IRB Protocol Review

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Protocol Review

IRB Application


		IRB Protocol Review
		The primary task of an IRB lies in the review of research proposals and their supporting documents, with special attention to the informed consent process, documentation, the suitability and feasibility of the protocol. IRB has the authority to approve, require modifications, or to disapprove research. IRB requires that information given to subjects meet informed consent requirements

		Submitting an Application
		The IHI IRB upholds the highest ethical and regulatory standards of research involving human subj Protocols that involve local PI only, and which do not involve clinical assessment, should be submitted at least two months before implementation of the study. Such protocols shall obtain IRB’s approval and will not need to be reviewed by the National Committee. However, IRB should report any approved protocol to the National Committee Protocols that involve external collaborators should be submitted three to four months prior to study commencement. This will allow enough time for protocols to be reviewed by IRB, NHRERC and COSTECH All protocols that need urgent action than the minimal time stipulated above will have to undergo expedited review and will be charged more than the minimal amount Requirements for Submitting an Application All protocols should be accompanied by the following documents: Protocol Application Form (IRB-01) Signed cover letter from the Investigator (should also include physical address, fax number, telephone number – preferably personal number - and email address) Summary of the protocol Ten (10) hard copies of research protocols and an electronic version Informed consent (in English and Kiswahili) Instruments for data collection Up-to-date CVs of PI and co-investigator (if applicable) Investigator’s brochure if the study involves a clinical drug/vaccine trial; this document provides adequate summary of all safety, pharmacological, pharmaceutical and toxicological data available on the study product, together with a summary of clinical experience of the study product to date (e.g. recent investigator’s brochure, published data, summary of the product’s characteristics etc) Importation approval by the Tanzania Food and Drug Authority (may be submitted at a later stage) In case of adverse events that are directly linked to protocols, the private investigator should fill the adverse event form (IRB-02) and submit it to the IRB Secretariat All materials to be used (including advertisements) for the recruitment of actual research participants must be attached to the protocol Budget and budget justification

		Types of Review
		Initial Review – for all new protocols The following shall be considered when reviewing research protocols: Detailed instructions filled in the protocol submission form will include: Protocol title, protocol number, protocol date, names of principle and co-investigators, funding agencies Project status (whether new/revised or rejected version) Type of review (whether initial, continue, or expedited) Scientific design and conduct of the study will include: The study objectives Social need and value Need for human participants for study Appropriateness of the methodology proposed Inclusion/exclusion criteria Control arms (placebo, if any) Withdrawal or discontinuation criteria Justification of the predictable risks and inconveniences weighed against anticipated benefits for research participants and the concerned community The adequacy of provisions made for monitoring and auditing the conduct of the research, including the constitution of Data Safety and Monitoring Board (DSMB) Recruitment of research participants: characteristics of the population from which the research participants will be drawn (including gender, age, literacy, culture, economic status and ethnicity) and the means by which initial contact and recruitment is to be conducted Plans to withdraw or withhold standard therapies for the purpose of the research, and justification for such action (placebo versus gold standard drug or assay) Clear justification for the intention to include in the research individuals who cannot consent, and a full account of arrangements for obtaining consent or authorisation for the participation of such individuals A statement describing any compensation for study participation (including expenses for and access to medical care) to be given to research participants, if applicable Qualifications of investigators (CVs) and study sites: Qualification of the investigators shall be examined to weigh whether study and training background of the participating investigators relate to the study Geographical distribution facilities, infrastructure accessibility and availability shall also be examined to accommodate the study Disclosure of potential conflict(s) of interest shall also be examined. Informed Consent The following shall be examined in the consent form: That the study involves research An explanation of the purposes That the study is being conducted by local and/or external investigators An explanation of how participants were selected for the study The expected duration of participation Description of procedures to be followed Description of any benefits to the subjects or to others that may reasonably be expected from the research Description of any reasonable foreseeable risks or discomforts to the subjects Appropriate alternative procedures or course of treatment, if any A statement that participation is voluntary A statement that the subject can withdraw at any time and that such withdrawal will not affect any benefit that they would normally receive A statement that subjects will not be penalised for withdrawing from the study A statement under which the subject’s participation may be terminated by the investigator, where appropriate A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights (name and phone number of primary investigator) The consent form should be written in participant’s native language, and the language should be non-technical, simple and easy to understand A statement of insurance or compensation Approximate number of subjects involved in the trial IRB and regulatory authorities to have access to monitor the study progress Anticipated payment to study participants Participant’s signature Subject’s responsibilities. Assurances that research participants will receive information relevant to their participation (including their rights, dignity, safety and well-being) that becomes available during the course of the research Expedited Review – when a protocol is below minimal risks IRB may review research under expedited procedure if it meets the following criteria: Risks to subjects are minimised Risks are reasonable in relation to anticipated benefits Equitable selection of subjects Informed consent will be obtained Informed consent will be documented Data monitoring plan, when appropriate Adequate provision to maintain privacy of subjects and confidentiality of data Additional safeguards to protect persons vulnerable to coercion Minor changes in previously approved research during the period for which approval is authorized Modification/amendment of protocol Protocol involves interviewing of non-confidential nature and not likely to harm the status or interest or not likely to offend the sensibility of study participants Collection of data or of small amount of biological specimen by non-invasive means (e.g. blood fluids, excreta, EEG or ECG electrodes, acoustic testing, tests using the Doppler Principle, blood pressure and other routine clinical measurements) Research involving data, documents or specimens that have already been collected or shall be collected for ongoing medical treatment or diagnosis. Continuing Review This review is for all approved protocols. It aims at reviewing progress of the entire study, not only changes made but also to ensure continuity, protection of rights and welfare of research participants.

© IFAKARA Health Institute (IHI), 2010