Is My Ancillary Study Considered a Clinical Trial?

It depends. Yes; if the ancillary study adds an additional prospectively assigned intervention to patients or a sub-population of patients within the larger clinical trial and all elements of the NIH clinical trial definition are met. No; if the ancillary study is only adding additional measures to an existing clinical trial. Continue reading

New Resources Available for Basic Experimental Studies with Humans (BESH) Funding Opportunities

In November, NIH announced the publication of new funding opportunities specifically for Basic Experimental Studies Involving Humans (BESH). Need help determining if your research fits within the scope of a BESH funding opportunity announcement (FOA)? Check out these new resources. 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

How Do I Determine if My Institution is Eligible For an R15 Research Enhancement Award?

As of January 24, 2019, NIH will no longer maintain its list of institutions ineligible to apply for R15 grants. Instead, for R15 applications submitted for due dates on or after February 25, 2019, institutions are responsible for determining their own eligibility. Institutions can determine eligibility using the NIH RePORT website. Continue reading

Always Check Your FOA for New Related Notices 30 Days Before Submission

You found a funding opportunity announcement (FOA) that fits your research, you’ve read it carefully, and have been working for months perfecting your application. Don’t forget to return to the FOA within 30 days of the due date to check for any new related notices which could impact  your submission. Continue reading