1 Questions on Ethical Responsibilities in STD Research in Resource-Limited Settings Personal Perspectives Salaam Semaan 1, DrPH and Kate MacQueen 2, PhD 1 Centers for Disease Control and Prevention, Atlanta, GA 2 Family Health International, Durham, NC Symposium Presentation National STD Prevention Conference Philadelphia, PA March 10, 2004

2 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

3 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

4 T hree 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

5 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

6 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

7 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

8 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?

9 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?

10 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?

11 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?

12 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?

13 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

14 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 don’t 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?

15 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