Medical researchers' ancillary clinical care responsibilities

doi:10.1136/bmj.328.7454.1494

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Leah Belsky, fellow (LBelskylbelsky@mail.cc.nih.gov)1,
Henry S Richardson, visiting scholar1

¹ Department of Clinical Bioethics, National Institutes of Health, 10 Center Drive, Bethesda, MD 20898, USA

Correspondence to:

Accepted 24 March 2004

Investigation of participants in clinical trials may identify conditions unrelated to the study. Researchers need guidance on whether they have a duty to treat such conditions

Introduction

Researchers testing a new treatment for tuberculosis in a developing country discover some patients have HIV infection. Do they have a responsibility to provide antiretroviral drugs? In general, when do researchers have a responsibility to provide clinical care to participants that is not stipulated in the trial's protocol? This question arises regularly, especially in developing countries, yet (with rare exceptions1) existing literature and guidelines on research ethics do not consider ancillary clinical care. We propose an ethical framework that will help delineate researchers' responsibilities.

What is ancillary care?

Ancillary care is that which is not required to make a study scientifically valid, to ensure a trial's safety, or to redress research injuries. Thus, stabilising patients to enrol them in a research protocol, monitoring drug interactions, or treating adverse reactions to experimental drugs are not ancillary care. By contrast, following up on diagnoses found by protocol tests or treating ailments that are unrelated to the study's aims would be ancillary care.

Two extreme views

When asked how much ancillary care they should provide to participants, the first reaction of many clinical researchers, especially those working in developing countries, is that they must provide whatever ancillary care their participants need. From an ethical perspective, this response makes sense. Research participants in trials in the developing world are typically desperately poor and ill, and everyone arguably has a duty to rescue those in need, at least when they can do so at minimal cost to themselves.2 3 Yet this response fails to acknowledge that the goal of research is to generate knowledge not care for patients.4 5 When researchers consider that offering ancillary care this broadly may drain limited human and …