360 Degrees of Human Subjects Protections in Community-Engaged Research
Ross, Lainie Friedman
Science translational medicine 2010 Aug 18; 2(45): 45cm23
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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Ross, Lainie Friedman; Loup, Allan; Nelson, Robert M.; Botkin, Jeffrey R.; Kost, Rhonda; Smith, George R., Jr.; Gehlert, Sarah (2010-03)In the 30 years since the Belmont Report, the role of the community in research has evolved and has taken on greater moral significance. Today, more and more translational research is being performed with the active ...
Nine Key Functions for a Human Subjects Protection Program for Community-Engaged Research: Points to Consider Ross, Lainie Friedman; Loup, Allan; Nelson, Robert M.; Botkin, Jeffrey R.; Kost, Rhonda; Smith, George R.; Gehlert, Sarah (2010-03)The ethical conduct of Community-Engaged Research (CEnR), of which the Community-Based Participatory Research (CBPR) model is the partnership model most widely discussed in the CEnR literature and is the primary model we ...