IRB

Institutional Review Board (IRB)

Protecting the rights and safety of people

Mandate

IRD’s independent Institutional Review Board (IRD-IRB) was formed to protect the rights and welfare of individuals who volunteer to participate in research managed by IRD, in research where IRD is either a partner or a collaborator or for institutes that have asked IRD to partner them in their institutional research such as The Indus Hospital.

While the ultimate responsibility for the treatment of all human participants in research rests with the individual researcher who has been given the privilege to conduct research with humans, the Institutional Review Board exists as a safeguard to promote the ethical and responsible treatment of human participants in research, by conducting scientific and ethical review of research studies while providing education and guidance for the research community.

IRD-IRB is registered with the U.S. Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) with registration number IRB 00005148. In addition, IRD-IRB utilizes electronic signatures compliant with 21 CFR Part 11.

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Human Participants Regulations & Guidance

In the planning and development of a research project, investigators must follow ethical principles for the protection of human participants involved in the research. The IRD-IRB is guided in its work by the OHRP (give a link to the document) as well as International Ethical Guidelines for Biomedical Research involving Human Subjects (give link for CIOMS 2002 document).

According to these guidelines, all research involving human subjects should be carried out in accordance with the fundamental ethical principles of respect, beneficence and justice.

IRB Administration

The IRB Administration unit provides education and training, administrative and record-keeping support, and conducts quality improvement audits for the IRB. In the absence of any Pakistani authority governing IRB management, IRD-IRB follows Bankert and Amdur’s Institutional Review Board: Management and Function publication as its standard reference for IRB management.

IRB Committee Composition

IRB guidelines require that membership of the IRB include at a minimum, one member whose primary concerns are in scientific areas, one member whose primary concerns are in nonscientific areas, numerous members representing more than a single profession, and at least one individual not affiliated with IRD.

Because IRD is a small organization, additional members are included to provide adequate representation of the diverse research community and to accommodate the workload associated with reviewing applications. Membership beyond the minimum required by IRB regulation is drawn from staff and collaborating institute faculty.

The membership of the IRB at IRD is comprised of fifteen to twenty voting members – primary and alternative.

HUMAN PARTICIPANTS SUBMISSION REQUIREMENTS & REVIEW OVERVIEW

TRAINING AND TRIAL REGISTRATION

FREQUENTLY ASKED QUESTIONS

FORMS