SOCRA 2024 Annual Conference Program Book - Flipbook - Page 65
Dealing with
Informed Consent Challenges
What’s Weighty and Relevant Comes First
This Photo by Unknown Author is licensed
under CC BY‐SA
• People’s attention is limited! Start by providing
the weighty and relevant information, the key
information that would help people decide about
participation.
Let any remaining required or legally necessary
information to follow in the same document (for
compliance purposes)
Consider putting instructional information in a
different document (e.g., day-by-day
information about the study procedures)
Use the front pages thoughtfully. Fill them with
information that would have an impact on
decision making, not FYIs
Remember
• Primary purpose is to facilitate
individuals making their own
decision about research participation
• Make it participant-centered
• Be creative and don’t hesitate to use
the flexibilities available in the
regulations
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Foster the development of more robust human
research protection programs within the
regulated community through…
About Research Participation Materials (General Public)
Printable List: Questions to
Ask
Video: What to Expect in Informed Consent
POLICY
https://www.hhs.gov/ohrp/education-and-outreach/about- https://www.hhs.gov/ohrp/education-and-outreach/aboutresearch-participation/informational-videos/index.html
research-participation/informational-videos/index.html
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Policy Initiatives:
GAO Recommendation 4:
• Draft Guidance
• The Secretary of Health and Human Services should ensure that
OHRP and FDA convene stakeholders to examine approaches for
measuring IRB effectiveness in protecting human subjects, and
implement the approaches as appropriate. These could include
effectiveness measures; peer audits of IRB meetings and
decisions; mock protocols; surveys of IRB members, investigators,
and human research participants; or other approaches.
March 1, 2024 Draft Guidance - Key Information and Facilitating Understanding in
Informed Consent
June 16, 2023 Draft Guidance - Frequently Asked Questions: Limited Institutional
Review Board Review and Related Exemptions
March 31, 2023 Draft Guidance - Research Involving Children as Subjects and Not
Otherwise Approvable by an Institutional Review Board: Process for Referrals to
Food and Drug Administration and Office for Human Research Protections
July 1, 2022 Draft Guidance – Use of a Single Institutional Review Board for
Cooperative Research
• Rulemaking
• Responding to the Government Accounting Office’s 2023 report on
IRB effectiveness
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