Ethics in medical research: a handbook of good practice
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Cambridge [u.a.]
Cambridge Univ. Press
1999
|
| Ausgabe: | 1. publ. |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XVII, 403 S. |
| ISBN: | 0521626196 |
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| 245 | 1 | 0 | |a Ethics in medical research |b a handbook of good practice |c Trevor Smith |
| 250 | |a 1. publ. | ||
| 264 | 1 | |a Cambridge [u.a.] |b Cambridge Univ. Press |c 1999 | |
| 300 | |a XVII, 403 S. | ||
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| 650 | 4 | |a Expérimentation humaine en médecine - Aspect moral | |
| 650 | 4 | |a Médecine - Recherche - Aspect moral | |
| 650 | 4 | |a Ethik | |
| 650 | 4 | |a Medizin | |
| 650 | 4 | |a Ethics, Medical | |
| 650 | 4 | |a Human Experimentation | |
| 650 | 4 | |a Human experimentation in medicine |x Moral and ethical aspects | |
| 650 | 4 | |a Medicine |x Research |x Moral and ethical aspects | |
| 650 | 4 | |a Research |x organization & administration | |
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Datensatz im Suchindex
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|---|---|
| adam_text | ? Contents
Preface xiii
Acknowledgements xvi
1 Origin of the ethical review of medical research i
The Declaration of Helsinki 2
The evolution of ethics committees 4
General ethical principles 6
What is medical research? 7
2 Medical research ethics committees: protecting patients,
researchers and institutions 12
Who decides what research can be done on patients? 12
Local research ethics committees and their role 12
Who should be responsible for setting up ethics committees? 14
Who should sit on an ethics committee? 15
Evaluation of a research proposal 22
Standard proposal form 23
Chairperson s action / expedited review 29
Charging for submissions to local research ethics committees 32
Potential weak points in the system of local research ethics
committees 36
Ethical review of multicentre research 41
3 Researchers and their facilities 50
The researcher 50
The facilities available 55
vii 4
? viii Contents
4 Importance of informed consent 57
Requirements for informed consent 57
Provision of information 58
Full opportunity and encouragement to ask questions 63
Consent must be freely given 64
Can active deception ever be ethical? 71
Allow adequate time to make a decision 73
A signed form as evidence of informed consent 76
Research on patients without informed consent 81
The right to withdraw consent 83
5 Evaluating risks and benefits 87
Do the potential benefits justify the risks? 87
Assessing risks 88
Minimising the risks 92
The well being of the researcher and support staff 94
Determining benefits 96
Research on participants without direct medical
benefit 98
6 Acceptable research procedures 104
Non invasive procedures 104
Ionising radiation 105
Invasive procedures 106
What should be the time interval between studies? 112
7 Confidentiality 115
Accessing medical records and databases 116
Contacting patients 118
Computerised case registers and other databases 119
Medical audit 121
The UK data protection act 122
Disclosure of personal information derived from
research 128
The use of video/audio recordings 131
Avoiding inadvertent breaches of confidentiality 131
Contents ix ¦*
8 Clinical trials 133
Development of a new drug or procedure 133
The International Conference on Harmonisation: Guideline for
Good Clinical Practice 133
Mutual responsibilities of investigators and ethics committees 136
The process of developing a new therapeutic drug 139
Reporting of adverse events and serious adverse events 145
9 Research with healthy volunteers 149
Justification for research with volunteers 149
Recruitment of volunteers 150
Susceptible groups of healthy volunteers 151
Ensuring that healthy volunteers really are healthy 155
10 Are placebos ethical? 159
The placebo effect 159
Is a placebo control always necessary? 160
Is the use of a placebo ethical? 161
Guidelines for the use of placebos in clinical trials 167
11 Arrangements for compensation 169
Clinical trials sponsored by a pharmaceutical company 169
Studies not sponsored by a pharmaceutical company 172
12 Research with children, seriously ill patients, persons with
learning disability and other vulnerable groups 174
Children 175
Seriously ill patients 187
Patients with learning disability, serious psychiatric
problems and all forms of dementia 190
13 Research on surplus blood and other tissue 200
Must patients permission be obtained? 200
Is the intended use of the tissue ethical? 201
The detection of unexpected illness 203
Genetic studies on archived tissues 203
^ x Contents
Uses less likely to raise serious ethical issues 204
Is the tissue really spare? 205
Proposed guidelines for consent for the use of spare blood and
other tissue 206
14 Questionnaire and interview studies 208
Epidemiological questionnaires 208
Quality of life questionnaires 209
Audit questionnaires 210
Questionnaires that raise patients expectations 210
Intrusive questions with significant ethical implications 211
Questionnaires for the seriously ill 212
Intrinsically distressing questionnaire studies 213
Questions suitable for some but not for others 214
Is informed consent required for questionnaire
studies? 214
Avoid exhausting the participant with too many
questionnaires 215
Arranging a home interview 215
Questionnaire studies on the Internet 216
If in doubt, seek the advice of the ethics committee 218
15 Epidemiological studies 219
Types of epidemiological study 219
Nutrition, an example of the ethical complexities of a typical
national survey 220
When informed consent must be obtained 223
Epidemiological studies which may not require informed
consent 225
Confidentiality of groups 226
16 Genetic research special ethical considerations 228
Informed consent for genetic testing 230
Aims of genetic research 232
Identifying and approaching a patient with a known
condition 233
Should relatives be sought? 235
Contents xi ^
The problem of explaining risks 238
Ensure that adequate counselling is available 240
Advantages and disadvantages of early detection 241
Confidentiality in genetic studies 244
Development of new methods of prenatal diagnosis 248
When the outcome of genetic research becomes normal
clinical practice 251
Research involving genetic testing 254
17 Gene therapy 259
What is gene therapy? 259
Regulation of gene therapy 261
Gene therapy in practice 263
Germ line gene therapy 266
18 Research on fetuses 267
Research on fetuses universally regarded as unethical 268
Separation of the source of tissue from the research 269
Potential uses to which tissue from a fetus may be put 270
Informed consent for research on aborted fetuses 271
Other considerations 275
Embryo research 276
Cloning 279
19 Animal to human transplantation 281
The practicalities 281
When will animal to human transplantation trials be
justified? 285
A central advisory committee 286
Informed consent from transplant recipients 287
Follow up of animal transplant recipients 288
Longer term implications for patients 289
Conclusion 291
20 Post approval monitoring of research by ethics committees 292
Monitoring of research by the Tayside Committee on Medical
Research Ethics 294
? xii Contents
Appendixes 306
1 Declaration of Helsinki 306
2 A specimen local medical research ethics committee
constitution 311
3 Specimen medical research ethics committee application
form 319
4 Guide to constructing a patient/volunteer information sheet 339
5 A specimen consent form for patients 351
6 A specimen letter and confidential questionnaire for
patients/healthy volunteers 353
7 A specimen review questionnaire for researchers 360
further reading 365
Some useful websites 372
Some useful addresses 375
Bibliography 378
Index 391
|
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| indexdate | 2024-07-09T18:37:22Z |
| institution | BVB |
| isbn | 0521626196 |
| language | English |
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| physical | XVII, 403 S. |
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| spelling | Smith, Trevor Verfasser aut Ethics in medical research a handbook of good practice Trevor Smith 1. publ. Cambridge [u.a.] Cambridge Univ. Press 1999 XVII, 403 S. txt rdacontent n rdamedia nc rdacarrier Expérimentation humaine en médecine - Aspect moral Médecine - Recherche - Aspect moral Ethik Medizin Ethics, Medical Human Experimentation Human experimentation in medicine Moral and ethical aspects Medicine Research Moral and ethical aspects Research organization & administration HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=008852553&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Smith, Trevor Ethics in medical research a handbook of good practice Expérimentation humaine en médecine - Aspect moral Médecine - Recherche - Aspect moral Ethik Medizin Ethics, Medical Human Experimentation Human experimentation in medicine Moral and ethical aspects Medicine Research Moral and ethical aspects Research organization & administration |
| title | Ethics in medical research a handbook of good practice |
| title_auth | Ethics in medical research a handbook of good practice |
| title_exact_search | Ethics in medical research a handbook of good practice |
| title_full | Ethics in medical research a handbook of good practice Trevor Smith |
| title_fullStr | Ethics in medical research a handbook of good practice Trevor Smith |
| title_full_unstemmed | Ethics in medical research a handbook of good practice Trevor Smith |
| title_short | Ethics in medical research |
| title_sort | ethics in medical research a handbook of good practice |
| title_sub | a handbook of good practice |
| topic | Expérimentation humaine en médecine - Aspect moral Médecine - Recherche - Aspect moral Ethik Medizin Ethics, Medical Human Experimentation Human experimentation in medicine Moral and ethical aspects Medicine Research Moral and ethical aspects Research organization & administration |
| topic_facet | Expérimentation humaine en médecine - Aspect moral Médecine - Recherche - Aspect moral Ethik Medizin Ethics, Medical Human Experimentation Human experimentation in medicine Moral and ethical aspects Medicine Research Moral and ethical aspects Research organization & administration |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=008852553&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
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