NIH-Funding

Implementing a New Human Subject and Clinical Trial Information Form

Rock Talk: NIH Extramural News - Wed, 10/11/2017 - 15:21

We have been talking a lot recently about NIH’s efforts to improve transparency and trust in NIH funded clinical trials. One important aspect of this effort is improving our ability to identify and describe the clinical trials we are supporting. In fact, a March 2016 GAO report GAO-16-304, entitled Additional Data Would Enhance the Stewardship of Clinical Trials across the Agency, highlighted the fact that “NIH is limited in its ability to make data-driven decisions regarding the use of its roughly $3 billion annual investment in clinical trials.” Many of the other aspects of this initiative, applying clinical trial specific review criteria, improving oversight, and registering and reporting in ClinicalTrials.gov depend upon our basic ability to identify and describe clinical trial applications and awards.

The new PHS Human Subject and Clinical Trial Information form will flag trials, helping us to achieve a number of goals. The form consolidates into a single location information on human subjects that is currently scattered across a number of forms. It allows us to capture structured and semi-structured descriptive information for each study included in a grant application or contract proposal, which will allow us to clearly identify which funded studies will require registration and timely reporting of results.

Each study record requires a minimum number of requested data elements. This starts with leading the applicant through the four questions that determine whether the study is considered by NIH to be a clinical trial. (See our August 11 post, 4 Questions for Researchers and Institutions Involved in Human Subjects Research for more on the NIH definition of a clinical trial.) The answers to those questions will determine whether or not the applicant will need to complete Section 4 of the form, the “Protocol Synopsis.” The form will help in peer review and will enable NIH to answer important questions, like how many clinical trial studies we are funding, the phase of those trials, and how many have as their primary purpose treatment evaluation or fundamental discovery.

Some information collected in this form is information that you likely would have included in the application elsewhere, either in the protection of human subjects attachment or in the research strategy. Now we are capturing that information in a structured format, which supports better monitoring of the studies by NIH staff after award. It also serves the purpose of leading the applicant or contractor through each of the elements we expect them to consider as they are planning for their grant application or contract proposal, which we expect will make for stronger applications. Collecting the protocol synopsis, study population characteristics, recruitments plans, and plans for statistical design and power in one place will also allow reviewers to more easily locate and evaluate these critical elements. For delayed onset studies, those studies for which the details are not known at the time of application, grantees will submit this information to NIH through the eRA Commons once it is known.

One question we are often asked is whether the information collected in the new form will be duplicative of the information provided in the research strategy. That is not our intent. The form allows you to spell out methodological details in the study record, allowing more space in the research strategy for higher-level descriptions and justifications of your experimental design(s) and methods.

A key element in the design of the form is that we were careful to be consistent with the data elements required for Clinicaltrials.gov reporting, which will help with data reuse and exchange between systems.

If you haven’t seen the new form, we have a 9 minute video  that will guide you through and give you a good idea of how it works. The form will be included as part of the Forms-E application packages, which you will be required to use for all grant applications submitted for due dates on or after January 25, 2018. You will see the form associated with funding opportunity announcements as early as the very end of October/early November.  We expect to make the PHS Human Subjects and Clinical Trial Information form available for Requests for Proposals for contracts posted as of January 25, 2018 as well. We recently published the instructions for FORMS-E (HTML/PDF) if you want to take an early look.

Categories: NIH-Funding

Guidance on Implementation of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research

NIH Funding Announcements - Wed, 10/11/2017 - 13:24
Notice NOT-OD-18-004 from the NIH Guide for Grants and Contracts
Categories: NIH-Funding

Guidance on Exceptions to the NIH Single IRB Policy

NIH Funding Announcements - Wed, 10/11/2017 - 13:16
Notice NOT-OD-18-003 from the NIH Guide for Grants and Contracts
Categories: NIH-Funding

Change in Application Types for PAR-15-353 NIOSH Centers for Agricultural Safety and Health (U54)

NIH Funding Announcements - Wed, 10/11/2017 - 13:07
Notice NOT-OH-18-001 from the NIH Guide for Grants and Contracts
Categories: NIH-Funding

Notice of Correction to Scientific Merit Review Dates in PAR-17-204, Inter-organelle Communication in Cancer (R21)

NIH Funding Announcements - Wed, 10/11/2017 - 11:32
Notice NOT-CA-18-004 from the NIH Guide for Grants and Contracts
Categories: NIH-Funding

Notice of Correction to Scientific Merit Review Dates in PAR-17-203, Inter-organelle Communication in Cancer (R01)

NIH Funding Announcements - Wed, 10/11/2017 - 11:23
Notice NOT-CA-18-003 from the NIH Guide for Grants and Contracts
Categories: NIH-Funding

By: writedit

WriteEdit-Grant Questions Blog - Wed, 10/11/2017 - 11:19

POs are busy and tend to triage requests based on urgency. He probably thinks you are not going to submit again until the next cycle, which means you would have plenty of time (so not urgent – and he probably needs some time to go over the summary statement and application). If you haven’t called him yet, I would suggest you start there, since it will be important for you to incorporate his feedback on the reviewers’ discussion at the study section meeting; if you only get his voicemail, be sure to note that you would like to submit for Oct 25th. You can resubmit once you have the summary statement (which you now have), but you do not want to submit again if you don’t have time to adequately address the concerns raised. Your application with the score of 28 will remain under consideration even if your subsequent application scores worse (ie, submitting again does not affect the first proposal).

Categories: NIH-Funding

Notice of Correction to Educational Activities Supported by PAR-17-339 "NIH Science Education Partnership Award (SEPA)(R25)"

NIH Funding Announcements - Wed, 10/11/2017 - 11:15
Notice NOT-GM-18-001 from the NIH Guide for Grants and Contracts
Categories: NIH-Funding

By: Craving for funding

WriteEdit-Grant Questions Blog - Wed, 10/11/2017 - 10:50

Hi – I asked the NCI program director after receiving a score of 28 for R15. He replied as ‘While we still don’t know what next year’s budget will bring I can tell you that I am not optimistic that the payline for R15’s will relax at all. Let’s arrange a time to chat once the reviewers comments are available.’ . After one week of that conversation, I sent him the review comments and asked for a conversation. He didnot reply. After another two weeks, I sent him the same email, and still didnot receive response for one week. What could be happening on the other end? Should I call him? In the mean time, can I submit the same proposal to catch deadline in this month? If I do this, will the scored proposal still be considered for funding? Thanks a lot!

Categories: NIH-Funding

By: writedit

WriteEdit-Grant Questions Blog - Tue, 10/10/2017 - 14:36

If the science is different, then I do not see why not, since a concurrent R01 is allowed, but you should contact the NIDA DP2 PO for confirmation. You would not be allowed to receive both DP2s, though, in the happy event that both are competitive.

Categories: NIH-Funding

By: writedit

WriteEdit-Grant Questions Blog - Tue, 10/10/2017 - 14:32

If you cannot extend your ESI status, then you won’t qualify for the extra NGRI payline breaks (each IC will determine their NHGRI funding thresholds, I believe, though the goal is the 25th percentile) … but when you have your summary statement, you can still talk with your PO about funding likelihood as select pay, given how close you are to ESI (they would be more reticent about funding breaks for a senior foreign (new to US) or former NIH research applying as a New Investigator), especially if your work is of high programmatic value. Your PO can give advice on whether to resubmit and, if so, strategies for addressing concerns raised during the discussion (that PO heard but did not get recorded in summary statement).

Categories: NIH-Funding

By: writedit

WriteEdit-Grant Questions Blog - Tue, 10/10/2017 - 14:24

You should contact your PO when you receive your summary statement, which is when he/she can comment on whether you might get funded based on reviewer comments (PO won’t know how far their budget will go until Congress passes a budget, probably not before December) and on whether you should prepare a new application (A0) for this proposal as insurance (the A1 remains under consideration). As ESI, you should be in good shape, especially with the NGRI, which seeks to increase the payline for NI/ESI applicants, though I believe it will be up to ICs to determine the higher payline vs an NIH-wide ESI payline. However, this depends on whether the NIH receives a slight boost to their budget, as is currently indicated by Congressional drafts but is not guaranteed. The most useful information you will be able to get from your PO at this point is whether you should submit again and, if so, strategy for doing so.

Categories: NIH-Funding

By: G

WriteEdit-Grant Questions Blog - Tue, 10/10/2017 - 13:25

Hi- I am an ESI. I have submitted DP2 this summer and am wondering whether I can apply for another DP2 from NIDA (Avenir Award Program for Research on Substance Abuse and HIV/AIDS) with a different research idea/project. Thanks.

Categories: NIH-Funding

Immuno-Oncology Translation Network (IOTN): Cancer Immunoprevention Research Projects (U01)

NIH Funding Announcements - Tue, 10/10/2017 - 12:39
Funding Opportunity RFA-CA-17-046 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) is associated with the Beau Biden Cancer MoonshotSM Initiative that is intended to accelerate cancer research. Specifically, this FOA targets the following area designated as scientific priority by the Blue Ribbon Panel (BRP): Recommendation B. Create a translational science network devoted exclusively to immunotherapy approaches to treat and prevent adult cancers. The goal of the network is to foster collaborative team science approaches to accelerate the discover of new immune targets and evaluate novel immune-based therapies and combination approaches that eliminate established cancers in adults or to prevent cancers before they occur.
Categories: NIH-Funding

Immuno-Oncology Translation Network (IOTN): Data Management and Resource-Sharing Center (DMRC) (U24)

NIH Funding Announcements - Tue, 10/10/2017 - 12:39
Funding Opportunity RFA-CA-17-047 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) is associated with the Beau Biden Cancer MoonshotSM Initiative that is intended to accelerate cancer research. Specifically, this FOA targets the following area designated as scientific priority by the Blue Ribbon Panel (BRP): Recommendation B. Create a translational science network devoted exclusively to immunotherapy approaches to treat and prevent adult cancers. The goal of the network is to foster collaborative team science approaches to accelerate the discover of new immune targets and evaluate novel immune-based therapies and combination approaches that eliminate established cancers in adults or to prevent cancers before they occur.
Categories: NIH-Funding

Immuno-Oncology Translation Network (IOTN): Cellular Immunotherapy Data Resource (CIDR) (U24)

NIH Funding Announcements - Tue, 10/10/2017 - 12:39
Funding Opportunity RFA-CA-17-048 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) is associated with the Beau Biden Cancer MoonshotSM Initiative that is intended to accelerate cancer research. Specifically, this FOA targets the following area designated as scientific priority by the Blue Ribbon Panel (BRP): Recommendation B. Create a translational science network devoted exclusively to immunotherapy approaches to treat and prevent adult cancers. The goal of the network is to foster collaborative team science approaches to accelerate the discover of new immune targets and evaluate novel immune-based therapies and combination approaches that eliminate established cancers in adults or to prevent cancers before they occur.
Categories: NIH-Funding

Immuno-Oncology Translational Network (IOTN): Cancer Immunotherapy Research Projects (U01)

NIH Funding Announcements - Tue, 10/10/2017 - 12:39
Funding Opportunity RFA-CA-17-045 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) is associated with the Beau Biden Cancer MoonshotSM Initiative that is intended to accelerate cancer research. Specifically, this FOA targets the following area designated as scientific priority by the Blue Ribbon Panel (BRP): Recommendation B. Create a translational science network devoted exclusively to immunotherapy approaches to treat and prevent adult cancers. The goal of the network is to foster collaborative team science approaches to accelerate the discover of new immune targets and evaluate novel immune-based therapies and combination approaches that eliminate established cancers in adults or to prevent cancers before they occur.
Categories: NIH-Funding

Testing Interventions for Health-Enhancing Physical Activity (R01 - Clinical Trial Optional)

NIH Funding Announcements - Tue, 10/10/2017 - 10:52
Funding Opportunity PAR-17-306 from the NIH Guide for Grants and Contracts. The purpose of this Funding Opportunity Announcement (FOA) is to fund highly innovative and promising research that tests multi-level physical activity intervention programs acting on at least two levels of the socio-ecological model and designed to increase health-enhancing physical activity: 1) in persons or groups that can benefit from such activity; and 2) that could be made scalable and sustainable for broad use across the nation. This FOA provides support for up to 5 years for research planning, intervention delivery, and follow-up activities.
Categories: NIH-Funding

Developing Interventions for Health-Enhancing Physical Activity (R21/R33 - Clinical Trial Optional)

NIH Funding Announcements - Tue, 10/10/2017 - 10:52
Funding Opportunity PAR-18-307 from the NIH Guide for Grants and Contracts. The purpose of this Funding Opportunity Announcement (FOA) is to fund highly innovative and promising research aimed at developing multi-level physical activity intervention programs acting on at least two levels of the socioecological model and designed to increase health-enhancing physical activity: 1) in persons or groups that can benefit from such activity; and 2) that could be made scalable and sustainable for broad use across the nation. This FOA provides support for up to two years (R21 phase) for research planning activities and feasibility studies, followed by a possible transition to expanded research support (R33 phase) for optimizing the intervention and conducting larger-scale feasibility studies. Transition to the R33 depends on the completion of applicant-defined milestones, as well as program priorities and the availability of funds.
Categories: NIH-Funding