360 Degrees of human subjects protections in community-engaged research
- PMID: 20720214
- PMCID: PMC4261185
- DOI: 10.1126/scitranslmed.3001162
360 Degrees of human subjects protections in community-engaged research
Abstract
With the introduction of the new National Institutes of Health Roadmap in 2003, there has been a growing emphasis on translational research. Translational research challenges current human subjects protections guidelines that were written in the 1970s and were focused on the protection of the individual participant in a clinical drug trial. Community engagement requires a critical examination of the range of risks that may arise when communities are both participants and partners in research, in order to promote appropriate and effective protection of human subjects as individuals and members of communities. Given that the principal investigator has ultimate responsibility for ensuring the ethical integrity of the research, researchers should be aware of the human subjects protections delineated in the federal regulations that must be fulfilled and the other entities that can help ensure human subjects protections.
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References
-
- Jones JW. Bad Blood: The Tuskegee Syphilis Experiment. New York: The Free Press; 1981.
-
- Beecher HK. Ethics and clinical research. New England Journal of Medicine. 1966;274(24):1354–1360. - PubMed
-
- National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. Government Printing Office; Washington DC: 1979. 1979, On the web at: http://ohsr.od.nih.gov/guidelines/belmont.html. Last accessed April 13, 2010. - PubMed
-
- Department of Health and Human Services (HHS) Protection of Human Subjects: Final Regulations Amending Basic HHS Policy for the Protection of Human Research Subjects (45 CFR 46, Subpart A) Federal Register. 1981;46:8366–91. Revised rules are on the web at: http://www.hhs.gov/ohrp/documents/OHRPRegulations.pdf. Last accessed April 13, 2010. - PubMed
-
- Dresser R. When science offers salvation: Patient advocacy and research ethics. Oxford University Press; New York: 2001.
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