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Assessing Risk in Human Research Protocols
Post: #1

Assessing Risk in Human Research Protocols

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45 CFR 46.111 (a)(2) states, "In evaluating risks and benefits, the IRB
should consider only those risks and benefits that may result from the
research (as distinguished from risks and benefits of therapies subjects
would receive even if not participating in the research)." How the study
is designed can minimize potential risks to participants. Studies that are
deemed "minimal risk" have greater options when it comes to using an
expedited review system and options for consent.
Risk rating also affects how elaborate a data safety monitoring plan will
be required and measures put in place to protect privacy for the
individuals and confidentiality of the data.

Areas Covered in the Session

What is risk assessment?
Why is risk assessment important?
How can you make preliminary risk assessments?
What does risk assessment affect?
What are some methods of reducing risks in a research study?
Post: #2

The Common Rule directs IECs to ensure that research risks are minimized through careful design of the study and that risks are "reasonable in relation to anticipated benefits, if any, with subjects and the importance of knowledge that reasonably can be expected to produce. " Many commentators favor imposing additional restrictions on acceptable risks in the investigation of people who, as a result of certain mental disorders, sometimes lack the capacity to make decisions.

This chapter discusses some of the conceptual and practical issues that arise not only for IRBs, but also for researchers and potential subjects who must make judgments about the acceptability of risk in relation to the benefit perspective. First, some of the difficulties inherent in the definition of risk are analyzed, followed by an explanation of the reason for NBAC to urge the IRB to evaluate the research protocols that involve this population in two categories: minimum risk and greater risk minimum. Some of the difficulties in defining benefits are discussed below. Finally, he comments on the difficulties of assessing the risks of research in relation to the potential benefits. In particular, this discussion focuses on the protections that must be required for research involving a greater than minimum risk that offers the possibility of direct medical benefit to the subjects and for research involving a greater than minimum risk that does not expose the possibility of direct medical benefit to the subjects.

The concept of risk is generally understood to refer to the combination of the probability and magnitude of some future damage. According to this understanding, risks are considered "high" or "low" depending on whether they are more (or less) likely to occur, and if the damage is more (or less) serious. In research on humans, risk is a central organizing principle, a filter through which protocols must pass; it is expected that research evaluated by IRBs that poses the greatest risk to potential research subjects will include larger or wider protections designed to reduce the likelihood of harm. The ethical basis for this position was summarized in a useful way in the National Commission's Belmont Report: "The requirement that research be justified on the basis of a favorable risk / benefit assessment is closely related to the principle of beneficence, is mainly obtained from the principle of respect for people. " On the contrary, relatively little progress has been made in describing IRB risk assessment criteria. This is largely due to the multiple difficulties inherent in the classification of risk judgements, including the difficulty associated with the perception of risk in general, and other aspects of the objective quantification of risk.

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