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

July 25, 2018

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?”

NIH Application Resubmission Policy

July 24, 2018

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.

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

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?”

Charting Your Small Business’ Course with NIH

July 10, 2018

At NIH, we maintain a broad and diverse portfolio of biomedical and behavioral research. To turn discovery into health, promising technologies must move from the laboratory into clinical trials, into the marketplace, into the doctor’s office, and into our every-day lives. A key way to transition promising technologies out of the laboratory is through the commercialization process.

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

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?”

New Podcast on NIH Advisory Councils: Understanding What Happens During the Second Round of Peer Review

July 5, 2018

Have you ever wondered why your grant application must undergo a separate round of peer review—even after a panel of experts initially weighed in on its scientific merit and provided a score to consider when making funding decisions? A new All About Grants podcast delves more into the second round of peer review at NIH … Continue reading “New Podcast on NIH Advisory Councils: Understanding What Happens During the Second Round of Peer Review”