OHRP Announces Availability of Three Draft Guidance Documents Related to Revised Common Rule

As you may recall, NIH issued guidance for implementing the burden-reducing provisions of the 2018 Common Rule (NOT-OD-18-211). Subsequently on July 20, 2018, the HHS Office for Human Research Protections (OHRP) has announced the availability of three draft guidance documents that relate to three burden-reducing provisions Continue reading

Expiring Appropriations and What it Means for You – New Video and Podcast

Did you know that grant funds can expire?  A recent interview with NIH experts on the topic of “Expiring Appropriations” addresses how you know if you have expiring funds, what to do if you find yourself in this situation, and whether money can be restored.  This 10 minute conversation is available as both a video and a podcast.  Continue reading

What do I do if my proposed study involves both an existing dataset/resource AND recruitment of new participants? How do I address inclusion and complete the forms?

If you are proposing a study that will include both an existing dataset and recruitment of new participants, you should provide separate inclusion forms for the existing dataset and the participants to be prospectively recruited.  The existing dataset sample can … Continue reading

Wait…It’s Not MY Grant?

Remembering back to my days as a PI, I can recall myself saying something like “yea, on my NIH grant…” when discussing my research. This may have been okay over coffee, but it is technically incorrect. We hear this confusion a lot. So, we thought it would be worthwhile to remind you about some of the respective roles of institutions and investigators working on an NIH award. Continue reading

Changing the Status of a PD/PI: Reminder of the NIH Prior Approval Policy

Have you wondered what happens when a program director/principal investigator (PD/PI) is no longer available to serve on an NIH grant? Maybe they have accepted a position at another institution? Or perhaps they are unable to carry out their duties for some other reason?
NIH recently issued a Guide Notice (NOT-OD-18-172) to remind the community about the NIH’s prior approval policy requirements when an institution seeks to change the status of a PI or other senior/key personnel as designated in the Notice of Award. This Notice also helps clarify the situations in which NIH’s prior approval is required.
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