IRBs: Contributors and Resolvers of Problems

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IRBs Contributors and Resolvers of Problems

• Presented by
• Bernard A Schwetz, D.V.M., Ph.D.
• Director
• Office for Human Research Protections
• 3rd Annual NPTEC IRB Conference
• Rapid City, SD
• July 11, 2005

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Topics

• Regulatory Update
• Secretarys Advisory Committee on Human Research
  Protections (SACHRP)
• Current Issues

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Regulatory Update

• Department of Homeland Security
• IOM committee research involving prisoners
• Workshops alternatives to local IRBs
• AE reporting
• Regulatory actions
• Equivalent protections
• FDA central IRB draft guidance
• IRB registration

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SACHRP

• Subcommittees
• Subpart C
• Research Involving Children
• Subpart A
• Other topics
• Role of Institutional Officials
• Training of research investigators
• AE reporting
• Alternatives to local IRBs (central IRB)

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Other Current Issues

• Vulnerabilities of the enterprise
• Burdens on the enterprise
• Public trust
• Can we prevent the next tragedy?

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Burdens on the Enterprise

• Burdens created by regulations
• Burdens of non-regulatory origin
• Doing whats right
• Over-interpretation of regulations
• Treating guidances as regulations
• Fear of litigation
• Gaps in the regulations/guidance's

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Risks Created By Gaps In The Regulations/Guidances

• Protection of the decisionally impaired
• Protection of non-english speaking subjects
• Institutional and professional conflicts of
  interest
• Inadequate consent process, no measure of
  understanding
• Requirement for training

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Dilemma

• IRBs and investigators want
• Guidance, and
• Flexibility
• Hard to have both

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Lack of Trust

• Minority populations
• Non-minorities

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Lack Of Trust Depends On The Community, The
Population

• Minorities
• Distrust of researchers
• Distrust of government
• Lack of helpful information
• Theyve been victimized abused
• High background of medical problems
• Not enough help from the government

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Lack Of Trust Depends On The Community, The
Population

• Non minorities
• Indifference
• Fear of harm
• Inconvenience, expense, time
• Lack of helpful information

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• Trust Depends On Credibility!

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Things Have Undermined Our Credibility

• Tragedies may have been preventable
• Heavy media attention
• Conflicts of interest
• Abuses of the past
• Unethical behaviors
• Intentional confusion treatment
  
• research

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How Do We Build Trust?How Do We Enhance Our
Credibility?

• Be honest with ourselves the public
• Comply with ethical legal standards
• Transparent timely processes
• Stronger emphasis on ethics
• Sensitivity to public interests and needs
• Cultural differences
• Local conditions
• Provide useful information to the public others
• Conferences on public trust
• Outreach to the public

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Can We Prevent the Next Tragedy?

• Learn from our mistakes!
• Accident Precursor Analysis and Management
  National Academy of Engineering, 2004

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Impact of the Next Tragedy?

• Erosion of public trust
• Disincentive for young investigators
• Congressional responses
• Mandatory accreditation, certification,
  education?
• Pay cost of harm to subjects?
• More strict regulations conflicts of interest,
  etc.?
• Registration of studies and trials?
• All research covered by Federal Regs

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Closing Thoughts

• The enterprise is vulnerable
• Must have ownership of burdens
• Human subject protection is highest priority
• Public trust is essential

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How to Contact OHRP?

• Address
• Office for Human Research Protections
• 1101 Wootton Parkway, Suite 200
• Rockville, Maryland 20852
• Phone
• Office [phone] Toll-Free within the
  U.S. [phone]
• Fax [phone]
• Email
• ohrp_at_osophs.dhhs.gov
• Website
• http//www.hhs.gov/ohrp/