Aron Spital, Conscription of Cadaveric Organs for Transplantation: A Stimulating Idea Whose Time Has Not Yet Come, 14 Camb Q Healthc Ethics 107 (2005). They allow IRBs to exercise discretion and allow for research without consent, although IRBs no doubt sometimes refuse to allow such waivers when they should, and sometimes wrongly grant such waivers when they should not. Owen Schaefer, Ezekiel J. Emanuel & Alan Wertheimer, The Obligation to Participate in Biomedical Research, 302 JAMA 67 (2009). And all this is unproblematic. Consider two cases: (1) some people are offended by the sight of an interracial couple; (2) many African-Americans would take offense at being called colored. If a sufficient number of surrogates for Alzheimer's patients did not consent for them to participate, would it be legitimate to require patients to undergo procedures such as a lumbar puncture or a blood draw for the non-therapeutic purpose aim of trying to identify biological markers of the disease? Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. I conclude that it probably is not. We have a moral responsibility to protect research participants from harm. We can also imagine requiring people to participate in a randomized controlled trial rather than receiving the treatment that the individual or her physician prefers, particularly when there is no evidence favoring such treatment. In the United States, the requirements for obtaining informed consent from research participants are stipulated by several regulations and policies. If some or most of the foregoing examples represent legitimate exercises of state coercion, are there good reasons to regard it as illegitimate to require people to accept the burdens of participation in research? For example, we usually cannot collect data from minors without parental or guardian permission. Second, even when a violation of bodily integrity does not interfere with one's life plans, it may give rise to considerable psychological distress. Here we may make a distinction between (1) research without valid consent and (2) coercive participation. If the principal justification for CR is that it protects and promotes the interests of the consenter, then that justification will have relatively little purchase in those cases where participation involves minimal risks and burdens. Informed Consent for Clinical Trials | FDA Even here, Jon Elster thinks there are good reasons to favor rules over something like the best interest standard; see Solomonic Judgments (1989). Informed consent and its importance is a significant part of science for good reasons. If I am right, the need for consent in interventional biomedical research or, indeed, in any form of research may have little to do with the fact that the interaction between investigators and subjects is pursuant to generalizable knowledge. Justice and the Integrity of the Person, 21 Utilitas 233 (2009). The question then becomes how to understand the moral importance of such distress. It is not of intrinsic importance. Consider a mandatory national service program that would require young adults (say 18 or 19 year olds) to serve in a national service program of some kind. Judith Thomson suggests that we should distinguish between belief-mediated distress and non-belief mediated distress.61 When A pricks B's finger or inserts a needle for a blood draw, A's action causes B to experience simple or non-belief-mediated distress. Confidentiality, public interest, and the human right to science: when can confidential information be used for the benefit of the wider community? Susan Wolf objects to this principle on the grounds that it might allow us to do things to someone even if we had no reason whatsoever to suppose that the person affected by it would consent to itindeed, it would allow us to do things to a person even if he explicitly refuses to consent to it under conditions of full rationality and information. So even if people have a moral obligation to participate in research, it does not follow that it would be legitimate to require them to do so or do on pain of penalty or, for that matter, to use them as subjects without their informed consent. Now the firstjudgement respectingdimension of autonomy is more relevant to medical care than to research. In sum, we can't weigh the benefits of using coercion as a benefit in our moral calculus without also counting its negative effects, and, at the end of the day, the game of facilitating recruitment may not be worth the candle. And this is so even if these activities or relationships should be governed by different norms. If I am forced I have no chance to consent. Consider what might seem to be a counterexamplea Phase I challenge study of an experimental cholera vaccine at the University of Vermont. David Wendler has argued that research-related risks are regarded as particularly fraught because the procedures such as blood draws and lumbar punctures are directly initiated by another person rather than being the result of employment activities that are organized by others but where the injuries are incidental to those activities.83 In addition, people may project some of their attitudes about the ethics of medical care, whose goal is to promote the interests of patients, to the ethics of medical research, whose goal is to yield generalizable knowledge. In effect, Mill is claiming that because interference with purely personal conduct is usually wrong and because society cannot be trusted to interfere primarily when it is likely that such interference is right, it is better to adopt a rule that bars paternalistic intervention. Some examples, such as educational research or research on welfare policy or health policy, can affect the quality of people's lives and sometimes whether they live or die. From this perspective, it does not matter much as to whether the use of coercion should be viewed so negatively. As Richard Arneson observes, you have a moral right not to be tortured murdered for fun, but you also have a moral right that your extra shirt button on your least favorite shirt not be taken from you without your consent.42 If we assume that something like the Common Rule's conditions for waivers of consent are reasonable, then it seems that if there is a general right not to be used in research without one's consent, that right cannot be very strong. So, considerations of reciprocity tell against requiring less from the sick than from healthy persons. There are at least three related difficulties with opting for discretionary decision processes as opposed to using rules or standards. whether prior consent or consent from surrogates can and should be sought, even if they are not explicitly required by regulations. He argues that we should reject any prescription never to treat people merely as a means. Three concluding points about the body are as follows. If we could turn back the clock such that the Constitution did not include the Second Amendment, then we might be well served by the sort of general prohibition on handguns. Finally, I argue that even if the use of coercion is legitimate and sometimes justifiable as a matter of first-order ethics, there are good moral reasons to adopt a rule or policy that bars coercive participation. Or compare the risks of participation in research with the risks of employment. The purpose of this article is to ask that question. Oxford University Press is a department of the University of Oxford. . As Nir Eyal puts it (in a related context), . e) Negative externalities. Second, much of what was or is standard medical practice, such as tonsillectomies, annual physicals, routine EKGs, and PSA tests, is harmful or without any demonstrated benefit. There are at least two moral questions we can ask about coercive participation. Here I want to explore the alleged tension between promoting a person's interests and respecting a person's judgement or autonomy. As Rawls puts it, acting autonomously is acting from principles that we would consent to as free and equal rational beings .45 This conception of autonomy does not preclude coercing people to do that which they have an obligation to do. As Parfit argues, there are some contexts in which we could give rational consent to a system or rule that does not require actual consent, but there are other contexts in which we could only give rational consent to a system or rule that requires actual consent. That depends. Can the state legitimately require people to undergo the inconvenience of participation, to answer surveys (as in the census), and to allow their deidentified medical records or stored tissues to be used to generate knowledge that would benefit others? Second, it is not clear how much weight to assign to these deontological considerations. In this view, it is one thing to confiscate a person's resources through taxation and quite another to coercively extract a unit of blood or a kidney. 2011). It turns out, however, that multiple overlapping justifications for CR have been and can be offered. In addition, comparative effectiveness research can establish which of several common treatments is most effective, and enables us to spend less to achieve comparable medical results. This is too quick. There are two points. Some belief-mediated distress is a function of normative beliefs. It merely states that the severity of the crime should be a factor in the decision. We reduce decision costs by using rules rather than standards or principles. Rules are the most constraining and rigid. A law that states Custody should be awarded to the mother or the primary caregiver if she (or he) wishes to have custody would be a rule. The origin of the modern regulations for informed consent in the U.S. date back to the 1930s, when Nazi physicians conducted horrific experiments on human subjects without their consent before and during WWII. In Parfit's view, A's doing X to B violates NMMP only when A's doing X ignores B's moral claims. After all, Kant defends a retributive theory of punishment on which the state does not violate NMMP when it punishes a criminal who has been judged to be guilty and who receives his just deserts. The police may stop and frisk people. Health Information Portability and Accountability Act (HIPAA) Privacy Rule, future research use and broad data sharing, special considerations for genomics research. . By contrast, given that the costs of allowing coercive participation in the biomedical context would be quite visible and provide a field day for Fox News, it is probably better to treat coercion as illegitimate as a matter of course and to require informed consent. And it is hard to see why we should regard paying people to participate in research as morally unworthy or unseemly while it is perfectly permissible to pay people to perform these otheroften dirty and disagreeabletasks. . To evaluate potential prevention modalities, researchers first need to identify biological markers for its presence. Nagel Thomas, Libertarianism without Foundations, 85 Yale Law J 136 (1975). Indeed, the same strategy can justify treating all deviations from CR as illegitimate in interventional biomedical research. It is possible, of course, that we should require explicit informed consent (without deception) in all research even though doing so would bring much valuable research to a screeching halt. Perhaps the interests of subjects should be weighed more heavily than the interests of the beneficiaries of research just as the interests of innocent defendants should be weighed more heavily than the public interest in a higher rate of conviction of the guilty. In addition, and as a general ethical principle, we are not entitled to ask others to spend time on our projectswhatever they arewithout their undeceived consent, whether or not our projects have anything to do with the development of generalizable knowledge. FROM LEGITIMACY TO JUSTIFIABILITY (AND BACK AGAIN), http://www.hhs.gov/ohrp/archive/nurcode.html, http://www.wma.net/en/30publications/10policies/b3/, http://digitalcommons.law.yale.edu/ylsop_papers/5/, http://www.sevendaysvt.com/vermont/uvm-will-make-people-sick-to-test-an-experimental-cholera-vaccine/Content?oid=2265749, Receive exclusive offers and updates from Oxford Academic, The most plausible pro-coercion view: requiring informed agreement while penalizing non-participation in research, Informed consent to participation in interventional studies: second-order in a different sense, Copyright 2023 Oxford University Press and Harvard, Duke and Stanford Law Schools. It cannot be entirely coincidental that the very conditions that are thought to render an agent's decisions less than fully autonomouscoercion, deception, and incompetenceare also conditions that reduce the likelihood that her decisions advance her well-being. If the positive case for research with or without consent is consequentialist, then it follows that coercive participation is surely not justified if the negative consequences outweigh the positive. And that makes a change in policy both politically unlikely and morally questionable given a commitment to democratic norms. A policy of coercive participation might also undermine trust in and support for the research enterprise. But the point remains that the state regularly makes policies that affect what happens to our bodies without our consent. We have obligations as patients to contribute to the common purpose of improving the quality and value of clinical care and the heath care system . DOES THIS ARGUMENT APPLY TO BOTH PATIENTS AND HEALTHY PERSONS? Second, even if that argument could be supported, it would not establish that it is illegitimate to coerce people into participating in research on the grounds that doing so violates a general right not to be used for research without their consent. 2014 Jul;40(7):435-6. doi: 10.1136/medethics-2014-102264. Additionally, HIPPA and the Common Rule permit research on information from deceased individuals who did not provide consent before death. Alzheimer disease constitutes an enormous burden on society and its members. If the penalties were severe enough to motivate people to comply (for example, like going to jail for contempt of court for refusing to testify as a witness), they might well be viewed as excessively harsh unless there was a substantial cultural shift with respect to the obligation to participate in research. What van der Graaf and van Delden call this the not merely as a means principle (NMMP) has achieved mantra-like status in bioethics.33 To say that a practice treats someone merely as a means is generally viewed as a conversation stopper. Alan Wertheimer, (Why) should we require consent to participation in research?, Journal of Law and the Biosciences, Volume 1, Issue 2, June 2014, Pages 137182, https://doi.org/10.1093/jlb/lsu008. Just as we are prepared to do more to save identifiable coal miners trapped in a mine than to prevent similar mining accidents to future statistical miners, we are more willing to conduct road salt research that puts unidentified drivers on slippery roads at risk than to require identifiable drivers to participate in road safety research. I have argued that the principle and its justificatory story are more complex and pluralistic. Third, much public policy research occurs in a context in which the state is entitled to make public policy without the specific consent of those affected. This involves a lumbar puncturethe insertion of a needle into the backs of subjectsto obtain a small amount of cerebrospinal fluid. Recall the Common Rule's conditions for waiver of consent. David Sobel, Self-Ownership and the Conflation Problem, in 3 Oxford Studies in Normative Ethics 98122 (Mark Timmons ed., 2013). So we return to the question: can we defend the view that it is illegitimate for the state to require people to participate in interventional research whereas it is legitimate for the state to require people to perform the wide variety of actions that have been mentioned (and others)? It is one thing to take someone's fungible money via taxation because we can plan on not having those resources and because few matters of importance are tied to a specific level of money. . Consider sexual relations between psychotherapists and patients.96 Such relations might be morally permissible if both parties could give valid consent and if such relations were not harmful to patients. Automated data extraction of unstructured grey literature in health If all citizens have an enforceable duty to make an easy rescue or report that they witnessed a crime should the situation arise, then there is a universal duty that requires action only when such situations arise. Kasper Lippert-Rasmussen, Against Self-Ownership: There are No Fact-Insensitive Ownership Rights Over One's Body, 36 Phil & Pub Aff 86 (2008). Biomedical Research / ethics Given the long lead-times of producing high-quality peer-reviewed health information this is causing a demand for new ways to provide prompt input for secondary research. John S. Mill, Principles of Political Economy (1848, book 5, c. 11, 12). Ectogestation and the Good Samaritan Argument, Ethical and Legal Issues of Social Experimentation 21, The Oxford Textbook of Clinical Research Ethics, Dan Ariely, The Honest Truth about Dishonesty: How We Lie to Everyone, Human Subjects Research Regulation: Perspectives on the Future, John Harris, Enhancing Evolution: The Ethical Case for Making Better People, Ethical and Regulatory Aspects of Clinical Research, Ruth R. Faden & Tom L. Beauchamp, A History and Theory of Informed Consent, Allan Gibbard, Reconciling Our Aims: In Search of Bases for Ethics, Tom L. Beauchamp & James F. Childress, Principles of Biomedical Ethics, Robert Nozick, Anarchy, State, and Utopia, Charles Fried, Medical Experimentation: Personal Integrity and Social Policy, Ethical and Legal Issues of Social Experimentation 105, John S. Mill, Principles of Political Economy, Frederick F. Schauer, Playing by the Rules, ARGUMENTS FOR THE ILLEGITIMACY OF COERCIVE PARTICIPATION, RESPECT FOR PERSONS AND RESPECT FOR AUTONOMY. As I have argued throughout, it is the interventional dimension of research that is crucial to the argument for CR, rather than the fact that any such intervention is undertaken as research. I disagree. Robert Wachbroit & David Wasserman, Research Participation: Are We Subject to a Duty?, 5 Am J Bioethics 48 (2005). If it does, then it is the special wrong of violating bodily integrity that does the moral work in applying NMMP. By contrast, such judgement respecting concerns are irrelevant to whether it is legitimate to coerce people into participation in research. If we pay people from public funds to participate in medical research and if the subject pool is disproportionately poor, then the affluents are effectively using the tax system to buy their way out of participating in research.
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