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. Advancing Excellence in Health Care Overview The Problem The Problem Toolkit Development Toolkit Development Toolkit Content Toolkit Content – The Forms – The Process Dissemination Dissemination

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

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

5. Advancing Excellence in Health Care Toolkit Development Draft Toolkit Draft Toolkit BU Contractor BU Contractor – Delphi Process – Cognitive testing of English and Spanish forms – Simulations Reviewed by OHRP and OCR Reviewed by OHRP and OCR

6. Advancing Excellence in Health Care Toolkit Content Background Background Improving the process Improving the process Improving the forms Improving the forms Regulatory Requirements Regulatory Requirements Resources Resources References References

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

8. Advancing Excellence in Health Care Focus Group Quotes Can’t get much clearer. Can’t get much clearer. Simple and straight to the point. Simple and straight to the point. It’s my decision. 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. 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. Advancing Excellence in Health Care Question-Answer Format What happens if I say yes, I want to be in the study? 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 no, I do not want to be in the study? What happens if I say yes, but change my mind later? What happens if I say yes, but change my mind later? Who will see my answers? Who will see my answers? What if I have questions? What if I have questions? Do I have to sign this document? Do I have to sign this document?

10. Advancing Excellence in Health Care Health Literacy Principles Plain Language Plain Language – No jargon – Short, simple sentences – Active voice Formatting Formatting – Big font – Short lines – Lots of white space

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

12. Advancing Excellence in Health Care Verifying Comprehension: Teach Back Ask open-ended questions, e.g., 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 Repeat until comprehension is verified Do not enroll if potential subject doesn’t comprehend Do not enroll if potential subject doesn’t comprehend

13. Advancing Excellence in Health Care 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. Advancing Excellence in Health Care Adoption of Changes Raise Awareness Raise Awareness Identify Leaders and Partners Identify Leaders and Partners Identify Mechanisms for Change Identify Mechanisms for Change Address Common Concerns Address Common Concerns Training Training

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