![Sample our Health and Social Care journals, sign in here to start your FREE access for 14 days]({"type":"image" , "src" : "/sda/5938/TOC-Subject-Sample-2021-Health-Social-Care.jpg"})
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.
Acknowledgments
The authors gratefully acknowledge intellectual and financial support from the Donaghue Initiative in Biomedical and Behavioral Research Ethics of the Yale Interdisciplinary Center for Bioethics. Research funding for Alison Norris was also generously provided by Yale's Center for Interdisciplinary Research on AIDS, the Fulbright Fellowship for Doctoral Research Abroad, the Yale Center for International and Area Studies, and the Ellertson Social Science Fellowship in Reproductive Health. We are grateful to the workers, residents, and administrative staff at TSE for their engagement with our work, to Dr. Sabina Mtweve for guidance and support, and for their dedication and insights to members of the research team: Elizabeth Urio, Michael Ndonde, Edina Ngowi, Max Mushi, Ngaya Harison, William Maro, Matilda Mrawa, Mary Shirima, Ndealilia Swai, and Julie Ulomi. We especially recognize the valuable contributions of Amani Kitali and Abu Mfundo in the gathering of field data.
Notes
TSE is a pseudonym.
“Opt out” HIV testing is a way of delivering voluntary HIV counseling and testing as part of routine health care. At TSE, initiation of “opt out” testing meant that women attending the TSE clinic for prenatal care would be told that HIV counseling and testing is provided routinely, and that if they do not wish to be tested, they can “opt out” and will not be tested. “Opt out” differs from an “opt in” paradigm, in which testing is offered and the patient is required to actively give permission before it can occur. “Opt out” has become standard of care in many settings because people can more easily agree to HIV counseling and testing when it presented as a part of regular care, rather than a special service to accept.