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International Research Ethics

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Stimulate further ethical review of your own projects. Definition. Ethics: ways of ... equipoise. Anti. beneficence. autonomy. nonmaleficence. exploitation ... – PowerPoint PPT presentation

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Title: International Research Ethics


1
International Research Ethics
  • Jenell Coleman, M.D.
  • Clinical Fellow, Reproductive Infectious
    Diseases, UCSF
  • M.P.H. Candidate 2005, UCB
  • March 1, 2005

2
My Experience
  • Ethical sensitivity
  • Lack of adequate training in ethics
  • International research
  • Unethical foundation
  • Goal
  • Stimulate further ethical review of your own
    projects

3
Definition
  • Ethics ways of examining the moral life
  • Normative formulation and defense of a system of
    fundamental moral principles and rules that
    determine which actions are right and which are
    wrong
  • What people ought to do
  • Non-normative factual investigation of moral
    behavior and beliefs
  • How people reason and act

Beauchamp and Childress. Principles of Biomedical
Ethics. 1989
4
General Terms
Theory
Principle
Rule
Action
5
Ethical Principles
  • Autonomy
  • Respect for persons self-governance
  • Free choice without coercion informed consent
  • Justice
  • Equal distribution of risks and benefits
  • Persons from groups unlikely to be among the
    beneficiaries of subsequent application should
    not be involved in research
  • Beneficence
  • Minimize risks and maximize benefits
  • Nonmaleficence
  • Do no harm

6
Ethical Theories
  • Utilitarian
  • Greatest good for the greatest number
  • Some people may have to carry the burden which
    will ultimately benefit society
  • Social benefits of research for future pts.
  • Deontological
  • Human rights based
  • Individual rights

7
Informed Consent
  • Disclosure of information
  • Understanding of this information
  • Voluntariness
  • Competence
  • Consent

8
Incompetence
  • Inability to evidence a choice or preference
  • Inability to understand ones situation
  • Inability to understand disclosed information
  • Inability to give a reason
  • Inability to give a rational reason
  • Inability to give risk/benefit-related reasons
  • Inability to reach a reasonable decision

Appelbaum and Roth. Archives of General
Psychiatry. 1982 Roth and Meisel. Emory Law
Journal. 1982
9
Vulnerable populations
  • People infected with HIV
  • Women
  • Children
  • People with drug addictions
  • Poor individuals
  • Elderly
  • Prisoners
  • Military recruits

10
Exploitation
  • Subjects participating in the research project
    are burdened with the risks of the project, yet
    are not recipients of the benefits
  • May even be doing harm
  • Violation of nonmaleficence principle

11
Ethical Guidelines
  • Post WWII
  • Nuremburg Code
  • Declaration of Helsinki
  • Belmont Report

12
Declaration of Helsinki
  • World Medical Association 1962
  • In any medical study, every patient-including
    those of the control group-should be assured the
    best proven diagnostic and therapeutic method

13
DHHS Ethical Guidelines
  • It is permissible to observe the standards of
    the host country, if it was determined that they
    afford protections that are at least equivalent
    to those provided in this policy

14
International Ethical Guidelines 1993
  • ...the ethical standards applied should be no
    less exacting than they would be for research in
    the sponsoring country itself

15
Placebo Trials
  • 1994 ACTG 076 Results
  • 800-1000
  • 1994 WHO Recommendations
  • 1995 15 RCTs and 1 equivalency trial
  • 1997 Public Citizen letter to DHHS
  • 1998 CDC funded trial results

16
Placebo Arguments
  • Pro
  • beneficence
  • standard of care
  • scientific rigor
  • equipoise
  • Anti
  • beneficence
  • autonomy
  • nonmaleficence
  • exploitation
  • violation of international ethical guidelines

17
-isms
Imperialism
Colonialism
Cultural Relativism
18
Colonialism
  • The state of developing countries is the
    byproduct of colonialism
  • Reason why substandard care is provided
  • Reason for the widespread poverty
  • Reason for the dependence on 1st world countries
    for financial assistance

19
Cultural Relativism
  • Cannot apply our ethical standards and
    definitions to a different culture
  • What are the ethical beliefs of the community?

20
Western Imperialism
  • These are Ugandan studies, conducted by Ugandan
    investigators, on Ugandans, for the good of their
    people
  • The extension or imposition of power, authority,
    or influence
  • Sweden RCT
  • South African viewpoint
  • Ethical Review Boards

21
Placebo Arguments
  • Pro
  • beneficence
  • standard of care
  • scientific rigor
  • equipoise
  • Anti
  • beneficence
  • autonomy
  • nonmaleficence
  • exploitation
  • violation of international ethical guidelines

22
Discussion
  • How do you define standard of care?
  • Are placebo controlled trials in low income
    countries unethical?
  • Are developing countries exploited?
  • What do researchers owe the subjects, if anything?

23
Responsibility of researchers
RESEARCH FINDINGS
POLICY
  • Disconnect between research and policy
  • Passive role of many researchers
  • Lack of support for subjects after study ends

24
Human Rights
  • Clarify the true purpose of the research
  • Must matter to the subjects
  • Evaluate likely effectiveness
  • Honest, rigorous investigation into the potential
    effectiveness in that population
  • Determine whether the research is well targeted
  • Disproportionately impacting certain groups in
    society?

25
Human Rights
  • Examine the research for possible human rights
    burdens
  • Balancing of potential benefits to the health of
    the community with the human rights repercussions
  • Determine whether the research is the least
    intrusive that can achieve the objective
  • If a coercive measure is truly necessary to avert
    a significant risk, guarantee fair procedures to
    persons affected

Gostin and Mann
26
In sum,
  • Researchers
  • aim to strengthen the community
  • know the purpose of the research
  • formulate a plan to implement study results

27
Declaration of HelsinkiRevision 2002
  • ...a placebo-controlled trial may be ethically
    acceptable, even if proven therapy is available,
    under the following circumstances
  •   - Where for compelling and scientifically sound
    methodological reasons its use is necessary to
    determine the efficacy or safety of a
    prophylactic, diagnostic or therapeutic method
    or
  •   - Where a prophylactic, diagnostic or
    therapeutic method is being investigated for a
    minor condition and the patients who receive
    placebo will not be subject to any additional
    risk of serious or irreversible harm.

28
  • The health of my patient will be my first
    consideration.

-Declaration of Geneva of the World Medical
Association
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