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The American Journal of Bioethics Publication details, including instructions for authors and subscription information: http://www.tandfonline.com/loi/uajb20
Conceptualizing Ancillary Care Obligations in Health Systems Research Nate W. Olson
a
a
Stanford University Published online: 12 Feb 2014.
To cite this article: Nate W. Olson (2014) Conceptualizing Ancillary Care Obligations in Health Systems Research, The American Journal of Bioethics, 14:2, 46-47, DOI: 10.1080/15265161.2013.868959 To link to this article: http://dx.doi.org/10.1080/15265161.2013.868959
PLEASE SCROLL DOWN FOR ARTICLE Taylor & Francis makes every effort to ensure the accuracy of all the information (the “Content”) contained in the publications on our platform. However, Taylor & Francis, our agents, and our licensors make no representations or warranties whatsoever as to the accuracy, completeness, or suitability for any purpose of the Content. Any opinions and views expressed in this publication are the opinions and views of the authors, and are not the views of or endorsed by Taylor & Francis. The accuracy of the Content should not be relied upon and should be independently verified with primary sources of information. Taylor and Francis shall not be liable for any losses, actions, claims, proceedings, demands, costs, expenses, damages, and other liabilities whatsoever or howsoever caused arising directly or indirectly in connection with, in relation to or arising out of the use of the Content. This article may be used for research, teaching, and private study purposes. Any substantial or systematic reproduction, redistribution, reselling, loan, sub-licensing, systematic supply, or distribution in any form to anyone is expressly forbidden. Terms & Conditions of access and use can be found at http:// www.tandfonline.com/page/terms-and-conditions
The American Journal of Bioethics
REFERENCES Cox, S. M., and M. McDonald. 2013. Ethics is for human subjects too: Participant perspectives on responsibility in health research. Social Science & Medicine 98: 224–231. Emanuel, E. J., D. Wendler, J. Killen, and C. Grady. 2004. What makes clinical research in developing countries ethical? The benchmarks of ethical research. Journal of Infectious Diseases 189(5): 930– 937.
Downloaded by [Universidad de Sevilla] at 04:58 21 October 2014
Hyder, A. A., A. Rattani, C. Krubiner, A. M. Bachani, and N. T. Tran. 2014. Ethical review of health systems research in low- and middleincome countries: A conceptual exploration. American Journal of Bioethics 14(2): 28–37.
Kass, N. E., R. R. Faden, S. N. Goodman, P. Pronovost, S. Tunis, and T. L. Beauchamp. 2013. The research–treatment distinction: A problematic approach for determining which activities should have ethical oversight. Hastings Center Report special (January–February): S4–S15. Marshall, P. A. 2008. “Cultural competence” and informed consent in international health research. Cambridge Quarterly of Healthcare Ethics 17(2): 206–215. Salinas Mulder, S., S. Rance, M. Serrate Suarez, and M. Castro Condori. 2000. Unethical ethics? Reflections on intercultural research practices. Reproductive Health Matters 8(15): 104–112. Weijer, C., and J. A. Anderson. 2001. The ethics wars. Disputes over international research. Hastings Center Report 31(3): 18–20.
Conceptualizing Ancillary Care Obligations in Health Systems Research Nate W. Olson, Stanford University In their target article, Hyder and colleagues (2014) provide an excellent conceptual framework for addressing the distinctive ethical issues posed by health systems research (HSR). With their general framework in place, I take up the task in this commentary of beginning to fill in one piece of it. I focus on a piece that has begun to receive attention in research ethics but still, in some respects, remains at the exploratory stage: ancillary care, or medical care that research participants need but that is not required for a study’s safety or validity or to redress research injuries (Richardson 2012, 2–3). What has been written on ancillary care has tended to concentrate on the obligations researchers have to individual participants.1 In HSR, however, the participants are often groups rather than individuals, as Hyder and colleagues note. Therefore, further conceptual work is needed to understand the nature of ancillary care obligations in HSR. Additionally, given Hyder and colleagues’ focus on HSR in low- and middle-income countries (LMIC), the need for better understanding of this issue is particularly important, as these are the research environments where the issue of ancillary care is thought to be the most pressing. Here, I explain how ancillary care concerns can arise in HSR. As I explain, ancillary care may take a somewhat different shape in HSR, but much of the rationale for thinking that researchers bear
ancillary care obligations carries over from the clinical research context. First, even given Hyder and colleagues’ claim that benefits that are ancillary to other types of research are central aims of HSR, it’s clear that health systems researchers can, and likely will, uncover ancillary health needs in the course of their research. Like other researchers, they are apt to discover individual health needs that are outside the scope of their studies. For example, when testing the effectiveness of a new delivery system for malaria bed nets, members of the research team may notice unrelated health needs in those who receive bed nets. But, importantly, health systems researchers are also uniquely well placed to discover systemic health needs. For instance, when studying the effectiveness of the bed net distribution system, the researchers may uncover previously unnoticed deficiencies in other health care distribution systems in the same community. Understanding that ancillary care needs may be systemic as well as individual allows us to identify the full breadth of needs health systems researchers may be obligated to address.2 It also lends further support to Hyder and colleagues’ claim that ethical reviews of HSR ought to take into account a wider range of benefits than is common practice.
1. See, for example, Belsky and Richardson (2004), Dickert and Wendler (2009), and Richardson (2012). Hyder and Merritt (2009) is a notable exception. 2. While Hyder and Merritt (2009) note that ancillary care in public health research may be owed to groups rather than individuals, the idea that health systems themselves may be the target of ancillary care has not been addressed, to my knowledge, in the literature. Address correspondence to Nate W. Olson, Stanford University, Center for Biomedical Ethics, 1215 Welch Road, Modular A, Stanford, CA 94305-5417, USA. E-mail: [email protected]
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Ethical Review of Health Systems Research
Establishing that health systems researchers do in fact bear ancillary care obligations is more than I can accomplish here, but if one is convinced that researchers in clinical trials have ancillary care obligations—as many are—then one likely ought to think that health systems researchers bear such obligations too. For instance, to justify ancillary care obligations, Merritt and colleagues (Merritt, Taylor, and Mullany 2010) appeal to the duty of rescue, that is, the duty to provide urgently needed assistance when one is uniquely able to do so at minimal cost. The same duty would apply to some ancillary health needs discovered in HSR, especially in LMIC. Belsky and Richardson’s (2004) “partial-entrustment” model offers a different justification of ancillary care obligations, one based in the permissions that are granted in the informed consent process. This justification can also transfer to HSR, even though consent often occurs at the group level. By giving permission to conduct research in their communities, groups may be said to entrust oversight of certain health needs to researchers. Therefore, while ethical reviews of ancillary care in HSR ought to take both individual and systemic benefits into account, the ethical considerations they employ to evaluate whether researchers ought to provide such benefits are likely to remain the same. Existing views of ancillary care obligations give us a couple of reasons to think that health systems researchers ought to pay particular attention to the systemic needs they discover. First, if ancillary care obligations are owed to research participants—as is usually thought—then such obligations would be owed primarily to groups in HSR, since they are the primary participants, as Hyder and colleagues indicate. The researchers’ ancillary care obligations would then be to address the group’s health needs, and addressing systemic needs would be the clearest means of doing so. Second, given the nature of their expertise, health systems researchers are particularly well positioned to identify and help repair systemic health needs. They may discover deficiencies in health systems that other sorts of researchers are unlikely to find, and they may be able to offer strategies for repairing these deficiencies that other sorts of researchers cannot. Consequently, communities may be particularly dependent on health systems researchers to
diagnose and repair systemic health needs, a factor that strengthens ancillary care obligations according to many views, including those of both Merritt and colleagues (2010) and Belsky and Richardson (2004). These two points support Hyder and colleagues’ contention that collective benefits are those that matter most in HSR. However, ethical reviews of HSR must be careful not to overlook relevant individual health needs. Health systems researchers may have ancillary care obligations for individuals too when they are secondary participants in studies, especially when their participation requires individual informed consent. Responsible ethical review of ancillary care in HSR will require careful attention to both the similarities to and differences from other forms of research. The differences, including the inclusion of systemic health needs and the use of group consent, provide further support for Hyder and colleagues’ view that ethical review of HSR ought to be modified to account for its unique features. However, the similarities to clinical research show that certain aspects of standard ethical review still have their place.3 REFERENCES Belsky, L., and H. S. Richardson. 2004. Medical researchers’ ancillary clinical care responsibilities. British Medical Journal 328: 1494– 1496. Dickert, N., and D. Wendler. 2009. Ancillary care obligations of medical researchers. Journal of the American Medical Association 302(4): 424–428. Hyder A. A., and M. W. Merritt. 2009. Ancillary care for public health research in developing countries. Journal of the American Medical Association 302(4): 429–431. Hyder, A. A., A. Rattani, C. Krubiner, A. M. Bachani, and N. T. Tran. 2014. Ethical review of health systems research in low- and middleincome countries: A conceptual exploration. American Journal of Bioethics 14(2): 28–37. Merritt, M. W., H. Taylor, and L. C. Mullany. 2010. Ancillary care in community-based public health intervention research. American Journal of Public Health 100: 211–216. Richardson, H. S. 2012. Moral entanglements: The ancillary-care obligations of medical researchers. Oxford, UK: Oxford University Press.
3. Thanks to Emily Borgelt for helpful discussion of many of the ideas in this commentary.
February, Volume 14, Number 2, 2014
ajob 47
The American Journal of Bioethics Publication details, including instructions for authors and subscription information: http://www.tandfonline.com/loi/uajb20
Conceptualizing Ancillary Care Obligations in Health Systems Research Nate W. Olson
a
a
Stanford University Published online: 12 Feb 2014.
To cite this article: Nate W. Olson (2014) Conceptualizing Ancillary Care Obligations in Health Systems Research, The American Journal of Bioethics, 14:2, 46-47, DOI: 10.1080/15265161.2013.868959 To link to this article: http://dx.doi.org/10.1080/15265161.2013.868959
PLEASE SCROLL DOWN FOR ARTICLE Taylor & Francis makes every effort to ensure the accuracy of all the information (the “Content”) contained in the publications on our platform. However, Taylor & Francis, our agents, and our licensors make no representations or warranties whatsoever as to the accuracy, completeness, or suitability for any purpose of the Content. Any opinions and views expressed in this publication are the opinions and views of the authors, and are not the views of or endorsed by Taylor & Francis. The accuracy of the Content should not be relied upon and should be independently verified with primary sources of information. Taylor and Francis shall not be liable for any losses, actions, claims, proceedings, demands, costs, expenses, damages, and other liabilities whatsoever or howsoever caused arising directly or indirectly in connection with, in relation to or arising out of the use of the Content. This article may be used for research, teaching, and private study purposes. Any substantial or systematic reproduction, redistribution, reselling, loan, sub-licensing, systematic supply, or distribution in any form to anyone is expressly forbidden. Terms & Conditions of access and use can be found at http:// www.tandfonline.com/page/terms-and-conditions
The American Journal of Bioethics
REFERENCES Cox, S. M., and M. McDonald. 2013. Ethics is for human subjects too: Participant perspectives on responsibility in health research. Social Science & Medicine 98: 224–231. Emanuel, E. J., D. Wendler, J. Killen, and C. Grady. 2004. What makes clinical research in developing countries ethical? The benchmarks of ethical research. Journal of Infectious Diseases 189(5): 930– 937.
Downloaded by [Universidad de Sevilla] at 04:58 21 October 2014
Hyder, A. A., A. Rattani, C. Krubiner, A. M. Bachani, and N. T. Tran. 2014. Ethical review of health systems research in low- and middleincome countries: A conceptual exploration. American Journal of Bioethics 14(2): 28–37.
Kass, N. E., R. R. Faden, S. N. Goodman, P. Pronovost, S. Tunis, and T. L. Beauchamp. 2013. The research–treatment distinction: A problematic approach for determining which activities should have ethical oversight. Hastings Center Report special (January–February): S4–S15. Marshall, P. A. 2008. “Cultural competence” and informed consent in international health research. Cambridge Quarterly of Healthcare Ethics 17(2): 206–215. Salinas Mulder, S., S. Rance, M. Serrate Suarez, and M. Castro Condori. 2000. Unethical ethics? Reflections on intercultural research practices. Reproductive Health Matters 8(15): 104–112. Weijer, C., and J. A. Anderson. 2001. The ethics wars. Disputes over international research. Hastings Center Report 31(3): 18–20.
Conceptualizing Ancillary Care Obligations in Health Systems Research Nate W. Olson, Stanford University In their target article, Hyder and colleagues (2014) provide an excellent conceptual framework for addressing the distinctive ethical issues posed by health systems research (HSR). With their general framework in place, I take up the task in this commentary of beginning to fill in one piece of it. I focus on a piece that has begun to receive attention in research ethics but still, in some respects, remains at the exploratory stage: ancillary care, or medical care that research participants need but that is not required for a study’s safety or validity or to redress research injuries (Richardson 2012, 2–3). What has been written on ancillary care has tended to concentrate on the obligations researchers have to individual participants.1 In HSR, however, the participants are often groups rather than individuals, as Hyder and colleagues note. Therefore, further conceptual work is needed to understand the nature of ancillary care obligations in HSR. Additionally, given Hyder and colleagues’ focus on HSR in low- and middle-income countries (LMIC), the need for better understanding of this issue is particularly important, as these are the research environments where the issue of ancillary care is thought to be the most pressing. Here, I explain how ancillary care concerns can arise in HSR. As I explain, ancillary care may take a somewhat different shape in HSR, but much of the rationale for thinking that researchers bear
ancillary care obligations carries over from the clinical research context. First, even given Hyder and colleagues’ claim that benefits that are ancillary to other types of research are central aims of HSR, it’s clear that health systems researchers can, and likely will, uncover ancillary health needs in the course of their research. Like other researchers, they are apt to discover individual health needs that are outside the scope of their studies. For example, when testing the effectiveness of a new delivery system for malaria bed nets, members of the research team may notice unrelated health needs in those who receive bed nets. But, importantly, health systems researchers are also uniquely well placed to discover systemic health needs. For instance, when studying the effectiveness of the bed net distribution system, the researchers may uncover previously unnoticed deficiencies in other health care distribution systems in the same community. Understanding that ancillary care needs may be systemic as well as individual allows us to identify the full breadth of needs health systems researchers may be obligated to address.2 It also lends further support to Hyder and colleagues’ claim that ethical reviews of HSR ought to take into account a wider range of benefits than is common practice.
1. See, for example, Belsky and Richardson (2004), Dickert and Wendler (2009), and Richardson (2012). Hyder and Merritt (2009) is a notable exception. 2. While Hyder and Merritt (2009) note that ancillary care in public health research may be owed to groups rather than individuals, the idea that health systems themselves may be the target of ancillary care has not been addressed, to my knowledge, in the literature. Address correspondence to Nate W. Olson, Stanford University, Center for Biomedical Ethics, 1215 Welch Road, Modular A, Stanford, CA 94305-5417, USA. E-mail: [email protected]
46 ajob
February, Volume 14, Number 2, 2014
Downloaded by [Universidad de Sevilla] at 04:58 21 October 2014
Ethical Review of Health Systems Research
Establishing that health systems researchers do in fact bear ancillary care obligations is more than I can accomplish here, but if one is convinced that researchers in clinical trials have ancillary care obligations—as many are—then one likely ought to think that health systems researchers bear such obligations too. For instance, to justify ancillary care obligations, Merritt and colleagues (Merritt, Taylor, and Mullany 2010) appeal to the duty of rescue, that is, the duty to provide urgently needed assistance when one is uniquely able to do so at minimal cost. The same duty would apply to some ancillary health needs discovered in HSR, especially in LMIC. Belsky and Richardson’s (2004) “partial-entrustment” model offers a different justification of ancillary care obligations, one based in the permissions that are granted in the informed consent process. This justification can also transfer to HSR, even though consent often occurs at the group level. By giving permission to conduct research in their communities, groups may be said to entrust oversight of certain health needs to researchers. Therefore, while ethical reviews of ancillary care in HSR ought to take both individual and systemic benefits into account, the ethical considerations they employ to evaluate whether researchers ought to provide such benefits are likely to remain the same. Existing views of ancillary care obligations give us a couple of reasons to think that health systems researchers ought to pay particular attention to the systemic needs they discover. First, if ancillary care obligations are owed to research participants—as is usually thought—then such obligations would be owed primarily to groups in HSR, since they are the primary participants, as Hyder and colleagues indicate. The researchers’ ancillary care obligations would then be to address the group’s health needs, and addressing systemic needs would be the clearest means of doing so. Second, given the nature of their expertise, health systems researchers are particularly well positioned to identify and help repair systemic health needs. They may discover deficiencies in health systems that other sorts of researchers are unlikely to find, and they may be able to offer strategies for repairing these deficiencies that other sorts of researchers cannot. Consequently, communities may be particularly dependent on health systems researchers to
diagnose and repair systemic health needs, a factor that strengthens ancillary care obligations according to many views, including those of both Merritt and colleagues (2010) and Belsky and Richardson (2004). These two points support Hyder and colleagues’ contention that collective benefits are those that matter most in HSR. However, ethical reviews of HSR must be careful not to overlook relevant individual health needs. Health systems researchers may have ancillary care obligations for individuals too when they are secondary participants in studies, especially when their participation requires individual informed consent. Responsible ethical review of ancillary care in HSR will require careful attention to both the similarities to and differences from other forms of research. The differences, including the inclusion of systemic health needs and the use of group consent, provide further support for Hyder and colleagues’ view that ethical review of HSR ought to be modified to account for its unique features. However, the similarities to clinical research show that certain aspects of standard ethical review still have their place.3 REFERENCES Belsky, L., and H. S. Richardson. 2004. Medical researchers’ ancillary clinical care responsibilities. British Medical Journal 328: 1494– 1496. Dickert, N., and D. Wendler. 2009. Ancillary care obligations of medical researchers. Journal of the American Medical Association 302(4): 424–428. Hyder A. A., and M. W. Merritt. 2009. Ancillary care for public health research in developing countries. Journal of the American Medical Association 302(4): 429–431. Hyder, A. A., A. Rattani, C. Krubiner, A. M. Bachani, and N. T. Tran. 2014. Ethical review of health systems research in low- and middleincome countries: A conceptual exploration. American Journal of Bioethics 14(2): 28–37. Merritt, M. W., H. Taylor, and L. C. Mullany. 2010. Ancillary care in community-based public health intervention research. American Journal of Public Health 100: 211–216. Richardson, H. S. 2012. Moral entanglements: The ancillary-care obligations of medical researchers. Oxford, UK: Oxford University Press.
3. Thanks to Emily Borgelt for helpful discussion of many of the ideas in this commentary.
February, Volume 14, Number 2, 2014
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