Overview of Ethical Underpinnings of Human Research Protections and Federal Regulations

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Overview of Ethical Underpinnings of Human
Research Protections and Federal
Regulations

• Ivor Pritchard, Ph.D.
• Institute of Education Sciences
• U.S. Department of Education
• Ivor.Pritchard_at_ed.gov

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Ethical Underpinnings The Belmont Report
National Commission (1979)

• Research/Practice
• The Principle of Respect for Persons
• The Principle of Beneficence
• The Principle of Justice

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Professional Codes of Ethics

• American Psychological Association (1953)
• American Sociological Association (1971)
• American Anthropological Association (1971)
• American Educational Research Association (1992)

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Three Ethical Injunctions

• Show Respect
• Do Good
• Be Fair

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Show Respect

• Principle Respect for Persons
• Subjects as Autonomous Beings
• Protection of Subjects with Limited Autonomy

• Applications
• Informed Consent as Informed, Competent, and
  Voluntary
• Subjects Assent and Third Party Consent

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Do Good

• Principle Beneficence
• Do No Harm
• Maximize Benefits and Minimize Possible Harms

• Applications
• Favorable Risk/Benefit Assessment
• Systematic Analysis and Minimization of
  Acceptable Risks of Harm

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Be Fair

• Principle Justice
• Distribute Burdens and Benefits Equitably
• Dont Exploit Vulnerable Populations

• Applications
• Select Individuals and Classes of Subjects
  Equitably
• Link Burdens to Benefits

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Do the Right Thing

• Show Respect Do Good
• Be Fair

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Some Federal Regulations and Laws

• Subpart A The Federal Policy for the Protection
  of Human Subjects (aka The Common Rule)
• Subpart D Additional Protections for Children
  Involved as Subjects in Research
• The Family Education Rights and Privacy Act
• The Protection of Pupil Rights Amendment

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Common Rule Protections

• An Assurance - The research institutions
  policies and procedures
• Institutional Review Board (IRB) Review - A
  disinterested review of proposed and continuing
  research
• Informed Consent - The research subjects prior
  and continuing voluntary, competent and
  knowledgeable agreement to participate

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The Scope of the Protections
Institutional Assurance
IRB Review
Informed Consent
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What Is the Assurance?

• A statement of principles of ethical conduct
  followed by the institutions researchers
• The identification of the IRB(s) and a list of
  IRB members
• The IRBs written policies and procedures for
  review and related activities
• Reporting procedures for problems, noncompliance,
  and approval suspensions

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What Is an IRB?

• Composition
• Operations
• Review Criteria
• Expedited Review
• Record-Keeping Requirements

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IRB Composition

• At least 5 members
• Scientific and Nonscientific Members
• At least 1 Non-affiliated Member
• Collective Expertise
• Sensitivity to Community Standards
• Diversity of Perspectives
• Knowledge of Vulnerable Subjects

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IRB Operations

• Initial and Continuing Reviews
• Education
• Oversight - Consent Process and Research
• Notification of IRB Actions
• Ensuring reports of changes, problems, or
  noncompliance
• Suspension or termination of research

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IRB Criteria for Review

• Risks are minimized
• Risks are reasonable
• Subjects are chosen equitably
• Informed Consent will be sought (or waiver is
  justified)
• Informed Consent will be documented

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Additional IRB Review Criteria

• Where appropriate, subject safety data will be
  monitored
• Where appropriate, subjects privacy and data
  confidentiality protections are in place
• Additional safeguards are in place for subjects
  vulnerable to undue influence

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Elements of Informed Consent

• The Research Project
• Foreseeable Risks/Discomforts
• Foreseeable Benefits
• Alternative Treatments
• Confidentiality Provisions
• Injury Compensation Provisions

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Elements of Informed Consent (cont.)

• Contact information for questions or injury
  reports
• Statement that participation in the research is
  voluntary, and that refusal to participate or
  withdrawal carries no penalty or loss of benefit
• 6 additional elements, as appropriate

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Waiving Consent

• Consent or Elements of Consent may be waived if -
• there is minimal risk
• subjects rights and welfare are preserved
• the research is not otherwise practicable
• pertinent information will be provided to
  subjects after participation, if appropriate

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Investigator Responsibilities

• Design sound, ethical research
• Obtain prior IRB approval
• Obtain and document informed consent (or meet
  waiver conditions)
• Implement approved research in conformity to
  federal regulations and IRB requirements

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Investigator Responsibilities

• Carry out ongoing requirements, including
• Changes to avoid immediate hazards
• Prior approval for other modifications
• Progress Reports and Continuing Review Requests
• Reports of unanticipated problems
• Records for 3 years after completion

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Information Sites

• U.S. Dept. of Education/Grants and Policy
  Oversight Staff http//www.ed.gov/offices/ocfo/hu
  mansub.html
• U.S. Dept. of Education/Family Policy Compliance
  Office http//www.ed.gov/offices/OM/fpco/
• U.S. Dept. of Health and Human Services/Office of
  Human Research Protections http//ohrp.osophs.dhh
  s.gov/