Module 5: Identifying, Assessing, and Minimizing Risks of Social
and Behavioral Research
Institutional Training for Research Involving Human Subjects
*adapted from a presentation by Jeffrey Cohen, OPRR
The Institutional Review Board (IRB) - called the
Committee for Research Involving Human Subjects, is responsible for reviewing
and approving activities involving all research with humans at KWU. The
performance of non-medical research in the social and/or behavioral arena
has the potential for significant risks that go beyond invasive procedures
or physical injury. These potential risks must be identified and considered
by the IRB during the review and approval process.
Institutional Review Board (IRB) Responsibilities
As with other forms of
research involving human subjects, KSU IRB review responsibilities include:
Identify risks
to human subjects
Determine that
risks are minimized
Determine that
“risks to subjects are reasonable in relation to anticipated benefits”
Determine that
subjects are adequately informed about any “reasonably foreseeable risks
or discomforts”
Identifying Risks
Physical risks are fairly
easy to identify.They would include
injury, illness, or allergic reactions.However,
it is important to remember that social and psychological risks are real
risks too.Examples of social and
psychological risks include: emotional distress, psychological trauma,
an invasion of privacy, embarrassment, loss of social status, and loss
of employment.
IRB’s should not rely solely
on investigators to identify risks. They should use investigator’s knowledge
coupled with resident or consultative expertise of the IRB to identify
risks.
Minimizing Risks
The three best ways to
minimize risk in social and behavioral research are to incorporate precautions,
to incorporate safeguards, and explore alternative methods to achieve the
same goals.
Risk/Benefit Analysis
IRB’s must make a Risk/Benefit
Analysis. This evaluation of a Risk/Benefit ratio is a subjective judgment.
The IRB must decide whether anticipated benefit justifies asking subjects
to undertake risks.
IRB should take into account
different subject populations and individual differences among subjects.Some
people are more sensitive or “at risk” than others, and some people would
benefit from participation more than others would.
Informed Consent
Consent process should empower subjects
to make their own determination about risk. Therefore, risks should be
explained in simple terms that subjects can relate to everyday life experiences. Risks
should be stated clearly and directly, not minimized or excused away. It
must be clear to the subject that they are participating in research, and
they should have enough information about what is expected of them to rationally
decide whether or not they choose to participate.