Frequently Asked Questions about NIAMS Research Innovations for Scientific Knowledge (RISK) (X02, R61/R33)

September 26, 2016

The NIAMS held two informational webinars (August 2016) for prospective applicants.

How does the science that NIAMS seeks through the RISK initiative differ from what NIAMS would support under the R21 mechanism?
If the idea has been proposed by the PI in a previous unsuccessful NIH application, is it still eligible for RISK?
May I propose more than one innovation in a RISK application?
How will the innovation be reviewed?
How will X02 reviewers be chosen?
Will a summary statement be released after the X02 peer review?
How will X02 applicants be informed of the X02 pre-application review and evaluation results?
Is the X02 pre-application a required step for submitting the R61/R33?
In the R61/R33 application, can/should the applicant make reference to the X02 review?
Are multi-PI applications accepted?
Is a multidisciplinary approach advantageous?
How will a fundable RISK application affect NI status?
Must human tissues be used?
What is meant by "disease-focused translational studies?"
Is there any funding associated with the X02?
How will decisions about transitioning to the R33 phase be made?

How does the science that NIAMS seeks through the RISK initiative differ from what NIAMS would support under the R21 mechanism?

RISK looks for innovations that are beyond the regular R21 mechanism. That said, the level of innovation is difficult to gauge, but if the PI feels an idea can be used for an R21 application, then it should not be used for applying for the RISK.

If the idea has been proposed by the PI in a previous unsuccessful NIH application, is it still eligible for RISK?

Perhaps. Applicants are cautioned to be aware that not all unsuccessful applications fail because the idea is too risky. Only highly risky ideas are appropriate for RISK.

May I propose more than one innovation in a RISK application?

What matters to a successful RISK application is the overall level of innovation, not the number of innovations in the application.

How will the innovation be reviewed?

The concept in a RISK pre-application (X02) will be peer-reviewed in an unprecedented way. The X02 review will focus on innovation and significance, with each receiving a separate score. No overall impact score will be given. In the X02 review, the applicants will be anonymous, so their experience, training, track-record, institutional affiliation, seniority and other factors will not enter into evaluating their ideas. This is the first attempt at an NIH review utilizing applicant anonymity.

In the R61/R33 stage, the 5 standard NIH criteria will be used to evaluate the application, with a focus on the design and execution of testing the innovative idea. At this stage, the applicant identity is known to the reviewers.

How will X02 reviewers be chosen?

Reviewers will be recruited based on the area of research and expertise needed. It is important to bear in mind that X02 reviewers will provide their scores independently; there will be no discussion among them.

Will a summary statement be released after the X02 peer review?

Yes, applicants will receive a brief summary statement with Significance and Innovation scores and critiques from the assigned reviewers. No overall impact score will be given. (Please note that there will be a numerical score shown in eRA Commons. This is for administrative purposes only. It is NOT the overall impact score for the application.)

How will X02 applicants be informed of the X02 pre-application review and evaluation results?

All investigators will be notified about the outcome of their X02 review by an email. Those applicants whose X02 pre-applications are deemed the most innovative and significant with respect to the RISK program priorities will be invited to submit an R61/R33 application under RFA-AR-17-008 or RFA-AR-17-009. Investigators whose X02 pre-applications do not meet the requirements for innovation and significance with respect to RISK will also be notified by a letter.

Is the X02 pre-application a required step for submitting the R61/R33?

The X02 is not required. However, NIAMS considers the X02 review an important part of the RISK initiative. It allows reviewers to evaluate innovation and significance without being distracted by the approach, which we feel will give a more accurate evaluation of innovation and significance. Thus, while it is not required, the lack of an X02 could impact the outcome of an applicant’s R61/R33.

In the R61/R33 application, can/should the applicant make reference to the X02 review?

No. According to NIH policy, because the R61/R33 will be a new application, you may not include previous scores, comments of the previous reviewers, or your responses to those comments, or place marks in the text of the research strategy or any other section of the application to indicate changes from a previous submission. Your application will be withdrawn from the review process if you include anywhere in your application the kind of information that would be found in a previous summary statement (score, critique criterion scores, reviewers comments), information that would be appropriate for an Introduction (response to the previous review and information about how the application was changed), or marks in the text of the application to show how it has changed since the last submission.

Are multi-PI applications accepted?

Yes. But programmatically, a single PI is preferred. In addition, it is not recommended that a new investigator act as a co-PI (one of the multi-PIs) for this mechanism.

Is a multidisciplinary approach advantageous?

Not necessarily. Only the level of innovation counts.

How will a fundable RISK application affect NI status?

If the R61/R33 is awarded, and a new investigator’s role is PI/PD, he or she will lose their new PI status. Submitting an X02 pre-application will not have any effect on new investigator status.

Must human tissues be used?

No. We invite studies performed in vitro, in animals, or in humans.

What is meant by "disease-focused translational studies?"

For the purposes of this FOA, we invite research studies aimed at understanding the mechanisms of diseases or conditions relevant to the NIAMS mission. We also invite studies aimed at developing or testing diagnostics, therapeutic agents, or preventive interventions up to, but not including, first in human studies.

Is there any funding associated with the X02?

No. Only the R61/R33 has funds associated with it.

How will decisions about transitioning to the R33 phase be made?

In the R61/R33 applicants must state explicitly the results that support, reject, or are inconclusive regarding testing of their concept/hypothesis. Program staff will use these applicant-defined and peer-reviewed criteria to determine if the R33 will be awarded.