Institutional Review Board IRB Prof Dr Md Jawadul

Institutional Review Board (IRB) Prof. Dr. Md. Jawadul Haque, Ph. D Professor of Community Medicine, RMC & Dean, Faculty of Preventive & Social Medicine, Rajshahi Medical University (RMU), Rajshahi

IRB • The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. Jawad/IRB/RMU 2

IRB Def. (as per FDA, USA guidance documents issued by Good Clinical Practice): An IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. An IRB has the authority to approve, require modification in or disapprove research. Jawad/IRB/RMU 3

Purpose of IRB The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research Jawad/IRB/RMU 4

Importance of IRB The IRB serves as an objective third party, an oversight committee approved by regulatory body (academic council) with the purpose of protecting and managing risk to human participants involved in research. To ensure that only ethical and scientifically valid research is implemented. Jawad/IRB/RMU 5

Who should be on an IRB An IRB consists of at least 5 to 15 members of varying backgrounds. IRB members should have the professional experience to provide appropriate scientific and ethical review. An IRB must have at least one scientist member, who knows study design and methodology well and at least one member whose primary concerns are nonscientific. Jawad/IRB/RMU 6

IRB should meet the following criteria At least 5 members with varying backgrounds to promote complete and adequate review of research commonly conducted by the organization. Not comprised of either all male or all female members. Not comprised of members who represent only a single profession. At least one member has primary concerns in scientific area. Jawad/IRB/RMU 7

IRB should meet the following criteria (contd. ) At least one member has primary concerns in nonscientific area. At least one member represents the perspective of research participants. One should not be a member who has conflict of interest Individuals who are responsible for business development are prohibited from serving as members or ex-officio members. Jawad/IRB/RMU 8

Formation of IRB & Selection of Members • The Institutional Head will form IRB with due approval of Academic Council. • The IRB Chair / Director are responsible for selecting members in consultation with Institutional Officials, Deans, Department Chairs and other IRB members. • The Institutional Head will appoint IRB Chair, Vice chair and members. Jawad/IRB/RMU 9

Responsibilities of IRB members Attending monthly IRB meetings and participating in the review of research Completing human subject research training Conducting review of research by expedited procedures Serving on IRB sub-committee as needed Working with investigators to resolve issues related to IRB review Jawad/IRB/RMU 10

Responsibilities of IRB members (contd. ) Maintaining current knowledge of applicable regulations, laws and institutional policies Participating in discussions of issues related to the review of human subjects research including policy development IRB members should report any attempts of undue influence to the authority. Jawad/IRB/RMU 11

Model of Executive Committee (EC) of IRB During review of the academic research concerned Head of the department and other two members of that department except those individuals who have conflict of interest, will be co-opt as temporary members of IRB during the review meeting. Jawad/IRB/RMU 14

Basic elements of the review by IRB: • Scientific design and conduct of the study. – Justification of predictable risk and benefit – Justification of the use of control – Criteria of withdrawing participants – Criteria for suspending or terminating the research – Publication plan, etc. Jawad/IRB/RMU 15

Basic elements of the review by IRB (contd. ): • Recruitment of research participants. • Care and protection of research participants. • Protection of research participants’ confidentiality. • Informed consent process. • Utility of the research findings. • Community consideration. Jawad/IRB/RMU 16

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