La conducción sin permiso por pérdida de vigencia o por pérdida de la

This chapter will be concerned with illustrating a significant problem with both the Declaration of Helsinki and the Belmont Report (and thus a

problem with the contemporary approach to research ethics); I will term this the “problem of beneficence”. The problem of beneficence, in short, is the failure of contemporary research ethics guidelines to adequately recognise the different obligations generated by a principle of beneficence in research and medical therapy and a tendency to thus rely on a notion of beneficence which is too influenced by medical therapy, leaving guidelines unable to deal with the special challenges that arise through the consideration of the role of this value in research.

Where beneficent concern in medical therapy is directed towards the

individual patient, beneficence in research involves a more complicated mix of interests. As well as the imperative to take the wellbeing of the

individual research subject into account, beneficence in research demands that we facilitate research that can benefit society as a whole. In research, therefore, we must balance the protection and promotion of the wellbeing of the individual research subject against the promotion of the wellbeing of society through beneficial research. The question of the extent to which the interests of society can legitimately trump the interests of the individual, or vice versa, is one of the most difficult ethical questions in human research. The Belmont Report and the Declaration of Helsinki, however, still contain an idea of beneficence which is too influenced by the ethics of medical therapy, and are thus unable to recognise, or to do justice to the challenges that attend the application of this value in a research context.

After a short introduction to the role of beneficence in research, I will illustrate the extent of this problem, and the need for a different approach, by first turning to some of the most significant revisions in the Declaration of Helsinki, which were made in part as an attempt to combat this problem. I will argue that these revisions do not adequately address the problem of beneficence in research, and that the contemporary version of the

Declaration of Helsinki is still based upon a notion of beneficence that is overly influenced by medical therapy. I will then look at the phenomenon of the therapeutic misconception in research (the research subject’s belief that research has therapeutic intent, or is conducted according to therapeutic norms of conduct) to further illustrate the shortcomings of the Declaration of Helsinki’s approach to beneficence, and the need for an ethical

framework for research that is distinct from the ethical framework in medical therapy.

Next, I will turn to the treatment of beneficence in the Belmont Report, arguing that although the Belmont Report makes significant progress in acknowledging the problem of beneficence, and clarifying its role in the context of research, it is still too influenced by therapeutic medical ethics, and is thus also unable to deal with the problems highlighted by the therapeutic misconception. By the end of this chapter, the significance of this problem to research ethics, and the need for a different approach to beneficence in research, will be established. I will conclude by providing some suggestions for an alternate approach to beneficence in research, which will be fully fleshed out in Chapter 5, after I have dealt with problems concerning autonomy, respect for persons and informed consent in Chapter 4.

Beneficence in Research

Beneficence is broadly understood in ethical theory as “including effectively all forms of action intended to benefit or promote the good of other

persons.”242 _{Though some philosophers argue that many beneficent acts are}

supererogatory, in the context of medical and research guidelines, acting beneficently is regarded as obligatory.243244 _{In fact, beneficence is regarded}

as a major justification for medical research.245 _{The aim of medicine is to}

promote and protect health and wellbeing, research in this context thus

242 _{T. Beauchamp, “The Principle of Beneficence in Applied Ethics”, Stanford}

Encyclopedia of Philosophy, 2008, accessed at:

http://plato.stanford.edu/entries/principle-beneficence/.

243 _{Beauchamp, “The Principle of Beneficence in Applied Ethics”.}

244 _{The National Commission, The Belmont Report, Part B: Basic Ethical Principles.} 245 _{McNeill, The Ethics and Politics of Human Experimentation, p.145.}

attempts to work out how best to achieve this aim, through, for example, developing new and more effective treatments against various types of illness. Beneficence, as we have seen in Chapter 2, also provides the major impetus for therapeutic medicine. The obligation to benefit the patient has been seen, from the time of the Hippocratic Oath, as the most fundamental obligation of the physician.

Production of benefit can also be regarded as a motivation for social science research. We saw, in Chapter 2, that Humphreys justified his controversial research by stressing the beneficial consequences that his results had generated. However, whether benefit can be said to provide the impetus for social science research is more contentious, and will clearly depend on how one defines what constitutes a social benefit. Social science research is more likely to be geared towards the acquisition of knowledge, with only a secondary, if any, emphasis on the beneficial applications of that

knowledge.246 _{Whether this knowledge in itself should be regarded as a}

societal benefit is an open question. I explore the specific issues that arise in the context of social science research in the second appendix. This chapter will focus primarily on medical research.

When we see that beneficence simply amounts to an obligation to produce benefit for others, it becomes apparent that the requirements of this

obligation will vary in different contexts. Though beneficence forms the driving force behind both medical therapy and research, the obligations that are generated by the imperative to act in a beneficent manner in these two fields are fundamentally different. In medical therapy, the beneficent concern of the doctors is, generally, primarily aimed towards protecting and promoting the wellbeing of the patient.247 _{Medical research can involve}

putting subjects at risk of harm, in order to determine what might benefit

246 _{T. Beauchamp et al, “Introduction” in T. Beauchamp et al (eds.), Ethical Issues in Social}

Science Research, Johns Hopkins University Press, Baltimore, 1982, p.26.

247 _{This is not to say that concern for the wellbeing of the patient is always the sole and}

foremost concern of the therapeutic physician; therapeutic physicians also have obligations to take the wellbeing of friends and family of the patient (e.g. when delivering a diagnosis, or dealing with a disease that may be transmitted to them) and society as a whole (e.g. concerning infection prevention methods such as vaccines and quarantines) into account.

others.248 _{Prioritising and promoting the wellbeing of the individual may}

function as an appropriate goal in medical therapy, but to adopt the same goal in research would be to preclude much potential overall benefit. This problem is compounded by the fact that advances in medical therapy are contingent on developments in research. By prioritising the wellbeing of the individual in research ethics, we prevent developments in patient care that will allow us to better benefit individual patients. The more

complicated mix of interests involved in research requires a different approach to the principle of beneficence.

The most fundamental challenge of beneficence in research involves balancing the imperative to generate benefit to science and society through research with the requirement to promote, or at least protect, the wellbeing of individual research subjects, two objectives that, although they are both based upon obligations of beneficence, will routinely clash. The

fundamental nature of this challenge and conflict should not be

underestimated. As we have seen in the previous chapter, the Tuskegee Syphilis Study’s Ad Hoc Advisory Panel continually emphasised that balancing the interests of the individual against the interests of society as a whole is the most fundamental problem of human research.249250 _{Unless we}

understand the differences in what beneficence demands in these two different fields, we will not be properly equipped to approach this significant challenge.

Beneficent Motives in the Jewish Chronic Hospital Disease Case In order to illustrate what can happen when the different roles of

beneficence in the context of medical therapy and medical research are not adequately understood, it is useful to return to the Jewish Chronic Hospital Disease Case, focusing specifically on the ways in which beneficent motives, broadly conceived, were used by the researchers as a justification

248 _{McNeill, The Ethics and Politics of Human Experimentation, p.145.}

249 _{DHEW, “Final Report of the Tuskegee Syphilis Study Ad Hoc Advisory Panel”, p.21.} 250 _{The interests of the individual research subjects are not limited to concerns of wellbeing;}

I will be looking at the other interests of the individual research subject in Chapter 4, and discussing how these interests are to be balanced against each other and against wider societal interests in Chapter 5.

for their conduct. This displays that in practice, where it is simply stipulated or understood that the physician must act in a beneficent manner, there is a risk that physicians, though acting from beneficent motives, will fail to protect the wellbeing of their research subjects, and will fail to appreciate the ethical concerns that are specific to the context of research ethics. The researchers’ use of beneficence to defend their conduct in the Jewish Chronic Disease Hospital Case highlights the differences between beneficence in research and in therapeutic medicine and displays the

importance of adequately recognising the distinction through demonstrating the potential confusion that may result when these different obligations of beneficence are confused. The several different ways that the researchers invoke beneficence in defense of their conduct highlights the ambiguities that can result from a lack of clear delineation between obligations of beneficence in research and in medical therapy, affirming the importance of recognising the separation between these fields.

As we have touched upon in the previous chapter, the researchers involved in the Jewish Chronic Disease Hospital Case defended several of their actions by arguing that their motives were beneficent. However, they invoked different notions of beneficence, some of which were judged by the Board of Regents as not providing appropriate standards of conduct in the context of research. Take, for example, the various arguments employed by Southam and his colleagues to justify eschewing consent. The researchers argued that failing to acquire the subjects’ consent was justified due to the fact that the research was motivated by considerations of beneficence. This justification is akin to the kind of discretion commonly allowed to doctors at the time to exercise the therapeutic privilege; avoiding consent could be justifiable if informing a patient is likely to lead to harm. However, the researchers here attempted to justify their conduct by arguing not that

conducting this research would be beneficial to the patients, but rather that it would benefit scientific inquiry.251

Even if this conduct is justifiable in therapeutic medicine, where failing to inform the patient is justified due to the fact that he will be likely to benefit through this omission, it is a different proposition entirely to avoid gaining a patient’s consent because this will be likely to prevent research that will benefit others. In therapeutic medical ethics, failing to inform a patient does not necessarily mean that their wellbeing will not be adequately protected and promoted, because the physician is obligated to prioritise the wellbeing of the patient. In research, however, failing to inform the subject risks leaving the subject vulnerable to exploitation and abuse, because the subject’s benefit is not the researcher’s only goal. The researcher, though acting from beneficent motives, may avoid the subject’s consent in order to produce benefit for others, leaving the subject at risk of harm.252 _The

researchers involved in this case were attempting to defend their actions by invoking norms that were specific to therapeutic ethics, but these norms were not an appropriate means to ensure ethical conduct when the physician took on the motivations of the researcher.

The researchers also invoked the therapeutic privilege in a different way in their justification for conducting the study without consent. They argued that informing the patients that they were being injected with cancer cells might cause distress, and for this reason, it was justifiable to withhold information about the nature of the experiment (or even the fact that the patient was taking part in an experiment).253 _{This involves a more}

straightforward use of the therapeutic privilege, as the omission here is aimed towards benefiting the subject, or avoiding causing him harm. However, even when the therapeutic privilege is used for its therapeutic purpose, the fact that the ultimate aim of the research is not to benefit the patient, but to benefit scientific inquiry, means that the failure to seek consent here still leaves the subject vulnerable to exploitation and abuse. Non-disclosure in a research context, where the interests of people other than the research subject come into play, presents a more difficult ethical

252 _{Or may show a lack of respect for the subject by treating them simply as a means; I will}

come back to issues concerning respect in research ethics in chapters 4 and 5.

situation that must be assessed on different terms. The risk that the interests of the subject will be sacrificed in order to produce benefit for others is a problem which is specific to the context of research, and is not adequately addressed simply by doctors acting with beneficent motives.

This study took place prior to the introduction of formal research protocols, and the violations here mainly came about as a result of these physician- researchers unquestioningly applying the ethical standards of medical therapy, or using substantial discretion in deciding what course of conduct would be appropriate. A significant development following this case, and from the Tuskegee Syphilis Study, was the introduction of requirements for prior external review of research, conducted by a panel including people from other professions and members of the general public, on the basis of set guidelines. This was an important development that forms the

foundation of contemporary ethical research guidelines, and that would certainly prevent doctors from exercising the substantial discretion that they were accustomed to having, at this time, in therapeutic situations. This kind of case would, in consequence, be very unlikely to be repeated today. This, then, is not intended as a criticism of current research ethics guidelines, but rather gives us an insight into the necessity of understanding the differences between beneficence in medical therapy and in research. When the kind of beneficent conduct that may be accepted in a therapeutic situation is simply translated to research, the outcome, and the potential for exploitation and abuse, can be very different. Any adequate approach to beneficence in research must be cognisant of these substantial differences.

Research Beneficence in Philosophical Commentary

The ideas that beneficence in research is very different from the situation in therapeutic medicine, and that beneficence in research necessarily involves addressing the conflict between the wellbeing of the individual and benefit to science and society, have been discussed in philosophical work on research ethics. The philosopher Jay Katz, who was one of the members of the Ad Hoc Advisory Panel (created, as we have seen in the previous chapter, as a response to controversy surrounding the Tuskegee Syphilis

Study, to report on this case and the adequacy of research guidelines in the United States in general), has stressed the significance of the confusion between these two areas, and the extent to which the various requirements of beneficence might conflict in research. Katz is concerned about what he sees as a pervasive “obfuscation of the distinction between therapy and research and the accompanying confusion of patients and subjects.”254 _He

notes that in “therapeutic encounters, unlike research encounters, physicians are expected to attend solely to the welfare of the individual patient before them…In clinical research, on the other hand, patient-subjects are also being used for the ends of science.”255 _{Katz suggests that the lack of a clear}

distinction between research and therapeutic ethics leads to a belief that physician-researchers (both researchers who are conducting therapeutic and non-therapeutic research on their patients, and researchers who also just happen to be physicians) can be trusted because they will put the interests of the patient-subject first. He maintains that without a clear delineation between therapeutic and research ethics, the potential research subject’s belief that physicians will always act according to therapeutic norms persists even in cases in which there is no existing therapeutic relationship between the physician and the research subject. Unless it is clear that the aims of research are distinct from medical therapy, the assumption that doctors will always act according to therapeutic norms endures. He contends that this belief is untenable in research situations, where physician-researchers have “dual allegiances to their patient-subjects and the research protocol.”256 _The

other interests that come into research, he posits, “can only be kept in check if both physician-investigators and patient-subjects fully appreciate that both are engaged in an enterprise in which patient-subjects are also being asked to serve as means for science’s ends”.257

254 _{J. Katz, “Human Experimentation and Human Rights” in the Saint Louis University Law}

Journal, Vol. 38, No. 1, 1993, p.11.

255 _{Katz, “Human Experimentation and Human Rights”, p.15. Again, it is worth noting here}

that even the therapeutic physician must sometimes take the wellbeing of others into account, and this can sometimes clash with his obligations to prioritise the wellbeing of the patient before him. It is, however, fair to say that the therapeutic physician

generally prioritises the health and wellbeing of the individual patient, while this is

generally not the case in research.

256 _{Katz, “Human Experimentation and Human Rights”, p.18.} 257 _{Katz, “Human Experimentation and Human Rights”, p.17.}

For this reason, Katz is concerned about the “lack of separate justifications for novel interventions employed for the benefit of future patients and science, in contrast to those employed for patients’ direct benefits.”258 _{It is}

imperative, Katz contends, that we recognise that the ethical situation in