KIE Scholar examines researchers’ obligations to provide ancillary care

Senior Research Scholar Henry Richardson has published a new co-authored paper in the New England Journal of Medicine. The paper, titled When Ancillary Care Clashes with Study Aims, examines whether medical researchers have a moral obligation to provide ancillary care in cases where doing so interferes with the study’s aims.

Authors Richardson, Nir Eyal, Jeffrey Campbell, and Jessica Haberer examine the role ancillary care plays in a specific study in Uganda and South Africa of different populations of individuals taking antiretroviral medication for HIV. To gather data about these different populations’ adherence to treatments, the participants were given electronic pill boxes that provided the research team with real-time information about treatment adherence. This put the researchers in the position of having reason to intervene with participants who were adhering poorly to the treatment regimen. ┬áThat would count as ancillary care; but it would also directly interfere with the phenomenon being studied.

In this particular case, the authors argue that the ancillary-care obligation does not prevail, stating that study participants’ claims to ancillary care are overridden by the importance of gathering information about these groups’ adherence rates – the aim of the study in question. In the actual case, however, the researchers opted to intervene with the poorly adhering pregnant participants, but not on account of the ancillary-care obligation.

An excerpt from the article:

We propose that when provision of otherwise obligatory ancillary care clashes with a study end point, researchers should first determine whether there is a compromise solution that would meet both the study’s scientific aims and ancillary care obligations. Advance planning and budgeting may make that prospect more feasible. When that’s impossible, researchers and oversight bodies should reexamine the study aims in light of the human costs and risks posed by not providing ancillary care. Where study aims matter greatly it may be permissible to prioritize study completion over ancillary care provision, as determined by an oversight body tasked with protecting participants’ rights. Whether prioritizing the study is permissible in a given case may depend on additional factors, including the interests of third parties.

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