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).

Geneva, Switzerland : CIOMS, [2016]

xii, 122 pages ; 24 cm

Includes index.

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 for 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: Reimbursement and compensation for research related harms -- Guideline 15: Research involving vulnerable persons -- 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 randomised trials -- Guideline 22: Use of data obtained from the online environment and digital tools in health-related research -- Guideline 23: Requirements for establishing research ethics committees and for their review of protocols -- Guideline24: 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 participants -- 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 -- Index