Regional Ethics Organizations to Protect Human Research Participants

1
Regional Ethics Organizations to Protect Human
Research Participants
Anne C. Wood, MA Ezekiel Emanuel, MD,
PhD Christine Grady, PhD Warren G. Magnuson
Clinical Center National Institutes of Health
2
Disclaimer

• Does NOT represent the views of
• the National Institutes of Health,
• the Public Health Service, or
• the Department of Health
• and Human Services

3
Prevailing View

• increasing volume and research complexity and
  cost are the primary threats to the systems
  effectiveness.
• Ellen Holt 2002

4
3 Types of Problems

• Structural Problems
• IRB Operations Problems
• Performance and Outcomes Assessment Problems

5
Structural Problems

• Not all research covered by federal regulations
• Fundamental inconsistencies in current
  regulations
• No mechanism for addressing major ethical issues
  in research
• Repetitive review

6
Structural Problems

• Inherent institutional conflicts of interest
• Inadequate education of IRB members, IRB staff,
  and investigators
• Inadequate resources and support for IRBs

7
IRB Operations Problems

• Review process is time-consuming
• IRBs may lack expertise in science of protocols
  under review
• Poor guidance on IRB operations
• Excessive focus on informed consent documents
• Inefficient and ineffective adverse event
  reporting system

8
Performance and Outcomes Assessment Problems

• No systematic data collection on outcomes or
  performance of the oversight system
• No systematic data collection specifically on IRB
  effectiveness
• No systemic data collection on clinical research

9
Proposed Reforms

• Accreditation of Human Research Participant
  Protection Programs
• Credentialing of IRB Professionals
• Legislative Proposals
• OHRP Initiatives
• Central IRBs
• IOM Report on Oversight System

10
An Alternative Reform Proposal

• Extend federal oversight regulations to all
  research
• Create Regional Ethics Organizations (REOs) in
  the place of local, institution-based review

11
Regional Ethics Organizations (REOs)

• Based geographically
• Number between 10-20 in the U.S
• Conduct all reviewing, monitoring, training, and
  ethical policy formulation

12
Regional Ethics Organizations
Regional Ethics Organization
Protocol Review Committees
Ethics Policy Committee
Liaisons
Ombudspersons
13
Protocol Review Committees (PRCs)

• A large number of PRCs per REO
• Conduct prospective reviews of each research
  study in the region
• Could be based on scientific area of research
• At least 25 lay members
• Meet weekly

14
Protocol Review Committees (PRCs)

• Each research study submitted to only one REO
• Submitted to REO in the region of the principal
  investigator
• Approval by one REO is sufficient for all
  participating sites, including sites outside that
  geographic region

15
Appeals Process

• If an REO rejects a protocol, the investigator
  can appeal the decision
• The federal oversight body would select an
  alternate REO to review the protocol

16
Performance Data

• Quarterly, each REO would report the number of
  people
• Approached to enroll in each study
• Enrolled in each study
• Removed from studies and why
• Who withdrew from studies
• Who had grade III and IV toxicities
• Who had serious adverse events
• Who died and why

17
Ethics Policy Committees

• Create a forum to examine major ethical issues in
  research
• Engage the public in thoughtful discussion of
  these issues
• Develop coherent and consistent policies on these
  issues

18
Institutional Liaisons

• Several liaisons per REO
• Coordinate submission of protocols
• Coordinate educational programs
• Provide feedback to the REO
• Provide knowledge of local research context

19
Ombudspersons

• Several per REO
• Would serve as an advocate for research
  participants
• Participants could contact them with concerns
  about a research study or policy

20
Education and Training in the REO System

• REOs would be responsible for education of all
  REO members and all investigators in the region

21
Oversight of the REO System

• OHRP or a similar federal body would conduct
  federal oversight of REOs
• Coordinate REOs
• Share ethical policies
• Share best practices
• Share education programs and materials
• Collect and disseminate REO performance data

22
Objections

• REOs would lack knowledge of the local research
  context
• Institutions may resist adoption of REOs because
  of concerns about liability

23
Cost of Current System An Estimate

• Costs dispersed throughout system, assigned to
  IRBs home institutions
• Between 4,000 and 6,000 IRBs
• Average expenditure of 75,000 per IRB
• Cost of current system between 300 million and
  450 million per year

24
REOs on 300 Million Per Year

• Assume a system of 20 REOs
• So each REO has access to 15 million per year
• Each REO reviews 5,000 protocols per year
• So each REO spends 3,000 per protocol

25
Where Will the 300 Million Come From?

• It will be assumed by those who utilize the
  system
• Institutions, contract research organizations,
  government, industry
• May seem like a large amount, but 300 million is
  about 2 of annual U.S. spending on clinical
  research.