Exploring the Ethics of Observational Research: The Case of an HIV Study in Tanzania

Abstract

Background Observational studies have generally been viewed as incurring minimal risk to participants, resulting in fewer ethical obligations for investigators than intervention studies. In 2004, the lead author (AN) carried out an observational study measuring sexual behavior and the prevalence of HIV, syphilis, and herpes simplex virus type 2 (HSV-2), among Tanzanian agricultural plantation residents (results reported elsewhere). This article uses an ethical lens to consider the consequences of the observational study and explore what, if any, effects it had on participants and their community. Methods Using a case study approach, we critically examine three core principles of research ethics—respect for persons/autonomy; beneficence/nonmaleficence; and distributive justice—as manifested in the 2004 observational study. We base our findings on three sources: discussions with plantation residents following presentations of observational research findings; in-depth interviews with key informants; and researcher observations. Results The observational research team was found to have ensured confidentiality and noncoercive recruitment. Ironically, maintenance of confidentiality and voluntary participation led some participants to doubt study results. Receiving HIV test results was important for participants and contributed to changing community norms about HIV testing. Conclusions Observational studies may act like de facto intervention studies and thus incur obligations similar to those of intervention studies. We found that ensuring respect for persons may have compromised the principles of beneficence and distributive justice. While in theory these three ethical principles have equal moral force, in practice, researchers may have to prioritize one over the others. Careful community engagement is necessary to promote well-considered ethical decisions.

Confidentiality, Privacy, and Respect: Experiences of Female Sex Workers Participating in HIV Research in Andhra Pradesh, India

“…The current paper builds on an expanding number of studies examining ethical challenges in the design and conduct of HIV prevention studies, particularly among highly stigmatized populations (Fisher et al, 2008; Fisher, 2010, Fisher & Wallace, 2000; Norris, Jackson, & Khoshnood, 2012; Simon, Mosavel, & van Stade, 2007). Overall, Participant responses illuminated aspects of the consent process, staff gender and demeanor, study environment, survey content, and administrative organization and monitoring that were key factors influencing whether FSW perceived their confidentiality and privacy had been maintained, and whether they felt the study was conducted respectfully.…”

Some ethical aspects of medical education research

“…These basic principles, at first limited to drug research, have been slowly and progressively applied to other fields of research. 2 However, there are still discussions about the ethical management in medical education, 3 understood as any research involving mostly students.…”

Algunos aspectos éticos de la investigación en educación médica

“…Estos principios básicos, en el inicio, limitados a la investigación farmacológica, lentamente, han ido aplicándose a otras vertientes de la investigación. 2 Sin embargo, todavía se discute el manejo ético de la investigación en educación médica, 3 que se entiende como aquella que involucra, sobre todo, a alumnos.…”