Risk

by Richard R. Riker MD

Vice-Chair, IRB

Maine Medical Center

What is Risk?

• A risk is a potential harm or injury associated with the research that a reasonable person in the subject's position would likely consider injurious.

• Risks can be categorized as physical, psychological, sociological, economic, and legal.

• Risks to subjects must be reasonable in relation to anticipated benefits, if any, to subjects; and to the importance of knowledge that may reasonably be expected to result from the research.

Types of Risk

• Minimal risk: 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.

• Greater than Minimal Risk: The probability and magnitude of harm or discomfort anticipated in the research are greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Minimal Risk Regulations

• According to the federal regulations [45CFR46.102 (i)], “minimal risk means that 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.”

Minimal Risk Example

An example of minimal risk is the risk of drawing a small amount of blood from a healthy individual for research purposes (because the risk of doing so is no greater than the risk of doing so as part of a routine physical examination).

Minimal Risk Determination

The definition of minimal risk serves as the starting point for the IRB chair's determination of the category of review.

If a project meets the definition of minimal risk, and falls into an exempt or expedited category, the Chair alone, Vice Chair, or designated IRB member may review and approve the project.

The categories of exempt and expedited are mutually exclusive. If the study is minimal risk, the Research Compliance Staff and Chair considers whether the research falls into an exempt category. If the research does not fall into one of the exempt categories, then the expedited review categories are considered.

Does Information Sensitivity Affect Risk?

Sometimes:In cases of however the IRB or research compliance staff shouldcounsel the investigator to make sure that the purpose ofthe study is clearly stated so that the subjects can make aninformed decision as to whether or not they want toparticipate and that the information is protected to thehighest degree possible.

What is Sensitive Information?

Sensitive Information includes, but is not limited toinformation relating to:

– sexual attitudes, preferences, or practices– use of alcohol, drugs, or other addictive products– illegal conduct– if released, might be damaging to an individual’s financial

standing, employability, or reputation within the community or might lead to social stigmatization or discrimination

– an individual’s psychological well-being or mental health– genetic information

When do you protect sensitive Information?

• Sensitive information must be protected if it is collected with identifiers attached. If there are no identifiers and it is anonymous, it can receive an exempt determination

• Can sensitive information be recorded with identifiers with waiver of consent and expedited IRB review?