Part II

pp 119-120

25 - Ethical principles for medical research involving human subjects

pp 121-125

26 - The Belmont Report: ethical principles and guidelines for the protection of human subjects of research

pp 126-132

27 - ICH Good Clinical Practice Guideline

pp 133-149

28 - Governance arrangements for NHS research ethics committees

pp 150-164

29 - The research governance framework for health and social care

pp 165-183

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

pp 184-195

31 - European Convention on human rights and biomedicine (ETS 164) and additional protocol on the prohibition of cloning human beings

pp 196-204

32 - Good research practice

pp 205-213

33 - Research: the role and responsibilities of doctors

pp 214-223

34 - Guidelines for company-sponsored safety assessment of marketed medicines (SAMM)

pp 224-227

35 - Guidelines for medical experiments in non-patient human volunteers

pp 228-233

36 - Facilities for non-patient volunteer studies

pp 234-236

37 - Multi-centre research in the NHS – the process of ethical review when there is no local researcher

pp 237-240

38 - Medical devices regulations and research ethics committees

pp 241-242

39 - NHS indemnity – arrangements for clinical negligence claims in the NHS

pp 243-253

40 - Clinical trial compensation guidelines

pp 254-256

41 - Research ethics: guidance for nurses involved in research or any investigative project involving human subjects

pp 257-268

42 - Ethical principles for conducting research with human participants

pp 269-273

43 - Statement of ethical practice

pp 274-278

44 - Human tissue and biological samples for use in research

pp 279-299

45 - Transitional guidelines to facilitate changes in procedures for handling ‘surplus’ and archival material from human biological samples

pp 300-312

46 - Code of practice on the use of fetuses and fetal material in research and treatment (extracts from the Polkinghorne Report)

pp 313-315

47 - Guidance on the supply of fetal tissue for research, diagnosis and therapy

pp 316-317

48 - Guidance on making proposals to conduct gene therapy research on human subjects (seventh annual report – section 1)

pp 318-328

49 - Report on the potential use of gene therapy in utero

pp 329-332

50 - Human fertilisation and embryology authority – code of practice (extracts)

pp 333-340

51 - Guidelines for researchers – patient information sheet and consent form

pp 341-347

52 - ABPI Guidance note – patient information and consents for clinical trials

pp 348-350