IRB and IACUC Research Subjects

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IRB and IACUCResearch Subjects Protection
Programs June 22, 2006 Carol Siegel, MLS,
CIPJeffery Perkey, CIP
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www.research.umn.edu/subjects/
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The Nuremberg Code (1947)

• As part of the verdict, the Court enumerated some
  rules for "Permissible Medical Experiments", now
  known as the Nuremberg Code. These rules
  include
• voluntary consent
• benefits outweigh risks
• ability of the subject to terminate participation

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National Research Act

• 1973 Kennedy Hearings Quality of Health Care -
  Human Experimentation
• 1974 National Research Act
• Established the National Commission for the
  Protection of Human Subjects of Biomedical and
  Behavioral Research
• Required IRBs at institutions receiving federal
  support for human subjects research

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The Belmont Report

• Basic Ethical Principles
• Respect for Persons
• Individual autonomy
• Protection of individuals with reduced autonomy
• Beneficence
• Maximize benefits and minimize harms
• Justice
• Equitable distribution of research costs and
  benefits

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Federal Regulations and Policy

• Office of Human Research Protection OHRP
• 45 CFR 46 DHHS Policy for Protection of Human
  Research Subjects- Subpart A
• Originally adopted January 13, 1981
• Revised June 18, 1991
• The Common Rule Federal Policy for Protection
  of Human Subjects, June 18, 1991 adopted by 17
  federal agencies

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Who is on the IRB?

• UMN Faculty (all campuses)
• UMN Staff
• UMN Students
• Fairview System Employees
• Community Representatives
• (non-affiliated members)

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Definition of Research

• A systematic investigation designed to develop or
  contribute to generalizable knowledge.
• 45 CFR 46.102(d)

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Definition of Human Subject

• A living individual about whom an
  investigatorconducting research obtains
• 1) data through intervention or interaction with
  the individual, or
• 2) identifiable private information
• 45 CFR 46.102(f)

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Review Continuum
Level of potential risk determines route of
review

• Exempt Expedited Full

Low Risk
High
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Exemptions45 CFR 46.101(b)

• Meets federal criteria for low-risk research
• Fits one of six categories of research (revised
  in 1991)
• Involves a non-vulnerable population
• Does not involve sensitive topics
• Typically of short duration
• Does not include identifiers (no permanent record
  of individual)

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Eligible for Expedited Review(Initial Review)

• Clinical studies IND/IDE NOT required
• Blood sample collection (routine methods small
  amounts)
• Prospective collection of biological
  samplesnoninvasive means
• Data collected though noninvasive means
  (routinely practiced in clinical settings)

• Materials (data, documents, specimens etc.) have
  been collected or will be collected for
  non-research purposes
• Collection of voice, video or digital data for
  research purposes
• Individual or group behavior, surveys,
  interviews, oral histories

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Research reviewed at a convened IRB meeting

• A full quorum is assembled
• All members review the application
• All members participate in discussion and make
  comments (plenary review)
• Decision is rendered by a majority of the
  assembled quorum.
• No member with a conflict of interest
  participated in the decision

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Continuing Review

• An IRB shall conduct continuing review of
  research covered by this policy at intervals
  appropriate to the degree of risk, but not less
  than once per year, and shall have authority to
  observe or have a third party observe the consent
  process and the research.
• 21 CFR 56.109
• 45 CFR 46.109

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Informed Consent

• What it is
• ongoing process of communication and mutual
  understanding
• What it isnt
• a piece of paper
• a moment in time
• a contract

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Essential Elements for Consent Document

• invitation to participate
• purpose, duration, procedures
• foreseeable risks/benefits
• alternatives, if any
• confidentiality conditions
• compensation for injury
• contact persons for questions
• voluntary nature of participation
• provide copy

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Current Animal Use

• Research
• Life Sciences
• Agriculture
• Education
• Medical School
• Veterinary Medicine
• Agriculture
• Behavioral Sciences
• Display
• Raptor Center
• Bell Museum

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History of Animal Welfare Concerns

• 1940s Animal Care Panel convened in Chicago to
  discuss issues
• 1960s Animal Facilities establish review
  committees
• 1963 Guide for Lab Animal Welfare
• 1966 Lab Animal Welfare Act (AWA)
• 1970 USDA federal enforcement agency for AWA
• 1979 First PHS Policy

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National and Local Authority

• Public Health Service Policy on Humane Care and
  Use of Laboratory Animals
• Animal Welfare Act (1966)
• Guide to Care and Use of Laboratory Animals
  (National Research Council)
• University of Minnesota Regents Policy

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External Oversight

• Office for Lab Animal Welfare (OLAW) NIH
• United States Department of Agriculture (USDA)
• AAALAC (intl organization)
• Public represented on IACUC

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3 Rs

• Replacement
• seek alternatives that involve as little pain
  and distress as possible
• Reduction
• the project should obtain the most information
  possible from the fewest number of animals
• Refinement
• Once the basic study design is formulated,
  investigators should refine the protocols used,
  making every effort to minimize any potential
  pain or distress and provide appropriate means of
  management

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Human Subjects Protection is a Shared
Responsibility
Investigator
IRB
Institution
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