The Institutional Review Board (IRB) is charged with the responsibility of reviewing, prior to its initiation, all research involving human or animal participants conducted by GMU-AHS. It is composed of members and invitees (external specialists and subject matter experts).
The main purpose of the IRB is to review and monitor research to ensure that they are following the principles of research ethics and to protect the rights and welfare of human and animal research subjects.
The IRB operates centrally under the umbrella of the Office of Vice Chancellor Research and meets to discuss research projects twice per semester.
Further, each college has its individual college research committee chaired by the college research coordinator (CRCs). CRCs of each college are members of the research administration office and the IRB.
Institutional Review Board (IRB) of Gulf Medical University
- INTRODUCTION
It is important for GMU to adhere to the ethical norms of research as such it has established principles and responsibilities for ethics in research that is conducted by all members of Gulf Medical University. It is important to adhere to ethical principles to protect the dignity, rights, and welfare of research participants. The IRB is charged with the responsibility of reviewing, prior to its initiation, all research (whether funded or not) involving human or animal participants.
- PURPOSE
The main purpose of the IRB is to review and monitor research to ensure that they are following the principles of research ethics. The IRB aims to protect the rights and welfare of human and animal research subjects recruited to participate in research activities conducted under GMU.
- SCOPE
The following terms of reference apply to all Researchers, Clinicians, employees and students who propose to undertake, administer, review and/or govern all research activities conducted at GMU.
- TERMS OF REFERENCE
The Institutional Review Board (IRB) terms of reference are to
- Develop mechanisms to foster research and approve/obtain funding from external agencies.
- Review, assess and give recommendations on all research proposals that are first reviewed by each college IRB.
- Ensure that the research involving human subjects conforms to the ethical standards laid down in the Declaration of Helsinki.
- Ensure that the research involving animals shall follow a globally accepted standards of laboratory animal care.
4.1 Constituents of the IRB
- A chairperson is nominated with 2 years renewable term in office
- The members of the GMU IRB are appointed by the Vice Chancellor for Research and include the CRCs.
- All members must be trained in medical ethics as per the ICH- GCP (International Conference on Harmonization – Good Clinical Practice) guidelines.
- The University IRB shall meet once per semester and when deemed necessary by the chairperson
- The members of the IRB will be permanent members as well as when necessary external members, that are subject matter experts, shall be invited.
- The IRB shall report to the Vice Chancellor for research
- DOCUMENTS TO BE SUBMITTED TO IRB:
The IRB shall obtain and peruse relevant documents prior to approval including:
- Research Proposal/ protocol
- Any protocol amendment
- Written informed consent form
- Written information to be provided to subjects
- Investigator’s Brochure, if applicable
- The investigator’s current curriculum vitae and/or other documentation evidencing qualifications
- Information about payments and compensation available to investigators and subjects
- The College IRB approval letter
- Any other documents that the IRB may need to fulfil its responsibilities.
- IRB PROCESS
6.1. The IRB shall consider the investigators’ qualifications and previous experience in the study area for the proposed research, as documented by a current curriculum vitae and / or by any other relevant documentation the IRB requests.
6.2. The IRB shall conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to human subjects, but at least once per year.
6.3. The IRB may request more information that is to be given to subjects when, in the judgment of the IRB, the additional information would be significant to protect the rights, safety and/or well-being of the subjects.
6.4. When a non-therapeutic study is to be carried out with the consent of the subject’s legally acceptable representative, the IRB shall determine that the proposed protocol and/or other document(s) adequately addresses relevant ethical concerns and meets applicable regulatory requirements for such studies.
6.5. Where the protocol indicates that prior consent of the subject or the subject’s legally acceptable representative is not possible, the IRB, shall determine that the proposed protocol and/or other document(s) adequately addresses relevant ethical concerns and meets applicable regulatory requirements for such studies (i.e. in emergency situations).
6.6. Reimbursements: The IRB shall review both the amount and method of payment to subjects to assure that neither presents problems of coercion or undue influence on the study subjects. The IRB shall ensure that information regarding payment to subjects, including the methods, amounts, and schedule of payment to trial subjects, is set forth in the written informed consent form and any other written information to be provided to the subject. The way payment will be prorated shall be specified.
6.7. IRB Response: The IRB shall review a proposed study/clinical trial within a reasonable time and document its views in writing, clearly identifying the study, the documents reviewed and the dates for the following:
- Approval/favorable opinion;
- Modifications required prior to its approval/favorable opinion;
- Disapproval / negative opinion; and
- Reversal of any prior approval/favorable opinion.
6.8. Expedited review: Certain types of research may be reviewed and approved without convening a meeting of the IRB. The IRB may also use the expedited review procedure to review minor changes in previously approved research during the period covered by the original approval. Under an expedited review procedure, review of research may be carried out by the IRB chairperson or by one or more experienced members of the IRB designated by the chairperson. The reviewer(s) may exercise all the authorities of the IRB, except disapproval. Research may only be disapproved following review by the full committee. The IRB is required to adopt a method of keeping all members advised of research studies that have been approved by expedited review.
6.9. Risk Prevention: The coordinator of risk prevention (to be nominated) will advise in the implementation of safety regulation and occupational health. He/she will ensure the implementation of good practices in research.
College Research Committee – Terms of Reference
- Purpose:
The college research committee acts as an initial filter to review the research proposals submitted by the college. It aims to review all research activities at the College, including ethics, methodology, consent forms and process and safety of the subjects under study.
- Terms of Reference:
The college research committee:
Reviews, evaluates, and gives recommendations on all research proposals submitted by their respective college.
- Ensures that the research involving human subjects shall conform to the ethical standards laid down in the Declaration of Helsinki.
- Ensures that the research involving animals shall follow a globally accepted standards of laboratory animal care.
- Members:
The college research committee shall be composed of the college research coordinator (CRC) and faculty members with experience in research. All members shall be trained in medical ethics as per the ICH- GCP (International Conference on Harmonization Good Clinical Practice) guidelines.
Chairperson: The chairperson is appointed by the College Council.
Term of Office: Two years (Renewable)
Frequency of Meeting: The Committee shall meet once per semester and as deemed necessary by the Chair.
Please refer to the “Institutional Review Board (IRB) of Gulf Medical University Terms of Reference” for further applicable details.