Institutional Review Board

Collaborative research on a wide range of diseases in PNG

Institutional Review Board (IRB)

The IRB is an independent board of review established by IMR to ensure that our research is conducted according to ICH E6 Good Clinical Practice Guidelines (PDF, 262kB).

All our research projects must pass the rigorous IRB vetting process before they can be funded. Researchers must gain approval for their study protocols, submit study reports and notify any severe adverse events.

Information for researchers:

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).

2023 Membership List

EXTERNAL MEMBERS

The University of Goroka
                                    Professor Dr Mark SOLON (Chairman)
                                    [Proxy:  Dr Jane AWI]

The Melanesian Institute, Goroka
                                   Mr Abraham DOMINIC
                                   [Proxy: Mr Merimba KASO]

Eastern Highlands Provincial Office of Health, Goroka
                                    Vacant
                                    [Proxy:  Vacant]

St John’s Congregation, Goroka
                                   Rev. Grahamme BAITAL

Anglican Church of Papua New Guinea
                                  [Proxy:  Fr. SIEP]

Family Support Center, Goroka, Goroka
                                   Mrs Luania Dika KIRORI
                                   [Proxy:  Vacant]

PNG INSTITUTE OF MEDICAL RESEARCH MEMBERS:

Goroka
Professor William POMAT (Secretary)
[Proxy: Dr Pamela TOLIMAN]

Ms Mition YOHANNES
[Proxy: Mr Jonah IGA]

Vacant
[Proxy: Herrick AENO]

Madang
Dr Moses LAMAN (Deputy Chairman)
[Proxy: Dr Alice MENGI]

Mr Henson DIMA 
[Proxy: Mr Bethuel KOTTY]

Mr Lincoln TIMINAO
[Proxy: Mr Shadrach JALLY ] 

Papua New Guinea Institute of Medical Research
Institutional Review Board (IRB)

Suggested Schedule of Meeting for 2023
 Times:  09:00 am to 1:00 pm

Proposed Venue – Goroka and Madang

  • Thursday, 9th February 2023 in Goroka

(Protocols must be submitted by Friday, 20th January 2023)

(Scientific Review by Friday, 27thJanuary 2023)

  • Thursday, 13th April 2023 in Goroka

(Protocols must be submitted by Friday, 17th March 2023)

Scientific Review by Friday, 24th March 2023)

  • Friday, 09th June 2023 in Madang

(Protocols must be submitted by Friday, 19th May 2023)

(Scientific Review by Friday, 26th May 2023)

  • Thursday, 10th August 2022 in Goroka

(Protocols must be submitted by Friday, 21st July 2023)

(Scientific Review by Friday, 28th July 2023)

  • Thursday, 12th October 2023 in Goroka

(Protocols must be submitted by Friday, 22nd September 2023)

(Scientific Review by Friday, 29th September 2023)

Friday, 08th December 2023 in Madang

(Protocols must be submitted by Friday, 17th November 2023)

(Scientific Review by Friday, 24thNovember 2023)

Guidelines

What is a Protocol Amendment

A protocol amendment occurs when there is a requirement for any change to the approved protocol. Unless there is an immediate hazard, any protocol amendment must be approved by both the IMR IRB and the MRAC, prior to implementation of the change(s).

Steps to Follow

  1. Identify the requirement for an amendment to the approved protocol.

  2. Mark required changes on a copy of the approved protocol, ensuring that the changes can be clearly identified. Microsoft word “Track Changes” can be used for this purpose.

  3. Complete the IMR Institutional Review Board Protocol Amendment Pro Forma.

  4. Submit the “marked” copy of the protocol together with the IMR Institutional Review Board Protocol Amendment Pro Forma electronically to [email protected] or alternatively by post to:

    IMR Institutional Review Board
    Papua New Guinea Institute of Medical Research
    PO Box 60
    Goroka, EHP 441
    Papua New Guinea

  5. IMR IRB will automatically forward protocol amendments to the MRAC. You do not need to submit any additional paperwork

Guidelines

Why Seek Ethics Approval

  • The primary reason for seeking ethics approval is to ensure that the rights, safety, and well-being of all participants are protected. This is particular important for those participants who are vulnerable such as children, prisoners, pregnant women, mentally disabled, or economically or educationally disadvantaged persons.
  • Ethics approval is also a legal requirement for all research involving human participants. Studies involving the Papua New Guinea Institute of Medical Research must not proceed without the approval of both the IMR Institutional Review Board and the Medical Research Advisory Committee

What Requires Ethics Approval

Any research involving contact with human participants including:

  • Clinical research
  • Field research
  • Use of human samples
  • Research involving data collection by interviews, questionnaires, focus groups observation
  • Informal conversations with people where systematic research data is collected
  • Research involving accessing medical or other records not normally available to the public

Research is defined as any systematic investigation designed to develop or contribute to generalizable knowledge.

Human participant is defined as any individual about whom an investigator obtains either data through interaction or intervention with the individual, or identifiable private information

Steps to Follow

  1. Determine whether your research requires ethics approval.
  2. Ensure your protocol/proposal contains all of the information required by the IMR Institutional Review Board and Medical Research Advisory Committee.
  3. Complete the IMR Institutional Review Board Pro Forma.
  4. Submit your protocol/proposal together with the IMR Institutional Review Board Pro Forma electronically to [email protected] or alternatively by post to:

    IMR Institutional Review Board
    Papua New Guinea Institute of Medical Research
    PO Box 60
    Goroka, EHP 441
    Papua New Guinea

  5. IMR IRB will automatically forward approved protocols to the MRAC. You do not need to submit any additional paperwork.

Protocol Content List

In reviewing your protocol the members of the IMR IRB and the MRAC will be looking for specific information about your proposed study. Following is a list of contents which if appropriate, should be contained within the study protocol prior to submission. Making sure that this information is not only included but also clearly marked will expediate the review process.

Suggested Protocol Content

Signature page confirming agreement and acceptance of protocol from all principal investigators

    1. List of all abbreviations and/or acronyms used in the protocol
    2. Layman Protocol summary
    3. List of key staff
      • Principal Investigators
      • Co Investigators
    4. Background information and rationale
    5. Objectives
    6. Study population
      • Inclusion and exclusion criteria
      • Subject confidentiality
      • Informed Consent
    7. Study design
      • Study procedures
      • Laboratory procedures
      • Study evaluations
      • Statistical considerations
    8. Risks and Benefits
  • Potential Risks
  • Known Potential Benefits
  1. Literature References

Appendices

  1. Curriculum vitas for all principal and co investigators

  2. Advertising in all languages

  3. Information Sheet in all languages

  4. Consent Form in pidgin and English. Pidgin version of the consent form must use standardized pidgin in the Gutnius Bible or pidgin dictionary.

Study Report

To comply with IMR IRB and MRAC requirements you must provide regular reports on any study throughout the study period. Unless otherwise stated a report will be required from the study and signed by at least one Principal Investigator, every 12 months from date of IMR IRB approval.

Steps to Follow

  1. Obtain a copy of the Protocol Reporting Pro Forma.

  2. Complete all sections of the Protocol Reporting Pro Forma.

  3. Submit the completed Protocol Reporting Pro Forma electronically to [email protected] or alternatively by post to: 

    IMR Institutional Review Board
    Papua New Guinea Institute of Medical Research
    PO Box 60
    Goroka, EHP 441
    Papua New Guinea

Serious Adverse Event (SAE) Guidelines

What is a Serious Adverse Event

A serious adverse event is any untoward medical occurrence involving a study participant which:

  • is life threatening

  • requires in patient hospitalisation or prolongation of existing hospitalisation

  • results in persistent or signficiant disability or incapacity

  • requires intervention to prevent permanent impairment or damage

  • results in death

All serious adverse events must be reported in writing to the IMR Institutional Review Board within one week of any study staff member becoming aware of the event.

Steps to Follow

  1. Identify the event and report to Principal Investigator.

  2. Complete the Serious Adverse Event Report. (RTF document 48kB) Please note that this report must also be sent to the Director PNG IMR, Principal Investigator(s) and any other appropriate parties within 24 hours of notification.

  3. Submit the Serious Adverse Event Report electronically to [email protected] or alternatively by post to:

    IMR Institutional Review Board
    Papua New Guinea Institute of Medical Research
    PO Box 60
    Goroka, EHP 441
    Papua New Guinea