1. A Multimedia Approach to Informed Consent Mildred Z. Solomon, EdD Vice President, Education Development Center, Inc (EDC) Director, EDC’s Center for Applied Ethics Associate Clinical Professor of Medical Ethics, Harvard Medical School Presented to Secretary’s Advisory Committee on Human Research Protection October 28, 2009 Washington, DC

2. An electronic approach can improve…  Understanding  Inclusiveness  Transparency  Standardization

3. Can improve understanding by…  Visuals which illustrate  Easy-to-understand colloquial speech  Monitoring respondents’ answers to key questions

4. Can improve inclusiveness by… Picturing people from diverse:  Ethnic groups  Socio-economic classes  Regions of the country

5. Can improve transparency by…  Making it clear how the study was explained during the informed consent encounter

6. Can improve standardization by…  Ensuring that everyone has the same things explained to them, and in the same manner

7. 1.Inform the subject Provide information purpose and scope of the study, what participation involves, and the risks and benefits of participating 2.Assess understanding Evaluate a potential subject’s comprehension 3.Obtain consent Give those who have demonstrated understanding of the information an opportunity to sign their consent Three functions an e-consent tool can perform

8. Structure of E-Consent Tool Follows federal requirements:  Explains study purposes  Describes what is involved in participation  Explains benefits and risks  Describes compensation if any  Addresses commonly asked questions  Asks for a decision If yes, captures e-signature If no, provides thank you and may ask why

9. The North Carolina Registry Informed Consent Project Participating Institutions: North Carolina Cancer Hospital UNC Lineberger Comprehensive Cancer Center UNC Gillings School of Global Public Health UNC School of Medicine Funded by: University Cancer Research Fund

10. The North Carolina Registry Informed Consent Project At University of North Carolina, Chapel Hill: H. Shelton Earp III, MD Debra E. Irwin, PhD, MSPH Jeannette Bensen, PhD, MS At Education Development Center, Inc.: Mildred Z. Solomon, EdD Sarah McGraw, PhD Carol Nutter, BS

11. Format Preferences of Video and Read-only Groups

12. How Likely Are You to Join the Study?

22. A Federal law called the Genetic Information Nondiscrimination Act (GINA)… makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. More information about GINA is found in the written consent form.

23. Who will decide what research will be done using the Registry? Each time researchers want to use the Registry, they will have to describe their research study to an Institutional Review Board or IRB. The IRB is responsible for protecting human research participants. Both a Registry governing committee and the IRB will have to approve the study.

24. Who will decide what research will be done using the Registry? (cont.) At times, the governing committee or the IRB may ask a researcher to re-contact you to consider participation in a particular, future research study. This would happen if the committee or the IRB thought that the proposed research was something Registry volunteers would want to think more about, before allowing their samples to be analyzed. If you are re-contacted, you could say yes or no to having your stored samples and data used in such a research study.

25. How many people will take part in this research and how long will the study last? If you decide to participate, you will be one of many thousands of people identified over the course of many years. Approximately 10,000 people will be followed annually.