Book contents
- Frontmatter
- Contents
- Editorial board
- Acknowledgements
- List of contributors
- Introduction
- Part I
- Part II
- 25 Ethical principles for medical research involving human subjects
- 26 The Belmont Report: ethical principles and guidelines for the protection of human subjects of research
- 27 ICH Good Clinical Practice Guideline
- 28 Governance arrangements for NHS research ethics committees
- 29 The research governance framework for health and social care
- 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
- 31 European Convention on human rights and biomedicine (ETS 164) and additional protocol on the prohibition of cloning human beings
- 32 Good research practice
- 33 Research: the role and responsibilities of doctors
- 34 Guidelines for company-sponsored safety assessment of marketed medicines (SAMM)
- 35 Guidelines for medical experiments in non-patient human volunteers
- 36 Facilities for non-patient volunteer studies
- 37 Multi-centre research in the NHS – the process of ethical review when there is no local researcher
- 38 Medical devices regulations and research ethics committees
- 39 NHS indemnity – arrangements for clinical negligence claims in the NHS
- 40 Clinical trial compensation guidelines
- 41 Research ethics: guidance for nurses involved in research or any investigative project involving human subjects
- 42 Ethical principles for conducting research with human participants
- 43 Statement of ethical practice
- 44 Human tissue and biological samples for use in research
- 45 Transitional guidelines to facilitate changes in procedures for handling ‘surplus’ and archival material from human biological samples
- 46 Code of practice on the use of fetuses and fetal material in research and treatment (extracts from the Polkinghorne Report)
- 47 Guidance on the supply of fetal tissue for research, diagnosis and therapy
- 48 Guidance on making proposals to conduct gene therapy research on human subjects (seventh annual report – section 1)
- 49 Report on the potential use of gene therapy in utero
- 50 Human fertilisation and embryology authority – code of practice (extracts)
- 51 Guidelines for researchers – patient information sheet and consent form
- 52 ABPI Guidance note – patient information and consents for clinical trials
- 53 The protection and use of patient information (HSG(96)18/LASSL(96)5)
- 54 The Caldicott Report on the review of patient-identifiable information – executive summary December 1997
- 55 Personal information in medical research
- 56 Use and disclosure of medical data – guidance on the Application of the Data Protection Act, 1998, May 2002
- 57 Guidelines for the ethical conduct of medical research involving children
- 58 Clinical investigation of medicinal products in the paediatric population
- 59 Guidelines for researchers and for ethics committees on psychiatric research involving human participants – executive summary
- 60 The ethical conduct of research on the mentally incapacitated
- 61 Volunteering for research into dementia Alzheimer's Society
- 62 Knowledge to care: research and development in hospice and specialist palliative care – executive summary
- 63 NUS guidelines for student participation in medical experiments and guidance for students considering participation in medical drug trials
- 64 Ethical considerations in HIV preventive vaccine research
- 65 2002 international ethical guidelines for biomedical research involving human subjects
- 66 1991 international guidelines for ethical review of epidemiological studies
- 67 Operational guidelines for ethics committees that review biomedical research
- 68 Registration of an institutional review board (IRB) or independent ethics committee (IEC)
- 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)
- Index
65 - 2002 international ethical guidelines for biomedical research involving human subjects
Published online by Cambridge University Press: 08 January 2010
Edited by
Book contents
- Frontmatter
- Contents
- Editorial board
- Acknowledgements
- List of contributors
- Introduction
- Part I
- Part II
- 25 Ethical principles for medical research involving human subjects
- 26 The Belmont Report: ethical principles and guidelines for the protection of human subjects of research
- 27 ICH Good Clinical Practice Guideline
- 28 Governance arrangements for NHS research ethics committees
- 29 The research governance framework for health and social care
- 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
- 31 European Convention on human rights and biomedicine (ETS 164) and additional protocol on the prohibition of cloning human beings
- 32 Good research practice
- 33 Research: the role and responsibilities of doctors
- 34 Guidelines for company-sponsored safety assessment of marketed medicines (SAMM)
- 35 Guidelines for medical experiments in non-patient human volunteers
- 36 Facilities for non-patient volunteer studies
- 37 Multi-centre research in the NHS – the process of ethical review when there is no local researcher
- 38 Medical devices regulations and research ethics committees
- 39 NHS indemnity – arrangements for clinical negligence claims in the NHS
- 40 Clinical trial compensation guidelines
- 41 Research ethics: guidance for nurses involved in research or any investigative project involving human subjects
- 42 Ethical principles for conducting research with human participants
- 43 Statement of ethical practice
- 44 Human tissue and biological samples for use in research
- 45 Transitional guidelines to facilitate changes in procedures for handling ‘surplus’ and archival material from human biological samples
- 46 Code of practice on the use of fetuses and fetal material in research and treatment (extracts from the Polkinghorne Report)
- 47 Guidance on the supply of fetal tissue for research, diagnosis and therapy
- 48 Guidance on making proposals to conduct gene therapy research on human subjects (seventh annual report – section 1)
- 49 Report on the potential use of gene therapy in utero
- 50 Human fertilisation and embryology authority – code of practice (extracts)
- 51 Guidelines for researchers – patient information sheet and consent form
- 52 ABPI Guidance note – patient information and consents for clinical trials
- 53 The protection and use of patient information (HSG(96)18/LASSL(96)5)
- 54 The Caldicott Report on the review of patient-identifiable information – executive summary December 1997
- 55 Personal information in medical research
- 56 Use and disclosure of medical data – guidance on the Application of the Data Protection Act, 1998, May 2002
- 57 Guidelines for the ethical conduct of medical research involving children
- 58 Clinical investigation of medicinal products in the paediatric population
- 59 Guidelines for researchers and for ethics committees on psychiatric research involving human participants – executive summary
- 60 The ethical conduct of research on the mentally incapacitated
- 61 Volunteering for research into dementia Alzheimer's Society
- 62 Knowledge to care: research and development in hospice and specialist palliative care – executive summary
- 63 NUS guidelines for student participation in medical experiments and guidance for students considering participation in medical drug trials
- 64 Ethical considerations in HIV preventive vaccine research
- 65 2002 international ethical guidelines for biomedical research involving human subjects
- 66 1991 international guidelines for ethical review of epidemiological studies
- 67 Operational guidelines for ethics committees that review biomedical research
- 68 Registration of an institutional review board (IRB) or independent ethics committee (IEC)
- 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)
- Index
Summary
See the CIOMS website for the complete text of the publication. http://www.cioms.ch/
Guideline 1: Ethical justification and scientific validity of biomedical research involving human beings
The ethical justification of biomedical research involving human subjects is the prospect of discovering new ways of benefiting people's health. Such research can be ethically justifiable only if it is carried out in ways that respect and protect, and are fair to, the subjects of that research and are morally acceptable within the communities in which the research is carried out. Moreover, because scientifically invalid research is unethical in that it exposes research subjects to risks without possible benefit, investigators and sponsors must ensure that proposed studies involving human subjects conform to generally accepted scientific principles and are based on adequate knowledge of the pertinent scientific literature.
Commentary on Guideline 1
Among the essential features of ethically justified research involving human subjects, including research with identifiable human tissue or data, are that the research offers a means of developing information not otherwise obtainable, that the design of the research is scientifically sound, and that the investigators and other research personnel are competent. The methods to be used should be appropriate to the objectives of the research and the field of study. Investigators and sponsors must also ensure that all who participate in the conduct of the research are qualified by virtue of their education and experience to perform competently in their roles. These considerations should be adequately reflected in the research protocol submitted for review and clearance to scientific and ethical review committees (Appendix I).
- Type
- Chapter
- Information
- Manual for Research Ethics CommitteesCentre of Medical Law and Ethics, King's College London, pp. 465 - 494Publisher: Cambridge University PressPrint publication year: 2003