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A regulatory criterion for approval
of research is that risks to participants are reasonable
in relation to anticipated benefits, if any, to participants,
and the importance of the knowledge that may reasonably
be expected to result.
When reviewing a proposal,
the IRB should evaluate whether research submitted
for review satisfies this criterion.
We should regularly assess the likelihood
and magnitude of harms and benefits, and understand
the importance of the knowledge reasonably expected
to result.
We should consider the range of harms,
including physical, social, economic, psychological,
and legal harm when reviewing specific protocols.
We should also be cognizant of the
range of benefits. Benefits can take the form of therapy,
education, information, resources or empowerment.
Benefits can be directed at participants or the community
at large.
Assessing
the adequacy of the plan for monitoring data
A regulatory criterion for approval
of research is that when appropriate, the research
plan makes adequate provisions for monitoring the
data to ensure the safety of participants.
When reviewing a proposal, the IRB
should evaluate whether research submitted for review
satisfies this criterion.
For clinical research involving no
more than minimal risk and for most behavioral and
social science research (because most involves no
more than minimal risk), specific detailed provisions
for data and safety monitoring are not usually needed
to protect participants. Usually, confidentiality
protections are the primary focus.
For research that involves more than
minimal risk, we should consider the research and
its potential risks and determine whether or not the
data and safety monitoring plan is adequate; remembering
that there are a number of approaches that are acceptable.
(Data and Safety Monitoring Boards review sheet, 5/06).
Such approaches might include monitoring by the investigator,
the sponsor (e.g., sponsor medical monitor with access
to all sites’ data) a safety monitoring committee,
or by an independent monitoring board.
References:
Revised from AAHRPP guidance
PHRC educational sheets June 2007
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