|
What is an IRB?
IRBs were created to review all research involving human subjects, their tissue
or data (including existing tissue and data). The University’s Federal
Wide Assurance with the federal government states that all research conducted on
or in relation to human subjects (funded or unfunded), will be reviewed in
accordance with the Code of Federal Regulations (45
CFR 46).
History
IRBs began in 1974 when the National Research Act was signed
into law, the Act created the National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research. The Commission was charged
with identifying the basic ethical principles that underlie the conduct of
Biomedical and Behavioral research and to develop guidelines for research
involving human subjects. Human subject research provides many societal
benefits, but it also brings some troubling ethical questions due to reported
abuses of human subjects. These abuses were most egregious during the
Second World War, but other cases occurred such as the U.S. Tuskegee Syphilis
trial in which rural black men with syphilis were not told they were
participating in research and were subsequently denied treatment for their
disease when penicillin became a known cure.
The Nuremberg Code was drafted from the Nuremberg War Crimes
trials of Nazi physicians and scientist who had conducted atrocious biomedical
experimentation on concentration camp prisoners. The Code comprises
certain basic principles that must be observed in order to satisfy the moral,
ethical and legal requirements for the conduct of human research, and has become
the prototype of many later codes. Another set of guidelines is the
Declaration of Helsinki, authored by the
World Medical Association, which allows
for research on subjects with the diminished capacity to participate in research
provided consent is obtained from their legal guardian.
IRB Review of Research
The
Belmont Report was drafted in response to numerous clinical trial
violations. The three basic ethical principles identified in the Belmont
Report are used to review proposed research involving human subjects.
- Respect for Persons
|
- Individuals should be treated as free thinking
people and are capable of making their own informed
decisions
- Persons with reduced free thinking abilities are
entitled to protection
|
- Beneficence
|
- Do not harm
- Make the most of benefits while reducing risks
|
-
Justice
|
-
That no one group is singled
out either to exclude them with no cause from
research (such as children or women) or to include
them because they are more accessible than other
populations.
|
The IRB at Washington University
The Washington University in St.
Louis’s Human Research Protection Office (HRPO) is the Institutional Review
Board (IRB) that serves Washington University, Barnes-Jewish Hospital and St.
Louis Children’s Hospital.
Washington University IRB
Committee Information
The Washington University HRPO
has 4 new submission reviewing committees, 4 continuing review committees, and 2
mixed reviewing committees (i.e. new and continuing review). Each one of
these 10 reviewing committee meet once a month. Our committee members
include; physicians, non-physician scientists, researchers, clinicians,
nurses, pharmacists, occupational therapists, physical therapists (among other
members of the medical community), lawyers, clergy, and lay people from the St.
Louis community.
|
