OHRP Webinar Series on the Common Rule NPRM

Posted: Oct 06, 2015
U. S. Department of Health and Human Services. 2015 Oct.
KEYWORDS: Regulatory Issues, Consent

Description

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. 

The information provided in these webinars is necessarily simplified. A complete and fully accurate description of the proposed changes is available in the attached full NPRM document. 

Details

The 6 key topics covered in the webinars are:

  1. Overview of the NPRM
  2. Exclusions and Exemptions
  3. Informed Consent
  4. IRB Review and Operations
  5. Research with Biospecimens
  6. Secondary Research Use of Data