What is ethics Research and why is it important

what are the ethics of research in sociology and what is research ethics principles and what are the ethics of research methodology what is ethics research paper
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DrLaurenHepburn,United Kingdom,Researcher
Published Date:07-07-2017
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KI-N1-24452-EN-C E U R O P E A N European Science COMMISSION Research Area in society This textbook is the output of the project “European Textbook on Ethics in Research”, funded by the European Textbook European Commission and delivered by members of the Centre for Professional Ethics at Keele University. It is designed for use in the training of science students, researchers and research ethics committee on Ethics in Research members throughout Europe and beyond. It is intended to be accessible to scientific and lay readers, including those with no previous experience of ethical theory and analysis. The scope of the textbook is the ethics of scientific research involving human beings. It contains case studies relating to a variety of scientific disciplines, including biomedical and human life sciences, new technologies and the social sciences. These have been chosen to illustrate and facilitate discussion of key ethical issues, and to give a flavour of the range of research settings in which these issues occur. Readers will be introduced to a range of philosophical perspectives and concepts, but without any particular approach being promoted. Similarly, reference will be made to major religious views where relevant, but without endorsing or rejecting any particular view. Studies and reports European Textbook on Ethics in ResearchC H APT E R 1 LO CATING E THICS IN RE SEAR CH Introduction requirements, many institutions, such as universities, professional bodies and funders of research, have This chapter introduces some central issues concern- decided to regulate the research that they control by ing the rationale and methods of ethical review, which setting up institutional research ethics committees and/ will provide a context and framework for the discus- or codes of practice. sion of more specific ethical issues in subsequent chap- ters. It begins with a consideration of the nature of What is research? research, its value, and some of the historical factors that have prompted the development of codes of Before we can identify the ethical issues that arise in research ethics and the system of ethical review. A sin- research we need to have at least a working account of gle case study is used to illustrate the types of ethical what research is. To readers who are engaged in research consideration that commonly arise in relation to this question may seem too obvious to need an answer. research. These are related to a range of key moral It is simply what we do. However, such a definition is frameworks or theories which can provide a broader needed in order to distinguish research from related structure for moral deliberation. The final part of the activities such as audit or journalism, which fall outside chapter discusses the role and legitimacy of ethics the scrutiny of research ethics committees, and it is committees. surprisingly difficult to find a definition that distin- 2 guishes satisfactorily between these things. ( ) Consider the following possible definitions of research: Why research ethics review? • a systematic investigation to establish facts; This part of the chapter focuses on the reasons for • an a ttempt to find out something in a systematic requiring research to be subjected to ethical review. and scientific manner; It first explores what research is and why we might think • a systematic investigation designed to develop it is valuable. Some historical cases of unethical research generalisable knowledge; are introduced, along with the development of codes • a f ocused systematic study undertaken to increase and laws governing research in response to these new knowledge and understanding; cases. These cases, along with a variety of other factors, • a sys tematic study directed toward fuller scientific provide a broad justification for the ethical regulation knowledge or understanding; of research. • t he collection of information about a particular subject; In most countries the majority of research involving • an inq uiry that involves seeking evidence to increase human participants is now reviewed by a research eth- knowledge. ics committee (REC) consisting of both professionals and lay people whose role is to assess the ethical Although these definitions capture elements that are acceptability of the research and to ensure adequate common to many types of research, they fail to distin- protections for research participants. Within the EU guish clearly between research and other activities. For 1 this is legally mandatory for all clinical trials, ( ) and example audit and journalism can also involve the many countries require similar levels of scrutiny for all attempt to generate new knowledge or to discover medical research. While there is much research involv- facts. On the other hand research conducted by stu- ing human participants that falls outside these legal dents as part of their training may not generate new 1. D irective 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Relating to the Implementation of Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use. http://europa.eu/eur-lex/pri/en/oj/dat/2001/l_121/l_12120010501en00340044.pdf 2. Wha t activities are scrutinised by research ethics committees varies of course from jurisdiction to jurisdiction and local regulations should always be followed. 13EUROPE AN TE XTB O OK ON ETHI CS IN R E SE ARCH knowledge but may nevertheless warrant ethical Why is research important? review. (This may depend on how ‘new’ is understood. Does it mean new to the investigator, to the public or When the subject of research ethics arises, the first to everyone?) Likewise many forms of study, such as thing many people think of is various scandalous exam- university-based education, are focused and systematic, ples of unethical research. It is important to recognise without being research. that research is not intrinsically ethically dubious. Despite the problems that can occur there are still This is further complicated by the array of different many reasons for holding that research is something to research areas and methodologies: there seems little in be encouraged. Several reasons might be given for view- common between the research carried out by a histo- ing research as a valuable activity: rian and a biomedical scientist for example. This means that even notions that are shared between different • Res earch has brought a better quality of life and research disciplines, such as the need for some method- increased welfare. We owe our present standard ology, will be interpreted in significantly different ways. of living to the huge amount of research that has made it possible – huge improvements in eco- These considerations suggest that we should adopt nomic efficiency, health care and wellbeing only an inclusive working definition of research, such as the exist because of research, and it is reasonable to following: expect that this will only continue. • Huge numbers of lives have been saved. If we think Research aims to generate (new) information, know- about medical research in particular, huge numbers ledge, understanding, or some other relevant cogni- of lives have been saved by medical advances. tive good, and does so by means of a systematic Moreover, advances in our basic understanding investigation. of nutrition, sanitation and the environment have had a profound impact on life expectancy and the While acknowledging that this doesn’t distinguish all quality of life. research from all other human activities, it nonetheless • Knowledge may be good for its own sake. Finally, appears to describe most activities which are currently even where new knowledge has no real world thought of as research. This working definition is used applications we may still think that we are in some because it seems to capture the important elements of way enriched by understanding more about our- 3 the partial definitions above. ( ) It is important to note selves, the universe we live in and our relationship that a fundamental aspect of research is uncertainty, in to it. relation to the outcome of the research, its potential benefits and the risks involved. Because research aims These reasons support two different arguments in at generating new knowledge, uncertainty is unavoid- favour of doing research, based on different accounts able. It is also important to recognise that research of the value of new knowledge. involving human subjects is carried out in a wide range of fields ranging from social sciences, to applied tech- The first is an ethical argument that builds upon the nology and design, and of course the biomedical sci- idea of the knowledge generated by good science (or ences. All of these areas of research can raise significant good research more generally) as extrinsically valuable. and specific ethical challenges. 3. Li sa Bortolotti and Bert Heinrichs, “Delimiting the concept of research: an ethical perspective”, Theoretical Medicine and Bioethics 28, no. 3 (2007): 157-79. 14C H APT E R 1 LO CATING E THICS IN RE SEAR CH On this view, research is valuable because of the ben- some reason for research ethics committees to ensure efits that the knowledge gained brings to society. that research is methodologically rigorous, but this This argument suggests that we ought to support does not necessarily require them to review the qual- and carry out research insofar as it has such benefits, ity of the science themselves, as they can rely on other and this should be weighed against the potential harms methods of ensuring this, such as requiring independ- – intended or accidental – that might occur during ent peer review reports evaluating the methodology research or as a result of the knowledge it generates. of the research project. The second argument appeals to the idea of knowledge Research ethics scandals as intrinsically valuable, that is, as being valuable in itself independently of any further benefits resulting from In this section we will introduce some famous and its application. This rests on the notion that there is less-well-known examples of research ethics ‘scandals’, something valuable about understanding ourselves and show how these have ultimately led to the estab- and the world around us, even if there is no practical lishment of the present system of independent ethics application of that knowledge. This second justifica- committees reviewing research. It should be noted that tion provides a reason why research without any antic- while the history of research ethics is often assumed to ipated applications or direct benefits may nonetheless have begun with the scandals that took place in Nazi be ethical. Germany, both unethical research and ethical regula- tion of research preceded those events. It is worth considering how these arguments relate to the justification of research involving human subjects. Edward Jenner’s smallpox vaccine, England, 1796 All research involving human subjects involves costs, ranging from the use of participants’ time to the risk This research involved injecting an eight-year-old child of harm, and it would be hard to justify this unless with pus from a cowpox infection and then deliberately the research was worthwhile in some way. This raises exposing the child to smallpox to establish their a question about whether research ethics committees acquired immunity. While a great step forward in should have a role in ensuring that research is not just the fight against smallpox, the exposure to risk this ethically sound but also scientifically sound. There is involved for the child would be unlikely to be con- 6 some debate about this question, since the operating doned today. ( ) principles for many RECs discourage them from look- ing at methodology as it is felt that they are not well The Neisser case, Prussia, 1898 constituted to make this judgement in relation to the 4 wide range of projects that they assess. ( ) On the other Albert Neisser conducted clinical trials on serum ther- hand, given that both of the arguments in favour of apy in patients with syphilis. This was done by injecting allowing research depend on the research having some serum from patients with syphilis into those who were chance of successfully reaching its objectives, it would admitted for other reasons, without either informing seem that research needs to be methodologically them of the experiment or seeking informed consent. sound to be ethical – especially when it involves risks When, subsequently, some of these patients contracted 5 to the participants. ( ) It seems, therefore, that there is syphilis Neisser concluded that the vaccination had 4. David Hunter, “Bad science equals poor, not necessarily bad, ethics”, in Ethics, Law and Society (Volume 3), Jennifer Gunning and Søren Holm, eds. (Aldershot: Ashgate Publishing Company, 2007): 61-70. 5. Angu s Dawson and Steve Yentis, “Contesting the science/ethics distinction in the review of clinical research”, Journal of Medical Ethics 33 (2007): 165-7. 6. Ernst Wynder, “A corner of history: Jenner and his smallpox vaccine”, Preventive Medicine 3, no. 1 (1974): 173-5. 15EUROPE AN TE XTB O OK ON ETHI CS IN R E SE ARCH failed. This was picked up by newspapers, drawing pub- endorse the gathering of that data. This, however, is not lic attention and ultimately leading to the minister an issue that research ethics committees normally have for religious, educational, and medical affairs issuing to deal with since they look at research prospectively a directive requiring that all non-therapeutic research rather than retrospectively. must have unambiguous consent. This was followed in 1931 by the German minister of the interior issuing These experiments led to the development of the Guidelines for New Therapy and Human Experimentation, Nuremberg Code in 1947, largely as a legal document which further emphasised the necessity of considering to codify what was unethical about the Nazi research, the risks involved in research, and seeking informed but also as a code for future research. It also strongly 7 consent, in particular for non-therapeutic research. ( ) influenced the development of the World Medical Association’s Declaration of Helsinki in 1964, a code The Little Albert experiment, United States, 1920 of ethics developed by physicians to self-regulate the conduct of medical experimentation. This research aimed to demonstrate the phenomenon of human conditioning by conditioning an 11-month- The Milgram experiments, United States, 1961-63 old infant to fear rats by associating them with fear inducing circumstances such as a loud noise. The In these experiments, designed to investigate people’s research was conducted without the knowledge or obedience to authority, the research subjects were 8 consent of Albert’s parents. ( ) deceived about the nature of the research and led to believe that they (in the process of a different experi- Medical experimentation in Nazi Germany, 1939-45 ment) were administering electric shocks to other research participants. The aim of the research, which Experiments carried out on concentration camp pris- turned out to be very distressing for many of the sub- oners included involuntary sterilisation, subjection to jects, was to see how far they would be willing to go in 10 radiation, freezing to induce hypothermia, infection of risking harm to the other research participants. ( ) research subjects with malaria and tuberculosis (TB), Surprisingly, the result was that most people (approxi- and many other unethical experiments, conducted mately 65 %) were willing to continue to the end of the without the consent of the research subjects, and often experiment, even though had the electric shocks been leading predictably to extreme pain, mutilation and real they would have been seriously endangering the 9 death. ( ) One difficult and highly controversial ques- other research participant. One observation that might tion arising from this research is whether it is ethical to be made about this research is that science that is ethi- use the results of such experiments in those cases cally questionable is not always scientifically weak or where they are considered to be scientifically valid. On unimportant, since from this research we learnt that the one hand not to do so does not help the victims people will often obey authorities even if this involves and may deprive others who could benefit from the behaviour that they would normally judge to be application of the knowledge generated. On the other unethical, which has important implications for psy- hand to use the research seems in some ways to chology, sociology and governance. 7. Jochen Vollmann and Rolf Winau, “Informed consent in human experimentation before the Nuremberg code”, British Medical Journal 313 (1996): 1445-7. 8. Ben Harris, “Whatever happened to Little Albert?”, American Psychologist 34, no. 2 (1979): 151-60. 9. Vivien Spitz, Doctors from Hell: The Horrific Account of Nazi Experiments on Humans (Boulder, CO: Sentient Publications, 2005). 10. Stanley Milgram, “Behavioral study of obedience”, Journal of Abnormal and Social Psychology 67 (1963): 371-8. 16C H APT E R 1 LO CATING E THICS IN RE SEAR CH Tuskegee syphilis study, United States, 1932-72 by today’s standards, has been carried out. Not all wor- ries about research ethics are spectacular big scandals, This was a clinical study carried out between 1932 and nor is it always the case, even in the examples men- 1972 in Tuskegee, Alabama, by the US Public Health tioned above, that unethical research involves research- Service. About 400 mostly illiterate African-Americans ers knowingly doing what they believe to be wrong. with syphilis were recruited into the study as well as Often researchers are either unaware of the ethical two hundred healthy controls. The aim of the study implications of their research, or, being aware of them, was to observe the natural progression of the disease believe that they are outweighed by the positive ben- when left untreated, and in particular to compare the efits of their research. Here are two examples recently progression of the disease in African-Americans with submitted to research ethics committees. the results of an earlier retrospective study of the dis- ease in Europeans. The participants were not told that Psychology of depression with eight-year-olds they were in a medical trial, and the tests were described as “special free treatments”. In this case the researcher wanted to use a questionnaire, part of which consisted of the Becks Depression Index, At the outset of the trial there was no effective treat- with 30 eight-year-old children. The Becks Depression ment for syphilis. However, by 1947 penicillin had Index asks participants to express their agreement or become the standard – effective – treatment for syph- disagreement on a scale of 1 to 5 with statements like: ilis. The researchers blocked the study subjects from receiving effective treatment, going so far as to prevent • I feel like harming myself. the subjects from being conscripted into the armed • If I died today no one would notice. forces since that would have necessitated them being • I think about killing myself. treated. At the end of the study only 74 subjects • There is no point growing up. remained alive, 40 of their wives had been infected and • I am useless. 19 children had been born with syphilis, some of which might have been prevented if these men had been The truly disturbing thing about this research was that 11 given treatment. ( ) The aftermath of Tuskegee led to the researcher was not actually interested in the chil- the formalisation of ethics review in America, and was dren’s responses to these questions, but included them also influential on the 1975 revision of the Declaration in the questionnaire as a ‘blind’ to conceal the true of Helsinki which introduced the requirement for the nature of the research from the participants so as to independent review of all research. avoid knowledge of the researcher’s intentions from biasing the results. This and the other well-known research ethics scandals listed above are clearly ethically troublesome, but it is Sports science muscle biopsy important to realise that these high-profile cases form only a minority of cases of unethical research. Most For a piece of research on the oxidation of muscle tis- countries have had public scandals regarding some sue a sports scientist wanted to take pea-sized chunks breaches of ethical norms in research, and even in those of muscle out of the legs of athletes. The main piece of that have not, it is likely that unethical research, at least information on the participant information sheet was 11. Joseph Brady and Albert Jonsen, “The evolution of regulatory influences on research with human subjects”, in Human Subjects Research – A Handbook for Institutional Review Boards, Robert A. Greenwald, Mary Kay Ryan and James E. Mulvihill, eds. (New York: Plenum Press, 1982): 3-5. 17EUROPE AN TE XTB O OK ON ETHI CS IN R E SE ARCH 13 that this might hurt a bit. No information was given • The Nuremberg Code. ( ) about ongoing pain, nor about the possible implica- • The World Medical Association’s Declaration of 14 tions the removal of muscle might have for athletic Helsinki. ( ) performance. • The Council for International Organizations of Medical Sciences’ (CIOMS) International Ethical In both of these cases the researchers declared that Guidelines for Biomedical Research Involving Human 15 there were no ethical issues. Obviously in the first case Subjects. ( ) there are clear risks involved in suggesting the notion • The Charter of Fundamental Rights of the European 16 of suicide to eight-year-old children. In the second case, Union. ( ) 17 while the research was not necessarily problematic, not • The European Convention on Human Rights. ( ) nearly enough information was given to participants to • The European Union Good Clinical Practice 18 allow them to decide for themselves. Directive. ( ) • The Convention for the protection of Human Rights All of these cases provide evidence of the abuses that and dignity of the human being with regard to can occur in unregulated research, and the more pub- the application of biology and medicine: Convention lic scandals outlined above have been a dominant driv- on Human Rights and Biomedicine (The Oviedo 19 ing force behind the development of ethical codes and Convention). ( ) 12 20 laws to govern research. ( ) • The European Union Clinical Trials Directive. ( ) Codes of Ethics and legal constraints Research ethics as a separate area of concern arose with the increasing formalisation of medical research Ethical codes and guidelines are a means of establish- in order to address the ethical concerns arising from ing and articulating the values of a particular institu- the conduct of research. Historically, the development tion or society, and the obligations that it expects of research ethics has been greatly influenced by exam- people engaged in certain practices to abide by. Some ples of scandals and unethical research such as those prominent examples of codes and laws which bear on described in the previous section. researchers’ conduct are listed below. 12. S ome further examples of unethical research can be found in the following: Henry Beecher, “Ethics and clinical research”, New England Journal of Medicine 274, no. 24 (1966): 1354-60; Laud Humphreys, Tearoom Trade: Impersonal Sex in Public Places (New York: Aldine, 1975); Maurice Pappworth, “Human guinea pigs: a warning”, Twentieth Century 171 (1962): 67-75; Udo Schüklenk, “Introduction to research ethics,” Developing World Bioethics 5, no. 1 (2005): 1-13; Philip Zimbardo, The Lucifer Effect: Understanding How Good People Turn Evil (New York: Random House, 2007). 13. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law 10, no. 2 (1949): 181-2. http://ohsr.od.nih.gov/guidelines/nuremberg.html 14. World Medical Association, Declaration of Helsinki: ethical principles for research involving human subjects (2008). http://www.wma.net/en/30publications/10policies/b3/index.html 15. Council for International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002). http://www.cioms.ch/frame_guidelines_nov_2002.htm 16. European Union, The Charter of Fundamental Rights of the European Union (2000/C 364/01). http://www.europarl.europa.eu/charter/default_en.htm 17. Convention for the Protection of Human Rights and Fundamental Freedoms (Rome, 4.XI.1950). http://conventions.coe.int/Treaty/en/Treaties/Html/005.htm 18. Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medic- inal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products. http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/dir_2005_28/dir_2005_28_en.pdf 19. Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (Oviedo, 4.IV.1997). http://conventions.coe.int/Treaty/en/Treaties/Html/164.htm 20. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Relating to the Implementation of Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use. http://europa.eu/eur-lex/pri/en/oj/dat/2001/l_121/l_12120010501en00340044.pdf 18C H APT E R 1 LO CATING E THICS IN RE SEAR CH 23 The norms of modern research ethics were codified between countries. ( ) Likewise funding bodies, includ- by the Nuremberg Code in 1947 in response to Nazi ing the European Commission, usually have their own medical research and further developed by the World requirements and guidance both for researchers and 24 Medical Association’s Declaration of Helsinki in 1964. research ethics review. ( ) Concerns about the effectiveness of the existing regu- lation arose when attention was drawn to various ethi- The relationship between codes, ethical practice and 21 cal concerns in ongoing research. ( ) These concerns the law is complex, however, and we should not assume led to the 1975 revision of the Declaration of Helsinki, that ethical evaluation can simply be a matter of ‘apply- which introduced the requirement of a formal inde- ing’ codes or laws. This is, firstly, because codes and laws pendent committee review of research protocols. are general and thus often fail to provide clear guidance in complex specific cases. Often judgement is required, Following this pattern, a bewildering array of guidelines and what is legal may depend on the judgement of for research has now been put into place, some of a research ethics committee. Secondly, codes and the which have a merely advisory status, such as CIOMS’ law are silent about many research practices, aiming to International Ethical Guidelines for Biomedical Research rule out certain very unethical behaviours but not to Involving Human Subjects. Others, such as the World give comprehensive ethical advice. Thirdly, the contents Medical Association’s Declaration of Helsinki are bind- of particular guidelines may be controversial and/ ing on members of particular professions (and most or contradictory (internally or with other guidelines). professional bodies have published their own guide- Finally, of course, even where the law or code is clear it lines). Others have legislative status, for example may not be ethically correct – for example research national laws and European laws such as the European practices in Nazi Germany may have been legal but 22 Union Clinical Trials Directive. ( ) were clearly immoral. This array of documentation can be bewildering both It is sometimes argued that since unethical research is to the researcher and to members of research ethics not widespread the present form of regulation consti- committees, since it can be unclear which documents tutes an over-reaction to rare scandalous behaviour in apply to which research and what status each docu- the conduct of research. It is felt by some that the reg- ment has. This is particularly problematic in cross- ulation of research treats all researchers as guilty of the jurisdictional research since local guidelines and laws crimes of a very few. Indeed, there is considerable com- can and do clash with international guidance. Most plaint in the research community about the scrutiny countries in the EU now have substantial guidance their research undergoes and the resources that it 25 for the establishment and operation of research ethics costs. ( ) There is a point here, given the positive ben- committees, although there is still significant variation efits of research as discussed earlier. Preventing research 21. H enry Beecher, “Ethics and clinical research”, New England Journal of Medicine 274, no. 24 (1966): 1354-60; Maurice Pappworth, “Human guinea pigs: a warning”, Twentieth Century 171, (1962): 67-75. 22. A listing o f legislation governing research can be found in: Office for Human Research Protections, International Compilation of Human Subject Research Protections (Washington: International Activities Program, Office for Human Research Protection, 2009). http://www.hhs.gov/ohrp/international/HSPCompilation.pdf. Likewise an outline of the regulation of research in the EU can be found in Michael Fuchs, Provision of Support for Producing a European Directory of Local Ethics Committees (LECs) (EC contract no. SAS5-CT-2002-30047, 2005). http://ec.europa.eu/research/conferences/2005/recs/pdf/lec_finalreport.pdf 23. E uropean Forum for Good Clinical Practice, “The procedure for the ethical review of protocols for clinical research projects in the European Union: a report on the structure and function of research ethics committees across Europe”, International Journal of Pharmaceutical Medicine 21, no. 1 (2007): 1-113. An updated version of this can be found on the EFGCP website: http://www.efgcp.be/html.asp?what=efgcpreport.htm&L1=5&L2=1report 24. F or example see http://ec.europa.eu/research/science-society/index.cfm?fuseaction=public.topic&id=36 for a guide to ethics review requirements for European Commission funded projects. 25. John Saunders, “Research ethics committees – time for change?”, Clinical Medicine 2 (2002): 534-8. 19EUROPE AN TE XTB O OK ON ETHI CS IN R E SE ARCH from going ahead, or even delaying it, means foregoing volunteers seems to have shown that it is well toler- some of these benefits. Nevertheless, in the light of the ated with minimal adverse reactions. The researchers history of research described above it would be rash to now propose further testing of the artificial blood think that regulation is now unnecessary. This is partic- by equipping five local ambulances with the artificial ularly the case because ethical decision-making is com- blood to be used in emergency care situations. plex. Because of this complexity individual researchers In many cases it will not be possible to obtain may not be best placed to decide about the ethical consent from the patients to take part in the issues a research project raises, and instead it may need research because of the urgency of treatment a group of experts, both scientific and ethical, to make and the fact that patients are often unconscious. a good decision. Likewise given the plurality of ethical views that exist within any society, a committee deci- The researchers argue that given the extensive sion can be representative in a fashion that an individ- laboratory testing the product has already under- ual decision about the ethical legitimacy of a course gone the best way to test the usefulness of the of action cannot. This can be shown by considering artificial blood is in a ‘real world’ test. Furthermore the possible reactions to the following case. they make the point that presently some people have to forego blood products until they reach the hospital in any case. Case Study 1.1 Testing of artificial blood product Questions 1. W hat arguments can the researchers put forward in support of their proposal? 2. What objections could be raised against the proposal? 3. In your opinion, should this research be allowed to proceed in its present form? If not, how might it be modified to make it more acceptable? Discussion Your ethics committee has been asked to review 26 the following application. ( ) Currently ambulances This case study provides the basis for exploring a range can only carry a partial range of blood of the various of different ethical considerations relevant to research. blood types, potentially significantly delaying In considering the questions attached to the case study the treatment of critically injured and ill individuals we will identify some of the key ethical issues that arise until they can be transported to the hospital. in research. These will then be related to a range of A replacement for human blood has been devel- moral theories and principles which will give a broader oped by a pharmaceutical company and now needs context to the moral considerations raised by the case, to be tested in the field. This artificial blood is and will provide a framework for further consideration blood-type neutral and initial testing with healthy of this and other cases. 26. T his case is based on the controversial trial of PolyHeme in the USA. A discussion of this research can be found in the American Journal of Bioethics 6, no. 3 (2006). 20C H APT E R 1 LO CATING E THICS IN RE SEAR CH In support of their project the researchers are likely first condition, and at risk of being exploited or used as to point out the benefits to future patients if the means to other peoples’ ends (for example those of the research goes ahead and is successful in demonstrating researchers or of future patients). Finally, some people the effectiveness of the artificial blood product. This, may be concerned about the motivation of the phar- after all, is the primary reason for carrying out the maceutical company involved in the research: are research and could lead to the saving of many lives. they just in it for the money, and if so, does this give us They may also point out that the research has poten- reason to be sceptical about the claimed benefits of tial benefits for the research subjects: the artificial prod- the research and is it likely to affect the way in which uct may be safer or more effective than standard the trial is conducted? donated blood. This is particularly the case for subjects who have the rarer blood types that are not standardly We have seen that there are plausible arguments for carried in ambulances, as it will enable them to receive and against this particular piece of research. However, a transfusion in the ambulance when they would oth- simply listing the arguments does not resolve whether erwise have to wait until reaching hospital. It might the research should go ahead. One way of moving also, although more controversially, be argued that towards a decision is to examine the strength of the patients have a duty to participate in research (at least competing arguments. For example, in response to the if the risks are not too great) since they have benefited concern about risks faced by the subjects it can be from the knowledge resulting from the contributions pointed out both that there may be counterbalancing 27 of previous research subjects. ( ) benefits for the same subjects, and that, given the extensive lab testing and prior testing with healthy Against this, opponents of the research might argue volunteers that the artificial blood product has under- that the risks to research subjects are too great. What gone, we may have some reason to think that it will be if the blood replacement product doesn’t work or, relatively safe. worse still, some subjects have an allergic reaction to the product? Opponents of the research might also It may also be that relatively minor modifications to object to the fact that many participants will be una- the design of the research could remove some of the ble to consent. This may in itself be taken as an objec- objections. For example, if the ambulances could be tion to the research (perhaps because researching on modified to carry both artificial and donated blood people without their consent is considered a violation this could enable patients to opt out of the research of their rights) and may also make it harder to justify without being disadvantaged. Likewise, if allergic reac- subjecting research participants to risk. Even in the tions are a possibility then the ambulance staff could cases where consent can be obtained, there may be be briefed and treatments for possible allergic reactions concerns about the quality of the consent, given that could be stocked in the ambulance. it takes place in an emergency situation where the potential subjects may not have a viable option other In response to concerns about the absence of consent than to consent, given the limited range of blood prod- it might be pointed out that this is rarely sought for ucts that ambulances presently carry, and where there emergency treatment given the urgency of the situa- is likely to be little time for explanations or deliberation. tion, so maybe we could apply a similar practice to this Concerns about the medical risks faced by participants research given its therapeutic aims. Perhaps also, as an and the absence of consent may be exacerbated by alternative to individual consent, we could consult the thought that we are dealing with research partici- widely with the community, and adopt some form of pants who are vulnerable, as a result of their medical community consent. If it is possible to carry both types 27. John Harris, “Scientific research is a moral duty”, Journal of Medical Ethics 31 (2005): 242-8. 21EUROPE AN TE XTB O OK ON ETHI CS IN R E SE ARCH of blood in the ambulances we could insist that the This approach to ethical decision-making is known as 28 artificial blood be given only to those who consent, or, consequentialism. ( ) The key feature of all consequen- if consent is not obtainable, to those who would nor- tialist theories is that they take the morality of an action mally receive no transfusion before reaching hospital to be determined entirely by its consequences. Different due to having a rare blood type. consequentialist theories have different accounts of what kinds of consequence we should seek to pro- Even after critiquing the arguments in this way we may mote, but one of the most influential forms is utilitari- be left with plausible arguments on both sides and it anism. This holds that our sole duty is to maximise may not be obvious how to weigh these up. In order utility, where this is understood as the happiness or to resolve the question of whether the research should welfare of all the individuals affected by the action. Thus, go ahead we need to understand better the bases for in the artificial blood case, the research should go ahead the various arguments and how they fit within more if, taking account of all the risks and benefits, this is general ethical frameworks. One way of doing this is likely to produce more utility than not going ahead. to identify different types of argument that are charac- Utilitarianism would also tell us that if there are steps teristic of different approaches to ethics. In particular that we can take to reduce the potential harms without we might notice that many of the arguments for and foregoing equivalent benefits then we should do so. against the research are about the consequences, or effects, of the research: the benefits or risks to partici- However, the case study also illustrates some objections pants or future patients, for example. Other arguments to a purely consequentialist approach to ethical deci- – mainly arguments against the research such as those sion-making. One objection is that while consequences concerned with consent and violations of rights – do seem to be an important factor in ethical delibera- might better be seen as expressing constraints on tion, consequentialist approaches treat them as the only research – limits to what it is permissible to do even in relevant factor. One of the ethical concerns raised about the successful pursuit of worthwhile aims. This distinc- this case was that individual consent would not be tion corresponds to the distinction between two of sought in all cases. To a consequentialist this would only the most common types of ethical framework, to be matter if the absence of consent had bad consequences examined alongside others in the following section. (for example if it led to a public outcry or if it resulted in participants who would have refused consent being included in the trial and suffering harm as a result). Many Ethical frameworks people think, however, that consent is important even if it does not have any such consequences. Consequentialism Another objection to consequentialism is that the In the discussion of the case study, several of the argu- focus on overall consequences can lead to a neglect of ments focused on the expected or possible conse- the interests of individuals. Suppose we could be sure quences of the research. These included potential that the research would be successful and would lead benefits to the research participants and to the wider to the saving of many lives in the future, but also that society, and risks to the participants. One way to assess it would involve the deaths of ten participants. Leaving this research would be to weigh up the potential ben- aside any secondary consequences (such as loss of efits and risks, so as to determine whether, overall, public support for research) a consequentialist might the consequences are likely to be good or bad. think that the sacrifice is worth the benefits, whereas 28. For further introductory reading on consequentialism see James Rachels and Stuart Rachels, The Elements of Moral Philosophy (New York: McGraw-Hill, 2009), Chapters 7 & 8. 22C H APT E R 1 LO CATING E THICS IN RE SEAR CH most people would consider that unconscionable. deontological approaches hold that we have prima facie As with consent, there might be secondary conse- or ‘defeasible’ duties, which can be overridden by suffi- quences that would lead the consequentialist to a view ciently weighty considerations. What distinguishes these more in line with most people’s moral instincts, but views from consequentialism, however, is that the rules to critics this would still show a failure to recognise or duties matter in themselves, so that deciding what the basic moral rights of individuals. we should do is not simply a matter of weighing up the consequences. A variety of duty-based approaches will A common view of many critics is that consequential- be explored below. ism correctly identifies consequences as an important factor in determining whether an action (or piece of One way of expressing the concerns raised about the research) is ethically permissible, but that a concern research in the case study is that it involves using peo- with consequences needs to be supplemented by other ple as a means to an end. This can clearly be seen in the principles and in particular by principles constraining case where we imagined the lives of ten participants what it is permissible to do even in pursuit of good being sacrificed to save a larger number of future consequences. patients. The idea that we should not treat people solely as means is associated with the deontological Duty-based ethics theory of Kant. In response to these concerns a rule-based or duty- Kant’s primary insight was to associate reason and con- based approach to ethics is often suggested as an alter- sistency with ethics. For the most part Kant thought native to consequentialism. In the case study, the ethical we already knew the right things to do; we simply failed concerns that are not well accounted for by consequen- to do them. Kant thought of this as a kind of inconsist- tialism might be better explained in terms of duties, ency: we expect the world to live by one rule, while we for example to respect the wishes of individuals (by live by a less strict one. For example, it is easy to be obtaining consent before involving them in research) annoyed by someone else behaving in a rude or incon- or avoid harming them (by not sacrificing their lives or siderate fashion when driving, but it is also easy to do important interests for the good of others). These rules this ourselves, “just this once”, or “because I’m in a real or duties can be thought of as placing constraints on hurry”. What Kant ultimately thought was that moral- the ways in which we may treat people. ity can be derived from reason via a requirement for consistency. This is important because, for morality to There is a wide variety of duty-based approaches to eth- function as we expect it to, it needs to be based on ics, but what they share is the view that the rightness or claims that have universal appeal and motivation. Kant wrongness of actions is not determined solely by their distinguished two different sorts of imperatives, hypo- consequences but instead is determined by the nature thetical imperatives and categorical imperatives. of the action itself. These are also referred to as ‘deon- Hypothetical imperatives have the form: 29 tological’ approaches. ( ) An example of a deontologi- cal approach to ethics that will be familiar to many if you want x then you need to do y. people is the Ten Commandments. This is a set of rules, identifying certain types of action as ones which we For example: have a duty to perform or refrain from irrespective of their consequences. In this case the duties are usually if you wan t your research to be ethical you need seen as absolute, so that breaking them can never be to obtain consent. morally justified regardless of the consequences. Other 29. For f urther introductory reading on deontology see James Rachels and, Stuart Rachels, The Elements of Moral Philosophy (New York: McGraw-Hill, 2009), Chapter 9. 23EUROPE AN TE XTB O OK ON ETHI CS IN R E SE ARCH The problem with this type of claim as a basis for moral being human, and that this moral importance gives rise action is that it only motivates someone if they want x; both to certain claims on others and to certain freedoms, so in our example if the researcher did not care about so each human has a set of rights that may not be vio- being ethical then the claim would fail to motivate lated. Rights can be based on claims about the nature of them to seek consent. persons (natural rights) but they might also be estab- lished by agreement, laws or treaties (contractual rights). Categorical imperatives, in contrast, are imperatives So, for example, many of the international treaties and that all rational agents should recognise and be moti- EU laws we discussed earlier establish various rights for vated by. Kant built his moral theory out of categorical research participants. imperatives, derived from reason, and in particular from the notion of consistency: Rights imply that other people have duties to respect those rights, and different types of rights establish dif- 1st formulation of Kant’s categorical imperative: ferent types of duties. A commonly drawn distinction Act only according to that maxim whereby you is between positive and negative rights. If someone has can at the same time will that it should become a positive right to something then either all or some a universal law. others have an obligation to ensure that the person gets the thing they have a right to. In contrast if someone From this notion of consistency Kant derived the idea has a negative right to something then others have of respecting people as persons or respecting their no duty to provide it, only a duty not to interfere with 30 dignity. ( ) the person getting their right fulfilled. For example, if someone has a positive right to life then the state 2nd formulation of Kant’s categorical imperative: might be obliged to do various things to protect this Act only in such a way that you always treat right such as providing food and shelter. However, if the humanity, whether in your own person or in the right to life is conceptualised in negative terms then the person of any other, never simply as a means, but state (at least as far as the right to life is concerned) always at the same time as an end. does not have a duty to provide the person with the things that they need to continue living, but only to To treat someone as a mere means would be to behave refrain from killing them. Rights are often related to the towards them as if they were just a tool to you, a means welfare of individuals and so can be linked to conse- to achieving your own goals. To treat them as an end quentialism, although in contrast to consequentialism is to treat their own goals as important and in general they tend to protect the individual’s interests against to treat them with the respect that is due to a rational, being sacrificed for the good of the group even if this autonomous agent. produces less overall utility. Another influential deontological approach is the human Deontological concerns could underwrite several of 31 rights approach. ( ) The basic idea here is that there is the arguments discussed in relation to the case study. something special that ought to be respected and For example, Kantian concerns for respect for persons treated appropriately about every human being. Like dig- might ground our concerns about the lack of consent. nity-based approaches, this approach is based on the Similarly, dignity might arise as a concern in relation to notion that there is something morally important about using research participants as means to others’ ends, 30. F or further introductory reading on rights see Leif Wenar, “Rights”, The Stanford Encyclopedia of Philosophy (Fall 2008 Edition), Edward N. Zalta, ed. http://plato.stanford.edu/archives/fall2008/entries/rights/ 31. For further introductory reading on respect for persons see James Rachels and Stuart Rachels, The Elements of Moral Philosophy (New York: McGraw-Hill, 2009), Chapter 10. 24C H APT E R 1 LO CATING E THICS IN RE SEAR CH particularly in view of the vulnerability of the research The essence of virtue ethics is that character is the pri- participants in this case and their inability to protect mary object of ethical appraisal, and actions are judged their own dignity through a standard consent process. according to what they tell us about the agent’s char- Human rights might play a role if we think that people acter. We might, for example, think that respectfulness have a right not to be used as subjects of experimen- is a virtue, and this might underwrite several of the tation without consent. objections that were raised to the research in the case study. Likewise, we might think that beneficence is A common objection to absolutist deontological a virtue and this might provide a reason to support approaches to ethics is that they are very inflexible. the research because of its potential benefits. Virtue is While informed consent, for example, is very impor- considered to be important because it leads to ‘eudai- tant, given the possibility of very significant benefit to monia’, or flourishing. So the basic idea is that the vir- the participants, we might want to be more flexible tues are those character traits that lead to human than an absolutist approach would allow. Another flourishing, and the vices are those character traits that problem with absolutist approaches is what to do destroy human flourishing. when different rights or duties come into conflict. One response to these problems is to adopt a different As with the previous two ethical frameworks, virtue type of deontological approach, where the rules can be ethics faces serious objections. One is that there can be traded off against each other (a prima facie or defeasi- competing accounts of what counts as human flour- bilist approach). This approach will be explored later ishing and thus competing accounts of virtue. Another in this chapter. objection is that virtue ethics does not provide us with a clear account of what we ought to do: it tells Some have argued that the general approach adopted what sort of person we ought to be, but not how to by Kantian and consequentialist approaches of focus- act in particular situations. One response to this is that ing on actions as the locus for moral evaluation is mis- the complaint is unfair, since we should not expect taken and that we need to view morality in a different an ethics of character to tell us about our actions. way. Two such approaches will be briefly outlined below. We might for example take the central insights of vir- tue ethics and incorporate them into another theory Virtue Ethics in order to evaluate both character and actions. Virtue ethics is an approach that addresses ethical Others have defended virtue ethics from the charge issues in terms of the character of the agent carrying that it is not action-guiding by appealing to the use of 32 out the action. ( ) Virtue ethical concerns might be moral exemplars. If I am not fully virtuous I may be able raised if we think about the character of the research- to decide how to act by emulating someone I believe ers or the motive they have for carrying out the to be more virtuous than me; by trying to do what they research. For example, the concern about the motiva- would do in the situation. So, for example, we might tion of the company financing the research might be think: “what would Gandhi do?” seen in these terms. But the other concerns could be captured in virtue terms by thinking about how a vir- This response might be too quick though. How do you tuous agent would act. know who is virtuous unless you yourself are virtuous? 32. For further introductory reading on virtue ethics see James Rachels and Stuart Rachels, The Elements of Moral Philosophy (New York: McGraw-Hill, 2009), Chapter 12. 25EUROPE AN TE XTB O OK ON ETHI CS IN R E SE ARCH And even those we think of as virtuous in some con- not merely resources for research. Although a Kantian texts may not be virtuous in others (for example, some might make a similar point, their focus would be slightly people believe that the way Gandhi treated his wife was different: the ethics of care theorist would focus on the neglectful). Finally it is difficult to identify moral exem- researcher and research participant’s relationship while plars in the context of research ethics; to do this we the Kantian would focus on the researcher’s action. would arguably need to have fairly settled intuitions about what the right actions would be. As with virtue ethics, though, we might be concerned about this as the basis for the entirety of our moral Ethics of care decision-making. While there is a strong case for think- ing that both character and relationships are morally Another non-action-focused approach to ethics is relevant, there appear to be equally strong grounds 33 known as the ethics of care. ( ) This starts from a criti- for thinking that actions and activities are morally cism of views like consequentialism and deontology, relevant, and not just insofar as they affect character which take ethical obligations to be impartial and uni- or relationships. versal, arguing that these rely on an unrealistic view of individuals as autonomous, self-sufficient beings, and that instead we ought to see people as social beings, Dealing with moral difference nested within a complex set of relationships. The eth- ics of care concentrates on these relationships and the We have introduced four of the most common emotions such as sympathy and solidarity that tend approaches to ethical decision-making, but it seems that to go with them. Because the ethics of care focuses in at least some cases they will lead us towards different on receptivity to the needs and desires of particular answers. For example, in the case study it seems likely people to whom we stand in particular relationships it that a consequentialist will be inclined to approve the tends to see moral judgements as highly contextual research because overall the benefits outweigh the risks, rather than deriving from general rules. Historically, the whereas a deontologist might reject it because enroll- ethics of care has been associated with feminist think- ing research subjects without consent might either vio- ers and has been said to reflect the ways in which late their rights or the researchers’ duty to treat people women and girls think about ethical issues, but its focus with respect, and a virtue ethicist might go either way, is broader than simply gender relationships and some depending on what they understand the relevant vir- feminists have criticised this view as reinforcing stereo- tues to be. Given a population with diverse moral views types about women as the ‘caring sex’. this creates an obvious problem for ethical decision- making especially when, as in the context of research Someone approaching research ethics from the per- ethics, we are making ethical decisions on behalf of spective of the ethics of care might focus on the rela- society. This is the problem of moral difference. tionship between the researcher and the research participants (although in the research in the case study Moral differences exist not only between the major the relationship would be minimal). On the question ethical frameworks described above, but within each of whether people taking part in research should be of them. As we saw above, there are different accounts termed ‘subjects’ or ‘participants’, those with an ethics of the consequences we should promote, the rights and of care perspective might argue that ‘participants’ is duties we should respect and the virtues we should a richer term that encourages the participants being cultivate. This raises a general question about the seen by the researcher as people to be engaged with, authority and mandate of research ethics committees: 33. For further introductory reading on the ethics of care see James Rachels and Stuart Rachels, The Elements of Moral Philosophy (New York: McGraw-Hill, 2009), Chapter 11. 26C H APT E R 1 LO CATING E THICS IN RE SEAR CH what gives a committee the authority to decide what a deadlock between members of the committee hold- others can do and on what basis should it make its ing different views, and if there happened to be con- decision? We will return to this issue towards the end sensus within the committee this would give rise to of this chapter and again in Chapter 7. concerns about its representativeness and hence about the legitimacy of its decisions. The second approach How should we respond to the problem of pluralism? threatens to undermine the rationale for having the We will quickly review and reject two initial responses ethical review of research in the first place. before exploring some more promising options. Instead we need a coherent account of how to find • We might adopt one ethical approach and reject an accommodation between several different ethical the others. This might mean trying to develop views, in essence a political approach to handling moral a version of the preferred approach that can differences. We will return to this issue in Chapter 7, overcome the objections raised against it and but for now we can identify some further moral frame- providing arguments for its superiority over other works which aim to explain how we can arrive at approaches. However, given that all the approaches shared moral judgements in societies characterised combine elements of plausibility with serious dif- by moral difference. ficulties, and that philosophers have been grap- pling with these problems for hundreds of years, Discourse Ethics we are unlikely to reach a consensus in the near future. To impose one approach in the face Discourse ethics, at least as it was articulated by of ongoing disagreement and in the absence of Habermas, claims to provide a universal account of our 34 compelling arguments would arguably be both moral obligations that all ought to agree with. ( ) disrespectful to those taking a different view and It does this by focusing on the normative commitments harmful to the authority and legitimacy of the that engaging in dialogue imposes on the participants research governance process. in that dialogue. As such, the moral claims made by • Alt ernatively we might give up on a search for discourse ethics are situationally dependent and answers to ethical problems. If we are unable emerge as a consensus from discourse about the situ- to come up with arguments that can command ation at hand. general agreement, perhaps that is because there are no answers to be found. One difficulty with this Habermas claims that: approach is that it conflicts with our sense that it matters what we think about ethical questions, Only those norms can claim to be valid that meet (or that people can be mistaken about such questions could meet) with the approval of all affected in their 35 and that it makes sense for us to protest when capacity as participants in a practical discourse. ( ) someone is doing something unethical. On this account, the appropriate moral norms can Both of these responses to ethical pluralism seem dif- only be established through dialogue under fair con- ficult to defend in the context of research ethics, given ditions in which all viewpoints are heard and taken the extent of moral disagreement in society and likely seriously. The norms that govern this discourse dis- to be found around the table at an ethics committee courage disingenuous debating techniques, irrele- meeting. The first approach is likely to end up with vancy and inappropriate claims of priority for particular 34. For furt her introductory reading on Discourse Ethics see James Bohman and William Rehg, “Jürgen Habermas”, The Stanford Encyclopedia of Philosophy (Fall 2008 Edition), Edward N. Zalta, ed. http://plato.stanford.edu/archives/fall2008/entries/habermas/ 35. Jürgen Habermas, “Discourse ethics: notes on a program of philosophical justification”, in The Communicative Ethics Controversy, Seyla Benhabib and Fred Dallmayr, eds. (Cambridge, Massachusetts: MIT Press, 1990): 11-77. 27EUROPE AN TE XTB O OK ON ETHI CS IN R E SE ARCH viewpoints. This provides a means of coping with the • beneficence (the obligation to provide benefits and plurality of moral views. to balance benefits against risks); • justice (the obligation of fairness in the distribution Two concerns might be raised for discourse ethics as of benefits and risks). a way forward for research ethics. The first is that we would need to establish what count as fair conditions These are to be viewed as defeasible, or prima facie prin- of discourse, but this itself might be subject to disa- ciples. If only one principle applies in a situation then greement. Habermas claims that the conditions of fair we should act on it but if two or more apply, and sug- discourse emerge from the nature of communication gest different courses of action, then some will be over- itself, but there is still the possibility of disagreement ridden by others. about what this entails. The second is that discourse does not always come to a single clear resolution that Principlism claims to provide a response to moral plu- is consistent with past decisions, so there still might ralism by basing moral decision-making on principles be uncertainty in what the committee should decide, which can be supported by people with different ethi- and researchers might find it hard to predict what kinds cal perspectives. For example, we have already seen how of research the ethics committee will approve. respect for autonomy is central to Kantian ethics and reflected in the requirement to treat others as ends in It is difficult to know without actually having the dis- themselves. Many consequentialists would also endorse course what practical conclusions would emerge the principle of respect for autonomy. This is because, regarding the research in the case study. However, since given that people have special insight into their own discourse ethicists believe that there are important preferences, they are generally better judges of their own norms within communicative transactions, and that interests than other people are; thus, if you want to these norms must be respected, it is likely that they make people better off you should generally let them would raise concerns about the consent process and choose what to do rather than dictating to them. the difficulties it faces. The principles themselves are supposed to capture Principlism what is intuitively plausible about both consequential- ist and deontological approaches, and to cover the full A framework that is very widely used in bioethics, and range of moral concerns. Sometimes these principles medical ethics in particular, is called ‘principlism’, or the will come into conflict (for example, in the case study ‘four principles approach’. This approach, popularised the principle of beneficence may support the proposed 36 by Tom Beauchamp and James F. Childress ( ) devel- research while the principles of non-maleficence and oped out of the Belmont report, an American report on respect for autonomy may oppose it in its current 37 the ethical conduct of research published in 1979. ( ) form). In some cases the conflict may be removed by a more careful ‘specification’ of the principles, which The four principles are: might lead us to conclude, for example, that the prin- ciple of respect for autonomy does not apply when the • respect for autonomy (the obligation to respect deci- subjects lack competence (for more on competence sion-making capacities of autonomous persons); see Chapter 3). When a conflict between principles • non-maleficence (the obligation to avoid causing cannot be avoided in this way we simply balance the harm); principles against each other, using our judgement to 36. Tom L. Beauchamp and James F. Childress, Principles of Biomedical Ethics (Oxford: Oxford University Press, 2009). 37. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1979). http://ohsr.od.nih.gov/guidelines/belmont.html 28C H APT E R 1 LO CATING E THICS IN RE SEAR CH assess which principle is most important in the partic- to do or forbear because it will be better for him ular circumstances under consideration. to do so, because it will make him happier, because, in the opinion of others, to do so would be wise, or However, critics allege that it is difficult to determine even right… The only part of the conduct of anyone, what answer the four principles approach gives to for which he is amenable to society, is that which any particular ethical problem – making it a difficult concerns others. In the part which merely concerns approach to apply. To see the strength of this objec- himself, his independence is, of right, absolute. Over tion, consider that each of the arguments for and himself, over his own body and mind, the individual 40 against the artificial blood research could be supported is sovereign. ( ) by one of the four principles; this still leaves us with the problem of how to weigh up the competing consider- T his leads to a strong emphasis on individual autonomy ations. Lacking any particular formula for the resolution and decision-making. In the context of research ethics of such conflicts, different people may come to differ- this would lead the research ethics committee to adopt ent judgements. It is therefore not clear that principlism a strongly non-paternalistic role. The ethics committee solves the problem of pluralism. Likewise there is a ques- would see its role as being to ensure that participants tion of whether the four principles really do capture the are fully informed, and after that it would be up to them entirety of moral concerns, or whether they highlight to decide what risks they are prepared to take. 38 a particular subset of concerns. ( ) The research in the case study presents a difficulty here, Liberalism in that many subjects are not in a position to decide for themselves whether to participate. In light of this A popular view in the light of the plurality of different they might insist that only participants who are in ethical concerns is to claim that the government ought a position to consent can be enrolled in the trial. Note to aim, as far as possible, to be neutral between differ- that for liberals an appeal to the potential benefit for 39 ent ethical views or ‘conceptions of the good’. ( ) This the participant is not likely to be compelling because view generally leads to a focus on not interfering with the harm principle (and more generally the liberal’s anti- the life choices of people unless their choices are liable paternalistic stance) implies that people should not be to bring about harm to others. This is known as the forced to do things for their own good. ‘harm principle’ and is most famously formulated by John Stuart Mill as follows: Communitarianism The sole end for which mankind are warranted, indi- Some authors have claimed that liberalism’s emphasis vidually or collectively, in interfering with the liberty on individual choice makes for an impoverished view of of action of any of their number, is self-protection. the individual which fails to recognise the extent to That the only purpose for which power can be right- which people’s values and sense of identity depend on 41 fully exercised over any member of a civilized com- the communities to which they belong. ( ) Instead it is munity, against his will, is to prevent harm to others. claimed that, due to the ‘embeddedness’ of people His own good, either physical or moral, is not suffi- within culture and society, decisions should focus on cient warrant. He cannot rightfully be compelled what maintains the community rather than what serves 38. Tom Walker, “What principlism misses”, Journal of Medical Ethics 35 (2009): 229-31. 39. For an excellent introduction to liberalism see Will Kymlicka, Contemporary Political Philosophy: an introduction (Oxford: Oxford University Press, 2001), Chapter 3. 40. John Stuart Mill, On Liberty (London: Longman, Roberts & Green, 1869; bartleby.com, 1999): 21-22. http://www.bartleby.com/130/ 41. For a g ood introduction to communitarian thought see Will Kymlicka, Contemporary Political Philosophy: an introduction (Oxford: Oxford University Press, 2001), Chapter 6. 29EUROPE AN TE XTB O OK ON ETHI CS IN R E SE ARCH the wants of individuals. This position is known as committee will have different ethical approaches and communitarianism. so will focus on different ethical issues arising from the research that they are reviewing. In contrast to liberalism, communitarians will allow consensual activities to be prohibited where they threaten the values of the community, even where The role and legitimacy of research there is no identifiable harm to individuals other than ethics committees disapproval, offence or disgust. The justification for this interference is that once individuals are properly con- In the first section of this chapter a case was made for ceptualised as part of their community rather than sep- the regulation of research. Given the preceding discus- arate objects, it becomes apparent that interfering with sion of moral decision-making it might now be asked their liberty in these cases is actually in their best inter- what role research ethics committees ought to play in ests because their interests are dependent on the flour- this regulation? ishing of the community. The European Union Clinical Trials Directive defines In relation to research ethics, a communitarian is likely a research ethics committee as: to question the view that individual consent is either necessary or sufficient to allow research to proceed. an independent body in a Member State, consisting For example, if a piece of research might be thought of of healthcare professionals and nonmedical mem- as undermining community values, a communitarian bers, whose responsibility it is to protect the rights, might think that it should be forbidden even if the safety and wellbeing of human subjects involved in individuals involved are consenting. In the case we a trial and to provide public assurance of that pro- are discussing, communitarians might insist on some tection, by, among other things, expressing an opin- form of community consultation and then allow ion on the trial protocol, the suitability of the the research to go ahead because of its potential ben- investigators and the adequacy of facilities, and on efits to the community despite the inability to seek the methods and documents to be used to inform 43 individual consent. trial subjects and obtain their informed consent. ( ) As we have elaborated in this section, there are many This of course only applies to committees governed different approaches to ethical issues generally and in by that directive, but many other committees follow research. Importantly, each of these approaches focuses similar lines. Nonetheless this remit is a broad one and on a different range of concerns and highlights different a significant amount of discretion exists for research ethical issues. One conclusion we can draw from this is ethics committees to interpret their role. that sometimes important ethical issues may be missed or sidelined if we just stick to a single approach to ethi- There are three main models of a research ethics com- cal decision-making. When thinking about ethical issues mittee’s role: in research it is useful to consider them from the per- 42 spective of several different ethical approaches. ( ) (i) To protect and support the autonomy of prospec- 44 This is one advantage of having a committee to review tive and existing research subjects/participants. ( ) research, since inevitably different members of the As noted earlier this is a broadly liberal approach. 42. David Hunter, “Proportional ethical review and the identification of ethical issues”, Journal of Medical Ethics 33 (2007): 241-5. 43. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Relating to the Implementation of Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use. http://europa.eu/eur-lex/pri/en/oj/dat/2001/l_121/l_12120010501en00340044.pdf 44. Sa rah Edwards, Simon Kirchin and Richard Huxtable, “Research ethics committees and paternalism”, Journal of Medical Ethics 30, (2004): 88-91. 30C H APT E R 1 LO CATING E THICS IN RE SEAR CH (ii) T o protect the welfare of prospective and existing A final challenge might be raised to the approach we research subjects/participants. This, in contrast, have developed thus far in this chapter: what should might be based on consequentialist grounds. a research ethics committee do if some of its members (iii) T o balance a number of relevant moral consider- have a religious or personal moral objection to some ations when considering research proposals, aspect of the research under consideration? Suppose, for including that of respect for autonomy and the example, that in the case study the blood was derived 45 protection and advancement of welfare. ( ) The from a process that relied on human embryos being sort of approach exemplified by the four princi- destroyed to create stem cells. Or suppose the artificial ples approach might support this view. blood was derived from pigs or cows. Many research ethics committees will have at least one member who Each of these models will generate different sorts of would object to this on the grounds of their personal conclusions about research proposals and different moral commitments, and in some contexts this may approaches to assessing them. be the majority view. So should they present this as an objection to allowing the research to go ahead? There are arguments for adopting any of these approaches, but in the light of the discussion above, It is important that these objections are presented the third position seems most defensible. As noted ear- so that they can be considered by the committee. lier, there is significant and widespread disagreement However, they should not be presented as trump cards among reasonable people about moral claims. Given ruling out the possibility of compromise and reasona- this, and the uncertainty that is necessarily involved in ble agreement. Part of the role of an ethics committee research, it is important to adopt a stance that allows is to provide a forum for a compromise and reasonable at least the consideration of a wide range of arguments, debate between different viewpoints that a simple even if some are ultimately rejected. opinion poll cannot capture. This relies on members expressing their own views. It also requires a commit- This is further buttressed by a consideration of the role tee that functions in a deliberative fashion, and which of research ethics committees in society. Research eth- welcomes discussion and consideration of potential ics committees are not (typically) private organisations, ethical challenges. they are instead public representatives. Their authority comes from the government, and they make ethical So the role of a research ethics committee is to regu- decisions on behalf of the public. As such, they need to late the ethical conduct of research. Primarily this be able to represent and take into account the differ- involves the review of research proposals before ent moral positions held by members of society. While research is carried out, though it may also involve some the neutrality between moral positions that liberalism role in monitoring the conduct of research and decid- offers is tempting, it seems sometimes inappropriate ing what should be done if something goes wrong. for an ethics committee precisely because its mandate Often the research ethics committee will require is to make moral decisions. While in principle neutrality changes to projects or make recommendations before between different moral claims is desirable in a public they allow them to proceed. In making such judge- body, strict adherence to neutrality in cases of contro- ments committees should bear in mind that over- versy would be likely to limit a committee too much. burdensome and interventionist ethical review can itself Given this, a pluralistic approach to moral decision- be unethical insofar as it prevents or delays worthwhile making is required. and ethical research. RECs might also consider it part 45. Eve Garrard and Angus Dawson, “What is the role of the research ethics committee? Paternalism, inducements, and harm in research ethics”, Journal of Medical Ethics 31, (2005): 419-23. 31

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