Ancillary Care

Ancillary Care Topics Page
Raafay H. Syed and Maria W. Merritt

What is ancillary care?

Ancillary care (AC) is defined as health care that research participants need “but that is required neither to successfully answer the researchers’ scientific question nor to avoid or mitigate harm resulting from participation in the research.”

Why does ancillary care matter?

Health researchers sometimes encounter the ethical question of the nature and extent of their responsibility to provide AC to participants in their studies. While this question may arise in principle in any research setting, it is typically more pressing in practice in the context of research conducted in low-resource settings (e.g., in a developing country where the local health system is unable to meet many health needs of its population). Furthermore, whatever the setting, even if a given researcher has acknowledged a positive AC obligation, it is often unclear what specific course of action such an obligation requires. For example, in a trial to evaluate whether children with malaria develop pulmonary hypertension, researchers might diagnose or encounter any of the following conditions that are unrelated to the trial:

• Sickle cell disease
• Respiratory infections
• Dehydration
• Congenital cardiac defects
• Rheumatic heart disease

Some of these conditions are simple and inexpensive to treat, whereas others, like congenital heart defects, are not. For which of the conditions (if any) do researchers have an obligation to provide or facilitate AC? In order to develop guidance for researchers and Research Ethics Committees (RECs) who regularly grapple with these sorts of perplexing ethical questions, and for other research actors (e.g., sponsoring institutions and funding agencies) who may bear related responsibilities, it is important to consider questions about AC through both conceptual and empirical inquiry.

Grateful acknowledgment is due to the Greenwall Foundation: the efforts of both authors were supported by an award from the Greenwall Faculty Scholars Program in Bioethics (PI Merritt). The authors thank Joseph Ali, Bridget Pratt, and Henry S. Richardson for valuable comments on earlier drafts.

Developed in association with the Johns Hopkins Berman Institute of Bioethics: Global Bioethics Engagement (GLOBE) Program, and the Johns Hopkins Bloomberg School of Public Health: Department of International Health, Health Systems Program.

Raafay H. Syed is a medical student at Stanford University.

Maria W. Merritt, PhD, is a core faculty member of the Johns Hopkins Berman Institute of Bioethics and an associate professor in the Department of International Health (Health Systems Program) at the Johns Hopkins Bloomberg School of Public Health.

Participants in the 2006 Georgetown University Workshop on the Ancillary-Care Obligations of Medical Researchers Working in Developing Countries 2008. The ancillary-care obligations of medical researchers working in developing countries. PLoS Med 5(5): e90: http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0050090

Dickert, N. & Wendler, D. 2009. Ancillary care obligations of medical researchers. Journal of the American Medical Association, 302, 424-28: http://www.ncbi.nlm.nih.gov/pubmed/19622821.

Are there any areas of broad agreement about health researchers’ ancillary-care responsibilities?

There is growing agreement that health researchers sometimes have moral obligations to provide or facilitate AC, either in virtue of general moral duties that hold among all persons, or in virtue of special duties that researchers bear specifically toward research participants, or both. For example, participants in the 2006 Georgetown University Workshop on the Ancillary-Care Obligations of Medical Researchers Working in Developing Countries generally agreed on a set of guidance points for researchers and research sponsors that they dubbed “The four P’s”: (1) the recognition of some positive obligation to provide AC to research participants; (2) the importance of planning to meet applicable AC obligations, both in general and as part of study design for each research protocol; (3) the importance of developing AC plans in partnership with the host community in which the research is to be conducted; and (4) the recommendation to undertake practical provisions in order to meet the AC obligations identified. They also agreed that the health conditions under study in the research questions and procedures of a given protocol (“target” conditions) should not be inherently privileged over conditions not directly under study (“unrelated” conditions) in deliberations about AC provision.

As a more recent example, a 2011 workshop held in the Democratic Republic of Congo (DRC) convened in-country stakeholders to address questions of AC and independently issued a statement that is broadly consistent with the aspects of the Georgetown paper summarized above.

For more information on both of the examples mentioned here, see “Guidelines and Reports” below.

Participants 2008, p. 0712, Box 2: http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0050090.

Tshikala T, Mupenda B, Dimany P, Malonga A, Ilunga V, Rennie R. 2012. Engaging with research ethics in central Francophone Africa: reflections on a workshop about ancillary care.

Philosophy, Ethics, and Humanities in Medicine 7:10: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3447659/.What are the main gaps in the current understanding of researchers’ ancillary-care responsibilities?

Institutional guidance

• Existing international guidance remains largely uninformative and, on the whole, inconsistent.

Conceptual understanding:
• There is a variety of moral reasons, some more controversial than others, that might ground obligations on the part of health researchers to provide AC. Contributors to a growing body of conceptual literature, surveyed below, have begun to offer accounts of each type of reason, but a significant gap remains with respect to understanding how such reasons figure into all-things-considered judgments about what ought to be done.
• It remains necessary to analyze differences that are morally relevant to AC responsibilities among the many varieties of health research and settings in which it is conducted.

Empirical understanding:
• Only a few empirical studies exist on the experiences and attitudes of health research participants (whether actual or potential) and the experiences, attitudes, and practices of researchers and sponsors regarding AC. Much more empirical work is needed.

For an illuminating discussion of this state of affairs, see pp. 27-29 of Richardson, Moral entanglements: the ancillary-care obligations of medical researchers (Oxford University Press 2012).
See Richardson (2012), cited above, Chapter 7.

Where can I learn more?

General Orientation

Richardson HS. 2012. Moral entanglements: the ancillary-care obligations of medical researchers. Oxford University Press.
http://www.oxfordscholarship.com/view/10.1093/acprof:oso/9780195388930.001.0001/acprof-9780195388930

• This book is a comprehensive resource for understanding the ethical issues pertaining to AC. Richardson offers an introduction to the issue of AC as well a detailed justification for his own conceptual model, which he originally developed with Leah Belsky in 2004. He also discusses other topics including the relationship of AC to justice and exploitation, as well as the concept of gradations of AC responsibility. Richardson devotes Chapter 7 (“Issues for Further Exploration”; pp. 171-201) to illuminating some important issues for further exploration, both conceptual and empirical. This chapter, in particular, is a valuable resource for readers interested in new areas of scholarly work on AC that are currently on the horizon.

Belsky L, Richardson, H.S. 2004. Medical researchers' ancillary clinical care responsibilities. BMJ 328:1494-1496: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC428526/. See also: Richardson HS, Belsky L. 2004. The ancillary-care responsibilities of medical researchers: an ethical framework for thinking about the clinical care that researchers owe their subjects. Hastings Center Report 34 (1): 25-33: http://www.ncbi.nlm.nih.gov/pubmed/15098404.

Richardson HS. 2007. Gradations of researchers' obligation to provide ancillary care for HIV/AIDS in developing countries. American Journal of Public Health 97(11):1956-1961: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2040358/.

Belsky L, Richardson, H.S. 2004. Medical researchers' ancillary clinical care responsibilities. BMJ 328:1494-1496: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC428526/.

Guidelines and Reports (listed in chronological order)

Participants in the 2006 Georgetown University Workshop on the
Ancillary-Care Obligations of Medical Researchers Working in Developing Countries
2008. The ancillary-care obligations of medical researchers working in developing
countries. PLoS Med 5(5): e90.
Full-text open access is available online:
http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0050090

• This paper summarizes points of agreement reached among bioethicists, scientists, and past or present officers of government and corporate research sponsors who participated by invitation in a 2006 Georgetown University workshop on AC. Of the 15 named authors, 11 were based in the US; the remaining 4 were based, respectively, in Ethiopia, India, Malawi, and the UK. After first characterizing the issue of AC and noting the inadequacies of existing (as of 2006) research ethics guidance pertaining to AC, the authors outline four types of argument in support of their view that researchers and research sponsors working in developing countries have some positive moral obligation to provide or facilitate AC for participants in their studies. These four types of argument are as follows: (1) due concern for the welfare of those with whom one interacts; (2) the duty of rescue, that is, the duty to provide urgently needed assistance when one is uniquely able to do so at little cost; (3) the duty to do one’s fair share in alleviating global injustice in the provision of health care; and (4) duties specific to the researcher-participant interaction or relationship (as exemplified in Belsky and Richardson’s “partial-entrustment model,” described below under “Conceptual Models”). The authors also argue, however, that AC obligations are not unlimited, and that more work is needed in order to enable researchers and sponsors to delineate their AC obligations more concretely. The authors suggest that any adequate guidance must address three questions – (1) What AC needs, if any, are likely to be encountered? (2) Can the local health system meet identified AC needs? (3) How strong is the responsibility of researchers and sponsors to address the identified AC needs? (p. 0711, Box 1) – and must contain “The Four P’s”: positive obligation, planning, partnership, and practical steps (p. 0712, Box 2). This paper, despite the limitation that its authorship is predominantly United-States-based, is important because it represents the first broadly interdisciplinary, international effort to take stock of existing ethical guidance on AC and to chart a path toward improvement. It remains a valuable resource for readers who want to learn more about the background concerns that motivate recent and ongoing conceptual, operational, and empirical work on AC.

Tshikala T, Mupenda B, Dimany P, Malonga A, Ilunga V, Rennie R. 2012. Engaging with research ethics in central Francophone Africa: reflections on a workshop
about ancillary care. Philosophy, Ethics, and Humanities in Medicine 7:10.
Full-text open access is available online: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3447659/

• This paper describes the process and outcomes of a 2011 workshop convened in Kinshasa, Democratic Republic of Congo (DR Congo) to build individual and institutional bioethics capacity in Francophone Africa. The host organizations proactively decided on AC responsibilities as the workshop’s topical theme, inspired both by their own perceptions that research participants commonly have significant AC needs in “settings with high disease burden and weak health infrastructure” (p. 2 of 7) and by the growing scholarly attention to AC (including the published report of the 2006 Georgetown workshop described above). Participants were invited from local institutions of higher learning, local health NGOs, local pediatric clinics, the DR Congo National AIDS Control Program, and research collaborations between DR Congo and the University of North Carolina. Participants undertook a critical assessment of existing conceptual models of AC responsibilities and developed their own alternative model. They also developed a “workshop message” to serve as a public statement addressed to both local and global audiences, with the final version to be presented to the National Health Ethics Committee of DR Congo and the DR Congo Ministry of Health. Of note, workshop participants were surprised at the disproportionate lack of internationally recognized research ethics guidance on AC in relation to the prevalence of AC questions that they experienced in local health research. A key attribute of their alternative model of AC responsibilities is a call for the systematic, prospective integration of “ancillary services” into local health systems, moving the discussion of AC needs explicitly from the individual level to the population level.

Conceptual Models (listed in chronological order)

Belsky L, Richardson HS. 2004. Medical researchers' ancillary clinical care responsibilities. BMJ 328: 1494-1496.
Full-text open access is available online:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC428526/

• In this paper, the authors present their partial-entrustment model of the researcher-participant relationship and show how it can be used to delineate researchers’ AC responsibilities. The partial-entrustment model is based on the idea that consent to undergo study procedures constitutes a tacit “partial and limited entrustment” (1495) of relevant specific aspects of the participant’s health to the researcher(s) in charge of the protocol. Thus, Belsky and Richardson argue, researchers can acquire special moral duties to provide AC, above and beyond any general moral duties they may also have. In order for a researcher to have a special duty to provide AC on grounds of partial entrustment, the relevant AC need must be within the “scope” of entrustment. The scope of entrustment depends on the study procedures to which the participant consents: for instance, it typically includes “caring, as needed” for a disease being monitored by the study and “following up on any clinically relevant information or diagnoses generated” by study-related tests (1495). According to the partial-entrustment model, AC needs that lie outside the scope of entrustment do not generate any special duties for the researcher. For AC needs that lie within the scope of entrustment, delineation of the researcher’s responsibility depends on factors such as the intensity and duration of study-related interactions, the degree of participants’ dependence on researchers for care, the financial and human resources available, and the requirements of scientific validity. This paper is important because it introduces the earliest normative model of researchers’ AC responsibilities, a model that remains highly influential.

Brownsword, R. 2007. The ancillary-care responsibilities of researchers: reasonable but not great expectations. Journal of Law, Medicine, and Ethics, 35 (4): 679-691.
http://www.ncbi.nlm.nih.gov/pubmed/18076518

• In this paper, Brownsword frames the issue of AC in terms of rights. After developing a theoretical account of a “community of rights,” defined as a moral community in which the substantive moral approach is based on rights (as opposed to utility or duty), Brownsword uses this framework to argue for the conclusion that researchers bear some positive rights-based ancillary-care responsibilities towards their participants, irrespective of whether the trial is in a developed or developing country. Finally, he discusses some implications of this approach for courts in a community of rights. This paper is important in that it offers a unique philosophical approach to AC. It is also highly relevant for readers who are interested in the intersection of law (contract or tort law, specifically) and research ethics in the context of AC.

Richardson HS. 2008. Incidental findings and ancillary-care obligations. Journal of Law, Medicine, and Ethics, 36 (2): 256-270.
Full-text open access is available online: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2575243/

• In this paper, Richardson discusses the relationship between AC and incidental findings: that is, findings of potential clinical relevance that arise as a by-product of research procedures such as brain imaging. Richardson argues that despite the vastly different contexts in which these two strands of bioethical inquiry arose – the problem of AC “based in poverty and deprivation” and the problem of incidental findings “a product of multi-million-dollar modern machinery”-- an understanding of the AC problem can nonetheless illuminate the problem of incidental findings. By comparing and contrasting the historical development and conceptual characterizations of AC and incidental findings, this paper offers a nuanced appreciation of the range of complex problems as well as the unresolved conceptual questions related to AC.

Dickert N, Wendler D. 2009. Ancillary care obligations of medical researchers. Journal of the American Medical Association 302 (4): 424-428.
http://www.ncbi.nlm.nih.gov/pubmed/19622821

• This paper draws on a case presentation to frame a critique of Belsky and Richardson’s conceptual model of AC responsibilities, and to offer an alternative model. Dickert and Wendler agree with Belsky and Richardson that researchers can have special duties to provide or facilitate AC in virtue of the researcher-participant relationship, but they reject the partial-entrustment model’s “scope” restriction on relevant AC needs. Dickert and Wendler argue that, given the moral importance of the researcher’s relationship with the participant as a whole person, any AC need might in principle be the object of a special duty, regardless of its relation to the study procedures that the participant has consented to undergo. This paper is a good resource for understanding how competing normative models can play out in an actual case, and for thinking about possible theoretical challenges to Belsky and Richardson’s partial-entrustment model.

Hooper CR. 2010. Ancillary care duties: the demands of justice. Journal of Medical Ethics 36: 708-711.
http://www.ncbi.nlm.nih.gov/pubmed/20675740

• Hooper argues that AC duties can be based on a principle of justice as rectification for harms that people in the developed world have caused to people in the developing world through institutional arrangements such as unjust global trade regimes and the perpetuation of unjust political administrations. Hooper states and addresses two objections against the claim that such considerations of global justice can generate duties borne by individual researchers toward individual participants. In addition, Hooper explores the ways in which the principle of justice as rectification might be used to delineate researchers’ AC responsibilities in particular cases. This paper is noteworthy because the author sets out to articulate and defend what some contributors to the AC discussion merely mention in passing, an appeal to justice as a possible ground for researchers’ AC duties.

Wertheimer A. 2011. Rethinking the ethics of clinical research: widening the lens. New York: Oxford University Press. See Chapter 6, especially pp. 276-283.
http://www.oxfordscholarship.com/view/10.1093/acprof:oso/9780199743513.001.0001/acprof-9780199743513

• In Chapter 6 of this book, Wertheimer undertakes an extended critique of what he calls The Interaction Principle (IP). According to IP, the researcher-participant interaction can generate obligations for the researcher to provide various types of benefits that are “super-contractual” in the sense that they go beyond whatever it is about being in the study that would already motivate the participant’s voluntary agreement. As part of his critique on IP, Wertheimer interrogates the partial-entrustment model of AC obligations introduced by Richardson and Belsky.

Merritt MW. 2011. Health Researchers’ ancillary care obligations in low-resource settings: how can we tell what is morally required? Kennedy Institute of Ethics Journal, 21(4): 311-347.
Full-text open access is available online:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3576820/

• In this paper, the author proposes an independent standard to guide comparative assessment of competing conceptual models of researchers’ obligations to respond to AC needs. The independent standard consists of three “performance criteria” that specify the work that a successful conceptual model should be able to do. After demonstrating how such a standard might be used by applying it to competing models, she introduces some areas for further research, including the reasonableness of different models of AC obligations from the standpoint of both participants and researchers. This paper should be of particular relevance to anyone interested in conceptual work on nature and extent of AC obligations. Readers who have some basic familiarity with the conceptual models outlined above (partial-entrustment, whole-person, and general-duty) will also find informative the discussion of these models and the proposed standard for judging their performance.

Richards MR, Helmchen LA. 2013. Adverse selection and moral hazard in the provision of clinical trial ancillary care. Health Economics, Policy, and Law 8: 225-234; doi: 10.1017/S1744133112000072.
http://journals.cambridge.org/action/displayAbstract?fromPage=online&aid=8854573

• This paper sheds light on two overlooked challenges in the provision of AC: adverse selection and moral hazard. With respect to the first challenge, the authors point out that the promise of AC provision might disproportionately attract study participants who are predisposed to accessing the range of AC services due to their illnesses or medical condition. Such adverse selection, in turn, can be problematic either by generating AC demands significantly in excess of projected costs or by compromising the external validity of study results. Regarding moral hazard, the authors claim that the promise of AC provision might encourage study participants to relax their efforts to engage in healthy behaviors or start engaging in more risky behaviors. Apart from the negative health-related consequences to the study participants, both short-term and long-term, moral hazard may also generate AC demands in excess of projected costs. Finally, the authors offer three recommendations intended to alleviate these problems: offering a choice between AC and cash, incentivizing low AC utilization, and involving a third-party insurer in order to offset the researcher’s risk of cost overruns. This paper is important because it focuses on the behavioral responses that participants might have to the promise of AC, a perspective that has not been thoroughly represented in the literature.

Pratt B, Zion D, Lwin KM, Cheah PY, Nosten F, Loff B. 2013. Ancillary care: from theory to practice in international clinical research. Public Health Ethics 6(2): 154-169.
Full-text open access is available online:
http://phe.oxfordjournals.org/content/early/2013/06/13/phe.pht015.short

• The authors use Jennifer Ruger’s “health capability paradigm” (a theory of global justice building on the work of Amartya Sen and Martha Nussbaum) to derive guidance on the AC obligations of researchers, funders, sponsors, and governments from high-income countries, in the context of international clinical research in low and middle-income countries. The authors argue that, in accordance with the health capability paradigm, a health need falls within the scope of candidate AC needs if the health condition is a major contributor to the health gap between the host communities’ health status and the optimum global level of health. Furthermore, they claim that the following three criteria ought to be used to determine whether an obligation exists to meet a given candidate AC need: local and/or state-run health providers are unable or choose not to meet the need, research personnel possess the expertise necessary to meet the need safely, and the AC intervention is cost-effective and appropriate. The conceptual analysis presented in this paper is unique in that it proposes, thus far, the only normative model of AC obligations in the literature that is grounded in a specific theory of global justice. In order to determine whether such obligations could be upheld in practice and, if so, what factors would make such compliance feasible, a case study methodology (see Pratt, et al., 2012 under “Empirical Research”) was also employed. Mixed qualitative methods were used to collect data on Shoklo Malaria Research Unit’s (SMRU) vivax malaria treatment trial. The authors found that SMRU not only upheld the AC obligations derived from the health capability paradigm but went above and beyond what the paradigm required. The following factors were identified as facilitating SMRU’s ability to meet the AC obligations: SMRU’s historical role as a dual research unit and health care provider, commitment from funders (Wellcome Trust) to permit use of funds toward AC costs, and SMRU’s sufficient clinical care capacity.

See also Richardson HS, Belsky L. 2004. The ancillary-care responsibilities of medical researchers: an ethical framework for thinking about the clinical care that researchers owe their subjects. Hastings Center Report 34 (1): 25-33: http://www.ncbi.nlm.nih.gov/pubmed/15098404.

 Richardson HS, Belsky L. 2004. The ancillary-care responsibilities of medical researchers: an ethical framework for thinking about the clinical care that researchers owe their subjects. Hastings Center Report 34 (1): 25-33: http://www.ncbi.nlm.nih.gov/pubmed/15098404.

Operationally Oriented Papers for Health Researchers (listed in chronological order)

Richardson HS. 2007. Gradations of researchers' obligation to provide ancillary care for HIV/AIDS in developing countries. American Journal of Public Health 97(11):1956-1961.
Full-text open access is available online:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2040358/

• In this paper, Richardson addresses the question of researchers’ AC obligations regarding the HIV/AIDS-related needs of persons living with HIV/AIDS who participate in studies that are neither HIV treatment trials nor HIV prevention trials. Richardson employs the partial-entrustment model (see above) to argue that researchers conducting such studies in developing countries do have AC obligations to respond to participants’ HIV/AIDS-related needs, and that the level of AC response demanded by these obligations depends on three main factors: the extent to which HIV/AIDS is relevant to the study design; the depth of the researcher-participant interaction; and the cost of care for HIV/AIDS relative to the study budget. Richardson shows how the partial-entrustment model can be used to calibrate a range of AC responsibilities for HIV/AIDS-related care – e.g., from clinical referral, to care for opportunistic infections, to funding for ART provided by others, to full provision of all HIV/AIDS-related care – depending on the circumstances. He illustrates this point by applying it to a variety of specific study designs.

Hyder AA, Merritt MW. 2009. Ancillary care for public health research in developing countries. JAMA 302(4): 429-431.
http://www.ncbi.nlm.nih.gov/pubmed/19622822

• In this paper, Hyder and Merritt extend the discussion of AC to public health studies in which the unit of research interest is a group, such as a community or a population, so that the participant role in the researcher-participant relationship is occupied primarily by the group rather than by any individual person. In this type of study, unmet needs of the participant group may exist chiefly at the collective level – for instance, a lack of trained community health workers. In order to guide the systematic assessment of researchers’ AC obligations in such studies, Hyder and Merritt introduce a distinction between research-specific factors and context-specific factors. An example of a research-specific factor is a disparity in health status between sub-groups within the study-defined participant group; such a disparity would tend to strengthen AC obligations toward the worse-off sub-group. An example of a context-specific factor is a lower index of human development across the entire study-defined participant group as compared with the surrounding national population, which would tend to strengthen AC obligations toward the participant group as a whole. The authors outline a 10-step operational process, incorporating both research-specific and context-specific factors that researchers and sponsors can use to identify their AC obligations in group-focused public health studies. The authors recommend that their proposed process be evaluated across several countries representing different contexts of development.

Merritt MW, Taylor HA, Mullany, LC. 2010. Ancillary care in community-based public health intervention research. American Journal of Public Health 100 (2): 211-216.
Full-text open access is available online.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2804641/

• In this paper, Merritt and colleagues extend the discussion of AC to research settings in which semi-skilled local community health workers and data collectors carry out research activities in people’s homes and other living spaces. They specifically focus on the duty of rescue – that is, the general moral duty to provide urgently needed assistance when one is uniquely able to do so at little cost – as a basis for AC responsibilities that had been often mentioned but rarely emphasized in the literature. The authors propose a 2-step sequence of questions to help researchers incorporate the duty of rescue into their decision making about AC in the settings of interest: 1) What are the candidate needs for the duty of rescue? 2) For which candidate needs might the study team leadership appropriately bear a duty of rescue? The authors outline specific factors to be considered in answering these questions. They refer to a neonatal survival study conducted in Nepal as a case example to illustrate how the duty of rescue can inform the delineation of AC obligations in response to a range of needs.

Richardson, HS, Cho MK. 2012. Secondary researchers’ duties to return incidental findings and individual research results: a partial-entrustment account. Genetics in Medicine 14: 467-472.
Full-text open access is available online.
http://www.nature.com/gim/journal/v14/n4/full/gim201212a.html

• This article explores the issue of whether and to what extent secondary researchers have obligations to return individual research results (IRRs) and incidental findings (IFs) to those who contributed genetic and/or other biological samples on which the secondary research was conducted. Secondary researchers are defined as researchers who do not have direct interaction with sample contributors but have obtained the data from primary researchers who interacted with the contributors or from biobanks that have stored the samples. After briefly discussing the failure of existing normative models to explain why secondary researchers might have obligations to return IFs and IRRs, the authors propose the partial-entrustment model (see Belsky and Richardson 2004 under “Conceptual Models” above) as a more useful alternative. According to the model, the secondary researcher retains AC responsibilities toward the sample contributors even in the absence of direct interaction. The authors reason as follows: the primary researcher or biobank, in granting the secondary researcher permission to access the samples, thereby transfers to the secondary researcher the waiver of privacy rights through which contributors implicitly entrust relevant aspects of their health to the primary researcher or biobank. Accordingly, the authors believe that the return of IFs and IRRs can, in some cases, comprise an essential part of fulfilling these AC responsibilities even when there is a lack of direct interaction between researchers and sample contributors. This paper is important because it delves into the AC obligations of researchers who do not have direct interaction with research subjects, an issue that has not yet been thoroughly explored in the literature. It also demonstrates how the partial-entrustment model can extend to and enhance discussions about the return of IFs and IRRs to sample contributors.

Bright PL, Nelson RM. 2012. A capacity-based approach for addressing ancillary care needs: implications for research in resource limited settings. Journal of Medical Ethics 38 (11): 672-676.
http://www.ncbi.nlm.nih.gov/pubmed/22562947

• Bright and Nelson orient this paper around the concerns of research team members who are responsible for making real-time decisions about care and referral for participants’ AC needs. As part of this orientation, the authors also address the formation of institutional policies and standard operating procedures (SOPs) regarding AC. According to the authors’ proposed “capacity-based approach,” the more urgent the AC need, the stronger the obligation to provide or facilitate care, other things being equal. Given an assessment of urgency, assessments of the capacity of local health system and of the research team, respectively, help to determine whether AC should be facilitated by referral or, instead, directly provided by the research team. The authors present a decision tree to guide the use of their capacity-based approach. They illustrate its use by means of a case discussion comparing two examples: (1) an enrolled infant with a mild non-urgent upper respiratory tract infection and (2) an enrolled infant with severe malaria infection. Bright and Nelson also discuss the relation of their approach to both operational and conceptual aspects of other leading accounts of AC responsibilities.

Merritt MW, Taylor HA. 2012. Responsibilities to plan for ancillary care pose ethical challenges for nutrition research in the community setting. Journal of Nutrition, 142 (10): 1787-1790.
http://www.ncbi.nlm.nih.gov/pubmed/22933751

• The aim of this paper is to encourage nutrition researchers to participate proactively in the emerging discourse on ethical issues related to AC. In light of this aim, the authors highlight and describe in detail three challenges involved in the planning of AC responses for nutrition research conducted in the community setting: the influence of AC provision on primary study outcomes; whether to extend AC provision beyond research participants to non-participants with the same health needs; and training of field workers likely to encounter anticipated AC needs.

Empirical Research (listed in chronological order)

Taylor HA, Merritt MW, Mullany LC. 2011. Ancillary care in public health intervention research in low-resource settings: researchers’ practices and decision-making. Journal of Empirical Research on Human Research Ethics 6(3): 73-81.
http://www.ncbi.nlm.nih.gov/pubmed/21931240

• Taylor and colleagues carried out 52 in-person in-depth interviews with researchers who had conducted public health intervention studies in low-resource settings in South Asia. The authors aimed to describe these researchers’ practices and the factors that influenced their decisions regarding the provision of AC. Types of AC response discovered in a content analysis of the interview data were categorized as either “prospective” or “ad hoc.” The prospective type of response involves the anticipation of AC needs by the study team prior to the initiation of the study, whereas the ad hoc type of response involves AC needs that researchers encounter only after the study has begun and for which they have not planned a response in advance. Taylor and colleagues found that, among the informants interviewed, investigators whose research was embedded in the community setting were much more likely to report engaging in the prospective type of AC response than were investigators whose research was based in clinical facilities. Moreover, they found that facility-based informants were more likely to engage in the ad hoc type of AC response as a matter of routine. The following two study limitations are worthy of mention: the possibility of social acceptability bias based on the fact that the informants were asked what they did rather than being observed, and the fact that data collection was limited to South Asia. This paper is an early contribution to the growing empirical literature on AC; in particular, it exemplifies insights that can be gained by using systematic methods to ask seasoned practitioners about their field experience.

Pratt B, Zion D, Lwin KM, Cheah PY, Nosten F, Loff B. 2012. Closing the translation gap for justice requirements in international research. Journal of Medical Ethics 38(9): 552-558.
Full-text open access is available online:
http://jme.bmj.com/content/38/9/552.long

• This paper focuses on international justice obligations regarding responsiveness, ancillary care, post-trial benefits, and research capacity strengthening in the context of international research. Although its emphasis is not directed exclusively at the issue of AC, its central arguments are highly relevant to current debates regarding the issue. The authors make two core arguments in this paper. First, they argue that international research ethics guidance must be informed by actual research practice in order for the guidance to be more feasible and practical in its implementation. Second, the authors propose a case study methodology as a useful tool for gathering empirical information about how such guidance is actually implemented by researchers in order to provide strategies that might be employed by future research groups. This paper illuminates the relevance of empirical research to the formation of international research ethics guidance, including guidance on AC, and it demonstrates how a case study methodology can be useful toward this end.

Haire BG. 2013. Ethics of medical care and clinical research: a qualitative study of principal investigators in biomedical HIV prevention research. Journal of Medical Ethics 39: 231-325.
http://www.ncbi.nlm.nih.gov/pubmed/23175459

• This paper reports results from a qualitative study in which a purposive sample of 14 principal investigators of HIV biomedical prevention trials in developing-country settings discussed their experiences of providing medical benefits to participants. Informants generally supported a responsibility to provide AC either for ethical reasons (due to a physician-like responsibility of concern for the welfare of research participants) or for pragmatic reasons (in order to build trust with the local community). Informants also acknowledged, in some instances with frustration and discomfort, the existence of limitations on care provision due to funding restrictions or local resource constraints. Some informants noted that they had facilitated care through referrals that were based on established partnerships with the local health system. The author argues that the experiences and views of these investigators fit most readily with a combination of the partial-entrustment (see above under “Conceptual Models”) and capacity-based approaches (see above under “Operationally Oriented Papers for Researchers”) to delineating AC responsibilities. This paper is a good resource for understanding how some investigators sampled from within a field of research specific to a disease (HIV) and study design (biomedical prevention trials) think about AC, and how their perspectives relate to leading theoretical and operational models of researchers’ AC responsibilities.

Pratt B, Zion D, Lwin KM, Cheah PY, Nosten F, Loff B. 2013. Ancillary care: from theory to practice in international clinical research. Public Health Ethics 6(2): 154-169.
Full-text open access is available online:
http://phe.oxfordjournals.org/content/early/2013/06/13/phe.pht015.short

• The authors of this article incorporate a significant empirical component as part of their contribution to the conceptual literature on AC; please see the full summary under “Conceptual Models” above.

Belsky L, Richardson, H.S. 2004. Medical researchers' ancillary clinical care responsibilities. BMJ 328:1494-1496: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC428526/;
Bright PL, Nelson RM. 2012. A capacity-based approach for addressing ancillary care needs: implications for research in resource limited settings. Journal of Medical Ethics, 38 (11): 672-676: http://www.ncbi.nlm.nih.gov/pubmed/22562947.