The Ethics of Medical Research on Humans

by Claire Foster

• ISBN13: 9780521645737
• ISBN10: 0521645735
• Format: Paperback
• Copyright: 2001-10-22
• Publisher: Cambridge University Press

Summary

One of the most difficult problems that confronts clinicians and medical professionals is how to apply ethical principles to real decisions affecting patients. In this even-handed book, Foster examines the three main approaches to moral decision-making: goal-based, duty-based and rights-based. She examines the underlying philosophical arguments behind each, their relative strengths and weaknesses, and how they can actually be applied. She also looks at the problematic boundaries where best practice ends and experimentation begins. Is it ethical to experiment with new cures on people who are probably dying anyway? And how do you assess quality of consent? This book provides a thorough, non-partisan grounding in what the ethical principles are and what informs them. It is an invaluable preparation both for a researcher being interviewed by an ethics committee and for the people sitting on the committee, and will be essential reading for all medical decision-makers.

Table of Contents

Foreword	xi
Professor Sir David Weatherall
Acknowledgements	xiii
An introduction to the ethical issues	1	(12)
Introduction	1	(2)
What is the value of research?	3	(2)
What are the limitations of research?	5	(1)
What is the right way to treat human research participants?	6	(2)
How can research participants' views be respected?	8	(1)
Three areas of ethical concern in research: science, best interests and autonomy	9	(4)
Goal-based morality: scientific rigour in research	13	(18)
The foundations of goal-based thinking	13	(5)
Research should manimize health and minimize harm	13	(1)
Utilitarianism's strengths and weaknesses	13	(4)
Goal-based moral thinking applied to medical research	17	(1)
The application of goal-based thinking	18	(12)
The goals of research	18	(3)
Methods of research	21	(4)
Disseminating the results of research	25	(5)
Summary and concluding remarks	30	(1)
Duty-based morality: acting in the research subjects' best interests	31	(16)
The foundations of duty-based thinking	31	(8)
From goals to duties	31	(1)
Natural law ethics	32	(2)
Kant's categorical imperative	34	(2)
Duty-based moral thinking applied to medical research	36	(3)
The application of duty-based thinking	39	(6)
Therapeutic research	39	(4)
Non-therapeutic research	43	(2)
Summary and concluding remarks	45	(2)
Right-based morality: respecting the autonomy of research participants	47	(18)
The foundations of right-based thinking	47	(10)
From duties to rights	47	(1)
Definitions of rights	48	(5)
The validity of rights	53	(4)
The applications of right-based thinking	57	(6)
The consent procedure	57	(4)
Concluding remarks on consent	61	(1)
Confidentiality	61	(2)
Summary and concluding remarks	63	(2)
From principles to practice	65	(8)
Introduction	65	(1)
Goal-based morality	65	(3)
Goal-based morality's theoretical basis summarized	65	(1)
Goal of research in theory and practice	66	(1)
Research method summarized	67	(1)
The practical implications of the choice of research method	67	(1)
Summary of the problems with disseminating the results of research	67	(1)
Introduction to practical examples of dissemination problems	68	(1)
Duty-based morality	68	(3)
Duty-based morality's theoretical basis summarized	68	(1)
The practical implications of duty-based morality	69	(1)
Introduction to examples	69	(2)
Right-based morality	71	(1)
Right-based morality's theoretical basis summarized	71	(1)
Introduction to examples	71	(1)
Does the three-approaches framework succeed?	72	(1)
Case studies of goal-based issues	73	(20)
Introduction	73	(1)
Goals of research	73	(7)
Organ transplantation	73	(2)
Maintaining the condition of donor organs	75	(2)
Xenotransplantation	77	(2)
Autografting using cloned embryos	79	(1)
Methods of research	80	(8)
The discovery of pencillin was due to luck and hard work, but not planning	81	(4)
Alternative and complementary therapy research needs open minds	85	(1)
Trials in homeopathy	86	(2)
Dissemination of the results of research	88	(2)
Results of research into futile treatment depend on what is understood by 'futile'	88	(1)
Results of pharmaceutical company research are always commercially favourable	89	(1)
Results should ultimately meet public need	90	(1)
Summary and concluding remarks	90	(3)
Case studies of duty-based issues	93	(20)
Introduction	93	(1)
Therapeutic research	94	(9)
Duty to care versus scientific goals: placebo controls in therapeutic research	94	(1)
Trails of folic acid in pregnancy	95	(1)
Trials for treatments of peptic ulcer disease	96	(1)
Scientific arguments against the use of placebo	97	(1)
The FDA's arguments for requiring placebo	98	(2)
Meta-analysis of trials of ondansetron	100	(2)
Concluding remarks	102	(1)
Non-therapeutic research	103	(7)
Duty to care versus scientific goals: potential risks in non-therapeutic research	103	(3)
Duty to care versus patient autonomy: non-therapeutic healthy volunteer research indicates the need to protect subjects from harm even if they consent	106	(4)
Summary and concluding remarks	110	(3)
Case studies of right-based issues	113	(20)
Introduction	113	(1)
Consent	113	(17)
Right-based difficulties with consent: the empirical evidence	114	(7)
Duty-based difficulties with consent	121	(2)
Goal-based difficulties with consent	123	(3)
Written consent	126	(2)
Concluding remarks	128	(2)
Confidentiality	130	(2)
Should records-based or epidemiological research take place if it compromises patient autonomy?	130	(2)
Concluding remarks	132	(1)
Summary and concluding remarks	132	(1)
A framework for ethical review: researches, research ethics committees, and moral responsibility	133	(14)
Introduction	133	(1)
The three approaches combined	133	(2)
A framework to assist ethical review	135	(1)
Goal-based questions	135	(1)
Duty-based questions	136	(1)
Right-based questions	136	(1)
Resolving conflicts between the three approaches	136	(3)
Goal-based questions to set the context	136	(1)
Goal-based and duty-based moral imperatives in conflict	136	(1)
Goal-based and right-based	137	(1)
Duty-based and right-based	138	(1)
Goal-based and right-based again	139	(1)
When the three approaches fail	139	(1)
Research ethics committees	140	(6)
The Nuremberg Code	141	(1)
Pappworth's guinea pigs	141	(1)
Sir Austin Bradford-Hill and Mrs. Hodgson	142	(1)
The Medical Research Council, the World Medical Association and the Royal College of Physicians	143	(1)
The Ministry of Health	143	(1)
The growth of research ethics committees' power	143	(1)
Multi-centre research ethics committees	144	(1)
'Who guards the guardians?'	145	(1)
Bradford-Hill's prophecy	145	(1)
Conclusion	146	(1)
References	147	(8)
Index	155