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Terms of reference

1. Role of Papua New Guinea institute of Medical Research Institutional Review Board

1.1. The purpose of the Papua New Guinea Institute of Medical Research Institutional Review Board (IMR IRB) is to contribute to safeguarding the dignity, rights, safety and well-being of all actual or potential research participants.

2. Responsibilities of the Papua New Guinea Institute of Medical Research Institutional Review Board

2.1. Safeguard the rights, safety, and well-being of all participants. Special attention should be paid to studies that may include vulnerable participants.

2.2. Obtain the following documents, where applicable:

2.2.1. study protocols and amendments;

2.2.2. written informed consent form(s) and consent form updates that the investigator proposes for use in the study;

2.2.3. participant recruitment procedures (e.g. advertisements;

2.2.4. written information to be provided to participants;

2.2.5. Investigator's Brochure;

2.2.6. available safety information;

2.2.7. information about payments and compensation available to participants;

2.2.8. investigator(s) current curriculum vitae and/or other documentation evidencing qualifications; and

2.2.9. any other documents that the IMR IRB members may require to fulfil their responsibilities.

 

2.3. Review a proposed study within a reasonable time and document its reviews in writing, clearly identifying the study, the documents reviewed and the dates for any:

2.3.1. approval;

2.3.2. modifications required prior to approval;

2.3.3. disapproval; and

2.3.4. termination/suspension of any prior approval.

2.4. Conduct continuing review of each ongoing study at intervals appropriate to the degree of risk to human participants, but at least once per year

2.5. Request more information than is outlined in the Informed Consent given to participants when, in the judgement of the IMR IRB, the additional information would add meaningfully to the protection of the rights, safety, and/or well-being of the participants.

2.6. Where the protocol indicates that prior consent of the participant or the participant's legally acceptable representative is not possible, the IMR IRB should determine that the proposed protocol and/or other document(s) adequately addresses relevant ethical concerns and meets applicable regulatory requirement for such studies (ie in emergency situations).

2.7. Should review both the amount and method of payment to participants to assure that neither presents problems of coercion or undue influence on the study participants. If applicable, payments to a participant should be prorated and not wholly contingent on completion of the study by the participant.

2.8. Should ensure that information regarding payment to participants, including the methods, amounts, and schedule of payment to study participants, is set forth in the written informed consent form and any other written information to be provided to participants. The way payment will be prorated should be specified.

2.9. Forward all study documents to the Papua New Guinea Medical Research Advisory Board for their consideration.

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IMR Institutional Review Board

Contact

Dr William Pomat
IRB Secretary

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