Where to Post Informed Consent Forms for NIH-Funded Clinical Trials

The revised Common Rule requires that an IRB-approved version of an informed consent form be posted on a public federal website for all NIH-funded clinical trials. This must be done after enrollment ends and within 60 days of the last study visit. See Guide Notice NOT-OD-19-050. Continue reading

Upcoming Change in Federal-wide Unique Entity Identifier Requirements

Currently when applying for Federal grants or cooperative agreements, all applicant organizations must have a DUNS number as the Universal Identifier. The General Services Administration (GSA) recently announced that DUNS will be replaced by a new Government-owned unique entity identifier in all systems, including Grants.gov and eRA Commons. The new government unique identifier will be incorporated into the SAM registration process, eliminating the need for applicants to seek external identifiers in order to register. Continue reading

NIH Implementation of the Final Rule on the Federal Policy for the Protection of Human Subjects (Common Rule)

NIH has issued initial guidance on the implementation of the Revised Common Rule NOT-OD-19-050. The effective date for the amended regulation is January 21, 2019.  It applies to studies initiated on or after this date, and ongoing studies that voluntarily transitioned to the Revised Common Rule, including those that implemented the three burden-reducing provisions during the delay period (July 19, 2018 through January 20, 2019). Continue reading