TRAINING FOR RESEARCHERS: HOW TO CONDUCT RESEARCH IN AIAN COMMUNITIES

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TRAINING FOR RESEARCHERS HOW TO CONDUCT
RESEARCH IN AI/AN COMMUNITIES

• Community Definitions of Research
• Elyse I. Summers, J.D.
• Division of Education Development
• Office for Human Research Protections
• June 16, 2005

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Presentation Objectives

• OHRP Brief Overview
• Ethical Principles
• Applicability of the Department of Health and
  Human Services (HHS) regulations for the
  protection of human subjects
• The regulatory definition of research
• Relationship between human subjects research and
  other activities
• Community role in human subjects protection

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Organizational Chart
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OHRP Responsibilities

• Policy and assurances
• Education/quality improvement
• Compliance
• International research

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Beecher Article

• Ethics and clinical research Henry K.
  Beecher New Engl J Med 274 (1966)1354-60
• 22 published medical studies presenting risk to
  subjects without their knowledge or approval
• Published in some of the most prestigious
  journals and conducted at some of the most
  prestigious institutions

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Public Health Service Policy

• NIH Director and Surgeon General requested that
  the National Advisory Health Council review human
  subject protections
• Council recommended prior institutional review
  for PHS supported research to
• Protect of the rights and welfare of the subjects
• Assure appropriate methods of informed consent
• Determine acceptable balance of risks and
  benefits
• Adopted as Public Health Service policy in 1966
• Beginnings of the Institutional Review Board (IRB)

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Tuskegee Syphilis Study

• American medical research project conducted by
  the U.S. Public Health Service from 1932 to
  1972, examined the natural course of untreated
  syphilis in black American men. The subjects,
  all impoverished sharecroppers from Macon
  county, Alabama, were unknowing participants in
  the study they were not told that they had
  syphilis, nor were they offered effective
  treatment.

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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 HEW
  support for human subjects research

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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
• Beneficence
• Justice

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The Belmont Report - Boundary Between Practice
and Research (1)

• The distinction between research and practice
  X activity is blurred partly because both often
  occur together.

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The Belmont Report - Boundary Between Practice
and Research (2)

• The term practice refers to interventions
  that are designed solely to enhance the
  well-being of an individualand have a reasonable
  expectation of success.

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The Belmont Report - Boundary Between Practice
and Research (3)

• By contrast, the term research designates an
  activity designed to test a hypothesis, permit
  conclusions to be drawn, and thereby develop or
  contribute to generalizable knowledge.

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The Belmont Report - Boundary Between Practice
and Research (4)

• Research is usually described in a formal
  protocol that sets forth an objective and a set
  of procedures designed to reach that objective.

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The Belmont Report - Boundary Between Practice
and Research (5)

• Research and practice X activity may be
  carried on together when research is designed to
  evaluate the safety and efficacy of a therapy.
  This need not cause confusion regarding whether
  or not the activity requires review the general
  rule is that if there is any element of research
  in an activity, that activity should undergo
  IRB review for the protection of human
  subjects.

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HHS Regulations

• Title 45
• Code of Federal Regulations
• Part 46
• Protection of Human Subjects
• (Last revised November 13, 2001)

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Applicability of the HHS Regulations

• Research 45 CFR 46.102(d)?
• Human subjects 45 CFR 46.102(f)?
• Exempt 45 CFR 46.101(b)?

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Definition of Research

• A systematic investigation, including research
  development, testing and evaluation, designed to
  develop or contribute to generalizable knowledge.
  
• 45 CFR 46.102(d)

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Human Subject

• A living individual about whom an investigator
  conducting 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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Exempt Research
Research that is exempt includes

• Normal educational practices in established
  educational settings
• Educational tests, surveys, interviews, or
  observation of public behavior unless identified
  and sensitive
• Research using existing data, if publicly
  available or recorded without identifiers

• Research on elected or appointed public officials
  or candidates for public office
• Evaluation of public benefit service programs
• Taste and food quality evaluation and consumer
  acceptance studies

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Applicability of the HHS Regulations

• Research involving human subjects conducted or
  supported by HHS that is not otherwise exempt
• Non-exempt human subjects research conducted at
  an institution holding an applicable Assurance of
  Compliance

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Points to Consider

• Generally, interactions or interventions with one
  individual for the purpose of providing benefit
  to the individual is NOT research

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Points to Consider

• 2. Interactions or interventions with two or more
  individuals for the purpose of developing or
  contributing to generalizable knowledge is
  research

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Points to Consider

• 3. Human Subject research can overlap with other
  activities.
• 4. Some of the joint activities are exempt.
• 5. Those that are not exempt must comply with the
  requirements of 45 CFR 46 when applicable.

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Points to Consider

• 6. Regulations are the floor and not the
  ceiling
• 7. Institutions can develop policies and
  procedures to ensure that activities adhere to
  ethical principles and protect all human subjects

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COMPOSITION OF IRB (45 CFR 46.107)

• VARYING BACKGROUNDS
• SUFFICIENTLY QUALIFIED
• EXPERIENCE AND EXPERTISE
• RACE, SEX (BOTH MUST BE INCLUDED), AND CULTURAL
  DIVERSITY OF MEMBERS
• MUST BE ABLE TO ASCERTAIN THE ACCEPTABILITY OF
  PROPOSED RESEARCH IN TERMS OF INSTITUTIONAL
  COMMITMENTS AND REGULATIONS, APPLICABLE LAW, AND
  STANDARDS OF PROFESSIONAL CONDUCT AND PRACTICE
• -- LOCAL CONTEXT See, http//www.hhs.gov/ohrp/h
  umansubjects/guidance/local.htm

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COMPOSITION OF IRB (45 CFR 46.107), CONTD

• PROFESSIONAL DIVERSITY
• AT LEAST ONE SCIENTIFIC MEMBER
• AT LEAST ONE NON-SCIENTIFIC MEMBER
• AT LEAST ONE NON-AFFILIATED MEMBER

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COMPOSITION OF IRB (45 CFR 46.107), CONTD

• MAY INCLUDE NON-VOTING EXPERTS, PRN
• MAY NOT INCLUDE ANYONE WITH A CONFLICT
• PERSON WITH CONFLICT MAY PROVIDE REQUESTED
  INFORMATION

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IRB RESPONSIBILITIES IN A NUTSHELL

• Review and approve, require modifications, or
  disapprove all covered research
• Require that informed consent is in accordance
  with regulations
• Require documentation of informed consent or may
  waive documentation in accordance with
  regulations
• Notify investigators in writing of decisions
• Conduct continuing review of research no less
  than once per year

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IRB REVIEW OF RESEARCH (45 CFR 46.109(b))

• IRB MUST REQUIRE SUBJECT TO RECEIVE CONSENT
  INFORMATION IN ACCORDANCE WITH INFORMED CONSENT
  REGULATIONS (45 CFR 46.116)
• IRB MAY REQUIRE ADDITIONAL INFORMATION BE
  PROVIDED TO SUBJECT

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IRB REVIEW OF RESEARCH (45 CFR 46.109(c)),
CONTD

• IRB MUST ADDRESS DOCUMENTATION OF INFORMED
  CONSENT IN ACCORDANCE WITH REGULATIONS (45 CFR
  46.117)

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IRB REVIEW OF RESEARCH, CONTD--CONTINUING REVIEW
(45 CFR 46.109(e))

• Appropriate to the degree of risk and not less
  than once per year
• Should be set for each protocol, not a routine
  annual review
• No grace period but may use original anniversary
  date
• Must be substantive and meaningful

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CRITERIA FOR IRB APPROVAL OF RESEARCH (45 CFR
46.111)

• IRB MUST DETERMINE THAT
• RISKS MINIMIZED
• RISKS REASONABLE IN RELATION TO BENEFITS
• SELECTION OF SUBJECTS EQUITABLEIRB SHOULD TAKE
  INTO ACCOUNT THE PURPOSES AND SETTING OF
  RESEARCH BE COGNIZANT OF SPECIAL PROBLEMS OF
  RESEARCH POPULATION

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IRB APPROVAL OF RESEARCH (45 CFR 46.111), CONTD

• IRB MUST DETERMINE THAT
• INFORMED CONSENT WILL BE SOUGHT IN ACCORDANCE
  WITH 45 CFR 46.116
• INFORMED CONSENT WILL BE DOCUMENTED IN ACCORDANCE
  WITH 45 CFR 46.117

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IRB APPROVAL OF RESEARCH (45 CFR 46.111), CONTD

• WHEN APPROPRIATE, IRB MUST DETERMINE THAT
• THERE ARE ADEQUATE PROVISIONS TO PROTECT PRIVACY
  OF SUBJECTS AND CONFIDENTIALITY OF DATA

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IRB APPROVAL OF RESEARCH (45 CFR 46.111), CONTD

• IRB MUST DETERMINE THAT
• WHEN SOME OR ALL OF THE SUBJECTS ARE LIKELY TO BE
  VULNERABLE TO COERCION OR UNDUE INFLUENCE,
  ADDITIONAL SAFEGUARDS ARE IN PLACE

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OHRP Electronic Access

• Web Site http//www.hhs.gov/ohrp
• IRB Registration Assurance Filing
• Quality Improvement Program
• Policy Guidance
• Compliance Oversight
• Educational Materials/Workshops
• SACHRP
• Listserv
• Email ohrp_at_osophs.dhhs.gov

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Office for Human Research Protections (OHRP)

• Elyse I. Summers, J.D.
• Education Coordinator
• Division of Education and Development
• Phone [phone]Fax (240)
  453-6909E-mail esummers_at_osophs.dhhs.gov
• ohrp_at_osophs.dhhs.gov
• Web Site www.hhs.gov/ohrp