Responsibilities of investigators engaged in research involving human subjects (data from Cohen, J.)

1. Design and conduct research in alignment with the ethical principles described in the Belmont Report

2. Comply with all federal regulations related pertaining to the protection of human subjects

3. Obtain approval for all research involving human subjects from the appropriate institutional IRB

4. Comply with all IRB policies, procedures and decisions and other requirements

5. Conduct research as approved by the IRB

6. Obtain IRB approval for all changes to the study protocol

7. Obtain and document informed consent and assent from subjects in compliance with federal regulations and as approved by the IRB

8. Report progress of research to the IRB as prescribed by the IRB

9. Report to the IRB any adverse events or unanticipated problems involving subjects or others

10. Retain research documents (e.g., signed consent forms) for at least three years following completion of the study are dependent, decisionally impaired, or dependent on others. Persons who comprise the former group do not differ from younger persons in any way except for chronological age, and the ethical principles governing research in general are sufficient to encompass research involving them. Research involving the latter group, however, is more complex; these elders are vulnerable, often institutionalized, and many lack decision-making capacity (Dubler, N., 1987). In fact, there are a number of unique aspects and potential ethical challenges of conducting research involving elderly subjects that merit special attention (Sachs, G. and Cohen, H., 2003). The remainder of this chapter will address these unique aspects and challenges.

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