p.000077:
p.000077:
p.000077:
p.000077:
p.000077: Have there been any changes in the participant population, recruitment or selection criteria since
p.000077: the last review?
p.000077: Have there been any changes in the informed consent process or documentation since
p.000077: the last review?
p.000077: Has any information appeared in the literature or evolved from this or similar research that
p.000077: might affect the committee’s evaluation of the risk/benefit analysis of human
p.000077: subjects involved in this protocol?
p.000077: Have any participants withdrawn for this study since the last approval?
p.000077: No [ ] Yes [ ] Explain:
p.000077:
p.000077:
p.000077: No [ ] Yes [ ] Explain:
p.000077:
p.000077:
p.000077: Yes [ ] Comment:
p.000077:
p.000077:
p.000077: No [ ] Comment:
p.000077:
p.000077:
p.000077:
p.000077: No [ ] Yes [ ] Explain:
p.000077:
p.000077: Summary of protocol Actual ceiling set by the NatHREC
p.000077:
p.000078: 78
p.000078:
p.000078: participants New participants accrued since last review Total participants accrued since
p.000078: protocol began
p.000078:
p.000078:
p.000078: Have any unexpected complications or side effects been noted since last review?
p.000078: Investigational new drug/device
...
Health / Physically Ill
Searching for indicator sick:
(return to top)
p.000040: Secretariat shall be placed on the agenda of the next Committee meeting.
p.000040: 3. A file shall be maintained that identifies investigators who are found to be in non-compliance with the
p.000040: requirements of the NatHREC, NIMR policy, TFDA and other relevant regulations, and any applicable international
p.000040: guidelines.
p.000040:
p.000041: 41
p.000041:
p.000041: 4. Researchers or others who fail to respond to the Committee’s requests will be notified in writing of
p.000041: the Committee’s decisions, and the appropriate institutions and individuals informed.
p.000041: 5. The Committee may elect to suspend or terminate approval of current studies or refuse subsequent applications
p.000041: from the investigators cited. Such decisions shall be recorded in the minutes.
p.000041: 6. The Secretariat shall notify the investigator of the Committee’s action in writing.
p.000041: 7. Four copies of the notification letter shall be produced. The original shall be sent to the
p.000041: investigator, the second copy to the relevant National Authority (e.g. TFDA, COSTECH), the third to the sponsor or the
p.000041: sponsor’s representative of the study and the fourth to the non-compliance file and stored on the shelf with an
p.000041: appropriate label.
p.000041: 8. The researcher must respond in writing with a description of any corrective actions that are to take
p.000041: place and a timeline for implementation.
p.000041: 9. The findings will be communicated to the MRCC for further action.
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041: SOP 17: ABSENCE OF PI
p.000041:
p.000041: From time to time, the PI may be absent due to annual leave, sick leave or for other reasons. For absences of up to one
p.000041: month, the PI is responsible for ensuring that his/her responsibilities as PI are carried out by a suitable temporary
p.000041: replacement and that that replacement is identified to the Secretariat.
p.000041: In case the PI is absent for one month to six months, he/she should notify NatHREC in writing. If the PI is absent for
p.000041: six months or more the proposal should be amended to replace the PI.
p.000041:
p.000041:
p.000041:
p.000041:
p.000042: 42
p.000042:
p.000042: SOP 18: REVIEW OF FINAL REPORTS AND CLOSURE OF A RESEARCH STUDY
p.000042:
p.000042: The purpose of this SOP is to provide instructions for the review and follow-up, if appropriate, of final reports
p.000042: for any study previously approved by the NatHREC. This SOP applies to the review and follow-up the final report
p.000042: which is an obligatory review of each investigator’s activities presented as a written report to
p.000042: the Committee after the last participant had completed all visits and all adverse experiences have
p.000042: been brought to appropriate resolution.
p.000042:
p.000042: Final reports must be submitted to NatHREC via a Close-out Form (Form 08) and processed as an expedited
p.000042: review.
p.000042:
p.000042: Detailed instruction
p.000042:
p.000042: 1. The Secretariat shall review all Continuing Review and Close-out Forms that indicate that the
p.000042: research is closing.
p.000042: 2. The expedited reviewer will request additional information from the researcher as needed.
p.000042: 3. Written documentation acknowledging the close-out will be provided to the investigator and a copy
p.000042: retained in the proposal file.
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.000062: during pregnancy resulted in an adverse outcome in the child. Examples: Vaginal cancer in female off
p.000062: spring from diethylstilbestrol during pregnancy, malformation in the offspring caused by thalidomide.
p.000062: Requires Intervention to Prevent Permanent Impairment or Damage-Report if suspect that the use of a
p.000062: medical product may result in a condition, which required medical or surgical intervention to
p.000062: preclude permanent impairment or damage to a patient. Examples: Acetaminophen overdose-induced
p.000062: hepatotoxicity requiring treatment with acetylcysteine to prevent permanent damage burns from radiation
p.000062: equipment requiring drug therapy, breakage of a screw requiring replacement of hardware to prevent
p.000062: malunion of a fractured long bone.
p.000062: Detailed, written instructions, in a certain format, describe activities and action undertaken by an
p.000062: organization to achieve uniformity of the performance of a specific function.
p.000062: Study site Is an organization, a unit that is responsible for carrying a research in a given
p.000062: locality.
p.000062:
p.000062: Vulnerable Participants
p.000062: A vulnerable category of participants includes children, prisoners, pregnant women, handicapped or mentally disabled
p.000062: persons, and economically or educationally disadvantaged persons, who are likely to be vulnerable to coercion or
p.000062: undue influence.
p.000062:
p.000062:
p.000062:
p.000062:
p.000063: 63
p.000063:
p.000063: APPENDIX II: FORMS/TOOLS
p.000063:
p.000063: FORM 01:
p.000063: CONFIDENTIALITY AND CONFLICT OF INTEREST DECLARATION FORM FOR MEMBERS OF THE NATIONAL HEALTH RESEARCH
p.000063: ETHICS REVIEW COMMITTEE
p.000063:
p.000063: ………… Meeting of National Health Research Ethics Review Committee/Clinical Trials Sub-committee
p.000063:
p.000063: Confidentiality:
p.000063:
p.000063: I agree to consider all discussions and / or
p.000063: statements made in this meeting as confidential information. I declare to safeguard confidentiality during and
p.000063: after the meeting. I also declare to consider any documents, materials or information provided to me in
p.000063: the course of the meeting, or in conducting activities of this committee after the meeting, as confidential materials,
p.000063: never to be divulged to any person without any prior written permission of the Chairperson of the
p.000063: committee.
p.000063:
p.000063: Conflict of Interest
p.000063: I declare that I have no/I have a conflict of interest in relation to the following/none of the proposals tabled for
...
p.000072: form of treatment or intervention, please respond to the following questions:
p.000072:
p.000072: a) Does the trial comply with Good Clinical Practice (GCP)?
p.000072:
p.000072: b) Does this trial involve testing a new drug, vaccine or medical device which is not
p.000072: registered in Tanzania?
p.000072:
p.000072: c) If this trial involves testing a new drug, vaccine or medical device, please attach the
p.000072: investigator brochure?
p.000072:
p.000072: If there is no investigator brochure, please explain the reason.
p.000072:
p.000072: d) What will be offered to the control arm?
p.000072:
p.000072: e) Please confirm that TFDA approval will be processed before data collection begins.
p.000072:
p.000072: f) Is there a Data Monitoring & Safety Committee in place? YES/NO
p.000072:
p.000072: If NO, please explain reasons
p.000072:
p.000072: g) If the intervention to be tested is found to be effective, describe plans to make it
p.000072: available to the participants and other people after the end of the trial.
p.000072:
p.000072: h) Have you obtained a certificate insurance cover for study participants locally (a cover
p.000072:
p.000072:
p.000073: 73
p.000073:
p.000073: from insurance company based in Tanzania)? YES/NO If YES please attach
p.000073:
p.000073: If NO please describe how this will be obtained
p.000073:
p.000073: 25. Is the study going to involve vulnerable population? YES/NO
p.000073: (Vulnerable population include: pregnant women, human foetuses, neonates, children, prisoners, hospitalized patients,
p.000073: mentally ill persons etc)
p.000073:
p.000073: If YES, describe steps which will be taken to ensure protection of human subjects
p.000073:
p.000073: 26. Please give details of the funder.
p.000073:
p.000073:
p.000073: 27. Please give details of research sponsor. This is not necessarily the funding body. The sponsor is
p.000073: responsible for the initiation and management of the study. All clinical trials should have an identified
p.000073: sponsor.
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000074: 74
p.000074:
p.000074: FORM 4: RESEARCH PROPOSAL ASSESSMENT FORM
p.000074:
p.000074: NATIONAL INSTITUTE FOR MEDICAL RESEARCH
p.000074:
p.000074: Telephone 255 22 2 121400
p.000074: Telex 41919 NIMR TZ P.O. Box
p.009653: 9653
...
Health / hospitalized patients
Searching for indicator hospitalized patients:
(return to top)
p.000072: registered in Tanzania?
p.000072:
p.000072: c) If this trial involves testing a new drug, vaccine or medical device, please attach the
p.000072: investigator brochure?
p.000072:
p.000072: If there is no investigator brochure, please explain the reason.
p.000072:
p.000072: d) What will be offered to the control arm?
p.000072:
p.000072: e) Please confirm that TFDA approval will be processed before data collection begins.
p.000072:
p.000072: f) Is there a Data Monitoring & Safety Committee in place? YES/NO
p.000072:
p.000072: If NO, please explain reasons
p.000072:
p.000072: g) If the intervention to be tested is found to be effective, describe plans to make it
p.000072: available to the participants and other people after the end of the trial.
p.000072:
p.000072: h) Have you obtained a certificate insurance cover for study participants locally (a cover
p.000072:
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p.000073: 73
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p.000073: from insurance company based in Tanzania)? YES/NO If YES please attach
p.000073:
p.000073: If NO please describe how this will be obtained
p.000073:
p.000073: 25. Is the study going to involve vulnerable population? YES/NO
p.000073: (Vulnerable population include: pregnant women, human foetuses, neonates, children, prisoners, hospitalized patients,
p.000073: mentally ill persons etc)
p.000073:
p.000073: If YES, describe steps which will be taken to ensure protection of human subjects
p.000073:
p.000073: 26. Please give details of the funder.
p.000073:
p.000073:
p.000073: 27. Please give details of research sponsor. This is not necessarily the funding body. The sponsor is
p.000073: responsible for the initiation and management of the study. All clinical trials should have an identified
p.000073: sponsor.
p.000073:
p.000073:
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p.000074: 74
p.000074:
p.000074: FORM 4: RESEARCH PROPOSAL ASSESSMENT FORM
p.000074:
p.000074: NATIONAL INSTITUTE FOR MEDICAL RESEARCH
p.000074:
p.000074: Telephone 255 22 2 121400
p.000074: Telex 41919 NIMR TZ P.O. Box
p.009653: 9653
p.009653: Telegrams MEDSEARCH Dar es Salaam
p.009653: Telefax 255 22 2 12120020
p.009653: Tanzania
p.009653: Email: headquaters@nimr.or.tz
p.009653: [DATE]
p.009653: Our Ref No. [####] Your Ref. [####]
p.009653:
p.009653: [Name of Reviewer] [Address]
p.009653:
p.009653: Dear [Name of Reviewer]
p.009653: REQUEST TO ASSESS A HEALTH RESEARCH PROPOSAL
p.009653:
...
Health / ill
Searching for indicator ill:
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p.000072: investigator brochure?
p.000072:
p.000072: If there is no investigator brochure, please explain the reason.
p.000072:
p.000072: d) What will be offered to the control arm?
p.000072:
p.000072: e) Please confirm that TFDA approval will be processed before data collection begins.
p.000072:
p.000072: f) Is there a Data Monitoring & Safety Committee in place? YES/NO
p.000072:
p.000072: If NO, please explain reasons
p.000072:
p.000072: g) If the intervention to be tested is found to be effective, describe plans to make it
p.000072: available to the participants and other people after the end of the trial.
p.000072:
p.000072: h) Have you obtained a certificate insurance cover for study participants locally (a cover
p.000072:
p.000072:
p.000073: 73
p.000073:
p.000073: from insurance company based in Tanzania)? YES/NO If YES please attach
p.000073:
p.000073: If NO please describe how this will be obtained
p.000073:
p.000073: 25. Is the study going to involve vulnerable population? YES/NO
p.000073: (Vulnerable population include: pregnant women, human foetuses, neonates, children, prisoners, hospitalized patients,
p.000073: mentally ill persons etc)
p.000073:
p.000073: If YES, describe steps which will be taken to ensure protection of human subjects
p.000073:
p.000073: 26. Please give details of the funder.
p.000073:
p.000073:
p.000073: 27. Please give details of research sponsor. This is not necessarily the funding body. The sponsor is
p.000073: responsible for the initiation and management of the study. All clinical trials should have an identified
p.000073: sponsor.
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
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p.000074: 74
p.000074:
p.000074: FORM 4: RESEARCH PROPOSAL ASSESSMENT FORM
p.000074:
p.000074: NATIONAL INSTITUTE FOR MEDICAL RESEARCH
p.000074:
p.000074: Telephone 255 22 2 121400
p.000074: Telex 41919 NIMR TZ P.O. Box
p.009653: 9653
p.009653: Telegrams MEDSEARCH Dar es Salaam
p.009653: Telefax 255 22 2 12120020
p.009653: Tanzania
p.009653: Email: headquaters@nimr.or.tz
p.009653: [DATE]
p.009653: Our Ref No. [####] Your Ref. [####]
p.009653:
p.009653: [Name of Reviewer] [Address]
p.009653:
p.009653: Dear [Name of Reviewer]
p.009653: REQUEST TO ASSESS A HEALTH RESEARCH PROPOSAL
p.009653:
p.009653: [SUMMARY OF REQUEST FOR REVIEW]
p.009653:
p.009653: The attached Proposal/Amendment research proposal entitled: [TITLE OF PROPOSAL AND NAME OF
...
Social / Access to Social Goods
Searching for indicator socialXwelfare:
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p.000088: Mr. Geoffrey Tibamanya.
p.000088:
p.000088: The Committee wishes to thank the NIMR management for facilitating preparation of this document and many thanks
p.000088: are directed to Research Triangle Institute International (RTI) for facilitating the development of this document.
p.000088:
p.000088: The NatHREC committee takes this opportunity to express sincere gratitude towards the team including the members of
p.000088: TANHER forum who participated in developing the first NatHREC SOPs in 2007. Furthermore, NatHREC committee extends a
p.000088: vote of thanks to the editor Dr. Leonard Mboera.
p.000088:
p.000088: Finally, the Committee wishes to express appreciation to all those in one way or another have
p.000088: facilitated and or contributed their thoughts in the preparation and finalization of the Standard Operating
p.000088: Procedures. Their valuable contribution will be cherished for many years to come.
p.000088:
p.000088: Julius Massaga PhD
p.000088: SECRETARY
p.000088: NATIONAL HEALTH RESEARCH ETHICS COMMITTEE
p.000088: iv
p.000088:
p.000088: ABBREVIATIONS
p.000088:
p.000088: CIOMS Council for International Organization of Medical Sciences CV
p.000088: Curriculum Vitae
p.000088: DSMB Data and Safety Monitoring Board
p.000088:
p.000088: ICH International Conference on Harmonization
p.000088:
p.000088: IRB Institutional Review Board
p.000088:
p.000088: IREC Institutional Review Ethics Committee MOHSW Ministry of Health and
p.000088: Social Welfare MRCC Medical Research Coordinating Committee NatHREC National
p.000088: Health Research Ethics Committee NIMR National Institute for Medical Research
p.000088: NSR Non-Significant Risk Device
p.000088:
p.000088: PI Principal Investigator
p.000088:
p.000088: RTI Research Triangle Institute International
p.000088:
p.000088: SAE Serious Adverse Events
p.000088:
p.000088: SOPs Standard Operating Procedures
p.000088:
p.000088: TANHER FORUM Tanzania National Health Research Forum TFDA Tanzania Food and Drug Authority
p.000088: UN United Nations
p.000088:
p.000088: WHO World Health Organization
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088: v
p.000088:
p.000088: FOREWORD
p.000088: It is with great pleasure that we have established the Standard Operating procedures (SOPs) for the National Health
p.000088: Research Ethics Committee (NatHREC), a Sub- Committee of the Medical Research Coordinating Committee
p.000088: of the National Institute for Medical Research (NIMR), Tanzania.
p.000088:
p.000088: The SOPs, by definition are detailed written instructions to achieve uniformity and maintain standards in the
p.000088: performance of a specific function. In this particular case, these instructions have detailed procedures
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Searching for indicator access:
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p.000050: viii. Continuing Review
p.000050: ix. Reports from site monitoring visits
p.000050:
p.000050: 2. Maintenance of study files
p.000050: All study files shall be kept throughout the course of the study with the most present documentation filed on top. All
p.000050: closed study files shall be sent to an off-site storage facility and stored for at least 15 years after the study
p.000050: closure. Archiving of files shall only be done when the NatHREC receives a final report of the study.
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050: SOP 25: PROCEDURES FOR MAINTAINING CONFIDENTIALITY
p.000050: OF NatHREC DOCUMENTS
p.000050:
p.000050: The sources of violation of confidentiality are usually found in the day-to-day use of copies of original documents.
p.000050: This SOP therefore describes how to handle original documents and copies of documents in order to
p.000050: protect confidentiality of documents. This SOP applies to all kinds of handling, distribution and
p.000050: storage of submitted study proposals, Committee documents, and correspondence with experts as well as
p.000050: the IRB auditors. It shall be mandatory to maintain confidentiality of study Committee documents, and correspondences.
p.000050: It is the responsibility of all members of the Committee and staff of the Secretariat to enforce confidentiality.
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
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p.000051: 51
p.000051:
p.000051: Detailed instruction
p.000051:
p.000051: 1. Committee members
p.000051: Committee members who have signed a confidentiality agreement with NIMR at the beginning of their term of service to
p.000051: the Committee (SOP # 01) shall have access to the confidential documents.
p.000051:
p.000051: 2. Confidential documents
p.000051: Confidential documents shall include documents reviewed by Committee members (Proposals and related documents, case
p.000051: report forms, informed consent documents, diary forms, scientific documents, expert opinion or reviews). They shall
p.000051: also include NatHREC documents (meeting minutes, advice and decisions) and correspondences (experts, auditors).
p.000051: Copies of documents, including draft and sequential versions, are considered to be confidential and are not
p.000051: permitted to be taken out except when a document is needed for day-to-day operations.
p.000051:
p.000051: 3. Authorization of acquisition of copies
p.000051: Only members of the NatHREC shall be allowed to ask for copies and only staff members of the Secretariat
p.000051: shall be allowed to make such copies.
p.000051:
p.000051: 4. Copies Issued to Non-Members of the Committee
p.000051: If non-members of the Committee need copies of original documents, it shall be the responsibility of the Secretariat to
p.000051: provide the copies.
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
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p.000051:
p.000052: 52
p.000052:
p.000052: SOP 26: AUDITING AND INSPECTION OF THE NatHREC
p.000052:
p.000052: The purpose of this procedure is to guide how to prepare for an audit or inspection of the IEC/IRB works. It
p.000052: is the responsibility of the Secretariat, members, Chairperson and administrative staff of the NatHREC
p.000052: for performing his/her task according to the SOPs and for being well prepared and available to answer questions
...
p.000053: some key staff shall also be present in the meeting room. The conversation shall start with the
p.000053: auditor(s)/inspector(s) stating the purpose of the visit and what kind of information and data they
p.000053: would need. The Chairperson/designated spokesperson of the Committee shall answer
p.000053: questions of the auditors/inspectors clearly, politely and truthfully with confidence and straight to the
p.000053: points. All information and files shall be made available as requested by the auditors/inspectors.
p.000053:
p.000053: 3. After the auditor(s)/inspector(s) have left, the Chairperson shall call for correction of
p.000053: any mistakes pointed out by the audit(s) and internal follow-up shall be carried out. A report shall be
p.000053: written and get approval from the Chairperson. Appropriate time for correction and improvement process
p.000053: shall be allowed and an outcome of the audit process shall be evaluated. The record of the report on the
p.000053: audit/inspection meeting shall be kept in the audit/inspection file and record of findings from the
p.000053: internal follow-up audit in the internal audit file.
p.000053:
p.000053: 4. Internal auditing of NatHREC should be conducted by MRCC while the external IRB auditing to be done
p.000053: by the NatHREC.
p.000053:
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p.000054: 54
p.000054:
p.000054: SOP 27: ARCHIVING OF NatHREC DOCUMENTS
p.000054:
p.000054: The purpose of this SOP is to provide instruments for storing inactive study files and administrative documents in a
p.000054: secure manner while maintaining access for review by auditors and inspectors. The files and documents are retained
p.000054: for at least fifteen years after completion of the research so that the records are accessible for auditors and
p.000054: inspectors. Copying files and documents for or by authorized representatives of the national authority when required
p.000054: is allowed.
p.000054:
p.000054: Maintenance and retrieval of archived documents
p.000054: 1. After a study has been completed and the final report accepted, the Secretary shall do the following:
p.000054: i. Remove the contents of the entire study file from the active study filing.
p.000054: ii. Verify that all the documents are present in organized manner.
p.000054: iii. Provide an archive number from these documents and enter the number into the database and/or
p.000054: Archive Logbook.
p.000054: iv. Place the file in a storage container.
p.000054: v. Send it to the appropriate storage facility.
p.000054: vi. Maintain a log of materials that have been archived.
p.000054:
p.000054: 2. To archiving administrative documents, an administrative staff of the Secretariat shall
p.000054: perform inventories of miscellaneous administrative documents, place the documents in an appropriate
p.000054: storage container, and send it to the appropriate storage facility. In retrieving documents the Secretary shall
p.000054: maintain confidentiality as stipulated in (SOP# 5) (Procedure for Maintaining Confidentiality of Ethical Review
p.000054: Committee Documents).
p.000054:
p.000054: 3. Retrieval of documents shall be done following NIMR institutional procedures. The retrieved files shall be
p.000054: returned to the archive after completion of use.
p.000054:
p.000054:
p.000054:
p.000054:
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Searching for indicator accessXtoXinformation:
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p.000065: the Committee and to abstain from any participation in discussions or recommendations in respect
p.000065: of such proposals.
p.000065:
p.000065: If an applicant submitting a protocol believes that an Ethics Review Committee member has a potential
p.000065: conflict, the investigator may request in writing or by telephone to the Chairperson that the member be
p.000065: excluded from the review of the protocol.
p.000065:
p.000065: Members will notify the Chairman any conflict of interest that they may have with any application and if so will not
p.000065: participate in evaluation of the proposal of interest.
p.000065:
p.000065: A member or members who may have a conflict of interest may not be counted toward a quorum and may not
p.000065: vote.
p.000065: All members of the National Ethics Review Committee will sign a Confidentiality and Conflict of Interest
p.000065: declaration form at the beginning of every meeting that they will attend. The form will define elements of Conflict of
p.000065: Interest.
p.000065:
p.000065: Confidentiality and non-disclosure
p.000065: In the course of your activities as a member of the National Ethics Review Committee, you may
p.000065: be provided with confidential information and documentation (referred to as the “Confidential Information”).
p.000065: You agree to take reasonable measures to protect the Confidential Information: subject to applicable
p.000065: legislation,
p.000065:
p.000066: 66
p.000066:
p.000066: including the Access to Information Act, not to disclose confidential information to any person; not to use
p.000066: confidential information for any purpose outside the committee, and for any purpose outside the Committee’s
p.000066: mandate, and in particular, in a manner which would result in a benefit to yourself or any third party, and to return
p.000066: all confidential information (including any minutes or notes you have made as part of your committee duties) to
p.000066: the Chairperson upon termination of your functions as a committee member.
p.000066:
p.000066: Please sign and date this agreement, if the undersigned agrees with the terms and conditions set forth above. The
p.000066: original shall be kept in file in the custody of the regularly compliance office. A copy shall be provided
p.000066: for your records.
p.000066:
p.000066: I (name) ……………………………… Address…………………………………………...
p.000066: ……………………………………………………………………………………………….. Have read and accept the aforementioned terms and conditions as explained in
p.000066: this agreement.
p.000066:
p.000066: ……………………………………… …………………………………….. Undersigned Signature
p.000066: Date
p.000066:
p.000066: ……………………………………… ……………………………………. Compliance Officer
p.000066: Date
p.000066:
p.000066:
p.000066:
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p.000067: 67
p.000067:
p.000067: FORM 2: CHECKLIST ETHICAL CLEARANCE APPLICATION SUBMISSION
p.000067:
p.000067: 1. NEW PROPOSAL AND AMENDMENT
p.000067:
p.000067: Required Documents: Five (5) hard copies of all documents Attached with
p.000067: application?
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Social / Age
Searching for indicator age:
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p.000070: clearances sought or obtained from
p.000070: other ethics committees? (This includes institutional ethics approval within Tanzania and in
p.000070: other countries if appropriate). Please attach approval certificates from other ethics committee(s).
p.000070: Provide the list of changes from the first (initial)/previous submission in case of
p.000070: revised/amended submission
p.000070:
p.000070: 1. Provide the scientific background, study design and objectives and hypotheses.
p.000070: Max 400 words
p.000070:
p.000070:
p.000070:
p.000070:
p.000070: 2. State the intended value of the project or rationale. Why it is important to conduct this study in
p.000070: Tanzania? Provide relevant references as appropriate.
p.000070: Max 300 words
p.000070:
p.000070:
p.000070:
p.000070:
p.000070: 3. State the total duration of the project, and where it will be undertaken in Tanzania (and also in other
p.000070: countries if appropriate).
p.000070:
p.000070:
p.000070:
p.000070: 4. Provide evidence (such as commitment/endorsement letter) to show that local government
p.000070: officials in the region(s)/district(s) where the proposed research will be conducted have been informed about
p.000070: this study.
p.000070: IF THIS HAS NOT BEEN DONE, describe how you plan to achieve this BEFORE the study starts.
p.000070:
p.000070:
p.000070:
p.000070: 5. Specify the number of the study participants, with scientific justification for sample size,
p.000070: age, gender.
p.000070:
p.000070:
p.000070:
p.000070: 6. Specify recruitment methods, inclusion and exclusion criteria and study end points.
p.000070:
p.000070:
p.000071: 71
p.000071:
p.000071:
p.000071:
p.000071:
p.000071: 7. Specify data collection procedures, including interviews and sample collection, involving
p.000071: human participants with brief details of actual methods. Attach copies of questionnaires and other data
p.000071: collection tools in English and Kiswahili.
p.000071: Max 500 words
p.000071:
p.000071:
p.000071:
p.000071: 8. If applicable, describe procedures to be used to process, store and test biological samples
p.000071: (e.g. blood, genital swabs, urine, etc).
p.000071:
p.000071:
p.000071:
p.000071: 9. If samples will be taken overseas, are there samples which will be left in Tanzania?
p.000071: Describe procedures to be used in their shipping, storage and when will be destroyed. Indicate which institution or
p.000071: laboratory samples will be analyzed. Please note that before samples are shipped outside Tanzania MTA clearance
p.000071: is required.
p.000071:
p.000071:
p.000071: 10 Is the technology required for analysis of samples available in Tanzania? YES/NO
p.000071:
p.000071: If YES, please describe why are samples being taken outside the country
p.000071:
p.000071: 11 Would local scientist(s)(Tanzanian) be involved in sample analysis? YES/NO
p.000071:
p.000071: If YES describe her/his involvement, and if NOT please explain what are the strategies for technology transfer
p.000071:
p.000071: 12 Specify data management procedures and methods to be used during data analysis.
p.000071:
...
Social / Child
Searching for indicator child:
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p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062: Standard Operating Procedures (SOPs)
p.000062: patient outcome is:
p.000062: Death - Report if the patient's death is suspected as being a direct outcome of the adverse event.
p.000062: Life- Threatening - Report if the patient was at substantial risk of dying at the time of the adverse event or it is
p.000062: suspected that the use or continued use of the product would result in the patient's death. Examples: Pacemaker
p.000062: failure; gastrointestinal haemorrhage; bone marrow suppression; infusion pump failure which permits uncontrolled free
p.000062: flow resulting in excessive drug dosing.
p.000062: Hospitalization - (initial or prolonged)-Report if admission to the hospital or prolongation of a hospital stay results
p.000062: because of the adverse event. Examples. Anaphylaxis pseudomembranous colitis or bleeding causing or prolonging
p.000062: hospitalisation.
p.000062: Disability - Report if the adverse event resulted in a significant, persistent, or permanent change,
p.000062: impairment, damage or disruption in the patient's body function/structure, physical activities or
p.000062: quality of life. Examples: Cerebrovascular accident due to drug-induced hypercoagulability; toxicity, peripheral
p.000062: neuropathy.
p.000062: Congenital Anomaly - Report if there is suspicions that exposure to a medical product prior to conception or
p.000062: during pregnancy resulted in an adverse outcome in the child. Examples: Vaginal cancer in female off
p.000062: spring from diethylstilbestrol during pregnancy, malformation in the offspring caused by thalidomide.
p.000062: Requires Intervention to Prevent Permanent Impairment or Damage-Report if suspect that the use of a
p.000062: medical product may result in a condition, which required medical or surgical intervention to
p.000062: preclude permanent impairment or damage to a patient. Examples: Acetaminophen overdose-induced
p.000062: hepatotoxicity requiring treatment with acetylcysteine to prevent permanent damage burns from radiation
p.000062: equipment requiring drug therapy, breakage of a screw requiring replacement of hardware to prevent
p.000062: malunion of a fractured long bone.
p.000062: Detailed, written instructions, in a certain format, describe activities and action undertaken by an
p.000062: organization to achieve uniformity of the performance of a specific function.
p.000062: Study site Is an organization, a unit that is responsible for carrying a research in a given
p.000062: locality.
p.000062:
p.000062: Vulnerable Participants
...
Searching for indicator children:
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p.000062: during pregnancy resulted in an adverse outcome in the child. Examples: Vaginal cancer in female off
p.000062: spring from diethylstilbestrol during pregnancy, malformation in the offspring caused by thalidomide.
p.000062: Requires Intervention to Prevent Permanent Impairment or Damage-Report if suspect that the use of a
p.000062: medical product may result in a condition, which required medical or surgical intervention to
p.000062: preclude permanent impairment or damage to a patient. Examples: Acetaminophen overdose-induced
p.000062: hepatotoxicity requiring treatment with acetylcysteine to prevent permanent damage burns from radiation
p.000062: equipment requiring drug therapy, breakage of a screw requiring replacement of hardware to prevent
p.000062: malunion of a fractured long bone.
p.000062: Detailed, written instructions, in a certain format, describe activities and action undertaken by an
p.000062: organization to achieve uniformity of the performance of a specific function.
p.000062: Study site Is an organization, a unit that is responsible for carrying a research in a given
p.000062: locality.
p.000062:
p.000062: Vulnerable Participants
p.000062: A vulnerable category of participants includes children, prisoners, pregnant women, handicapped or mentally disabled
p.000062: persons, and economically or educationally disadvantaged persons, who are likely to be vulnerable to coercion or
p.000062: undue influence.
p.000062:
p.000062:
p.000062:
p.000062:
p.000063: 63
p.000063:
p.000063: APPENDIX II: FORMS/TOOLS
p.000063:
p.000063: FORM 01:
p.000063: CONFIDENTIALITY AND CONFLICT OF INTEREST DECLARATION FORM FOR MEMBERS OF THE NATIONAL HEALTH RESEARCH
p.000063: ETHICS REVIEW COMMITTEE
p.000063:
p.000063: ………… Meeting of National Health Research Ethics Review Committee/Clinical Trials Sub-committee
p.000063:
p.000063: Confidentiality:
p.000063:
p.000063: I agree to consider all discussions and / or
p.000063: statements made in this meeting as confidential information. I declare to safeguard confidentiality during and
p.000063: after the meeting. I also declare to consider any documents, materials or information provided to me in
p.000063: the course of the meeting, or in conducting activities of this committee after the meeting, as confidential materials,
p.000063: never to be divulged to any person without any prior written permission of the Chairperson of the
p.000063: committee.
p.000063:
...
p.000072: registered in Tanzania?
p.000072:
p.000072: c) If this trial involves testing a new drug, vaccine or medical device, please attach the
p.000072: investigator brochure?
p.000072:
p.000072: If there is no investigator brochure, please explain the reason.
p.000072:
p.000072: d) What will be offered to the control arm?
p.000072:
p.000072: e) Please confirm that TFDA approval will be processed before data collection begins.
p.000072:
p.000072: f) Is there a Data Monitoring & Safety Committee in place? YES/NO
p.000072:
p.000072: If NO, please explain reasons
p.000072:
p.000072: g) If the intervention to be tested is found to be effective, describe plans to make it
p.000072: available to the participants and other people after the end of the trial.
p.000072:
p.000072: h) Have you obtained a certificate insurance cover for study participants locally (a cover
p.000072:
p.000072:
p.000073: 73
p.000073:
p.000073: from insurance company based in Tanzania)? YES/NO If YES please attach
p.000073:
p.000073: If NO please describe how this will be obtained
p.000073:
p.000073: 25. Is the study going to involve vulnerable population? YES/NO
p.000073: (Vulnerable population include: pregnant women, human foetuses, neonates, children, prisoners, hospitalized patients,
p.000073: mentally ill persons etc)
p.000073:
p.000073: If YES, describe steps which will be taken to ensure protection of human subjects
p.000073:
p.000073: 26. Please give details of the funder.
p.000073:
p.000073:
p.000073: 27. Please give details of research sponsor. This is not necessarily the funding body. The sponsor is
p.000073: responsible for the initiation and management of the study. All clinical trials should have an identified
p.000073: sponsor.
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
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p.000073:
p.000073:
p.000073:
p.000074: 74
p.000074:
p.000074: FORM 4: RESEARCH PROPOSAL ASSESSMENT FORM
p.000074:
p.000074: NATIONAL INSTITUTE FOR MEDICAL RESEARCH
p.000074:
p.000074: Telephone 255 22 2 121400
p.000074: Telex 41919 NIMR TZ P.O. Box
p.009653: 9653
p.009653: Telegrams MEDSEARCH Dar es Salaam
p.009653: Telefax 255 22 2 12120020
p.009653: Tanzania
p.009653: Email: headquaters@nimr.or.tz
p.009653: [DATE]
p.009653: Our Ref No. [####] Your Ref. [####]
p.009653:
p.009653: [Name of Reviewer] [Address]
...
Social / Fetus/Neonate
Searching for indicator foetuses:
(return to top)
p.000072: a) Does the trial comply with Good Clinical Practice (GCP)?
p.000072:
p.000072: b) Does this trial involve testing a new drug, vaccine or medical device which is not
p.000072: registered in Tanzania?
p.000072:
p.000072: c) If this trial involves testing a new drug, vaccine or medical device, please attach the
p.000072: investigator brochure?
p.000072:
p.000072: If there is no investigator brochure, please explain the reason.
p.000072:
p.000072: d) What will be offered to the control arm?
p.000072:
p.000072: e) Please confirm that TFDA approval will be processed before data collection begins.
p.000072:
p.000072: f) Is there a Data Monitoring & Safety Committee in place? YES/NO
p.000072:
p.000072: If NO, please explain reasons
p.000072:
p.000072: g) If the intervention to be tested is found to be effective, describe plans to make it
p.000072: available to the participants and other people after the end of the trial.
p.000072:
p.000072: h) Have you obtained a certificate insurance cover for study participants locally (a cover
p.000072:
p.000072:
p.000073: 73
p.000073:
p.000073: from insurance company based in Tanzania)? YES/NO If YES please attach
p.000073:
p.000073: If NO please describe how this will be obtained
p.000073:
p.000073: 25. Is the study going to involve vulnerable population? YES/NO
p.000073: (Vulnerable population include: pregnant women, human foetuses, neonates, children, prisoners, hospitalized patients,
p.000073: mentally ill persons etc)
p.000073:
p.000073: If YES, describe steps which will be taken to ensure protection of human subjects
p.000073:
p.000073: 26. Please give details of the funder.
p.000073:
p.000073:
p.000073: 27. Please give details of research sponsor. This is not necessarily the funding body. The sponsor is
p.000073: responsible for the initiation and management of the study. All clinical trials should have an identified
p.000073: sponsor.
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000074: 74
p.000074:
p.000074: FORM 4: RESEARCH PROPOSAL ASSESSMENT FORM
p.000074:
p.000074: NATIONAL INSTITUTE FOR MEDICAL RESEARCH
p.000074:
p.000074: Telephone 255 22 2 121400
p.000074: Telex 41919 NIMR TZ P.O. Box
p.009653: 9653
p.009653: Telegrams MEDSEARCH Dar es Salaam
p.009653: Telefax 255 22 2 12120020
...
Searching for indicator neonates:
(return to top)
p.000072: registered in Tanzania?
p.000072:
p.000072: c) If this trial involves testing a new drug, vaccine or medical device, please attach the
p.000072: investigator brochure?
p.000072:
p.000072: If there is no investigator brochure, please explain the reason.
p.000072:
p.000072: d) What will be offered to the control arm?
p.000072:
p.000072: e) Please confirm that TFDA approval will be processed before data collection begins.
p.000072:
p.000072: f) Is there a Data Monitoring & Safety Committee in place? YES/NO
p.000072:
p.000072: If NO, please explain reasons
p.000072:
p.000072: g) If the intervention to be tested is found to be effective, describe plans to make it
p.000072: available to the participants and other people after the end of the trial.
p.000072:
p.000072: h) Have you obtained a certificate insurance cover for study participants locally (a cover
p.000072:
p.000072:
p.000073: 73
p.000073:
p.000073: from insurance company based in Tanzania)? YES/NO If YES please attach
p.000073:
p.000073: If NO please describe how this will be obtained
p.000073:
p.000073: 25. Is the study going to involve vulnerable population? YES/NO
p.000073: (Vulnerable population include: pregnant women, human foetuses, neonates, children, prisoners, hospitalized patients,
p.000073: mentally ill persons etc)
p.000073:
p.000073: If YES, describe steps which will be taken to ensure protection of human subjects
p.000073:
p.000073: 26. Please give details of the funder.
p.000073:
p.000073:
p.000073: 27. Please give details of research sponsor. This is not necessarily the funding body. The sponsor is
p.000073: responsible for the initiation and management of the study. All clinical trials should have an identified
p.000073: sponsor.
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
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p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000074: 74
p.000074:
p.000074: FORM 4: RESEARCH PROPOSAL ASSESSMENT FORM
p.000074:
p.000074: NATIONAL INSTITUTE FOR MEDICAL RESEARCH
p.000074:
p.000074: Telephone 255 22 2 121400
p.000074: Telex 41919 NIMR TZ P.O. Box
p.009653: 9653
p.009653: Telegrams MEDSEARCH Dar es Salaam
p.009653: Telefax 255 22 2 12120020
p.009653: Tanzania
p.009653: Email: headquaters@nimr.or.tz
p.009653: [DATE]
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000001: consent and the appropriate protection of those unable to consent as essential measures to protect the individual
p.000001: persons and communities who participate in biomedical research and related fields involving human
p.000001: participants. It is against this background that the National Health Research Ethics Review Committee (NatHREC)
p.000001: was established by the Medical Research Coordinating Committee (MRCC) of the National Institute
p.000001: for Medical Research (NIMR) which was mandated to carryout, control, coordinate, register, monitor,
p.000001:
p.000002: 2
p.000002:
p.000002: evaluate and promote health research in Tanzania, or elsewhere on behalf of or for the benefit of the government of
p.000002: Tanzania (NIMR Act of Parliament in 1979).
p.000002:
p.000002: The purpose of this document is to outline the process for reviewing, authorizing, archiving, and amending Standard
p.000002: Operating Procedures (SOPs) for the NatHREC and other health research ethics committees operating in
p.000002: the country. The Institutional health research ethics committees in Tanzania are expected to adapt these
p.000002: standard operating procedures.
p.000002:
p.000002: The procedures shall be written in immediate future tense using active verbs and shall be written in simple
p.000002: language so that a reader unfamiliar with the procedures would be able to understand and apply the procedures
p.000002: accurately in proper time sequence by following the document.
p.000002:
p.000002: Health research ethical review determination criteria
p.000002:
p.000002: Health Research means a systematic investigation, including research development, testing and evaluation, designed to
p.000002: develop or contribute to new knowledge.
p.000002:
p.000002: Activities which meet this definition constitute health research for purposes of this SOP document, whether or not they
p.000002: are conducted or supported under a program which is considered health research for other purposes. For
p.000002: example, some demonstration, use of secondary data, use of stored specimen, studies involving vectors for
p.000002: human diseases and service programs may include health research activities.
p.000002:
p.000002: Health Research subject to regulation, encompass those research activities for which data is collected by any
p.000002: method for the purpose of generating knowledge or improving program or interventions in any area of
p.000002: public health in Tanzania mainland.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: VISION, MISSION AND FUNCTIONS
p.000003:
p.000003:
p.000003: The Vision and Mission statements for NatHREC together with the roles and functions are summarized herein:
p.000003:
p.000003: Vision Statement
p.000003: To have ethically and scientifically sound health research conducted in Tanzania.
p.000003:
p.000003: Mission Statement
p.000003: To ensure the scientific and ethical merits of health research and guarantee the rights, dignity, safety
...
p.000024: in literature review, objectives of the study, appropriateness of the methodology proposed,
p.000024: inclusion/exclusion criteria, control arms (placebo, if any) and withdrawal or discontinuation criteria. The
p.000024: study sites shall also be examined for suitability of the study in terms of geographical
p.000024: distribution of the problem under study, facility and infrastructure accessibility and availability at study sites to
p.000024: accommodate the study.
p.000024:
p.000024: 3. Qualifications of investigators
p.000024: Qualifications and experience of investigators shall be examined to see whether the proposed study and background
p.000024: of the participating investigators demonstrate sufficient capacity to conduct the study. Disclosure of potential
p.000024: conflicts of interest shall also be examined. In case of investigators from outside Tanzania, the proposal will be
p.000024: examined to ensure that it includes a local investigator who has sufficient capacity to carry out the study.
p.000024:
p.000024: 4. Study Participation
p.000024: Under this item the assessment shall be done with a view of evaluating voluntary, non-coercive recruitment of
p.000024: participation. The following aspects shall be assessed to see if they have been adequately considered in the proposal:
p.000024: i. Procedures for obtaining informed consent
p.000024:
p.000024:
p.000025: 25
p.000025:
p.000025: ii. Contents of the patient information sheet
p.000025: iii. Contents and language of the informed consent document
p.000025: iv. Translation of the informed consent document to the local language
p.000025: v. Language used is plain and easy to understand by the general public
p.000025: vi. Contact persons with address and phone numbers
p.000025: vii. Privacy and confidentiality
p.000025: viii. Risks -physical/mental/social
p.000025: ix. Benefits -to participants and to others
p.000025: x. Compensation -reasonable/ unreasonable
p.000025: xi. Involvement of vulnerable participants
p.000025: xii. Provisions for medical/psychosocial support
p.000025: xiii. Treatment for study related injuries
p.000025: xiv. Use of biological materials
p.000025: xv. Matters related to insurance of research participants and
p.000025: sponsor/researcher indemnity
p.000025:
p.000025: 5. Examination of Local Institutions and community Involvement
p.000025: Ethical research conduct involving human participation requires community consultation and involvement
p.000025: of local researchers and institutions in the study design, analysis and publication of the results. It
p.000025: also requires contribution to development of local capacity for research and treatment and benefit to
p.000025: local communities and availability of study results. The proposal shall be examined to assess adequate
p.000025: consideration of these aspects.
p.000025:
p.000025: 6. Decision by the Committee members
p.000025: The guidance, advice and decision reached by the Committee members shall be summarized in the Reviewers
p.000025: Guide. The summary shall include proposal title and date of review, checklist of documents reviewed, and
...
Social / Police Officer
Searching for indicator officer:
(return to top)
p.000042: the Committee after the last participant had completed all visits and all adverse experiences have
p.000042: been brought to appropriate resolution.
p.000042:
p.000042: Final reports must be submitted to NatHREC via a Close-out Form (Form 08) and processed as an expedited
p.000042: review.
p.000042:
p.000042: Detailed instruction
p.000042:
p.000042: 1. The Secretariat shall review all Continuing Review and Close-out Forms that indicate that the
p.000042: research is closing.
p.000042: 2. The expedited reviewer will request additional information from the researcher as needed.
p.000042: 3. Written documentation acknowledging the close-out will be provided to the investigator and a copy
p.000042: retained in the proposal file.
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000043: 43
p.000043:
p.000043: SOP 19: COMMUNICATION RECORDS
p.000043:
p.000043: The purpose of this SOP is to ensure proper completion, distribution and filing of verbal and written
p.000043: communication and other study-related or process-related information with investigators, sponsors,
p.000043: volunteer participants, institutes and TFDA. This SOP applies to all communicating activities related to the
p.000043: studies under the approval of the NatHREC.
p.000043:
p.000043: Detailed instruction
p.000043: 1. Individuals may utilize different communication recording mechanisms; that may be handwritten, typed or
p.000043: computer-generated.
p.000043:
p.000043: 2. The attending officer will fill out the communication form (Form 09) for keeping records.
p.000043:
p.000043: 3. Written record shall contain, but not limited to, the following: date of communication,
p.000043: study information (e.g. sponsor, proposal number, investigator), name of person contacted,
p.000043: contact address, telephone number, and e-mail, summary of the communication made, notation of any
p.000043: follow-up necessary and signature of individual making the record.
p.000043:
p.000043: 4. Upon completion of the record, the individual shall distribute copies as appropriate for
p.000043: filing.
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000044: 44
p.000044:
p.000044: SOP 20: SITE MONITORING VISITS
p.000044:
p.000044: The purpose of this SOP is to provide procedures as to when and how a study site should be visited and monitored with
p.000044: regards to the implementation of the proposal as approved by the NatHREC. This SOP applies to any visits and/or
p.000044: monitoring of any study sites identified in the approved proposal as the place where the studies and/or laboratory
p.000044: tests are being carried out or performed. It is the responsibility of the NatHREC to perform or designate some
p.000044: qualified agents to perform on its behalf site monitoring of the research projects it has approved.
p.000044: The Secretariat in consultation with the Chairperson shall initiate site monitoring of a study site for
p.000044: cause or not-for-cause.
p.000044:
p.000044: Detailed Instruction
p.000044:
p.000044:
p.000044: 1. Selection of study sites
...
p.000065: be provided with confidential information and documentation (referred to as the “Confidential Information”).
p.000065: You agree to take reasonable measures to protect the Confidential Information: subject to applicable
p.000065: legislation,
p.000065:
p.000066: 66
p.000066:
p.000066: including the Access to Information Act, not to disclose confidential information to any person; not to use
p.000066: confidential information for any purpose outside the committee, and for any purpose outside the Committee’s
p.000066: mandate, and in particular, in a manner which would result in a benefit to yourself or any third party, and to return
p.000066: all confidential information (including any minutes or notes you have made as part of your committee duties) to
p.000066: the Chairperson upon termination of your functions as a committee member.
p.000066:
p.000066: Please sign and date this agreement, if the undersigned agrees with the terms and conditions set forth above. The
p.000066: original shall be kept in file in the custody of the regularly compliance office. A copy shall be provided
p.000066: for your records.
p.000066:
p.000066: I (name) ……………………………… Address…………………………………………...
p.000066: ……………………………………………………………………………………………….. Have read and accept the aforementioned terms and conditions as explained in
p.000066: this agreement.
p.000066:
p.000066: ……………………………………… …………………………………….. Undersigned Signature
p.000066: Date
p.000066:
p.000066: ……………………………………… ……………………………………. Compliance Officer
p.000066: Date
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000067: 67
p.000067:
p.000067: FORM 2: CHECKLIST ETHICAL CLEARANCE APPLICATION SUBMISSION
p.000067:
p.000067: 1. NEW PROPOSAL AND AMENDMENT
p.000067:
p.000067: Required Documents: Five (5) hard copies of all documents Attached with
p.000067: application?
p.000067: 1. National Health Research Ethics Committee (NatHREC) Application Form □
p.000067: 2. Cover letter with Institution logo signed by PI or CO-PI □
p.000067: 3. Commitment letter from affiliated institution and/or local government
p.000067: officials
p.000067: □
p.000067: 4. Full study proposal (s) /or Amendment (s) with all relevant sections:
p.000067: Summary, Background and Rationale, Objectives, Methodology, Ethical □ considerations, Budget and
p.000067: Budget justification, References and
p.000067: Appendices, etc.
p.000067: 5. Informed Consent Forms/Assent Forms in English and Kiswahili with
p.000067: institution logo Local PI and NatHREC contacts □
p.000067: 6. IRB approval certificate from affiliating institution (s) where applicable □
p.000067: 7. Data collection tools in English and Kiswahili □
p.000067: 8. Elaborated recruitment procedure □
p.000067: 9. Written information to be provided to participants in English & Kiswahili □
...
p.000075:
p.000075: Yes, with minor revisions shown under. “Any Other Comment”
p.000075:
p.000075: Yes, with major revisions shown under, “Any Other
p.000075: Comments
p.000075:
p.000075: No, I do not recommend it; see under, “Any Other Comments”
p.000075:
p.000075: I am thanking you in advance for your early co-operation. Yours sincerely,
p.000075:
p.000075: Director General
p.000075: -------------------------------------------------------------------------------------------------------------------
p.000075: Please use another sheet of paper for your precise comments to the proposer, please do not sign the comments sheet, as
p.000075: it may be sent to the proposer.
p.000075:
p.000075:
p.000075:
p.000076: 76
p.000076:
p.000076: FORM 05: PARTICIPANT’S INQUIRY FORM
p.000076:
p.000076:
p.000076: Date Received Requested from:
p.000076: Telephone call:
p.000076:
p.000076: Fax: ...………………...............…… Of ................…………………………......
p.000076: Date: ……………………...................
p.000076:
p.000076: Mailed letter Ref: …………………………………. Of …………………….
p.000076: Date: ……………....................................
p.000076:
p.000076: Email of: …………………………………….......................................................
p.000076: Date: …………………………………….......
p.000076: Other methods (Specify):
p.000076:
p.000076: Name of participant:
p.000076:
p.000076: Address:
p.000076:
p.000076: Title of the protocol being participated in Starting date of participation: What is requested:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076: Action taken
p.000076:
p.000076:
p.000076:
p.000076:
p.000076: Outcome
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076: ………………………………… ………………………………………
p.000076: Name of receiving officer Signature
p.000076:
p.000077: 77
p.000077:
p.000077: FORM 06: ANNUAL CONTINUING REVIEW APPLICATION/ASSESSMENT
p.000077:
p.000077: Protocol title:
p.000077:
p.000077:
p.000077: Certificate approval no. Principal Investigator:
p.000077: Action requested: Review for new subject accrual to continue [ ]
p.000077: Review for enrolled participants follow-up only [ ] Review for termination of study
p.000077: [ ]
p.000077:
p.000077:
p.000077: Have there been any amendments since last review?
p.000077: Yes [ ] Comment:
p.000077:
p.000077:
p.000077: No [ ] Comment:
p.000077:
p.000077:
p.000077: Impaired participants None [ ] Physically [ ] Mentally [ ] Both [ ]
p.000077: Others (Specify):
p.000077:
p.000077:
p.000077:
p.000077:
p.000077: Have there been any changes in the participant population, recruitment or selection criteria since
p.000077: the last review?
p.000077: Have there been any changes in the informed consent process or documentation since
p.000077: the last review?
p.000077: Has any information appeared in the literature or evolved from this or similar research that
p.000077: might affect the committee’s evaluation of the risk/benefit analysis of human
p.000077: subjects involved in this protocol?
p.000077: Have any participants withdrawn for this study since the last approval?
...
p.000082:
p.000082:
p.000083: 83
p.000083:
p.000083: research summary - must be retained by the research team for at least 5 years after completion of the research (per
p.000083: regulations), unless NatHREC waived the requirement for informed consent or documentation of informed consent.
p.000083:
p.000083: Research was never done (lack of funding, etc.)
p.000083:
p.000083: Other reason to close the study, specify
p.000083:
p.000083:
p.000083:
p.000083: ………………………………… Name of Principal Investigator
p.000083:
p.000083: ………………………………… ……………………………………… Signature Date
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
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p.000083:
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p.000083:
p.000083:
p.000084: 84
p.000084:
p.000084: FORM 09: COMMUNICATION RECORD FORM
p.000084:
p.000084: Date
p.000084: Attention requested
p.000084:
p.000084:
p.000084:
p.000084: Requested by:
p.000084: Contact information
p.000084: Institution
p.000084:
p.000084:
p.000084:
p.000084: Postal address:
p.000084:
p.000084:
p.000084:
p.000084: Telephone number: Mobile number:
p.000084: Email:
p.000084:
p.000084:
p.000084: Action taken
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084: ………………………………… ……………………………………… Name of attending officer Signature
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
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p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000085: 85
p.000085:
p.000085:
p.000085: FORM 10: INSTITUTIONAL REVIEW BOARD (IRB) REPORT FORM
p.000085:
p.000085: Name of Institution/Institutional Review Board:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085: Date of Submission: / /
p.000085: DD MM YYYY
p.000085:
p.000085: Period: [_] Qtr 1 (Jan-Mar) [_] Q2 (Apr-Jun) [_] Q3 (Jul-Sep) [_] Q4 (Oct-Dec)
p.000085:
p.000085:
p.000085:
p.000085: No. Proposal IRB
p.000085: approval number
p.000085: Date approval issued
p.000085: Source of funds
p.000085: Principal Investigator (PI)
p.000085: Contact information for PI
p.000085: Type of study Duration of
p.000085: study
p.000085: Study area
p.000001: 1
p.000001:
p.000001:
p.000001:
p.000001:
p.000002: 2
p.000002:
p.000002:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003:
p.000003:
p.000003:
p.000001: 1
p.000001:
p.000001:
p.000004: 4
p.000004:
p.000004:
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: Comments:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000002: 2
p.000002:
p.000002: References
p.000002:
p.000002: 1. Standard Operational Procedure (SOPs) for NatHREC, 2007 edition 1 2. ADD THE TANZANIAN GUIDELINES
...
Social / Property Ownership
Searching for indicator home:
(return to top)
p.000063: Conflict of Interest
p.000063: I declare that I have no/I have a conflict of interest in relation to the following/none of the proposals tabled for
p.000063: discussion in this meeting.
p.000063:
p.000063: Conflict of Interest: (Write down)
p.000063: …………………………………………………………………………………………………..
p.000063: ………………………………………………………………………………………………….. Proposal for which I have a Conflict of Interest
p.000063: Proposal title:
p.000063: ……………………………………………………………………………………………….…
p.000063: ………………………………………………………………………………………………….
p.000063: PI:
p.000063: Type of Conflict of Interest:
p.000063: Financial
p.000063: Proposal Development Other aspects of the proposal
p.000063:
p.000063: Signature: …………………………………………………………
p.000063:
p.000063: Date: ………………………..............................................................
p.000063:
p.000063:
p.000063:
p.000063:
p.000064: 64
p.000064:
p.000064: FORM 01: CONFIDENTIALITY/CONFLICT OF INTEREST AGREEMENT
p.000064:
p.000064: CONFIDENTIALITY
p.000064:
p.000064: In recognition of the fact that, member’s name, and his/her affiliation herein after referred to as the
p.000064: “undersigned” and as a member of the National Ethics Review Committee has been asked and appointed to
p.000064: assess research studies involving human subjects, in order to ensure that the studies are conducted in a
p.000064: humane ethical manner, with highest standard of care according to the applied national local regulations,
p.000064: institutional policies and guidelines;
p.000064:
p.000064: You have been appointed as a member of the National ethics review committee as an individual, not as an
p.000064: advocate or representative of your home province/territory/community or as the
p.000064: delegate of any organization or private interest. Your fundamental duty is to independently review both
p.000064: scientific and ethical aspects of research protocols involving human subjects and make a
p.000064: determination and the best possible objective recommendations, based on the merits of the submissions you review.
p.000064:
p.000064: The National Ethics Review Committee aims to meet the highest ethical standards in order to merit the trust and
p.000064: confidence of the communities’ protection of rights and wellbeing of human subjects. As a member of
p.000064: the National Ethics Review Committee you are expected to meet the same high standards of ethical behaviour as you
p.000064: carry out your mandate.
p.000064:
p.000064: This Agreement, encompasses any information deemed confidential or proprietary provided to the Undersigned in
p.000064: conjunction with duties as a member of the National Ethics Review Committee. Any written information provided
p.000064: to the undersigned that is of a confidential, proprietary or privileged nature shall be
p.000064: identified accordingly.
p.000064:
p.000064: As such, the undersigned agrees to hold all confidential or proprietary trade secrets (“information”) in trust or
p.000064: confidence and agrees that it shall be used only for contemplated purposes; shall not be used for any other
p.000064: purpose or disclosed to any third party. Written confidential information provided for review shall not be
...
Searching for indicator property:
(return to top)
p.000064: determination and the best possible objective recommendations, based on the merits of the submissions you review.
p.000064:
p.000064: The National Ethics Review Committee aims to meet the highest ethical standards in order to merit the trust and
p.000064: confidence of the communities’ protection of rights and wellbeing of human subjects. As a member of
p.000064: the National Ethics Review Committee you are expected to meet the same high standards of ethical behaviour as you
p.000064: carry out your mandate.
p.000064:
p.000064: This Agreement, encompasses any information deemed confidential or proprietary provided to the Undersigned in
p.000064: conjunction with duties as a member of the National Ethics Review Committee. Any written information provided
p.000064: to the undersigned that is of a confidential, proprietary or privileged nature shall be
p.000064: identified accordingly.
p.000064:
p.000064: As such, the undersigned agrees to hold all confidential or proprietary trade secrets (“information”) in trust or
p.000064: confidence and agrees that it shall be used only for contemplated purposes; shall not be used for any other
p.000064: purpose or disclosed to any third party. Written confidential information provided for review shall not be
p.000064: copied or retained, and all confidential information (and any copies and notes thereof) shall remain the
p.000064: sole property of the National Ethics Review committee.
p.000064:
p.000064: The Undersigned agrees not to disclose or utilize, directly or indirectly, any confidential or
p.000064: proprietary information belonging to a third party in fulfilling this agreement. Furthermore, the undersigned
p.000064: confirms that his/her performance of this agreement is consistent with the institute’s policies and any contractual
p.000064: obligations they may have to third parties.
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000065: 65
p.000065:
p.000065: CONFLICT OF INTEREST
p.000065:
p.000065: It is a policy of the National Ethics Review Committee that no member may participate in the review or
p.000065: approval for activities in which that member has a conflict of interest except to provide information as
p.000065: requested by the National Ethics Review Committee.
p.000065:
p.000065: You shall immediately disclose to the Chairperson of the National Ethics Review Committee any actual or
p.000065: potential conflicts of interest that you may have in relation to any particular proposal submitted for review by
p.000065: the Committee and to abstain from any participation in discussions or recommendations in respect
p.000065: of such proposals.
p.000065:
p.000065: If an applicant submitting a protocol believes that an Ethics Review Committee member has a potential
...
Social / Religion
Searching for indicator faith:
(return to top)
p.000005: review have been articulated to give guidance to health research review committees in the protection and
p.000005: furtherance of the rights of research participants while taking cognizance of the key roles of relevant
p.000005: health research in improving the welfare of humankind.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: SOP 01: CONSTITUTING THE HEALTH RESEARCH ETHICS REVIEW COMMITTEE
p.000005: This SOP describes procedures for constituting the NatHREC, its composition, terms of reference and ethical basis. It
p.000005: also gives membership conditions of appointment, resignation or disqualification and replacement.
p.000005:
p.000005: Composition
p.000005: The Committee consists of up to 15 members who collectively have the relevant qualification and experience
p.000005: to review and evaluate the science, medical aspects, and ethics of health research proposals. It is composed
p.000005: of members with varying backgrounds to promote a complete and adequate review of health research
p.000005: proposals commonly received by NIMR. The NatHREC shall include the following category members:
p.000005:
p.000005: • Medical scientists;
p.000005: • Biomedical scientists;
p.000005: • Social scientists;
p.000005: • Legal representative
p.000005: • Unaffiliated community representatives (Teacher/Nurse);
p.000005: • Representatives of religious/Faith-Based Organizations.
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006: Terms of reference
p.000006: The Committee operates within specified Standard Operating Procedure (SOPs), which are detailed, written
p.000006: instructions presented in a format that describes all activities and actions to be undertaken by an organization
p.000006: for achieving uniformity of the performance of specific functions. The aim of the SOPs and
p.000006: their accompanying checklists and forms is to simplify the organization and documentation of
p.000006: operation, whilst maintaining high standard of performance. They facilitate and support ethical review by
p.000006: improving the standard and uniformity of the decision-making and assure and gain the confidence of the public in the
p.000006: working of NatHREC. The SOPs promote transparency and efficiency in communication and operations of NatHREC.
p.000006:
p.000006: The following are terms of reference under which the Committee operates:
p.000006:
p.000006: 1. Review health research proposals submitted to it within a reasonable time and document its views in writing to
p.000006: the applicant(s), clearly identifying the study, the documents reviewed and the dates for the following:
p.000006: 1.1 Approval for commencement of the study
p.000006: 1.2 Modifications required prior to its approval
p.000006: 1.3 Disapproval
p.000006: 1.4 Termination/suspension of any prior approval
p.000006:
p.000006: 2. Safeguard the dignity, rights, safety and wellbeing of study participants and communities. Special
p.000006: attention shall be paid to studies that may include vulnerable participants.
p.000006:
...
Searching for indicator religious:
(return to top)
p.000005:
p.000005: Under this part of the document the Standard Operating Procedures (SOPs) for health research ethics
p.000005: review have been articulated to give guidance to health research review committees in the protection and
p.000005: furtherance of the rights of research participants while taking cognizance of the key roles of relevant
p.000005: health research in improving the welfare of humankind.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: SOP 01: CONSTITUTING THE HEALTH RESEARCH ETHICS REVIEW COMMITTEE
p.000005: This SOP describes procedures for constituting the NatHREC, its composition, terms of reference and ethical basis. It
p.000005: also gives membership conditions of appointment, resignation or disqualification and replacement.
p.000005:
p.000005: Composition
p.000005: The Committee consists of up to 15 members who collectively have the relevant qualification and experience
p.000005: to review and evaluate the science, medical aspects, and ethics of health research proposals. It is composed
p.000005: of members with varying backgrounds to promote a complete and adequate review of health research
p.000005: proposals commonly received by NIMR. The NatHREC shall include the following category members:
p.000005:
p.000005: • Medical scientists;
p.000005: • Biomedical scientists;
p.000005: • Social scientists;
p.000005: • Legal representative
p.000005: • Unaffiliated community representatives (Teacher/Nurse);
p.000005: • Representatives of religious/Faith-Based Organizations.
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006: Terms of reference
p.000006: The Committee operates within specified Standard Operating Procedure (SOPs), which are detailed, written
p.000006: instructions presented in a format that describes all activities and actions to be undertaken by an organization
p.000006: for achieving uniformity of the performance of specific functions. The aim of the SOPs and
p.000006: their accompanying checklists and forms is to simplify the organization and documentation of
p.000006: operation, whilst maintaining high standard of performance. They facilitate and support ethical review by
p.000006: improving the standard and uniformity of the decision-making and assure and gain the confidence of the public in the
p.000006: working of NatHREC. The SOPs promote transparency and efficiency in communication and operations of NatHREC.
p.000006:
p.000006: The following are terms of reference under which the Committee operates:
p.000006:
p.000006: 1. Review health research proposals submitted to it within a reasonable time and document its views in writing to
p.000006: the applicant(s), clearly identifying the study, the documents reviewed and the dates for the following:
p.000006: 1.1 Approval for commencement of the study
p.000006: 1.2 Modifications required prior to its approval
p.000006: 1.3 Disapproval
p.000006: 1.4 Termination/suspension of any prior approval
p.000006:
p.000006: 2. Safeguard the dignity, rights, safety and wellbeing of study participants and communities. Special
p.000006: attention shall be paid to studies that may include vulnerable participants.
p.000006:
...
Social / Student
Searching for indicator student:
(return to top)
p.000068:
p.000069: 69
p.000069:
p.000069: APPLICATION FORM FOR ETHICS APPROVAL
p.000069:
p.000069: For use of Ethics Committee only Application No.
p.000069: Name, date and signature of
p.000069:
p.000069: NatREC administrator receiving the application
p.000069: Name:
p.000069: Signature: Date: -------------------
p.000069:
p.000069: Instructions: All applications for ethics approval should be submitted using this form. The Principal Investigator is
p.000069: required to ensure the information provided is accurate and will sign on this form to indicate that he/she
p.000069: approves the content. Although it is required that the final protocol approved by the sponsor and other relevant
p.000069: documents are submitted for review together with this form, the information provided in this form is
p.000069: expected to be complete and adequate for reviewers to make a decision on the final disposition of the
p.000069: proposal.
p.000069:
p.000069: First (initial) submission: YES/NO Revised/Amended submission: YES/NO
p.000069:
p.000069: Protocol Version/Revision No……………………….Protocol Version Date…………….,……………..
p.000069:
p.000069: Title of Project:
p.000069:
p.000069:
p.000069: Name of the Principal Investigator (PI) based in Tanzania
p.000069: Names of other investigators (PIs and Co-PIs)
p.000069: Qualifications of PI Position
p.000069: Institution and Department/Unit Other co-investigators at the PI institution
p.000069: Signature of the PI
p.000069: If Research student:
p.000069: Name, signature and approval of Supervisor
p.000069: (include letter from the student institution or university)
p.000069: Contact details for correspondence (include the name of contact if different from the PI)
p.000069: If this study involves more than one institution, name the overall study PI, institution and contact address Name
p.000069: of other institutions involved in the study if this study involves
p.000069:
p.000070: 70
p.000070:
p.000070: more than one institution
p.000070:
p.000070: Is this a randomized controlled trial?
p.000070: YES/NO
p.000070: Does this study involve the taking of blood and/or any other biological samples? YES/NO Does this study involve
p.000070: shipment of biological samples outside Tanzania? YES/NO Does this study going to involve data transfer
p.000070: outside Tanzania? YES/NO Provide details of all ethical
p.000070: clearances sought or obtained from
p.000070: other ethics committees? (This includes institutional ethics approval within Tanzania and in
p.000070: other countries if appropriate). Please attach approval certificates from other ethics committee(s).
p.000070: Provide the list of changes from the first (initial)/previous submission in case of
p.000070: revised/amended submission
p.000070:
p.000070: 1. Provide the scientific background, study design and objectives and hypotheses.
p.000070: Max 400 words
p.000070:
p.000070:
p.000070:
p.000070:
p.000070: 2. State the intended value of the project or rationale. Why it is important to conduct this study in
p.000070: Tanzania? Provide relevant references as appropriate.
p.000070: Max 300 words
p.000070:
p.000070:
p.000070:
...
Social / Victim of Abuse
Searching for indicator abuse:
(return to top)
p.000088: their basic functions. The document outlines procedures for structuring and administering IRBs, and
p.000088: reviewing as well as monitoring research during the phase of implementation.
p.000088:
p.000088: NatHREC followed these SOPs since 2007 but with time it was realized that certain procedures outlined in the SOPs 2007
p.000088: required modification to ensure their practical implementation. This, coupled with the fact that it was always
p.000088: envisaged the SOPs would be a dynamic document that would be reviewed when the need arises the NatHREC
p.000088: decided to review the SOP in 2014
p.000088:
p.000088: As a dynamic and living document, the SOPs will be reviewed from time to time in the future and NIMR will
p.000088: endeavor to ensure the full participation of all stakeholders.
p.000088:
p.000088:
p.000088:
p.000088: Mwelecele Malecela, PhD
p.000088: CHAIR, MEDICAL RESEARCH COORDINATING COMMITTEE
p.000088: Chair, Medical Research Coordinating Committee
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000001: 1
p.000001:
p.000001: INTRODUCTION
p.000001:
p.000001: Health research in Tanzania like in all developing countries and in particular Africa is increasing because of many
p.000001: discoveries that are being made in biomedical sciences and the new diagnostic procedures, drugs, vaccines and
p.000001: devices that need testing. However, much as this is a positive development, the high disease
p.000001: burden, ignorance, poverty, weak regulatory organs and ethical review frameworks expose people in these regions to
p.000001: abuse of human rights by researchers who may not be inclined to observing research ethics stipulated in
p.000001: the international guidelines. In addition, this also exposes the population in these areas to potential
p.000001: exploitation. The situation is compounded more by limited awareness and knowledge among local health
p.000001: research scientists about existence of international guidelines or even understanding them for those who have
p.000001: ever come across or heard about them.
p.000001:
p.000001: The need for good basis, applied and clinical research practices is the basis for establishment of various
p.000001: health research guidelines that include: the Declaration of Helsinki, CIOMS, International Ethical
p.000001: Guidelines for Biomedical Research Involving Human Subjects, WHO and ICH Guidelines for Good Clinical
p.000001: Practices and guideline on Ethics for Health Research in Tanzania 2nd Edition, 2009. Compliance
p.000001: with these guidelines helps to ensure that the dignity, rights, safety, and wellbeing for research participants
p.000001: are promoted and that the results of the investigations are credible.
p.000001:
p.000001: All international guidelines require ethical and scientific review of biomedical research alongside informed
p.000001: consent and the appropriate protection of those unable to consent as essential measures to protect the individual
...
Social / Women
Searching for indicator women:
(return to top)
p.000062: spring from diethylstilbestrol during pregnancy, malformation in the offspring caused by thalidomide.
p.000062: Requires Intervention to Prevent Permanent Impairment or Damage-Report if suspect that the use of a
p.000062: medical product may result in a condition, which required medical or surgical intervention to
p.000062: preclude permanent impairment or damage to a patient. Examples: Acetaminophen overdose-induced
p.000062: hepatotoxicity requiring treatment with acetylcysteine to prevent permanent damage burns from radiation
p.000062: equipment requiring drug therapy, breakage of a screw requiring replacement of hardware to prevent
p.000062: malunion of a fractured long bone.
p.000062: Detailed, written instructions, in a certain format, describe activities and action undertaken by an
p.000062: organization to achieve uniformity of the performance of a specific function.
p.000062: Study site Is an organization, a unit that is responsible for carrying a research in a given
p.000062: locality.
p.000062:
p.000062: Vulnerable Participants
p.000062: A vulnerable category of participants includes children, prisoners, pregnant women, handicapped or mentally disabled
p.000062: persons, and economically or educationally disadvantaged persons, who are likely to be vulnerable to coercion or
p.000062: undue influence.
p.000062:
p.000062:
p.000062:
p.000062:
p.000063: 63
p.000063:
p.000063: APPENDIX II: FORMS/TOOLS
p.000063:
p.000063: FORM 01:
p.000063: CONFIDENTIALITY AND CONFLICT OF INTEREST DECLARATION FORM FOR MEMBERS OF THE NATIONAL HEALTH RESEARCH
p.000063: ETHICS REVIEW COMMITTEE
p.000063:
p.000063: ………… Meeting of National Health Research Ethics Review Committee/Clinical Trials Sub-committee
p.000063:
p.000063: Confidentiality:
p.000063:
p.000063: I agree to consider all discussions and / or
p.000063: statements made in this meeting as confidential information. I declare to safeguard confidentiality during and
p.000063: after the meeting. I also declare to consider any documents, materials or information provided to me in
p.000063: the course of the meeting, or in conducting activities of this committee after the meeting, as confidential materials,
p.000063: never to be divulged to any person without any prior written permission of the Chairperson of the
p.000063: committee.
p.000063:
p.000063: Conflict of Interest
p.000063: I declare that I have no/I have a conflict of interest in relation to the following/none of the proposals tabled for
p.000063: discussion in this meeting.
p.000063:
...
p.000072:
p.000072: a) Does the trial comply with Good Clinical Practice (GCP)?
p.000072:
p.000072: b) Does this trial involve testing a new drug, vaccine or medical device which is not
p.000072: registered in Tanzania?
p.000072:
p.000072: c) If this trial involves testing a new drug, vaccine or medical device, please attach the
p.000072: investigator brochure?
p.000072:
p.000072: If there is no investigator brochure, please explain the reason.
p.000072:
p.000072: d) What will be offered to the control arm?
p.000072:
p.000072: e) Please confirm that TFDA approval will be processed before data collection begins.
p.000072:
p.000072: f) Is there a Data Monitoring & Safety Committee in place? YES/NO
p.000072:
p.000072: If NO, please explain reasons
p.000072:
p.000072: g) If the intervention to be tested is found to be effective, describe plans to make it
p.000072: available to the participants and other people after the end of the trial.
p.000072:
p.000072: h) Have you obtained a certificate insurance cover for study participants locally (a cover
p.000072:
p.000072:
p.000073: 73
p.000073:
p.000073: from insurance company based in Tanzania)? YES/NO If YES please attach
p.000073:
p.000073: If NO please describe how this will be obtained
p.000073:
p.000073: 25. Is the study going to involve vulnerable population? YES/NO
p.000073: (Vulnerable population include: pregnant women, human foetuses, neonates, children, prisoners, hospitalized patients,
p.000073: mentally ill persons etc)
p.000073:
p.000073: If YES, describe steps which will be taken to ensure protection of human subjects
p.000073:
p.000073: 26. Please give details of the funder.
p.000073:
p.000073:
p.000073: 27. Please give details of research sponsor. This is not necessarily the funding body. The sponsor is
p.000073: responsible for the initiation and management of the study. All clinical trials should have an identified
p.000073: sponsor.
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000074: 74
p.000074:
p.000074: FORM 4: RESEARCH PROPOSAL ASSESSMENT FORM
p.000074:
p.000074: NATIONAL INSTITUTE FOR MEDICAL RESEARCH
p.000074:
p.000074: Telephone 255 22 2 121400
p.000074: Telex 41919 NIMR TZ P.O. Box
p.009653: 9653
p.009653: Telegrams MEDSEARCH Dar es Salaam
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000026: reasons, may appeal that decision in writing to the NatHREC within 30 days of receipt of the decision, stating
p.000026: the precise issues upon which the appeal is based.
p.000026:
p.000026: 2. The NatHREC will respond to PIs in writing within 30 days or upon scrutiny of the complains, the NatHREC may
p.000026: invite the PI to present in person to the full committee within 30 days on receiving the written complaints.
p.000026:
p.000026:
p.000026:
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p.000026:
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p.000026:
p.000027: 27
p.000027:
p.000027: SOP 10: REVIEW OF PROPOSAL AMENDMENTS
p.000027:
p.000027: The purpose of this procedure is to describe how proposal amendments are managed and reviewed by
p.000027: the NatHREC. This SOP applies to previously approved study proposals but later being amended and
p.000027: submitted for approval from NatHREC.
p.000027:
p.000027: Amendments made to proposals may not be implemented until reviewed and approved by the Committee. It is the
p.000027: responsibility of the Committee Secretariat to manage proposal amendments. Investigators may amend the contents of
p.000027: proposals from time to time. Proposal amendments must be submitted to the Committee for either expedited review (SOP
p.000027: # 11) or review by the convened NatHREC.
p.000027:
p.000027: Types of Amendment
p.000027: There are three types of amendment
p.000027: 1. Minor: of relatively little importance and therefore not considered as substantial
p.000027: 2. Substantial: the following changes should normally be regarded as substantial:
p.000027: i. Changes to the design or methodology of the study, or to background information affecting its scientific value
p.000027: ii. Changes to the procedures undertaken by participants
p.000027: iii. Any change relating to the safety or physical or mental integrity of participants, or to the risk/benefit
p.000027: assessment for the study
p.000027: iv. Changes to study documentation such as participant information sheets, consent forms,
p.000027: questionnaires, letters of invitation, letters to other clinicians/scientists, information sheets for relatives or
p.000027: caregivers
p.000027: v. Change in the use of biological samples
p.000027: vi. A change of sponsor(s) or sponsor’s legal representative
p.000027: vii. Appointment of a new PI or key collaborator
p.000027: viii. A change to the responsibility and liability insurance coverage for the study
p.000027:
p.000028: 28
p.000028:
p.000028: ix. Appointment of a new PI at a research site
p.000028: x. A significant change to the definition of a research site
p.000028: xi. A change to the definition of the end of the study
p.000028: xii. Any other significant change to the protocol or the terms of the original application
p.000028: 3. Major: whatever procedural changes alter the risk which participants are exposed to, or the potential benefit,
p.000028: constitutes a major amendment. Examples include:
p.000028: i. A change in the primary purpose or objective of the research, such as introduction of additional genetic
...
p.000030:
p.000030: 9. The Reviewers’ Guide shall be used to review amended proposals and proposal- related documents.
p.000030:
p.000030: 10. The Chairperson shall call for a vote on the proposed amendments.
p.000030:
p.000030: 11. Changes to the proposal and/or informed consent requested by Committee members shall be recorded in
p.000030: the minutes and communicated to the clinical trial office or Principal Investigator in writing.
p.000030:
p.000030: 12. If the Committee does not approve the proposal amendment, the notification to the investigator shall also state the
p.000030: reason for not approving the amendment.
p.000030:
p.000030: 13. If the NatHREC requires modifications to any of the documents, specific changes required shall also be communicated
p.000030: to the investigator instructing him/her to make
p.000030: the necessary changes and resubmit the documents to the Secretariat.
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
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p.000030:
p.000030:
p.000031: 31
p.000031:
p.000031: SOP 11: EXPEDITED REVIEW PROCESS
p.000031:
p.000031: The SOP on expedited review is meant to give instructions on how this process shall be determined and done. The
p.000031: Secretariat in collaboration with the Chairperson shall determine which proposals may require expedited review. The
p.000031: following categories shall be qualified for an expedited review:
p.000031: 1. Research activities that present no more than minimal risk to human subjects.
p.000031: 2. Minor changes (modification or amendment) to a previously approved research proposal.
p.000031: 3. Studies that involve interviews of non-confidential nature and not likely to harm the status or
p.000031: interest or not likely to offend study participants.
p.000031: 4. Studies that involve collection of small amounts of biological specimens by non-invasive means (e.g.
p.000031: Body fluids, excreta, hair or nail in non-disfiguring or threatening manner) for local analysis and no transfer of
p.000031: specimens outside of Tanzania.
p.000031: 5. Collection of data for research purposes through non-invasive procedures (not involving general anaesthesia
p.000031: or sedation), routinely employed in clinical practices and using medical devices which have been already approved
p.000031: for use. Examples of such procedures include application of EEG or ECG electrodes, acoustic testing, tests
p.000031: using the Doppler principle, non-invasive blood pressure and other routine clinical measurements.
p.000031: 6. Research involving data, documents or specimens that have been already collected or shall be collected
p.000031: for on-going medical treatment or diagnosis.
p.000031: 7. Continuing review of research previously approved by NatHREC as follows:
p.000031: a. where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have
p.000031: completed all research-related interventions; and (iii) the research remains active only for long-term
p.000031: follow-up of subjects; or
p.000031: b. where no subjects have been enrolled and no additional risks have been identified (i.e. the study has not yet been
p.000031: initiated); or
p.000031: c. where the remaining research activities are limited to data analysis, or
p.000031:
p.000031:
...
p.000046: Chairperson or the Committee may invite individuals with competence in special areas to assist in
p.000046: the review of issues that require expertise beyond or in addition to those available on the Committee. It shall be
p.000046: the responsibility of the Secretariat to nominate the Consultant.
p.000046:
p.000046: Detailed instruction
p.000046:
p.000046:
p.000046: 1. Selection of Independent consultants
p.000046: The Secretariat shall propose an appropriate consultant to review study documents from a roster of consultants.
p.000046: The roster of consultants shall be maintained by the Secretariat. The Chairperson or the Committee
p.000046: selects the consultant based on criteria including the most current CV, availability, and
p.000046: independence. The
p.000046:
p.000046:
p.000046:
p.000047: 47
p.000047:
p.000047: consultant shall sign a Confidentiality and Conflict of Interest Agreement (Form # 01). This document shall be
p.000047: maintained in a consultant file.
p.000047:
p.000047: 2. Consultation Services
p.000047: The Secretariat shall provide proposal packages to appropriate consultants. The Consultant will be provided
p.000047: with the relevant guidelines for review of the assigned work. The consultant may either attend the meeting to
p.000047: participate in the review of the study as a non-voting member and/or may review the documents and prepare a consultant
p.000047: report to be reviewed by the Committee in their regular meetings or extraordinary meetings. The
p.000047: Consultant’s report shall become a permanent part of the study file.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: SOP 22: PROTOCOL DEVIATIONS AND VIOLATIONS
p.000047:
p.000047: i. The sponsor or PI may make minor deviations from a protocol to deal with unforeseen circumstances and
p.000047: communicate to NatHREC later. However, for deviations that would meet the criteria for a “substantial amendment” as
p.000047: defined in SOP #14 such amendment should be sought from NatHREC.
p.000047: ii. Failure to report to NatHREC (substantial amendment) will necessitate NatHREC to write a warning letter to PI
p.000047: with relevant instruction on the deviation.
p.000047: iii. Flagrant protocol deviation particularly that increases the risk of participants of breeches scientific
p.000047: principles shall be terminated by NatHREC.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000048: 48
p.000048:
p.000048: SOP 23: RESEARCH STUDY TERMINATION
p.000048:
p.000048: This procedure describes how premature termination of NatHREC approved proposals is managed by the
p.000048: NatHREC. It is the responsibility of the NatHREC to terminate research studies in the interest of
p.000048: participants’ health or welfare. Proposals may be terminated at the recommendation of the Chairperson of MRCC,
p.000048: the NatHREC or local IRB, DSMB, study sponsor or any other authorized body. The Secretariat is responsible for
p.000048: management of the termination process.
p.000048:
p.000048: Detailed instruction
p.000048:
p.000048: 1. Upon receiving a notification of study termination the Secretariat shall verify the contents of the
p.000048: package for inclusion of the following:
p.000048: i. Close out Form (Form 08).
p.000048: ii. Indicate termination as recommended action on the Close Out form
...
p.000054: v. Send it to the appropriate storage facility.
p.000054: vi. Maintain a log of materials that have been archived.
p.000054:
p.000054: 2. To archiving administrative documents, an administrative staff of the Secretariat shall
p.000054: perform inventories of miscellaneous administrative documents, place the documents in an appropriate
p.000054: storage container, and send it to the appropriate storage facility. In retrieving documents the Secretary shall
p.000054: maintain confidentiality as stipulated in (SOP# 5) (Procedure for Maintaining Confidentiality of Ethical Review
p.000054: Committee Documents).
p.000054:
p.000054: 3. Retrieval of documents shall be done following NIMR institutional procedures. The retrieved files shall be
p.000054: returned to the archive after completion of use.
p.000054:
p.000054:
p.000054:
p.000054:
p.000055: 55
p.000055:
p.000055: SOP 28: DISTRIBUTION OF SOPs AND GUIDELINES
p.000055:
p.000055: This standard operating procedure describes how to distribute and to control the distribution of the NatHREC
p.000055: approved SOPs and Guidelines. The NatHREC works according to internal rules as described in its written SOPs. In
p.000055: order to maintain a transparent relationship with the research community, the SOPs shall be made publicly
p.000055: available. The SOPs will be published in print and electronically, and made freely available.
p.000055:
p.000055:
p.000055:
p.000055:
p.000055: SOP 29: REVISION OF SOPs
p.000055:
p.000055: The purpose of this SOP is to address when and how SOPs shall be reviewed and, if necessary, revised. If the committee
p.000055: wishes to review and/or revise the SOP:
p.000055: 1. It shall request an electronic copy of the document from the Secretary or may request minor changes to be made
p.000055: directly by the Secretariat.
p.000055: 2. The SOP shall be reviewed for accuracy and timeliness every three years. SOPs may be revised more frequently
p.000055: when required.
p.000055: 3. The Secretary in consultation with the NatHREC shall ensure that the SOP reflects the actual
p.000055: procedures and all applicable regulatory requirements.
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000056: 56
p.000056:
p.000056: SOP 30: COORDINATION WITH INSTITUTIONAL REVIEW BOARDS
p.000056: The purpose of this SOP is to address the relationship between the NatHREC and the local institutional review boards
p.000056: (IRBs) that may also review health research in Tanzania. It is acknowledged that not all human subject’s research
p.000056: require review and approval at the national level. Consequently, ethics review at the institution conducting
p.000056: the research is important and complementary to the national-level review provided by the NatHREC.
p.000056:
p.000056: Health researches that routinely require review by the NatHREC as well as the local IRB include clinical trials of
p.000056: investigational products or interventions and other health research with collaborators between local institutions
p.000056: as well as with foreign institutions.
p.000056:
p.000056: In cases where research does not need to be reviewed at the national level, the local IRBs shall submit the IRB
p.000056: report (Form 10) to the NatHREC Secretariat, listing all studies which were approved by the local IRB in the
p.000056: preceding quarter.
p.000056:
...
p.000075: See CPI
p.000075:
p.000075: 7. BUDGET AND See CPI JUSTIFICATION
p.000075:
p.000075: 8. ETHICAL CONSIDERATION: Have Ethical issues been well addressed in this proposal? Please Comment (Use an
p.000075: additional sheet of paper if necessary)
p.000075: ........................................................................................................................
p.000075: ........................
p.000075: ........................................................................................................................
p.000075: ........................
p.000075: ........................................................................................................................
p.000075: ........................
p.000075: ........................................................................................................................
p.000075: ........................
p.000075:
p.000075: 9. ANY OTHER COMMENTS: (Use an additional sheet of paper if necessary)
p.000075: ........................................................................................................................
p.000075: ........................
p.000075: ........................................................................................................................
p.000075: ........................
p.000075: ........................................................................................................................
p.000075: ........................
p.000075: ........................................................................................................................
p.000075: ........................
p.000075:
p.000075: 10. CONCLUSION: Do you recommend approval of this proposal?
p.000075:
p.000075: Yes, as presented
p.000075:
p.000075: Yes, with minor revisions shown under. “Any Other Comment”
p.000075:
p.000075: Yes, with major revisions shown under, “Any Other
p.000075: Comments
p.000075:
p.000075: No, I do not recommend it; see under, “Any Other Comments”
p.000075:
p.000075: I am thanking you in advance for your early co-operation. Yours sincerely,
p.000075:
p.000075: Director General
p.000075: -------------------------------------------------------------------------------------------------------------------
p.000075: Please use another sheet of paper for your precise comments to the proposer, please do not sign the comments sheet, as
p.000075: it may be sent to the proposer.
p.000075:
p.000075:
p.000075:
p.000076: 76
p.000076:
p.000076: FORM 05: PARTICIPANT’S INQUIRY FORM
p.000076:
p.000076:
p.000076: Date Received Requested from:
p.000076: Telephone call:
p.000076:
p.000076: Fax: ...………………...............…… Of ................…………………………......
p.000076: Date: ……………………...................
p.000076:
p.000076: Mailed letter Ref: …………………………………. Of …………………….
p.000076: Date: ……………....................................
p.000076:
p.000076: Email of: …………………………………….......................................................
p.000076: Date: …………………………………….......
p.000076: Other methods (Specify):
p.000076:
p.000076: Name of participant:
p.000076:
p.000076: Address:
p.000076:
p.000076: Title of the protocol being participated in Starting date of participation: What is requested:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076: Action taken
p.000076:
p.000076:
p.000076:
p.000076:
p.000076: Outcome
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076: ………………………………… ………………………………………
p.000076: Name of receiving officer Signature
p.000076:
p.000077: 77
p.000077:
...
Social / education
Searching for indicator education:
(return to top)
p.000015: timely manner.
p.000015: 18. Communicate with all submitting researchers at all times throughout the submission and review
p.000015: process, while remaining independent of the researcher’s proposal operations. Advise submitting
p.000015: investigators on preparing and submitting proposals for review according to relevant SOPs.
p.000015: 19. Maintain files of all correspondences.
p.000015: 20. Assist the Chairperson with the conduct of Committee meetings.
p.000015: 21. Nominate Consultant Reviewers.
p.000015:
p.000015: Functions of the NatHREC Chairperson
p.000015: 1. To chair Committee meetings in accordance with all regulations.
p.000015: 2. With the assistance from the Secretariat, to identify expedited review proposals and facilitate the review of
p.000015: research that meets the expedited review criteria.
p.000015: 3. To approve and sign minutes of the committee meetings.
p.000015:
p.000015: Functions of the NatHREC Vice-Chairperson
p.000015: 1. In the absence of the Chairperson, the Vice-Chairperson will take on the responsibilities of
p.000015: Chairperson.
p.000015:
p.000016: 16
p.000016:
p.000016: Responsibilities of Members of the Committee
p.000016: 1. Review, discuss and consider research proposals submitted for evaluation.
p.000016: 2. Review progress reports and monitor on-going studies as appropriate.
p.000016: 3. Review reports on Serious Adverse Events (SAEs) and recommend appropriate actions.
p.000016: 4. Support the Secretariat in the discharge of their duties when called upon.
p.000016: 5. Maintain professional confidentiality of documents and deliberations of the Committee meetings.
p.000016: 6. Declare conflicts of interest when they exist.
p.000016: 7. Participate in continuing education activities in biomedical ethics and research.
p.000016: 8. Undertake duties assigned to them by the Chairperson.
p.000016: 9. Attend meetings regularly and participate actively during deliberations.
p.000016: 10. Participate in the review of SOPs.
p.000016: 11. Conduct site monitoring visits.
p.000016:
p.000016: Responsibilities of the Director General of NIMR
p.000016: 1. Provide a statement of assurance when required by regulation, guidelines, or sponsor requirements.
p.000016: 2. Ensure the provision of the necessary logistics and financial support for the operations of the
p.000016: Committee.
p.000016: 3. Sign ethical clearance certificates.
p.000016:
p.000016: Dissolving the Committee
p.000016: 1. At any point in time, should NIMR cease to exist, the Committee is automatically
p.000016: dissolved.
p.000016: 2. The Director General of NIMR, following written notification to each member, may also dissolve the Committee at
p.000016: any time.
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000017: 17
p.000017:
p.000017: SOP 05: COMMITTEE MEETING
p.000017:
p.000017: This SOP describes procedure for scheduling meeting, distribution of agendas and meeting procedures. Except for
p.000017: unavoidable circumstances, the Committee shall meet once a month unless stated otherwise and in such a case, an
p.000017: alternate meeting time, date, and venue shall be provided by the Secretary.
p.000017:
p.000017: Quorum requirements and meeting attendance
p.000017: A quorum of at least half the number of Committee members, including at least one member whose primary concerns is in
p.000017: non-scientific areas and one medical scientist is required for the NatHREC to conduct business.
p.000017:
...
Searching for indicator educational:
(return to top)
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
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p.000013: 13
p.000013:
p.000013: SOP 04: ADMINISTRATION AND FUNCTIONS OF THE COMMITTEE
p.000013: The purpose of this SOP is to describe the administration, office bearers and their functions in the
p.000013: NatHREC. It therefore describes the Secretariat, functions of the Chairperson, Secretary, the Committee,
p.000013: Director General of NIMR, Consultant reviewer and dissolution of the Committee.
p.000013:
p.000013: Secretariat and Officers
p.000013: 1. The officers of the Committee shall comprise of the Chairperson and Secretary.
p.000013: 2. The Chairperson is elected from among appointed members of the Committee and the Secretary shall always be an
p.000013: employee of NIMR.
p.000013: 3. The Chairperson shall be a respected person in the community, who has the qualifications of Health
p.000013: and Health related science is concerned about human rights and ethical issues and is well informed in regulations
p.000013: relevant to the use of human subjects in research. The Committee shall have a permanent secretariat
p.000013: at NIMR managed by the Committee Secretary and administrative supporting staff who are also employees of NIMR
p.000013: 4. NIMR shall also provide the necessary office space for the operations of the Committee.
p.000013:
p.000013: Function of the Secretary:
p.000013: 1. The Secretary will be in charge of the day to day running on the Secretariat.
p.000013: 2. Undertake all administrative procedures in providing training and educational programs to
p.000013: new and continuing Committee members, and the scientific community in Tanzania on issue related to
p.000013: health research ethics. The training shall include programs about the basic principles of human subject
p.000013: protection, current literature and regulations and guidelines affecting the Committee and NIMR.
p.000013: 3. Assist the institution to recruit new Committee members
p.000013: 4. Prepare and submit annual Committee operational budget and plan to NIMR management in consultation with the
p.000013: Chair.
p.000013:
p.000014: 14
p.000014:
p.000014: 5. When appropriate, update the NatHREC about revisions to applicable regulations and guidelines.
p.000014: 6. Evaluate final reports and outcomes of NatHREC-approved research.
p.000014: 7. Be available for and attend any outside investigations or audits of the Committee.
p.000014: 8. Comply with requests during an investigation or audit.
p.000014: 9. Determine submissions that could be exempted from full review, and notify the Committee and the respective
p.000014: investigator of such exemptions.
p.000014: 10. Review and accept revisions that were made as per the Committee recommendation pending
p.000014: proposal approval.
p.000014: 11. Preparation of the Annual ALMANAC and Compilation of the quarterly and annual reports.
p.000014:
p.000014: Functions of the Secretariat
p.000014: 1. Organizing an effective and efficient tracking procedure for each proposal received.
p.000014: 2. Prepare, maintain, and distribute proposals and meeting materials for review.
p.000014: 3. Organize Committee meetings according to the meeting almanac.
...
Social / employees
Searching for indicator employees:
(return to top)
p.000012: iv. Sign and date both copies at the undersigned signature and give the forms back to a Secretariat.
p.000012: v. Keeps a copy as their records (Secretariat and Members).
p.000012:
p.000012:
p.000012: The Secretariat shall keep a copy of the signed Agreement as the NatHREC’s records in a Conflict of Interest Agreement
p.000012: file.
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013: SOP 04: ADMINISTRATION AND FUNCTIONS OF THE COMMITTEE
p.000013: The purpose of this SOP is to describe the administration, office bearers and their functions in the
p.000013: NatHREC. It therefore describes the Secretariat, functions of the Chairperson, Secretary, the Committee,
p.000013: Director General of NIMR, Consultant reviewer and dissolution of the Committee.
p.000013:
p.000013: Secretariat and Officers
p.000013: 1. The officers of the Committee shall comprise of the Chairperson and Secretary.
p.000013: 2. The Chairperson is elected from among appointed members of the Committee and the Secretary shall always be an
p.000013: employee of NIMR.
p.000013: 3. The Chairperson shall be a respected person in the community, who has the qualifications of Health
p.000013: and Health related science is concerned about human rights and ethical issues and is well informed in regulations
p.000013: relevant to the use of human subjects in research. The Committee shall have a permanent secretariat
p.000013: at NIMR managed by the Committee Secretary and administrative supporting staff who are also employees of NIMR
p.000013: 4. NIMR shall also provide the necessary office space for the operations of the Committee.
p.000013:
p.000013: Function of the Secretary:
p.000013: 1. The Secretary will be in charge of the day to day running on the Secretariat.
p.000013: 2. Undertake all administrative procedures in providing training and educational programs to
p.000013: new and continuing Committee members, and the scientific community in Tanzania on issue related to
p.000013: health research ethics. The training shall include programs about the basic principles of human subject
p.000013: protection, current literature and regulations and guidelines affecting the Committee and NIMR.
p.000013: 3. Assist the institution to recruit new Committee members
p.000013: 4. Prepare and submit annual Committee operational budget and plan to NIMR management in consultation with the
p.000013: Chair.
p.000013:
p.000014: 14
p.000014:
p.000014: 5. When appropriate, update the NatHREC about revisions to applicable regulations and guidelines.
p.000014: 6. Evaluate final reports and outcomes of NatHREC-approved research.
p.000014: 7. Be available for and attend any outside investigations or audits of the Committee.
p.000014: 8. Comply with requests during an investigation or audit.
p.000014: 9. Determine submissions that could be exempted from full review, and notify the Committee and the respective
p.000014: investigator of such exemptions.
p.000014: 10. Review and accept revisions that were made as per the Committee recommendation pending
p.000014: proposal approval.
...
Social / gender
Searching for indicator gender:
(return to top)
p.000070: other ethics committees? (This includes institutional ethics approval within Tanzania and in
p.000070: other countries if appropriate). Please attach approval certificates from other ethics committee(s).
p.000070: Provide the list of changes from the first (initial)/previous submission in case of
p.000070: revised/amended submission
p.000070:
p.000070: 1. Provide the scientific background, study design and objectives and hypotheses.
p.000070: Max 400 words
p.000070:
p.000070:
p.000070:
p.000070:
p.000070: 2. State the intended value of the project or rationale. Why it is important to conduct this study in
p.000070: Tanzania? Provide relevant references as appropriate.
p.000070: Max 300 words
p.000070:
p.000070:
p.000070:
p.000070:
p.000070: 3. State the total duration of the project, and where it will be undertaken in Tanzania (and also in other
p.000070: countries if appropriate).
p.000070:
p.000070:
p.000070:
p.000070: 4. Provide evidence (such as commitment/endorsement letter) to show that local government
p.000070: officials in the region(s)/district(s) where the proposed research will be conducted have been informed about
p.000070: this study.
p.000070: IF THIS HAS NOT BEEN DONE, describe how you plan to achieve this BEFORE the study starts.
p.000070:
p.000070:
p.000070:
p.000070: 5. Specify the number of the study participants, with scientific justification for sample size,
p.000070: age, gender.
p.000070:
p.000070:
p.000070:
p.000070: 6. Specify recruitment methods, inclusion and exclusion criteria and study end points.
p.000070:
p.000070:
p.000071: 71
p.000071:
p.000071:
p.000071:
p.000071:
p.000071: 7. Specify data collection procedures, including interviews and sample collection, involving
p.000071: human participants with brief details of actual methods. Attach copies of questionnaires and other data
p.000071: collection tools in English and Kiswahili.
p.000071: Max 500 words
p.000071:
p.000071:
p.000071:
p.000071: 8. If applicable, describe procedures to be used to process, store and test biological samples
p.000071: (e.g. blood, genital swabs, urine, etc).
p.000071:
p.000071:
p.000071:
p.000071: 9. If samples will be taken overseas, are there samples which will be left in Tanzania?
p.000071: Describe procedures to be used in their shipping, storage and when will be destroyed. Indicate which institution or
p.000071: laboratory samples will be analyzed. Please note that before samples are shipped outside Tanzania MTA clearance
p.000071: is required.
p.000071:
p.000071:
p.000071: 10 Is the technology required for analysis of samples available in Tanzania? YES/NO
p.000071:
p.000071: If YES, please describe why are samples being taken outside the country
p.000071:
p.000071: 11 Would local scientist(s)(Tanzanian) be involved in sample analysis? YES/NO
p.000071:
p.000071: If YES describe her/his involvement, and if NOT please explain what are the strategies for technology transfer
p.000071:
p.000071: 12 Specify data management procedures and methods to be used during data analysis.
p.000071:
p.000071: 13 If data will be taken overseas, please describe why are being taken outside the country Please note that
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000050: closure. Archiving of files shall only be done when the NatHREC receives a final report of the study.
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050: SOP 25: PROCEDURES FOR MAINTAINING CONFIDENTIALITY
p.000050: OF NatHREC DOCUMENTS
p.000050:
p.000050: The sources of violation of confidentiality are usually found in the day-to-day use of copies of original documents.
p.000050: This SOP therefore describes how to handle original documents and copies of documents in order to
p.000050: protect confidentiality of documents. This SOP applies to all kinds of handling, distribution and
p.000050: storage of submitted study proposals, Committee documents, and correspondence with experts as well as
p.000050: the IRB auditors. It shall be mandatory to maintain confidentiality of study Committee documents, and correspondences.
p.000050: It is the responsibility of all members of the Committee and staff of the Secretariat to enforce confidentiality.
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000051: 51
p.000051:
p.000051: Detailed instruction
p.000051:
p.000051: 1. Committee members
p.000051: Committee members who have signed a confidentiality agreement with NIMR at the beginning of their term of service to
p.000051: the Committee (SOP # 01) shall have access to the confidential documents.
p.000051:
p.000051: 2. Confidential documents
p.000051: Confidential documents shall include documents reviewed by Committee members (Proposals and related documents, case
p.000051: report forms, informed consent documents, diary forms, scientific documents, expert opinion or reviews). They shall
p.000051: also include NatHREC documents (meeting minutes, advice and decisions) and correspondences (experts, auditors).
p.000051: Copies of documents, including draft and sequential versions, are considered to be confidential and are not
p.000051: permitted to be taken out except when a document is needed for day-to-day operations.
p.000051:
p.000051: 3. Authorization of acquisition of copies
p.000051: Only members of the NatHREC shall be allowed to ask for copies and only staff members of the Secretariat
p.000051: shall be allowed to make such copies.
p.000051:
p.000051: 4. Copies Issued to Non-Members of the Committee
p.000051: If non-members of the Committee need copies of original documents, it shall be the responsibility of the Secretariat to
p.000051: provide the copies.
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000052: 52
p.000052:
p.000052: SOP 26: AUDITING AND INSPECTION OF THE NatHREC
p.000052:
p.000052: The purpose of this procedure is to guide how to prepare for an audit or inspection of the IEC/IRB works. It
p.000052: is the responsibility of the Secretariat, members, Chairperson and administrative staff of the NatHREC
p.000052: for performing his/her task according to the SOPs and for being well prepared and available to answer questions
p.000052: during evaluation, audit or inspection visits of authorities and guests.
p.000052:
p.000052: Detailed instruction
p.000052: 1. Upon receiving a notice of inspection visit, the Chairperson shall inform the Secretariat and
p.000052: alert every unit to prepare for the visit. The Secretariat shall prepare for the visit by going through all
...
Economic / Economic/Poverty
Searching for indicator poverty:
(return to top)
p.000088: guiding the establishment of Institutional Health Research Review Committees or Boards (IRBs) and
p.000088: their basic functions. The document outlines procedures for structuring and administering IRBs, and
p.000088: reviewing as well as monitoring research during the phase of implementation.
p.000088:
p.000088: NatHREC followed these SOPs since 2007 but with time it was realized that certain procedures outlined in the SOPs 2007
p.000088: required modification to ensure their practical implementation. This, coupled with the fact that it was always
p.000088: envisaged the SOPs would be a dynamic document that would be reviewed when the need arises the NatHREC
p.000088: decided to review the SOP in 2014
p.000088:
p.000088: As a dynamic and living document, the SOPs will be reviewed from time to time in the future and NIMR will
p.000088: endeavor to ensure the full participation of all stakeholders.
p.000088:
p.000088:
p.000088:
p.000088: Mwelecele Malecela, PhD
p.000088: CHAIR, MEDICAL RESEARCH COORDINATING COMMITTEE
p.000088: Chair, Medical Research Coordinating Committee
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000001: 1
p.000001:
p.000001: INTRODUCTION
p.000001:
p.000001: Health research in Tanzania like in all developing countries and in particular Africa is increasing because of many
p.000001: discoveries that are being made in biomedical sciences and the new diagnostic procedures, drugs, vaccines and
p.000001: devices that need testing. However, much as this is a positive development, the high disease
p.000001: burden, ignorance, poverty, weak regulatory organs and ethical review frameworks expose people in these regions to
p.000001: abuse of human rights by researchers who may not be inclined to observing research ethics stipulated in
p.000001: the international guidelines. In addition, this also exposes the population in these areas to potential
p.000001: exploitation. The situation is compounded more by limited awareness and knowledge among local health
p.000001: research scientists about existence of international guidelines or even understanding them for those who have
p.000001: ever come across or heard about them.
p.000001:
p.000001: The need for good basis, applied and clinical research practices is the basis for establishment of various
p.000001: health research guidelines that include: the Declaration of Helsinki, CIOMS, International Ethical
p.000001: Guidelines for Biomedical Research Involving Human Subjects, WHO and ICH Guidelines for Good Clinical
p.000001: Practices and guideline on Ethics for Health Research in Tanzania 2nd Edition, 2009. Compliance
p.000001: with these guidelines helps to ensure that the dignity, rights, safety, and wellbeing for research participants
p.000001: are promoted and that the results of the investigations are credible.
p.000001:
p.000001: All international guidelines require ethical and scientific review of biomedical research alongside informed
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
(return to top)
p.000002: example, some demonstration, use of secondary data, use of stored specimen, studies involving vectors for
p.000002: human diseases and service programs may include health research activities.
p.000002:
p.000002: Health Research subject to regulation, encompass those research activities for which data is collected by any
p.000002: method for the purpose of generating knowledge or improving program or interventions in any area of
p.000002: public health in Tanzania mainland.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: VISION, MISSION AND FUNCTIONS
p.000003:
p.000003:
p.000003: The Vision and Mission statements for NatHREC together with the roles and functions are summarized herein:
p.000003:
p.000003: Vision Statement
p.000003: To have ethically and scientifically sound health research conducted in Tanzania.
p.000003:
p.000003: Mission Statement
p.000003: To ensure the scientific and ethical merits of health research and guarantee the rights, dignity, safety
p.000003: and protection of all health researchers, research participants and the entire community.
p.000003:
p.000003: The role of the NatHREC in Tanzania
p.000003: The National Health Research Ethics Review Committee (NatHREC) was established in 2002 with the major role of
p.000003: overseeing health research conducted in Tanzania and safeguarding the national interests, protecting research
p.000003: participants while taking into account the interests of the researcher and the research. Protection of research
p.000003: participants is based on five principles namely: Respect of autonomy, Beneficence, Justice, Community
p.000003: engagement and informed consent.
p.000003:
p.000003: Functions of the NatHREC
p.000003: • Provide national level ethical approval for health research in Tanzania.
p.000003:
p.000003: • Review proposed research involving human subjects and ensure that all health research is scientifically
p.000003: sound and ethically conducted.
p.000003: • Advise the MRCC on any relevant matters related to health research.
p.000003: • Develop and establish mechanisms for monitoring of health research approved by the NatHREC.
p.000003: • To receive, review, and document bi-annual reports of approved local health research by IRBs.
p.000003:
p.000004: 4
p.000004:
p.000004: • To receive and document approved health research proposals by local IRBs on a quarterly basis.
p.000004: • To sensitize and update researchers, the community and other stakeholders on health research related
p.000004: issues.
p.000004: • Establishment of an internal quality improvement program.
p.000004: • To accredit and monitor IRBs reviewing health research.
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: THE STANDARD OPERATING PROCEDURES
p.000005:
...
General/Other / Incapacitated
Searching for indicator incapacity:
(return to top)
p.000061: should be one overall PI to be answerable, with other CO –PI’s as the case may be.
p.000061: Project Manager Individual responsible for coordinating an investigational study. This person may
p.000061: also be referred to as a Site Coordinator. Serve as the primary point of contact for the NatHREC.
p.000061:
p.000061: Proposal Deviation/ Violation
p.000061: Any instance in which the NatHREC-approved proposal has not been followed.
p.000061: Protocol A document that describes the objectives, design, methodology, statistical
p.000061: considerations (or other methods of data analysis) and organisation of a research study.
p.000061: Quorum Attendance at any convened meeting of the board where at least half of
p.000061: the regular (or alternate) members, including at least one physician and one layperson, is maintained
p.000061: throughout the discussions and voting portions of the meeting.
p.000061: Research Research is a systematic process of steps used to collect and analyze
p.000061: information to increase understanding of a topic or issue". It consists of three steps: Pose a question, collect data
p.000061: to answer the question, and present an answer to the question.
p.000061: Research Participant Is a patient, service user, or any healthy person who is taking part in the study
p.000061:
p.000061: Serious Adverse Event (SAE)
p.000061: Is untoward occurrence that results in death, is life-threatening, and requires hospitalization or
p.000061: prolongation of existing hospitalization, results in persistent or significant disability or
p.000061: incapacity or that maybe consistence with development of a congenital anomaly.
p.000061: The adverse event is SERIOUS and should be reported when the
p.000061:
p.000061:
p.000062: 62
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062: Standard Operating Procedures (SOPs)
p.000062: patient outcome is:
p.000062: Death - Report if the patient's death is suspected as being a direct outcome of the adverse event.
p.000062: Life- Threatening - Report if the patient was at substantial risk of dying at the time of the adverse event or it is
p.000062: suspected that the use or continued use of the product would result in the patient's death. Examples: Pacemaker
p.000062: failure; gastrointestinal haemorrhage; bone marrow suppression; infusion pump failure which permits uncontrolled free
p.000062: flow resulting in excessive drug dosing.
p.000062: Hospitalization - (initial or prolonged)-Report if admission to the hospital or prolongation of a hospital stay results
p.000062: because of the adverse event. Examples. Anaphylaxis pseudomembranous colitis or bleeding causing or prolonging
p.000062: hospitalisation.
p.000062: Disability - Report if the adverse event resulted in a significant, persistent, or permanent change,
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023: SOP 09: ASSESSMENT OF STUDY PROPOSALS
p.000023:
p.000023: This SOP describes how the NatHREC reviews and assesses the proposal documents submitted for approval. The
p.000023: Research Proposal Guideline Form (Form 04) is designed to structure the proposal review process and
p.000023: to facilitate reporting recommendation and comments. Specific questions in the Research Proposal
p.000023: Assessment Form must be adequately addressed in the proposal itself and/or proposal-related documents under
p.000023: review. Relevant points made during discussion and deliberation about a specific proposal shall be recorded
p.000023: on the form. The decision reached by the committee and the reasons for its decision shall be recorded on the
p.000023: Assessment Form. The reviewers will use the Health Research Reviewer’s Guides (Clinical Trials, Biomedical and
p.000023: Humanities) to conduct their review.
p.000023:
p.000023: Where the Committee had sought expert’s advice on a proposal received for assessment, the Consultant shall
p.000023: also use the Research Proposal Guideline (Form 04) in assessing the proposal.
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000024: 24
p.000024:
p.000024: 1. Detailed instruction
p.000024: The Proposal in the Application Form shall be summarized to include general information about the proposal
p.000024: such as title of the proposal, proposal number and date, principal investigators and co-investigators, funding agency
p.000024: and project status whether new/revised/rejected version. Other information to be included in the summary
p.000024: shall be type of review whether regular, expedited or emergency, principal reviewer(s) from the Committee, brief
p.000024: summary of the study and comment by the Principal reviewer(s).
p.000024:
p.000024: 2. Study Design
p.000024: The study design shall be reviewed with a view of evaluating the need for human participants for study, adequacy
p.000024: in literature review, objectives of the study, appropriateness of the methodology proposed,
p.000024: inclusion/exclusion criteria, control arms (placebo, if any) and withdrawal or discontinuation criteria. The
p.000024: study sites shall also be examined for suitability of the study in terms of geographical
p.000024: distribution of the problem under study, facility and infrastructure accessibility and availability at study sites to
p.000024: accommodate the study.
p.000024:
p.000024: 3. Qualifications of investigators
p.000024: Qualifications and experience of investigators shall be examined to see whether the proposed study and background
p.000024: of the participating investigators demonstrate sufficient capacity to conduct the study. Disclosure of potential
p.000024: conflicts of interest shall also be examined. In case of investigators from outside Tanzania, the proposal will be
p.000024: examined to ensure that it includes a local investigator who has sufficient capacity to carry out the study.
p.000024:
p.000024: 4. Study Participation
p.000024: Under this item the assessment shall be done with a view of evaluating voluntary, non-coercive recruitment of
p.000024: participation. The following aspects shall be assessed to see if they have been adequately considered in the proposal:
...
p.000036: All clinical studies require safety monitoring throughout the duration of the research, but not all studies require
p.000036: monitoring by a Data and Safety Monitoring Board (DSMB). DSMB’s may be critical for studies intended to save lives,
p.000036: prevent serious disease progression, or reduce the risk of a major adverse health outcome. DSMBs are particularly
p.000036: important in studies where interim data analysis is required to ensure the safety of research participants.
p.000036:
p.000036: The primary responsibility of a DSMB is to safeguard human subjects by analysing accumulating data relevant to the
p.000036: risks and benefits on a regular basis. Especially in long-term trials, the DSMB reviews data periodically to
p.000036: assess effectiveness and toxicity, and to decide if and when the data are sufficiently favourable to one
p.000036: treatment that the study should be discontinued. The DSMB shall also decide whether adverse events are
p.000036: serious enough to warrant termination of the study.
p.000036:
p.000036: NatHREC considers DSMBs to be relevant in the following kinds of studies:
p.000036: i. Controlled studies with mortality and/or severe morbidity as a primary or secondary end-point.
p.000036: ii. Randomized controlled studies focused on evaluating clinical efficacy and safety of a new intervention.
p.000036: iii. Early studies of a high-risk intervention.
p.000036: iv. Studies in the early phases of a novel intervention with very limited information on clinical safety.
p.000036: v. Studies where the design or expected data accrual is complex, particularly studies that take long
p.000036: duration.
p.000036: vi. Studies carried out in emergency situations.
p.000036: vii. Studies which involve vulnerable populations.
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000037: 37
p.000037:
p.000037: For clinical trials conducted only in Tanzania, the DSMB must include representation from Tanzania. For multi-country
p.000037: clinical trials, the DSMB should include regional representation, preferably Tanzanian, on its roster.
p.000037: For Studies with DSMBs, the most recent report from the DSMB should be submitted to the NatHREC as an information item.
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: SOP 14: INQUIRIES FROM RESEARCH PARTICIPANTS, COMMUNITY MEMBERS OR ANY PERSON INTERESTED IN THE STUDY
p.000037: The NatHREC shall consider its prime responsibility by assuming the protection of the rights and welfare of human
p.000037: subjects in research approved by the Committee. This SOP applies to all requests concerning the rights
p.000037: and well-being of the participants in the studies approved by the NatHREC. This procedure shall provide guidelines
p.000037: for dealing with and accommodating requests by participants regarding their rights as participants in any
p.000037: approved clinical research studies. It is the responsibility of all Staff and Committee members acting on
p.000037: behalf of the Committee to facilitate subjects/patients' requests within the scope of their responsibilities.
p.000037:
p.000037: Informed Consent documents reviewed by the Committee may routinely contain the statement, "Questions regarding the
p.000037: rights of a subject/patient” may be addressed to the Chairperson, address and/or phone number. On some occasions the
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000088:
p.000088: Julius Massaga PhD
p.000088: SECRETARY
p.000088: NATIONAL HEALTH RESEARCH ETHICS COMMITTEE
p.000088: iv
p.000088:
p.000088: ABBREVIATIONS
p.000088:
p.000088: CIOMS Council for International Organization of Medical Sciences CV
p.000088: Curriculum Vitae
p.000088: DSMB Data and Safety Monitoring Board
p.000088:
p.000088: ICH International Conference on Harmonization
p.000088:
p.000088: IRB Institutional Review Board
p.000088:
p.000088: IREC Institutional Review Ethics Committee MOHSW Ministry of Health and
p.000088: Social Welfare MRCC Medical Research Coordinating Committee NatHREC National
p.000088: Health Research Ethics Committee NIMR National Institute for Medical Research
p.000088: NSR Non-Significant Risk Device
p.000088:
p.000088: PI Principal Investigator
p.000088:
p.000088: RTI Research Triangle Institute International
p.000088:
p.000088: SAE Serious Adverse Events
p.000088:
p.000088: SOPs Standard Operating Procedures
p.000088:
p.000088: TANHER FORUM Tanzania National Health Research Forum TFDA Tanzania Food and Drug Authority
p.000088: UN United Nations
p.000088:
p.000088: WHO World Health Organization
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088: v
p.000088:
p.000088: FOREWORD
p.000088: It is with great pleasure that we have established the Standard Operating procedures (SOPs) for the National Health
p.000088: Research Ethics Committee (NatHREC), a Sub- Committee of the Medical Research Coordinating Committee
p.000088: of the National Institute for Medical Research (NIMR), Tanzania.
p.000088:
p.000088: The SOPs, by definition are detailed written instructions to achieve uniformity and maintain standards in the
p.000088: performance of a specific function. In this particular case, these instructions have detailed procedures
p.000088: guiding the establishment of Institutional Health Research Review Committees or Boards (IRBs) and
p.000088: their basic functions. The document outlines procedures for structuring and administering IRBs, and
p.000088: reviewing as well as monitoring research during the phase of implementation.
p.000088:
p.000088: NatHREC followed these SOPs since 2007 but with time it was realized that certain procedures outlined in the SOPs 2007
p.000088: required modification to ensure their practical implementation. This, coupled with the fact that it was always
p.000088: envisaged the SOPs would be a dynamic document that would be reviewed when the need arises the NatHREC
p.000088: decided to review the SOP in 2014
p.000088:
p.000088: As a dynamic and living document, the SOPs will be reviewed from time to time in the future and NIMR will
p.000088: endeavor to ensure the full participation of all stakeholders.
...
p.000009: scientific knowledge, and expertise, as well as on their commitment and willingness to volunteer the
p.000009: necessary time and effort for the Committee’s work.
p.000009: 3. Membership will be reviewed every 4 years.
p.000009:
p.000009: Condition of Appointment
p.000009: 1. Willingness to publicize their identity, name, profession and affiliation to the Committee.
p.000009: 2. Willingness to sign a confidentiality agreement at the start of the term and abide by the
p.000009: confidentiality agreement regarding meeting deliberations, applications, proposal submissions, information
p.000009: on research participants and related matters which they have had the privilege to have as a result of being members
p.000009: of the Committee. The confidentiality protects the privacy and confidentiality of all parties whose
p.000009: information may be disclosed to the Committee in the course of its work.
p.000009: 3. Willingness to disclose any conflict of interest– financial, professional, or otherwise – in a project
p.000009: or proposal under consideration.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: 4. Any member who has any vested interest in a proposal submitted to the Committee for review may
p.000010: provide the NatHREC with information about the proposal, but shall not participate in the deliberations on the
p.000010: proposal.
p.000010:
p.000010: Resignation, Disqualification, Replacement of Members
p.000010: 1. Members may resign their position by submitting a letter of resignation to the Chairperson.
p.000010: 2. Members may also be disqualified from continuance should the appointing authority provide written
p.000010: reasons to the NatHREC members and there is unanimous agreement.
p.000010: 3. NatHREC shall request for a replacement of any member under the following circumstances:
p.000010: i. Protracted illness of a member, which does not permit him/her to participate in the
p.000010: deliberations of the Committee.
p.000010: ii. Persistent absenteeism of a member without reasonable cause
p.000010: iii. Voluntary withdrawal by a member.
p.000010: iv. Ethical misconduct (s)
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: SOP 02. CONFIDENTIALITY OF PROCEEDINGS
p.000011:
p.000011: 1. Members do not sit on the NatHREC meeting in any specific representative capacity (institutions,
p.000011: associations, departments) and must be able to discuss freely the applications submitted to them.
p.000011: 2. The NatHREC meetings must be completely confidential.
p.000011: 3. Any breaches of confidentiality by members will result in termination of their membership.
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: SOP 03: CONFLICT OF INTEREST AGREEMENT
p.000011:
p.000011: The WHO Declaration of Interests for WHO Experts defines a conflict of interest as follows: “A conflict of interest
p.000011: means that the expert or his/her partner (“partner” includes a spouse or other person with whom s/he has a
...
p.000040: research or who fail to correspond to the NatHREC requests. This SOP applies to all research projects
p.000040: approved by the NatHREC as well as non-authorized researches. The Secretariat is responsible for
p.000040: maintaining documentation of alleged non-compliance.
p.000040:
p.000040: Detailed instruction
p.000040:
p.000040:
p.000040: 1. Whenever non-compliance or non-authorized research has been alleged, the NatHREC shall investigate the
p.000040: allegations within 30 days to determine if they can be substantiated.
p.000040: 2. When non-compliance has occurred, or non-authorized research has been identified, a report from the
p.000040: Secretariat shall be placed on the agenda of the next Committee meeting.
p.000040: 3. A file shall be maintained that identifies investigators who are found to be in non-compliance with the
p.000040: requirements of the NatHREC, NIMR policy, TFDA and other relevant regulations, and any applicable international
p.000040: guidelines.
p.000040:
p.000041: 41
p.000041:
p.000041: 4. Researchers or others who fail to respond to the Committee’s requests will be notified in writing of
p.000041: the Committee’s decisions, and the appropriate institutions and individuals informed.
p.000041: 5. The Committee may elect to suspend or terminate approval of current studies or refuse subsequent applications
p.000041: from the investigators cited. Such decisions shall be recorded in the minutes.
p.000041: 6. The Secretariat shall notify the investigator of the Committee’s action in writing.
p.000041: 7. Four copies of the notification letter shall be produced. The original shall be sent to the
p.000041: investigator, the second copy to the relevant National Authority (e.g. TFDA, COSTECH), the third to the sponsor or the
p.000041: sponsor’s representative of the study and the fourth to the non-compliance file and stored on the shelf with an
p.000041: appropriate label.
p.000041: 8. The researcher must respond in writing with a description of any corrective actions that are to take
p.000041: place and a timeline for implementation.
p.000041: 9. The findings will be communicated to the MRCC for further action.
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041: SOP 17: ABSENCE OF PI
p.000041:
p.000041: From time to time, the PI may be absent due to annual leave, sick leave or for other reasons. For absences of up to one
p.000041: month, the PI is responsible for ensuring that his/her responsibilities as PI are carried out by a suitable temporary
p.000041: replacement and that that replacement is identified to the Secretariat.
p.000041: In case the PI is absent for one month to six months, he/she should notify NatHREC in writing. If the PI is absent for
p.000041: six months or more the proposal should be amended to replace the PI.
p.000041:
p.000041:
p.000041:
p.000041:
p.000042: 42
p.000042:
p.000042: SOP 18: REVIEW OF FINAL REPORTS AND CLOSURE OF A RESEARCH STUDY
p.000042:
p.000042: The purpose of this SOP is to provide instructions for the review and follow-up, if appropriate, of final reports
p.000042: for any study previously approved by the NatHREC. This SOP applies to the review and follow-up the final report
p.000042: which is an obligatory review of each investigator’s activities presented as a written report to
p.000042: the Committee after the last participant had completed all visits and all adverse experiences have
p.000042: been brought to appropriate resolution.
p.000042:
...
p.000053: questions of the auditors/inspectors clearly, politely and truthfully with confidence and straight to the
p.000053: points. All information and files shall be made available as requested by the auditors/inspectors.
p.000053:
p.000053: 3. After the auditor(s)/inspector(s) have left, the Chairperson shall call for correction of
p.000053: any mistakes pointed out by the audit(s) and internal follow-up shall be carried out. A report shall be
p.000053: written and get approval from the Chairperson. Appropriate time for correction and improvement process
p.000053: shall be allowed and an outcome of the audit process shall be evaluated. The record of the report on the
p.000053: audit/inspection meeting shall be kept in the audit/inspection file and record of findings from the
p.000053: internal follow-up audit in the internal audit file.
p.000053:
p.000053: 4. Internal auditing of NatHREC should be conducted by MRCC while the external IRB auditing to be done
p.000053: by the NatHREC.
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000054: 54
p.000054:
p.000054: SOP 27: ARCHIVING OF NatHREC DOCUMENTS
p.000054:
p.000054: The purpose of this SOP is to provide instruments for storing inactive study files and administrative documents in a
p.000054: secure manner while maintaining access for review by auditors and inspectors. The files and documents are retained
p.000054: for at least fifteen years after completion of the research so that the records are accessible for auditors and
p.000054: inspectors. Copying files and documents for or by authorized representatives of the national authority when required
p.000054: is allowed.
p.000054:
p.000054: Maintenance and retrieval of archived documents
p.000054: 1. After a study has been completed and the final report accepted, the Secretary shall do the following:
p.000054: i. Remove the contents of the entire study file from the active study filing.
p.000054: ii. Verify that all the documents are present in organized manner.
p.000054: iii. Provide an archive number from these documents and enter the number into the database and/or
p.000054: Archive Logbook.
p.000054: iv. Place the file in a storage container.
p.000054: v. Send it to the appropriate storage facility.
p.000054: vi. Maintain a log of materials that have been archived.
p.000054:
p.000054: 2. To archiving administrative documents, an administrative staff of the Secretariat shall
p.000054: perform inventories of miscellaneous administrative documents, place the documents in an appropriate
p.000054: storage container, and send it to the appropriate storage facility. In retrieving documents the Secretary shall
p.000054: maintain confidentiality as stipulated in (SOP# 5) (Procedure for Maintaining Confidentiality of Ethical Review
p.000054: Committee Documents).
p.000054:
p.000054: 3. Retrieval of documents shall be done following NIMR institutional procedures. The retrieved files shall be
p.000054: returned to the archive after completion of use.
p.000054:
p.000054:
p.000054:
p.000054:
p.000055: 55
p.000055:
p.000055: SOP 28: DISTRIBUTION OF SOPs AND GUIDELINES
p.000055:
p.000055: This standard operating procedure describes how to distribute and to control the distribution of the NatHREC
p.000055: approved SOPs and Guidelines. The NatHREC works according to internal rules as described in its written SOPs. In
...
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000059: 59
p.000059:
p.000059: APPENDIX I: GLOSSARY OF TERMS AND DEFINITIONS
p.000059:
p.000059: Description of titles of the personnel
p.000059: Titles Description
p.000059: Active Study Files Supporting and approved documents, records containing communications,
p.000059: and reports that correspond to each active (current) study approved by the NatHREC.
p.000059:
p.000059: Administrative Documents
p.000059: These includes official minutes of the Committee meetings as described in SOP # 04 the SOPs, historical files
p.000059: and Master Files as described in SOP # 20, Distribution, Implementation and File Maintenance.
p.000059: Administrative Staff They are NatHREC staff that are responsible for the day-to-day administrative
p.000059: functions and duties, which support the activities and responsibilities of the Committee.
p.000059: Adverse Event Is any untoward and unintended response in a research participant which is related to any
p.000059: dose administered, medical devise or psychological disturbance.
p.000059: Adverse Reaction Is any untoward and unintended response in a subject to an investigational medicinal
p.000059: product which is related to any dose administered to a research participant
p.000059: Amendment Any change to a NatHREC approved study. Amendments must be prospectively approved unless
p.000059: the change is required to package of the amended parts and related documents of the proposal,
p.000059: previously approved by the IEC/IRB, but later decided to make changes after the study had been carried for
p.000059: some time.
p.000059: Appointing Authority The body responsible for the establishment and support of NatHREC, in this case is the
p.000059: MRCC-NIMR
p.000059: Audit A systematic and independent examination of research trial approval
p.000059: activities and documents to determine whether the review and approval activities were conducted and
p.000059: data were recorded and accurately reported according to the SOPs, GCP, Declaration of Helsinki and applicable
p.000059: regulatory requirements
p.000059: Chairperson A member of the Committee presiding over a meeting.
p.000059: Clients As a national review Committee, NATREC considers investigators, investigational
p.000059: sites, sponsors or sponsor representatives as its clients or customers. Clients requesting the services of
p.000059: NATREC are asked to accept and abide by the procedures set forth in SOPs.
p.000059: Committee Members Individuals serving as regular and alternate members on the NatHREC’s
p.000059: operations. This Committee is constituted in accordance with the NatHREC membership requirements set
p.000059: forth in SOP # 01.
p.000059: Confidentiality Prevention of disclosure, to other than authorized individuals, of Committee
p.000059: information and documents
p.000059: Conflict of Interest A situation in which a person, such as a public official, an
p.000059: employee, or a professional, has a private or personal interest
p.000059:
p.000059:
p.000060: 60
p.000060:
p.000060: sufficient to appear to influence the objective exercise of his or her official duties. There are three key
...
General/Other / Undue Influence
Searching for indicator undue influence:
(return to top)
p.000007: proposes for use in the study
p.000007: v. Participant recruitment procedures
p.000007: vi. Written information to be provided to participants
p.000007: vii. In case of a clinical trial, the investigator’s brochure should be provided
p.000007: viii. For clinical trials there should be a document of intent of insurance from an insurance company
p.000007: ix. Institutional Review Board certificate of applicant’s institution
p.000007: x. Institutional Review Board certificate of collaborating foreign institution where
p.000007: applicable
p.000007: xi. IRB certificate and/or commitment letter of collaborating local institutions
p.000007: xii. Research budget and its justification
p.000007: xiii. Curriculum vitae (CVs) and composition of the research team
p.000007:
p.000007: 5. Consider the suitability of the investigator(s) for the proposed study by considering
p.000007: relevant qualification, training and experience, as documented by current curriculum vitae and/or by any other relevant
p.000007: documentation:
p.000007: a) May request more information than is given when additional information would assist
p.000007: NatHREC in taking a decision on the proposal or provide protection of the rights, safety and/or well-being of
p.000007: participants researchers.
p.000007: b) Review both the amount and type of benefit to participants to ensure that such benefits do not
p.000007: present problems of coercion or undue influence on the study participants.
p.000007:
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: c) Concerns itself strictly on the scientific and ethical merits of submitted proposals for approval;
p.000008: executing the tasks free from bias or influence and not involving itself in the day to day administration,
p.000008: policy and other Institutional issues.
p.000008: d) Assists investigator(s) in the submission process. In this regard, the following items shall
p.000008: be made available to them by the Committee Secretariat:
p.000008: i. Proposal submission forms and all relevant guidelines as stipulated in this Standard Operating Procedures
p.000008: (SOPs)
p.000008: ii. Meeting Almanac
p.000008: iii. Checklist
p.000008:
p.000008: 6. The Committee members and consultant reviewers shall be provided by the Committee Secretariat with all
p.000008: relevant SOPs to guide them in the review process of the proposals given to them.
p.000008:
p.000008: Ethical review basis
p.000008: 1. The Committee recognizes that the proposals it approves may also be approved by institutional review
p.000008: committees/community committees prior to submission to this Committee or their implementation in specific localities.
p.000008: 2. In evaluating proposed health research, the Committee is aware of the diversity of laws, cultures and
p.000008: practices governing research and medical practices in various communities in Tanzania.
p.000008: 3. It attempts to inform itself where possible of requirements and conditions of the various localities where
p.000008: proposed health research is being considered.
p.000008: 4. The Committee seeks to be informed, as appropriate, by institutional review boards and researchers of
...
p.000062: preclude permanent impairment or damage to a patient. Examples: Acetaminophen overdose-induced
p.000062: hepatotoxicity requiring treatment with acetylcysteine to prevent permanent damage burns from radiation
p.000062: equipment requiring drug therapy, breakage of a screw requiring replacement of hardware to prevent
p.000062: malunion of a fractured long bone.
p.000062: Detailed, written instructions, in a certain format, describe activities and action undertaken by an
p.000062: organization to achieve uniformity of the performance of a specific function.
p.000062: Study site Is an organization, a unit that is responsible for carrying a research in a given
p.000062: locality.
p.000062:
p.000062: Vulnerable Participants
p.000062: A vulnerable category of participants includes children, prisoners, pregnant women, handicapped or mentally disabled
p.000062: persons, and economically or educationally disadvantaged persons, who are likely to be vulnerable to coercion or
p.000062: undue influence.
p.000062:
p.000062:
p.000062:
p.000062:
p.000063: 63
p.000063:
p.000063: APPENDIX II: FORMS/TOOLS
p.000063:
p.000063: FORM 01:
p.000063: CONFIDENTIALITY AND CONFLICT OF INTEREST DECLARATION FORM FOR MEMBERS OF THE NATIONAL HEALTH RESEARCH
p.000063: ETHICS REVIEW COMMITTEE
p.000063:
p.000063: ………… Meeting of National Health Research Ethics Review Committee/Clinical Trials Sub-committee
p.000063:
p.000063: Confidentiality:
p.000063:
p.000063: I agree to consider all discussions and / or
p.000063: statements made in this meeting as confidential information. I declare to safeguard confidentiality during and
p.000063: after the meeting. I also declare to consider any documents, materials or information provided to me in
p.000063: the course of the meeting, or in conducting activities of this committee after the meeting, as confidential materials,
p.000063: never to be divulged to any person without any prior written permission of the Chairperson of the
p.000063: committee.
p.000063:
p.000063: Conflict of Interest
p.000063: I declare that I have no/I have a conflict of interest in relation to the following/none of the proposals tabled for
p.000063: discussion in this meeting.
p.000063:
p.000063: Conflict of Interest: (Write down)
p.000063: …………………………………………………………………………………………………..
p.000063: ………………………………………………………………………………………………….. Proposal for which I have a Conflict of Interest
p.000063: Proposal title:
p.000063: ……………………………………………………………………………………………….…
p.000063: ………………………………………………………………………………………………….
p.000063: PI:
p.000063: Type of Conflict of Interest:
p.000063: Financial
p.000063: Proposal Development Other aspects of the proposal
p.000063:
...
General/Other / participants in a control group
Searching for indicator placebo:
(return to top)
p.000023: review. Relevant points made during discussion and deliberation about a specific proposal shall be recorded
p.000023: on the form. The decision reached by the committee and the reasons for its decision shall be recorded on the
p.000023: Assessment Form. The reviewers will use the Health Research Reviewer’s Guides (Clinical Trials, Biomedical and
p.000023: Humanities) to conduct their review.
p.000023:
p.000023: Where the Committee had sought expert’s advice on a proposal received for assessment, the Consultant shall
p.000023: also use the Research Proposal Guideline (Form 04) in assessing the proposal.
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000024: 24
p.000024:
p.000024: 1. Detailed instruction
p.000024: The Proposal in the Application Form shall be summarized to include general information about the proposal
p.000024: such as title of the proposal, proposal number and date, principal investigators and co-investigators, funding agency
p.000024: and project status whether new/revised/rejected version. Other information to be included in the summary
p.000024: shall be type of review whether regular, expedited or emergency, principal reviewer(s) from the Committee, brief
p.000024: summary of the study and comment by the Principal reviewer(s).
p.000024:
p.000024: 2. Study Design
p.000024: The study design shall be reviewed with a view of evaluating the need for human participants for study, adequacy
p.000024: in literature review, objectives of the study, appropriateness of the methodology proposed,
p.000024: inclusion/exclusion criteria, control arms (placebo, if any) and withdrawal or discontinuation criteria. The
p.000024: study sites shall also be examined for suitability of the study in terms of geographical
p.000024: distribution of the problem under study, facility and infrastructure accessibility and availability at study sites to
p.000024: accommodate the study.
p.000024:
p.000024: 3. Qualifications of investigators
p.000024: Qualifications and experience of investigators shall be examined to see whether the proposed study and background
p.000024: of the participating investigators demonstrate sufficient capacity to conduct the study. Disclosure of potential
p.000024: conflicts of interest shall also be examined. In case of investigators from outside Tanzania, the proposal will be
p.000024: examined to ensure that it includes a local investigator who has sufficient capacity to carry out the study.
p.000024:
p.000024: 4. Study Participation
p.000024: Under this item the assessment shall be done with a view of evaluating voluntary, non-coercive recruitment of
p.000024: participation. The following aspects shall be assessed to see if they have been adequately considered in the proposal:
p.000024: i. Procedures for obtaining informed consent
p.000024:
p.000024:
p.000025: 25
p.000025:
p.000025: ii. Contents of the patient information sheet
p.000025: iii. Contents and language of the informed consent document
...
Orphaned Trigger Words
p.000045: SOP 23: RESEARCH STUDY TERMINATION 49
p.000045: SOP 24: PREPARATION AND MAINTENANCE OF STUDY FILES 50
p.000045: SOP 25: PROCEDURES FOR MAINTAINING CONFIDENTIALITY OF NatHREC
p.000045: DOCUMENTS
p.000051: 51
p.000051: SOP 26:AUDITING AND INSPECTION OF THE NatHREC 53
...
p.000088: iv
p.000088:
p.000088: ABBREVIATIONS
p.000088:
p.000088: CIOMS Council for International Organization of Medical Sciences CV
p.000088: Curriculum Vitae
p.000088: DSMB Data and Safety Monitoring Board
p.000088:
p.000088: ICH International Conference on Harmonization
p.000088:
p.000088: IRB Institutional Review Board
p.000088:
p.000088: IREC Institutional Review Ethics Committee MOHSW Ministry of Health and
p.000088: SocialXWelfare MRCC Medical Research Coordinating Committee NatHREC National
p.000088: Health Research Ethics Committee NIMR National Institute for Medical Research
p.000088: NSR Non-Significant Risk Device
p.000088:
p.000088: PI Principal Investigator
p.000088:
p.000088: RTI Research Triangle Institute International
p.000088:
p.000088: SAE Serious Adverse Events
p.000088:
p.000088: SOPs Standard Operating Procedures
p.000088:
p.000088: TANHER FORUM Tanzania National Health Research Forum TFDA Tanzania Food and Drug Authority
p.000088: UN United Nations
p.000088:
p.000088: WHO World Health Organization
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088: v
p.000088:
p.000088: FOREWORD
p.000088: It is with great pleasure that we have established the Standard Operating procedures (SOPs) for the National Health
p.000088: Research Ethics Committee (NatHREC), a Sub- Committee of the Medical Research Coordinating Committee
p.000088: of the National Institute for Medical Research (NIMR), Tanzania.
p.000088:
p.000088: The SOPs, by definition are detailed written instructions to achieve uniformity and maintain standards in the
p.000088: performance of a specific function. In this particular case, these instructions have detailed procedures
p.000088: guiding the establishment of Institutional Health Research Review Committees or Boards (IRBs) and
p.000088: their basic functions. The document outlines procedures for structuring and administering IRBs, and
p.000088: reviewing as well as monitoring research during the phase of implementation.
p.000088:
p.000088: NatHREC followed these SOPs since 2007 but with time it was realized that certain procedures outlined in the SOPs 2007
p.000088: required modification to ensure their practical implementation. This, coupled with the fact that it was always
p.000088: envisaged the SOPs would be a dynamic document that would be reviewed when the need arises the NatHREC
p.000088: decided to review the SOP in 2014
p.000088:
p.000088: As a dynamic and living document, the SOPs will be reviewed from time to time in the future and NIMR will
p.000088: endeavor to ensure the full participation of all stakeholders.
p.000088:
p.000088:
p.000088:
p.000088: Mwelecele Malecela, PhD
p.000088: CHAIR, MEDICAL RESEARCH COORDINATING COMMITTEE
p.000088: Chair, Medical Research Coordinating Committee
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000001: 1
p.000001:
p.000001: INTRODUCTION
p.000001:
p.000001: Health research in Tanzania like in all developing countries and in particular Africa is increasing because of many
p.000001: discoveries that are being made in biomedical sciences and the new diagnostic procedures, drugs, vaccines and
p.000001: devices that need testing. However, much as this is a positive development, the high disease
p.000001: burden, ignorance, poverty, weak regulatory organs and ethical review frameworks expose people in these regions to
p.000001: abuse of human rights by researchers who may not be inclined to observing research ethics stipulated in
p.000001: the international guidelines. In addition, this also exposes the population in these areas to potential
p.000001: exploitation. The situation is compounded more by limited awareness and knowledge among local health
p.000001: research scientists about existence of international guidelines or even understanding them for those who have
p.000001: ever come across or heard about them.
p.000001:
p.000001: The need for good basis, applied and clinical research practices is the basis for establishment of various
p.000001: health research guidelines that include: the Declaration of Helsinki, CIOMS, International Ethical
p.000001: Guidelines for Biomedical Research Involving Human Subjects, WHO and ICH Guidelines for Good Clinical
p.000001: Practices and guideline on Ethics for Health Research in Tanzania 2nd Edition, 2009. Compliance
p.000001: with these guidelines helps to ensure that the dignity, rights, safety, and wellbeing for research participants
p.000001: are promoted and that the results of the investigations are credible.
p.000001:
p.000001: All international guidelines require ethical and scientific review of biomedical research alongside informed
p.000001: consent and the appropriate protection of those unable to consent as essential measures to protect the individual
p.000001: persons and communities who participate in biomedical research and related fields involving human
p.000001: participants. It is against this background that the National Health Research Ethics Review Committee (NatHREC)
p.000001: was established by the Medical Research Coordinating Committee (MRCC) of the National Institute
p.000001: for Medical Research (NIMR) which was mandated to carryout, control, coordinate, register, monitor,
p.000001:
p.000002: 2
p.000002:
p.000002: evaluate and promote health research in Tanzania, or elsewhere on behalf of or for the benefit of the government of
p.000002: Tanzania (NIMR Act of Parliament in 1979).
p.000002:
p.000002: The purpose of this document is to outline the process for reviewing, authorizing, archiving, and amending Standard
p.000002: Operating Procedures (SOPs) for the NatHREC and other health research ethics committees operating in
p.000002: the country. The Institutional health research ethics committees in Tanzania are expected to adapt these
p.000002: standard operating procedures.
p.000002:
p.000002: The procedures shall be written in immediate future tense using active verbs and shall be written in simple
p.000002: language so that a reader unfamiliar with the procedures would be able to understand and apply the procedures
p.000002: accurately in proper time sequence by following the document.
p.000002:
p.000002: Health research ethical review determination criteria
p.000002:
p.000002: Health Research means a systematic investigation, including research development, testing and evaluation, designed to
p.000002: develop or contribute to new knowledge.
p.000002:
p.000002: Activities which meet this definition constitute health research for purposes of this SOP document, whether or not they
p.000002: are conducted or supported under a program which is considered health research for other purposes. For
p.000002: example, some demonstration, use of secondary data, use of stored specimen, studies involving vectors for
p.000002: human diseases and service programs may include health research activities.
p.000002:
p.000002: Health Research subject to regulation, encompass those research activities for which data is collected by any
p.000002: method for the purpose of generating knowledge or improving program or interventions in any area of
p.000002: public health in Tanzania mainland.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: VISION, MISSION AND FUNCTIONS
p.000003:
p.000003:
p.000003: The Vision and Mission statements for NatHREC together with the roles and functions are summarized herein:
p.000003:
p.000003: Vision Statement
p.000003: To have ethically and scientifically sound health research conducted in Tanzania.
p.000003:
p.000003: Mission Statement
p.000003: To ensure the scientific and ethical merits of health research and guarantee the rights, dignity, safety
p.000003: and protection of all health researchers, research participants and the entire community.
p.000003:
p.000003: The role of the NatHREC in Tanzania
p.000003: The National Health Research Ethics Review Committee (NatHREC) was established in 2002 with the major role of
p.000003: overseeing health research conducted in Tanzania and safeguarding the national interests, protecting research
p.000003: participants while taking into account the interests of the researcher and the research. Protection of research
p.000003: participants is based on five principles namely: Respect of autonomy, Beneficence, Justice, Community
p.000003: engagement and informed consent.
p.000003:
p.000003: Functions of the NatHREC
p.000003: • Provide national level ethical approval for health research in Tanzania.
p.000003:
p.000003: • Review proposed research involving human subjects and ensure that all health research is scientifically
p.000003: sound and ethically conducted.
p.000003: • Advise the MRCC on any relevant matters related to health research.
p.000003: • Develop and establish mechanisms for monitoring of health research approved by the NatHREC.
p.000003: • To receive, review, and document bi-annual reports of approved local health research by IRBs.
p.000003:
p.000004: 4
p.000004:
p.000004: • To receive and document approved health research proposals by local IRBs on a quarterly basis.
p.000004: • To sensitize and update researchers, the community and other stakeholders on health research related
p.000004: issues.
p.000004: • Establishment of an internal quality improvement program.
p.000004: • To accredit and monitor IRBs reviewing health research.
p.000004:
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p.000004:
p.000005: 5
p.000005:
p.000005: THE STANDARD OPERATING PROCEDURES
p.000005:
p.000005: Under this part of the document the Standard Operating Procedures (SOPs) for health research ethics
p.000005: review have been articulated to give guidance to health research review committees in the protection and
p.000005: furtherance of the rights of research participants while taking cognizance of the key roles of relevant
p.000005: health research in improving the welfare of humankind.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: SOP 01: CONSTITUTING THE HEALTH RESEARCH ETHICS REVIEW COMMITTEE
p.000005: This SOP describes procedures for constituting the NatHREC, its composition, terms of reference and ethical basis. It
p.000005: also gives membership conditions of appointment, resignation or disqualification and replacement.
p.000005:
p.000005: Composition
p.000005: The Committee consists of up to 15 members who collectively have the relevant qualification and experience
p.000005: to review and evaluate the science, medical aspects, and ethics of health research proposals. It is composed
p.000005: of members with varying backgrounds to promote a complete and adequate review of health research
p.000005: proposals commonly received by NIMR. The NatHREC shall include the following category members:
p.000005:
p.000005: • Medical scientists;
p.000005: • Biomedical scientists;
p.000005: • Social scientists;
p.000005: • Legal representative
p.000005: • Unaffiliated community representatives (Teacher/Nurse);
p.000005: • Representatives of religious/Faith-Based Organizations.
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006: Terms of reference
p.000006: The Committee operates within specified Standard Operating Procedure (SOPs), which are detailed, written
p.000006: instructions presented in a format that describes all activities and actions to be undertaken by an organization
p.000006: for achieving uniformity of the performance of specific functions. The aim of the SOPs and
p.000006: their accompanying checklists and forms is to simplify the organization and documentation of
p.000006: operation, whilst maintaining high standard of performance. They facilitate and support ethical review by
p.000006: improving the standard and uniformity of the decision-making and assure and gain the confidence of the public in the
p.000006: working of NatHREC. The SOPs promote transparency and efficiency in communication and operations of NatHREC.
p.000006:
p.000006: The following are terms of reference under which the Committee operates:
p.000006:
p.000006: 1. Review health research proposals submitted to it within a reasonable time and document its views in writing to
p.000006: the applicant(s), clearly identifying the study, the documents reviewed and the dates for the following:
p.000006: 1.1 Approval for commencement of the study
p.000006: 1.2 Modifications required prior to its approval
p.000006: 1.3 Disapproval
p.000006: 1.4 Termination/suspension of any prior approval
p.000006:
p.000006: 2. Safeguard the dignity, rights, safety and wellbeing of study participants and communities. Special
p.000006: attention shall be paid to studies that may include vulnerable participants.
p.000006:
p.000006: 3. The Committee may ask the Principal Investigator (s) to provide additional information on
p.000006: any aspect of the study, including physical presentation/personal communication
p.000006: regarding the research proposal to the full committee; however, the researcher/investigator shall not participate
p.000006: in the deliberations of the Committee or in the voting of the Committee on any issue.
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: 4. Obtain the following documents from Principal Investigator(s):
p.000007: i. Application form
p.000007: ii. Summary of Proposal
p.000007: iii. Study proposal(s) and/or amendment(s)
p.000007: iv. Written Informed consent forms and consent form updates that the Principal Investigator(s)
p.000007: proposes for use in the study
p.000007: v. Participant recruitment procedures
p.000007: vi. Written information to be provided to participants
p.000007: vii. In case of a clinical trial, the investigator’s brochure should be provided
p.000007: viii. For clinical trials there should be a document of intent of insurance from an insurance company
p.000007: ix. Institutional Review Board certificate of applicant’s institution
p.000007: x. Institutional Review Board certificate of collaborating foreign institution where
p.000007: applicable
p.000007: xi. IRB certificate and/or commitment letter of collaborating local institutions
p.000007: xii. Research budget and its justification
p.000007: xiii. Curriculum vitae (CVs) and composition of the research team
p.000007:
p.000007: 5. Consider the suitability of the investigator(s) for the proposed study by considering
p.000007: relevant qualification, training and experience, as documented by current curriculum vitae and/or by any other relevant
p.000007: documentation:
p.000007: a) May request more information than is given when additional information would assist
p.000007: NatHREC in taking a decision on the proposal or provide protection of the rights, safety and/or well-being of
p.000007: participants researchers.
p.000007: b) Review both the amount and type of benefit to participants to ensure that such benefits do not
p.000007: present problems of coercion or undueXinfluence on the study participants.
p.000007:
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: c) Concerns itself strictly on the scientific and ethical merits of submitted proposals for approval;
p.000008: executing the tasks free from bias or influence and not involving itself in the day to day administration,
p.000008: policy and other Institutional issues.
...
p.000010: provide the NatHREC with information about the proposal, but shall not participate in the deliberations on the
p.000010: proposal.
p.000010:
p.000010: Resignation, Disqualification, Replacement of Members
p.000010: 1. Members may resign their position by submitting a letter of resignation to the Chairperson.
p.000010: 2. Members may also be disqualified from continuance should the appointing authority provide written
p.000010: reasons to the NatHREC members and there is unanimous agreement.
p.000010: 3. NatHREC shall request for a replacement of any member under the following circumstances:
p.000010: i. Protracted illness of a member, which does not permit him/her to participate in the
p.000010: deliberations of the Committee.
p.000010: ii. Persistent absenteeism of a member without reasonable cause
p.000010: iii. Voluntary withdrawal by a member.
p.000010: iv. Ethical misconduct (s)
p.000010:
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p.000011: 11
p.000011:
p.000011: SOP 02. CONFIDENTIALITY OF PROCEEDINGS
p.000011:
p.000011: 1. Members do not sit on the NatHREC meeting in any specific representative capacity (institutions,
p.000011: associations, departments) and must be able to discuss freely the applications submitted to them.
p.000011: 2. The NatHREC meetings must be completely confidential.
p.000011: 3. Any breaches of confidentiality by members will result in termination of their membership.
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: SOP 03: CONFLICT OF INTEREST AGREEMENT
p.000011:
p.000011: The WHO Declaration of Interests for WHO Experts defines a conflict of interest as follows: “A conflict of interest
p.000011: means that the expert or his/her partner (“partner” includes a spouse or other person with whom s/he has a
p.000011: similar close personal relationship), or the administrative unit with which the expert has an employment
p.000011: relationship, has a financial or other interest that could unduly influence the expert’s position with respect to the
p.000011: subject matter being considered. An apparent conflict of interest exists when an interest would not necessarily
p.000011: influence the expert but could result in the expert’s objectivity being questioned by others. A potential conflict of
p.000011: interest exists with an interest which any reasonable person could be uncertain whether or not should be
p.000011: reported”.
p.000011:
p.000011: The purpose of this procedure is to provide a form of Conflict of Interest Agreement, who should read, keep in mind and
p.000011: sign it, when and where to sign and how the signed document be kept. This SOP covers the Agreement on both
p.000011: Confidentiality and Conflict of Interest, concerning activities and information of NatHREC.
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000012: 12
p.000012:
p.000012: It is the responsibility of all newly appointed Committee members and Consultant reviewers to read, understand,
p.000012: accept and sign the agreement stated on the Confidentiality/Conflict of Interest form (Form 01) before
p.000012: beginning their tasks on conducting activities with NatHREC to protect the rights of the participants.
p.000012:
p.000012: Detailed instructions
p.000012:
p.000012: 1. Newly appointed members or consultant reviewers shall:
p.000012: i. Obtain two copies of the Agreement Form (Form 01) from the Secretariat.
p.000012: ii. Read through the context of the form very carefully and fill in their names and their address in the
p.000012: blanks.
p.000012: iii. Ask questions, if any and the Secretariat shall explain or clarify the context.
p.000012: iv. Sign and date both copies at the undersigned signature and give the forms back to a Secretariat.
p.000012: v. Keeps a copy as their records (Secretariat and Members).
p.000012:
p.000012:
p.000012: The Secretariat shall keep a copy of the signed Agreement as the NatHREC’s records in a Conflict of Interest Agreement
p.000012: file.
p.000012:
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p.000012:
p.000013: 13
p.000013:
p.000013: SOP 04: ADMINISTRATION AND FUNCTIONS OF THE COMMITTEE
p.000013: The purpose of this SOP is to describe the administration, office bearers and their functions in the
p.000013: NatHREC. It therefore describes the Secretariat, functions of the Chairperson, Secretary, the Committee,
p.000013: Director General of NIMR, Consultant reviewer and dissolution of the Committee.
p.000013:
p.000013: Secretariat and Officers
p.000013: 1. The officers of the Committee shall comprise of the Chairperson and Secretary.
p.000013: 2. The Chairperson is elected from among appointed members of the Committee and the Secretary shall always be an
p.000013: employee of NIMR.
p.000013: 3. The Chairperson shall be a respected person in the community, who has the qualifications of Health
p.000013: and Health related science is concerned about human rights and ethical issues and is well informed in regulations
p.000013: relevant to the use of human subjects in research. The Committee shall have a permanent secretariat
p.000013: at NIMR managed by the Committee Secretary and administrative supporting staff who are also employees of NIMR
p.000013: 4. NIMR shall also provide the necessary office space for the operations of the Committee.
p.000013:
p.000013: Function of the Secretary:
p.000013: 1. The Secretary will be in charge of the day to day running on the Secretariat.
p.000013: 2. Undertake all administrative procedures in providing training and educational programs to
p.000013: new and continuing Committee members, and the scientific community in Tanzania on issue related to
p.000013: health research ethics. The training shall include programs about the basic principles of human subject
p.000013: protection, current literature and regulations and guidelines affecting the Committee and NIMR.
p.000013: 3. Assist the institution to recruit new Committee members
...
p.000015:
p.000016: 16
p.000016:
p.000016: Responsibilities of Members of the Committee
p.000016: 1. Review, discuss and consider research proposals submitted for evaluation.
p.000016: 2. Review progress reports and monitor on-going studies as appropriate.
p.000016: 3. Review reports on Serious Adverse Events (SAEs) and recommend appropriate actions.
p.000016: 4. Support the Secretariat in the discharge of their duties when called upon.
p.000016: 5. Maintain professional confidentiality of documents and deliberations of the Committee meetings.
p.000016: 6. Declare conflicts of interest when they exist.
p.000016: 7. Participate in continuing education activities in biomedical ethics and research.
p.000016: 8. Undertake duties assigned to them by the Chairperson.
p.000016: 9. Attend meetings regularly and participate actively during deliberations.
p.000016: 10. Participate in the review of SOPs.
p.000016: 11. Conduct site monitoring visits.
p.000016:
p.000016: Responsibilities of the Director General of NIMR
p.000016: 1. Provide a statement of assurance when required by regulation, guidelines, or sponsor requirements.
p.000016: 2. Ensure the provision of the necessary logistics and financial support for the operations of the
p.000016: Committee.
...
p.000018: electronically.
p.000018: 2. The minutes shall include a list of attendees, actions taken by the Committee, the decision, the basis for
p.000018: requiring changes in or disapproving research, and a written summary of the discussion of controversial or controverted
p.000018: issues and their resolution.
...
p.000022: After the presentation, the PI shall remain in the meeting to answer questions, concerns and receive suggestions from
p.000022: members.
p.000022: 4. After the question and answer period, the PI and any other attendees with a potential conflict
p.000022: of interest with the proposal or institution submitting shall leave the meeting during the decision period.
p.000022: 5. Each Committee member shall have a say for or against a proposal. An absentee member is allowed
p.000022: to send in his/her comments.
p.000022: 6. In order for a proposal to be approved, it shall receive the approval on members’ consensus. The
p.000022: Committee may also decide to postpone decisions on a proposal if more information or consideration is required.
p.000022: 7. After the Committee has voted on a proposal, the PI may be invited into the meeting room for
p.000022: immediate notification. The Committee may also decide to
p.000022:
p.000023: 23
p.000023:
p.000023: contact the PI by other means to communicate the decision on the relevant proposal made in the meeting.
p.000023: 8. If the Committee decides to disapprove a research proposal, it shall include in its written notification to
p.000023: the investigator a statement of the reasons for its decision, and shall give the investigator an opportunity to
p.000023: respond in person or in writing.
p.000023: 9. If the PI is not satisfied with the committee’s decision, the arbitration mechanism shall
p.000023: involve the PI presenting an appeal to MRCC.
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023: SOP 09: ASSESSMENT OF STUDY PROPOSALS
p.000023:
p.000023: This SOP describes how the NatHREC reviews and assesses the proposal documents submitted for approval. The
p.000023: Research Proposal Guideline Form (Form 04) is designed to structure the proposal review process and
p.000023: to facilitate reporting recommendation and comments. Specific questions in the Research Proposal
p.000023: Assessment Form must be adequately addressed in the proposal itself and/or proposal-related documents under
p.000023: review. Relevant points made during discussion and deliberation about a specific proposal shall be recorded
p.000023: on the form. The decision reached by the committee and the reasons for its decision shall be recorded on the
p.000023: Assessment Form. The reviewers will use the Health Research Reviewer’s Guides (Clinical Trials, Biomedical and
p.000023: Humanities) to conduct their review.
p.000023:
p.000023: Where the Committee had sought expert’s advice on a proposal received for assessment, the Consultant shall
p.000023: also use the Research Proposal Guideline (Form 04) in assessing the proposal.
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000024: 24
p.000024:
p.000024: 1. Detailed instruction
p.000024: The Proposal in the Application Form shall be summarized to include general information about the proposal
p.000024: such as title of the proposal, proposal number and date, principal investigators and co-investigators, funding agency
p.000024: and project status whether new/revised/rejected version. Other information to be included in the summary
p.000024: shall be type of review whether regular, expedited or emergency, principal reviewer(s) from the Committee, brief
p.000024: summary of the study and comment by the Principal reviewer(s).
p.000024:
p.000024: 2. Study Design
p.000024: The study design shall be reviewed with a view of evaluating the need for human participants for study, adequacy
p.000024: in literature review, objectives of the study, appropriateness of the methodology proposed,
p.000024: inclusion/exclusion criteria, control arms (placebo, if any) and withdrawal or discontinuation criteria. The
p.000024: study sites shall also be examined for suitability of the study in terms of geographical
p.000024: distribution of the problem under study, facility and infrastructure accessibility and availability at study sites to
p.000024: accommodate the study.
p.000024:
p.000024: 3. Qualifications of investigators
p.000024: Qualifications and experience of investigators shall be examined to see whether the proposed study and background
p.000024: of the participating investigators demonstrate sufficient capacity to conduct the study. Disclosure of potential
p.000024: conflicts of interest shall also be examined. In case of investigators from outside Tanzania, the proposal will be
p.000024: examined to ensure that it includes a local investigator who has sufficient capacity to carry out the study.
p.000024:
p.000024: 4. Study Participation
p.000024: Under this item the assessment shall be done with a view of evaluating voluntary, non-coercive recruitment of
p.000024: participation. The following aspects shall be assessed to see if they have been adequately considered in the proposal:
p.000024: i. Procedures for obtaining informed consent
p.000024:
p.000024:
p.000025: 25
p.000025:
p.000025: ii. Contents of the patient information sheet
p.000025: iii. Contents and language of the informed consent document
p.000025: iv. Translation of the informed consent document to the local language
p.000025: v. Language used is plain and easy to understand by the general public
p.000025: vi. Contact persons with address and phone numbers
p.000025: vii. Privacy and confidentiality
p.000025: viii. Risks -physical/mental/social
p.000025: ix. Benefits -to participants and to others
p.000025: x. Compensation -reasonable/ unreasonable
p.000025: xi. Involvement of vulnerable participants
p.000025: xii. Provisions for medical/psychosocial support
p.000025: xiii. Treatment for study related injuries
p.000025: xiv. Use of biological materials
p.000025: xv. Matters related to insurance of research participants and
p.000025: sponsor/researcher indemnity
p.000025:
p.000025: 5. Examination of Local Institutions and community Involvement
p.000025: Ethical research conduct involving human participation requires community consultation and involvement
p.000025: of local researchers and institutions in the study design, analysis and publication of the results. It
p.000025: also requires contribution to development of local capacity for research and treatment and benefit to
p.000025: local communities and availability of study results. The proposal shall be examined to assess adequate
p.000025: consideration of these aspects.
p.000025:
p.000025: 6. Decision by the Committee members
p.000025: The guidance, advice and decision reached by the Committee members shall be summarized in the Reviewers
p.000025: Guide. The summary shall include proposal title and date of review, checklist of documents reviewed, and
p.000025: decision reached by the Committee for example approved/approved with stipulation/recommended for resubmission
p.000025: after revision or rejected. Recommendations and/or suggestions, if
p.000025:
p.000025:
p.000025:
p.000026: 26
p.000026:
p.000026: any including reasons for disapproving a study (if so) shall be part of the summary. The summary shall also include a
p.000026: list of members participating in a review meeting.
p.000026:
p.000026: 7. Appeal procedures
p.000026: 1. A PI who considers that a decision of the NatHREC is flawed, and where there are substantial and compelling
p.000026: reasons, may appeal that decision in writing to the NatHREC within 30 days of receipt of the decision, stating
p.000026: the precise issues upon which the appeal is based.
p.000026:
p.000026: 2. The NatHREC will respond to PIs in writing within 30 days or upon scrutiny of the complains, the NatHREC may
p.000026: invite the PI to present in person to the full committee within 30 days on receiving the written complaints.
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p.000027: 27
p.000027:
p.000027: SOP 10: REVIEW OF PROPOSAL AMENDMENTS
p.000027:
p.000027: The purpose of this procedure is to describe how proposal amendments are managed and reviewed by
p.000027: the NatHREC. This SOP applies to previously approved study proposals but later being amended and
p.000027: submitted for approval from NatHREC.
p.000027:
p.000027: Amendments made to proposals may not be implemented until reviewed and approved by the Committee. It is the
p.000027: responsibility of the Committee Secretariat to manage proposal amendments. Investigators may amend the contents of
p.000027: proposals from time to time. Proposal amendments must be submitted to the Committee for either expedited review (SOP
p.000027: # 11) or review by the convened NatHREC.
p.000027:
p.000027: Types of Amendment
p.000027: There are three types of amendment
p.000027: 1. Minor: of relatively little importance and therefore not considered as substantial
p.000027: 2. Substantial: the following changes should normally be regarded as substantial:
p.000027: i. Changes to the design or methodology of the study, or to background information affecting its scientific value
p.000027: ii. Changes to the procedures undertaken by participants
p.000027: iii. Any change relating to the safety or physical or mental integrity of participants, or to the risk/benefit
p.000027: assessment for the study
p.000027: iv. Changes to study documentation such as participant information sheets, consent forms,
p.000027: questionnaires, letters of invitation, letters to other clinicians/scientists, information sheets for relatives or
p.000027: caregivers
p.000027: v. Change in the use of biological samples
p.000027: vi. A change of sponsor(s) or sponsor’s legal representative
p.000027: vii. Appointment of a new PI or key collaborator
p.000027: viii. A change to the responsibility and liability insurance coverage for the study
p.000027:
p.000028: 28
p.000028:
p.000028: ix. Appointment of a new PI at a research site
p.000028: x. A significant change to the definition of a research site
p.000028: xi. A change to the definition of the end of the study
p.000028: xii. Any other significant change to the protocol or the terms of the original application
p.000028: 3. Major: whatever procedural changes alter the risk which participants are exposed to, or the potential benefit,
p.000028: constitutes a major amendment. Examples include:
p.000028: i. A change in the primary purpose or objective of the research, such as introduction of additional genetic
p.000028: studies.
p.000028: ii. A substantial change in research methodology
p.000028: iii. Introduction of new classes of investigations or other interventions (rather than simply re-scheduling or
p.000028: modifying those already approved)
p.000028: iv. Recruitment of a new type of participant (especially if these would be regarded as being from vulnerable
p.000028: groups)
p.000028:
...
p.000031: 1. Research activities that present no more than minimal risk to human subjects.
p.000031: 2. Minor changes (modification or amendment) to a previously approved research proposal.
...
p.000033: are responsible for determining whether the research is reviewed annually, or more frequently
p.000033: appropriate to the degree of risk. The Committee is also responsible for determining whether an independent data
p.000033: and safety monitoring board is required. The investigator of the research is responsible for
p.000033: keeping the Committee informed of significant findings that affect the risk/benefit ratio and thus the
p.000033: need for more frequent review. The investigator is also responsible for following the continuing review
p.000033: procedures and deadlines.
p.000033:
p.000033: Determination of Frequency of Continuing Review
p.000033: 1. At a research activity’s initial review, the Committee shall determine:
p.000033: i. How often it shall re-evaluate the research project. All research shall be reviewed at intervals
p.000033: appropriate to the degree of risk, but not less than once per year.
p.000033: ii. The factors to be considered in setting the frequency of review should include the nature of the
p.000033: study, the degree of risk involved, and the vulnerability of the study subject population.
p.000033: iii. Whether these studies need verification from sources other than the investigator that no
p.000033: material changes in the research have occurred.
p.000033:
p.000033: 2. The investigator shall utilize the Continuing Review Form (Form 05) to complete the review
p.000033: report and shall include all required elements, including the following:
p.000033: i. Number and demographics of participants enrolled
p.000033: ii. Changes in principal or Co-investigator(s)
p.000033: iii. A summary description of subject experiences
p.000033:
p.000033:
p.000034: 34
p.000034:
p.000034: iv. Any serious adverse events experienced
p.000034: v. Numbers of and reasons for withdrawals from the research
p.000034: vi. The research results obtained thus far
...
p.000035:
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p.000036: 36
p.000036:
p.000036: SOP 13: USE OF DATA AND SAFETY MONITORING BOARD (DSMB)
p.000036: All clinical studies require safety monitoring throughout the duration of the research, but not all studies require
p.000036: monitoring by a Data and Safety Monitoring Board (DSMB). DSMB’s may be critical for studies intended to save lives,
p.000036: prevent serious disease progression, or reduce the risk of a major adverse health outcome. DSMBs are particularly
p.000036: important in studies where interim data analysis is required to ensure the safety of research participants.
p.000036:
p.000036: The primary responsibility of a DSMB is to safeguard human subjects by analysing accumulating data relevant to the
p.000036: risks and benefits on a regular basis. Especially in long-term trials, the DSMB reviews data periodically to
p.000036: assess effectiveness and toxicity, and to decide if and when the data are sufficiently favourable to one
p.000036: treatment that the study should be discontinued. The DSMB shall also decide whether adverse events are
p.000036: serious enough to warrant termination of the study.
p.000036:
p.000036: NatHREC considers DSMBs to be relevant in the following kinds of studies:
p.000036: i. Controlled studies with mortality and/or severe morbidity as a primary or secondary end-point.
p.000036: ii. Randomized controlled studies focused on evaluating clinical efficacy and safety of a new intervention.
p.000036: iii. Early studies of a high-risk intervention.
p.000036: iv. Studies in the early phases of a novel intervention with very limited information on clinical safety.
p.000036: v. Studies where the design or expected data accrual is complex, particularly studies that take long
p.000036: duration.
p.000036: vi. Studies carried out in emergency situations.
p.000036: vii. Studies which involve vulnerable populations.
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000037: 37
p.000037:
p.000037: For clinical trials conducted only in Tanzania, the DSMB must include representation from Tanzania. For multi-country
p.000037: clinical trials, the DSMB should include regional representation, preferably Tanzanian, on its roster.
p.000037: For Studies with DSMBs, the most recent report from the DSMB should be submitted to the NatHREC as an information item.
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: SOP 14: INQUIRIES FROM RESEARCH PARTICIPANTS, COMMUNITY MEMBERS OR ANY PERSON INTERESTED IN THE STUDY
p.000037: The NatHREC shall consider its prime responsibility by assuming the protection of the rights and welfare of human
p.000037: subjects in research approved by the Committee. This SOP applies to all requests concerning the rights
p.000037: and well-being of the participants in the studies approved by the NatHREC. This procedure shall provide guidelines
p.000037: for dealing with and accommodating requests by participants regarding their rights as participants in any
p.000037: approved clinical research studies. It is the responsibility of all Staff and Committee members acting on
p.000037: behalf of the Committee to facilitate subjects/patients' requests within the scope of their responsibilities.
p.000037:
...
p.000039: depending upon the severity of the event.
p.000039: iii. If an adverse experience/investigational new drug or product safety report that has
p.000039: previously been seen by the full Committee is being resubmitted by another investigator in the same
p.000039: study (as part of a multi- Centre study), this notification shall not require full Committee review. Rather, the
p.000039: Chairperson will determine the course of action.
p.000039:
p.000039: 2. During the Committee meeting
p.000039: After reading and reviewing the report, the Chairperson or designee shall entertain discussion on the report
p.000039: and similar adverse experiences or advisories. If appropriate to the discussions, the Chairperson may call
p.000039: for a consensus on whether to:
p.000039: i. Request an amendment to the proposal or consent
p.000039:
p.000039:
p.000040: 40
p.000040:
p.000040: ii. Request further information
p.000040: iii. Suspend or terminate the study
p.000040: iv. Take no action at the present time
p.000040:
p.000040: 3. The Secretariat shall notify the investigator in writing of any required actions. The Committee’s decision
p.000040: shall be noted in the minutes.
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040: SOP 16: ALLEGATIONS OF NON–COMPLIANCE AND NON- AUTHORIZED RESEARCH
p.000040:
p.000040: The purpose of this SOP is to provide instructions for maintaining records that identify
p.000040: investigators/institutes who fail to comply with National/International guidelines for the conduct of human
p.000040: research or who fail to correspond to the NatHREC requests. This SOP applies to all research projects
p.000040: approved by the NatHREC as well as non-authorized researches. The Secretariat is responsible for
p.000040: maintaining documentation of alleged non-compliance.
p.000040:
p.000040: Detailed instruction
p.000040:
p.000040:
p.000040: 1. Whenever non-compliance or non-authorized research has been alleged, the NatHREC shall investigate the
p.000040: allegations within 30 days to determine if they can be substantiated.
p.000040: 2. When non-compliance has occurred, or non-authorized research has been identified, a report from the
p.000040: Secretariat shall be placed on the agenda of the next Committee meeting.
p.000040: 3. A file shall be maintained that identifies investigators who are found to be in non-compliance with the
p.000040: requirements of the NatHREC, NIMR policy, TFDA and other relevant regulations, and any applicable international
p.000040: guidelines.
p.000040:
p.000041: 41
p.000041:
p.000041: 4. Researchers or others who fail to respond to the Committee’s requests will be notified in writing of
p.000041: the Committee’s decisions, and the appropriate institutions and individuals informed.
p.000041: 5. The Committee may elect to suspend or terminate approval of current studies or refuse subsequent applications
p.000041: from the investigators cited. Such decisions shall be recorded in the minutes.
p.000041: 6. The Secretariat shall notify the investigator of the Committee’s action in writing.
p.000041: 7. Four copies of the notification letter shall be produced. The original shall be sent to the
p.000041: investigator, the second copy to the relevant National Authority (e.g. TFDA, COSTECH), the third to the sponsor or the
p.000041: sponsor’s representative of the study and the fourth to the non-compliance file and stored on the shelf with an
p.000041: appropriate label.
p.000041: 8. The researcher must respond in writing with a description of any corrective actions that are to take
p.000041: place and a timeline for implementation.
p.000041: 9. The findings will be communicated to the MRCC for further action.
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041: SOP 17: ABSENCE OF PI
p.000041:
p.000041: From time to time, the PI may be absent due to annual leave, sick leave or for other reasons. For absences of up to one
p.000041: month, the PI is responsible for ensuring that his/her responsibilities as PI are carried out by a suitable temporary
p.000041: replacement and that that replacement is identified to the Secretariat.
p.000041: In case the PI is absent for one month to six months, he/she should notify NatHREC in writing. If the PI is absent for
p.000041: six months or more the proposal should be amended to replace the PI.
p.000041:
p.000041:
p.000041:
p.000041:
p.000042: 42
p.000042:
p.000042: SOP 18: REVIEW OF FINAL REPORTS AND CLOSURE OF A RESEARCH STUDY
p.000042:
p.000042: The purpose of this SOP is to provide instructions for the review and follow-up, if appropriate, of final reports
p.000042: for any study previously approved by the NatHREC. This SOP applies to the review and follow-up the final report
p.000042: which is an obligatory review of each investigator’s activities presented as a written report to
p.000042: the Committee after the last participant had completed all visits and all adverse experiences have
p.000042: been brought to appropriate resolution.
p.000042:
p.000042: Final reports must be submitted to NatHREC via a Close-out Form (Form 08) and processed as an expedited
p.000042: review.
p.000042:
p.000042: Detailed instruction
p.000042:
p.000042: 1. The Secretariat shall review all Continuing Review and Close-out Forms that indicate that the
p.000042: research is closing.
p.000042: 2. The expedited reviewer will request additional information from the researcher as needed.
p.000042: 3. Written documentation acknowledging the close-out will be provided to the investigator and a copy
p.000042: retained in the proposal file.
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000043: 43
p.000043:
p.000043: SOP 19: COMMUNICATION RECORDS
p.000043:
p.000043: The purpose of this SOP is to ensure proper completion, distribution and filing of verbal and written
p.000043: communication and other study-related or process-related information with investigators, sponsors,
p.000043: volunteer participants, institutes and TFDA. This SOP applies to all communicating activities related to the
p.000043: studies under the approval of the NatHREC.
p.000043:
p.000043: Detailed instruction
p.000043: 1. Individuals may utilize different communication recording mechanisms; that may be handwritten, typed or
p.000043: computer-generated.
p.000043:
p.000043: 2. The attending officer will fill out the communication form (Form 09) for keeping records.
p.000043:
p.000043: 3. Written record shall contain, but not limited to, the following: date of communication,
p.000043: study information (e.g. sponsor, proposal number, investigator), name of person contacted,
p.000043: contact address, telephone number, and e-mail, summary of the communication made, notation of any
p.000043: follow-up necessary and signature of individual making the record.
p.000043:
p.000043: 4. Upon completion of the record, the individual shall distribute copies as appropriate for
p.000043: filing.
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000044: 44
p.000044:
p.000044: SOP 20: SITE MONITORING VISITS
p.000044:
p.000044: The purpose of this SOP is to provide procedures as to when and how a study site should be visited and monitored with
p.000044: regards to the implementation of the proposal as approved by the NatHREC. This SOP applies to any visits and/or
p.000044: monitoring of any study sites identified in the approved proposal as the place where the studies and/or laboratory
p.000044: tests are being carried out or performed. It is the responsibility of the NatHREC to perform or designate some
p.000044: qualified agents to perform on its behalf site monitoring of the research projects it has approved.
p.000044: The Secretariat in consultation with the Chairperson shall initiate site monitoring of a study site for
p.000044: cause or not-for-cause.
p.000044:
p.000044: Detailed Instruction
p.000044:
p.000044:
p.000044: 1. Selection of study sites
p.000044: The database files of the approved proposals shall be reviewed periodically. Study sites to be monitored may be
...
p.000046: the review of issues that require expertise beyond or in addition to those available on the Committee. It shall be
p.000046: the responsibility of the Secretariat to nominate the Consultant.
p.000046:
p.000046: Detailed instruction
p.000046:
p.000046:
p.000046: 1. Selection of Independent consultants
p.000046: The Secretariat shall propose an appropriate consultant to review study documents from a roster of consultants.
p.000046: The roster of consultants shall be maintained by the Secretariat. The Chairperson or the Committee
p.000046: selects the consultant based on criteria including the most current CV, availability, and
p.000046: independence. The
p.000046:
p.000046:
p.000046:
p.000047: 47
p.000047:
p.000047: consultant shall sign a Confidentiality and Conflict of Interest Agreement (Form # 01). This document shall be
p.000047: maintained in a consultant file.
p.000047:
p.000047: 2. Consultation Services
p.000047: The Secretariat shall provide proposal packages to appropriate consultants. The Consultant will be provided
p.000047: with the relevant guidelines for review of the assigned work. The consultant may either attend the meeting to
p.000047: participate in the review of the study as a non-voting member and/or may review the documents and prepare a consultant
p.000047: report to be reviewed by the Committee in their regular meetings or extraordinary meetings. The
p.000047: Consultant’s report shall become a permanent part of the study file.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: SOP 22: PROTOCOL DEVIATIONS AND VIOLATIONS
p.000047:
p.000047: i. The sponsor or PI may make minor deviations from a protocol to deal with unforeseen circumstances and
p.000047: communicate to NatHREC later. However, for deviations that would meet the criteria for a “substantial amendment” as
p.000047: defined in SOP #14 such amendment should be sought from NatHREC.
p.000047: ii. Failure to report to NatHREC (substantial amendment) will necessitate NatHREC to write a warning letter to PI
p.000047: with relevant instruction on the deviation.
p.000047: iii. Flagrant protocol deviation particularly that increases the risk of participants of breeches scientific
p.000047: principles shall be terminated by NatHREC.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000048: 48
p.000048:
p.000048: SOP 23: RESEARCH STUDY TERMINATION
p.000048:
p.000048: This procedure describes how premature termination of NatHREC approved proposals is managed by the
p.000048: NatHREC. It is the responsibility of the NatHREC to terminate research studies in the interest of
p.000048: participants’ health or welfare. Proposals may be terminated at the recommendation of the Chairperson of MRCC,
p.000048: the NatHREC or local IRB, DSMB, study sponsor or any other authorized body. The Secretariat is responsible for
p.000048: management of the termination process.
p.000048:
p.000048: Detailed instruction
p.000048:
p.000048: 1. Upon receiving a notification of study termination the Secretariat shall verify the contents of the
p.000048: package for inclusion of the following:
p.000048: i. Close out Form (Form 08).
p.000048: ii. Indicate termination as recommended action on the Close Out form
p.000048: iii. A cover letter providing the rationale for early termination of the study, and a
p.000048: description of how the study closure will be managed, including procedures for the orderly withdrawal of
p.000048: participants.
p.000048: iv. Additional relevant information and documentation.
p.000048:
p.000048: 2. The Secretariat shall notify the Chairperson regarding the request for proposal
p.000048: termination by sending a copy of the termination package to the Chairperson within one working
p.000048: day upon receipt of the termination request. The Chairperson shall review the submission and convene an ad
p.000048: hoc meeting of the NatHREC, if warranted.
p.000048:
p.000048: 3. The Secretariat shall sign and date the Continuing Review Application Form in acknowledgement and approval
...
p.000051:
p.000051: Detailed instruction
p.000051:
p.000051: 1. Committee members
p.000051: Committee members who have signed a confidentiality agreement with NIMR at the beginning of their term of service to
p.000051: the Committee (SOP # 01) shall have access to the confidential documents.
p.000051:
p.000051: 2. Confidential documents
p.000051: Confidential documents shall include documents reviewed by Committee members (Proposals and related documents, case
p.000051: report forms, informed consent documents, diary forms, scientific documents, expert opinion or reviews). They shall
p.000051: also include NatHREC documents (meeting minutes, advice and decisions) and correspondences (experts, auditors).
p.000051: Copies of documents, including draft and sequential versions, are considered to be confidential and are not
p.000051: permitted to be taken out except when a document is needed for day-to-day operations.
p.000051:
p.000051: 3. Authorization of acquisition of copies
p.000051: Only members of the NatHREC shall be allowed to ask for copies and only staff members of the Secretariat
p.000051: shall be allowed to make such copies.
p.000051:
p.000051: 4. Copies Issued to Non-Members of the Committee
p.000051: If non-members of the Committee need copies of original documents, it shall be the responsibility of the Secretariat to
p.000051: provide the copies.
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000052: 52
p.000052:
p.000052: SOP 26: AUDITING AND INSPECTION OF THE NatHREC
p.000052:
p.000052: The purpose of this procedure is to guide how to prepare for an audit or inspection of the IEC/IRB works. It
p.000052: is the responsibility of the Secretariat, members, Chairperson and administrative staff of the NatHREC
p.000052: for performing his/her task according to the SOPs and for being well prepared and available to answer questions
p.000052: during evaluation, audit or inspection visits of authorities and guests.
p.000052:
p.000052: Detailed instruction
p.000052: 1. Upon receiving a notice of inspection visit, the Chairperson shall inform the Secretariat and
p.000052: alert every unit to prepare for the visit. The Secretariat shall prepare for the visit by going through all
p.000052: steps in a Checklist of Auditing and Inspection (Form 07). Specifically the following shall be made
p.000052: ready for inspection:
p.000052: i. Check if all documents are labelled and kept in the right order for easy and quick search.
p.000052: ii. Check for any missing or miss-organized records
p.000052: iii. Background and training records of NatHREC members and the Secretariat
p.000052: iv. Application Submission Records
p.000052: v. Proposal Assessment Records
p.000052: vi. Communication Records
p.000052: vii. Amendment Approvals
p.000052: viii. Meeting Agenda, Minutes, Action letters
p.000052: ix. Active files
p.000052: x. Continuing and Final reports
p.000052: xi. Reserve a meeting room and all necessary facilities.
p.000052: xii. Review the SOPs.
p.000052: xiii. Make sure that no omission or deviation exists.
p.000052: xiv. Make sure to have good reasons for any omission or deviation.
p.000052:
p.000052:
p.000052:
p.000052:
p.000053: 53
p.000053:
p.000053: xv. Inform Committee members about the inspection date if they are able to attend the audit/inspection
p.000053: meeting.
p.000053: xvi. Any other document needed by auditors
p.000053:
p.000053: 2. Upon arrival of the Auditor(s)/Inspector(s), the Director General of NIMR, Chairperson and the
p.000053: Secretary shall welcome and accompany the auditors/inspectors to the reserved meeting room. Members and
p.000053: some key staff shall also be present in the meeting room. The conversation shall start with the
p.000053: auditor(s)/inspector(s) stating the purpose of the visit and what kind of information and data they
p.000053: would need. The Chairperson/designated spokesperson of the Committee shall answer
p.000053: questions of the auditors/inspectors clearly, politely and truthfully with confidence and straight to the
p.000053: points. All information and files shall be made available as requested by the auditors/inspectors.
p.000053:
p.000053: 3. After the auditor(s)/inspector(s) have left, the Chairperson shall call for correction of
p.000053: any mistakes pointed out by the audit(s) and internal follow-up shall be carried out. A report shall be
p.000053: written and get approval from the Chairperson. Appropriate time for correction and improvement process
p.000053: shall be allowed and an outcome of the audit process shall be evaluated. The record of the report on the
p.000053: audit/inspection meeting shall be kept in the audit/inspection file and record of findings from the
p.000053: internal follow-up audit in the internal audit file.
p.000053:
p.000053: 4. Internal auditing of NatHREC should be conducted by MRCC while the external IRB auditing to be done
p.000053: by the NatHREC.
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000054: 54
p.000054:
p.000054: SOP 27: ARCHIVING OF NatHREC DOCUMENTS
p.000054:
p.000054: The purpose of this SOP is to provide instruments for storing inactive study files and administrative documents in a
p.000054: secure manner while maintaining access for review by auditors and inspectors. The files and documents are retained
p.000054: for at least fifteen years after completion of the research so that the records are accessible for auditors and
p.000054: inspectors. Copying files and documents for or by authorized representatives of the national authority when required
p.000054: is allowed.
p.000054:
p.000054: Maintenance and retrieval of archived documents
p.000054: 1. After a study has been completed and the final report accepted, the Secretary shall do the following:
p.000054: i. Remove the contents of the entire study file from the active study filing.
p.000054: ii. Verify that all the documents are present in organized manner.
p.000054: iii. Provide an archive number from these documents and enter the number into the database and/or
p.000054: Archive Logbook.
p.000054: iv. Place the file in a storage container.
p.000054: v. Send it to the appropriate storage facility.
p.000054: vi. Maintain a log of materials that have been archived.
p.000054:
p.000054: 2. To archiving administrative documents, an administrative staff of the Secretariat shall
p.000054: perform inventories of miscellaneous administrative documents, place the documents in an appropriate
p.000054: storage container, and send it to the appropriate storage facility. In retrieving documents the Secretary shall
p.000054: maintain confidentiality as stipulated in (SOP# 5) (Procedure for Maintaining Confidentiality of Ethical Review
p.000054: Committee Documents).
p.000054:
p.000054: 3. Retrieval of documents shall be done following NIMR institutional procedures. The retrieved files shall be
p.000054: returned to the archive after completion of use.
p.000054:
p.000054:
p.000054:
p.000054:
p.000055: 55
p.000055:
p.000055: SOP 28: DISTRIBUTION OF SOPs AND GUIDELINES
p.000055:
p.000055: This standard operating procedure describes how to distribute and to control the distribution of the NatHREC
p.000055: approved SOPs and Guidelines. The NatHREC works according to internal rules as described in its written SOPs. In
p.000055: order to maintain a transparent relationship with the research community, the SOPs shall be made publicly
p.000055: available. The SOPs will be published in print and electronically, and made freely available.
p.000055:
p.000055:
p.000055:
p.000055:
p.000055: SOP 29: REVISION OF SOPs
p.000055:
p.000055: The purpose of this SOP is to address when and how SOPs shall be reviewed and, if necessary, revised. If the committee
p.000055: wishes to review and/or revise the SOP:
p.000055: 1. It shall request an electronic copy of the document from the Secretary or may request minor changes to be made
p.000055: directly by the Secretariat.
p.000055: 2. The SOP shall be reviewed for accuracy and timeliness every three years. SOPs may be revised more frequently
p.000055: when required.
p.000055: 3. The Secretary in consultation with the NatHREC shall ensure that the SOP reflects the actual
p.000055: procedures and all applicable regulatory requirements.
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000056: 56
p.000056:
p.000056: SOP 30: COORDINATION WITH INSTITUTIONAL REVIEW BOARDS
p.000056: The purpose of this SOP is to address the relationship between the NatHREC and the local institutional review boards
p.000056: (IRBs) that may also review health research in Tanzania. It is acknowledged that not all human subject’s research
p.000056: require review and approval at the national level. Consequently, ethics review at the institution conducting
p.000056: the research is important and complementary to the national-level review provided by the NatHREC.
p.000056:
...
p.000059:
p.000059: Description of titles of the personnel
p.000059: Titles Description
p.000059: Active Study Files Supporting and approved documents, records containing communications,
p.000059: and reports that correspond to each active (current) study approved by the NatHREC.
p.000059:
p.000059: Administrative Documents
p.000059: These includes official minutes of the Committee meetings as described in SOP # 04 the SOPs, historical files
p.000059: and Master Files as described in SOP # 20, Distribution, Implementation and File Maintenance.
p.000059: Administrative Staff They are NatHREC staff that are responsible for the day-to-day administrative
p.000059: functions and duties, which support the activities and responsibilities of the Committee.
p.000059: Adverse Event Is any untoward and unintended response in a research participant which is related to any
p.000059: dose administered, medical devise or psychological disturbance.
p.000059: Adverse Reaction Is any untoward and unintended response in a subject to an investigational medicinal
p.000059: product which is related to any dose administered to a research participant
p.000059: Amendment Any change to a NatHREC approved study. Amendments must be prospectively approved unless
p.000059: the change is required to package of the amended parts and related documents of the proposal,
p.000059: previously approved by the IEC/IRB, but later decided to make changes after the study had been carried for
p.000059: some time.
p.000059: Appointing Authority The body responsible for the establishment and support of NatHREC, in this case is the
p.000059: MRCC-NIMR
p.000059: Audit A systematic and independent examination of research trial approval
p.000059: activities and documents to determine whether the review and approval activities were conducted and
p.000059: data were recorded and accurately reported according to the SOPs, GCP, Declaration of Helsinki and applicable
p.000059: regulatory requirements
p.000059: Chairperson A member of the Committee presiding over a meeting.
p.000059: Clients As a national review Committee, NATREC considers investigators, investigational
p.000059: sites, sponsors or sponsor representatives as its clients or customers. Clients requesting the services of
p.000059: NATREC are asked to accept and abide by the procedures set forth in SOPs.
p.000059: Committee Members Individuals serving as regular and alternate members on the NatHREC’s
p.000059: operations. This Committee is constituted in accordance with the NatHREC membership requirements set
p.000059: forth in SOP # 01.
p.000059: Confidentiality Prevention of disclosure, to other than authorized individuals, of Committee
p.000059: information and documents
p.000059: Conflict of Interest A situation in which a person, such as a public official, an
p.000059: employee, or a professional, has a private or personal interest
p.000059:
p.000059:
p.000060: 60
p.000060:
p.000060: sufficient to appear to influence the objective exercise of his or her official duties. There are three key
p.000060: elements in this definition: financial interest; official duties; professional interest. A conflict of interest
p.000060: occurs when:
p.000060: (i) An individual's private interest differs from his or her professional obligations to the
p.000060: institute.
p.000060: (ii) Professional actions or decisions occur that an independent observer might reasonably question.
p.000060: (iii) A conflict depends upon situation and not on the character or actions of the individual.
p.000060: (iv) Potential conflicts of interest must be disclosed and managed as per policy.
p.000060: Expedited review A review process in which one or more experienced NatHREC members review and
p.000060: approve research on behalf of the NatHREC. Only activities that meet the criteria for expedited review (see SOP #11)
p.000060: may be reviewed using the expedited review procedures.
p.000060:
p.000060: External researchers/ collaborators
p.000060: These are non-Tanzanians that are participating in a research in the country.
p.000060: Final Report An obligatory review of study activities presented as a written report to
p.000060: the Committee after the last subject has completed all visits and all adverse experiences have
p.000060: been brought to appropriate resolution.
p.000060: Health Health is a state of complete physical, mental and social well-being and not
p.000060: merely the absence of disease or infirmity.
p.000060:
p.000060: Independent Consultant
p.000060: An expert who gives advice, comments and suggestions to the NatHREC with no affiliation to the
p.000060: institutes or investigators proposing the research proposals.
p.000060: Inspection The act by a regulatory authorities of conducting an official review of documents,
p.000060: facilities, records, and any other resources that are deemed by the authorities to be related to the clinical
p.000060: trial and that may be located at the site of the trial, at the sponsor's and/or contract research
p.000060: organizations (CRO) facilities, Office of Ethics Committees, or at other establishments deemed appropriate by the
p.000060: regulatory authorities.
p.000060:
p.000060: Investigational New Drug
p.000060:
p.000060:
p.000060: Investigator’s Brochure
p.000060: Investigational new drug means a new drug, antibiotic drug, or biological drug that is used in a clinical
p.000060: investigation. The term also includes a biological product that is used in vitro for diagnostic purposes.
p.000060: The terms "investigational drug" and "investigational new drug" are deemed to be synonymous for purposes of this
p.000060: part. Is a document containing a summary of the clinical and non- clinical data relating to an investigational
p.000060: medicinal product which are relevant to the study of the product in human subjects
p.000060: Medical Device A medical device is any health care product that does not achieve any of its intended
p.000060: purposes by chemical action or by being metabolized. Medical devices include items such as diagnostic test kids,
p.000060: crutches, electrodes, prescribed beds, pacemakers, arterial
p.000060:
p.000061: 61
p.000061:
p.000061: grafts, intraocular lenses, and orthopaedic pins. Medical devices also include diagnostic aids such as
p.000061: reagents and test kids for in vitro diagnosis of disease and other conditions, for example,
p.000061: pregnancy.
p.000061: Minutes The official record of events, activities, and actions taken by the
p.000061: convened NatHREC.
p.000061: Monitoring visit Oversight visits to study sites by the NatHREC or its
p.000061: representatives to assess the conduct of NatHREC-approved research.
p.000061:
p.000061: National Research Ethics Committee (NatHREC)
p.000061: A national independent ethics review committee that is housed within the NIMR structure. The NatHREC is
p.000061: a subcommittee to the MRCC.
p.000061: Nutrient Supplements Substances, which may or may not be regulated that are necessary for the body's nutritional and
p.000061: metabolic processes.
p.000061: Participants’ rights Recognition of the inherent dignity and of the equal and inalienable
p.000061: rights of all members of the human family is the foundation of freedom, justice and peace in the
p.000061: world. It is essential that Human Rights should be protected by the rule of law.
p.000061:
p.000061: Principal Investigator (PI)
p.000061: The investigator/researcher with overall responsibility for the research. In a multi-site study, in a country, there
p.000061: should be one overall PI to be answerable, with other CO –PI’s as the case may be.
p.000061: Project Manager Individual responsible for coordinating an investigational study. This person may
p.000061: also be referred to as a Site Coordinator. Serve as the primary point of contact for the NatHREC.
p.000061:
p.000061: Proposal Deviation/ Violation
p.000061: Any instance in which the NatHREC-approved proposal has not been followed.
p.000061: Protocol A document that describes the objectives, design, methodology, statistical
p.000061: considerations (or other methods of data analysis) and organisation of a research study.
p.000061: Quorum Attendance at any convened meeting of the board where at least half of
p.000061: the regular (or alternate) members, including at least one physician and one layperson, is maintained
p.000061: throughout the discussions and voting portions of the meeting.
p.000061: Research Research is a systematic process of steps used to collect and analyze
p.000061: information to increase understanding of a topic or issue". It consists of three steps: Pose a question, collect data
p.000061: to answer the question, and present an answer to the question.
p.000061: Research Participant Is a patient, service user, or any healthy person who is taking part in the study
p.000061:
p.000061: Serious Adverse Event (SAE)
p.000061: Is untoward occurrence that results in death, is life-threatening, and requires hospitalization or
p.000061: prolongation of existing hospitalization, results in persistent or significant disability or
p.000061: incapacity or that maybe consistence with development of a congenital anomaly.
p.000061: The adverse event is SERIOUS and should be reported when the
p.000061:
p.000061:
p.000062: 62
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062: Standard Operating Procedures (SOPs)
p.000062: patient outcome is:
p.000062: Death - Report if the patient's death is suspected as being a direct outcome of the adverse event.
p.000062: Life- Threatening - Report if the patient was at substantial risk of dying at the time of the adverse event or it is
p.000062: suspected that the use or continued use of the product would result in the patient's death. Examples: Pacemaker
p.000062: failure; gastrointestinal haemorrhage; bone marrow suppression; infusion pump failure which permits uncontrolled free
p.000062: flow resulting in excessive drug dosing.
p.000062: Hospitalization - (initial or prolonged)-Report if admission to the hospital or prolongation of a hospital stay results
p.000062: because of the adverse event. Examples. Anaphylaxis pseudomembranous colitis or bleeding causing or prolonging
p.000062: hospitalisation.
p.000062: Disability - Report if the adverse event resulted in a significant, persistent, or permanent change,
p.000062: impairment, damage or disruption in the patient's body function/structure, physical activities or
p.000062: quality of life. Examples: Cerebrovascular accident due to drug-induced hypercoagulability; toxicity, peripheral
p.000062: neuropathy.
p.000062: Congenital Anomaly - Report if there is suspicions that exposure to a medical product prior to conception or
p.000062: during pregnancy resulted in an adverse outcome in the child. Examples: Vaginal cancer in female off
p.000062: spring from diethylstilbestrol during pregnancy, malformation in the offspring caused by thalidomide.
p.000062: Requires Intervention to Prevent Permanent Impairment or Damage-Report if suspect that the use of a
p.000062: medical product may result in a condition, which required medical or surgical intervention to
p.000062: preclude permanent impairment or damage to a patient. Examples: Acetaminophen overdose-induced
p.000062: hepatotoxicity requiring treatment with acetylcysteine to prevent permanent damage burns from radiation
p.000062: equipment requiring drug therapy, breakage of a screw requiring replacement of hardware to prevent
p.000062: malunion of a fractured long bone.
p.000062: Detailed, written instructions, in a certain format, describe activities and action undertaken by an
p.000062: organization to achieve uniformity of the performance of a specific function.
p.000062: Study site Is an organization, a unit that is responsible for carrying a research in a given
p.000062: locality.
p.000062:
p.000062: Vulnerable Participants
p.000062: A vulnerable category of participants includes children, prisoners, pregnant women, handicapped or mentally disabled
p.000062: persons, and economically or educationally disadvantaged persons, who are likely to be vulnerable to coercion or
p.000062: undueXinfluence.
p.000062:
p.000062:
p.000062:
p.000062:
p.000063: 63
p.000063:
p.000063: APPENDIX II: FORMS/TOOLS
p.000063:
p.000063: FORM 01:
p.000063: CONFIDENTIALITY AND CONFLICT OF INTEREST DECLARATION FORM FOR MEMBERS OF THE NATIONAL HEALTH RESEARCH
p.000063: ETHICS REVIEW COMMITTEE
p.000063:
p.000063: ………… Meeting of National Health Research Ethics Review Committee/Clinical Trials Sub-committee
p.000063:
p.000063: Confidentiality:
p.000063:
p.000063: I agree to consider all discussions and / or
p.000063: statements made in this meeting as confidential information. I declare to safeguard confidentiality during and
p.000063: after the meeting. I also declare to consider any documents, materials or information provided to me in
p.000063: the course of the meeting, or in conducting activities of this committee after the meeting, as confidential materials,
p.000063: never to be divulged to any person without any prior written permission of the Chairperson of the
p.000063: committee.
p.000063:
p.000063: Conflict of Interest
p.000063: I declare that I have no/I have a conflict of interest in relation to the following/none of the proposals tabled for
p.000063: discussion in this meeting.
p.000063:
p.000063: Conflict of Interest: (Write down)
p.000063: …………………………………………………………………………………………………..
p.000063: ………………………………………………………………………………………………….. Proposal for which I have a Conflict of Interest
p.000063: Proposal title:
p.000063: ……………………………………………………………………………………………….…
p.000063: ………………………………………………………………………………………………….
p.000063: PI:
p.000063: Type of Conflict of Interest:
p.000063: Financial
p.000063: Proposal Development Other aspects of the proposal
p.000063:
p.000063: Signature: …………………………………………………………
p.000063:
p.000063: Date: ………………………..............................................................
p.000063:
p.000063:
p.000063:
p.000063:
p.000064: 64
p.000064:
p.000064: FORM 01: CONFIDENTIALITY/CONFLICT OF INTEREST AGREEMENT
p.000064:
p.000064: CONFIDENTIALITY
p.000064:
p.000064: In recognition of the fact that, member’s name, and his/her affiliation herein after referred to as the
p.000064: “undersigned” and as a member of the National Ethics Review Committee has been asked and appointed to
p.000064: assess research studies involving human subjects, in order to ensure that the studies are conducted in a
p.000064: humane ethical manner, with highest standard of care according to the applied national local regulations,
p.000064: institutional policies and guidelines;
p.000064:
p.000064: You have been appointed as a member of the National ethics review committee as an individual, not as an
p.000064: advocate or representative of your home province/territory/community or as the
p.000064: delegate of any organization or private interest. Your fundamental duty is to independently review both
p.000064: scientific and ethical aspects of research protocols involving human subjects and make a
p.000064: determination and the best possible objective recommendations, based on the merits of the submissions you review.
p.000064:
p.000064: The National Ethics Review Committee aims to meet the highest ethical standards in order to merit the trust and
p.000064: confidence of the communities’ protection of rights and wellbeing of human subjects. As a member of
p.000064: the National Ethics Review Committee you are expected to meet the same high standards of ethical behaviour as you
p.000064: carry out your mandate.
p.000064:
p.000064: This Agreement, encompasses any information deemed confidential or proprietary provided to the Undersigned in
p.000064: conjunction with duties as a member of the National Ethics Review Committee. Any written information provided
p.000064: to the undersigned that is of a confidential, proprietary or privileged nature shall be
p.000064: identified accordingly.
p.000064:
p.000064: As such, the undersigned agrees to hold all confidential or proprietary trade secrets (“information”) in trust or
p.000064: confidence and agrees that it shall be used only for contemplated purposes; shall not be used for any other
p.000064: purpose or disclosed to any third party. Written confidential information provided for review shall not be
p.000064: copied or retained, and all confidential information (and any copies and notes thereof) shall remain the
p.000064: sole property of the National Ethics Review committee.
p.000064:
p.000064: The Undersigned agrees not to disclose or utilize, directly or indirectly, any confidential or
p.000064: proprietary information belonging to a third party in fulfilling this agreement. Furthermore, the undersigned
p.000064: confirms that his/her performance of this agreement is consistent with the institute’s policies and any contractual
p.000064: obligations they may have to third parties.
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000065: 65
p.000065:
p.000065: CONFLICT OF INTEREST
p.000065:
p.000065: It is a policy of the National Ethics Review Committee that no member may participate in the review or
p.000065: approval for activities in which that member has a conflict of interest except to provide information as
p.000065: requested by the National Ethics Review Committee.
p.000065:
p.000065: You shall immediately disclose to the Chairperson of the National Ethics Review Committee any actual or
p.000065: potential conflicts of interest that you may have in relation to any particular proposal submitted for review by
p.000065: the Committee and to abstain from any participation in discussions or recommendations in respect
p.000065: of such proposals.
p.000065:
p.000065: If an applicant submitting a protocol believes that an Ethics Review Committee member has a potential
p.000065: conflict, the investigator may request in writing or by telephone to the Chairperson that the member be
p.000065: excluded from the review of the protocol.
p.000065:
p.000065: Members will notify the Chairman any conflict of interest that they may have with any application and if so will not
p.000065: participate in evaluation of the proposal of interest.
p.000065:
p.000065: A member or members who may have a conflict of interest may not be counted toward a quorum and may not
p.000065: vote.
p.000065: All members of the National Ethics Review Committee will sign a Confidentiality and Conflict of Interest
p.000065: declaration form at the beginning of every meeting that they will attend. The form will define elements of Conflict of
p.000065: Interest.
p.000065:
p.000065: Confidentiality and non-disclosure
p.000065: In the course of your activities as a member of the National Ethics Review Committee, you may
p.000065: be provided with confidential information and documentation (referred to as the “Confidential Information”).
p.000065: You agree to take reasonable measures to protect the Confidential Information: subject to applicable
p.000065: legislation,
p.000065:
p.000066: 66
p.000066:
p.000066: including the AccessXtoXInformation Act, not to disclose confidential information to any person; not to use
p.000066: confidential information for any purpose outside the committee, and for any purpose outside the Committee’s
p.000066: mandate, and in particular, in a manner which would result in a benefit to yourself or any third party, and to return
p.000066: all confidential information (including any minutes or notes you have made as part of your committee duties) to
p.000066: the Chairperson upon termination of your functions as a committee member.
p.000066:
p.000066: Please sign and date this agreement, if the undersigned agrees with the terms and conditions set forth above. The
p.000066: original shall be kept in file in the custody of the regularly compliance office. A copy shall be provided
p.000066: for your records.
p.000066:
p.000066: I (name) ……………………………… Address…………………………………………...
p.000066: ……………………………………………………………………………………………….. Have read and accept the aforementioned terms and conditions as explained in
p.000066: this agreement.
p.000066:
p.000066: ……………………………………… …………………………………….. Undersigned Signature
p.000066: Date
p.000066:
p.000066: ……………………………………… ……………………………………. Compliance Officer
p.000066: Date
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000067: 67
p.000067:
p.000067: FORM 2: CHECKLIST ETHICAL CLEARANCE APPLICATION SUBMISSION
p.000067:
p.000067: 1. NEW PROPOSAL AND AMENDMENT
p.000067:
p.000067: Required Documents: Five (5) hard copies of all documents Attached with
p.000067: application?
p.000067: 1. National Health Research Ethics Committee (NatHREC) Application Form □
p.000067: 2. Cover letter with Institution logo signed by PI or CO-PI □
p.000067: 3. Commitment letter from affiliated institution and/or local government
p.000067: officials
p.000067: □
p.000067: 4. Full study proposal (s) /or Amendment (s) with all relevant sections:
p.000067: Summary, Background and Rationale, Objectives, Methodology, Ethical □ considerations, Budget and
p.000067: Budget justification, References and
p.000067: Appendices, etc.
p.000067: 5. Informed Consent Forms/Assent Forms in English and Kiswahili with
p.000067: institution logo Local PI and NatHREC contacts □
p.000067: 6. IRB approval certificate from affiliating institution (s) where applicable □
p.000067: 7. Data collection tools in English and Kiswahili □
p.000067: 8. Elaborated recruitment procedure □
p.000067: 9. Written information to be provided to participants in English & Kiswahili □
p.000067: 10. Curriculum Vitae (CVs) and composition of the research team □
p.000067: 11. Evidence of application and registration fees payment (Bank slip) □
p.000067: 12. Filled in Data Transfer Agreement (DTA) and/or Material Transfer
p.000067: Agreement (MTA) (where applicable) □
p.000067: For Clinical Trials:
p.000067: Additional documents must be submitted with application
p.000067: 1. Investigator’s Brochure and Case Report Forms □
p.000067: 2. Proof of Insurance Coverage arrangement □
...
p.000069: Institution and Department/Unit Other co-investigators at the PI institution
p.000069: Signature of the PI
p.000069: If Research student:
p.000069: Name, signature and approval of Supervisor
p.000069: (include letter from the student institution or university)
p.000069: Contact details for correspondence (include the name of contact if different from the PI)
p.000069: If this study involves more than one institution, name the overall study PI, institution and contact address Name
p.000069: of other institutions involved in the study if this study involves
p.000069:
p.000070: 70
p.000070:
p.000070: more than one institution
p.000070:
p.000070: Is this a randomized controlled trial?
p.000070: YES/NO
p.000070: Does this study involve the taking of blood and/or any other biological samples? YES/NO Does this study involve
p.000070: shipment of biological samples outside Tanzania? YES/NO Does this study going to involve data transfer
p.000070: outside Tanzania? YES/NO Provide details of all ethical
p.000070: clearances sought or obtained from
p.000070: other ethics committees? (This includes institutional ethics approval within Tanzania and in
p.000070: other countries if appropriate). Please attach approval certificates from other ethics committee(s).
p.000070: Provide the list of changes from the first (initial)/previous submission in case of
p.000070: revised/amended submission
p.000070:
p.000070: 1. Provide the scientific background, study design and objectives and hypotheses.
p.000070: Max 400 words
p.000070:
p.000070:
p.000070:
p.000070:
p.000070: 2. State the intended value of the project or rationale. Why it is important to conduct this study in
p.000070: Tanzania? Provide relevant references as appropriate.
p.000070: Max 300 words
p.000070:
p.000070:
p.000070:
p.000070:
p.000070: 3. State the total duration of the project, and where it will be undertaken in Tanzania (and also in other
p.000070: countries if appropriate).
p.000070:
p.000070:
p.000070:
p.000070: 4. Provide evidence (such as commitment/endorsement letter) to show that local government
p.000070: officials in the region(s)/district(s) where the proposed research will be conducted have been informed about
p.000070: this study.
p.000070: IF THIS HAS NOT BEEN DONE, describe how you plan to achieve this BEFORE the study starts.
p.000070:
p.000070:
p.000070:
p.000070: 5. Specify the number of the study participants, with scientific justification for sample size,
p.000070: age, gender.
p.000070:
p.000070:
p.000070:
p.000070: 6. Specify recruitment methods, inclusion and exclusion criteria and study end points.
p.000070:
p.000070:
p.000071: 71
p.000071:
p.000071:
p.000071:
p.000071:
p.000071: 7. Specify data collection procedures, including interviews and sample collection, involving
p.000071: human participants with brief details of actual methods. Attach copies of questionnaires and other data
p.000071: collection tools in English and Kiswahili.
p.000071: Max 500 words
p.000071:
p.000071:
p.000071:
p.000071: 8. If applicable, describe procedures to be used to process, store and test biological samples
p.000071: (e.g. blood, genital swabs, urine, etc).
p.000071:
p.000071:
p.000071:
p.000071: 9. If samples will be taken overseas, are there samples which will be left in Tanzania?
p.000071: Describe procedures to be used in their shipping, storage and when will be destroyed. Indicate which institution or
p.000071: laboratory samples will be analyzed. Please note that before samples are shipped outside Tanzania MTA clearance
p.000071: is required.
p.000071:
p.000071:
p.000071: 10 Is the technology required for analysis of samples available in Tanzania? YES/NO
p.000071:
p.000071: If YES, please describe why are samples being taken outside the country
p.000071:
p.000071: 11 Would local scientist(s)(Tanzanian) be involved in sample analysis? YES/NO
p.000071:
p.000071: If YES describe her/his involvement, and if NOT please explain what are the strategies for technology transfer
p.000071:
p.000071: 12 Specify data management procedures and methods to be used during data analysis.
p.000071:
p.000071: 13 If data will be taken overseas, please describe why are being taken outside the country Please note that
p.000071: before data are take outside Tanzania, clearance is required by completing a Data Transfer Management
p.000071: Agreement Form
p.000071:
p.000071: 14 Describe the potential risks, discomfort, distress or hazards that research participants may be exposed
p.000071: to (these may be physical, biological and/or psychological). What precautions will be taken to reduce risks and
p.000071: ensure participants’ safety?
p.000071:
p.000071: 15 Describe potential benefits for the participants and the population where they come from. Are there
p.000071: direct benefits for the people of Tanzania and/or other countries?
p.000071:
p.000071: 16 Specify how confidentiality of the study participants and data collected will be maintained.
p.000071:
p.000071: 17 State the manner in which consent will be obtained and documented in writing. Provide copies
p.000071: of the informed consent forms and other relevant documents in English and Kiswahili. Describe steps to be taken
p.000071: to minimize coercion/undue influence
p.000071:
p.000071:
p.000072: 72
p.000072:
p.000072: during the consent process.
p.000072:
p.000072:
p.000072: 18 Describe how you are going to assess comprehension of the information provided during the
p.000072: consent process.
p.000072:
p.000072: 19 Will payments be made to participants? (These should usually not be for more thantravelling
p.000072: expenses and/or loss of earnings and must not be coercive or represent an undue inducement to take part) NO.
p.000072: If YES give details and justification.
p.000072:
p.000072: 20 State theexperience of the PI and co-investigators in the study in the field concerned, and their role
p.000072: will be on the project.
p.000072:
p.000072:
p.000072: 21 Please describe how project staff (PI and other staff) will be trained on the protection of study
p.000072: participants in research. In case already trained attach certificate.
p.000072:
p.000072: 22 When applicable, state what medical supervision is available to the participants
p.000072:
p.000072: 23 Describe the facilities available to support the successful conduct of the proposed research
p.000072: study, i.e.; office space, equipped laboratories.
p.000072:
p.000072: 24 If this is a clinical/intervention trial of a medicine, device, biologic/vaccine, or any other
p.000072: form of treatment or intervention, please respond to the following questions:
p.000072:
p.000072: a) Does the trial comply with Good Clinical Practice (GCP)?
p.000072:
p.000072: b) Does this trial involve testing a new drug, vaccine or medical device which is not
p.000072: registered in Tanzania?
p.000072:
p.000072: c) If this trial involves testing a new drug, vaccine or medical device, please attach the
p.000072: investigator brochure?
p.000072:
p.000072: If there is no investigator brochure, please explain the reason.
p.000072:
p.000072: d) What will be offered to the control arm?
p.000072:
p.000072: e) Please confirm that TFDA approval will be processed before data collection begins.
p.000072:
p.000072: f) Is there a Data Monitoring & Safety Committee in place? YES/NO
p.000072:
p.000072: If NO, please explain reasons
p.000072:
p.000072: g) If the intervention to be tested is found to be effective, describe plans to make it
p.000072: available to the participants and other people after the end of the trial.
p.000072:
p.000072: h) Have you obtained a certificate insurance cover for study participants locally (a cover
p.000072:
p.000072:
p.000073: 73
p.000073:
p.000073: from insurance company based in Tanzania)? YES/NO If YES please attach
p.000073:
p.000073: If NO please describe how this will be obtained
p.000073:
p.000073: 25. Is the study going to involve vulnerable population? YES/NO
p.000073: (Vulnerable population include: pregnant women, human foetuses, neonates, children, prisoners, hospitalizedXpatients,
p.000073: mentally ill persons etc)
p.000073:
p.000073: If YES, describe steps which will be taken to ensure protection of human subjects
p.000073:
p.000073: 26. Please give details of the funder.
p.000073:
p.000073:
p.000073: 27. Please give details of research sponsor. This is not necessarily the funding body. The sponsor is
p.000073: responsible for the initiation and management of the study. All clinical trials should have an identified
p.000073: sponsor.
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000074: 74
p.000074:
p.000074: FORM 4: RESEARCH PROPOSAL ASSESSMENT FORM
p.000074:
p.000074: NATIONAL INSTITUTE FOR MEDICAL RESEARCH
p.000074:
p.000074: Telephone 255 22 2 121400
p.000074: Telex 41919 NIMR TZ P.O. Box
p.009653: 9653
p.009653: Telegrams MEDSEARCH Dar es Salaam
p.009653: Telefax 255 22 2 12120020
p.009653: Tanzania
p.009653: Email: headquaters@nimr.or.tz
p.009653: [DATE]
p.009653: Our Ref No. [####] Your Ref. [####]
p.009653:
p.009653: [Name of Reviewer] [Address]
p.009653:
p.009653: Dear [Name of Reviewer]
p.009653: REQUEST TO ASSESS A HEALTH RESEARCH PROPOSAL
p.009653:
p.009653: [SUMMARY OF REQUEST FOR REVIEW]
p.009653:
p.009653: The attached Proposal/Amendment research proposal entitled: [TITLE OF PROPOSAL AND NAME OF
p.009653: PRINCIPAL INVESTIGATOR] has been submitted for both scientific and ethical clearance by the MRCC Secretariat.
p.009653: I should be most grateful for your help in evaluating it. In case you do not agree with the statement given check
p.009653: Comments to Principal Investigator (CPI).
p.009653:
p.009653: 1. SUMMARY Is clear, succinct, and has all element of the proposal.
p.009653: See CPI
p.009653:
p.009653: 2. BACKGROUND Clearly, stated, and meets users’ demands See CPI
p.009653: 3. OBJECTIVES Relevant to the research problem See CPI
p.009653: 4. RATIONALE Proposal well reasoned out See CPI
p.009653:
p.009653:
p.009653:
p.009653:
p.000075: 75
p.000075:
p.000075: 5. METHODOLOGY Proper, well designed and related to all objectives Stated
p.000075: See CPI
p.000075:
p.000075: 6. PERSONNEL (CVs) Proposers are scientifically and technically capable
p.000075:
p.000075: See CPI
p.000075:
p.000075: 7. BUDGET AND See CPI JUSTIFICATION
p.000075:
p.000075: 8. ETHICAL CONSIDERATION: Have Ethical issues been well addressed in this proposal? Please Comment (Use an
p.000075: additional sheet of paper if necessary)
p.000075: ........................................................................................................................
p.000075: ........................
p.000075: ........................................................................................................................
p.000075: ........................
p.000075: ........................................................................................................................
p.000075: ........................
p.000075: ........................................................................................................................
p.000075: ........................
p.000075:
p.000075: 9. ANY OTHER COMMENTS: (Use an additional sheet of paper if necessary)
p.000075: ........................................................................................................................
p.000075: ........................
p.000075: ........................................................................................................................
p.000075: ........................
p.000075: ........................................................................................................................
p.000075: ........................
p.000075: ........................................................................................................................
p.000075: ........................
p.000075:
p.000075: 10. CONCLUSION: Do you recommend approval of this proposal?
p.000075:
p.000075: Yes, as presented
p.000075:
p.000075: Yes, with minor revisions shown under. “Any Other Comment”
p.000075:
p.000075: Yes, with major revisions shown under, “Any Other
p.000075: Comments
p.000075:
p.000075: No, I do not recommend it; see under, “Any Other Comments”
p.000075:
p.000075: I am thanking you in advance for your early co-operation. Yours sincerely,
p.000075:
p.000075: Director General
p.000075: -------------------------------------------------------------------------------------------------------------------
p.000075: Please use another sheet of paper for your precise comments to the proposer, please do not sign the comments sheet, as
p.000075: it may be sent to the proposer.
p.000075:
p.000075:
p.000075:
p.000076: 76
p.000076:
p.000076: FORM 05: PARTICIPANT’S INQUIRY FORM
p.000076:
p.000076:
p.000076: Date Received Requested from:
p.000076: Telephone call:
p.000076:
p.000076: Fax: ...………………...............…… Of ................…………………………......
p.000076: Date: ……………………...................
p.000076:
p.000076: Mailed letter Ref: …………………………………. Of …………………….
p.000076: Date: ……………....................................
p.000076:
p.000076: Email of: …………………………………….......................................................
p.000076: Date: …………………………………….......
p.000076: Other methods (Specify):
p.000076:
p.000076: Name of participant:
p.000076:
p.000076: Address:
p.000076:
p.000076: Title of the protocol being participated in Starting date of participation: What is requested:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076: Action taken
p.000076:
p.000076:
p.000076:
p.000076:
p.000076: Outcome
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076: ………………………………… ………………………………………
p.000076: Name of receiving officer Signature
p.000076:
p.000077: 77
p.000077:
p.000077: FORM 06: ANNUAL CONTINUING REVIEW APPLICATION/ASSESSMENT
p.000077:
p.000077: Protocol title:
p.000077:
p.000077:
p.000077: Certificate approval no. Principal Investigator:
p.000077: Action requested: Review for new subject accrual to continue [ ]
p.000077: Review for enrolled participants follow-up only [ ] Review for termination of study
p.000077: [ ]
p.000077:
p.000077:
p.000077: Have there been any amendments since last review?
p.000077: Yes [ ] Comment:
p.000077:
p.000077:
p.000077: No [ ] Comment:
p.000077:
p.000077:
p.000077: Impaired participants None [ ] Physically [ ] Mentally [ ] Both [ ]
p.000077: Others (Specify):
p.000077:
p.000077:
p.000077:
p.000077:
p.000077: Have there been any changes in the participant population, recruitment or selection criteria since
p.000077: the last review?
p.000077: Have there been any changes in the informed consent process or documentation since
p.000077: the last review?
p.000077: Has any information appeared in the literature or evolved from this or similar research that
p.000077: might affect the committee’s evaluation of the risk/benefit analysis of human
p.000077: subjects involved in this protocol?
p.000077: Have any participants withdrawn for this study since the last approval?
p.000077: No [ ] Yes [ ] Explain:
p.000077:
p.000077:
p.000077: No [ ] Yes [ ] Explain:
p.000077:
p.000077:
p.000077: Yes [ ] Comment:
p.000077:
p.000077:
p.000077: No [ ] Comment:
p.000077:
p.000077:
p.000077:
p.000077: No [ ] Yes [ ] Explain:
p.000077:
p.000077: Summary of protocol Actual ceiling set by the NatHREC
p.000077:
p.000078: 78
p.000078:
p.000078: participants New participants accrued since last review Total participants accrued since
p.000078: protocol began
p.000078:
p.000078:
p.000078: Have any unexpected complications or side effects been noted since last review?
p.000078: Investigational new drug/device
p.000078: Have any investigators been added or deleted since the last review?
p.000078: Changes in medical advisory/investigation?
p.000078:
p.000078: Have any investigators developed an equity or consultative relationship with a source
p.000078: related to this protocol which might be considered a conflict of interest?
p.000078: Signature
p.000078:
p.000078:
p.000078: Committee Comment/decision
p.000078: Yes [ ] Comment:
p.000078:
p.000078:
p.000078: No [ ] Comment:
p.000078:
p.000078: No [ ]
p.000078: Yes [ ] Comment:
p.000078: No [ ]
p.000078: Yes [ ] Comment:
p.000078: No [ ]
p.000078:
p.000078: Yes [ ] (Append a statement of disclosure)
p.000078:
p.000078:
p.000078:
p.000078:
p.000078: Principal Investigator ………………………………....................
p.000078:
p.000078: Date …………………..........
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078: Approvals Chairperson, NatHREC………………………………….….......
p.000078:
p.000078: Date…………….................
p.000078:
p.000078: Completion Secretary, NatHREC ……………………………….....................
p.000078:
p.000078: Date ……………...................
p.000078:
p.000079: 79
p.000079:
p.000079: FORM 07: CHECKLIST FOR AUDITING AND INSPECTION
p.000079:
p.000079:
p.000079: Type of Audit Internal Audit [ ] External Audit [ ]
p.000079: The Date(s) which the audit/inspection has been agreed for:
p.000079: Shall an interpreter be
p.000079:
p.000079: required? If Yes what arrangement has been made?
p.000079: Review the SOPs and note details of any omissions or deviations, with reasons
p.000079: Yes [ ] No [ ]
p.000079: Check the files for the presence of all signed documents: Note any that are missing and action taken
p.000079:
p.000079: Components Present Missing Action taken
p.000079:
p.000079:
p.000079: Background and training
p.000079: Application submission records
p.000079: Protocol Assessment Records Communication Records
p.000079: [ ] [ ]
p.000079:
p.000079: [ ] [ ]
p.000079:
p.000079: [ ] [ ]
p.000079:
p.000079: [ ] [ ]
p.000079: Amendment Approval [ ] [ ]
p.000079:
p.000079: Meeting Agenda, Minutes, Action letters
p.000079: [ ] [ ]
p.000079: Active files [ ] [ ]
p.000079:
p.000079: Continuing and Final reports
p.000079: [ ] [ ]
p.000079:
p.000079: Are any documents known to be missing from the study master file?
p.000079: Which personnel and members shall be available? Give details of times and dates.
p.000079: What arrangements are there in the event the auditor/inspector needs to make copies of documents?
p.000079: Checklist completed by:
p.000079:
p.000079: Name ………………………………………….......................
p.000079: Signature …………………………………………….............
p.000079: Auditor’s Institution ……………………………..................
p.000079: Yes [ ] No [ ]
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079: Date …………………….......
p.000079:
p.000079:
p.000079:
p.000080: 80
p.000080:
p.000080: FORM 08: CLOSE-OUT FORM
p.000080:
p.000080: Instructions for Closure of a Research Study Send to the NatHREC:
p.000080: 1. This completed Close-out Form only.
p.000080: Complete and submit this form before the expiration date for your study. If NatHREC approval is not granted by the
p.000080: expiration date, all study participants’ activities will be suspended until approval is regained.
p.000080:
p.000080: Date of this Submission:
p.000080:
p.000080:
p.000080: Study Title:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080: Proposal Number:
p.000080:
p.000080:
p.000080: Sponsor/Funding Agency:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080: Date of last Continuing Review Approval:
p.000080:
p.000080:
p.000080: Section A. Study Status
p.000080:
p.000080: 1. Summary of research activities to date.
p.000080:
p.000080:
p.000080:
p.000080:
p.000080: 2. Number of subjects involved in the study to date (cumulative) either through direct contact or through use of
p.000080: their data. (complete all blanks)
p.000080:
p.000080: a. Number of people screened:
p.000080:
p.000080: b. Number of subjects enrolled (i.e., the number who consented/assented and took part in any part of the study
p.000080: intervention or data collection, for randomized trials list those who were randomized) in the study to date:
p.000080:
p.000080:
p.000080:
p.000081: 81
p.000081:
p.000081: c. Projected number of enrolled subjects, as approved by the NatHREC in the proposal. Numbers must match the numbers
p.000081: listed in the initial approval for the study. If amendments have been submitted to increase sample size after initial
p.000081: approval, list both original approved sample size and note the approved amended sample size:
p.000081:
p.000081:
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| accessXtoXinformation | Access to information |
| age | Age |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| child | Child |
| children | Child |
| disability | Mentally Disabled |
| disabled | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| educational | education |
| emergency | Public Emergency |
| employees | employees |
| faith | Religion |
| family | Motherhood/Family |
| foetuses | Fetus/Neonate |
| gender | gender |
| home | Property Ownership |
| hospitalized patients | hospitalized patients |
| ill | ill |
| illness | Physically Disabled |
| impaired | Cognitive Impairment |
| impairment | Cognitive Impairment |
| incapacity | Incapacitated |
| influence | Drug Usage |
| language | Linguistic Proficiency |
| mentally | Mentally Disabled |
| minor | Youth/Minors |
| neonates | Fetus/Neonate |
| officer | Police Officer |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| physically | Physically Disabled |
| placebo | participants in a control group |
| poverty | Economic/Poverty |
| pregnant | Pregnant |
| prisoners | Criminal Convictions |
| property | Property Ownership |
| religious | Religion |
| sick | Physically Ill |
| socialXwelfare | Access to Social Goods |
| student | Student |
| undue influence | Undue Influence |
| vulnerability | vulnerable |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| access | ['socialXwelfare'] |
| child | ['children'] |
| children | ['child'] |
| disability | ['disabled', 'mentally'] |
| disabled | ['mentally', 'disability'] |
| drug | ['influence'] |
| education | ['educational'] |
| educational | ['education'] |
| faith | ['religious'] |
| foetuses | ['neonates'] |
| home | ['property'] |
| illness | ['physically'] |
| impaired | ['impairment'] |
| impairment | ['impaired'] |
| influence | ['drug'] |
| mentally | ['disabled', 'disability'] |
| neonates | ['foetuses'] |
| physically | ['illness'] |
| property | ['home'] |
| religious | ['faith'] |
| socialXwelfare | ['access'] |
| vulnerability | ['vulnerable'] |
| vulnerable | ['vulnerability'] |
Trigger Words
capacity
coercion
consent
developing
ethics
harm
justice
protect
protection
risk
volunteer
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input