The IRB is responsible for evaluating the potential risks and weighing the probability of the risk occurring and the magnitude of harm that may result. It must then judge whether the anticipated benefit, either of new knowledge or of improved health for the research subjects, justifies inviting any person to undertake the risks. The IRB cannot approve research in which the risks are judged unreasonable in relation to the anticipated benefits. Show
In This Section
What is the Requirement?45 CFR 46.111 (a) (1) Risks to subjects are minimized: (i) By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes. (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. 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). The IRB should not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
How do I Comply with this Requirement?Initial Review Application You will be asked to select all procedures that will be conducted for research purposes as directed by the study protocol:
Your selection will assist in routing the application for the appropriate level of review. Research Protocol Describe the known risks related to participation in research. Describe any actions taken to minimize risk. Clearly state which procedures are being done specifically for research purposes and which are done as standard of care or normal practice. Describe any anticipated benefits the research subjects may receive from participation in the research. For minimal risk research, there is no requirement of direct benefit to research subjects; it is acceptable to state that there is no anticipated benefit to subjects. When research is greater than minimal risk, the anticipated benefits must justify the known risks. Please note that compensation for participation in research may not be listed as a benefit. Consent Documents Describe the known risks and anticipated benefits in laypersons terms. List all risks and benefits that are described in the research protocol. Ethical ConsiderationsWhen making this determination in research with adult populations, the IRB weighs the risks to participants against the anticipated benefits (either direct or indirect) of the research. When vulnerable subjects take part, the regulations place limits on the extent of risk permitted. Children may only participate in greater than minimal risk research when there is a prospect for direct benefit. The IRB will:
Risk GuidanceIn human subject research, research is categorized into in two categories:
Research is considered minimal risk when the risks of the research are not greater than those experienced in regular daily life. Researchers are responsible for identifying any possible risks of the research and minimizing risks to subjects whenever possible. Some common types of risks are:
Strategies for Minimizing Risks Eliminating Risks Risks are eliminated by limiting research procedures or data collection to those that are necessary for the research. Some examples:
When risks cannot be eliminated, there are often opportunities to decrease the risk to research subjects. Some examples:
Combining research procedures with clinical care If procedures can be timed to take place at the same time as a clinically indicated procedure or if clinical test results can be used instead of repeating the measurements, the risks are often greatly reduced. Some examples:
Benefits GuidanceNancy King has defined three types of benefit that may occur in the context of clinical research (J Law Med Ethics. 2000 Winter;28(4):332-43) Direct Benefit: A benefit arising from receiving the intervention being studied. Indirect Benefits
Research with a direct benefitAny study that involves an intervention could have an anticipated direct benefit. In these studies, participants may receive some intervention (medical, behavioral, or other), that they would not otherwise receive. The purpose of the research is typically to test the effectiveness of the intervention. When describing the anticipated benefits of research in the consent document, it is important that researchers make subjects aware that the benefits of the intervention are not known, and that the research is being conducted to evaluate the effectiveness of the intervention. Whenever possible, the researcher should provide any known information about the probability and magnitude of the anticipated benefit. Research with an indirect benefitWhen research does not involve an intervention there is little opportunity for direct benefit. When the risks of the research are no greater than those encountered in the everyday life, there is no requirement for direct benefit. When the research risks are greater than minimal risk, then the researcher must provide justification that explains how the anticipated benefits of the research justify the risks to the subjects.
DefinitionsBenefit is a valued or desired outcome; an advantage. Minimal Risk means the probability and magnitude of harm or discomfort anticipated in the research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Which of the following is an example of minimal risk research?Examples of Minimal Risk are: Study poses no more risk than expected in daily life (e.g., blood draw, physical exam, routine psychological testing). Non-interventional studies (e.g., observational studies of behavior or nutrition). Survey/Questionnaire studies of a non-sensitive nature.
How can psychological risks be minimized in research?You can take several concrete steps to minimize risks and deception in your research. These include making changes to your research design, prescreening to identify and eliminate high-risk participants, and providing participants with as much information as possible during informed consent and debriefing.
Which of the following is true about institutional review boards IRBs?Which of the following is true of Institutional Review Boards (IRBs)? They are liable for the research they approve.
Which of the following is true of the use of deception in psychological research?Which of the following is true of the use of deception in psychological research? It is acceptable if there is no alternative way to conduct the study.
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