Chapter
What is the value of research?
What are the limitations of research?
What is the right way to treat human research participants?
How can research participants' views be respected?
Three areas of ethical concern in research: science, best interests and autonomy
2 Goal-based morality: scientific rigour in research
The foundations of goal-based thinking
Research should aim to maximize health and minimize harm
Utilitarianism's strengths and weaknesses
Goal-based moral thinking applied to medical research
The application of goal-based thinking
Immediate goals and general directions
Judging the morality of the goals of research proposals
Researcher’s motive a guide: problems with paying researchers to conduct research
Why researchers should always aim for the sky
Randomized controlled trials
Observational or epidemiological research
Disseminating the results of research
Encouraging clinicians to put knowledge into practice
Collecting the results of research
The limitations of evidence-based medicine
Summary and concluding remarks
3 Duty-based morality: acting in the research subjects' best interests
The foundations of duty-based thinking
Kant's categorical imperative
Duty-based moral thinking applied to medical research
The application of duty-based thinking
Can patients still think their doctors are giving them individualized treatment if they are also participants in their…
Additional, non-therapeutic tests demanded by the research protocol
Does it matter that the best interests test fails in non-therapeutic research?
Should consent be the deciding factor?
Summary and concluding remarks
4 Right-based morality: respecting the autonomy of research participants
The foundations of right-based thinking
Interest theory and choice theory
Kant’s autonomy of reason
Kennedy’s rights for the weaker party
The applications of right-based thinking
Competence and the use of vulnerable groups in research
Determining a child’s competence
Decisions on behalf of an incompetent child or adult
Competence in the ordinary adult
Voluntary nature of the decision
Concluding remarks on consent
Summary and concluding remarks
5 From principles to practice
Goal-based morality’s theoretical basis summarized
Goals of research in theory and practice
Research method summarized
The practical implications of the choice of research method
Summary of the problems with disseminating the results of research
Introduction to practical examples of dissemination problems
Duty-based morality’s theoretical basis summarized
The practical implications of duty-based morality
Right-based morality’s theoretical basis summarized
Does the three-approaches framework succeed?
6 Case studies of goal-based issues
Maintaining the condition of donor organs
Autografting using cloned embryos
The discovery of penicillin was due to luck and hard work, but not planning
Alternative and complementary therapy research needs open minds
Dissemination of the results of research
Results of research into futile treatment depend on what is understood by ‘futile’
Results of pharmaceutical company research are always commercially favourable
Results should ultimately meet public need
Summary and concluding remarks
7 Case studies of duty-based issues
Duty to care versus scientific goals: placebo controls in therapeutic research
Trials of folic acid in pregnancy
Trials for treatments of peptic ulcer disease
Scientific arguments against the use of placebo
The FDA’s arguments for requiring placebo
Meta-analysis of trials of ondansetron
Duty to care versus scientific goals: potential risks in non-therapeutic research
Duty to care versus patient autonomy: non-therapeutic healthy volunteer research indicates the need to protect subjects from…
Healthy volunteer study of eproxindine hydrochloride, 1985
Audit of volunteer screening procedures
Does payment to research subjects make a moral difference?
Women of child-bearing potential as healthy volunteers
Summary and concluding remarks
8 Case studies of right-based issues
Right-based difficulties with consent: the empirical evidence
Patients felt they were well-informed
King’s review of the literature
Volunteers tend to be less well-educated
Patients do not understand information sheets
Benefits remembered more than risks
Randomization not really understood: the ECMO study
Duty-based difficulties with consent
Empirical evidence of whether information increases anxiety
Patients' consent should not automatically be sought in therapeutic research
Problems with this argument
Lord Scarman’s prudent patient test
Goal-based difficulties with consent
Empirical evidence that consent reduces recruitment
The ISIS Trial in the United Kingdom and the United States
The breast conservation trial and the President's Commission
Patients will not happily agree to being randomized
Research which cannot take place if consent is sought
Interjection: should research be published if it was conducted unethically?
Empirical evidence that patients think their signature protects the doctor
Consent as a separate, necessary procedure
The effect of the consent form on the research participant
Should records-based or epidemiological research take place if it compromises patient autonomy?
Summary and concluding remarks
9 A framework for ethical review: researchers, research ethics committees, and moral responsibility
The three approaches combined
A framework to assist ethical review
Resolving conflicts between the three approaches
Goal-based questions to set the context
Goal-based and duty-based moral imperatives in conflict
Goal-based and right-based
Duty-based and right-based
Goal-based and right-based again
When the three approaches fail
Research ethics committees
Sir Austin Bradford-Hill and Mrs Hodgson
The Medical Research Council, the World Medical Association and the Royal College of Physicians
The growth of research ethics committees’ power
Multi-centre research ethics committees
'Who guards the guardians?'
The Ethics of Medical Research on Humans
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