Measuring Ethical Effectiveness of Human Research Protection Programs

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Measuring Ethical Effectiveness of Human Research
Protection Programs
Capstone Brief 7 December 2009
Sarah L Donahue, PhD Sarah.L.Donahue_at_amedd.army.mi
l MPH Program Public Health Policy and Management
Emphasis Advisor Holly Taylor, PhD
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BRIEFING OUTLINE

• Problem Statement
• Background
• Human Subjects Research Ethical Principles
• Tools for Measuring Ethical Effectiveness
• Timeline and Program Evaluation

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PROBLEM STATEMENT

• USAMRMC headquarters oversees HRPPs at
  subordinate commands
• Oversight has focused on procedural compliance as
  surrogate measures for quality
• Time to approval measurements,
• Number of protection lapses,
• Number of regulatory non-compliance events,
• Number of incorrect Institutional Review Board
  (IRB) determinations.
• PROBLEM over time priorities of HRPPs has
  shifted from ensuring the fundamental ethical
  principles are upheld to mandating
  regulatorily-compliant documentation
• current oversight model measures
  regulatory-compliance, not ethical quality.
• GOAL develop tools to evaluate ethical
  effectiveness (quality) of human subjects
  research at USAMRMC subordinate commands.

United States Army Medical Research and
Materiel Command Human research protection
program
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USAMRMC Structure
United States Army Medical Research and
Materiel Command
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BACKGROUND EVOLUTION OF HUMAN SUBJECT RESEARCH
PROTECTIONS

• Nazi Doctors Trial (1946), The Nuremberg Code
  (1947)
• Declaration of Helsinki (1964)
• Scandals and Public Awareness
• Thalodimide (1961)
• Experiments at Willowbrook State School Jewish
  Chronic Disease Hospital (1960s)
• Milgram Study (1963)
• Beecher Article (1966)
• Tuskegee Syphilis Study (1932-1972)
• Belmont Report (1979)
• Federal regulations, known as the Common Rule
  (1991)

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Ethical Principles of Human Subjects Research

• Respect for Persons - protect autonomy of
  subjects to freely decide whether or not to take
  part in research,
• Beneficence - maximize benefits from research
  projects while minimizing risks,
• Justice - ensure risks and benefits to research
  participants are fairly distributed.

Risks to Subject
Benefit to Subject Benefit to society
National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research.
The Belmont Report Ethical Principles and
Guidelines for the Protection of Human Subjects
of Research. Washington, D.C. U.S. Government
Printing Office (1979). DHEW Publication No. (OS)
78-0008.
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Tools to Measure Ethical Effectiveness

• Checklists and Interview Questions
• Protocol Ethics Checklist
• Consent Observation Checklist
• IRB Meeting Observation Checklist
• IRB Minutes Review Checklist
• Subject Interview Questionnaire
• Investigator Interview Questionnaire
• Checklists yes/no questions
• Interview Questions open-ended

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Respect for Persons

• Information
• Was the subject given a copy of the consent form
  to read/review prior to signing?
• Was the subject told that participation was
  voluntary, that he/she could decide not to
  participate, or withdraw at any time without
  penalty?
• Comprehension
• Is there a test of understanding before
  prospective subjects sign the consent form?
• Was the subjects understanding assessed?
• Was the subject given time and opportunity to ask
  questions?
• Voluntariness
• Was undue influence used during the consent
  process?
• Was the subject given sufficient opportunity to
  consider whether or not to participate?
• Protection of Subjects with Diminished Autonomy
• Was there a consideration of whether the subject
  could provide informed consent?
• Were the wishes of the subject respected?

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Beneficence

• Assessment of Risks/Benefits
• All risks to subjects from the research are
  identified (including physical, psychological,
  legal, social, economic, and other)?
• Any benefits to subjects or others are
  identified?
• The risks to subjects are acceptable given the
  prospect of benefits?
• Risks are Minimized
• The proposed project is designed so that risks
  are reduced to those necessary to achieve the
  research objective?
• There are appropriate procedures/protections in
  place to minimize the risks?
• The provisions for safety monitoring for the
  study are appropriate?
• The provisions for protecting subject privacy and
  confidentiality for the study are appropriate?

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Justice

• Fairness in the selection of individual subjects
• Is the selection of subjects free from favoritism
  or bias?
• Does the design of the study support the
  objective(s) of the study?
• Is the study designed so that it will provide
  valid results?
• Is the population targeted in the study necessary
  to answer the study objectives(s)?
• Social justice (protecting classes of subjects
  who may lack personal, economic, or social power
  from unfair distribution of research burdens)
• Are the selection criteria for subjects adequate
  and complete given the nature and setting of the
  study?
• Payments/in-kind benefits are appropriate for the
  study and are not overstated?
• Recruitment procedures and information provided
  to potential subjects (advertisements, consent
  form) do not unduly influence potential subjects?

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Proposed Oversight Model

• Quarterly Activities
• Protocol Ethics Checklist - evaluate
  determinations made at the subordinate commands
  for a subset of protocols
• IRB Minutes Review Checklist - review minutes
  from at least one meeting of each of the
  subordinate commands to ensure ethical standards
  are correctly applied and protocols are reviewed
  in accordance with applicable regulations, laws
  and policies
• Metrics Reports track number the type of
  protocols reviewed and implemented
• Annual Activities
• Consent Observation Checklist observe at least
  one consent procedure on-site
• Subject Interview Questionnaire interview at
  least one subject on-site
• IRB Meeting Observation Checklist observe at
  least one IRB meeting on-site
• Investigator Interview Questionnaire interview
  at least one investigator on-site
• Conduct audits of at least 10 of records from
  active protocols to ensure regulatory compliance

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Timeline and Program Evaluation

• Projected Timeline to Implementation
• Program Evaluation
• Collect quarterly and annual effectiveness
  assessments
• Quantitative assessment (checklists)
• Qualitative assessments (interviews)
• Compare individual HRPPs and between all 6 HRPPs
• Report results and recommend changes to USAMRMC
  based on outcomes

Develop Tools (checklists/ Interviews)
First Program Evaluation
Revise Tools Based on Test
Alpha Test Tools
Beta Test Tools
Implement Tools
Dec09
Feb09
Apr09
July09
Oct09
Oct10
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Thank You!Questions?