Elyse I. Summers, J.D. President and CEO

Transcription

1 IRB HRPP: The Time Is Now 2014 HSR CommUnity Conference September 11, 2014 Miami, FL Elyse I. Summers, J.D. President and CEO Copyright 2013 AAHRPP All rights reserved.

2 Outline History Context IRB/EC HRPP One model for addressing cross-cutting HRPP issues (AAHRPP) 2

3 Ethical Principles Nuremberg Code Declaration of Helsinki The Belmont Report 3

4 Nuremburg Doctors Trial Voluntary consent Risks outweigh benefits Right to withdraw

5 Declaration of Helsinki Concern for the interests of the subject must always prevail over the interests of science and society.

6 U.S. Pre-Belmont (1966) Beecher article detailing ethical problems in human research PHS Policy: prior institutional review to -- protect the rights and welfare of the subjects -- assure appropriate methods of informed consent -- determine acceptable balance of risks and benefits Beginnings of the Institutional Review Board (IRB)

7 Tuskegee Syphilis Study Congressional action Belmont Report

8 The Belmont Report Basic Ethical Principles: Respect for Persons Beneficence Justice

9 U.S. Federal Regulation and Policy HHS regulations: Title 45 CFR part 46 Subpart A basic HHS Policy IRB & informed consent requirements The Common Rule - Federal Policy Other Federal Departments & Agencies have adopted Departments of Agriculture, Energy, Commerce, HUD, Justice, Defense, Education, Veterans Affairs, Transportation, HHS & Homeland Security; NSF, NASA, EPA, AID, CIA, and the Consumer Product Safety Commission 9

10 U.S. Food and Drug Administration Regulations: IRB- 21 CFR 56 Informed Consent- 21 CFR 50 10

11 IRB HRPP: Questions: Is an HRPP a fancy name for an IRB? Do regulations address overarching HRPP issues? 11

12 IRB HRPP: Answer: Well, kind of: US regulations at 45 CFR part ; no direct analog in FDA regulations But, regulations mostly IRB/EC-centric 12

13 IRB HRPP Put more bluntly, can IRB-focused regulations, as they are, standing alone, get the job done? 13

14 Problems U.S. Halts Human Research at Duke By Rick Weiss Washington Post Staff Writer Wednesday, May 12, 1999; Page A1 The U.S. government has temporarily shut down federally funded research on humans at Duke University Medical Center, one of the nation's largest and most prestigious medical research facilities, after federal investigators determined that the university could not ensure the safety of participants. UIC Suspended From Doing Most Human Research Some Test Subjects Not Fully Informed August 28, 1999 By Jeremy Manier, Tribune Staff Writer. The federal government on Friday suspended virtually all research on humans at the University of Illinois at Chicago, marking the second time in a year that regulators have imposed severe sanctions on a local medical institution. 14

15 Tragedies Jessie Gelsinger Ellen Roche 15

16 Turn of the Century, Community Takes Action 16

17 In parallel, enter the IOM (2001)

18 The 2001 IOM Report Report supported accreditation as one promising approach to improve research protections and help restore public trust. 18

19 In parallel, enter the IOM (2002)

20 The 2002 IOM Report New way of thinking emerged: Responsible Research: A Systems Approach to Protecting Research Participants, Washington DC, Oct An HRPP should be viewed as a system of interdependent elements that involve the research organization, the IRB, the investigators, the sponsors and the volunteer participants 20

21 The 2002 IOM Report, cont d. Responsibility resides at the highest level of an organization Accountability at each level, including quality assurance and quality improvement measures Adequate resources Ethics education programs for research personnel, oversight committees and staff Recommendations included a broader program that would include financial conflicts of interest, obligations of sponsors regarding injury, dissemination of results, data and safety monitoring 21

22 The 2002 IOM Report, cont d. Transparency internal and external: -- open and defined communication among those involved in participant protection should be established and maintained -- communication and interaction with the local community, research participants, investigators, and other stakeholders 22

23 The 2002 IOM Report, cont d. Refocus the mission of the IRB on the thorough ethical review and oversight of research protocols IRB /EC to focus on the protection of research participants and regulatory criteria for approval of research 23

24 So, then, is an HRPP a Fancy Name for No an IRB/EC? It s an infrastructure that goes beyond protocol review It highlights all of the activities that contribute to research participant safety and research integrity It s a communication system that works together to fill the gaps that put participants at risk It s a nimble and responsive systems approach that can adapt to changes and realities on the ground It s a real paradigm shift in approach 24

25 Human Research Protection Program (HRPP) Investigators and Research Staff Education Programs Conflict of Interest Compliance Oversight Organizational Plan Pharmacy Services Participant Outreach IRB/EC Contracts and Grants 25

26 The time is now: Data Example I Sharing data: NIH policy--required where funding is $500K or more.

27 The time is now: Data Example II Big data:

28 The time is now: Data Example III Returning data:

29 One model for addressing cross-cutting HRPP issues: AAHRPP accreditation

30 The focus of AAHRPP accreditation Organization } IRB or EC Researchers and Research staff Human Research Protection Program Protecting research participants is a shared responsibility

31 Human Research Protection Program Investigators and Research Staff Education Programs Conflict of Interest Compliance Oversight Organizational Plan Pharmacy Services Participant Outreach IRB or EC Contracts and Grants

32 AAHRPP Accreditation standards AAHRPP process is outcomes-based many possible avenues to achieve shared goal: Protection of the health and welfare of research volunteers, whose participation makes the whole enterprise possible

33 Add Burden? No Benefits? Yes Self-assessment and peer review Raises participant protection to an organizational priority More visible role of IRB/EC Better efficiency and streamlining Improved communication Operational transparency Increases ability to act nimbly and responsively to ever-changing research landscape 33

34 The next five to ten years Collaborations emerge and increase Between industry and academia; NGOs Between US research organizations and international universities and hospitals Increased use of reliance agreements between IRBs in the U.S. and beyond (CTSAs, regional groups, local hospitals) Increased use of central IRBs (e.g., NCI Central IRB, NeuroNext) Increased use of independent IRBs for multi-centered trials 34

35 The next five to ten years, continued Research enterprise will continue to grow in scope and complexity, nationally and internationally accountability will be essential push toward collaboration Development of comprehensive HRPP will allow organization to meet the challenges that are coming and already upon us

36 Contact AAHRPP Elyse I. Summers, JD President and CEO Sandra Jackson, MBA Chief Financial Officer Sarah Giannakopoulos, MA Director of Operations Sarah Kiskaddon, JD Director of Global Business Development and Public Affairs