Ethical Dilemmas and Standards Ethical Dilemmas and Standards in - PowerPoint PPT Presentation

Ethical Dilemmas and Standards Ethical Dilemmas and Standards in Research with Drug Users in Research with Drug Users Center for Center for Interdisciplinary Interdisciplinary Research on Research on AIDS AIDS cira.med.yale.edu cira.med.yale.edu Kaveh Khoshnood & Kevin Irwin Yale School of Public Health UCONN – UCONN – CHIP CHIP Yale University Yale University School of School of March 31, 2005 March 31, 2005 Medicine Medicine Acknowledgment: NIDA, NIMH, Donaghue Foundation and CIRA

Take Home Message (1) Center for Center for Interdisciplinary Interdisciplinary Current ethical principles do not: Research on Research on AIDS AIDS cira.med.yale.edu cira.med.yale.edu A) adequately identify ethical dilemmas arising in field-based research with out-of-treatment drug users Yale University Yale University B) nor do they offer pragmatic School of School of Medicine Medicine guidance on resolving these dilemmas

Take Home Message (2) 1. There is a need for the Center for Center for Interdisciplinary Interdisciplinary development of specific ethical Research on Research on AIDS AIDS guidelines for field-based cira.med.yale.edu cira.med.yale.edu research involving active drug users in international settings. 2. We must provide incentives and venues for researchers to document not only their research Yale University Yale University School of School of outcomes but also their research Medicine Medicine experiences, particularly regarding ethical issues.

Why/How Did we Get Interested in this Issue? Center for Center for Interdisciplinary Interdisciplinary Research on Research on AIDS AIDS • Confronted thorny ethical dilemmas in cira.med.yale.edu cira.med.yale.edu conducting field based HIV prevention research in US • As we expanded our research to international settings, new ethical issues emerged Yale University Yale University School of School of Medicine Medicine

What Did We Do? Center for Center for Interdisciplinary Interdisciplinary Research on Research on 1) Document our own research experiences AIDS AIDS cira.med.yale.edu cira.med.yale.edu Ethical dilemmas created by the criminalization of status behaviors: Case studies from ethnographic field research with injection drug users. Health Behavior and Education. 2002; 29: 30-42. 2) Applied for funds to investigate this issue Yale University Yale University further School of School of Medicine Medicine a) Domestic Research Study (Donaghue) b) International Research Study (CIRA)

“Generic” Ethical Dilemmas in Drug Use Research Center for Center for Interdisciplinary Interdisciplinary Research on Research on • Illegal nature of drug use and related AIDS AIDS activities can result in a variety of cira.med.yale.edu cira.med.yale.edu risks to subjects and staff • Stigma attached to illicit drug use • Drug Use is a highly personal and emotionally charged behavior Yale University Yale University School of School of Medicine Medicine • Vulnerability of drug users creates potential for their exploitation in research

Selected Ethical Dilemmas: Study Participants Center for Center for Interdisciplinary Interdisciplinary Research on Research on AIDS AIDS • Risk of arrest and incarceration cira.med.yale.edu cira.med.yale.edu • Achieving Informed Consent and “voluntary participation” under desperate circumstances • Rise of unrealistic expectations from the researchers Yale University Yale University School of School of Medicine Medicine • Unforseeable Challenges resulting from field-based research

Selected Ethical Dilemmas: Study Staff (1) Center for Center for Interdisciplinary Interdisciplinary Research on Research on AIDS AIDS • Risk of physical harm or arrest cira.med.yale.edu cira.med.yale.edu • Stigma of working with “Junkies” • Assisting participants in procuring or using drugs • Risk of relapse for former IDUs • Blurring of personal/professional Yale University Yale University School of School of Medicine Medicine boundaries

Selected Ethical Dilemmas: Study Staff (2) Center for Center for Interdisciplinary Interdisciplinary Research on Research on AIDS AIDS • Observing a significant risk behavior cira.med.yale.edu cira.med.yale.edu by study participant (unprotected sex, sharing syringes, etc) • Learning of study participant’s intention to hurt someone Yale University Yale University • Damage to social relationships and School of School of Medicine Medicine social standing of staff in the community due to unanticipated problems in the study

Center for Center for Should We Pay Drug Interdisciplinary Interdisciplinary Research on Research on AIDS AIDS Users for Participation in cira.med.yale.edu cira.med.yale.edu Research? Yale University Yale University School of School of Medicine Medicine

Center for Center for Interdisciplinary Interdisciplinary Research on Research on Does paying drug users AIDS AIDS cira.med.yale.edu cira.med.yale.edu undermine informed consent? Yale University Yale University School of School of Medicine Medicine

Informed Consent: Coercion or undue influence Center for Center for Interdisciplinary Interdisciplinary Research on Research on AIDS AIDS “An investigator shall seek consent only cira.med.yale.edu cira.med.yale.edu under circumstances that provide the prospective subject or representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence” (emphasis added) Yale University Yale University US Common Rule for Protection of Human School of School of Medicine Medicine Subjects (1991)

Does Payment to drug users for Center for Center for participation in research Interdisciplinary Interdisciplinary Research on Research on AIDS AIDS constitute “coercion” or “undue cira.med.yale.edu cira.med.yale.edu influence”? Is money special? Yale University Yale University School of School of Medicine Medicine

Additional Ethical Challenges in Drug Use Research in International Settings Center for Center for Interdisciplinary Interdisciplinary Research on Research on • No or little tradition of research with AIDS AIDS drug users. cira.med.yale.edu cira.med.yale.edu • No or inexperienced IRBs. • No or limited medical (including drug treatment) and social service resources. • Extremely punitive law enforcement against drug use. Yale University Yale University School of School of Medicine Medicine • Competing agendas of funders, researchers, participants, local IRBs and partners.

Center for Center for Interdisciplinary Interdisciplinary Research on Research on AIDS AIDS Is there any help out cira.med.yale.edu cira.med.yale.edu there for researchers to resolve these ethical dilemmas?! Yale University Yale University School of School of Medicine Medicine

Overarching Guiding Principles for Ethical Conduct of Research Center for Center for Interdisciplinary Interdisciplinary Research on Research on AIDS AIDS 1. Respect for persons cira.med.yale.edu cira.med.yale.edu (ensuring voluntary & informed consent) 2. Beneficence/non-maleficence (do good, minimize harm) Yale University Yale University 3. {Distributive} Justice School of School of Medicine Medicine (fair distribution of benefits & risks)

Ethical Guidelines Ethical Guidelines versus versus Research Experience Research Experience Center for Center for Interdisciplinary Interdisciplinary Research on Research on AIDS AIDS cira.med.yale.edu cira.med.yale.edu Ethical guidelines provide principles that can guide human subject research, But, • What about research experiences? What actually happened and how were ethical dilemmas resolved? Yale University Yale University School of School of Medicine Medicine • How do we know what worked and what didn’t work?

Don’t Ask, Don’t Tell ! Center for Center for • Drug Researchers often confront and Interdisciplinary Interdisciplinary Research on Research on deal with thorny ethical issues; AIDS AIDS however these experiences are rarely cira.med.yale.edu cira.med.yale.edu reported or made accessible to other colleagues. • There are perceived disincentives for researchers to openly discuss these experiences that could make them vulnerable to reprisals from funders, Yale University Yale University School of School of regulatory agencies or those who find Medicine Medicine such research objectionable on moral, ideological and political grounds.

Expanding the Ethical Discourse (1) Center for Center for Interdisciplinary Interdisciplinary Research on Research on AIDS AIDS • What were the researchers’ experiences cira.med.yale.edu cira.med.yale.edu with local NGOs, police, government officials, IRBs and general community? • How was the adequacy of informed consent ensured? Yale University Yale University School of School of • How was the material inducement Medicine Medicine (incentive) for participation in research determined and negotiated?