1. Department of Health and Human Services1 Update: October 2006 Public Meeting on Emergency Research Diane Maloney, J.D. Associate Director for Policy FDA Center for Biologics Evaluation and Research Blood Products Advisory Committee Meeting December 14, 2006

2. Department of Health and Human Services 2 Meeting Overview Meeting Scope – emergency research conducted without informed consent Purpose –obtain views from public on experiences/concerns – determine whether changes are needed Audience – interested parties, including –Patient advocacy groups –Individuals who have participated in these studies –IRBs, sponsors, clinical investigators –Medical societies –Ethicists

3. Department of Health and Human Services 3 Background Rule- facilitate research and protect subjects Studies involving patients in life-threatening situations Cannot give consent Available treatments unproven or unsatisfactory Product holds out prospect of direct benefit Cannot practicably carry out study with consent Additional protections

4. Department of Health and Human Services 4 Emergency Research Regulation 10 year experience with rule Informal input received –Additional guidance needed –Adequacy of safeguards –Research not occurring for multiple reasons Decision to seek public input –Public meeting –Docket for written comments

5. Department of Health and Human Services 5 Federal Register Notice Announced the meeting in Aug Fed. Reg. Identified specific questions Issued draft guidance at same time Requested comments to docket by Nov 27 Meeting held October 11, 2006

6. Department of Health and Human Services 6 Public Responses Docket - ~ 80 written responses –Most voiced support for regulation to allow research with exception from informed consent –Some voiced need for additional guidance (especially for community consultation, public disclosure) –Some expressed opposition to any research without informed consent Part 15 Hearing – 17 speakers (all supported need for rule and exception from consent; suggestions)

7. Department of Health and Human Services 7 Issues Discussed at Meeting Scientific Aspects of Emergency Research and Human Subject Protection Additional Human Subject Protections –Community consultation –Public disclosure

8. Department of Health and Human Services 8 Clarification of Criteria Prospect of direct benefit Available treatment is unsatisfactory or unproven

9. Department of Health and Human Services 9 Community Consultation Issues Costs, feasibility of consultation Effectiveness as a HSP mechanism Adequacy of consultation

10. Department of Health and Human Services 10 Public Disclosure Purpose Level of detail of information –Types of information

11. Department of Health and Human Services 11 Additional Review/Discussion Questions on use of national advisory body Additional public discussion

12. Department of Health and Human Services 12 Next Steps Review written comments submitted to FDA docket on questions found in Federal Register Notice for Part 15 Hearing published on 8/29/06 Review comments submitted to FDA docket on draft guidance Review submitted presentations associated with public input from Part 15 Hearing Evaluate possible options that respond to received feedback