Informed Consent in Emergency Research

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Informed Consent in Emergency Research

• Judith Brooks, M.S.
• Health Policy Analyst
• Education Division
• Office of Human Research Protections

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Boundary Between Practice and Research

• The distinction between research and practice is
  blurred partly because both often occur
  togetherand partly because notable departures
  from standard practice are often called
  experimental. Belmont Report, 1979

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Practice vs. Research

• Practice interventions that are designed
  solely to enhance the well-being of an
  individual patient or client that have a
  reasonable expectation of success.
• Research an activity designed to test a
  hypothesis, permit conclusions to be drawn, and
  thereby develop or contribute to generalizable
  knowledge. Research is usually described in a
  formal protocol that sets forth an objective and
  a set of procedures designed to reach that
  objective.
• Belmont Report, 1979

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Practice vs. Research

• Conflicts result from
• Different ethical standards
• Different responsibilities for physician/researche
  rs

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Conflicting Roles

• Physician
• Decisions based solely on best interest of
  patient
• Risks offset by anticipated benefits to patient
• Researcher
• Decisions based on scientific needs
• Benefits may not be to individual but to science
  and society, less risk may be justified

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The Belmont Report

• Ethical Principles and Guidelines for the
  Protection of Human Subjects of Research
• The National Commission for the Protection of
  Human Subjects of Biomedical and Behavioral
  Research
• April 18, 1979

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The Belmont Report
Three 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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Emergency Research Waiver

• 1996 Secretary, HHS, announced a waiver under 45
  CFR 46, for obtaining and documenting informed
  consent
• Subjects medical condition
• No legally effective informed consent can be
  obtained

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OHRP Policy and Revised Policy

• 1991,Emergency Medical Care
• VS
• 1996, Informed Consent Requirements in Emergency
  Research

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Applicability

• Subjects under 45 CFR 46, Subpart A
• Subjects under 45 CFR 46, Subpart D
• NEW!
• Subjects under 45 CFR 46, Subpart B
• (revised December 13, 2001)

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Research not subject to FDA Regulation 21 CFR 50

• IRB review, approval and continuing review is
  required.
• Certain conditions are found, documented, and
  reported to OHRP are met.

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Conditions

• Emergency Research
• Informed consent is not feasible
• Direct benefit
• Not practicable
• Therapeutic window
• Informed consent
• Additional Protection
• -Community Consultation

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Additional IRB Responsibilities

• Notification that research has occurred to
• Subject
• Legally authorized representative
• Family member
• The option to discontinue participation

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Family Member

• Spouses
• Parents
• Children
• Siblings
• Spouses of brothers and sisters
• Any one related by blood or affinity
• State Law

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OHRP Electronic Access

• E-mail ohrp_at_osophs.dhhs.gov
• Web Site http//ohrp.osophs.dhhs.gov

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