To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter. Developed by: U-MIC

Key information in informed consent documents Revised Common Rule Developed by: U-MIC University of Michigan IRB Collaborative

Common Rule Key information in informed consent documents 45 CFR 46 subpart A basic responsibilities researchers IRBs informed consent 2018 revised Common Rule effective January 21, 2019 key information beginning of document Developed by: U-MIC

Revised Common Rule Key information in informed consent documents 45 CFR 46.116(a)(5)(i) Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension. 45 CFR 46.116(a)(5)(ii) Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject’s or legally authorized representative’s understanding of the reasons why one might or might not want to participate. Developed by: U-MIC

Revised Common Rule Key information in informed consent documents reasonable person standard hypothetical average person particular nature of the study Key information should accommodate to concerns of subject population. researchers developing consent materials IRBs reviewing research Developed by: U-MIC

Key information in informed consent documents Considerations for reviewing the key study information section of an informed consent document IRBMED’s standard informed consent template designed to comply with revised Common Rule including the key information requirement HHS: key information requirement usually satisfied by five elements consent sought for research, participation voluntary purpose of research, duration of participation, study procedures risks benefits alternatives Developed by: U-MIC

Key information in informed consent documents Considerations for reviewing the key study information section of an informed consent document key information section voluntariness research differs from clinical care study purpose blue boxes contain prepared language pertaining to common types of research drug/device studies behavioral interventions data/biospecimen collection definitions randomization washout IRB confirms accuracy/conciseness of study purpose summary. Developed by: U-MIC

Key information in informed consent documents Considerations for reviewing the key study information section of an informed consent document risks sample risk language designed to orient potential subjects to study highlight significant risks Risk language taken from elsewhere in document may not be adequate. IRB assesses appropriateness of risk summary. whether most common or serious whether general statement preferable to list of risks “Participation in this study involves serious risks, some of which could be painful, require hospitalization, or be life-threatening.” Developed by: U-MIC

Key information in informed consent documents Considerations for reviewing the key study information section of an informed consent document benefits General statement may suffice. IRB confirms consistency with benefits section. direct indirect Developed by: U-MIC

Key information in informed consent documents Considerations for reviewing the key study information section of an informed consent document duration of study participation alternatives to taking part IRB ensures consistency with remainder of document. Developed by: U-MIC

Key information section does not Key information in informed consent documents Key information section does not supplant complete consent process opportunity to discuss and consider participation satisfy all informed consent requirements Developed by: U-MIC

Key information in informed consent documents Developed by: U-MIC

Thank you. Ray-Nitra Reynolds Brian Seabolt IRBMED Developed by: U-MIC