The Institutional Review Board (IRB) is an independent committee that approves, monitors, and reviews human biomedical, behavioral and psychosocial research. The committee is responsible for ensuring the protection of the rights, safety, and well-being of human subjects and the rational use of animals involved in research. The IRB of Colonel Maleque Medical College follows the rules and guidelines adopted by the Bangladesh Medical Research Council BMRC guidelines and is operated in accordance with The Nuremberg Code, The Declaration of Helsinki, The Belmont Report and CIOMS guideline as well. Their responsibilities are to approve any research proposal to be made and to monitor any ongoing research in CMMC campus and affiliated institutes in Manikganj to ensure that the study continues to meet scientific, ethical and legal standards.
- The IRB of CMMC will deal with research projects ongoing or proposed to be done in the CMMC campus and the nearby collaborative institutes in Manikganj, if any, where there is no IRB.
- The IRB is responsible to review and to monitor that the research proposals/projects under the auspices of CMMC would follow ethical and legal standards to minimize the risks to human subjects justified by the potential benefits of the research for the community and society. These include the principles of respect for persons (informed consent and protection of the autonomy), beneficence (minimizing risks and maximizing potential benefits), and justice.
- The IRB of CMMC is mandated to supervise and monitor the technical and scientific soundness of these research protocols performed under the institution's auspices with the best possible use of available funding, logistics, human & animal resources, personnels, and field locations.
- The IRB of CMMC will deal with simple interventional studies such as health educational interventions, psychological interventions, community interventions, treatment regimens using DGDA approved drugs, and students’ theses/dissertations on small scale clinical trials. It will not deal with clinical trials on new drugs or molecules or devices which are under discretion of NREC; these studies, however, are usually accomplished by statutory institutes/organizations such as BSMMU, BCPS, and icddr,b.
- The IRB has the authority to suspend or terminate research if it is found to be non-compliant with regulations or if there is an ethical concern.
- The IRB is responsible to prepare, amend and announce their own standard operating procedure (SOP) to provide the institution's standard approach to the interpretation of the evaluation and approval process of research protocols in accordance with best practices, institutional facilities, local laws, and international standards.
The IRB committee of Colonel Maleque Medical College comprises the following persons -
Chairman: Professor Md. Bazlul Karim Choudhury, Professor of Biochemistry
- Professor Md. Motahar Hossain, Professor of Medicine
- Professor Anowara Begum, Professor of Gyanae & Obs
- Professor Nazman Begum, Professor of Paediatrics
- Professor Md. Toufiqur Rahman, Professor of Cardiology
- Professor Nayma Sultana, Professor of Physiology
- Professor Samira Hossain, Professor of Anatomy
- Dr. Md. Mahbubur Rahman, Associate Professor of Psychiatry
- Dr. ATM Sulaiman Kabir, Associate Professor of Nephrology
- Dr. Md. Abu Bakar Siddique, Associate Professor of Medicine
- Dr. Monira Akter, Associate Professor of Community Medicine
- Dr. Md. Osman Goni, Assistant Professor of Surgery
- Dr. Shamima Rahman, Assistant Professor of Gynae & Obs
- Dr. Md. Asfaq Rafed Rahman, Assistant Professor of Physiology
Member Secretary: Dr. Md. Kamrul Hasan, Associate Professor of He
- The protocol should be submitted to the member secretary of the IRB committee with a letter addressing to the chairman of IRB.
- The protocol will be sent to all the members of the committee, including 2-4 primary reviewers for expert opinion; their review summary will be delivered online to all the IRB members, and a printed copy to the IRB chairman.
- A meeting will be scheduled for discussion and decision about the protocol. If the primary reviewers advise, the chairman can invite 1-2 non-member expert persons to attend the meeting for their comment. The protocol is also sent to the non-member experts.
- The primary investigator shall attend the meeting, along with the guide, in case of thesis/dissertation, and shall present the protocol in the meeting.
- In the meeting, the protocol is decided to be approved, rejected, or advised for modification/ correction based on consensus of the members of the IRB committee.
- The protocol and revisions: four print copies and the soft copy by email at firstname.lastname@example.org.
- Informed Consent form: both Bangla with an English version.
- The investigator's credentials for the proposed study: it should include a recent curriculum vitae and any other relevant material.
- Additional information about the proposed procedure, such as other regulatory needs.
- The budget of the study: it should include prorated amount and manner of payment.
- Other research instruments, such as questionnaires, checklists, guidelines, etc.
A project proposal may be exempted from IRB review if it has no or very low risk to human participants. The IRB chairperson and member secretary shall determine suitability of protocols for such exemptions as are directed by BMRC guidelines. Such exemptions include the following criteria –
- The investigator can access the data, documents, records, pathology specimens, or diagnostic specimens,
- The information is recorded in such a way that participants cannot be identified, either directly or through identifiers linked to participants.
- Any human participants' responses will not expose them to criminal or legal liability, as well as jeopardize their financial standing, employability, or reputation.
- Research and demonstration projects that are designed to explore, assess, or investigate public interest or programs and are carried out by or with the permission of government agencies or departments.