Manual for research ethics committees : Centre of Medical Law and Ethics, King's College, London / edited by Sue Eckstein.

Format:

Book

Contributor:

Eckstein, Sue, 1959-

Language:

English

Subjects (All):

Medicine--Research--Moral and ethical aspects.

Medicine.

Medical sciences--Research--Moral and ethical aspects.

Medical sciences.

Medical ethics.

Medicine--Research.

Physical Description:

xix, 558 pages : illustrations ; 29 cm

Edition:

Sixth edition.

Place of Publication:

Cambridge, UK ; New York : Cambridge University Press, 2003.

Summary:

The sixth edition of the Manual for Research Ethics Committees is a unique compilation of legal and ethical guidance which will prove invaluable 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. In the sixth edition there are fifteen new chapters covering key issues from participation in clinical trials to cloning, and for the first time the manual has been produced in one easy-to-search hardback volume.

Contents:

Section I Fundamental ethical and legal considerations

1 The ethics of clinical research / Calliope (Bobbie) Farsides 5

2 Research ethics committees and the law / Ian Kennedy, Phil Bates 15

3 The regulation of medical research: a historical overview / Richard H. Nicholson 18

Section II The research process

4 The regulation of medical research in the UK / Pamela Charnley Nickols 25

5 Observational and epidemiological research / Nick Dunn 34

6 Social survey research / Crispin Jenkinson 37

7 Approaching qualitative research / Alan Cribb 40

8 Complementary and alternative medicine: challenges for research ethics committees / Julie Stone 49

9 The ethical review of student research in the context of the governance arrangements for research ethics committees / Richard Ashcroft, Michael Parker 53

10 The ethics of genetic research / Ruth Chadwick 57

11 Research or audit? / Anthony Madden 60

12 Randomised controlled trials / Hazel Inskip, Richard W. Morris 61

13 Determining the study size / Hazel Inskip, Richard W. Morris 64

14 Risk assessment for research participants / Kenneth Calman 67

15 Absorbed radiation in patient and volunteer studies submitted to the ethical committee: a memorandum / Keith Britton, Rosemary Foley 69

16 A guide to the use of radioactive materials and radiological procedures for research purposes / Niall Moore 72

17 Indemnity in medical research / Janet Jeffs, Richard Mayon-White 75

18 The prevention and management of fraud and misconduct: the role of the LREC / Jennifer Blunt, Frank Wells 79

Section III Protecting the interests of research participants

19 Understanding clinical trials: a model for providing information to potential participants / Philippa Easterbrook, Joan Houghton 85

20 The law relating to consent / Andrew Grubb, Rosamund Scott, Penney Lewis, Phil Bates 89

21 Writing information for potential research participants / Elizabeth Mellor, David K. Raynor, Jonathan Silcock 96

22 The law relating to confidentiality / Andrew Grubb, Ian Kennedy, Sabine Michalowski 100

Section III(B) Vulnerable participants

23 Research involving vulnerable participants: some ethical issues / Sue Eckstein 105

Section IV International research

24 The ethics of research related to healthcare in developing countries / Nuffield Council on Bioethics 113

Section I Fundamental legal and ethical considerations

25 Ethical principles for medical research involving human subjects / World Medical Association 123

26 The Belmont Report: ethical principles and guidelines for the protection of human subjects of research / National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 126

27 ICH Good Clinical Practice Guideline / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 133

28 Governance arrangements for NHS research ethics committees / Department of Health 150

29 The research governance framework for health and social care / Department of Health 165

30 EU Clinical Directive 2001/20/EC of the 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 184

31 European Convention on human rights and biomedicine (ETS 164) and additional protocol on the prohibition of cloning human beings / Council of Europe 196

Section II(A) General guidelines

32 Good research practice / Medical Research Council 207

33 Research: the role and responsibilities of doctors / General Medical Council 214

34 Guidelines for company-sponsored safety assessment of marketed medicines (SAMM) / Association of the British Pharmaceutical Industry 224

35 Guidelines for medical experiments in non-patient human volunteers / Association of the British Pharmaceutical Industry 228

36 Facilities for non-patient volunteer studies / Association of the British Pharmaceutical Industry 234

37 Multi-centre research in the NHS

the process of ethical review when there is no local researcher / Central Office for Research Ethics Committees 237

38 Medical devices regulations and research ethics committees / Medical Devices Agency 241

39 NHS indemnity

arrangements for clinical negligence claims in the NHS / Department of Health 243

40 Clinical trial compensation guidelines / Association of the British Pharmaceutical Industry 254

41 Research ethics: guidance for nurses involved in research or any investigative project involving human subjects / Royal College of Nursing 257

42 Ethical principles for conducting research with human participants / The British Psychological Society 269

43 Statement of ethical practice / British Sociological Association 274

Section II(B) Tissue and genes

44 Human tissue and biological samples for use in research / Medical Research Council 281

45 Transitional guidelines to facilitate changes in procedures for handling 'surplus' and archival material from human biological samples / Royal College of Pathologists 300

46 Code of practice on the use of fetuses and fetal material in research and treatment (extracts from the Polkinghorne Report) / The Stationery Office/Department of Health 313

47 Guidance on the supply of fetal tissue for research, diagnosis and therapy / Department of Health 316

48 Guidance on making proposals to conduct gene therapy research on human subjects (seventh annual report

section 1) / Gene Therapy Advisory Committee 318

49 Report on the potential use of gene therapy in utero / Gene Therapy Advisory Committee 329

50 Human fertilisation and embryology authority

code of practice (extracts) / Human Fertilisation and Embryology Authority 333

51 Guidelines for researchers

patient information sheet and consent form / Central Office for Research Ethics Committees 343

52 ABPI Guidance note

patient information and consents for clinical trials / Association of the British Pharmaceutical Industry 348

53 The protection and use of patient information (HSG(96)18/LASSL (96)5) / Department of Health 351

54 The Caldicott Report on the review of patient-identifiable information

executive summary December 1997 / The Caldicott Committee, Department of Health 365

55 Personal information in medical research / Medical Research Council 367

56 Use and disclosure of medical data

guidance on the application of the Data Protection Act, 1998, May 2002 / The Information Commissioner 391

57 Guidelines for the ethical conduct of medical research involving children Royal College of Paediatrics and Child Health / Ethics Advisory Committee 413

58 Clinical investigation of medicinal products in the paediatric population / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 420

59 Guidelines for researchers and for ethics committees on psychiatric research involving human participants

executive summary / Royal College of Psychiatrists 429

60 The ethical conduct of research on the mentally incapacitated / Medical Research Council 435

61 Volunteering for research into dementia / Alzheimer's Society 444

62 Knowledge to care: research and development in hospice and specialist palliative care

executive summary / National Council for Hospice and Specialist Palliative Care Services 447

63 NUS guidelines for student participation in medical experiments and guidance for students considering participation in medical drug trials / National Union of Students 449

64 Ethical considerations in HIV preventive vaccine research / Joint United Nations Programme on HIV/AIDS (UNAIDS) 451

65 2002 international ethical

guidelines for biomedical research involving human subjects / Council for International Organisations of Medical Sciences (CIOMS) 467

66 1991 international guidelines for ethical review of epidemiological studies / Council for International Organisations of Medical Sciences 495

67 Operational guidelines for ethics committees that review biomedical research / UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Disease (TDR) 505

68 Registration of an institutional review board (IRB) or independent ethics committee (IEC) / Office for Human Research Protections (OHRP) 516

69 International guidelines on bioethics (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 521.

Notes:

Includes bibliographical references and index.

ISBN:

0521810043

OCLC:

49386068

Online:

Publisher description