Questions%20on%20Ethical%20Responsibilities%20in%20STD%20Research%20in%20Resource-Limited%20Settings%20%20Personal%20Perspectives

1
Questions on Ethical Responsibilities in STD
Research in Resource-Limited Settings Personal
Perspectives

• Salaam Semaan1, DrPH and Kate MacQueen2, PhD
• 1Centers for Disease Control and Prevention,
  Atlanta, GA
• 2Family Health International, Durham, NC
• Symposium Presentation
• National STD Prevention Conference
• Philadelphia, PA
• March 10, 2004

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Background

• STDs still a major problem globally
• Collaborative research studies
• Differences between and within countries
• Resources and infrastructure
• Ethical questions about optimal conduct of
  research studies
• Use of data
• Population benefits
• Benefits of study participants

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Purpose

• List of questions
• Rights of study participants
• Responsibilities of investigators
• Three examples of research studies
• Five areas
• Take-home message -- For a given study
• Identify relevant questions
• Provide optimal answers

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Three Examples of Research Studies

• Surveillance
• Collect behavioral data to assess risk behaviors
• Collect biologic data to describe or monitor
  burden of infection
• Use data collected to design relevant
  interventions and programs
• STD validation
• Evaluate performance of syndromic clinical
  algorithms
• Guide diagnosis and treatment of STDs
• Partner management
• Evaluate strategies for notifying partners
  possibly exposed to infection
• Refer for medical evaluation, treatment, and
  prevention
• Reduce ping-pong effect of transmission

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Ethical Questions to Consider -- Given
Study Five Areas

1. Informing participants about test results
2. Provisions for treatment
3. Implications for prevention
4. Rights and responsibilities of investigators
5. Optimal balance and resolution in a given study

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How to Frame and Answer the Questions

• Use the three ethical principles of
• Respect
• Beneficence
• Justice
• Other principles also apply
• Human rights
• Responsibilities based in governance

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Ethical Principles

• Respect for Persons
• People should choose what happens to them based
  on relevant information
• People should understand implications of their
  decisions to participate in a study
• Beneficence
• Maximize benefits
• Minimize risks
• Provide valid and generalizable results
• Justice
• Distribute risks and benefits equally among those
  who may benefit
• Vulnerable subjects are not targeted for
  convenience
• People who are likely to benefit from research
  participation are not systematically excluded

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I. Reporting of Test Results

• Ethical Principle of Respect
• Can participants accept or refuse knowledge of
  test results?
• Are results identifiable by investigator or only
  by participant confidential anonymous linked
  only by participant or completely anonymous?
• Does counseling erode individuals freedom of
  choice?
• Do decisions of people in disadvantaged
  situations get overridden on patronizing grounds?

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I. Reporting of Test Results

• Ethical Principle of Beneficence
• Is there a duty not to report the results when
  stigmatizing?
• Do we inform participants of the possibility to
  get the test done at nearby medical facilities or
  offer that possibility?
• Does reporting affect recruitment and duration of
  study and validity of results?
• Is doing something better than doing nothing,
  when doing everything is not possible?
• Does delaying doing something, until we can do
  everything, cause harm?
• Are we abiding by government policies on
  reporting of test results?
• Ethical Principle of Justice
• Is the burden on the participants to come back to
  get the test results?
• Is it practical for all participants to be
  re-contacted to inform them about the results?
• Does cost of reporting exceed available resources
  or take away from other studies or activities?
• Does doing something and not doing everything
  bolster systems of inequity?
• Do Investigators decide on options by themselves
  or in consultation with collaborating scientists
  and community representatives?

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II. Provision of Treatment

• Ethical Principle of Respect
• Would it be coercive, if, to encourage
  participation in the study, we offer treatment,
  particularly in situations of severe lack of
  access to treatment?
• Ethical Principle of Beneficence
• Does study offer treatment (or referral for
  treatment) based on STD symptoms?
• Does study offer treatment (or referral for
  treatment) based on test results for STDs?
• Do referral and treatment really happen?
• Ethical Principle of Justice
• Do investigators decide on options for treatment
  by themselves or in consultation with
  collaborating scientists and community
  representatives?
• Is it practical to offer treatment or referral
  for treatment to all participants?
• Would it be unjust, not, to offer treatment,
  especially to those who need it, when treatment
  has been developed by public money?

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III. Implications for Prevention

• Ethical Principle of Beneficence
• Should we inform spouses and partners about the
  possibility of exposure to infection and need for
  medical evaluation?
• Ethical Principle of Respect
• Who should tell spouses and sex partners?
• How to protect privacy and confidentiality of
  study participants?
• How to minimize potential for breakdown in
  relations, abuse, or increase in risky behaviors?
• Ethical Principle of Justice
• Can we expect to inform spouses and sex partners
  of all participants?

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IV. Responsibilities of Investigators

• How much do we expect a study to do?
• Does the study pose or simply highlight issues
  related to human rights and social injustices?
• Are scientists and investigators also advocates
  for human rights and social justice?
• Is there agreement between scientists and
  ethicists on what needs to be done?
• Do scientists have procedures for revising or
  defending their decisions if challenged by
  others?

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V. Optimal Balance and Resolution for a Given
Study

• Is it possible to address in a given study all
  ethical principles, regulations, and guidelines?
• Tension not only because of
• Nature of Questions
• Nature of Infections
• Social Conditions and Infrastructure
• But also because of
• Some inherent tension between the three ethical
  principles and the differences in regulations
  between countries and between professional
  guidelines

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Overall Questions

• How and why do we need to reconcile implications
  of ethical principles when their interpretations
  seem to provide conflicting solutions or call for
  different actions?
• Which ethical principle takes precedence over the
  other two principles in a given study? Why or why
  not?
• What are the factors that need to be included in
  the calculation of risks and benefits?
• Why do stigma and discrimination seem to
  accompany every disease, from the early leprosy
  days, to our days of STDs and HIV/AIDS, and to
  the days of evolving infections such as SARS?
• Why dont we have better protections against
  stigma and discrimination?
• What are the ethics-related questions that need
  to be examined in an era of economic
  globalization and world-wide health concerns?

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Conclusions

• Investigators need to
• Understand ethical principles
• Address ethical questions and obligations
• Consult with ethicists
• Ensure collaborative decisions
• Ensure transparent and ethically defensible
  decisions
• Respond to criticisms or other perspectives
• Conducting a study is both scientifically complex
  and ethically complex
• Addressing ethical questions is doable and may
  lead to reductions in health disparities and
  improvements in health status