Research Ethics Regulations and Guidelines

National and International Guidelines for Protecting Participants in Research

Altman, D. G., Schulz, K. F., Moher, D., Egger, M., Davidoff, F., Elbourne, D., … Lang, T. (2001). The revised CONSORT statement for reporting randomized trials: Explanation and elaboration. Annals of Internal Medicine, 134(8), 663-694. Council for International Organizations of Medical Sciences (CIOMS). (2002). International ethical guidelines for biomedical research involving human subjects. Joint United Nations Programme on HIV/AIDS (UNAIDS). (2000). Ethical considerations in HIV preventive vaccine research: UNAIDS guidance document. Joint United Nations Programme on HIV/AIDS (UNAIDS). (2005). HIV-related stigma, discrimination and human rights violations: Case studies of successful programmes. Joint United Nations Programme on HIV/AIDS (UNAIDS). (2007). Practical guidelines for intensifying HIV prevention: Towards universal access. Joint United Nations Programme on HIV/AIDS (UNAIDS) Reference Group on HIV and Human Rights. (2007). Criminalization of HIV transmission. Joint United Nations Programme on HIV/AIDS (UNAIDS) & AIDS Vaccine Advocacy Group (AVAC). (2007). Good participatory practice: Guidelines for biomedical HIV prevention trials. Joint United Nations Programme on HIV/AIDS (UNAIDS) & World Health Organization (WHO). (2007). Ethical considerations in biomedical HIV prevential trials: UNAIDS/WHO guidance document. MacQueen, K. M., Karim, Q. A., Sugarman, J., & The HPTN Ethics Working Group (2003). Ethics guidance for HIV prevention trials. McKeown, R. E., Weed, D. L., Kahn, J. P., & Soto, M. A. (2003). American college of epidemiology ethics guidelines: Foundations and dissemination. Science and Engineering Ethics, 9, 207-214. National Institute of Drug Abuse (NIDA). (2010). Policy on counseling and testing for HIV/AIDS and other infectious diseases. Nuffield Council on Bioethics. (2004). Research in developing countries. National Institute on Drug Abuse (NIDA) & International AIDS Society. (2011). Meeting report: Prevention and treatment of HIV/AIDS among drug using populations: A global perspectives. Open Society Foundations. (2011). Health and human rights: A resource guide. Rennie, S., Sugarman, J., & The HPTN Ethics Working Group (2009). HIV Prevention Trials Network ethics guidance for research. Sahota, P.C. (2007). Research regulation in American Indian /Alaska Native communities: Policy and practice considerations. National Congress of the American Indian Policy Research Center. Sahota, P.C. (2007). Research regulation in American Indian /Alaska native communities: A guide to reviewing research studies. National Congress of the American Indian Policy Research Center. South African AIDS Vaccine Initiative (SAAVI). (2007). South African AIDS Vaccine Initiative guidelines for advisory groups (CAGs). U.S. Department of Health and Human Services (DHHS). (2004). The confidentiality of alcohol and drug abuse patient records regulation and the HIPAA privacy rule: Implications for alcohol and substance abuse programs. U. S. Department of Health and Human Services (DHHS). (2009). Title 45 Public Welfare, Part 46, Code of Federal Regulations Protection of Human Subjects. Washington, DC: Government Printing Office. U. S. Department of Health and Human Services (DHHS). (2011). Improving data collection for the LGBT community. U. S. Department of Health and Human Services (DHHS). (1979). The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. World Medical Association. (2008). World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. National Bioethics Advisory Commission. (2001). Ethical and policy issues in international research: Clinical trials in developing countries. Presidential Commission for the Study of Bioethical Issues. (2011). President's Bioethics Commission Report on Human Subjects Protection. World Health Organization. (2003). Ethical and safety recommendations for interviewing trafficked women.