The Ancillary-Care Obligations of Medical Researchers Working in Developing Countries

Brownsword, Roger; Cermak, Allegra; Chaisson, Richard E.; Clayman, Michael D.; Corr, Peter B.; DeCherney, Stephen; Grady, Christine; Higgs, Elizabeth; Kumar, Nandini; Lie, Reidar K.; Merritt, Maria W.; Molyneux, Malcolm E.; Petros, Beyene; Richardson, Henry S.; Sugarman, Jeremy

doi:10.1371/journal.pmed.0050090

Cited by 55 publications

(36 citation statements)

References 14 publications

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“…International guidance on the subject is vague. Some documents prioritize the role of researcher as physician (World Medical Association 2008), but many critics agree this charge is unrealistically expansive (Participants in 2006 Georgetown University Workshop 2008). Other guidance documents do not include any provisions for ancillary care, or are vague in their recommendations.…”

Section: Can the Ancillary Care Framework Be Expanded To Encompass Anmentioning

confidence: 99%

“…For example, the Council for International Organizations of Medical Sciences calls ancillary care “morally praiseworthy” but does not recognize it as a general obligation of researchers (CIOMS and WHO 2002, commentary on Guideline 21). There is an identified need for clearer advice and regulation on this issue (Participants in 2006 Georgetown University Workshop 2008). …”

Section: Can the Ancillary Care Framework Be Expanded To Encompass Anmentioning

confidence: 99%

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Do Researchers Have an Obligation to Actively Look for Genetic Incidental Findings?

Gliwa

Berkman

2013

The American Journal of Bioethics

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The rapid growth of next-generation genetic sequencing has prompted debate about the responsibilities of researchers toward genetic incidental findings. Assuming there is a duty to disclose significant incidental findings, might there be an obligation for researchers to actively look for these findings? We present an ethical framework for analyzing whether there is a positive duty to look for genetic incidental findings. Using the ancillary care framework as a guide, we identify three main criteria that must be present to give rise to an obligation to look: high benefit to participants, lack of alternative access for participants, and reasonable burden on researchers. Our analysis indicates that there is no obligation to look for incidental findings today, but during the ongoing translation of genomic analysis from research to clinical care, this obligation may arise.

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Section: Can the Ancillary Care Framework Be Expanded To Encompass Anmentioning

confidence: 99%

Section: Can the Ancillary Care Framework Be Expanded To Encompass Anmentioning

confidence: 99%

Do Researchers Have an Obligation to Actively Look for Genetic Incidental Findings?

Gliwa

Berkman

2013

The American Journal of Bioethics

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“…Recommendations were selected for inclusion in the questionnaire if they were relevant to the complex, unresolved and topical care and prevention issues being debated in ethics discourse [15,19,27,50]. …”

Section: Methodsmentioning

confidence: 99%

Stakeholder views of ethical guidance regarding prevention and care in HIV vaccine trials

et al. 2014

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BackgroundSouth Africa is a major hub of HIV prevention trials, with plans for a licensure trial to start in 2015. The appropriate standards of care and of prevention in HIV vaccine trials are complex and debated issues and ethical guidelines offer some direction. However, there has been limited empirical exploration of South African stakeholders’ perspectives on ethical guidance related to prevention and care in HIV vaccine trials.MethodsSite staff, Community Advisory Board members and Research Ethics Committee members involved with current HIV vaccine trials in South Africa were invited to participate in an exploration of their views. A questionnaire listed 10 care and 10 prevention recommendations drawn from two widely available sets of ethical guidelines for biomedical HIV prevention trials. Respondents (n = 98) rated each recommendation on five dimensions: “Familiarity with”, “Ease of Understanding”, “Ease of Implementing”, “Perceived Protection”, and “Agreement with” each ethical recommendation. The ratings were used to describe stakeholder perspectives on dimensions for each recommendation. Dimension ratings were averaged across the five dimensions and used as an indication of overall merit for each recommendation. Differences were explored across dimensions, between care-oriented and prevention-oriented recommendations, and between stakeholder groups.ResultsBoth care and prevention recommendations were rated highly overall, with median ratings well above the scale midpoint. In general, informed consent recommendations were most positively rated. Care-related recommendations were rated significantly more positively than prevention-related recommendations, with the five lowest-rated recommendations being prevention-related. The most problematic dimension across all recommendations was “Ease of Implementing,” and the least problematic was “Agreement with,” suggesting the most pressing stakeholder concerns are practical rather than theoretical; that is, respondents agree with but see barriers to the attainment of these recommendations.ConclusionsWe propose that prevention recommendations be prioritized for refinement, especially those assigned bottom-ranking scores for “Ease of Implementing”, and/ or “Ease of Understanding” in order to assist vaccine stakeholders to better comprehend and implement these recommendations. Further qualitative research could also assist to better understand nuances in stakeholder reservations about implementing such recommendations.

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“…Overburdened investigators could, for instance, partner with local health systems to alert providers without responding to non-adherence directly. 34 In addition, the development and promotion of low-intensity adherence interventions (e.g., home visits or text messages when non-adherence is detected [35][36][37] ) as part of EAM-based research studies could address the challenges associated with frequent intervention without imposing onerous demands on investigators or clinicians.…”

Section: Ancillary Care Obligationsmentioning

confidence: 99%

Ethical Questions in Medical Electronic Adherence Monitoring

et al. 2015

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Electronic adherence monitors (EAMs) record and report an array of health behaviors, ranging from taking daily medications to wearing medical devices. EAMs are utilized in research worldwide and are being investigated for clinical use. However, there is also growing popular concern about the extent to which electronic devices may be used to monitor individuals, including allegations in the media that EAMs represent a move towards BBig Brother^in medicine. Here, we highlight the unique benefits as well as the potential ethical challenges that electronic adherence monitoring generates. These challenges surround autonomy, privacy and confidentiality, trust, and ancillary care obligations. We describe key questions within each of these domains that warrant further investigation, and present potential solutions to many of the concerns raised.

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The Ancillary-Care Obligations of Medical Researchers Working in Developing Countries

Abstract: The authors provide an ethical framework for considering researchers' obligations to human research participants in low-income countries.

Cited by 55 publications

References 14 publications

Do Researchers Have an Obligation to Actively Look for Genetic Incidental Findings?

Do Researchers Have an Obligation to Actively Look for Genetic Incidental Findings?

Stakeholder views of ethical guidance regarding prevention and care in HIV vaccine trials

Ethical Questions in Medical Electronic Adherence Monitoring

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