Bylaws of the

Institutional Review Board (IRB)

The Institutional Review Board (IRB) shall consist of at least 5 members who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed research.  The IRB shall include:                                                                                                                                                                 

1.  The Dean or her/his representative as the chairperson.

2.  At least one member who has primary area of interest is nonscientific.

3.  At least one member not affiliated with the institution/trial site, who is familiar with the community's attitudes and sensitive to its issues.    

In appointing the committee members, the necessary qualifications of experience, expertise, and sensitivity to community attitudes shall be observed. Membership should be from both sexes and from varied backgrounds. Appointments should be for two years subject to renewal.

b.  Functions

1.  The IRB shall ascertain the acceptability of proposed research in terms of institutional commitments and regulations, accreditation requirements, applicable laws and ethical standards of professional conduct and practice.

2.  The IRB shall conduct an initial and continuing review of all research activities to ensure compliance with international standards of ethical practice regarding the use of human subjects in research, in order to ascertain their welfare and safety.

3.  The IRB shall approve, deny approval to, or require modifications for the purpose of approval in, research activities proposing the use of human subjects.

4.  The IRB shall recommend the suspension of an ongoing research activity in case of deviation from the existing guidelines for the use of human subjects in research.