Ethics in clinical research
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Vulnerable article: guidelines for human subject directly a local institutional review board oversees the clinical research ethics of any given clinical trial. Each countries national law is guided by international principles, such as the belmont report's directive that all study participants have a right to "respect for persons", "beneficence", and "justice" when participating in clinical participant rights[edit]. Is a range of autonomy which study participants may have in deciding their participation in clinical research. One of the measures for safeguarding this right is the use of informed consent for clinical researches. 2] researchers refer to populations which have low autonomy as "vulnerable populations"; these are groups which may not be able to fairly decide for themselves whether to participate in clinical trials. Examples of groups which are vulnerable populations include incarcerated persons, children, prisoners, soldiers, people under detention, migrants, persons exhibiting insanity or any other condition which precludes their autonomy, and to a lesser extent, any population for which there is reason to believe that the research study could seem particularly or unfairly persuasive or misleading. Isbn of research participant rights from harvard school of public al trial ethics ethics in clinical ch participant y for research subject al research ines for human subject of medical ethics ation of ring in clinical utional review monitoring ity advisory ries: research ethicsmedical ethicsclinical research logged intalkcontributionscreate accountlog pagecontentsfeatured contentcurrent eventsrandom articledonate to wikipediawikipedia out wikipediacommunity portalrecent changescontact links hererelated changesupload filespecial pagespermanent linkpage informationwikidata itemcite this a bookdownload as pdfprintable page was last edited on 17 june 2017, at 23: is available under the creative commons attribution-sharealike license;. A non-profit rd encyclopedia of ial and citation ethics of clinical researchfirst published fri jan 30, 2009; substantive revision mon feb 27, al research attempts to address a relatively straightforward,And extremely important challenge: how do we determine whether l intervention is better than another, whether it offers greater clinical benefit and/or poses fewer risks? Clinicians may one day to answer these questions by relying on computer models, ng reliance on clinical research and the ethical concerns . Until that day, clinical researchers begin by ial new medical interventions in the laboratory, and often s. While these methods can provide valuable information and, case of animal research, raise important ethical issues of , potential new interventions eventually must be tested . In this way, the process of collecting data to improve health and well-being exposes research subjects to risks for the benefit of future patients. These studies thus provide a e of the central ethical challenge posed by ch: when is it ethically permissible to expose research subjects to risks of harm for the benefit of others? The present entry ts the range of interesting and important ethical challenges in the course of conducting clinical research: how should it ed? Might attempt to address the central ethical limiting clinical research to the medical setting, mental interventions to patients who want to try them. Ch, which has the virtue of evaluating interventions in s of trying to help individual patients, can make sense for comparisons of two or more interventions that are widely accepted and already in clinical use. Therefore, in addition to being of its own right, evaluation of the ethics of clinical es an opportunity to consider one of the more ns in moral theory: when is it acceptable to expose duals to risks of harm for the potential benefit of others? Clinical to the subset of human subjects research which focuses on interventions e human health and well-being. The present analysis focuses on research that is designed e human health and well-being by identifying better methods , cure or prevent illness. This focus on treating, curing ting illness is intended to bracket the question r research on enhancements qualifies as clinical research. Ch has the potential to improve well-being, allowing us to remember more and worry less, without identifying methods to address shall also bracket the question of whether quality quality assurance projects qualify as clinical research. Y consider the type of research at the heart of this debate,Consider a hospital which proposes to evaluate the impact ists on the quality of patient care. The whether this activity constitutes clinical research is tical interest for clarifying the precise boundaries of t. Should we say that this is not clinical research because ist is used by the nurses, not administered to the patients? We say this is clinical research because it involves atic testing of a hypothesis which is answered by on patient outcomes? And this theoretical clarification has significant practical implications, determining whether these activities must satisfy tions for clinical research, including whether the to obtain patients’ informed consent to use the clinical medicine is enormously better than it was 100 50 years ago, there remain many diseases against which al medicine offers an inadequate response.
The social value of clinical research lies ability to collect information that might be useful to ed methods to treat these conditions. Yet, it is the al research study which definitively establishes that ular method is effective and safe for treating, curing ting some illness. The success of specific research studies ly lies in the gathering of information needed to inform to establishing the efficacy of an experimental treatment for. Given condition, researchers typically need to identify the cause condition, possible mechanisms for treating it, a safe ive dose, and ways of testing whether the drug is having on the process of testing potential new treatments can take , and is standardly divided into phases. As a result, icant amount of the ethical concern over clinical s on phase 1 phase 1 testing is successful, potential new treatments go on phase 2 studies which are designed to further assess risks to evaluate whether there is any evidence that the be beneficial. Finally, post-marketing or phase s evaluate the use of interventions in clinical al trials of experimental treatments typically include ch procedures, such as blood draws, imaging scans, or biopsies,That are performed to collect data regarding the treatment . Analysis of the ethics of clinical research thus tion of three related risk-benefit profiles: (a) -benefit profile of the interventions(s) ; (b) the risk-benefit profile of the included ures; and (c) the risk-benefit profile of the study as ial new treatments sometimes are in the ex ante interests ch subjects. Cases, participation in research poses ‘net’ risks,That is, risks of harm which are not, or not entirely, justified ial clinical benefits to individual subjects. The qualifier to ‘essentially’ no chance of clinical benefit is intended to capture the fact that the research ed in clinical trials may inadvertently end up providing some clinical benefit to some subjects. For example, a biopsy that is used to collect research data may disclose a previously unidentified and treatable condition. Whether a study as a whole poses net risks depends r the potential benefits of the experimental sate for its risks plus the net risks of the research ed in the al research which poses net risks raises important n. Research procedures that pose net risks may seem to concern when they are embedded within a study which offers ble risk-benefit profile overall. Igator who is about to insert a needle into a research obtain some blood purely for laboratory purposes faces the whether doing so is ethically justified, even when the procedure is included in a study that offers subjects the potential for important medical benefit. Absolute net risks arise when of an intervention or procedure are not justified by ial clinical benefits. Most commentators focus on ility with respect to research procedures which pose some offer no chance of clinical benefit, such as blood draws to for laboratory studies. Clinical research also poses absolute net risks when a chance for clinical benefit which is not sufficient y the risks subjects face. This eless poses net risks if the chance for clinical benefit for the subjects is ient to justify the risks of their undergoing the ve net risks arise when the risks of a research justified by its potential clinical benefits, but ention’s risk-benefit profile is less favorable than -benefit profile of one or more available alternatives. The trial thus poses relative ct net risks arise when a research intervention has ble risk-benefit profile, but the intervention diminishes -benefit profile of other interventions provided as part of or el to the study. The risks of research participation can nded if the indicated response to the harm in question posse additional risks. Kidney damage suffered as the result of research participation might lead to the need -term dialysis which poses additional risks to the individual; a subject who experiences a re headache might need a ‘blood patch’ some risk of blood entering al space which would call for a further response which brings with it additional risks. While commentators tend to focus on the risks al harm, participation in clinical research can pose of risks as well, including psychological, economic, and . Depending on the study and the circumstances, individuals injured as the result of participating in research might icant expenses. Most guidelines and regulations stipulate tion of the acceptability of clinical research studies into account all the different risks to which subjects assess the ethics of exposing subjects to risks, one needs an account exposing others to risks raises ethical concern in the first exposed to risks obviously raises concern to the extent that ial harm to which the risk refers is realized: the chance of he turns into an actual headache. In contrast, the literature on the ethics of clinical itly assumes that being exposed to risks is not itself harmful. Fact that subjects are exposed to risks is not regarded as necessarily making them worse singly, researchers are storing human biological samples them in future research projects. Individuals undoubtedly have an interest in avoiding of physical harms they face in clinical research. It seems duals’ interests also may be implicated, and possibly thwarted,When they contribute to particular projects, activities and e that an individual provides a blood sample igators store and use in future research projects designed e goals which conflict with the individual’s fundamental values. Are the interests of an fundamentally opposes cloning, and constructs her life s to stop it, set back if she contributes to a research identifies improved methods to clone human beings? Research subjects to risks of harm is considered matic largely because it has the potential to result in harmed. Reveals an important although typically implicit feature of es of the ethics of clinical research.
In fact, while tion of research subjects is important, it does not exhaust of clinical research. Put generally, a full analysis of the ethics of exposing subjects to risks needs to justify both the treatment of the subjects and the behavior of the future oriented aspect of clinical research is izing. Almost no one objects to operating on y, consenting adult to obtain a kidney that might save an g, even though the operation poses some risk of serious harm and offers the donor no potential for clinical benefit. Many clinical research studies expose subjects to risks to collect generalizable information which, if combined with s of other, as yet non-existent studies, may eventually patients through the identification of a new intervention, assuming the appropriate regulatory e it, some company or group chooses to manufacture it, ts can afford to purchase it. Thus, to understand the current state ethics of clinical research, it is useful to know something of its. Early clinical clinical research may have begun on the 20th of may,1747, aboard the hms salisbury. Lind assigned a different intervention of the groups, including two sailors turned research subjects ed 2 oranges and 1 lemon each day. Within a week these two s again; the others remained patients, and several were ethics of clinical research begins by asking how we should the fate of these latter sailors. To put ental concern raised by clinical research in its simplest form:Did lind sacrifice these two sailors, patients under his care, for ’s experiments represent perhaps the first modern clinical e he attempted to address one of the primary challenges who set out to evaluate medical treatments. It is also that lind’s dramatic results were largely ignored for decades,Leading to uncounted and unnecessary deaths, and highlighting ance of combining clinical research with effective promulgation entation. And, by taking the choice of which treatment a given es out of the hands of the treating clinician, these core and, some argue, exacerbate the ethical concerns raised al research (hellman and hellman 1991). A clinical investigator on the same methods receives awards and gets published in elite journals. Indeed, one account maintains that the history ric research is “largely one of child abuse”. This history has had a significant influence on how research ethicists concerns raised by clinical research and on makers attempt to address them. 1997), which is frequently regarded as set of formal guidelines for clinical research, an ironic two counts. First, there is some debate over whether the was intended to apply generally to clinical research or whether,As a legal ruling in a specific trial, it was intended to address cases before the court (katz 1996). These guidelines were still legally in force at the time of atrocities and clearly prohibited a great deal of what the addition to being ignored by practicing researchers, wide ped by the end of the 1950s that the nuremberg code uate to the ethics of clinical research. Specifically, erg code did not include a requirement that clinical e independent ethics review and approval. In addition, the longest principle in the nuremberg code states that t is “essential” to ethical clinical research. It s to preclude clinical research with individuals who could simply insist that the informed consent of subjects is ethical clinical research and accept the opportunity costs ed. They recognized that insisting ed consent as a necessary condition for clinical research de a good deal of research designed to find better ways to ia and conditions affecting children, as well as research ncy situations. Regarding consent as necessary precludes ch even when it poses only minimal risks or offers subjects sating potential for important clinical benefit. The challenge,Still facing us today, is to identify protections for ts which are sufficient to protect them without being so to preclude appropriate research designed to benefit the groups declaration of helsinki (world medical organization 1996) duals who cannot consent to be enrolled in clinical on the permission of the subject’s representative. These regulations are not laws in the strict sense of by congress and applying to all research conducted on. Federal monies, for instance,Research funded by the nih, or research involving nih researchers,Must follow the u. Regulations continue to exert enormous influence around the e so much clinical research is conducted using u. National commission,Which was charged with evaluating the ethics of clinical research and developing recommendations for ards. These deliberations resulted in a series endations for the conduct of clinical research, which became ork for existing u. In contrast, are placed on the level of research risks to which those consent may be exposed, particularly children. In the case ric research, the standard process for review and approval d to studies that offer a ‘prospect of direct’.
Regulations do e a ceiling on the risks to which pediatric research be exposed for the benefit of others. Clinical research and clinical l attempts have been made to justify exposing research risks for the benefit of future patients. Lind’s experiments exemplify the fact that clinical research is often conducted ians and often is conducted on patients. Many commentators assumed that the ethics of clinical research should be the ethics of clinical care, and the methods of research should e from the methods that are acceptable in clinical care. Approach, subjects should not be denied any beneficial ble in the clinical setting and they should not be exposed risks not present in the clinical proponents (rothman 2000) argue that this approach is implied kind of treatment that patients, understood as individuals a condition or illness needing treatment, are owed. These commentators argue is unacceptable for a physician to participate in, or even participation of her patients in a clinical trial unless is consistent with the patients’ medical interests. To do to provide substandard medical treatment and to violate one’tions as a claim that the treatment of research subjects should be the norms which govern clinical care has been applied ently to the ethics of randomized clinical trials (hellman &. Because this aspect al research represents a clear departure from the practice al medicine it appears to sacrifice the interests of subjects to collect valid of the most influential responses to this concern(freedman 1987) argues that randomization able when the study in question satisfies what has come to as ‘clinical equipoise. Clinical equipoise , for the population of patients from which subjects will ed, the available clinical evidence does not favor one of ents being used over the others. Satisfaction of these to imply that the interests of research subjects will not ined in the service of collecting scientific information. Available data do not favor any of the treatments being used,Randomizing subjects seems as good a process as any other for treatment they ents of clinical equipoise as an ethical requirement for clinical research determine whether equipoise obtains not by appeal to states of individual clinicians, but based on whether there sus among the community of experts regarding which treatment . Yet, in the absence of agreement among the community s, this view essentially constituted an individual than a clinical norm. In this way, the existence of uncertainty within ity of experts seems to offer a way to reconcile the methods al research with the norms of clinical s respond that even when clinical equipoise obtains for tion of patients, the specific circumstances of ts within that population may imply that one of the investigation is better for them (gifford 2007). Current debate focuses on ized clinical trials can take these possibilities into a way that is consistent with the norms of clinical if the existence of clinical equipoise can justify ized trials, a significant problem remains, namely, many studies and procedures which l to the identification and development of improved methods ting and advancing health and well-being istent with subjects’ medical interests. This for many phase 1 studies which offer essentially no chance l benefit and pose at least some risks, and to that extent istent with the subjects’ medical 3 studies which randomize subjects to a potential new existing standard treatment, and satisfy clinical equipoise,Typically include non-beneficial procedures, such as additional , to evaluate the drugs being tested. Yet, evaluation of the overall risk-benefit profile of the study masks that it includes individual procedures which are subjects’ medical interests, and contrary to the norms of attempt to protect research subjects by appeal to the ians have to promote the medical interests of their seems to leave healthy volunteers unprotected. It follows that appeal to clinical equipoise render clinical research consistent with the norms of tators sometimes attempt to justify net-risk procedures that ed within studies, and studies that overall pose net risks guishing between ‘therapeutic’ and. The claim is that the consistency with subjects’ medical interests applies only eutic research; non-therapeutic research studies and diverge from these norms to a certain extent, provided subjects’. The n therapeutic and non-therapeutic research is sometimes based design of the studies in question, and sometimes based on the intentions investigators. Those designed to collect generalizable in which the investigators intend to do so -therapeutic problem with the distinction between therapeutic -therapeutic research so defined is that research itself often d as a practice designed to collect generalizable knowledge ted by investigators who intend to achieve this end (levine. Perhaps they design the study in a provides subjects with clinically useful findings, or e minor care not required for research purposes, or referrals gues. Even if one can make good on the distinction eutic and non-therapeutic research in theory, these to render it irrelevant to the practice of ch. Why investigators are allowed to expose patients to some risks benefit of others, but only in the context of research that is ed to benefit the subjects? This view would imply that physicians may not ts’ medical interests when conducting therapeutic studies, seems to prohibit non-therapeutic research procedures ts. Alternatively, one might argue that physicians’ sibilities apply only in the context of clinical care and so apply in the context of clinical research at all. It provides to think that physicians’ obligations differ based on the research in critics argue that these problems highlight the ion that results when one attempts to evaluate clinical on norms appropriate to clinical medicine. They guish between the ethics of clinical research and the ethics al care, arguing that it is inappropriate to assume igators are subject to the claims and obligations which apply ians, despite the fact that the individuals who conduct ch often are physicians (miller and brody 2007). Claim that clinical research should satisfy the norms of ne has this strong virtue: it provides a clear method t individual research subjects and reassure the public that being so protected. If research subjects must be tent with their medical interests, we can be ent that improvements in clinical medicine will not be won expense of exploiting them. Most accounts of the ethics al research now recognize the limitations of this approach le to find ways to ensure that research subjects are not excessive risks without assuming that the claims of ne apply to clinical researchers (emanuel, wendler, and grady.
Dismissal of the distinction between non-therapeutic research thus yields an increase in tual clarity and concern regarding the potential of research ians, first trained as physicians taught to act in the sts of the patient in front of them, often struggle with s of exposing some patients to risky procedures for the others. It is one thing for philosophers to insist, no matter tely, that research subjects are not patients and need not d according to the norms of clinical medicine. It is for clinical researchers to regard research subjects who ing from disease and illness as anything other ts. These clinical instincts, while understandable and laudable,Have the potential to obscure the true nature of clinical research, igators and subjects alike try to convince themselves al research involves nothing more than the provision of . A libertarian is often said that those working in bioethics are obsessed with ple of respect for individual autonomy. One might this view within bioethics traces to implicit endorsement of a libertarian analysis according it is permissible for competent and informed individuals to er they prefer, provided those with whom they interact ent, informed and in agreement. In the words of mill,Investigators should be permitted to conduct research and ts to risks provided they obtain subjects’ “free,Voluntary, and undeceived consent and participation” (y, page 11). Setting aside the question of whether this view accurately characterizes bioethics and bioethicists generally, it does not apply to the vast majority of work done on of clinical research. Almost no one in the that it is permissible for investigators to conduct ch they want provided they obtain the free and informed the subjects they t research ethics does place significant weight on t and many regulations and guidelines devote much of to articulating the requirement for informed consent. Most regulations and guidelines, beginning with ation of helsinki, first adopted in 1964 (world medical organization 1996), igators to conduct research on human subjects only when it approved by an independent group charged with ensuring that is ethically acceptable. They must find that the research has value and the risks have been minimized before approving it,Thereby restricting the types of research to which even may consent. Presumably, ements placed on clinical research have the effect of some extent the number of research studies that get conducted. That at least some of the prohibited studies likely would ant social value, helping to identify better ways to and well-being, provides a normative reason to eliminate ctions, unless there is some compelling reason to might regard the limitations as betraying the paternalism most approaches to the ethics of clinical research (miller and wertheimer 2007). Although of paternalism often carries with it some degree nation, there is a strong history of what is regarded riate paternalism in the context of clinical research. However, if the thesis that clinical research is normatively distinct al care, we need some reason to think that the norms al care are relevant to clinical research. The fact that ctions on the options available to competent adults in t of clinical research trace to its close relationship al care does not constitute a justification for applying ctions to this normatively distinct context. As noted, this ally important given that the restrictions at least otherwise socially valuable libertarian claim that valid informed consent is necessary ient to justify exposing research subjects to risks for t of others seems to imply, consistent with the first the nuremberg code, that research with individuals who t is unethical. This plausible and tempting claim commits one view that research with children, research in many ions, and research with the demented elderly all are issible. Absent clinical research en, pediatricians will be forced to continue to mes inappropriate treatment, leading to significant harms have been avoided by pursuing clinical research to response would be to argue that the libertarian analysis is ed as an analysis of the conditions under which ch is acceptable. Instead, the claim might be that it analysis of the conditions under which it is acceptable to al research with competent adults. While does not imply that research with subjects who cannot consent issible, it faces the not insignificant challenge of account for why such research might be ting the question of individuals who cannot consent, many of tions on clinical research apply to research with . Even otherwise competent adults often fail tand clinical research sufficiently to make their own ons regarding whether to enroll (flory and emanuel 2004). Consider an example which is much discussed in the research ture, it is commonly assumed that valid consent for al trials requires individuals to understand randomization. There is an impressive wealth of data ts that many, perhaps most individuals who participate al research do not understand this (snowden 1997; donovan 2002; appelbaum 2004). Hard’ paternalism, st, involves interfering with the liberty of an individual to promote their interests, despite the fact that the interfered with is the result of an informed and by a competent the myriad restrictions on clinical research were justified on of hard paternalism they would represent restrictions duals’ autonomous actions. This suggests that restrictions may limit the liberty of adult research subjects, not limit their autonomy. In this way, one may of the regulations on clinical research not as inconsistent libertarian ideal, but instead as starting from that ideal izing that otherwise competent adults often fail to if most research participants have sufficient understanding to provide valid consent, it would that there should be no limitations ch with competent adults. Although this undoubtedly is an important and perhaps on of the regulations, they also have an important role ng the extent to which investigators harm research subjects, ng the extent to which society supports and benefits from s which inappropriately harms others. Investigators should not expose them to such risks ling reason, and society should not support and benefit from their doing aspect of the ethics of clinical research has strong the view that the obligations of clinicians restrict what sort al research they may conduct. This connection highlights the ons that arise once we attempt to move beyond the view al research is subject to the norms of clinical medicine.
A certain plausibility to the claim that a researcher is not a clinician and so may not be subject to the obligations that clinicians. Or perhaps we might say that the researcher/ is distinct from the physician/patient dyad and is arily subject to the same norms. But, once one concludes that an account of the ethics of clinical research, distinct ethics of clinical care, one is left with the question of tions apply to what researchers may do to research seems clear that researchers may not expose research subjects without sufficient justification, and also clear that this s even to those who provide free and informed consent. To consider briefly the extent challenge, and to underscore and clarify the claim that of clinical research go beyond the protection of ts to include the independent consideration of what riate behavior on the part of investigators, consider al and emotional abuse cause enormous suffering, and a good research is designed to study various methods to reduce abuse and also to help victims recover from being abused. Finally, even if these questions ed in a way which supports the research, the question r investigators may treat their subjects in this way. That essentially everyone working in research ethics would this study is unethical—investigators are not permitted subjects in this way—suggests that research ethics, terms of how it is practiced and how it should be practiced, respect for individual autonomy to include rds on investigator behavior. Defining those ents one of the more important challenges for exemplified by lind’s experiments on treatments for scurvy,Clinical research studies were first conducted by clinicians r the methods they were using were effective. In this way, clinical research studies intially of, but an exception to standard clinical practice. And widespread recognition of clinical research’s abuses led to the view that this activity needed its own recently, some commentators have come to question the view al research is a unique human activity, as well as tions and guidelines which result from this view. In particular,It has been argued that this view has led to overly ements on clinical research, requirements that ists’ ability to improve medical care for future patients, fail to respect the liberty of potential research subjects. Is often described in terms of the claim that many guidelines for clinical research are based on an unjustified. Central ethical concern raised by clinical research involves ce of exposing subjects to risks for the benefit of others. Despite this similarity,Non-beneficial clinical research is widely regarded as matic and is subject to significantly greater regulation,Review, and oversight (wilson and hunter 2010). One argues that charitable activities should satisfy ements that are routinely applied to clinical research, such requirements for independent review and written consent based exhaustive description of the risks and potential benefits of ty, its purpose, duration, scope, and that many activities expose some to risks for the benefit , yet are not subject to such extensive regulation, tators conclude that many of the requirements for ch are unjustified (sachs 2010, stewart et al. And this to a straightforward solution to our central ethical problem ying the practice of exposing research subjects to risks for ng factory workers to risks for the benefit of others is deemed able when they agree to do the work and are paid a . This view is much ctive than current regulations for clinical research, but be less permissive than a libertarian analysis. The ence is evident in claims that research studies should ts fairly and not exploit them, even if individuals consent gap between this approach and the traditional view of is evident in the fact that advocates of the traditional to regard payment of research subjects as exacerbating resolving its ethical concerns, raising, among others, worries inducement and commodification. Those who are concerned ch exceptionalism, in contrast, tend to regard payment as it ed in most other contexts in daily life: some is good and claims of research exceptionalism have led to valuable the extent to which clinical research differs from other pose risks to participants for the benefit of others and of the differences justify the extensive regulations ines standardly applied to clinical research. Proponents ch exceptionalism who regard many of the existing regulations ified face the challenge of articulating an appropriate set tions for clinical research. While comparisons to factory e a useful lens for thinking about the ethics of ch, it is not immediately obvious what positive from this perspective. Few commentators (caplan 1984; harris 2005; heyd 1996) ered the possibility of justifying the exposure ts to risks for the benefit of others on the grounds that an obligation to participate in clinical research. One to ground this obligation in the fact that current individuals ted from clinical research conducted on individuals in the least all individuals who have access to medical care have the efforts of previous research subjects in the form of es and better medical t participation in clinical research typically benefits ts. However, if we incur an obligation for the benefits we ed from previous research studies, we presumably are the patients who participated in those studies, an obligation discharge by participating in current studies. This does not provide a way to justify the very first clinical trials,Such as lind’s, which of necessity enrolled subjects who had tted from previous clinical atively, one might argue that the obligation to participate trace to benefits the individuals in fact received from s of previous research participants. A rawlsian vein, one might try to establish an obligation ipate in non-beneficial research based on the duals would make regarding the structure of society from on of ignorance regarding their own place within that society,From behind a veil of ignorance (rawls 1999). The knowledge that one is currently living could well ’s decision against the conduct of clinical research. Those they are alive at the time the decision is being made y reaped many of the benefits they will receive from the clinical avoid these biases, we might stretch the veil of ignorance e the generation to which one belongs—past, present (brock 1994). Under a veil of ignorance so stretched,Individuals might choose to participate in clinical research,Including non-beneficial research as long as the benefits of ce exceed its overall burdens. One could then argue that fairness gives all individuals an obligation to participate al research when their turn comes. This approach seems to advantage of explaining why we can expose even children to for the benefit of others, and why parents can give their children to participate in such research.
This argument to imply not simply that clinical research is acceptable, , in a range of cases, individuals have an obligation to participate in it. It adults whose turn has come are obligated to participate in clinical research,Although for practical reasons we might refrain from forcing them justification for clinical research faces several challenges. At most, then, the present argument can show that it is to enroll a given individual in a research study, that this is. If it isn’t, then it seems that this should be a limitation on the choices individuals can make from behind the veil of ignorance, in which case appeal to those choices will not be able to justify non-beneficial pediatric research, nor ch with incompetent adults. And if this research is ethical it is unclear why we need this mechanism to justify ents might avoid this dilemma by assuming that the veil of ignorance will make decisions based purely -interest, unconstrained by moral limits erations. Many endorse the view that clinical research studies no potential benefit to subjects and pose a high chance s risk, such as death, are unethical, independent of ude of the social value to be gained. For example, almost all research ethicists as unethical a study which intentionally infects a few the hiv virus, even when the study offers the potential to identify. Since the least desirable circumstances (being infected ) are the same in both cases, the reasonable choice, even if es the maximin strategy, seems to be whichever option total number of individuals who are in those circumstances,Revealing that, in the present case at least, the rawlsian not to take into account the way in which individuals end up positions they on risks are a central part of almost t research regulations and guidelines. With respect to those who t, there is an essentially implicit agreement that the not be too high in the context of non-beneficial research ( some argue that there should not be any net risks to ent adults in the context of so-called ch). With respect to those who cannot consent, many commentators argue -beneficial research is acceptable provided that the net risks low. The challenge, currently faced by many in clinical research,Is to identify a standard, and find a reliable way to implement it,For what constitutes a sufficiently low risk in this context. Argue that the risks of clinical research qualify as when they are ‘negligible’, understood as risks not pose any chance of serious harm (nicholson 1986). Ask children a few questions for research purposes may expose risks no more worrisome than that of being mildly upset for a s. Even routine procedures that accepted in pediatric research, such as single blood draws,Pose some, typically very low risk of more than negligible (kopelman 2000; resnik 2005) define risks as sufficiently ‘minimal’ when they do not exceed the risks during the performance of routine examinations. Yet, the risks of routine medical procedures for duals are so low that this standard seems to prohibit intuitively acceptable research. This approach faces the m that, as the techniques of clinical medicine become safer invasive, increasing numbers of procedures used in ch would be deemed excessively risky. And, at a , one might wonder why we should think that the risks tly happen to accept in the context of clinical care for healthy children the level of risk that is acceptable in clinical research. Why think that the ethical acceptability of a non-beneficial blood draw in pediatric research depends on whether clinicians still use blood draws as part of clinical screening for healthy children? National health and medical research council 1999) tators take the view that non-beneficial research is able as long as the risks do not exceed the risks individuals daily life. Many of ed in clinical research implicitly assume that this minimal rd is essentially equivalent to the negligible risk standard. Risks of research are no greater than the risks individuals daily life, then the research does not pose risk of any . Ramsey reports that during the deliberations of the sion on pediatric research, members often used the terms negligible risks in a way which seemed to imply that they g to allow minimal risk research, even with children, on s that it poses no chance of serious harm (ramsey 1978). S then went on to argue that an additional ethical such research is a guarantee of compensation for any ch injuries. The our attitude toward the risks of everyday life is justified ability to help us to get through the day undermines its provide an ethical justification for exposing research subjects same risks in the context of non-beneficial research (ross &. To that extent, these attitudes do e an ethical argument for exposing research subjects to the benefit of others. Probabilities being what they are, the risks of daily rd implies that if we conduct enough minimal risk ally a few subjects will die and scores will suffer suggested above, a more plausible line of argument would be clinical research that poses minimal risks on the grounds does not increase the risks to which subjects are seems plausible to assume that at any given time an individual be participating in research or involved in the activities life. For example, participation in a study might require the subject to drive to for a research visit. In that case, the subject’s risk of from a car trip may be doubled as a result of her research. Finally,And strictly speaking, this justification seems to imply igators should evaluate what risks individuals would face did not enroll in the research, and enroll only those who ise face similar or greater levels of risk. Goals and one of the most influential papers in the history of , hans jonas (1969) argues that the progress ch offers is normatively optional, whereas the need to duals from the harms to which clinical research exposes them ory.
He writes:… unless the present state is intolerable, istic goal [of biomedical research] is in a sense gratuitous,And this is not only from the vantage point of the present. S view does not imply that clinical research is cal, but the conditions on when it may be conducted are . This argument may seem plausible to the extent that s, as jonas does, the benefits of clinical research to be make an acceptable state in life even better. If this were all that clinical research had , we might be reluctant to accept many risks in order e its goals. In response, one might understand jonas to be arguing present state of affairs involves sufficiently good medicine tely flourishing lives such that the needs which could now sed by additional clinical research are not of ance to justify the risks raised by conducting it. First, it might be thought that the conduct cal research reaches beyond individual investigators to y as a whole. This does not seem unreasonable given al research typically is conducted in the name of and often benefit of society. Second, one might be concerned that igators to expose research subjects to some risks for t of others might put us on a slippery slope that ends s abuses throughout alternative reading would be to interpret jonas as arguing from. The idea is that conducting clinical research igators actively exposing individuals to risks of harm and, harms are realized, it involves investigators actively . And, to that clinical research is conducted in the name of and for t of society in general, one can say without too much society is complicit in causing these harms. Not conducting ch, in contrast, involves our allowing individuals to be diseases that we might otherwise have been able to avoid or this situation, albeit tragic and unfortunate, has the virtue involving clear moral problem with at least this version of the argument is that ts of clinical research often involve finding safer ways disease. The benefits of this type of clinical research, to they are realized, involve clinicians being able to harmful, less toxic medications to patients. Put differently,Many types of clinical research offer the potential to l treatments which harm patients less than current ones. One study found that the incidence of e events from the appropriate use of clinical medications. Instead, we decide how to trade off the possibility of clinicians ts to greater risks of harm (albeit with a still favorable risk-benefit ratio) in the process of treating clinical researchers exposing subjects to risk of harm in s of trying to identify improved methods to treat others. The argument that needs to be made is that duals in the process of conducting clinical research es a significant moral wrong not present when clinicians ts in the process of treating primary concern here is that, by exposing subjects to harm, the process of conducting clinical research involves of exploitation of a particular kind. The worry here is not so much that investigators ts enter together into the shared activity of clinical different, perhaps even conflicting goals. The concern is , in the process of conducting clinical research, subjects as if they had no goals at all or, perhaps, that they might have are normatively argues that this concern can be addressed, and the process menting on some to benefit others made ethically acceptable,Only when the research subjects share the goals of the . Ethically appropriate research, on jonas’, is marked by: “appropriation of the research purpose person’s own scheme of ends” (jonas 1969, 236). And it is in one’s interests to achieve one’s, at least, , it follows that, by participating in research, subjects will in their own interests, despite the fact that they are exposed to risky procedures which are performed to ation to benefit claims in some passages that research subjects, at least an illness, can share the goals of a clinical research study they have the condition or illness under study (jonas. On this view, participation al research would promote an individual’s interests as long was well informed and wanted to participate. Jonas’s view, st, seems to be that there are objective conditions under duals can share the goals of a given research study. One might have s with the disease, or co-religionists, or have adopted ent of the disease as an important personal larger question is whether subjects endorsing the goals of al research study is a necessary condition on ability. It might be assumed, that is, that competent, informed, and duals will enroll in research only when they share the goals study in was cognizant of the extent to which the normative by clinical research are not exhausted by the risks to ts are exposed, but also include the extent to igators and by implication society are the agents of re to risks. Moreover,Although we will not pursue the point here, appeal to an t of human interests raises the possibility of justifying s of exposing research subjects to risks for the benefit on the grounds that contributing to valuable projects,Including presumably some clinical research studies, is objectively in. Industry sponsored fundamental ethical challenge posed by clinical research r it is acceptable to expose some to research risks for t of others. In the standard formulation, the one we have ering to this point, the benefits that others enjoy as of subjects’ participation in clinical research are medical benefits, better treatments for disease, better methods ry funded research introduces the potential for a very of benefit and thereby potentially alters, in a fundamental way,The moral concerns raised by clinical research. Y may be able, by relying on a savvy marketing department, ce physicians to prescribe, and consumers to request the , thus increasing profit for the company without advancing majority of clinical research was once conducted by es. For example, the us nih is likely the largest governmental sponsor of clinical research in the world. However, its research budget has declined over the past 20 years (mervis 2004, 2008), and it is estimated that a majority,Perhaps a significant majority of clinical research studies conducted by industry: “as recently as 1991 eighty per cent ry-sponsored trials were conducted in academic s…impatient with the slow pace of academic bureaucracies,Pharmaceutical companies have moved trials to the private sector,Where more than seventy per cent of them are now conducted”.
Addition to transforming the fundamental ethical challenge posed al research, industry sponsored research has the potential orm the way that many of the specific ethical concerns sed within that context. For example, the possibility that investigators s may earn significant amounts of money from their clinical research might, it is thought, warp their judgment in conflict with appropriate protection of research subjects. When applied igators and funders this concern calls into question the icant percentage of research funded by and often conducted -profit organizations. Skeptics might wonder whether the goal money has any greater potential to influence opriately compared to many other motivations that are ed, even esteemed in the context of clinical research, such g tenure and fame, impressing one’s colleagues, or winning ial conflicts of interest in clinical research point to n between relying on profits to motivate research ting drug development and testing from the profit motive as of protecting research subjects and future patients (psaty l 2008). Recognizing that a fair level of benefit is a on of participants’ inputs compared to the inputs of others, extent to which third parties benefit from those inputs, it ult to see how one might fill in the details of this scenario that the typically minimal, or non-existent compensation research participants is the same time, addressing this potential for exploitation ng substantial payments to research participants who contribute to especially lucrative studies would introduce its own ethical concerns: is payment an appropriate response to the kind bution made by research participants; might payment undue inducement to participate; will payment undermine ipants’ altruistic motivations; to what extent does age research subject to provide misleading or false investigators in order to enroll and remain in research studies? End, then, as commentators struggle to address the l concerns raised by clinical research, its conduct in the raises new ethical concerns and, thereby, offers philosophers looking for interesting, not to mention important issues in need of analysis and , m. A change in ch: from alternation to randomised allocation in clinical the 1940s,” bmj, 319: 572–ment of health and human services, 2005. Interventions to ch participants’ understanding in informed consent for research:A systematic review,” journal of the american ation, 292: 1593–arosa p. Reporting conflicts of interest, financial aspects of research,And role of sponsors in funded studies,” journal of an medical association, 294: 110–an, b. Pulling the plug on ise: a critique of miller and weijer,” ute of ethics journal, 17: 203–ar, m. Of mice but not men:Problems of the randomized clinical trial,” the new l of medicine, 324: 1585–, d. Clinical trials in pediatric cancer: ctives on informed consent,” journal of logy and oncology, 25: 787–u, j. Ethical dimensions of ch on children”, in research on children: tives, ethical quandaries, and legal constraints, j. Eliminating the daily life rd from the definition of minimal risk,” journal l ethics, 31: 35–, a. Of randomization: responses of parents of critically ill random allocation of treatment in a clinical trial,”. Declaration ki, british medical journal, 313 (7070):How to cite this w the pdf version of this entry at s of the sep up this entry the indiana philosophy ontology ed bibliography for this philpapers, with links to its internet zed by the editors of the american journal of ics literature database,German site for conducting al reference center for bioethics literature,Organized by the research library at the kennedy institute of ld council on bioethics,Organized by the nuffield council, the preeminent organization for human research protections. Research responsibility in medicine and south african research ethics training cts, theories of the common law of |. Access to the sep is made possible by a world-wide funding encyclopedia now needs your read how you can help keep the encyclopedia ial this site from another server:Csli, stanford about mirror stanford encyclopedia of philosophy is copyright © 2016 by the metaphysics research lab, center for the study of language and information (csli), stanford y of congress catalog data: issn are herehome » health information » nih clinical research trials and clinical research trials and g principles for ethical researchpursuing potential research participants protections. When people are invited to participate in research, there is a strong belief that it should be their choice based on their understanding of what the study is about, and what the risks and benefits of the study are,” said dr. Christine grady, chief of the nih clinical center department of bioethics, to clinical center radio in a al research advances the understanding of science and promotes human health. There are precautions researchers can take – in the planning, implementation and follow-up of studies – to protect these participants in research. Ethical guidelines are established for clinical research to protect patient volunteers and to preserve the integrity of the clinical center researchers published seven main principles to guide the conduct of ethical research:Social and clinical subject ble risk-benefit t for potential and enrolled and clinical research study is designed to answer a specific question. In other words, answers to the research question should contribute to scientific understanding of health or improve our ways of preventing, treating, or caring for people with a given disease to justify exposing participants to the risk and burden of research. Study should be designed in a way that will get an understandable answer to the important research question. This includes considering whether the question asked is answerable, whether the research methods are valid and feasible, and whether the study is designed with accepted principles, clear methods, and reliable practices. Invalid research is unethical because it is a waste of resources and exposes people to risk for no subject primary basis for recruiting participants should be the scientific goals of the study — not vulnerability, privilege, or other unrelated factors. Participants who accept the risks of research should be in a position to enjoy its benefits. Specific groups of participants (for example, women or children) should not be excluded from the research opportunities without a good scientific reason or a particular susceptibility to ble risk-benefit ainty about the degree of risks and benefits associated with a clinical research study is inherent. Everything should be done to minimize the risks and inconvenience to research participants to maximize the potential benefits, and to determine that the potential benefits are proportionate to, or outweigh, the minimize potential conflicts of interest and make sure a study is ethically acceptable before it starts, an independent review panel should review the proposal and ask important questions, including: are those conducting the trial sufficiently free of bias? The panel also monitors a study while it is ial participants should make their own decision about whether they want to participate or continue participating in research.
This is done through a process of informed consent in which individuals (1) are accurately informed of the purpose, methods, risks, benefits, and alternatives to the research, (2) understand this information and how it relates to their own clinical situation or interests, and (3) make a voluntary decision about whether to t for potential and enrolled duals should be treated with respect from the time they are approached for possible participation — even if they refuse enrollment in a study — throughout their participation and after their participation ends. This includes:Respecting their privacy and keeping their private information ting their right to change their mind, to decide that the research does not match their interests, and to withdraw without a ing them of new information that might emerge in the course of research, which might change their assessment of the risks and benefits of ring their welfare and, if they experience adverse reactions, unexpected effects, or changes in clinical status, ensuring appropriate treatment and, when necessary, removal from the ing them about what was learned from the information on these seven guiding principles and on bioethics in page last reviewed on march 16, media & outreach.