Guidance and clarifications from NIH

The NIH released two new guidance and clarification documents of existing policies related to research approval and grant resubmissions.

One notice (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-129.html ) outlines the process for requesting approval in the event that research under an active NIH award has changed to involve an increased risk to human subjects. If changes occur within a UMBC IRB approved protocol, where prior NIH approval is required before implementation, contact the Office for Research Protections and Compliance (at 5-2737 or compliance@umbc.edu)  as soon as possible so that we may assist in the processing and review of protocol modification documents.

A second notice (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-130.html) describes the approval process for the addition of human subjects research to projects that were originally awarded without definitive plans for human subjects research described in the grant application. The UMBC IRB has issued guidance that may assist investigators in situations described in this second notice. Investigators may request planning phase administrative approval to obtain IRB approval. Please see http://www.umbc.edu/research/ORPC/irb_forms.html#planning for more information.