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.

3. Membership

3.1. The IMR IRB will consist of at least seven (7) members, who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed study.

3.2. At least one (1) member must have a primary interest which is outside of the scientific area.

3.3. At least one (1) member must be independent of the Papua New Guinea Institute of Medical Research.

3.4. Each of the Papua New Guinea Institute of Medical Research research units must be represented by at least one (1) member.

3.5. Members will be appointed to the IMR IRB by the Director Papua New Guinea Institute of Medical Research for a period of two (2) years.

3.6. Members may be reappointed to the IMR IRB by the Director Papua New Guinea Institute of Medical research for further two (2) year terms.

3.7. Members must be willing to publicise their full name, profession and affiliation.

3.8. Members will sign a confidentiality agreement regarding meeting deliberations, applications, information on research participants, and related matters.

3.9. Members who wish to resign must do so by writing to the IMR IRB chairperson.

3.10. Any member who contravenes these Terms of Reference, or commits a criminal offence under Papua New Guinean law, may be disqualified from membership of the IMR IRB. Decisions on disqualification will be made by majority vote at a scheduled meeting and will take immediate effect.

4. Offices

4.1. At the first meeting of each calendar year IMR IRB members will appoint a chairperson and a secretary from the appointed members.

4.2. The chairperson will be responsible for:
4.2.1. be fully informed on roles and responsibilities of IMR IRB;
4.2.2. preside over meetings; and
4.2.3. maintain good communication between members at all times.
4.3. The secretary will be responsible for:
4.3.1. the recording and distribution of accurate minutes in a timely manner;
4.3.2. the collection and distribution of required documentation; and
4.3.3. the maintenance of required records.

4.4. A support staff member will be appointed to the secretary for approximately 20 hours per meeting, to assist in undertaking their responsibilities.

5. Meetings

5.1. The IMR IRB will schedule at least six (6) meetings in each calendar year.

5.2. A meeting schedule will be developed by December each year for the following full calendar year. The schedule will be published on the Papua New Guinea Institute of Medical Research website.

5.3. Changes to the meeting schedule will be made no later than one (1) month prior to the scheduled meeting date and will be published on the Papua New Guinea Institute of Medical Research website.

6. Decisions and Opinions

6.1. Decisions must be made unless in accordance with 6.1.1, at a scheduled meeting where a quorum is present.
6.1.1. In exceptional circumstances the, the Chairman and one other person may meet and approve an urgent request for amendment however their decisions must be tabled and minuted, at the next full meeting and they may not use this process to consider full study proposals.
6.1.2. The Chairman will decided whether a request under 6.1.1 can be considered exceptional.

6.2. A quorum consists of four (4) IMR IRB members.

6.3. Decisions will be made if possible by consensus, or if a consensus appears unlikely then by majority vote.

6.4. Only members who participate in the IMR IRB review and discussion should vote/provide their opinion and/or advise.

6.5. The Investigator may provide information on any aspect of the study, but should not participate in the deliberations of the IMR IRB or in the vote/opinion of the IMR IRB.

6.6. A member of the IMR IRB who has other direct or indirect pecuniary or other interest in a matter being considered at a meeting of the IMR IRB must, as soon as possible after the relevant facts have come to the member's attention, disclose the nature of the interest at a meeting of the IMR IRB.
6.6.1. The disclosure is to be recorded in the minutes of the meeting and the member must not, unless the IMR IRB otherwise determines be present during any deliberation of the IMR IRB with respect to the matter.

6.7. The IMR IRB may invite non members with expertise in special areas for assistance.

7. Functions and Operations

7.1. The IMR IRB will at all times perform its functions according to written the Papua New Guinea Institute of Medical Research Standard Operating Procedures for IRBs

7.2. Appropriate written records of activities and minutes of meetings should be maintained at all times.

7.3. ICH E6 GCP Guidelines and applicable regulatory requirement(s), will be complied with at all times.

7.4. The IMR IRB will specify to all appropriate parties that:
7.4.1. no participant should be admitted to a study before the IMR IRB and the PNG MRAC issues its written approval of the study;
7.4.2. no deviations from, or changes of, the protocol should be initiated without prior written IMR IRB and PNG MRAC approval of an appropriate amendment, except when necessary to eliminate immediate hazards to the participants or when the change(s) involves only logistical or administrative aspects of the study (eg change of monitor(s) \, telephone number(s)); and
7.4.3. the investigator should promptly report to the IMR IRB and PNG MRAC:
7.4.3.1. deviations from or changes of, the protocol to eliminate immediate hazards to the study participants;
7.4.3.2. changes increasing the risk to participants and/or affecting significantly the conduct of the study;
7.4.3.3. all adverse drug reactions that are both serious and unexpected; and
7.4.3.4. new information that may affect adversely the safety of the participants of the conduct of the study.
7.5. The IMR IRB will promptly notify in writing the investigator and the Director of the Papua New Guinea Institute of Medical Research concerning:
7.5.1. IMR IRB study-related decisions/opinions.
7.5.2. reasons for its decisions/opinions
7.5.3. procedures for appeal of its decisions/opinions.

7.6. The IMR IRB will retain all relevant records for a period of at least three (3) years after completion of the study and make them available upon request from the regulatory authority(ies).