1. 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

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

3. 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

4. Revised Common Rule Key information in informed consent documents
45 CFR (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 (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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

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

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