***The following question needs to be answered, Question 1)***
1. Whether or not there is a moral duty to participate in research, there are categories of potential subjects – such as employees, students, and researchers themselves – whose participation may merit extra scrutiny. Should IRBs provide special protections for one or more of these potential subject groups? Why or why not?
UAJB_A_348027.tex This article was downloaded by: [Wake Forest University] On: 17 September 2013, At: 09:03 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 In Defense of the Duty to Participate in Biomedical Research Rosamond Rhodes a a Mount Sinai School of Medicine, Published online: 17 Nov 2008. To cite this article: Rosamond Rhodes (2008) In Defense of the Duty to Participate in Biomedical Research, The American Journal of Bioethics, 8:10, 37-38, DOI: 10.1080/15265160802478594 To link to this article: http://dx.doi.org/10.1080/15265160802478594 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. 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Terms & Conditions of access and use can be found at http:// www.tandfonline.com/page/terms-and-conditions http://www.tandfonline.com/loi/uajb20 http://www.tandfonline.com/action/showCitFormats?doi=10.1080/15265160802478594 http://dx.doi.org/10.1080/15265160802478594 http://www.tandfonline.com/page/terms-and-conditions http://www.tandfonline.com/page/terms-and-conditions The American Journal of Bioethics, 8(10): 37–44, 2008 Copyright c© Taylor & Francis Group, LLC ISSN: 1526-5161 print / 1536-0075 online DOI: 10.1080/15265160802478594 Open Peer Commentaries In Defense of the Duty to Participate in Biomedical Research Rosamond Rhodes, Mount Sinai School of Medicine In de Melo-Martin’s (2008) criticism of my position in “Re- thinking Research Ethics” (Rhodes 2005) and my “Reply to Comments on ’Rethinking Research Ethics”’ (Rhodes 2005a), de Melo-Martin (2008) takes it that I have argued for “universal obligations independently of the social con- texts” (28) and been “blinded... to the importance of the so- cial context” (28). Unfortunately, she has not appreciated the critical point that my target article and response presented arguments for a prima facie duty to participate in research which may, of course, be overridden by competing duties. Our ability to fulfill duties to ourselves and others is cer- tainly sometimes compromised by existing circumstances. In this case, the lack of a United States healthcare system and the current healthcare delivery arrangements which leave millions without access to healthcare and research partic- ipants without indemnification for harms incurred in re- search collaboration, are circumstances that could very well leave people with competing duties that override their duty to participate in research. That said, I shall take this opportunity to briefly reprise three inter-related arguments for a duty to participate in re- search: 1) the argument from justice, 2) the argument from beneficence, 3) the argument from self-development. I shall then go on to explain that de Melo-Martin actually focuses on a very narrow range of examples, namely, clinical stud- ies of pharmaceutical agents. In opposition to her stand, I maintain that looking at the broad spectrum of biomedical research suggests the conclusion that we all have a duty to participate in research and that participation also serves our interests. As I see it, these arguments are untouched by de Melo-Martin’s (2008) points about the social context of United States biomedical research. THE ARGUMENT FROM JUSTICE We are all vulnerable to death, pain, disability, and the loss of pleasure and freedom that may be consequent to disease. These are conditions that we all would prefer to avoid, and This commentary draws on my remarks at the (APA), Pacific Division meeting, Pasadena, CA (March 20, 2008), where I presented comments on an article by Inmaculada de Melo-Martin: “A response to De Melo-Martin on a duty to participate in research.” Address correspondence to Rosamond Rhodes, Mount Sinai School of Medicine, One Gustave Levy Place, New York, NY. E-mail:
[email protected] when we or our loved ones are afflicted, we would all want a remedy to be available. Almost everyone has and almost all of their loved ones have medical needs at some point in their lives. Yet, we must acknowledge the need for improv- ing on the standard of care for numerous conditions such as Alzheimer’s disease, Parkinson’s disease, sickle cell dis- ease, end-stage renal disease, schizophrenia, and stroke. We need to learn about the causes and natural development of diseases, and the effectiveness of treatment for conditions such as burns, cancer, and severed spinal cords. The desired advance in treatment can only be achieved by studying our bodies. Study involves some sacrifice of our flesh, our pri- vacy, our safety, our comfort, and our time. Because these basic goods are precious to everyone, non-instrumental ba- sic principles of justice, such as equality and the anti-free- rider principle, require each to do her fair share to advance the common good. Because we each expect ourselves and our loved ones to share in the benefits of future medical ad- vances, at least to some degree, each of us must participate. THE ARGUMENT FROM BENEFICENCE Our obligation to do unto others as we would be done by leads to the same conclusion. Because we would each want effective treatment when we had a medical need, and because such medical advances require the coopera- tion of many in the research enterprise, non-instrumental basic principles of universalization and mutual love dictate that we should give of ourselves to help advance medical sci- ence. Our emotional and genetic interrelatedness, the lack of an adequate alternative, and the commonality of the desire to benefit from medical knowledge create the participatory duty. THE ARGUMENT FROM SELF-DEVELOPMENT We each should live our lives by taking responsibility for ourselves, in Kantian terms, as good rulers over ourselves. ajob 37 D ow nl oa de d by [ W ak e Fo re st U ni ve rs ity ] at 0 9: 03 1 7 Se pt em be r 20 13 The American Journal of Bioethics Looking into the future with awareness of the fragility of our bodies, we owe it to ourselves to take steps that would make it most likely that we could fend off disease and disability so as to retain our autonomy. Because biomedical research offers our best chance for achieving that end, and because we cannot will an end without also willing the necessary means to achieve it, we are duty-bound to participate in research. DE MELO-MARTIN’S NARROW VIEW De Melo-Martin’s (2008) position appears to derive from focusing attention on a narrow set of examples, specifically clinical studies of pharmaceutical agents. Looking instead at the broad spectrum of biomedical research and the emerging work on personalized medicine yields different conclusions about the duty to participate in biomedical research. Although approximately 45 million uninsured Ameri- cans have no access to primary care, we all have access to emergency medical care and to some measure of charity care, and the children of many uninsured households are covered by the State Children’s Health Insurance Program (S-CHIP). Beyond that, many of us are hopeful that the in- tolerable status quo will be corrected in the not too distant future. This amounts to saying that, although the current dis- tribution of healthcare is far from just, we all do have a stake in advancing the field. In addition, even at present, a good deal of biomedical research helps everyone or everyone with a similar medical need. Public health research, disease con- trol research, preventive medicine research, mass casualty medical research, quality assurance research, health policy research all focus on populations, leaving no one out. This amounts to saying that the social disparities are not so sig- nificant as to defuse the duty to participate in research. Furthermore, while some research, particularly some of the phase one drug studies that De Melo-Martin (2008) dis- cusses, may involve significant risks, a good deal of research does not. Even when drug and device studies involve risk, thoughtful regulations and proper oversight should assure that only a reasonable degree of risk is involved and that steps should be taken to minimize even that risk. OUR INTERESTS Looking into the genetics-informed future makes the case even more strongly. The expectation is that researchers will learn a great deal more about the human genome and the human microbiome and that this new knowledge will allow medicine to tailor treatments to individuals. These advances promises to make medicine more effective and, therefore, more affordable. The studies, however, will require the de- velopment of biobank and sample bank repositories with the participation of a tremendous number of subjects. To reap the rewards of advancing the practice of medicine, broad public participation will be required. Furthermore, to the extent that any group abstains from participation, their members will be less able to share in the rewards precisely because their genetic and microbiomic samples are absent from the pool. When you and yours are not studied, the information to help you will not be available. I am in no way an apologist for current injustices in our healthcare arrangements. The poor, those in the lower middle-class, part-time workers, those who have lost their jobs, those with chronic illness, undocumented immigrants and their children all lack good access to health care, and those injustices call out for correction. I do, however, want to point out that existing injustices can only be exacerbated by members of those groups refusing to participate in research. If your group is not studied, it is less likely that advances to benefit people with your disease or with your genetic sus- ceptibilities will be developed. And if your group does not participate in studies that assess health disparities, no one will know that health disparities of the sort that negatively affect you exist, and corrective measures will not be taken. So, in addition to the principle-based arguments for a duty to participate in research, add the prudential argument for research participation. Furthermore, if you do not play, you have little say. When research participation is a voluntary activity involv- ing a relatively small group of kind-hearted and gullible individuals, the rest of the population is