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Institutional Review Board (IRB)

1. TITLE OF BOARD

Institutional Review Board (IRB), CMH Lahore Medical College and Institute of Dentistry.

2. ESTABLISHMENT

The Institutional Review Board (IRB) is established as an independent board to review and approve research involving human subjects. It ensures that the researcher fulfills the ethical standards of research and standards given in the National Accreditation Framework for Medical and Dental School in Pakistan 2019.

3. FUNCTIONS AND RESPONSIBILITIES

The Institutional Review Board (IRB), CMH Lahore Medical College and Institute of Dentistry is responsible for providing scientific and ethical review of proposed studies.  including the ethical aspect with human participants to ensure that they conform to internationally and locally accepted ethical guidelines, monitor studies once they have begun and where relevant, take part in follow-up action and surveillance after the end of the research. The board has the authority to approve, reject or stop studies or require modifications to research protocols. They may also perform other functions, such as setting policies or offering opinions on ongoing ethical issues in research.

Review by the board will facilitate researchers in addressing the shortcomings of their proposed studies and ensure that the ethical aspects are in conformation with the  international ethical standards governing research involving human participants, as well as by local law in many jurisdictions. In international cooperative research, review may be required by the laws of the country in which the research is being sponsored, even if it is not required by the host country’s own laws. Review is also essential if the researchers intend to publish the results of their investigation, as most medical journals will not publish the results of research that has not received the approval of IRB.

The main responsibility of the IRB is to protect potential participants in the research, but it must also take into account potential risks and benefits for the community in which the research will be carried out. Its ultimate goal is to promote high quality research meeting the ethical standards in research for health.

The functions of IRB include;

  • Identifying the scientific shortcomings in research proposals
  • Facilitating the researchers in methodology and statistical analysis
  • Identifying and weighing the risks and potential benefits of research
  • Evaluating the process and materials (printed documents and other tools) that will be used for seeking participants’ informed consent.
  • Assessing the recruitment process and any incentives that will be given to participants.
  • Evaluating risks to participants.
  • Confidentiality (and the related risk of discrimination) and the adequacy of confidentiality protections
  • Examining any other issues that may affect the ethical acceptability of the research.
  • In international research, the board represents the interests of the local population. Thus, it should ensure that the participants and their communities will receive fair benefits from the arrangement.
  • In studies involving medical interventions, institutional review board must determine that adequate care and treatment will be provided for participants. This can be a significant issue in studies involving placebo controls (see Declaration of Helsinki, Section 322).
  • IRB should consider what will happen to participants who need medical attention during or after the study, either because they suffer injuries as a result of participation or because of the natural progression of a pre-existing illness. Sponsors’ obligations to provide care in such circumstances should be clearly established before a study begins and made clear to potential participants during the informed-consent process.
  • IRB will judge the adequacy and accuracy of information on the informed consent document.
  • IRB will send written notification to the investigator including reasons for the decision and give the investigator an opportunity to respond in person or writing.

4. POWERS OF THE BOARD

The Board may:

  • Revoke approval if dissatisfied with the conduct of the research or of the researcher
  • Reject the research proposal in whole or in part
  • Defer consideration of a research proposal to a subsequent meeting if substantial modification is required or where significant additional information is needed.
  • Authorize the research to proceed without requiring any amendment.
  • Require clarification or modification of parts of the research submission. The Chair will normally be granted authority to approve the amendments without requiring further deliberations by the full Board

5. MEMBERSHIP

  • The board will be headed by a chairperson.
  • The number of members should be at least 5.
  • One Member must be from Clinical and one from Basic Science department.
  • A secretary will be selected by the chairperson.
  • The secretary will be responsible for organizing the meetings, agenda formation and maintaining record of minutes of meetings.

The Chairperson may invite additional non-voting attendees and may also co-opt additional members by mutual agreement.

6. CHAIR

The Chair of the IRB will be appointed by the Principal of CMH LMC & IOD. 

7. SECRETARY

Administrative support will be provided by.

8. TERM OF OFFICE

  • Staff members will hold office for the term of their appointment in their designated role.
  • An elected member may resign from his or her position on the Board by notifying the Chairperson in writing specifying the reason of resignation.

9.QUORUM

The quorum will be 50% of the voting membership plus one.

10. MEETINGS

The Board will meet on at least six (06) occasions in a year with provision for in-person and technology mediated meetings. The Chair may call additional meetings if necessary.

11. RESOLUTIONS OF THE BOARD

Matters requiring a resolution or recommendation by the Board are to be determined by simple majority. In the event of a tied vote the Chair will have a casting vote. 

12. AGENDA

There will be a written agenda distributed prior to each meeting.

13. REPORTING

The report from each meeting of the board will be provided to the next meeting of IRB.

 

Signatures:                 

   

Chair of the Institutional Review Board

Chair ORIC

Principal