1.  PRIM&R Conference Presented by: Katherine Hayden February 8, 2011

2. General Session Entertainment

3. Advanced Research Ethics Seema Shah: J.D. Informed Consent Department of Bioethics: NIH Clinical Center

4. Informed Consent  Research and data on Informed Consent  Used in 84 countries  It is a process, not a form  Elements of Informed Consent  Disclosure of information  Understanding  Voluntariness  Consent authorization

5. Disclosure – Required Elements  Statement of Research  Purpose and procedures  Foreseeable risks and discomforts  Any benefits to subjects and others  Appropriate alternatives  Extent of Confidentiality  Treatment or compensation for injury  Who to contact for answers to questions  Participation is voluntary

6. Considerations About Presentation of Information 1. Reading level should be understandable to research subjects 2. Formatting-Headings? White Space? 3. Content-basic elements included? 4. Length-can document be shortened without compromising clarity or other requirements?

7. Data on Disclosure  Content documents  Readability (studies show reading levels are typically too high and forms are too long.) Should be 8 th grade level.  Content: only 3/16 consent forms had all required elements  Discussion  Content: some say consent forms are for researcher and are not really read by participant.  Quality of interaction: a study showed this method had higher level of completeness in video format than f2f meeting.  Assessment of understanding is rarely done.

8. Factors that Affect Understanding  Age  Severity of illness  Educational Level  Cognitive capacity  Familiarity with research  Language and customs  Literacy  Variable Data that affect understanding  College education - speaking only English at home  Education and age  Research Experience

9. Placebo  Often, participants do not understand that they might be receiving a placebo  10 % of Gambian mothers understood placebo design of vaccine trial  67% of US participants in rheumatoid arthritis trial knew some people would get a placebo.

10. How to Measure Voluntariness  Did individuals choose not to participate?  Did participants feel pressure to join?  Did participants know that they could refuse or withdraw?  Data shows that few people opt out of studies.  About half knew they could quit.

11. How to Improve Consent  Multimedia (e.g. audiotapes, videotapes, interactive computers)  Enhanced consent form (e.g. modified style, format or length.  Extended discussion (with team member or neutral educator)  Test/feedback (e.g. quizzes and review)  More person to person contact

12. Conclusions  Consent forms are long and complex  Understanding is variable and especially lacking in certain areas (randomization)  Many participants do not know/feel they can quit  Spending more time may enhance understanding