The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have announced proposed revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. A Notice of Proposed Rulemaking (NPRM) was published in the Federal Register on September 8, 2015.
In order to help the public better understand the goals and impact of the new proposals, the Office for Human Research Protections (OHRP) has developed six webinars covering key aspects of the NPRM. The webinars aim to explain the NPRM proposals that are most relevant to each topic. As such, there is a fair amount of overlap in content and material covered in the webinars.
It is important to remind the audience that information provided in these webinars is necessarily simplified. For a complete and fully accurate description of the proposed changes, the audience is advised to refer to the full NPRM document (PDF 1063 KB).
6 key topics covered by the webinars:
- Overview of the NPRM (approx. 34 mins.), Jerry Menikoff, Director, OHRP
- Exclusions and Exemptions (approx. 30 mins.), Jerry Menikoff, Director, OHRP
- Informed Consent (approx. 28 mins.), Jerry Menikoff, Director, OHRP
- IRB Review and Operations (approx. 18 mins.), Julia Gorey, Policy Analyst, Division of Policy and Assurances, OHRP
- Research with Biospecimens (approx. 22 mins.), Julie Kaneshiro, Deputy Director, OHRP
- Secondary Research Use of Data (approx. 21 mins.), Ivor Pritchard, Senior Advisor to the Director, OHRP
Please send any questions or comments about the webinars to [email protected].
To submit comments on the NPRM, please follow the instructions provided on the OHRP webpage entitled "NPRM for Revisions to the Common Rule" that is also accessible from the OHRP home page.