The Ancillary-Care Responsibilities of Medical Researchers: An Ethical Framework for Thinking about the Clinical Care That Researchers Owe Their Subjects
Abstract
Malaria researchers may detect that their juvenile subjects are suffering from schistosomiasis, a serious parasitic disease common in many malarial areas. Do the researchers have a responsibility to treat the schistosomiasis? Functional brain scans collected for research purposes may contain information that would enable the appropriate specialist to diagnose a subject with a condition unrelated to what is being studied. Is there a responsibility to have images that were collected for research purposes read diagnostically? Such questions about researchers' responsibilities to provide clinical arise pervasively, yet there is an almost total absence of guidance. Providing guidance requires confronting some very basic questions about the relationship between researcher and subject. What sort of care, if any, ought medical researchers provide their subjects, beyond what is necessary to implement a study's design safely and validly? Ought they respond to their subjects' needs as fully as a physician would to a patient's? If they owe less than that, what ethical principles explain the proper bounds of researchers' ancillary-care responsibilities? To address these questions, we develop an ethical framework that will help individual investigators, institutional review boards, and policy-makers anticipate the ancillary-care responsibilities that will arise during a given study and ensure that enough research funds are earmarked to meet them. This framework is intended as a first step in what will need to be an ongoing process of working out further guidance. What Is Ancillary Care? Defining ancillary care in the context of clinical research requires examining the rationale of the care. Ancillary is that which goes beyond the requirements of scientific validity, safety, keeping promises, or rectifying injuries. Stabilizing subjects to get them on a protocol is not care, since it is required for carrying out the study. Monitoring subjects' drug interactions also does not count as care, since it is typically required in order to minimize risks caused by the study. Two additional rationales for need to be excluded. In order to recruit and enroll a sufficient number of subjects, it is sometimes pragmatically necessary to promise potential subjects extra that would not be required by science or safety. Of course, anything can be promised; but we are examining the ethical reasons to provide extra whether one has promised it or not. Further, even when careful safety measures are in place, research participation can cause injury to subjects. Although participants sustaining research injuries are generally owed care, we set compensation for research injury aside as a separate ethical question. Ancillary care, then, is not required by sound science, safe trial conduct, morally optional promises, or redressing subject injury. This ethically neutral definition allows us to pursue the ethical question of what sorts of extra clinical researchers ought to provide and to raise (and reject) the hypothesis that the extra they ought to provide is just what is research-related. It allows that any given instance of ancillary care may or may not be morally required (or even morally permissible) and may or may not be research-related. The General Duty of Rescue Before we come to the responsibilities that are specially incumbent on clinical researchers, we should note that all moral agents, whether individual or collective, have duties to rescue those in need. For instance, everyone has a duty to help a person who is in need and whom no one else can help, at least when one can provide the help without serious sacrifice or risk. (1) Even if one's ability to help is not strictly unique, an urgent need can generate a duty to help when it is predictable that no one else will. (2) These duties are quite general and generate moral demands not only on individual researchers' medical skills but also on the collective financial and political resources of the research team and its sponsors. …
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
It is generally agreed that trial sponsors and investigators have an ethical obligation to plan to provide care for participants' healthcare needs that arise as a direct consequence of participation in a trial.
“It is generally agreed that trial sponsors and investigators have an ethical obligation to plan to provide care for participants’ healthcare needs that arise as a direct consequence of participation in a trial.2 501 502”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [501]
Cites
False Hopes and Best Data: Consent to Research and the Therapeutic Misconception
Appelbaum, P. S., Roth, L. H., Lidz, C. W., Benson, P. R., & Winslade, W. J. (1987) · The Hastings Center Report · doi:10.2307/3562038 · Cited by 956 · see citing works
Human Experimentation and Human Rights*
Katz, J. (2017) · Routledge eBooks · doi:10.4324/9781315198231-13 · Cited by 126 · see citing works
The Duty to Rescue and the Slippery Slope Problem
Smith, P. G. (1990) · Social Theory and Practice · doi:10.5840/soctheorpract19901612 · Cited by 64 · see citing works
Evaluation of Two Self-Care Treatments for Prevention of Vaginal Candidiasis in Women With HIV
Williams, A. B., Yu, C., Tashima, K. T., Burgess, J. D., & Danvers, K. (2001) · Journal of the Association of Nurses in AIDS Care · doi:10.1016/s1055-3290(06)60216-1 · Cited by 50 · see citing works
Flagged first, then by citations
Cited by
Sorted by citations
SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
Chan, A.-W., Tetzlaff, J. M., Gotzsche, P. C., Altman, D. G., Mann, H., Berlin, J. A., Dickersin, K., Hrobjartsson, A., Schulz, K. F., Parulekar, W. R., et al. (2013) · BMJ · doi:10.1136/bmj.e7586 · Cited by 6,251 · see citing works
Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations
Wolf, S. M., Lawrenz, F. P., Nelson, C. A., Kahn, J. P., Cho, M. K., Clayton, E. W., Fletcher, J. G., Georgieff, M., Hammerschmidt, D. E., Hudson, K., et al. (2008) · The Journal of Law Medicine & Ethics · doi:10.1111/j.1748-720x.2008.00266.x · Cited by 710 · see citing works
Wolf, S., Crock, B. N., Ness, B. V. V., Lawrenz, F., Kahn, J., Beskow, L., Cho, M., Christman, M., Green, R., Hall, R. F., et al. (2012) · Genetics in Medicine · doi:10.1038/gim.2012.23 · Cited by 435 · see citing works
Self-citationDisclosing Individual Genetic Results to Research Participants
Ravitsky, V., & Wilfond, B. S. (2006) · The American Journal of Bioethics · doi:10.1080/15265160600934772 · Cited by 283 · see citing works
Kraft, S. A., Cho, M. K., Gillespie, K., Halley, M., Varsava, N., Ormond, K. E., Luft, H. S., Wilfond, B. S., & Lee, S. S.-J. (2018) · The American Journal of Bioethics · doi:10.1080/15265161.2018.1431322 · Cited by 271 · see citing works
Responsible Conduct of Research
Shamoo, A. E., & Resnik, D. B. (2022) · doi:10.1093/oso/9780197547090.001.0001 · Cited by 224 · see citing works
Disclosure of individual genetic data to research participants: the debate reconsidered
Bredenoord, A. L., Kroes, H. Y., Cuppen, E. P. J. G., Parker, M. J., & van Delden, J. J. M. (2010) · Trends in Genetics · doi:10.1016/j.tig.2010.11.004 · Cited by 217 · see citing works
Offering Individual Genetic Research Results: Context Matters
Beskow, L. M., & Burke, W. (2010) · Science Translational Medicine · doi:10.1126/scitranslmed.3000952 · Cited by 192 · see citing works
Molyneux, S. C., Wassenaar, D. R., Peshu, N. M., & Marsh, K. (2005) · Social Science & Medicine · doi:10.1016/j.socscimed.2004.12.003 · Cited by 178 · see citing works
Medical researchers' ancillary clinical care responsibilities
Belsky, L., & Richardson, H. S. (2004) · BMJ · doi:10.1136/bmj.328.7454.1494 · Cited by 157 · see citing works
Self-citationSPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials
Hróbjartsson, A., Boutron, I., Hopewell, S., Moher, D., Schulz, K. F., Collins, G. S., Tunn, R., Aggarwal, R., Berkwits, M., Berlin, J. A., et al. (2025) · BMJ · doi:10.1136/bmj-2024-081660 · Cited by 171 · see citing works
Responsibilities in international research: a new look revisited
Benatar, S. R., & SINGER, P. A. (2010) · Journal of Medical Ethics · doi:10.1136/jme.2009.032672 · Cited by 150 · see citing works
Wolf, S. M. (2013) · Annual Review of Genomics and Human Genetics · doi:10.1146/annurev-genom-091212-153506 · Cited by 138 · see citing works
“Richardson and Belsky have offered ethical analysis to translate these concerns into investigator duties to return IFs to research participants (62, 63).”
BackgroundBombard, Y., Brothers, K. B., Fitzgerald‐Butt, S. M., Garrison, N. A., Jamal, L., James, C. A., Jarvik, G. P., McCormick, J. B., Nelson, T. N., Ormond, K. E., et al. (2019) · The American Journal of Human Genetics · doi:10.1016/j.ajhg.2019.02.025 · Cited by 128 · see citing works
Therapeutic misconception in early phase gene transfer trials
Henderson, G. E., Easter, M. M., Zimmer, C., King, N. M. P., Davis, A. M., Rothschild, B. B., Churchill, L. R., Wilfond, B. S., & Nelson, D. K. (2005) · Social Science & Medicine · doi:10.1016/j.socscimed.2005.05.022 · Cited by 119 · see citing works
Incidental Findings in Human Subjects Research: What Do Investigators Owe Research Participants?
Miller, F. G., Mello, M. M., & Joffe, S. (2008) · The Journal of Law Medicine & Ethics · doi:10.1111/j.1748-720x.2008.00269.x · Cited by 112 · see citing works
Sofaer, N., & Strech, D. (2011) · Public Health Ethics · doi:10.1093/phe/phr013 · Cited by 111 · see citing works
Practical approaches to incidental findings in brain imaging research
Illes, J., Kirschen, M. P., Edwards, E., Bandettini, P. A., Cho, M. K., Ford, P. J., Glover, G. H., Kulynych, J. J., Macklin, R., Michael, D. B., et al. (2008) · Neurology · doi:10.1212/01.wnl.0000280469.17461.94 · Cited by 109 · see citing works
The Law of Incidental Findings in Human Subjects Research: Establishing Researchers' Duties
Wolf, S. M., Paradise, J. K., & Caga-Anan, C. (2008) · The Journal of Law Medicine & Ethics · doi:10.1111/j.1748-720x.2008.00281.x · Cited by 107 · see citing works
(2015) · Jahrbuch für Wissenschaft und Ethik · doi:10.1515/jwiet-2015-0119 · Cited by 104 · see citing works
Returning a Research Participant's Genomic Results to Relatives: Analysis and Recommendations
Wolf, S. M., Branum, R., Koenig, B. A., Petersen, G. M., Berry, S. A., Beskow, L. M., Daly, M. B., Fernandez, C. V., Green, R. C., LeRoy, B. S., et al. (2015) · The Journal of Law Medicine & Ethics · doi:10.1111/jlme.12288 · Cited by 94 · see citing works
Bench to Bedside: Mapping the Moral Terrain of Clinical Research
Joffe, S., & Miller, F. G. (2008) · Hastings Center Report · doi:10.1353/hcr.2008.0019 · Cited by 122 · see citing works
Incidental Findings and Ancillary-Care Obligations
Richardson, H. S. (2008) · The Journal of Law Medicine & Ethics · doi:10.1111/j.1748-720x.2008.00268.x · Cited by 91 · see citing works
Self-citationDoes DOTS work in populations with drug-resistant tuberculosis?
DeRiemer, K., García‐García, L., Bobadilla-del-Valle, M., Palacios-Martínez, M., Martínez‐Gamboa, A., Small, P. M., Sifuentes‐Osornio, J., & Ponce‐de‐León, A. (2005) · The Lancet · doi:10.1016/s0140-6736(05)74812-1 · Cited by 90 · see citing works
Vulnerable Populations in Research: The Case of the Seriously Ill
Nickel, P. J. (2006) · Metamedicine · doi:10.1007/s11017-006-9000-2 · Cited by 85 · see citing works
THE NEED FOR SYSTEMATIC REVIEWS OF REASONS
SOFAER, N., & STRECH, D. (2012) · Bioethics · doi:10.1111/j.1467-8519.2011.01858.x · Cited by 80 · see citing works
Do Researchers Have an Obligation to Actively Look for Genetic Incidental Findings?
Gliwa, C., & Berkman, B. E. (2013) · The American Journal of Bioethics · doi:10.1080/15265161.2012.754062 · Cited by 83 · see citing works
“Yet medical researchers are often in a unique position to help their participants through application of an experimental therapy or simply the knowledge, abilities, and resources they hold as scientists and/or physicians (Richardson and Belsky 2004).”
BackgroundInfluentialContinued access to investigational brain implants
Lázaro‐Muñoz, G., Yoshor, D., Beauchamp, M. S., Goodman, W. K., & McGuire, A. L. (2018) · Nature reviews. Neuroscience · doi:10.1038/s41583-018-0004-5 · Cited by 77 · see citing works
Fiduciary Obligation in Clinical Research
Miller, P. B. W., & Weijer, C. (2006) · The Journal of Law Medicine & Ethics · doi:10.1111/j.1748-720x.2006.00049.x · Cited by 77 · see citing works
The many meanings of care in clinical research.
Easter, M., Henderson, G., Davis, A. M., Churchill, L., & King, N. (2006) · Sociology of Health and Illness · doi:10.1111/j.1467-9566.2006.00537.x · Cited by 79 · see citing works
The Ethics of International Research with Abandoned Children
Millum, J., & Emanuel, E. J. (2007) · Science · doi:10.1126/science.1153822 · Cited by 75 · see citing works
The Ancillary-Care Obligations of Medical Researchers Working in Developing Countries
Participants in the 2006 Georgetown University Workshop on the Ancillary-Care Obligations of Medical Researchers Working in Developing Countries (2008) · PLoS Medicine · doi:10.1371/journal.pmed.0050090 · Cited by 67 · see citing works
Researcher Perspectives on Disclosure of Incidental Findings in Genetic Research
Meacham, M. C., Starks, H. E., Burke, W., & Edwards, K. (2010) · Journal of Empirical Research on Human Research Ethics · doi:10.1525/jer.2010.5.3.31 · Cited by 66 · see citing works
“Trust of the researchers by the participants and responsibility as a trained expert were alluded to several times, reflecting the defining aspects, respectively, of the partial entrustment model (Richardson & Belsky, 2004) and the professional duty of beneficence (F.G. Miller et al., 2008).”
BackgroundThe return of individual research findings in paediatric genetic research
Hens, K., Nys, H., Cassiman, J., & Dierickx, K. (2010) · Journal of Medical Ethics · doi:10.1136/jme.2010.037473 · Cited by 65 · see citing works
Provision of HIV treatment in HIV preventive vaccine trials: a developing country perspective
Slack, C. M., STOBIE, M., Milford, C., Lindegger, G., Wassenaar, D. R., Strode, A. E., & IJsselmuiden, C. (2004) · Social Science & Medicine · doi:10.1016/j.socscimed.2004.06.049 · Cited by 63 · see citing works
Motivations, Understanding, and Voluntariness in International Randomized Trials
KASS, N. E., Maman, S., & Atkinson, J. (2005) · IRB Ethics and Human Research · doi:10.2307/3563534 · Cited by 62 · see citing works
Holm, I. A., Savage, S. K., Green, R. C., Juengst, E. T., McGuire, A. L., Kornetsky, S. Z., Brewster, S. J., Joffe, S., & Taylor, P. (2014) · Genetics in Medicine · doi:10.1038/gim.2013.190 · Cited by 58 · see citing works
Ancillary Care for Public Health Research in Developing Countries
Hyder, A. A. (2009) · JAMA · doi:10.1001/jama.2009.1072 · Cited by 54 · see citing works
“BELSKY AND RICHARDSON 1 DEFINED ANCILLARY CARE as care needed by research participants but not necessary to ensure scientific validity, prevent studyrelated harms, or address study-related injuries and introduced a framework for evaluating ancillary care based on 2 questions.(2) Does a participant’s need for care fall…”
BackgroundRulli, T., & Millum, J. (2014) · Journal of Medical Ethics · doi:10.1136/medethics-2013-101643 · Cited by 54 · see citing works
POST‐TRIAL ACCESS TO ANTIRETROVIRALS: WHO OWES WHAT TO WHOM?
Millum, J. (2009) · Bioethics · doi:10.1111/j.1467-8519.2009.01736.x · Cited by 53 · see citing works
Risk-benefit assessment in medical research--critical review and open questions
Rid, A., & Wendler, D. S. (2010) · Law Probability and Risk · doi:10.1093/lpr/mgq006 · Cited by 52 · see citing works
Ancillary Care Obligations of Medical Researchers
Dickert, N. W. (2009) · JAMA · doi:10.1001/jama.2009.1076 · Cited by 51 · see citing works
Post-trial access in implanted neural device research: Device maintenance, abandonment, and cost
Lázaro‐Muñoz, G., Pham, M. T., Muñoz, K. A., Kostick, K. M., Sanchez, C. E., Torgerson, L. N., Robinson, J. O., Pereira, S., Outram, S. M., Koenig, B. A., et al. (2022) · Brain stimulation · doi:10.1016/j.brs.2022.07.051 · Cited by 45 · see citing works
“In-depth, semi-structured interviews were conducted with researchers (n ¼ 23) and patient-participants (n ¼ 21) involved in aDBS trials in the United States.”
InfluentialAncillary Care in Community-Based Public Health Intervention Research
Merritt, M. W., Taylor, H. A., & Mullany, L. C. (2009) · American Journal of Public Health · doi:10.2105/ajph.2009.168393 · Cited by 45 · see citing works
Kamuya, D., Marsh, V., Njuguna, P., Munywoki, P. K., Parker, M. J., & Molyneux, S. C. (2014) · BMC Medical Ethics · doi:10.1186/1472-6939-15-90 · Cited by 43 · see citing works
“Based on the findings of this research, and the literature on the role of the duration and intensity of relationships between researchers and study participants being important in influencing researcher’s responsibilities [10,39], there are strong ethical arguments that a long term relatively wealthy research centre h…”
BackgroundThe Advantages and Challenges of Testing Children for Heritable Predisposition to Cancer
Kesserwan, C. A., Ross, L. F., Bradbury, A. R., & Nichols, K. E. (2016) · American Society of Clinical Oncology Educational Book · doi:10.1200/edbk_160621 · Cited by 42 · see citing works
A Belmont Reboot: Building a Normative Foundation for Human Research in the 21st Century
Brothers, K. B., Rivera, S. M., Cadigan, R. J., Sharp, R. R., & Goldenberg, A. J. (2019) · The Journal of Law Medicine & Ethics · doi:10.1177/1073110519840497 · Cited by 41 · see citing works
Newman, P. A., & Rubincam, C. (2014) · Expert Review of Vaccines · doi:10.1586/14760584.2014.953484 · Cited by 39 · see citing works
“A critical overview of ethical parameters guiding ancillary care indicates the lack of specific guidelines and argues for a ‘middle position’ between responsibilities of a ‘personal physician’ and a ‘mere scientist’: ‘Researchers do not owe their subjects the same level of care that physicians owe patients, but they o…”
BackgroundBunnik, E. M., van Bodegom, L., Pinxten, W., de Beaufort, I. D., & Vernooij, M. W. (2017) · BMC Medical Ethics · doi:10.1186/s12910-017-0168-y · Cited by 39 · see citing works
“This is consistent with the entrustment model of the researcher-research participant relationship [33, 34], which sets out role-specific ancillary care obligations for researchers.”
ResultRichardson, H. S., & Cho, M. K. (2012) · Genetics in Medicine · doi:10.1038/gim.2012.12 · Cited by 39 · see citing works
Self-citationGradations of Researchers’ Obligation to Provide Ancillary Care for HIV/AIDS in Developing Countries
Richardson, H. S. (2007) · American Journal of Public Health · doi:10.2105/ajph.2006.093658 · Cited by 38 · see citing works
Self-citationDevice Removal Following Brain Implant Research
Sierra‐Mercado, D., Zuk, P. D., Beauchamp, M. S., Sheth, S. A., Yoshor, D., Goodman, W. K., McGuire, A. L., & Lázaro‐Muñoz, G. (2019) · Neuron · doi:10.1016/j.neuron.2019.08.024 · Cited by 38 · see citing works
Return of Research Results: General Principles and International Perspectives
Lévesque, E., Joly, Y., & Simard, J. (2011) · The Journal of Law Medicine & Ethics · doi:10.1111/j.1748-720x.2011.00625.x · Cited by 38 · see citing works
Johnson, G., Lawrenz, F. P., & Thao, M. (2012) · Genetics in Medicine · doi:10.1038/gim.2012.20 · Cited by 37 · see citing works
“Will information of some sort be returned? 7/43 (16) 14/43 (33) 22/43 (51) 6/30 (20) 7/30 (23) 17/30 (57) 4/12c (33) 4/12c (33) 6/12c (50)”
Phillips, J., Cole, C., Gluck, J. P., Shoemaker, J. M., Petree, L. E., Helitzer, D., Schrader, R. M., & Holdsworth, M. T. (2014) · Ethics & Behavior · doi:10.1080/10508422.2014.938338 · Cited by 36 · see citing works
“Henry Richardson argued that the parameters of this obligation are defined through a fundamental relationship of partial entrustment that exists between investigators and research participants (Richardson, 2012; Richardson & Belsky, 2004).”
BackgroundNavigating the research–clinical interface in genomic medicine: analysis from the CSER Consortium
Wolf, S. M., Amendola, L. M., Berg, J. S., Chung, W. K., Clayton, E. W., Green, R. C., Harris-Wai, J. N., Henderson, G. E., Jarvik, G. P., Koenig, B. A., et al. (2017) · Genetics in Medicine · doi:10.1038/gim.2017.137 · Cited by 36 · see citing works
“…in research studies, but the questions raised by patient access to and clinical use of well-validated and clinically significant results from a CLIA-certified lab go beyond research design and even the ancillary care obligations of investigators, 28 to questions of appropriate clinical care.”
What is the Best Standard for the Standard of Care in Clinical Research?
van der Graaf, R., & van Delden, J. J. M. (2009) · The American Journal of Bioethics · doi:10.1080/15265160802654129 · Cited by 36 · see citing works
“This second conception is also called ‘ancillary care’, meaning “that which goes beyond the requirements of scientific validity, safety, keeping promises, or rectifying injuries” (Richardson and Belsky 2004, 26).”
BackgroundAncillary care obligations in light of an African bioethic: from entrustment to communion
Metz, T. (2017) · Metamedicine · doi:10.1007/s11017-017-9404-1 · Cited by 34 · see citing works
Goering, S., Brown, A. I., & Klein, E. P. (2024) · The Hastings Center Report · doi:10.1002/hast.1566 · Cited by 35 · see citing works
The clinical investigator-subject relationship: a contextual approach
Resnik, D. B. (2009) · Philosophy, Ethics, and Humanities in Medicine · doi:10.1186/1747-5341-4-16 · Cited by 32 · see citing works
“the obligation to make a reasonable effort to help a person who is endangered[9].”
InfluentialDisclosure and Management of Research Findings in Stem Cell Research and Banking: Policy Statement
Isasi, R. M., Knoppers, B. M., Andrews, P. W., Bredenoord, A. L., Colman, A., Lee, E. H., Hull, S. C., Kim, O.-J., Lomax, G. P., Morris, C., et al. (2012) · Regenerative Medicine · doi:10.2217/rme.12.23 · Cited by 32 · see citing works
Philosophy, Ethics, and Humanities in Medicine
Rennie, S., & Mupenda, B. (2008) · Cited by 31 · see citing works
Evers, D. L., Fowler, C. B., Mason, J. T., & Mimnall, R. K. (2014) · Science and Engineering Ethics · doi:10.1007/s11948-014-9579-z · Cited by 30 · see citing works
“Alternatively, a partial entrustment model favors a limited duty of care that is consistent with physician responsibilities to healthy research subjects that are less than their responsibilities to patients (Richardson and Belsky 2004).”
BackgroundBeyond the ‘therapeutic misconception’: Research, care and moral friction
Wadmann, S., & Hoeyer, K. (2014) · BioSocieties · doi:10.1057/biosoc.2013.37
“9© 2014 Macmillan Publishers Ltd. 1745-8552 BioSocieties Vol. 9, 1, 3–23 practice; they constitute what some bioethicists term “ancillary care” (Richardson and Belsky, 2004; Richardson, 2012).”
BackgroundInfluentialLiving apart together: reflections on bioethics, global inequality and social justice
Rennie, S., & Mupenda, B. (2008) · Philosophy Ethics and Humanities in Medicine · doi:10.1186/1747-5341-3-25 · Cited by 29 · see citing works
“Such decisions regarding 'ancillary care' in biomedical research always have ethical dimensions and implications[38-40].”
Merritt, M. W. (2011) · Kennedy Institute of Ethics journal · doi:10.1353/ken.2011.0019 · Cited by 29 · see citing works
“…duties of rescue may “reinforce” relationship-based factors such as vulnerability and dependence and may “expand” researchers’ AC responsibilities in severely resource-constrained settings where they have “rare abilities to provide urgently needed help” (Richardson and Belsky 2004, pp. 30, 32).”
BackgroundInfluentialSofaer, N., Thiessen, C., Goold, S. D., Ballou, J. M., Getz, K. A., Koski, G., Krueger, R. A., & Weissman, J. S. (2009) · Journal of Medical Ethics · doi:10.1136/jme.2008.024711 · Cited by 28 · see citing works
Evaluating institutional capacity for research ethics in Africa: a case study from Botswana
Hyder, A. A., Zafar, W., Ali, J., Ssekubugu, R., Ndebele, P., & KASS, N. E. (2013) · BMC Medical Ethics · doi:10.1186/1472-6939-14-31 · Cited by 28 · see citing works
“Finally, there are concerns regarding equitable access of LMIC populations to the fruits of health research, in addition to the expectation from researchers to provide "ancillary care" for medical problems unrelated to the research study [8,9].”
BackgroundAncillary-care responsibilities in observational research: two cases, two issues
Dickert, N. W., DeRiemer, K., Duffy, P. E., García‐García, L., Mutabingwa, T., Sina, B. J., Tindana, P. O., & Lie, R. K. (2007) · The Lancet · doi:10.1016/s0140-6736(07)60416-4 · Cited by 28 · see citing works
Eborall, H. C., Dallosso, H. M., Daly, H., Martin-Stacey, L., & Heller, S. R. (2014) · Trials · doi:10.1186/1745-6215-15-15 · Cited by 27 · see citing works
“In the case of the doctor-researcher, conflict may arise from different care responsibilities imbued by ‘normal’ doctor and researcher roles, whereby the level of care owed to trial participants differs from that owed to the doctor’s own patients [21,22].”
BackgroundWhen the Trial Ends: The Case for Post-Trial Provisions in Clinical Psychedelic Research
Jacobs, E., Murphy-Beiner, A., Rouiller, I., Nutt, D. J., & Spriggs, M. J. (2023) · Neuroethics · doi:10.1007/s12152-023-09536-z · Cited by 29 · see citing works
“The potential ethical obligations of a researcher-therapist likely fall somewhere between two Page 9 of 17 3 Vol.: (0123456789) extremes [66].”
BackgroundBradbury, A. R., Patrick‐Miller, L. J., Egleston, B. L., Maxwell, K. N., DiGiovanni, L., Brower, J., Fetzer, D., Gaieski, J. B., Brandt, A. C., McKenna, D. B., et al. (2018) · JCO Precision Oncology · doi:10.1200/po.17.00250 · Cited by 27 · see citing works
Molyneux, S. C., Sukhtankar, P., Thitiri, J., Njeru, R. W., Muraya, K., Sanga, G., Walson, J. L., Berkley, J. A., Kelley, M. C., & Marsh, V. (2021) · BMJ Global Health · doi:10.1136/bmjgh-2021-004937 · Cited by 27 · see citing works
“48 49 For the CHAIN-related sessions shared in this paper, we took this a step further by drawing on the benefit-sharing and ancillary care literature and in particular on Rich-ardson and Belsky’s partial entrustment model, 44 to guide the discussions themselves.”
MethodSlack, C. M. (2014) · Journal of Empirical Research on Human Research Ethics · doi:10.1525/jer.2014.9.1.83 · Cited by 26 · see citing works
“…such steps are not needed for the success or even the safety of the trial, but rather represent “positive helping performances” (Richardson, 2012, p. 206) or ancillary care that forms no part of the scientific protocol (Richardson & Belsky, 2004; Richardson, 2007; Taylor, Merritt, & Mullany, 2011).”
BackgroundCole, C., Petree, L. E., Phillips, J., Shoemaker, J. M., Holdsworth, M. T., & Helitzer, D. (2015) · Journal of Medical Ethics · doi:10.1136/medethics-2014-102552 · Cited by 24 · see citing works
Wolf, S. M., & Green, R. C. (2023) · Annual Review of Genomics and Human Genetics · doi:10.1146/annurev-genom-101122-103209 · Cited by 23 · see citing works
What Happens After a Neural Implant Study? Neuroethics Expert Workshop on Post-Trial Obligations
Dasgupta, I., Klein, E. P., Cabrera, L. Y., Chiong, W., Feinsinger, A., Fins, J. J., Haeusermann, T., Hendriks, S., Lázaro‐Muñoz, G., Kubu, C. S., et al. (2024) · Neuroethics · doi:10.1007/s12152-024-09549-2 · Cited by 23 · see citing works
Mamotte, N., Wassenaar, D. R., Koen, J., & Essack, Z. (2010) · BMC Medical Ethics · doi:10.1186/1472-6939-11-3 · Cited by 22 · see citing works
Ethics and Collateral Findings in Pragmatic Clinical Trials
Morain, S. R., Weinfurt, K. P., Bollinger, J. M., Geller, G., Mathews, D., & Sugarman, J. (2020) · The American Journal of Bioethics · doi:10.1080/15265161.2020.1689031 · Cited by 21 · see citing works
“Arguments related to the scope of researchers’ duties for environmental health research parallel those made in the normative literature regarding researchers’ duties related to ancillary care (Richardson and Belsky 2004).”
BackgroundWolf, S. M., Ossorio, P. N., Berry, S. A., Greely, H. T., McGuire, A. L., Penny, M. A., Terry, S. F., & for the LawSeq Framework Task Force (2020) · The Journal of Law Medicine & Ethics · doi:10.1177/1073110520916996 · Cited by 21 · see citing works
Taylor, H. A., Merritt, M. W., & Mullany, L. C. (2011) · Journal of Empirical Research on Human Research Ethics · doi:10.1525/jer.2011.6.3.73 · Cited by 21 · see citing works
“Almost all existing work to date has been theoretical (Richardson & Belsky, 2004; Participants, 2008; Belsky & Richardson, 2004; Dickert et al., 2007; Merritt, 2007; Richardson, 2007, 2008; Dickert & Wendler, 2009; Hyder & Merritt, 2009; Merritt, Taylor, & Mullany, 2010).”
BackgroundWhen Should Genome Researchers Disclose Misattributed Pahentage?
Mandava, A., Millum, J., & Berkman, B. E. (2015) · The Hastings Center Report · doi:10.1002/hast.452 · Cited by 20 · see citing works
Incidental Findings: A Common Law Approach
Tovino, S. A. (2008) · Accountability in Research · doi:10.1080/08989620802388705 · Cited by 20 · see citing works
“…yet appear in the case law but has been suggested by scholars is a theory of partial or limited entrustment, or bailment D o w n l o a d e d B y : [ S u l z b a c h , D e b o r a h ] A t : 1 7 : 5 9 3 0 J u l y 2 0 0 9 (Belsky and Richardson, 2004; Richardson, 2008; Richardson and Belsky, 2004).”
BackgroundInfluentialWhat Results Should Be Returned from Opportunistic Screening in Translational Research?
Halverson, C. M. E., Jones, S. H., Novak, L. L., Simpson, C., Edwards, D. R. V., Zhao, S. K., & Clayton, E. W. (2020) · Journal of Personalized Medicine · doi:10.3390/jpm10010013 · Cited by 19 · see citing works
“relegates participants to the status of means-to-an-end, denying them the potential benefits of the data that their participation helped to generate [3,5].”
BackgroundStakeholder Views on Returning Research Results
Haga, S. B., & Zhao, J. Q. (2013) · Advances in genetics · doi:10.1016/b978-0-12-407703-4.00002-5 · Cited by 19 · see citing works
Bright, P. L., & Nelson, R. M. (2012) · Journal of Medical Ethics · doi:10.1136/medethics-2011-100205 · Cited by 19 · see citing works
“Scope depends on permissions obtained during the consent process required to carry out the protocol generally covering illnesses/ conditions related to the disease under study and clinically significant diagnosis identified through the medical information collected for the study.(5) To evaluate the extent of obligatio…”
BackgroundMethodInfluentialCzoli, C. D., Silva, M. D., Shaul, R. Z., d’Agincourt-Canning, L., Simpson, C., Boydell, K., Rashkovan, N., & Vanin, S. (2011) · Philosophy Ethics and Humanities in Medicine · doi:10.1186/1747-5341-6-15 · Cited by 19 · see citing works
“It is thus unsurprising that various accounts of the physician-researcher role have been put forth that assume a middle ground [17,25-28].”
BackgroundThe Duty to Rescue in Genomic Research
Ulrich, M. R. (2013) · The American Journal of Bioethics · doi:10.1080/15265161.2012.754067 · Cited by 18 · see citing works
A Conceptual Model for the Translation of Bioethics Research and Scholarship
Mathews, D., Hester, D. M., Kahn, J. P., McGuire, A. L., McKinney, R. E., Meador, K. G., Philpott‐Jones, S., Youngner, S. J., & Wilfond, B. S. (2016) · The Hastings Center Report · doi:10.1002/hast.615 · Cited by 18 · see citing works
Ethical conflicts in translational genetic research: lessons learned from the eMERGE-III experience
Halverson, C. M. E., Bland, H. T., Leppig, K. A., Marasà, M., Myers, M. F., Rasouly, H. M., Wynn, J., & Clayton, E. W. (2020) · Genetics in Medicine · doi:10.1038/s41436-020-0863-9 · Cited by 18 · see citing works
Tshikala, T., Mupenda, B., Dimany, P., Malonga, A., Ilunga, V., & Rennie, S. (2012) · Philosophy Ethics and Humanities in Medicine · doi:10.1186/1747-5341-7-10 · Cited by 18 · see citing works
“[3-8] For this reason, members of GIRIE, CIBAF and KSPH faculty decided to hold a 3-day workshop on ancillary care in healthrelated research in the DR Congo.”
BackgroundPersonal and community benefits and harms of research: views from Rakai, Uganda
Thiessen, C., Ssekubugu, R., Wagman, J. A., Kiddugavu, M., Wawer, M. J., Emanuel, E. J., Gray, R. H., Serwadda, D., & Grady, C. (2007) · AIDS · doi:10.1097/qad.0b013e3282f029d3 · Cited by 17 · see citing works
“The complexities of providing such care in the context of community-based research merits further attention, particularly in light of the recent debate about researchers’ obligations to offer ancillary care to subjects and their communities [25,26].”
BackgroundBystander Ethics and Good Samaritanism: A Paradox for Learning Health Organizations
Sabin, J. E., Cocoros, N. M., Garcia, C., Goldsack, J. C., Haynes, K., Lin, N. D., McCall, D., Nair, V. P., Pokorney, S. D., McMahill‐Walraven, C. N., et al. (2019) · The Hastings Center Report · doi:10.1002/hast.1031 · Cited by 17 · see citing works
A Just Standard: The Ethical Management of Incidental Findings in Brain Imaging Research
Graham, M., Hallowell, N., & Savulescu, J. (2021) · The Journal of Law Medicine & Ethics · doi:10.1017/jme.2021.38 · Cited by 17 · see citing works
“32 Yet incidental findings of unknown or uncertain clinical significance in a neuroimaging context are different than often-cited cases of valuable non-clinical information, like misattributed paternity, or the APOe4 genetic variant that is associated with Alzheimer’s Disease.”
Marsh, V., Kombe, F. K., Fitzpatrick, R. M., Molyneux, S. C., & Parker, M. J. (2013) · Social Science & Medicine · doi:10.1016/j.socscimed.2013.07.028 · Cited by 16 · see citing works
“Commercial paternity testing offers some comparisons (Davis, 2007) but here there are arguably even greater differences in the way that responsibilities might be understood (Richardson & Belsky, 2004).”
BackgroundEpilepsy Patient-Participants and Genetic Research Results as “Answers”
Namey, E., & Beskow, L. M. (2011) · Journal of Empirical Research on Human Research Ethics · doi:10.1525/jer.2011.6.4.21 · Cited by 16 · see citing works
“Both the vulnerability of research participants and their relationships with researchers have been identified as potentially important considerations when evaluating researcher obligations (Belsky & Richardson, 2004; Richardson & Belsky, 2004).”
BackgroundPost-Trial Considerations for an Early Phase Optogenetic Trial in the Human Brain
White, M. S., & Whittaker, R. G. (2022) · Open Access Journal of Clinical Trials · doi:10.2147/oajct.s345482 · Cited by 15 · see citing works
The Ancillary-Care Responsibilities of Researchers: Reasonable but Not Great Expectations
Brownsword, R. (2007) · The Journal of Law Medicine & Ethics · doi:10.1111/j.1748-720x.2007.00190.x · Cited by 15 · see citing works
“For example, the case is easily made out (1) if the relevant undertaking (assuring advice, assistance, or treatment) has been given prior to enrolment; (2) if it is an explicit term of the contract to participate; or (3) if the responsibility to offer such ancillary care is generally accepted and acted upon as a matte…”
BackgroundGenomic Incidental Findings: Reducing the Burden to Be Fair
Anastasova, V., Blasimme, A., Julia, S., & Cambon‐Thomsen, A. (2013) · The American Journal of Bioethics · doi:10.1080/15265161.2012.754066 · Cited by 15 · see citing works
Managing Incidental Genomic Findings in Clinical Trials: Fulfillment of the Principle of Justice
Dal‐Ré, R., Katsanis, N., Huston, S., Parker, L. S., & Ayuso, C. (2014) · PLoS Medicine · doi:10.1371/journal.pmed.1001584 · Cited by 14 · see citing works
“Following the ancillary care framework [16,18], it seems appropriate to apply a standard-of-care list of genes for which to actively seek pathogenic variants in clinical research.”
BackgroundMethod
- Authors
- Richardson, H. S., & Belsky, L.
- Affiliations
- Georgetown University (US)
- National Institutes of Health (US)
- ORCID
- Richardson, Henry S.
- Venue
- The Hastings Center Report
- Publisher
- JSTOR
- Published
- 2004-01
- Volume
- 34
- Issue
- 1
- Pages
- 25
- ISSN
- 0093-0334 (ISSN-L)
- OpenAlex
- W2002888583
- Cited by
- 217
- References
- 4
- Citations by year
- 2026: 5 · 2025: 4 · 2024: 11 · 2023: 11 · 2022: 26 · 2021: 9 · 2020: 13 · 2019: 7 · 2018: 12 · 2017: 10 · 2016: 7 · 2015: 5 · 2014: 15 · 2013: 10 · 2012: 12
- FWCI
- 7.13
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Hastings Center Report (publishedVersion)
- PubMed (publishedVersion)
- DigitalGeorgetown (Georgetown University Library) (submittedVersion)
- Funders
- U.S. Department of Health and Human Services
- National Institute of Allergy and Infectious Diseases
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics and bioethics in healthcare
- Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
- Keywords
- ancillary care, research ethics, clinical research ethics, researcher-subject relationship, ethical frameworks, research funding allocation, research ethics committees, promise-keeping, incidental finding
- MeSH terms
- Delivery of Health Care, Humans, Models, Theoretical, Physician-Patient Relations, Social Responsibility, Ethical Theory, Ethics, Research, Vulnerable Populations
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
