Appendix F
IRB and Ethical Issues in Conducting International Behavioral Science Research

Charles A. Nelson, Ph.D.1


Workshop on International Collaborations in Behavioral and Social Sciences Research


Northwestern University

Evanston, IL

October 5-6, 2006

WHAT MAKES CLINICAL RESEARCH ETHICAL

  1. Collaborative partnership—develops partnerships with researchers, makers of health policies, and the community, and involves each in meaningful ways

  2. Value—enhancements of health or knowledge must be derived from the research

  3. Scientific validity—methodological rigor

  4. Fair subject selection—scientific objectives, not vulnerability or privilege, and the potential for and distributions of risks and benefits, determine the communities selected as study sites and the inclusion criteria for individual subjects

  5. Favorable risk-benefit ratio—within the context of standard clinical practice and research protocol, risks must be minimized, and the potential for society must outweigh the risks

  6. Independent review—unaffiliated individuals must review the research and approve, amend, or terminate it

  7. Informed consent—individuals should be informed about the research and provide their voluntary consent

1

Dr. Charles Nelson is professor of pediatrics at Harvard Medical School Children’s Hospital in Boston, Massachusetts.



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appendix f IRb and ethical Issues in Conducting International behavioral science Research Charles A. nelson, Ph.d.1 Workshop on International Collaborations in behavioral and social sciences Research northwestern University evanston, Il october 5-6, 2006 WHAT MAKES CLINICAL RESEARCH ETHICAL 1. Collaborative partnership—develops partnerships with research- ers, makers of health policies, and the community, and involves each in meaningful ways 2. value—enhancements of health or knowledge must be derived from the research 3. scientific validity—methodological rigor 4. fair subject selection—scientific objectives, not vulnerability or privilege, and the potential for and distributions of risks and benefits, de- termine the communities selected as study sites and the inclusion criteria for individual subjects 5. favorable risk-benefit ratio—within the context of standard clinical practice and research protocol, risks must be minimized, and the potential for society must outweigh the risks 6. Independent review—unaffiliated individuals must review the research and approve, amend, or terminate it 7. Informed consent—individuals should be informed about the research and provide their voluntary consent dr. Charles nelson is professor of pediatrics at harvard Medical school Children’s 1 hospital in boston, Massachusetts. 

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 APPEndIX F 8. Respect for enrolled subjects—subjects must have their privacy protected, they must have the opportunity to withdraw, and their well-be- ing must be monitored. THE FAIR bENEFITS FRAMEWORK Fair benefits 1. benefits to participants during the research—improvements to health and health care 2. Collateral health services unnecessary for research study 3. benefits to population during the research 4. Collateral health services unnecessary for research study 5. public health measures 6. employment and economic activity 7. benefits to population after the research 8. Reasonable availability of effective intervention 9. Research and medical care capacity development 10. public health measures 11. long-term research collaboration 12. sharing of financial rewards from research results Collaborative Partnership 1. Community involvement at all stages 2. free uncoerced decision-making by population bearing the burdens of the research Transparency 1. Central publicly accessible repository of benefits agreements 2. process of community consultations