Manual for Research Ethics Committees : Centre of Medical Law and Ethics, King's College London (6TH)

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Manual for Research Ethics Committees : Centre of Medical Law and Ethics, King's College London (6TH)

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  • 製本 Paperback:紙装版/ペーパーバック版/ページ数 558 p.
  • 言語 ENG,ENG
  • 商品コード 9780521399395
  • DDC分類 174

Full Description


The sixth edition of the Manual for Research Ethics Committees was first published in 2003, and is a unique compilation of legal and ethical guidance which will prove useful for members of research ethics committees, researchers involved in research with humans, members of the pharmaceutical industry and students of law, medicine, ethics and philosophy. Presented in a clear and authoritative form, it incorporates the key legal and ethical guidelines and specially written chapters on major topics in bioethics by leading academic authors and practitioners, pharmaceutical industry associations and professional bodies.

Table of Contents

Editorial board                                    ix
Acknowledgements xi
List of contributors xiii
Introduction xvii
Sue Eckstein
PART I
Section I Fundamental ethical and legal
considerations
1 The ethics of clinical research 5 (10)
Calliope (Bobbie) Farsides
2 Research ethics committees and the law 15 (3)
Ian Kennedy
Phil Bates
3 The regulation of medical research: a 18 (7)
historical overview
Richard H. Nicholson
Section II The research process
4 The regulation of medical research in the 25 (9)
UK
Pamela Charnley Nickols
5 Observational and epidemiological research 34 (3)
Nick Dunn
6 Social survey research 37 (3)
Crispin Jenkinson
7 Approaching qualitative research 40 (9)
Alan Cribb
8 Complementary and alternative medicine: 49 (4)
challenges for research ethics committees
Julie Stone
9 The ethical review of student research in 53 (4)
the context of the governance arrangements
for research ethics committees
Richard Ashcroft
Michael Parker
10 The ethics of genetic research 57 (3)
Ruth Chadwick
11 Research or audit? 60 (1)
Anthony Madden
12 Randomised controlled trials 61 (3)
Hazel Inskip
Richard W. Morris
13 Determining the study size 64 (3)
Hazel Inskip
Richard W. Morris
14 Risk assessment for research participants 67 (2)
Kenneth Calman
15 Absorbed radiation in patient and 69 (3)
volunteer studies submitted to the ethical
committee: a memorandum
Keith Britton
Rosemary Foley
16 A guide to the use of radioactive 72 (3)
materials and radiological procedures for
research purposes
Niall Moore
17 Indemnity in medical research 75 (4)
Janet Jeffs
Richard Mayon-White
18 The prevention and management of fraud 79 (6)
and misconduct: the role of the LREC
Jennifer Blunt
Frank Wells
Section III Protecting the interests of
research participants
Section III(A) General principles
19 Understanding clinical trials: a model 85 (4)
for providing information to potential
participants
Philippa Easterbrook
Joan Houghton
20 The law relating to consent 89 (7)
Andrew Grubb
Rosamund Scott
Penney Lewis
Phil Bates
21 Writing information for potential 96 (4)
research participants
Elizabeth Mellor
David K. Raynor
Jonathan Silcock
22 The law relating to confidentiality 100 (5)
Andrew Grubb
Ian Kennedy
Sabine Michalowski
Section III(B) Vulnerable participants
23 Research involving vulnerable 105 (8)
participants: some ethical issues
Sue Eckstein
Section IV International research
24 The ethics of research related to 113 (10)
healthcare in developing countries
Nuffield Council on Bioethics
PART II
Section I Fundamental legal and ethical
considerations
25 Ethical principles for medical research 123 (3)
involving human subjects
World Medical Association
26 The Belmont Report: ethical principles 126 (7)
and guidelines for the protection of human
subjects of research
National Commission for the
Protection of Human Subjects of
Biomedical and Behavioral Research
27 ICH Good Clinical Practice Guideline 133 (17)
International Conference on
Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use
28 Governance arrangements for NHS research 150 (15)
ethics committees
Department of Health
29 The research governance framework for 165 (19)
health and social care
Department of Health
30 EU Clinical Directive 2001/20/EC of the 184 (12)
European Parliament and of the Council of 4
April 2001 on the approximation of the
laws, regulations, and administrative
provisions of the Member States relating to
the implementation of good clinical
practice in the conduct of clinical trials
on medicinal products for human use
The European Parliament and the
Council of the European Union
31 European Convention on human rights and 196 (11)
biomedicine (ETS 164) and additional
protocol on the prohibition of cloning
human beings
Council of Europe
Section II The research process
Section II(A) General guidelines
32 Good research practice 207 (7)
Medical Research Council
33 Research: the role and responsibilities 214 (10)
of doctors
General Medical Council
34 Guidelines for company-sponsored safety 224 (4)
assessment of marketed medicines (SAMM)
Association of the British
Pharmaceutical Industry
35 Guidelines for medical experiments in 228 (6)
non-patient human volunteers
Association of the British
Pharmaceutical Industry
36 Facilities for non-patient volunteer 234 (3)
studies
Association of the British
Pharmaceutical Industry
37 Multi-centre research in the NHS -- the 237 (4)
process of ethical review when there is no
local researcher
Central Office for Research Ethics
Committees
38 Medical devices regulations and research 241 (2)
ethics committees
Medical Devices Agency
39 NHS indemnity -- arrangements for 243 (11)
clinical negligence claims in the NHS
Department of Health
40 Clinical trial compensation guidelines 254 (3)
Association of the British
Pharmaceutical Industry
41 Research ethics: guidance for nurses 257 (12)
involved in research or any investigative
project involving human subjects
Royal College of Nursing
42 Ethical principles for conducting 269 (5)
research with human participants
The British Psychological Society
43 Statement of ethical practice 274 (7)
British Sociological Association
Section II(B) Tissue and genes
44 Human tissue and biological samples for 281 (19)
use in research
Medical Research Council
45 Transitional guidelines to facilitate 300 (13)
changes in procedures for handling
`surplus' and archival material from human
biological samples
Royal College of Pathologists
46 Code of practice on the use of fetuses 313 (3)
and fetal material in research and
treatment (extracts from the Polkinghorne
Report)
The Stationery Office/Department of
Health
47 Guidance on the supply of fetal tissue 316 (2)
for research, diagnosis and therapy
Department of Health
48 Guidance on making proposals to conduct 318 (11)
gene therapy research on human subjects
(seventh annual report -- section 1)
Gene Therapy Advisory Committee
49 Report on the potential use of gene 329 (4)
therapy in utero
Gene Therapy Advisory Committee
50 Human fertilisation and embryology 333 (10)
authority -- code of practice (extracts)
Human Fertilisation and Embryology
Authority
Section III Protecting the interests of
research participants
Section III(A) General principles
51 Guidelines for researchers -- patient 343 (5)
information sheet and consent form
Central Office for Research Ethics
Committees
52 ABPI Guidance note -- patient 348 (3)
information and consents for clinical trials
Association of the British
Pharmaceutical Industry
53 The protection and use of patient 351 (14)
information (HSG(96) 18/LASSL (96)5)
Department of Health
54 The Caldicott Report on the review of 365 (2)
patient-identifiable information --
executive summary December 1997
The Caldicott Committee, Department
of Health
55 Personal information in medical research 367 (24)
Medical Research Council
56 Use and disclosure of medical data -- 391 (22)
guidance on the application of the Data
Protection Act, 1998, May 2002
The Information Commissioner
Section III(B) Vulnerable participants
57 Guidelines for the ethical conduct of 413 (7)
medical research involving children
Royal College of Paediatrics and
Child Health: Ethics Advisory
Committee
58 Clinical investigation of medicinal 420 (9)
products in the paediatric population
International Conference on
Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use
59 Guidelines for researchers and for 429 (6)
ethics committees on psychiatric research
involving human participants -- executive
summary
Royal College of Psychiatrists
60 The ethical conduct of research on the 435 (9)
mentally incapacitated
Medical Research Council
61 Volunteering for research into dementia 444 (3)
Alzheimer's Society
62 Knowledge to care: research and 447 (2)
development in hospice and specialist
palliative care -- executive summary
National Council for Hospice and
Specialist Palliative Care Services
63 NUS guidelines for student participation 449 (2)
in medical experiments and guidance for
students considering participation in
medical drug trials
National Union of Students
64 Ethical considerations in HIV preventive 451 (16)
vaccine research
Joint United Nations Programme on
HIV/AIDS (UNAIDS)
Section IV International research
65 2002 international ethical guidelines 467 (28)
for biomedical research involving human
subjects
Council for International
Organisations of Medical Sciences
(CIOMS)
66 1991 international guidelines for 495 (10)
ethical review of epidemiological studies
Council for International
Organisations of Medical Sciences
67 Operational guidelines for ethics 505 (11)
committees that review biomedical research
UNDP/World Bank/WHO Special Programme
for Research and Training in Tropical
Disease (TDR)
68 Registration of an institutional review 516 (5)
board (IRB) or independent ethics committee
(IEC)
Office for Human Research Protections
(OHRP)
69 International guidelines on bioethics 521 (10)
(informal listing of selected international
codes, declarations, guidelines etc. on
medical ethics/bioethics/health care
ethics/human rights aspects of health)
European Forum for Good Clinical
Practice/Council for International
Organisations of Medical Sciences
Index 531