AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research

1. AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research Cindy Brach Agency for Healthcare Research and Quality Center for Delivery, Organization, and Markets

2. Overview • The Problem • Toolkit Development • Toolkit Content • The Forms • The Process • Dissemination

3. The Problem Research participants often do not understand essential information regarding their participation in research • Form complexity ≠ reading skills • Process not standardized • No verification of understanding

4. AHQR Informed Consent and Authorization Toolkit Health Services Researchers wanted templates that: • Addressed both HIPAA Privacy Rule and Informed Consent • Were appropriate for low-literate audiences • Designed for health services research

5. Toolkit Development • Draft Toolkit • BU Contractor • Delphi Process • Cognitive testing of English and Spanish forms • Simulations • Reviewed by OHRP and OCR

6. Toolkit Content • Background • Improving the process • Improving the forms • Regulatory Requirements • Resources • References

7. Sample Form Language • We are asking you to be in a research study. • You do not have to be in the study. • If you say yes, you can quit the study at any time. • Please take as much time as you need to make your choice. • Your medical care will not change in any way if you say no.

8. Focus Group Quotes • Can’t get much clearer. • Simple and straight to the point. • It’s my decision. • I think in this way it’s clear because it’s not using really professional, big words that you get confused that you don’t know what they’re talking about; all medical words that the doctors use, or professional. You know, this is our level that we can understand.

9. Question-Answer Format • What happens if I say yes, I want to be in the study? • What happens if I say no, I do not want to be in the study? • What happens if I say yes, but change my mind later? • Who will see my answers? • What if I have questions? • Do I have to sign this document?

10. Health Literacy Principles • Plain Language • No jargon • Short, simple sentences • Active voice • Formatting • Big font • Short lines • Lots of white space

11. Informed Consent and Authorization is a Process, Not Just a Form • Private place • Interpreters • Offer to read form out loud • Verify comprehension • Solicit questions

12. Verifying Comprehension:Teach Back • Ask open-ended questions, e.g., • What do you expect to gain by taking part in this research? • Who will be able to see the information you give us? • What should you do if you agree to be in the study but later change your mind? • Repeat until comprehension is verified • Do not enroll if potential subject doesn’t comprehend

13. Certification Form I have: ___ Conducted the informed consent and/or authorization discussion in private, or only in the presence of those people that the potential subject wanted to hear the discussion.    ___ N/A ___ Noted that the potential subject is fluent in English or that the subject (check all that apply):     ___ Signed form written in own language: __________________.     ___ Was assisted by study personnel fluent in _______________.     ___ Was assisted by a professional medical interpreter.     ___ Was not enrolled because refused offer of professional medical interpreter.     ___ Was not enrolled because study restricted to those fluent in English. ___ Read the Informed Consent and/or the Authorization Document with subjects who do not choose to read the document on their own.    ___ N/A

14. Adoption of Changes • Raise Awareness • Identify Leaders and Partners • Identify Mechanisms for Change • Address Common Concerns • Training

15. Dissemination • Posted on AHRQ’s Web Site • Email to 20,000 • IRB Advisor and Clinical Trials Administrator • PRIM&R web link and newsletters • NIH to circulate to intramural and extramural communities, e.g., NIH Clinical Center News • CDC Public Health Law News • Suggestions?