Lecture 5: Ethics and research

HEST 5001

Personal experiences of taking part in research as a subject

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Hippocratic Oath I swear by Apollo, the healer, Asclepius, Hygieia, and Panacea, and I take to witness all

the gods, all the goddesses, to keep according to my ability and my judgment, the following Oath and agreement: To consider dear to me, as my parents, him who taught me this art; to live in common with him and, if necessary, to share my goods with him; To look upon his children as my own brothers, to teach them this art.

I will prescribe regimens for the good of my patients according to my ability and my judgment and never do harm to anyone.

I will not give a lethal drug to anyone if I am asked, nor will I advise such a plan; and similarly I will not give a woman a pessary to cause an abortion.

But I will preserve the purity of my life and my arts. I will not cut for stone, even for patients in whom the disease is manifest; I will leave this

operation to be performed by practitioners, specialists in this art. In every house where I come I will enter only for the good of my patients, keeping myself

far from all intentional ill-doing and all seduction and especially from the pleasures of love with women or with men, be they free or slaves.

All that may come to my knowledge in the exercise of my profession or in daily commerce with men, which ought not to be spread abroad, I will keep secret and will never reveal.

If I keep this oath faithfully, may I enjoy my life and practice my art, respected by all men and in all times; but if I swerve from it or violate it, may the reverse be my lot.

Aristotle384-322 BCE

Declaration of HelsinkiWorld Medical Association 1964

I. Basic Principles II. Medical Research Combined with

Professional Care III. Non-Therapeutic Biomedical

Research Involving Human Subjects

Bristol Cancer Study of 1980s

Bagenal, F.S.; Easton, D.F; Harris, E.; Chilvers, C.E.D. and McElwain, T.J. (1990) Survival of patients with Breast Cancer attending Bristol Cancer Help Centre Lancet 336: 606-610.

Film

Principles

No harm (physical/psychological) Informed consent (participation, risks, procedures,

time, purposes, results) Voluntary participation Confidentiality Dignity and self-respect Couchman, W. & Dawson, J. (1990) Nursing and

Health Care Research London: Scutari Press.

Stages for Permissions

Research proposal Programme Research Review Meeting University Human Research Ethics Committee R&D Office/Primary Care Research Alliance NHS Trust or PCT Local Research Ethics Committee Trust Data Protection Officer Practitioners and managers Clients/participants

The Politics of Ethics 1

Vulnerable groups Ethics Committees (inter- and intra-professional

relations) Staff (e.g. occupational stress) Self-help groups (Lawson, 1991; Dyson, 2000) Randomisation (Oakley, 1990) Commercial interests (Olivieri vs Apotex)

The Politics of Ethics 2a

Professional imperialism Defining practice and research (Oakley, 1990) Defining audit, service evaluation and research Styles of research: opposition, then incorporation,

then redefinition Researching the powerful Observation

The Politics of Ethics 2b

The Tuskegee Syphilis Experiment1932-1973

"The United States government did something that was wrong—deeply, profoundly, morally wrong. It was an outrage to our commitment to integrity and equality for all our citizens... clearly racist."

—President Clinton's apology for the Tuskegee Syphilis Experiment to the eight remaining survivors, May 16, 1997

The Politics of Ethics 2c http://auschwitz.dk/Mengele

The Nuremberg Code (1947) i

Permissible Medical Experiments The great weight of the evidence before us to effect

that certain types of medical experiments on human beings, when kept within reasonably well-defined bounds, conform to the ethics of the medical profession generally. The protagonists of the practice of human experimentation justify their views on the basis that such experiments yield results for the good of society that are unprocurable by other methods or means of study. All agree, however, that certain basic principles must be observed in order to satisfy moral, ethical and legal concepts:

The voluntary 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 exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.

The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs, or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity

The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.

The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results justify the performance of the experiment.

The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.

No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.

The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.

Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability or death.

The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.

During the course of the experiment the human subject 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.

During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him, that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

The Politics of Ethics 3

Service providers claim IPR Funders University structures Risk management Withdrawal of independent social

scientists from health research Stricter rules than society at large (CCTV)

The Politics of Ethics 4

Contradictory demands (e.g. number of articles cited)

Factually incorrect assertions (“theoretical sampling does not go with grounded theory”)

Greater demand than service delivery (languages)

Hypocritical claims to protect patients (demands for original CRB checks when many in service do not have such checks)

Dixon-Woods et al (2007): incompetent, inconsistent and turn researchers into supplicants.

The Politics of Ethics 5 Policy makers do not receive prompt or cost-

effective research to inform policy Researchers adapt poor designs in response to

research governance Skilled investigators subject to excessive and

inappropriate bureaucracy Medicine (Mengele, Shipman, Alderhay, Bristol)

behind the atrocities not social science HSR Individual informed consent not the appropriate

model for HSR which is responsible to wider society

Capacity of social science HSR to do harm is not there in same way

Transfer of the governance model, developed in wake of real medical atrocities is not appropriate for HSR (Dingwall, 2006)

What’s Wrong with Ethics? (1)

This focus on technical issues at the expense of philosophical and ethical ones is a characteristic a number of authors have identified as being pervasive in the modern era. Giddens (1990, 1991) and Bauman (1993) argue that modernity is characterized by an unwillingness to confront major moral and existential issues. Furthermore, Giddens argues that this reluctance to address philosophical questions has something to do with the sheer pace of social and technical change.

This is allied to an increasing global scope of change and proceeds in tandem with increases in the complexity of institutional frameworks that render modern society discontinuous with its pre-modern forms. These tendencies can be seen in health care research, inasmuch as the explosion in publications in the health sciences in the last fifty years has been accompanied by ever more complex problems and a growing pace of revolution in health care organizations as well as the communities they serve. (Dyson and Brown, 2006: 135-6)

What’s Wrong with Ethics? (2)

Zygmunt Bauman (1993) points to the pervasive experience of what he calls ‘fragmentation’. In working life equally complex systems of expertise have come to predominate, and under regimes of evidence-based practice these generate truth claims that cannot be accessed or challenged by everyday lay understanding.

Thus, it is increasingly difficult to reflect on what our knowledge and our scientific practice mean in any broader sense. Thus most existing accounts of methodology contain very little of the philosophy from which they are derived. As secularization strips away spiritual truths and their moral imperatives, ethics too become focused on the narrow technical sense of the rights of participants and less on the role of our inquiry in the grander body politic. In Bauman’s view, modernity seeks certainty in universality and foundations. Hence evidence, research and faith in science have an increasingly central role in modern life. (Dyson and Brown, 2006: 136)

Baumann, Z. (1993) Postmodern Ethics, Oxford: Blackwell

Dingwall, R (2006)An exercise in fatuity: research governance and the emasculation of health services research Journal of Health Services Research Policy 11 (4): 193-4.

Dixon-Woods, M; Angell, E; Ashcroft, RE and Bryman, A (2007) Written work: The social functions of Research Ethics Committee letters Social Science and Medicine 65 (4): 792-802

Giddens, A. (1990) The Consequences of Modernity, Cambridge: Polity Press

Giddens, A. (1991) Modernity and Self Identity, Cambridge: Polity Press

Nuremberg Doctor's Trial, BMJ 1996;313(7070):1445-75.