Towards New Foundations in Research Ethics

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Towards New Foundations in Research Ethics

• Ross Upshur
• BA(Hons),MA,MD,MSc, CCFP, FRCPC
• Director, Joint Centre for Bioethics
• University of Toronto
• Canada Research Chair in Primary Care Research

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Outline

• Historical Background
• Problems of Calibration
• Problems of Trust
• Problems of Integrity
• Emerging Issues
• Moving Forward

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Historical context

• World War 2 Medical War Crimes
• The Tuskegee Syphilis Study
• The Jewish Chronic Disease Hospital Study
• The Willowbrook Study
• The San Antonio Contraceptive Study
• For More see http//www.ahrp.org/history/chronolo
  gy.php

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Evolution of Codes

• Nuremberg Code
• Declaration of Helsinki
• CIOMS
• Belmont Report
• National Guidelines

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Fundamental principles

• The moral imperative of respect for human dignity
  translates into other correlative ethical
  principles
• Respect for free and informed consent
• Respect for vulnerable persons
• Respect for privacy and confidentiality
• Respect for justice and inclusiveness
• Balancing harms and benefits

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Emanuels 7 Requirements
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Ethics review
Research requiring review REBs are responsible
for ethics review of research involving humans as
subjects of research Research Ethics Boards
(REBs) The REB has the authority to approve,
disapprove, propose modifications to, or
terminate any proposed or ongoing research
involving human subjects Review process REBs
adopt a proportionate approach to ethics review,
based on the principle that the more potentially
invasive or harmful the research, the more care
should be taken in its review. FOCUS IS ON
HUMAN SUBJECT PROTECTION

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Canadian guidelines

Tri-Council Policy Statement
Living document, reflecting evolving field of
scholarship

• HOWEVER
• It mandates minimum and universal standards

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Ethics Review

• Problems of Calibration

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Problems of Trust

• External Influences on Science

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Problems of Integrity
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Scientists behaving badlyBrian C. Martinson,
Melissa S. Anderson and Raymond de VriesNature
435, 737-738 (9 June 2005)
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Emerging Issues

• 1.) Embracing Determinants of Health
• 2.) Globalization of Research
• 3.) Ethics of Information Databases and
  Genomics

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Overarching Recommendations

• Improve living conditions
• Tackle the inequitable distribution of power
  money and resources
• Measure and understand the problem and assess the
  impact of action

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Margaret Chan WHO Director General

• The values and principles embodied in primary
  health, the United Nations Millennium
  Declaration, and initiatives such as PLoS
  Neglected Tropical Diseases are all about
  fairness, solidarity, collective responsibility,
  participatory approaches, and a duty to take care
  of vulnerable groups. Equity is a fundamental
  principle of health development. Access to
  life-saving and health-promoting interventions
  should not be denied for unjust reasons,
  including an inability to pay.

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Public Health as Social Justice

• Gostin and Powers Our account of justice
  stresses the fair disbursement of common
  advantages and the sharing of common burdens. It
  captures the twin moral impulses that animate
  public health to advance human well-being by
  improving health and to do so by focusing on the
  needs of the most disadvantaged.

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Globalization
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Informational Ethics
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Moving Forward
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Fost and Levine

• Inflexible requirements for adherence to narrow
  interpretations of every word in regulations and
  other policies have led to a system that is more
  concerned with protection of the institution than
  protection of human research participants.
• The cost of the system is increasing without
  evidence of a return on investment with regard to
  protection of patients and other research
  participants.
• The burdens of IRB review discourage young
  investigators. Senior faculty commonly avoid
  serving on IRBs because the work is perceived as
  primarily bureaucratic and focused on unimportant
  minutiae IRB members feel constrained in their
  efforts to exercise independent judgment.
• Reactive Hyperprotectionism

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Responding and Moving Forward

• Generalized dissatisfaction with current
  situation
• Easy to point fingers and rant
• Most criticisms of process have failed to provide
  constructive avenues for improvement
• Ways forward may be in QA and research traditions

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Innovations

• New Scholarship Focus on public health and
  social determinants and their role in research
  ethics review
• Information Ethics
• Proactive models of engagement between researcher
  and research ethics review
• Upstream solutions

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Research in Research Ethics

• Empirical and conceptual approaches
• Interdisciplinary environment
• Opportunities to innovate with intervention
  approaches

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Combined Approach

• Local RE2
• National Tricouncil Revision, Canadian Network
  for the Governance of Ethical Health Research
  Involving Humans.
• Global Training and Capacity Building (Fogarty
  International Grant, GCGH ESC Program)

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Research and Education in Research Ethics (RE2)

• Started in 2006 at University of Toronto
• Started with monthly meetings and 8
• Now meets bimonthly with over 30 members
• Open to all interested in scholarly dimensions of
  research
• Foster education and research in research ethics

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Conclusion

• Current situation is unsustainable
• New challenges require new thinking
• No point in blaming under-resourced, under-
  supported, under-appreciated REBs
• Researchers cannot be unaccountable
• Many of the key issues in research integrity
  would not be caught by REBs
• Much to be gained by a focus on legitimating the
  scholarly dimensions of research ethics