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Final Rule, Federal Policy for the Protection of Human Subjects, 82 Fed. Reg. 7149, Jan. 19, 2017.
These new regulations are scheduled to become effective on 19 January 2018, except for the single-IRB
review requirement, which will take effect on 20 January 2020.
Since the Common Rule was promulgated, the volume and landscape of research involving human subjects have changed considerably. Research with human subjects has grown in scale and become more diverse.
Examples of developments include: an expansion in the number and types of clinical trials, as well as observational studies and cohort studies; a diversification of the types of social and behavioral studies
being used in human subjects research; increased use of sophisticated analytic techniques to study human biospecimens; and the growing use of electronic health data and owith human subjects has grown in scale and become more diverse. Among other changes, the final rule adopts new requirements to improve informed consent forms and the consent process itself. The final rule establishes new exempt categories of research based on their risk profile.