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10 Research and society

Is bad science ipso facto bad ethics?

What are the ethical limits to research? We saw in Chapter 1 how sometimes good motives brought about ethically indefensible research and we ques- tioned whether good use might be made of morally culpable research. These are some of the easier questions when examining more globally the relation- ship between research and ethics. A subtle problem, confronted frequently by Institutional Research Boards (IRBs) and Research Ethics Committees (RECs), concerns the matter of how one can precisely draw lines between the ethical dimensions of research and the epistemological or method- ological ones. And this is no easy matter. How should we think about gene therapy to combat muscular dystrophy or Erythropoietin (EPO) for cir- culation difficulties, which is then used to assist violations of commonly accepted sports rules? What about research into psychological preparation which is used to motivate players to such an extent that they knowingly injure other athletes? Or what if we study the ergonomic implications of holding a shooting rifle in a certain position for biathlon competitors, with obvious potential consequences for future harm beyond sports? These sim- ple examples raise deep questions about ethics and research. Some are more direct in their implications than others. While it has been suggested that the ethical review of research should (somehow) cauterise the epistemological from the ethical, it is not always possible and sometimes it is not desirable to do this. What we shall aim to achieve in this final chapter is a considera- tion of the reasonable limits researchers and IRBs/RECs might consider in the development and appraisal of research projects.

The research/ethics duplex in research governance

If one talks to members of IRBs/RECs about why they spend so much time discussing the scientific design of a project, you are likely to get a response along the lines that they have to be sure that the science is good because ‘Bad research (or, more often, bad science) equals bad ethics.’ For many people it is a sine qua non of research ethics that to be ethically acceptable a project must be of sound scientific research design. Is this necessarily the case?

One of the key sets of international guidelines on research ethics, from

the Council for International Organizations of Medical Sciences (CIOMS), makes it clear in its guidelines that it considers bad science to be ethically indefensible:

Guideline 1: Ethical justification and scientific validity of biomedical research involving human beings

The ethical justification of biomedical research involving human sub- jects is the prospect of discovering new ways of benefiting people’s health. Such research can be ethically justifiable only if it is carried out in ways that respect and protect, and are fair to, the subjects of that research and are morally acceptable within the communities in which the research is carried out. Moreover, because scientifically invalid research is unethical in that it exposes research subjects to risks without possible benefit, investigators and sponsors must ensure that proposed studies involving human subjects conform to generally accepted scientific prin- ciples and are based on adequate knowledge of the pertinent scientific literature.

(CIOMS, 2002, emphasis added) The document goes on to elaborate this principle in some detail, arguing that an ‘essential feature’ of ethical research is that ‘the research offers a means of developing information not otherwise obtainable, that the design of the research is scientifically sound, and that the investigators and other research personnel are competent’ and that ‘Investigators and sponsors must also ensure that all who participate in the conduct of the research are qualified by virtue of their education and experience to perform competently in their roles’ (CIOMS, 2002).

At first sight, these strictures seem uncontroversial. Surely we would not wish to involve people in taking part in research, at some personal inconvenience and possibly risk of harm, if the project were so ill-conceived that there was little or no prospect of benefit from the research. Does accep- ting the notion that research should be beneficent not require this? Should members of IRBs/RECs, in carrying out their roles, prevent research partici- pants from being exposed to incompetent researchers? We will argue that the problem is often not quite so straightforward as it might unthinkingly seem.

In this chapter we will analyse the claim that ‘bad science equals bad ethics’

and suggest that, at the very least, we need a more subtle account than is usually offered.

The CIOMS guidelines are particularly aimed at medical research – including sports medicine1 – though their reach might well be thought to extend into the overlaps with exercise and health sciences. The scope and variety of sports sciences – traditionally thought of as sports biomechanics, sports physiology and sports psychology but here used in the broader Euro- pean sense to refer to any disciplined research – extends beyond the confines of biomedical science.2 However, there is a lack of comparable international

guidelines for exercise and sports science research ethics, and we would argue that the relationship between sports and exercise science and health or medi- cal science is so close as to make the CIOMS and similar research ethics guidance relevant and worthy of critical reflection. Of course, not all exer- cise and sports sciences research is aimed at performance enhancement. To the contrary, a substantial proportion – perhaps even the majority – is inti- mately connected with the health and well-being of broader populations, with the objectives of reducing risk of injury, improving treatments, creating safer training environments and demonstrating the mental, physical and societal benefits that are connected with exercise.

Participants in such research may be subjected to exceptionally physically demanding procedures at no small cost, physically, to themselves and poten- tially at some personal risk. The results of such work will be generalised to the wider population and taken up by a range of people in different settings.

Therefore, any interventions or recommendations as to exercise or training regimes, as with medical treatments, must be rigorously tested. If we transfer these ideas into the CIOMS guidelines, we might say that the ethical justifi- cation of research in exercise and sport sciences is that it holds out the prospect of improving fitness, or health and well-being, or enhancing phys- ical performance or the quality of participation in a variety of physically active pursuits. Even if this were to be reduced to aims such as improving health, albeit in a narrow and particular conception of health (as species- typical functioning)3 and improving performance the argument we offer will apply. Research involving human subjects in the name of exercise and sports sciences that offered no prospect of such benefit might thus be thought to be unethical. Of course, research that improved performance of some, per- haps at the expense of the participants, or other performers’ health, would also be unethical.

Are there essential features of ethical research?

Ethical merit in research at the very least embraces respect for the dignity of participants. As we have argued throughout the book, this includes, among other things, safeguarding their privacy, ensuring their safety and acknowledging their human rights. It also involves obligations on the part of researchers to assess and minimise risk, to perform risk–benefit assess- ments, to avoid conflicts of interest, to provide recompense or reward where appropriate, to provide compensation for injury and to preserve anonymity and confidentiality where appropriate.4

Before moving to the central features of our argument, it might be worth, as an aside, introducing the notion of consideration of future consequences raised in Chapter 2, in our critical remarks on consequentialist ethical theo- ries. How far ought we to go in trying to determine the potential impact of our research? For example, imagine that you are a sports scientist with particular expertise in ergonomics. As part of a much larger-scale project,

you might be asked to do some contract research to determine optimal com- fort and alertness relating to a seated position in a cramped space. The aim is to design a seat that is both comfortable and functional, with the best charac- teristics to ensure visual recognition and associated manually dextrous acti- vity. It might be easy to conceive of such research being sponsored by a Formula 1 racing team. Imagine, by contrast, that the sponsor is a military department of the government and you have been asked to design a seat inside a battle tank, where the operator will sight, aim and fire on selected (lawful?) targets.

At first glance, your research does not seem to contravene any of the principles outlined above (Benatar, 2002), not least because your participants will not suffer any harms while engaging in your research. Your research may in fact be methodologically rigorous; it may follow sound tenets of data collection, but is it ethically defensible? Clearly, research of this nature car- ries the potential to contribute significantly to harming others. You, as the researcher, are obliged to consider the future consequences of your work.

Does this mean that we should attempt to suppress advances in science that could be used for harmful ends (as well as good ones)? Of course not. Yet it does introduce the notion that we should consider, to some extent, how we manage science for the greater good, rather than just engaging with the technical procedures of science.

More specifically, for the purposes of our argument, according to the most recent CIOMS guidelines, the essential features of ethically justified research involving human subjects could be paraphrased for exercise, health and sports and sciences as follows:

• The research must offer the prospect of discovering new ways of bene- fiting people’s health, well-being, fitness or performance, or improving the quality of their participation in physical activities.

• The research must offer a means of developing information not other- wise obtainable.

• The research must conform to generally accepted scientific principles and be based on adequate knowledge of the pertinent scientific literatures.

• The investigators and other research personnel must be competent.

• The methods to be used must be appropriate to the objectives of the research and the field of study.

• The research must be carried out in ways that respect, protect and are fair to the subjects of that research, and that are acceptable within the communities in which the research is carried out.5

Put more formally, an argument can be constructed which runs roughly as follows:

1 The ethical justification for research is the prospect of discovering ways of benefiting health, fitness, participation, etc.

2 The information sought cannot be obtained by other means.

3 Only research that respects, protects and is fair to the research subjects is ethically acceptable.

4 Research exposes subjects to risks.

5 A (proportionate) degree of risk can be accepted if there are expected benefits (i.e. benefit in better ways of achieving health and fitness or promoting participation etc.).

6 Scientifically invalid research offers no prospect of (these kinds of) benefits.

Therefore:

7 Scientifically invalid research is unethical.

Do these essential features of research amount to a valid argument?

Premise 1 states that the ethical justification for research is the prospect of discovering new ways to benefit people’s fitness, well-being, etc. through the creation of generalisable new knowledge. Everything else that follows in the argument takes this as its starting point and we might well be prepared to accept it as true. But is this type of benefit the only (or supreme) ethical justification, or just one among others (notwithstanding its importance)? If we are to agree with the conclusion of the argument, we have to accept that it is the only justification, but this is never explicitly stated. The assumption seems to be that the only ethically significant benefit is the scientific benefit of obtaining new knowledge that cannot be obtained in any other way, and no account can be taken of other possible benefits, for example to the par- ticipant, the researcher or society. What if there were other plausible ethical justifications apart from the prospect of narrowly defined scientific benefit?

Indeed, should research whose effects are neither significantly harmful nor beneficial other than as an educational tool be rejected by IRBs or RECs?

One situation alluded to in Chapter 2, in which RECs6 frequently come up against complaints that a project cannot possibly generate new knowledge is that of the student project. Many students on undergraduate and graduate programmes are expected to produce a dissertation and this is frequently based on a piece of empirical research. In some subjects it may be possible to conduct such projects in the laboratory or the library, using sources of data other than living human subjects. In the UK at least, certain university departments have simply stopped undergraduates gaining empirical data where this has required Local Research Ethics Committee (LREC) approval for this, and also for reasons of time and expediency. But in disciplines such as psychology, the social sciences, health sciences and sports and exercise science, students not unreasonably desire to carry out projects using human participants. For many students, of course, the constraints of time-scales,

other courses or modules, financial resources and so on will mean their projects must necessarily be small scale. This in turn will limit their scien- tific merit, as will their status as novice researchers – after all, the purpose of the project is for the student to learn about research. If we accept the dictum that ‘bad science equals bad ethics’, these projects will therefore be unethical. This is surely an inappropriate application of the principle.

A fictional example may assist in teasing out just some of the issues.

Imagine you are a sports sciences lecturer who has been assigned a total of 13 undergraduate dissertation projects to supervise (a scandalous but not infrequent allocation). One of these deals with attitudes towards structured versus unstructured physical activity, using children as research subjects.

Using a semantic differential attitude scale as the data collection instrument, your student has the laudable aim of making recommendations as to which mode of activity best serves to motivate children with regard to participation in physical activity. In the analysis section of the research proposal, she suggests that she will treat the data as interval, for purposes of comparative statistical analysis.

Given your workload of 13 students, and given that this is not a specialist area of yours, you do what reading you are able to and agree to supervise the research as proposed by the student. In your university, all studies using human subjects/participants must pass ethical scrutiny, in this case the departmental ethics sub-committee comprising the normal range of mem- bers (see Chapter 3). One of the members (perhaps an external member, who may be unfamiliar with the methods of your discipline), takes issue with the fact that the data are considered interval rather than, say ordinal. The mem- ber (probably incorrectly) suggests that the suggested related t-test is inappropriate, and the project is referred back to the student for revision.

There are several issues to consider here. First, should an ethics committee concern itself with matters that are not overtly ethical per se, such as stat- istical applications? Put differently, even if the committee member were cor- rect in his interpretation, should they raise the issue at all? Perhaps we might resolve that the reservations should only turn into recommendations if there are ethically significant repercussions arising from the ‘bad’ statistics.7 If the project were to go ahead as proposed (and even assuming that the proposed analysis were incorrect), it is difficult to see what harm might result. Of course, it could be argued that there is always harm to subjects, however insignificant it might be, such as occupying time that might have been more profitably used. What though, of the goods produced? In this case, the subjects/participants may have enjoyed participation, and it may have led them to think more deeply about their enjoyment of physical activity. Also, and importantly, we need to recognise that no project is perfect, and there is an educational benefit to researchers inherent in all research. In this case the student would benefit through the assessment process, and in more sophisti- cated work researchers benefit through both collaboration with peers and through scrutiny of proposals and of work intended for publication.