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ARA
Institutional
Review Board (IRB)
In
addition to several levels of scientific review and approvals
that must be achieved prior to the initiation of new research
projects, all clinical trials conducted at AIDS Research Alliance
must also be approved by a human subjects protection committee
that ensures the ethical and equitable treatment of all study
participants. Following is an overview of the role the Institutional
Review Board and an introduction to the individuals that comprise
this all-important group.
An
Institutional Review Board (IRB) is a committee of individuals
who are responsible for ensuring the ethical treatment of
participants in human clinical research studies. The IRB accomplishes
this by carefully reviewing prior to initiation (and on an
ongoing basis) all research protocols, informed consent documents
and advertisements used to promote participation in a study.
The
IRB is charged with being an advocate and protector of the
rights and welfare of potential study participants; ensuring
that studies are designed to minimize risk and maximize potential
benefit to patients. In accordance with Federal regulations,
all research conducted using human subjects must be reviewed
and approved by an IRB (also known as a Human Subjects Protection
Committee). Therefore, most institutions that conduct a large
amount of research maintain their own IRB.
The
AIDS Research Alliance IRB meets monthly to review new clinical
trials protocols, informed consent documents, proposed study
advertisements and all ongoing clinical studies. It is common
for the IRB to request changes to the study protocol itself
and particularly the informed consent document.
The
AIDS Research Alliance IRB recently passed a FDA IRB audit
with a "no findings" result. This means that
the audit revealed no significant problems or shortcomings
in the procedures, composition or documentation of the ARA
IRB. The audit was conducted in July 1999 and covered a 3-year
period (1996-1999). It included a comprehensive review of
all clinical research conducted by ARA during that 3-year
period.
IRB
FAQs
AIDS
Research Alliance Institutional Review Board (IRB) was established
as an independent IRB in 1995 operating in compliance with
federal regulations governing institutional review boards
set forth in 21 CFR Part 56 and regulations governing informed
consent set forth in 21 CFR part 50.
What
is an IRB?
An Institutional Review Board (IRB) is a committee of individuals
who are responsible for conducting the initial and ongoing
review of clinical research involving human subjects according
to FDA regulations. Through assessing the acceptability of
the proposed study in terms of applicable law. Investigator
commitment, and standards of practice in the community where
the research is to be conducted our IRB ensures the following:
1.
Safeguards are provided to protect the rights and welfare
of subjects.
2.
Risks to the subjects do not outweigh benefits or knowledge
gained through the study.
3.
Selection of subjects is fair and equitable.
4.
Each subject gives informed consent prior to participation
according to FDA requirements.
5.
Adequate evaluation of the data occurs to ensure the ongoing
safety of subjects.
6.
Provisions are in place to protect the privacy of subjects
and confidentiality of data collected.
What
is the Required Composition of an IRB?
FDA
regulations require that an IRB be comprised of at least 5
individuals and include the following:
•
Men and women
•
Members with both scientific and nonscientific backgrounds
•
At least one member representing cultural or ethnic diversity
•
At least one member representing the welfare of special interest
groups (i.e., physically or mentally handicapped), when applicable
•
At least one member not affiliated with the company or institution,
when applicable
What
Type of Documentation Must an IRB Maintain?
The
FDA requires that an IRB maintain the following documentation
during the study and for 3 years after study completion:
•
Written policies and procedures
• Records
of all initial, ongoing, and expedited study reviews and approvals
• Safety data collected during the study (reports on
serious events and unexpected events)
• Written records of all activities, including accurate
minutes of all IRB meetings.
IRB
Members
- Stephen
Lloyd Fefferman, Psy.D., MFT, CHAIR
- Kristin
Allen (IRB Administrator)
- Dawn
Brewer
- Jose
Cabreros Castro II
- John
Dratz, Jr.
- Michael
D. Grahn, Esq
- Anthony
Mills, M.D.
- Herminio
Reyes, Ph.D.
- Seymour
Young, M.D., VICE–CHAIR
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