International Ethical Guidelines for Health-related Research Involving Humans: Prepared by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO) [Internet]
- PMID: 40523065
- Bookshelf ID: NBK614410
- DOI: 10.56759/rgxl7405
International Ethical Guidelines for Health-related Research Involving Humans: Prepared by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO) [Internet]
Excerpt
CIOMS, in association with the World Health Organization, started its work on ethics in health-related research in the late 1970s. Accordingly, CIOMS set out, in cooperation with WHO, to prepare guidelines to indicate how the ethical principles set forth in the Declaration of Helsinki of the World Medical Association, could be effectively applied, particularly in low-resource settings, given their socio-economic circumstances, laws and regulations, and executive and administrative arrangements. Since then revised editions of the CIOMS ethical guidelines were published in 1993 and 2002. New developments in research have prompted CIOMS to again revise their ethical guidelines. The result is now available in this new publication.
In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research.
© Council for International Organizations of Medical Sciences (CIOMS) 2016.
Sections
- Acknowledgements
- Preface
- Evidence Retrieval and Synthesis
- Preamble
- GUIDELINE 1. SCIENTIFIC AND SOCIAL VALUE AND RESPECT FOR RIGHTS
- GUIDELINE 2. RESEARCH CONDUCTED IN LOW-RESOURCE SETTINGS
- GUIDELINE 3. EQUITABLE DISTRIBUTION OF BENEFITS AND BURDENS IN THE SELECTION OF INDIVIDUALS AND GROUPS OF PARTICIPANTS IN RESEARCH
- GUIDELINE 4. POTENTIAL INDIVIDUAL BENEFITS AND RISKS OF RESEARCH
- GUIDELINE 5. CHOICE OF CONTROL IN CLINICAL TRIALS
- GUIDELINE 6. CARING FOR PARTICIPANTS' HEALTH NEEDS
- GUIDELINE 7. COMMUNITY ENGAGEMENT
- GUIDELINE 8. COLLABORATIVE PARTNERSHIP AND CAPACITY-BUILDING FOR RESEARCH AND RESEARCH REVIEW
- GUIDELINE 9. INDIVIDUALS CAPABLE OF GIVING INFORMED CONSENT
- GUIDELINE 10. MODIFICATIONS AND WAIVERS OF INFORMED CONSENT
- GUIDELINE 11. COLLECTION, STORAGE AND USE OF BIOLOGICAL MATERIALS AND RELATED DATA
- GUIDELINE 12. COLLECTION, STORAGE AND USE OF DATA IN HEALTH-RELATED RESEARCH
- GUIDELINE 13. REIMBURSEMENT AND COMPENSATION FOR RESEARCH PARTICIPANTS
- GUIDELINE 14. TREATMENT AND COMPENSATION FOR RESEARCH-RELATED HARMS
- GUIDELINE 15: RESEARCH INVOLVING VULNERABLE PERSONS AND GROUPS
- GUIDELINE 16. RESEARCH INVOLVING ADULTS INCAPABLE OF GIVING INFORMED CONSENT
- GUIDELINE 17:RESEARCH INVOLVING CHILDREN AND ADOLESCENTS
- GUIDELINE 18. WOMEN AS RESEARCH PARTICIPANTS
- GUIDELINE 19. PREGNANT AND BREASTFEEDING WOMEN AS RESEARCH PARTICIPANTS
- GUIDELINE 20. RESEARCH IN DISASTERS AND DISEASE OUTBREAKS
- GUIDELINE 21. CLUSTER RANDOMIZED TRIALS
- GUIDELINE 22. USE OF DATA OBTAINED FROM THE ONLINE ENVIRONMENT AND DIGITAL TOOLS IN HEALTH-RELATEDRESEARCH
- GUIDELINE 23. REQUIREMENTS FOR ESTABLISHING RESEARCH ETHICS COMMITTEES AND FOR THEIR REVIEW OF PROTOCOLS
- GUIDELINE 24. PUBLIC ACCOUNTABILITY FOR HEALTH-RELATED RESEARCH
- GUIDELINE 25. CONFLICTS OF INTEREST
- APPENDIX 1. ITEMS TO BE INCLUDED IN A PROTOCOL (OR ASSOCIATED DOCUMENTS) FOR HEALTH-RELATED RESEARCH INVOLVING HUMANS
- APPENDIX 2. OBTAINING INFORMED CONSENT: ESSENTIAL INFORMATION FOR PROSPECTIVE RESEARCH PARTICIPANTS
- APPENDIX 3. CIOMS WORKING GROUP ON THE REVISION OF THE 2002 INTERNATIONAL GUIDELINES FOR BIOMEDICAL RESEARCH INVOLVING HUMANS
- APPENDIX 4. COMMENTATORS
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