Protecting Human Subjects

Transcription

1 Emerging Government Initiatives in Biomedical Research: Protecting Human Subjects Medical Research Summit Washington, DC -- March 19, 2001 Tom Puglisi, PhD PwC

2 Inititial Federal Regulations for the Protection of Human Subjects HHS Regulations Revised CFR Part 46 Core Protections => Subpart A Special Protections => Subparts B, C, D FDA Regulations Revision 21 CFR Part CFR Part 56

3 The Federal Policy (Common Rule) for the Protection of Human Subjects HHS Subpart A (Core Protections) IRB Review Informed Consent Codified Separately by 17 Federal Departments and Agencies Common Rule Cannot be Changed Easily HHS Subparts B, C, D Typically Not Adopted

4 Other Human Subject Research 17 Federal Agencies Codified the Common Rule Some Agencies Required Additional Protections VA => Treatment for Research - Related Injuries Some Agencies Do Not Require Informed Consent or IRB Review Department of Labor => Miners and Coal Dust Appalachian Regional Commission => Telemedicine Department of Transportation => Sleepy Truck Drivers No Federal Regulation for Research Not Covered Under The Common Rule or FDA Regulations

5 Increased Vigilance Needed in Protecting Human Subjects PwC

6 Problems Identified Coercive Recruitment Deceptive Advertisement Good Clinical Practice Ignored Conflict of Interest

7 Public Concern Heightened Human Research Halted at Major Institutions Deficient Informed Consent Inadequate IRB Review Lack of Continuing Review Death in Gene Transfer Research Conflicts of Interest Unreported Deaths and Injuries Media Attention -- Congressional Hearings

8 Research Involving Human Subjects What s at Stake is the Integrity of Research and Public Confidence in Research HHS Secretary, Donna Shalala, May 2000

9 HHS INITIATIVES: SHARED RESPONSIBILITY TRUST ACCOUNTABILITY PwC

10 National Human Research Protections Advisory Committee (NHRPAC) PwC

11 Education / Training PwC

12 Education and Training NIH => Clinical Investigator and Key Personnel OHRP => Institutional Official, IRB Members, IRB Staff OHRP => Research Investigators ORI => Responsible Conduct Research

13 Conflict of Interest PwC

14 Conflict of Interest Public Discussion Disclosure of Interests Management of Conflicts New Guidance for Comment

15 Monitoring and Oversight PwC

16 Informed Consent Initiatives Specific FDA / NIH Guidance Institutional & Sponsor Audits Confirmation of Willingness to Continue When Warranted FDA Civil Penalties for Violations

17 Monitoring Guidelines Phase 1, 2, 3 NIH Trials FDA DSMB Guidelines DSMB < = > IRB Relationship

18 Office for Human Research Protections (OHRP) PwC

19 OPRR OHRP Increased Status, Resources, Clout Educational Outreach -- Workshops -- Web and Phone Q&A -- No Fault Tech Assistance Simplified Assurance Process

20 OHRP Federalwide Assurance (FWA) MPAs, CPAs, SPAs, CAs, IAs, AIIs, NIAs eliminated Single Assurance Document 1 Institution = 1 Assurance* *some international exceptions International Standards OK

21 OHRP Federalwide Assurance (FWA) All Institutions Eligible Web-Based IRB Registration Rely on own institutional IRB, other institutional IRB, commercial

22 OHRP Federalwide Assurance (FWA) Institutional Education Program: Initial and Continuing Education for Signatory Official, IRB Chair, IRB Members, IRB Staff, Investigators, and Reseach Staff Institutional Monitoring Program

23 Accreditation of IRBs and Institutional Protection Systems PwC

24 IRB Accreditation Institute of Medicine (IOM) Study Performance Standards Independent Accrediting Organizations

25 IRB Accreditation Flexibility Responsibility Accountability Doing It Right Together

26 Continued Research Depends Upon Continued Public Trust PwC