Codes and Principles - Research Ethics for Social Scientists

Introduction

There is a conventional story told about the emergence of research ethics.

After the Second World War, horrified by the medical experimentation under-taken by Nazi Germany, the West developed the Nuremberg Code (1947) which, coupled with the World Medical Association’s Declaration of Helsinki in 1964, became the cornerstones of bioethics. Slowly, concepts developed in bioethics have been extended to research endeavours across the research spec-trum, including social science.

Of course, real life is rarely so simple (see Table 3.1). First, regulations governing medical experimentation existed before the war in, of all places, Germany (Prussia) (Vollmann and Winau, 1996). Second, the Nuremburg Doctors’ Trial was largely an American initiative – Britain distanced itself from it publicly, though its agencies worked covertly in both the trial and in estab-lishing the framework for the Code (Hazelgrove, 2002).Third, both American and British medical researchers engaged in highly questionable experimenta-tion before and during the Second World War (Hazelgrove, 2002). Far from putting a stop to these activities, Nuremberg marked the beginning of a util-itarian approach to human experimentation on prisoners in the United States (Hornblum, 1998). Finally, the spread to social science of regulations based on bioethics has been neither uniform nor uncontested.

Nevertheless, changes have occurred since 1945 through the develop-ment of four major and highly influential formal ethical statedevelop-ments: the Nuremberg Code (1947), the Declaration of Helsinki (1964), the Belmont Report (1979) and the Council for International Organisations of Medical

Research Ethics for Social Scientists

Year Event

1945 • Nuremberg trials commence

1946

1947 • Nuremberg Code r eleased

1948 • United Nations Universal Declaration of Human Rights 1949

1950 1951 1952

1953 • Wichita jur y study

1954 1955

1956 • Willowbrook hepatitis studies commence in New Y ork and continue until 1972

1957 1958 1959 1960

1961 • Milgram’s ‘obedience to authority’ experiments commence

• Draft Declaration of Helsinki r eleased

1962 • Pappworth’s paper on ‘human guinea pigs’ published in popular magazine Twentieth Centur y

1963 • Jewish Chr onic Disease Hospital study

1964 • Declaration of Helsinki adopted by W orld Medical Association 1965

1966 • Beecher paper on unethical r esearch published in New England Journal of Medicine

• First institutional r esearch ethics committee in South Africa formed at University of Witwatersrand

• Australia’s NHMRC publishes Statement on Human Experimentation and Supplementar y Notes

• Cer vical cancer experiments commence at New Zealand’s National W omen’s Hospital

1967 • Pappworth’s book Human Guinea Pigs: Experimentation on Man published

1968 1969

Sciences (CIOMS) (1982).These statements on biomedical research provide key foundations for much current thinking and practice in social science research – either intellectually or institutionally through the dominance of the biomedical research model in shaping institutional ethical practice – and for this reason justify an exploration of their development in this book.

Table 3.1 Ethical code and regulatory developments since 1945

1970 • Laud Humphreys’ book Tearoom Trade published

1971 • San Antonio contraception study

• Zimbardo’s mock prison experiments at Stanfor d University 1972 • Tuskegee syphilis trials conclude, after r unning for 40 years

• Willowbrook hepatitis studies conclude 1973

1974 • US National Commission for the Pr otection of Human Subjects of Biomedical and Behavioral Resear ch (‘The National Commission’) cr eated as par t of the National Resear ch Act.

Prepared the 1979 Belmont Repor t 1975

1976

1977 • Canada Council’s Consultative Gr oup on Ethics publishes repor t on ethical principles for r esear chers and r eview committees

1978 • Medical Resear ch Council of Canada publishes Ethics in Human Experimentation

1979 • Belmont Repor t published

1980

1981 • Report of the US Pr esident’s Commission for the Study of Ethical Pr oblems in Medicine and Biomedical and Behavioral Research released, r ecommending that a Common Rule for all federally funded r esearch be developed

1982 • CIOMS (Council for Inter national Or ganizations of Medical Sciences) with W orld Health Or ganisation first pr oposes International Ethical Guidelines for Biomedical Resear ch Involving Human Subjects

1983 1984 1985 1986

1987 • ‘Car twright Inquir y’ into the tr eatment of cer vical cancer at New Zealand’s National W omen’s Hospital commences

• South Africa’s Human Sciences Resear ch Council publishes its Code of Resear ch Ethics

1988 • Results of New Zealand’s ‘Car twright Inquir y’ r eleased 1989 • United Nations Convention on the Rights of the Child

1990 • Norwegian Parliament appr oves establishment of thr ee national committees for r esearch ethics, including NESH

1991 • ‘Common Rule’ (CFR 46) adopted by 16 US federal departments and agencies

• Interim Guidelines on Ethical Matters in Aboriginal and T orres Strait Islander Resear ch released in Australia

1992 • Australian Health Ethics Committee (AHEC) established

• Research Ethics Committees established in Denmark

1993 • Vancouver Pr otocol published by Inter national Committee of Medical Jour nal Editors

1994 • US Advisor y Committee on Human Radiation Experiments formed

• Canada’s thr ee key research Councils (MRC, NSERC and SSHRC) release Statement on Integrity in Resear ch and Scholarship

(Continued)

Research Ethics for Social Scientists

• Canadian T ri-Council W orking Gr oup established to develop a code of ethics for r esearch involving humans

1995 • US Advisor y Committee on Human Radiation Experiments releases r eport. President Bill Clinton apologizes to the citizens who wer e subjected to these experiments, their families and communities

1996 • Australian Commonwealth Gover nment r eleases Report of the Review of the Role and Functioning of Institutional Review Committees

1997 • US Pr esident Bill Clinton apologizes to T uskegee experimental subjects

• Joint NHRMC/A V-CC Statement and Guidelines on Resear ch Practice released in Australia

1998 • Canada’s T ri-Council Policy Statement: Ethical Conduct for Research Involving Humans published

1999 • Australia’s NHMRC pr oduces Human Resear ch Ethics

Handbook

2000 • Guidelines for Good Practice in the Conduct of Clinical T rials in Human Par ticipants in South Africa published

• United States Federal Policy on Resear ch Misconduct published 2001 • Canadian Interagency Advisor y Panel on Resear ch Ethics (PRE)

created

2002 • Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and T orres Strait Islander Health Resear ch published in Australia

• American Anthr opology Association’s El Dorado T ask Force final report published

• CIOMS most r ecent r evision of International Ethical Guidelines for Biomedical Resear ch Involving Human Subjects

2003 • Canadian PRE cr eates Social Sciences and Humanities Research Ethics Special W orking Committee to examine issues from Tri-Council Policy Statement: Ethical Conduct for Resear ch Involving Humans related to humanities and social science research

2004 • Canadian PRE r eleases its r eport Giving Voice to the Spectr um

• RESPECT Principles for Ethical Socio-Economic Resear ch released

2005 • Review of Australian National Statement on Ethical Conduct in Research Involving Humans commences

• ARC, NHMRC and A V-CC begin pr eparing an Australian Code for Conducting Resear ch

• EUREC Declaration to establish a Eur opean Network of Research Ethics Committees

• OHRP set out pr eliminar y criteria for deter mining whether institutions outside the United States of fer protections equiva-lent to their ‘Common Rule’

2006 • Britain’s ESRC’s Research Ethics Framework comes into for ce

The Nuremberg Code

Before the Second World War, most biomedical research was conducted on a small scale and, when patients agreed to participate in research, their consent was typically made on the basis of trust rather than informed consent: ‘Patients trusted their physicians not to harm them, to do some-thing positive for them (even if they could not cure them – and cure was not routinely expected in the 1940s), and to act in their best interests’

(Kaufman, 1997, p. 179).

In this pre-War era, some medical and professional organizations took tentative steps to move from a relationship based on covenant to something slightly more ‘contractual’ by formalizing ethical dimensions of the doctor–patient or researcher–subject relationship. For instance, in develop-ments of relatively limited immediate significance, the American Psychological Association established an ethics committee in 1938 (Adams et al., 2001) and German and American doctors developed voluntary guidelines for ethical research (Adair, 2001).

Much greater and broader attention was directed to relationships between researchers and their subjects as a result of the Nuremberg trials after the Second World War.

Revelations at the trials about Nazi ‘science’ threatened to undermine

‘public faith in the “normal” science of the western liberal democracies’

(Hazelgrove, 2002, p. 111), so high-level British officials, for example, endeav-oured to ensure that research undertaken by the Allies not be tainted. These activities included development of a set of tenets upon which future research might be conducted (Hazelgrove, 2002, p. 111).

The Nuremberg Code emerged in part from fear of the consequences for science of any public loss of trust in doctors and researchers as well as from straightforward public abhorrence of cruel wartime experimentation.

The Code set out 10 key principles for human experimentation (see Box 3.1), renouncing a position taken by defendants in the Nuremberg trials that the community or species ought to have precedence over the individual (Bower and de Gasparis, 1978). Its drafters were concerned with experimen-tal or non-therapeutic research involving healthy, adult, competent and fully informed subjects – and not with research conducted during medical care (therapeutic research). The Code gave considerable emphasis to the vol-untary and informed consent of people competent to make decisions. Indeed, it was underpinned by the concept of voluntary consent. Under the Code,

BOX 3.1 THE NUREMBERG CODE (1947)

Permissible medical experiments

The great weight of the evidence befor e us is to the ef fect that cer tain types of medical experiments on human beings, when kept within r easonably well-defined bounds, confor m to the ethics of the medical pr ofession generally . The pr otagonists of the practice of human experimentation justify their views on the basis that such experiments yield r esults for the good of soci-ety that ar e unpr ocurable by other methods or means of study . All agr ee, however, that cer tain basic principles must be obser ved in or der to satisfy moral, ethical and legal concepts:

1. The voluntar y consent of the human subject is absolutely essential.

This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exer cise fr ee power of choice, without the inter vention of any element of for ce, fraud, deceit, duress, over reaching, or other ulterior for m of constraint or coer cion;

and should have suf ficient knowledge and compr ehension of the elements of the subject matter involved as to enable him to make an under-standing and enlightened decision. This latter element r equires that before the acceptance of an af firmative decision by the experimental subject ther e should be made known to him the natur e, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazar ds reasonably to be expected;

and the ef fects upon his health or person which may possibly come from his par ticipation in the experiment.

The duty and r esponsibility for ascer taining the quality of the consent r ests upon each individual who initiates, dir ects, or engages in the experiment. It is a personal duty and r esponsibility which may not be delegated to another with impunity .

2. The experiment should be such as to yield fr uitful results for the good of society , unpr ocurable by other methods or means of study , and not random and unnecessar y in natur e.

3. The experiment should be so designed and based on the r esults of animal experimentation and a knowledge of the natural histor y of the disease or other pr oblem under study that the anticipated r esults justify the per formance of the experiment.

(Continued) Research Ethics for Social Scientists

4. The experiment should be so conducted as to avoid all unnecessar y physical and mental suf fering and injur y.

5. No experiment should be conducted wher e there is an a priori reason to believe that death or disabling injur y will occur; except, per haps, in those experiments wher e the experimental physicians also ser ve as subjects.

6. The degr ee of risk to be taken should never exceed that deter mined by the humanitarian impor tance of the pr oblem to be solved by the experiment.

7. Proper preparations should be made and adequate facilities pr ovided to protect the experimental subject against even r emote possibilities of injur y, disability or death.

8. The experiment should be conducted only by scientifically qualified persons. The highest degr ee of skill and car e should be r equired through all stages of the experiment of those who conduct or engage in the experiment.

9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has r eached the physi-cal or mental state wher e continuation of the experiment seems to him to be impossible.

10. During the course of the experiment the scientist in char ge must be prepared to ter minate the experiment at any stage, if he has pr oba-ble cause to believe, in the exer cise of the good faith, superior skill and careful judgment required of him, that a continuation of the exper-iment is likely to r esult in injur y, disability , or death to the experimen-tal subject.

Source: Mitscherlich and Mielke, 1949, pp. xxiii–xxv

‘subjects’ had the right to cancel experiments and researchers were required to stop work if they were likely to cause injury or death to their subjects.

The Nuremberg Code became a central building block for subsequent codes of ethics (Jones, 1994), but its impact was not universal.

Public revelations about Nazi experimentation and the outcomes of the Nuremberg trials raised concerns about medical research in some parts of the world such as France (Weisz, 1990). Nuremberg had imperceptible significance in the United States (Oakes, 2002). The American public

maintained their faith in the Hippocratic Oath and the integrity of doctors – faith and trust that would be tested repeatedly by a series of shocks and scan-dals. However, before these incidents came to public attention some medical researchers began to develop their own codes of practice.

The Declaration of Helsinki

The World Medical Association’s (WMA) Declaration of Helsinki draws from, but amends, some provisions of the Nuremberg Code (Bošnjak, 2001; Bower and de Gasparis, 1978; Carlson et al., 2004). The Declaration has been described as ‘the fundamental document in the field of ethics in biomedical research and has influenced the formulation of international, regional and national legislation and codes of conduct’ (CIOMS, 2002).

The Declaration traces its beginnings to work of the WMA’s Medical Ethics Committee in 1953 (WMA, 2003). After several years of preliminary effort, a draft Declaration was tabled in 1961 and was adopted at the WMA’s 18th General Assembly in Helsinki, Finland in 1964.

This document spells out in mor e detail, in medical language specific to the scientific understanding that has evolved since Nur emberg, the natur e of the arguments that must be weighed befor e asking a patient (not a healthy , compe-tent volunteer) to consent to par ticipate in diagnostic or therapeutic r esearch. It does not contain an absolute r equirement that infor med consent be obtained in the setting of therapeutic r esearch and intr oduces the notion of guar dianship as a means of obtaining consent fr om incompetent subjects. (Leaning, 1996, p. 1413)

Ten of the 12 original markers of ethical research that were identified in the Nuremberg Code were adopted in the Declaration of Helsinki while two were amended significantly (Carlson et al., 2004; Seidelman, 1996).

First, where the Nuremberg Code had stated that ‘the voluntary consent of the human subject is absolutely essential’, the Helsinki Declaration allowed consent to be given by legal guardians in cases of ‘legal incapacity’. Second, the requirement that ‘During the course of the experiment the human sub-ject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible’ was removed. In its place – and over and above the subject’s freedom to withdraw – was the paternalist recommendation

Research Ethics for Social Scientists

that researchers should discontinue research if they believe it could prove harmful.

The 1964 Declaration set out 12 basic precepts which require that research conform to scientific principles, that it be conducted by an expert and that research procedures are considered, commented on and guided by specially appointed independent committees to ensure they are procedurally and legally acceptable (Levine, 1993).This recommendation has now been extended signif-icantly. Research risks need to be justifiable in terms of likely outcomes and respect for the subject is critical, in terms of reporting (for example, issues of privacy) and ensuring free and informed consent – particularly with dependent populations.

Like the Nuremberg Code before it, the Declaration of Helsinki gives emphasis to autonomy. However, the Declaration makes it quite clear that in all instances the researcher is responsible for research subjects: ‘The responsi-bility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given his or her consent’ (1964, I.3).

Five revisions to the Declaration of Helsinki have been made in its 40-year life. Revisions have occurred with increasing frequency since the early 1980s but the central tenets remain the same.

However, one particularly interesting – yet remarkably uncontroversial – amendment to the Declaration sets the document up as guidelines that super-sede national regulations (Carlson et al., 2004). Before 2000, the Declaration stated ‘It must be stressed that the standards as drafted are only a guide to physicians all over the world. Physicians are not relieved from criminal, civil and ethical responsibilities under the laws of their own countries’ (1996, Introduction, para. 8).This was amended in Edinburgh in 2000 to read:

Research investigators should be awar e of the ethical, legal and r egulator y requirements for r esearch on subjects in their own countries as well as applicable international r equirements. No national ethical, legal or r egulator y r equirement should be allowed to r educe or eliminate any of the pr otections for human sub-jects set for th in this Declaration. (2000, A.9).

Thus, the Declaration is now positioned ‘above’ diverse, culturally specific regulations but it provides no specific form of guidance to researchers confronted with a clash between the ethical guidelines of the world’s largest global grouping of doctors and ‘local’ laws and standards.The globally homog-enizing thrust of the Declaration of Helsinki with its apparent resistance to

local variation is something that is taken up in the Council for International Organizations of Medical Sciences’ International Ethical Guidelines for Biomedical Research Involving Humans (CIOMS, 2002), discussed later in this chapter.

The Belmont Report

The Declaration of Helsinki and the Nuremberg Code served as models for some professional organizations’ approaches to ethical research conduct (Jones, 1994) but proved difficult to use in non-biomedical settings. Moreover, it became increasingly evident from revelations of medical and scientific misconduct in the 1960s and 1970s on both sides of the Atlantic that doctors and medical researchers were betraying the trust members of the public placed in them.

First, in the 1960s, Maurice Pappworth drew attention to two decades of harmful experiments, often conducted on vulnerable populations, without appropriate consent (Hazelgrove, 2002, p. 119). Pappworth’s (1962/3) short article in the popular journal Twentieth Century and his book entitled Human Guinea Pigs: Experimentation on Man (1967) sparked public and professional debate and, according to Hazelgrove (2002), demonstrated that the Nuremberg Code’s principle of informed consent had become part of broad public con-sciousness. It appears from the debate that surrounded Pappworth’s publica-tions that trust, so important in pre-war research relapublica-tionships, was giving way

In document Research Ethics for Social Scientists (Page 38-55)