For your convenience, here is a roundup of recently announced changes impacting grant application submission for due dates on or after January 25, 2019.
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.
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.
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).
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.
NIH (including help desks) will be closed on Monday, January 21, 2019, for the federal holiday (Birthday of Martin Luther King, Jr.). If a grant application due date falls on a federal holiday, the application deadline is automatically extended to the next business day.
We would like to remind the extramural research community that both the NIH and Grants.gov remain operational during the current partial federal government shutdown.
Advancing public health depends on science being empirical, transparent, and rigorous. As yet another step towards fostering rigorous science, we have revamped the Rigor and Reproducibility webpage to highlight and include more resources you might find helpful. Since sketching out our plan last summer with the Advisory Council to the NIH Director, the webpage now reflects policy updates and explores new resources, all in a simple and easy to read manner.