The Ethics of Medical Research on HumansOne 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. -- Book Jacket. |
Contents
An introduction to the ethical issues | 1 |
What is the value of research? | 3 |
What are the limitations of research? | 5 |
What is the right way to treat human research participants? | 6 |
How can research participants views be respected? | 8 |
science best interests and autonomy | 9 |
Goalbased morality scientific rigour in research | 13 |
Goalbased moral thinking applied to medical research | 17 |
Trials in homeopathy | 86 |
Dissemination of the results of research | 88 |
Results of pharmaceutical company research are always commercially favourable | 89 |
Results should ultimately meet public need | 90 |
Case studies of dutybased issues | 93 |
Therapeutic research | 94 |
Trials of folic acid in pregnancy | 95 |
Trials for treatments of peptic ulcer disease | 96 |
The application of goalbased thinking | 18 |
Methods of research | 21 |
Disseminating the results of research | 25 |
Summary and concluding remarks | 30 |
Dutybased morality acting in the research subjects best interests | 31 |
Natural law ethics | 32 |
Kants categorical imperative | 34 |
Dutybased moral thinking applied to medical research | 36 |
The application of dutybased thinking | 39 |
Nontherapeutic research | 43 |
Summary and concluding remarks | 45 |
Rightbased morality respecting the autonomy of research participants | 47 |
Definitions of rights | 48 |
The validity of rights | 53 |
The applications of rightbased thinking | 57 |
Concluding remarks on consent | 61 |
Summary and concluding remarks | 63 |
From principles to practice | 65 |
Goals of research in theory and practice | 66 |
Research method summarized | 67 |
Introduction to practical examples of dissemination problems | 68 |
The practical implications of dutybased morality | 69 |
Rightbased morality | 71 |
Does the threeapproaches framework succeed? | 72 |
Case studies of goalbased issues | 73 |
Maintaining the condition of donor organs | 75 |
Xenotransplantation | 77 |
Autografting using cloned embryos | 79 |
Methods of research | 80 |
The discovery of penicillin was due to luck and hard work but not planning | 81 |
Alternative and complementary therapy research needs open minds | 85 |
Scientific arguments against the use of placebo | 97 |
The FDAs arguments for requiring placebo | 98 |
Metaanalysis of trials of ondansetron | 100 |
Concluding remarks | 102 |
Nontherapeutic research | 103 |
nontherapeutic healthy volunteer research indicates the need to protect subjects from harm even if they consent | 106 |
Summary and concluding remarks | 110 |
Case studies of rightbased issues | 113 |
the empirical evidence | 114 |
Dutybased difficulties with consent | 121 |
Goalbased difficulties with consent | 123 |
Written consent | 126 |
Concluding remarks | 128 |
Confidentiality | 130 |
Concluding remarks | 132 |
A framework for ethical review researchers research ethics committees and moral responsibility | 133 |
A framework to assist ethical review | 135 |
Dutybased questions | 136 |
Goalbased and rightbased | 137 |
Dutybased and rightbased | 138 |
Goalbased and rightbased again | 139 |
Research ethics committees | 140 |
The Nuremberg Code | 141 |
Sir Austin BradfordHill and Mrs Hodgson | 142 |
The Medical Research Council the World Medical Association and the Royal College of Physicians | 143 |
Multicentre research ethics committees | 144 |
Who guards the guardians? | 145 |
Conclusion | 146 |
| 147 | |
| 155 | |
Common terms and phrases
accept action allocation argued arguments asked autonomy babies believe benefit best interests British Medical Journal cancer categorical imperative Chapter clinical trial clinicians conducted confidentiality consent form consent procedure consider context decision Declaration of Helsinki deontological discussed dissemination doctor doctor's duty drug duty-based concern duty-based morality duty-based perspective ECMO effect ensure equipoise ethics of research evidence evidence-based medicine example folic acid goal-based morality goals of research harm healthy volunteer Hence homeopathy important individual infants informed consent involved issue justified maximize happiness medical research moral thinking nature non-therapeutic research ondansetron organ transplantation parents penicillin person placebo arm placebo controlled trials practice principle problems randomized controlled trial reason requires research ethics committees research methods research on humans research participants research project research subjects responsibility right-based morality risk rule utilitarianism scientific seeking consent strong equipoise therapeutic research three approaches treat treatment unethical utilitarianism validity xenotransplantation