This article was downloaded by: [Northwestern University] On: 26 December 2014, At: 18:49 Publisher: Routledge Informa Ltd Registered in England and Wales Registered Number: 1072954 Registered office: Mortimer House, 37-41 Mortimer Street, London W1T 3JH, UK
The American Journal of Bioethics Publication details, including instructions for authors and subscription information: http://www.tandfonline.com/loi/uajb20
Vulnerability as a Concept for Health Systems Research Margaret Meek Lange
a
a
Macquarie University Published online: 12 Feb 2014.
Click for updates To cite this article: Margaret Meek Lange (2014) Vulnerability as a Concept for Health Systems Research, The American Journal of Bioethics, 14:2, 41-43, DOI: 10.1080/15265161.2014.872437 To link to this article: http://dx.doi.org/10.1080/15265161.2014.872437
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
Ethical Review of Health Systems Research
Applied Environmental Microbiology 74(10): 2997–3001. PubMed PMID: 18359829. Pubmed Central PMCID: 2394916. Council for International Organizations of Medical Sciences. 2002. International ethical guidelines for biomedical research involving human subjects. Geneva, Switzerland: CIOMS. 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: 930–937. Fontaine, O., and C. Newton. 2001. A revolution in the management of diarrhoea. Bulletin of the World Health Organization 79(5): 471–472. PubMed PMID: 11417043. Pubmed Central PMCID: 2566417.
Downloaded by [Northwestern University] at 18:49 26 December 2014
Gold, M. 2009. Pathways to the use of health services research in policy. Health Services Research 44(4): 1111–1136. PubMed PMID: 19490163. Pubmed Central PMCID: 2739019. Hurst, S. A. 2008. Vulnerability in research and health care: Describing the elephant in the room? Bioethics 22(4): 191–202. Hurst, S. A., S. Reiter-Theil, A. M. Slowther, R. Pegoraro, R. Forde, and M. Danis. 2008. Should ethics consultants help clinicians face scarcity in their practice? Journal of Medical Ethics 34(4): 241–246. PubMed PMID: 18375673. Epub 2008/04/01. eng.
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. Millum, J., D. Wendler, and E. J. Emanuel. 2013. The 50th anniversary of the Declaration of Helsinki: Progress but many remaining challenges. Journal of the American Medical Association 310(20): 2143– 2144. Participants in the 2001 Conference on Ethical Aspect of Research in Developing Countries. 2002. Fair benefits for research in developing countries. Science 298(5601): 2133–2134. PubMed PMID: 12481120. Rubenstein, L. V., and J. Pugh. 2006. Strategies for promoting organizational and practice change by advancing implementation research. Journal of General Internal Medicine 21(suppl. 2): S58–S64. PubMed PMID: 16637962. Pubmed Central PMCID: 2557137. World Medical Association. 2013. World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. Journal of the American Medical Association 310(20): 2191–2194.
Vulnerability as a Concept for Health Systems Research Margaret Meek Lange, Macquarie University In “Ethical Review of Health Systems Research in Lowand Middle-Income Countries: A Conceptual Exploration,” Hyder and colleagues (2014) discuss the emerging field of health systems research (HSR). The term refers to a broad class of projects and studies. Underlying their apparent diversity, these projects investigate the delivery of existing treatments rather than, as in the case of clinical research, testing new treatments (World Health Organization 2009, 7). The struggles of various low- and middle-income countries to approach the United Nations Millennium Development Goals underscore the need for such projects. It has become clear that the greatest barriers to reaching healthrelated goals are not lack of treatment but systemic—social, cultural, or material—factors that make it difficult to match treatment with the individuals who need it (Travis et al. 2004, 900). An example of an HSR project is testing the efficacy of directly observed treatment, short-course (DOTS) delivery for tuberculosis, or testing whether conditional cash transfers encourage people to vaccinate their children. The authors of the article argue that HSR projects should be subject to a review process but that the criteria for review should not be the same as those used for clinical research projects. They argue that HSR projects differ from tradi-
tional clinical research in eight ways and that each category of difference motivates a corresponding alteration of the ethical review process. This commentary focuses on the authors’ discussion of the inclusion of vulnerable groups in HSR, and complicates the sharp distinction the authors draw between HSR and clinical research. Within clinical research ethics, vulnerable groups are defined as those populations especially at risk of harms and wrongs. The Belmont Report, for instance, speaks of prisoners and the poor as examples of vulnerable groups (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1979). Scholarly treatments of vulnerability in the setting of clinical ethics grapple with the question of how to treat the vulnerable as research subjects. Options include a variety of special protections, as well as exclusion from research altogether. Hyder and colleagues point out that, compared to clinical research projects, prospective HSR projects are more likely to confront populations considered vulnerable, such as the poor in developing countries. This is because vulnerable groups are more likely to occupy the weak health systems that would utilize such research, especially as their countries struggle to meet the Millennium Development
Address correspondence to Dr. Margaret Meek Lange, 244 Euclid Street, Santa Monica, CA 90402, USA. E-mail: [email protected]
February, Volume 14, Number 2, 2014
ajob 41
Downloaded by [Northwestern University] at 18:49 26 December 2014
The American Journal of Bioethics
Goals. The authors argue that excluding these groups from research would be unfair, given the potential benefits, as well as objectionably paternalistic. They also consider the question of groups—like women, or men who have sex with men—that constitute subpopulations of the vulnerable poor and are at even greater risk. They emphasize that HSR will face issues with respect to these subpopulations. First of all, improving health across the population as a whole with new delivery methods may increase inequity, if the especially vulnerable subpopulations are left behind. This outcome should be guarded against. Second, if HSR projects require processes of group consultation or group consent to go forward, it is important that these subpopulations are adequately represented in the consultation process. Rogers, Mackenzie, and Dodds (2012) have developed a typology of vulnerability that can guide thinking about obligations to the vulnerable. This typology, I argue, can help guide thinking in the context of HSR in particular, and is worth proposing as a guide to review bodies. First, the typology distinguishes among inherent, situational, and pathogenic sources of vulnerability. Inherent sources of vulnerability are those all humans share, and are due to our corporeality, mortality, and social nature. Situational sources vary from person to person, and include the many social, economic, and political causes of vulnerability (Rogers et al. 2012, 24). Finally, pathogenic sources of vulnerability are those situational sources that are due to objectionable social arrangements. It is emphasized that one important cause of pathogenic vulnerability is the failure to respect individual autonomy (Rogers et al. 2012, 25). The two states of vulnerability, in turn, are occurrent and dispositional. Although all vulnerability is risk of harm, occurrent vulnerability refers to very likely outcomes in the near future, while dispositional vulnerability refers to farther off and less likely outcomes (Rogers et al. 2012, 24–25). In general, the distinctions made by the typology map onto different duties, both long-term and short-term. In the short term, we have a duty to mitigate vulnerability from all sources by taking steps to decrease risks. Occurrent vulnerability is a more urgent priority than dispositional vulnerability, but we should take care that dispositional vulnerability does not become occurrent (Rogers et al. 2012, 25). In the long term, we should work to eliminate situational sources of vulnerability whenever possible, especially those that are pathogenic, and build resilience to inherent sources of vulnerability. In both the short and the long term, the goal of fostering autonomy should be seen as a goal complementary to that of protecting the vulnerable, not in conflict with it (Rogers et al. 2012, 23–24). So far, we have adapted the typology to the context of research ethics, with a focus on clinical research (Lange, Rogers, and Dodds 2013; Rogers and Lange 2013). We begin by classifying the sources and states of vulnerability of the representative member of the population to be employed as a research subject. In the case of the extra vulnerable individual, there will be many situational sources of vulnerability, especially pathogenic sources of vulnerability, and vulnerability will tend to be occurrent. In the
42 ajob
context of a research project, the researcher has a duty not to exacerbate existing vulnerabilities, especially occurrent ones. We emphasize that, while paying attention to vulnerability, the researcher should respect autonomy as much as possible (Lange et al. 2013, 4–5). In the context of a research program, the researcher has a duty to help eliminate situational sources of vulnerability whenever possible, again with a focus on pathogenic vulnerability (Rogers and Lange 2013, 2144). We suggest that these considerations can be integrated into the current review process (Lange et al. 2013, 2). Guided by the typology, we have considered projects both in clinical research and in HSR. In our Bioethics paper, we consider the example of clinical trials for pre-exposure prophylaxes for HIV (Lange et al. 2013, 5–7). In our paper on minority vulnerability published in the American Journal of Public Health, we consider both clinical trials and studies that fall into the category of HSR, such as a study of the efficacy of individualized instruction for management of type II diabetes in patients with poor literacy (Rogers and Lange 2013, 2144). Thus, in general, our approach to vulnerability applies equally to the setting of clinical ethics and to HSR. If the HSR case is distinctive, its special nature will be reflected in the particular sources and states of vulnerability experienced in the HSR context. Here the authors’ comments can be explicated in terms of the typology and its attendant duties. For instance, consider the worry that HSR, which is successful overall may further marginalize or leave behind certain subpopulations. The researcher’s duty to avoid this outcome can be framed as the duty to avoid creating pathogenic vulnerability with the research. The focus of our account on fostering the autonomy of the vulnerable also explains the need to include all subgroups in consultations about research. While there is still work to be done in integrating our account of vulnerability into the existing review of research ethics, I argue that it can play a part in both clinical research and health systems research. At the highest level, the same considerations about the vulnerable are relevant to both types of research. FUNDING The research for this paper was supported by an Australian Research Council grant DP110102272: Vulnerability, Autonomy and Justice (CIs C. Mackenzie, W. Rogers and S. Dodds). REFERENCES 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. Lange, M.M., W. Rogers, and S. Dodds. 2013. Vulnerability in research ethics: A way forward. Bioethics 27(6): 333–340. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1979. The Belmont Report: Ethical principles and guidelines for the protection of human subjects of
February, Volume 14, Number 2, 2014
Ethical Review of Health Systems Research
research. Washington, DC: Department of Health, Education, and Welfare. Available at: http://www.hhs.gov/ohrp/ humansubjects/guidance/belmont.html
Travis P., S. Bennett, A. Haines, et al. 2004. Overcoming healthsystems constraints to achieve the Millennium Development Goals. Lancet 364:900–1006.
Rogers, W., and M. M. Lange. 2013. Rethinking the vulnerability of minority populations in research. American Journal of Public Health 103(12): 2141–2146.
World Health Organization. 2009. Scaling up research and learning for health systems: Now is the time. Report of a High Level Task Force (presented and endorsed at the Global Ministerial Forum on Research for Health 2008), Bamako, Mali. Available at: http:// www.who.int/rpc/publications/scaling up research/en/index. html
Rogers, W., C. Mackenzie, and S. Dodds. 2012. Why bioethics needs a concept of vulnerability. International Journal of Feminist Approaches to Bioethics 5(2): 11–38.
Tinkering With the Health of the Poor Downloaded by [Northwestern University] at 18:49 26 December 2014
Stuart Rennie, University of Chapel Hill When teaching ethics at our school of public health, I sometimes refer to public health activities as forms of “tinkering.” This does not make me popular. After all, the definition of tinkering, according to the Oxford English Dictionary (2010), refers to “attempts to repair or improve something in a casual or desultory way, often to no useful effect.” Those who tinker are tinkers, historically associated with those who used to travel from place to place mending metal utensils as a way of making a living. Particularly among young public health students, these descriptions fly in the face of their budding self-image as future professionals aiming to improve population health by means of rigorous scientific methodologies. Changing the world, yes. Tinkering, no. I obviously bring in the concept of tinkering to be provocative. It helps to elicit assumptions and underline how public health is a child of the Enlightenment. Public health is part of a larger mind set that takes societies to be a human artifacts rather than (say) expressions of a God-given order, hence something that can and should be manipulated by means of reason to produce improved outcomes over the status quo. This way of viewing society as improvable through reason—that we hold our (health) destiny in our own hands—is relatively new. The institution of public health is but one of its manifestations. The close historical relationship between the rise of public health and the rise of the modern state drives the point home. But after reading the engaging and informative article by Hyder and colleagues (2014), the association between public health and tinkering may be more than rhetorical. The main focus of the article is on the inadequacy of current regulations to capture what is specific to what they call “health systems research” (HSR). But that conceptualization of HSR is not quite right, since some of the research interventions they describe are not directed at improving health systems per se. Some of them are research interventions in the community that attempt to link groups with health systems (i.e., incentives for taxi drivers to transport pregnant
women to clinics), while others aim to improve the health of communities fairly straightforwardly (i.e., using social media for smoking prevention). When Hyder and colleagues endorse the view that HSR “aims to understand how new interventions that are efficacious can be made more widely accessible to potential beneficiaries through policies, organizations, and programs,” this sounds much like another concept often used in this context, namely, “implementation science.” The latter has the advantage of not being restricted to health systems. Or to go back to my theme: Implementation science indicates that not only health systems are in need of tinkering. So what is the relationship between public health and tinkering? Perhaps a place to start is the well-known thesis of the social determinants of health (Marmot 2005). If population health and disease are largely due to social (including cultural, religious, economic, political) factors, then we ought to design interventions that positively impact those factors. Moreover, we should test to make sure that the interventions will actually work (and to what extent) in the rough-and-tumble of social reality. This is where things can get murky. As Hyder and colleagues note, even interventions whose efficacy seems proven can produce unintended social and ethical challenges in the course of their implementation. Stimulating the use of clinics for childbirth (rather than home delivery) seems like an obvious way to reduce infant and maternal mortality. But how actually it plays out depends on contextual factors. What if women strongly associate home delivery with what it is to be a “real” mother, and the medicalization of birth as a sign of weakness? What effects will such initiatives have on women’s other health-seeking behaviors? Health interventions are always interventions in the fabric of social worlds, and the nature, scope, and magnitude of the impacts produced by the interventions are not always easy to anticipate or control. Of course, even with clinical research, there is a gap between an intervention’s
Address correspondence to Stuart Rennie, PhD, MA, 333D MacNider Hall, 333 South Columbia Street, Department of Social Medicine, UNC Bioethics Center, University of Chapel Hill, Chapel Hill, NC 27599, USA. E-mail: stuart [email protected]
February, Volume 14, Number 2, 2014
ajob 43
The American Journal of Bioethics Publication details, including instructions for authors and subscription information: http://www.tandfonline.com/loi/uajb20
Vulnerability as a Concept for Health Systems Research Margaret Meek Lange
a
a
Macquarie University Published online: 12 Feb 2014.
Click for updates To cite this article: Margaret Meek Lange (2014) Vulnerability as a Concept for Health Systems Research, The American Journal of Bioethics, 14:2, 41-43, DOI: 10.1080/15265161.2014.872437 To link to this article: http://dx.doi.org/10.1080/15265161.2014.872437
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
Ethical Review of Health Systems Research
Applied Environmental Microbiology 74(10): 2997–3001. PubMed PMID: 18359829. Pubmed Central PMCID: 2394916. Council for International Organizations of Medical Sciences. 2002. International ethical guidelines for biomedical research involving human subjects. Geneva, Switzerland: CIOMS. 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: 930–937. Fontaine, O., and C. Newton. 2001. A revolution in the management of diarrhoea. Bulletin of the World Health Organization 79(5): 471–472. PubMed PMID: 11417043. Pubmed Central PMCID: 2566417.
Downloaded by [Northwestern University] at 18:49 26 December 2014
Gold, M. 2009. Pathways to the use of health services research in policy. Health Services Research 44(4): 1111–1136. PubMed PMID: 19490163. Pubmed Central PMCID: 2739019. Hurst, S. A. 2008. Vulnerability in research and health care: Describing the elephant in the room? Bioethics 22(4): 191–202. Hurst, S. A., S. Reiter-Theil, A. M. Slowther, R. Pegoraro, R. Forde, and M. Danis. 2008. Should ethics consultants help clinicians face scarcity in their practice? Journal of Medical Ethics 34(4): 241–246. PubMed PMID: 18375673. Epub 2008/04/01. eng.
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. Millum, J., D. Wendler, and E. J. Emanuel. 2013. The 50th anniversary of the Declaration of Helsinki: Progress but many remaining challenges. Journal of the American Medical Association 310(20): 2143– 2144. Participants in the 2001 Conference on Ethical Aspect of Research in Developing Countries. 2002. Fair benefits for research in developing countries. Science 298(5601): 2133–2134. PubMed PMID: 12481120. Rubenstein, L. V., and J. Pugh. 2006. Strategies for promoting organizational and practice change by advancing implementation research. Journal of General Internal Medicine 21(suppl. 2): S58–S64. PubMed PMID: 16637962. Pubmed Central PMCID: 2557137. World Medical Association. 2013. World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. Journal of the American Medical Association 310(20): 2191–2194.
Vulnerability as a Concept for Health Systems Research Margaret Meek Lange, Macquarie University In “Ethical Review of Health Systems Research in Lowand Middle-Income Countries: A Conceptual Exploration,” Hyder and colleagues (2014) discuss the emerging field of health systems research (HSR). The term refers to a broad class of projects and studies. Underlying their apparent diversity, these projects investigate the delivery of existing treatments rather than, as in the case of clinical research, testing new treatments (World Health Organization 2009, 7). The struggles of various low- and middle-income countries to approach the United Nations Millennium Development Goals underscore the need for such projects. It has become clear that the greatest barriers to reaching healthrelated goals are not lack of treatment but systemic—social, cultural, or material—factors that make it difficult to match treatment with the individuals who need it (Travis et al. 2004, 900). An example of an HSR project is testing the efficacy of directly observed treatment, short-course (DOTS) delivery for tuberculosis, or testing whether conditional cash transfers encourage people to vaccinate their children. The authors of the article argue that HSR projects should be subject to a review process but that the criteria for review should not be the same as those used for clinical research projects. They argue that HSR projects differ from tradi-
tional clinical research in eight ways and that each category of difference motivates a corresponding alteration of the ethical review process. This commentary focuses on the authors’ discussion of the inclusion of vulnerable groups in HSR, and complicates the sharp distinction the authors draw between HSR and clinical research. Within clinical research ethics, vulnerable groups are defined as those populations especially at risk of harms and wrongs. The Belmont Report, for instance, speaks of prisoners and the poor as examples of vulnerable groups (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1979). Scholarly treatments of vulnerability in the setting of clinical ethics grapple with the question of how to treat the vulnerable as research subjects. Options include a variety of special protections, as well as exclusion from research altogether. Hyder and colleagues point out that, compared to clinical research projects, prospective HSR projects are more likely to confront populations considered vulnerable, such as the poor in developing countries. This is because vulnerable groups are more likely to occupy the weak health systems that would utilize such research, especially as their countries struggle to meet the Millennium Development
Address correspondence to Dr. Margaret Meek Lange, 244 Euclid Street, Santa Monica, CA 90402, USA. E-mail: [email protected]
February, Volume 14, Number 2, 2014
ajob 41
Downloaded by [Northwestern University] at 18:49 26 December 2014
The American Journal of Bioethics
Goals. The authors argue that excluding these groups from research would be unfair, given the potential benefits, as well as objectionably paternalistic. They also consider the question of groups—like women, or men who have sex with men—that constitute subpopulations of the vulnerable poor and are at even greater risk. They emphasize that HSR will face issues with respect to these subpopulations. First of all, improving health across the population as a whole with new delivery methods may increase inequity, if the especially vulnerable subpopulations are left behind. This outcome should be guarded against. Second, if HSR projects require processes of group consultation or group consent to go forward, it is important that these subpopulations are adequately represented in the consultation process. Rogers, Mackenzie, and Dodds (2012) have developed a typology of vulnerability that can guide thinking about obligations to the vulnerable. This typology, I argue, can help guide thinking in the context of HSR in particular, and is worth proposing as a guide to review bodies. First, the typology distinguishes among inherent, situational, and pathogenic sources of vulnerability. Inherent sources of vulnerability are those all humans share, and are due to our corporeality, mortality, and social nature. Situational sources vary from person to person, and include the many social, economic, and political causes of vulnerability (Rogers et al. 2012, 24). Finally, pathogenic sources of vulnerability are those situational sources that are due to objectionable social arrangements. It is emphasized that one important cause of pathogenic vulnerability is the failure to respect individual autonomy (Rogers et al. 2012, 25). The two states of vulnerability, in turn, are occurrent and dispositional. Although all vulnerability is risk of harm, occurrent vulnerability refers to very likely outcomes in the near future, while dispositional vulnerability refers to farther off and less likely outcomes (Rogers et al. 2012, 24–25). In general, the distinctions made by the typology map onto different duties, both long-term and short-term. In the short term, we have a duty to mitigate vulnerability from all sources by taking steps to decrease risks. Occurrent vulnerability is a more urgent priority than dispositional vulnerability, but we should take care that dispositional vulnerability does not become occurrent (Rogers et al. 2012, 25). In the long term, we should work to eliminate situational sources of vulnerability whenever possible, especially those that are pathogenic, and build resilience to inherent sources of vulnerability. In both the short and the long term, the goal of fostering autonomy should be seen as a goal complementary to that of protecting the vulnerable, not in conflict with it (Rogers et al. 2012, 23–24). So far, we have adapted the typology to the context of research ethics, with a focus on clinical research (Lange, Rogers, and Dodds 2013; Rogers and Lange 2013). We begin by classifying the sources and states of vulnerability of the representative member of the population to be employed as a research subject. In the case of the extra vulnerable individual, there will be many situational sources of vulnerability, especially pathogenic sources of vulnerability, and vulnerability will tend to be occurrent. In the
42 ajob
context of a research project, the researcher has a duty not to exacerbate existing vulnerabilities, especially occurrent ones. We emphasize that, while paying attention to vulnerability, the researcher should respect autonomy as much as possible (Lange et al. 2013, 4–5). In the context of a research program, the researcher has a duty to help eliminate situational sources of vulnerability whenever possible, again with a focus on pathogenic vulnerability (Rogers and Lange 2013, 2144). We suggest that these considerations can be integrated into the current review process (Lange et al. 2013, 2). Guided by the typology, we have considered projects both in clinical research and in HSR. In our Bioethics paper, we consider the example of clinical trials for pre-exposure prophylaxes for HIV (Lange et al. 2013, 5–7). In our paper on minority vulnerability published in the American Journal of Public Health, we consider both clinical trials and studies that fall into the category of HSR, such as a study of the efficacy of individualized instruction for management of type II diabetes in patients with poor literacy (Rogers and Lange 2013, 2144). Thus, in general, our approach to vulnerability applies equally to the setting of clinical ethics and to HSR. If the HSR case is distinctive, its special nature will be reflected in the particular sources and states of vulnerability experienced in the HSR context. Here the authors’ comments can be explicated in terms of the typology and its attendant duties. For instance, consider the worry that HSR, which is successful overall may further marginalize or leave behind certain subpopulations. The researcher’s duty to avoid this outcome can be framed as the duty to avoid creating pathogenic vulnerability with the research. The focus of our account on fostering the autonomy of the vulnerable also explains the need to include all subgroups in consultations about research. While there is still work to be done in integrating our account of vulnerability into the existing review of research ethics, I argue that it can play a part in both clinical research and health systems research. At the highest level, the same considerations about the vulnerable are relevant to both types of research. FUNDING The research for this paper was supported by an Australian Research Council grant DP110102272: Vulnerability, Autonomy and Justice (CIs C. Mackenzie, W. Rogers and S. Dodds). REFERENCES 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. Lange, M.M., W. Rogers, and S. Dodds. 2013. Vulnerability in research ethics: A way forward. Bioethics 27(6): 333–340. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1979. The Belmont Report: Ethical principles and guidelines for the protection of human subjects of
February, Volume 14, Number 2, 2014
Ethical Review of Health Systems Research
research. Washington, DC: Department of Health, Education, and Welfare. Available at: http://www.hhs.gov/ohrp/ humansubjects/guidance/belmont.html
Travis P., S. Bennett, A. Haines, et al. 2004. Overcoming healthsystems constraints to achieve the Millennium Development Goals. Lancet 364:900–1006.
Rogers, W., and M. M. Lange. 2013. Rethinking the vulnerability of minority populations in research. American Journal of Public Health 103(12): 2141–2146.
World Health Organization. 2009. Scaling up research and learning for health systems: Now is the time. Report of a High Level Task Force (presented and endorsed at the Global Ministerial Forum on Research for Health 2008), Bamako, Mali. Available at: http:// www.who.int/rpc/publications/scaling up research/en/index. html
Rogers, W., C. Mackenzie, and S. Dodds. 2012. Why bioethics needs a concept of vulnerability. International Journal of Feminist Approaches to Bioethics 5(2): 11–38.
Tinkering With the Health of the Poor Downloaded by [Northwestern University] at 18:49 26 December 2014
Stuart Rennie, University of Chapel Hill When teaching ethics at our school of public health, I sometimes refer to public health activities as forms of “tinkering.” This does not make me popular. After all, the definition of tinkering, according to the Oxford English Dictionary (2010), refers to “attempts to repair or improve something in a casual or desultory way, often to no useful effect.” Those who tinker are tinkers, historically associated with those who used to travel from place to place mending metal utensils as a way of making a living. Particularly among young public health students, these descriptions fly in the face of their budding self-image as future professionals aiming to improve population health by means of rigorous scientific methodologies. Changing the world, yes. Tinkering, no. I obviously bring in the concept of tinkering to be provocative. It helps to elicit assumptions and underline how public health is a child of the Enlightenment. Public health is part of a larger mind set that takes societies to be a human artifacts rather than (say) expressions of a God-given order, hence something that can and should be manipulated by means of reason to produce improved outcomes over the status quo. This way of viewing society as improvable through reason—that we hold our (health) destiny in our own hands—is relatively new. The institution of public health is but one of its manifestations. The close historical relationship between the rise of public health and the rise of the modern state drives the point home. But after reading the engaging and informative article by Hyder and colleagues (2014), the association between public health and tinkering may be more than rhetorical. The main focus of the article is on the inadequacy of current regulations to capture what is specific to what they call “health systems research” (HSR). But that conceptualization of HSR is not quite right, since some of the research interventions they describe are not directed at improving health systems per se. Some of them are research interventions in the community that attempt to link groups with health systems (i.e., incentives for taxi drivers to transport pregnant
women to clinics), while others aim to improve the health of communities fairly straightforwardly (i.e., using social media for smoking prevention). When Hyder and colleagues endorse the view that HSR “aims to understand how new interventions that are efficacious can be made more widely accessible to potential beneficiaries through policies, organizations, and programs,” this sounds much like another concept often used in this context, namely, “implementation science.” The latter has the advantage of not being restricted to health systems. Or to go back to my theme: Implementation science indicates that not only health systems are in need of tinkering. So what is the relationship between public health and tinkering? Perhaps a place to start is the well-known thesis of the social determinants of health (Marmot 2005). If population health and disease are largely due to social (including cultural, religious, economic, political) factors, then we ought to design interventions that positively impact those factors. Moreover, we should test to make sure that the interventions will actually work (and to what extent) in the rough-and-tumble of social reality. This is where things can get murky. As Hyder and colleagues note, even interventions whose efficacy seems proven can produce unintended social and ethical challenges in the course of their implementation. Stimulating the use of clinics for childbirth (rather than home delivery) seems like an obvious way to reduce infant and maternal mortality. But how actually it plays out depends on contextual factors. What if women strongly associate home delivery with what it is to be a “real” mother, and the medicalization of birth as a sign of weakness? What effects will such initiatives have on women’s other health-seeking behaviors? Health interventions are always interventions in the fabric of social worlds, and the nature, scope, and magnitude of the impacts produced by the interventions are not always easy to anticipate or control. Of course, even with clinical research, there is a gap between an intervention’s
Address correspondence to Stuart Rennie, PhD, MA, 333D MacNider Hall, 333 South Columbia Street, Department of Social Medicine, UNC Bioethics Center, University of Chapel Hill, Chapel Hill, NC 27599, USA. E-mail: stuart [email protected]
February, Volume 14, Number 2, 2014
ajob 43
