An
IRB is comprised of qualified men and women who have
no vested interest in the research study or its outcomes.
Their responsibility is to assure that all research studies
are ethical and justified.
The Common Rule stipulates that an IRB must
have at least five members with varied backgrounds, at least
one being a non-scientist and at least one being unaffiliated
with the institution; however, an IRB may have as many members
as needed for it to carry out its responsibilities effectively.
Membership should be diverse in regards to race, gender, culture,
and profession to promote sensitivity to issues and to promote
respect for its advice and counsel in safeguarding the rights
and welfare of research participants.

Federal
Policy for the Protection of Human Subjects (28 CFR Part 46)
regulates the establishment of an institution’s IRB. This
chart provides an overview of the composition of an Institutional
Review Board, as detailed in the Institutional Review Board
Guidebook published by the Office for Protection from Research
Risks (OHRP).
The IRB must include persons knowledgeable about the acceptability
of proposed research in terms of institutional commitments
and regulations, applicable law, and standards of professional
conduct and practice. Because research with juvenile justice
departments involves children who are classified by the Common
Rule as vulnerable subjects, the IRB must consider
including one or more persons who are knowledgeable about
and experienced in working with youth in the justice system.
The IRB may also invite individuals with competence in special
areas, such as learning disabilities or quantitative analyses,
to assist in the review of issues; however, these individuals
are not voting members.
One of the most important steps in establishing and maintaining an
IRB is selecting the individual who will function as a chair.
The IRB chairperson is primarily responsible for ensuring
that the IRB is respected throughout the institution. The
person selected as chair should be highly regarded by individuals
within and outside the agency and fully capable of managing
the IRB and the issues brought before it with impartiality.
Any IRB member who has conflicting interests in a research project
may not participate in its review. A list of IRB members must
be submitted to the Office of Human Resource Protections (OHRP).
Each IRB must have a Chair, a Deputy Chair, and a Research Administrator.
The selection and tenure of each position are determined by
the organization. Each position has specific job responsibilities.
- IRB Chair
The IRB Chair serves as the head of the IRB, leading the
IRB through review and discussion regarding proposed research
projects. He or she is also responsible for conducting the
expedited IRB review process when appropriate, which includes
preparing the information and documentation necessary to
fully explain the basis of his or her decision regarding
the proposed research project.
- IRB Deputy Chair
The IRB Deputy Chair fulfills the responsibilities of the
IRB Chair when the IRB Chair is unavailable.
- IRB Research Administrator
The IRB Research Administrator is responsible for providing
new IRB members with introductory materials relating to
the policies and procedures of the IRB. He or she is also
responsible for preparing an agenda for each IRB review
meeting and providing IRB members with the documentation
necessary to completely and adequately review all proposed
research projects scheduled for the meeting. The major function
of this position is to maintain all records regarding the
administration and activities of the IRB, including but
not limited to the following:
- All correspondence, records and documentation regarding
the recruitment, review and selection of IRB members.
- All minutes and agendas of IRB meetings.
- All records pertaining to each research project including
but not limited to any documentation reviewed by the IRB,
correspondence, and minutes of IRB meetings addressing the
project. The IRB Research Administrator must maintain records
for each research project in a separate file.
- A secure database containing current information about all
research projects reviewed, including project titles, assigned
IRB numbers, approved staff, current approval status and
the dates of IRB approval.
|