Social and Behavioral Research and the IRB: History and Guidelines. Behavioral Research and the Belmont Report. “It is important to distinguish between biomedical and behavioral research.”
Definition of a “Human Subject”
Individuals whose physiologic or behavioral characteristics and responses are the object of study in a research project. Under federal regulations, they are defined as: living individual(s) about whom an investigator conducting research obtains: (1)data through intervention or interaction with the individual; or (2)identifiable private information.
(Webster’s New Collegiate Dictionary, Cambridge, MA, G & G Merriam Co., 1961).
Nazi War Crimes WWII
DECLARATION of HELSINKI
World Medical Association, 1964 updated in 2000
revised 1975, 1983, 1989, 1996, 2000
Tearoom Trade StudyLaud Humphreys, 1970
Legacy of Tuskegee
“The study continues to cast a long shadow over the relationship between African Americans and the bio-medical professions; it is argued that the studyis a significant factor in the low participation of African Americans in clinical trials, organ donation efforts, and routine preventive care.”
Charge to the National Commission
National Research Act, 1974 (PL 93-348)
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979
Regulatory requirements stem directly from ethical principles
Social & Psychological Risk
Social and psychological risks are
Examples of Social and Behavioral risk
The Primary source of social risk results from
a breach of confidentiality.
21 CFR 56.109 and 45 CFR 46.109
According to federal mandate “An IRB shall
review and have authority to approve,
require modification in (to secure approval),
or disapprove all research activities covered
by this policy”
So, What Is the IRB’s Purpose?
The IRB’s Purpose and Responsibility Is to Protect the Rights and Welfare of Human Subjects.
The IRB Reviews and Oversees Such Research to Ensure That It Complies With Federal Regulations, That Pertain to Human Subject Protection.
There are three ways to minimize risk
The Common Rule provides sufficient flexibility for
IRBs to effectively and efficiently review non-
Research that may meet expedited review criteria include minimal risk studies and only those which fall under those categories :
The following activities with school children do not
qualify for exemption under 45CFR 46 Subpart D:
In contrast, the following research activities in
schools may qualify for exemption:
The effective and efficient application of the
Common Rule to non-biomedical research
requires that an institution must have:
As part of the Institutional Review Board’s
requirements, which are mandated by the
regulations during the approval year, researchers
are required to report to the IRB in the event of any
of the following:
Mandatory training for researchers using human subjects can be accessed at:
This is a link to the Collaborative IRB Training Initiative's Course in The Protection of Human Research Subjects. You will need to register for a free account to access the training module.