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

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    • Title:Manual for research ethics committees / Centre of Medical Law and Ethics, King's College, London ; edited by Sue Eckstein.
    •    
    • Other Contributors/Collections:Eckstein, Sue, 1959-
      King's College London. Centre of Medical Law and Ethics.
    • Published/Created:Cambridge, UK ; New York : Cambridge University Press, 2003.

    • Holdings

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    • Library of Congress Subjects:Medicine--Research--Moral and ethical aspects.
      Medical sciences--Research--Moral and ethical aspects.
      Medical ethics.
    • Medical Subjects: Ethics Committees, Research
      Ethics, Medical
      Ethics, Research
    • Edition:6th ed.
    • Description:xix, 558 pages ; 28 cm.
    • Summary:A compilation of legal and ethical guidance which will be 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.
    • Notes:Includes bibliographical references and index.
    • ISBN:0521810043
    • Contents:Introduction / Sue Eckstein
      1. ethics of clinical research / Calliope (Bobbie) Farsides
      2. Research ethics committees and the law / Ian Kennedy and Phil Bates
      3. regulation of medical research: a historical overview / Richard H. Nicholson
      4. regulation of medical research in the UK / Pamela Charnley Nickols
      5. Observational and epidemiological research / Nick Dunn
      6. Social survey research / Crispin Jenkinson
      7. Approaching qualitative research / Alan Cribb
      8. Complementary and alternative medicine: challenges for research ethics committees / Julie Stone
      9. ethical review of student research in the context of the governance arrangements for research ethics committees / Richard Ashcroft and Michael Parker
      10. ethics of genetic research / Ruth Chadwick
      11. Research or audit? / Anthony Madden
      12. Randomised controlled trials / Hazel Inskip and Richard W. Morris
      13. Determining the study size / Hazel Inskip and Richard W. Morris
      14. Risk assessment for research participants / Kenneth Calman
      15. Absorbed radiation in patient and volunteer studies submitted to the ethical committee: a memorandum / Keith Britton and Rosemary Foley
      16. guide to the use of radioactive materials and radiological procedures for research purposes / Niall Moore
      17. Indemnity in medical research / Janet Jeffs and Richard Mayon-White
      18. prevention and management of fraud and misconduct: the role of the LREC / Jennifer Blunt and Frank Wells
      19. Understanding clinical trials: a model for providing information to potential participants / Phillippa Easterbrook and Joan Houghton
      20. law relating to consent / Andrew Grubb, Rosamund Scott, Penney Lewis and Phil Bates
      21. Writing information for potential research participants / Elizabeth Mellor, David K. Raynor and Jonathan Silcock
      22. law relating to confidentiality / Andrew Grubb, Ian Kennedy and Sabine Michalowski
      23. Research involving vulnerable participants: some ethical issues / Sue Eckstein
      24. ethics of research related to healthcare in developing countries / Nuffield Council on Bioethics
      25. Ethical principles for medical research involving human subjects / World Medical Association
      26. 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
      27. ICH Good Clinical Practice Guideline / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
      28. Governance arrangements for NHS research ethics committees / Department of Health
      29. research governance framework for health and social care / Department of Health
      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
      31. European Convention on Human rights and biomedicine (ETS 164) and additional protocol on the prohibition of cloning human beings / Council of Europe
      32. Good research practice / Medical Research Council
      33. Research: the role and responsibilities of doctors / General Medical Council
      34. Guidelines for company-sponsored safety assessment of marketed medicines (SAMM) / Association of the British Pharmaceutical Industry
      35. Guidelines for medical experiments in non-patient human volunteers / Association of the British Pharmaceutical Industry
      36. Facilities for non-patient volunteer studies / Association of the British Pharmaceutical Industry
      37. Multi-centre research in the NHS - the process of ethical review when there is no local researcher / Central Office for Research Ethics Committees
      38. Medical devices regulations and research ethics committees / Medical Devices Agency
      39. NHS indemnity - arrangements for clinical negligence claims in the NHS / Department of Health
      40. Clinical trial compensation guidelines / Association of the British Pharmaceutical Industry
      41. Research ethics: guidance for nurses involved in research or any investigative project involving human subjects / Royal College of Nursing
      42. Ethical principles for conducting research with human participants / The British Psychological Society
      43. Statement of ethical practice / British Sociological Association
      44. Human tissue and biological samples for use in research / Medical Research Council
      45. Transitional guidelines to facilitate 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 and fetal material in research and treatment / The Stationery Office and Department of Health
      47. Guidance on the supply of fetal tissue for research, diagnosis and therapy / Department of Health
      48. Guidance on making proposals to conduct gene therapy research on human subjects (seventh annual report - section 1) / Gene Therapy Advisory Committee
      49. Report on the potential use of gene therapy in utero / Gene Therapy Advisory Committee
      50. Human fertilisation and embryology authority - code of practice / Human Fertilisation and Embryology Authority
      51. Guidelines for researchers - patient information sheet and consent form / Central Office for Research Ethics Committees
      52. ABPI Guidance note - patient information and consents for clinical trials / Association of the British Pharmaceutical Industry
      53. protection and use of patient information (HSG(96)18/LASSL (96)5) / Department of Health
      54. Caldicott Report on the review of patient-identifiable information - executive summary December 1997 / The Caldicott Committee, Department of Health
      55. Personal information in medical research / Medical Research Council
      56. Use and disclosure of medical data - guidance on the application of the Data Protection Act, 1998, May 2002 / The Information Commissioner
      57. Guidelines for the ethical conduct of medical research involving children / Royal College of Paediatrics and Child Health: Ethics Advisory Committee
      58. Clinical investigation of medicinal 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 ethics committees on psychiatric research involving human participants - executive summary / Royal College of Psychiatrists
      60. ethical conduct of research on the mentally incapacitated / Medical Research Council
      61. Volunteering for research into dementia / Alzheimer's Society
      62. Knowledge to care: research and development in hospice and specialist palliative care - executive summary / National Council for Hospice and Specialist Palliative Care Services
      63. NUS guidelines for student participation in medical experiments and guidance for students considering participation in medical drug trials / National Union of Students
      64. Ethical considerations in HIV preventive vaccine research / Joint United Nations Programme on HIV/AIDS (UNAIDS)
      65. 2002 International ethical guidelines for biomedical research involving human subjects / Council for International Organisations of Medical Sciences (CIOMS)
      66. 1991 international guidelines for ethical review of epidemiological studies / Council for International Organisations of Medical Sciences
      67. Operational guidelines for ethics committees that review biomedical research / UNDP, World Bank and WHO Special Programme for Research and Training in Tropical Disease (TDR)
      68. Registration of an institutional review board (IRB) or independent ethics committee (IEC) / Office for Human Research Protections (OHRP)
      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 and Council for International Organisations of Medical Sciences.
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