Author: NIH Staff

New to NIH Grants? Would a Workshop on Intellectual Property, Human Subjects, NIH Policy-Making, eRA, or an NIH Administrator’s Boot Camp Help?

July 11, 2019
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If you’ve been searching for an opportunity to learn more about the NIH grants process and perhaps delve into more specific topics to help you do your job…then look no further! The NIH Regional Seminar on Program Funding and Grants Administration provides an array of pre-seminar workshops and sessions over the course of three days … Continue reading “New to NIH Grants? Would a Workshop on Intellectual Property, Human Subjects, NIH Policy-Making, eRA, or an NIH Administrator’s Boot Camp Help?”

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How Do You Define a “Study” for the Purposes of Providing Information on the PHS Human Subject and Clinical Trial Form?

July 25, 2018
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We recognize that it may be difficult to determine whether two or more closely related protocols should be considered a single study. Generally, if you have research activities that use the same human subjects population, follow the same core research protocol and procedures, and intend to combine the data for analysis in aggregate, this would … Continue reading “How Do You Define a “Study” for the Purposes of Providing Information on the PHS Human Subject and Clinical Trial Form?”

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NIH Application Resubmission Policy

July 24, 2018
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NIH’s resubmission policy has not changed, but the policy notice highlights some important points: only a single resubmission (A1) of an original application (A0) will be accepted, an A0 application may be submitted following an unsuccessful A0 or A1 application (with a few exceptions), what happens when switching FOAs between the A0 and A1 applications, and generally a change of activity code (e.g., R01) between the A0 and A1 is not allowed, with one exception.

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In the RPPR, do we need to fill out the Human Subjects and Clinical Trials Information form if we submitted a competing application before January 25, 2018?

July 24, 2018
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The Human Subjects and Clinical Trials Information form appears for all recipients with human subjects studies. However, those who submitted competing applications for due dates on or before January 25, 2018 only need to update inclusion data via the Human Subjects link in the RPPR.  The remaining fields (e.g. milestones) are not required to be … Continue reading “In the RPPR, do we need to fill out the Human Subjects and Clinical Trials Information form if we submitted a competing application before January 25, 2018?”

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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?

July 5, 2018
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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 be provided on the Cumulative Inclusion Enrollment Report. You should provide the sex/gender, race, and … 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?”

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