NIH-Funding

Cancer Prevention and Control Clinical Trials Grant Program (R01 Clinical Trial Required)

NIH Funding Announcements - Fri, 01/05/2018 - 13:57
Funding Opportunity PAR-18-559 from the NIH Guide for Grants and Contracts. Through this Funding Opportunity Announcement (FOA), the National Cancer Institute (NCI) invites applications that include investigator-initiated clinical trials related to the programmatic interests of the NCI Division of Cancer Prevention and the NCI Division of Cancer Control and Population Sciences as based on their scientific missions. Applications for clinical trials submitted under this FOA should be hypothesis-driven, have clearly described aims and objectives, and have the potential to reduce the burden of cancer through improvements in knowledge, early detection and diagnosis, prevention, healthcare delivery, quality of life, and/or survivorship related to cancer; with such attributes, the proposed studies should also have the potential to positively impact clinical practice and/or public health.
Categories: NIH-Funding

By: XKong

WriteEdit-Grant Questions Blog - Thu, 01/04/2018 - 23:12

Dear writedit, Thank you so much for the very helpful information!

Categories: NIH-Funding

By: writedit

WriteEdit-Grant Questions Blog - Thu, 01/04/2018 - 22:49

Only NINR can be assigned to the PA specific to that institute (with no other participating ICs). I would suggest you talk with the PO at NINR for his/her advice.

FIC is extremely limited in its budget and what it will fund and generally has FIC-specific FOAs (they do not participate in the parent R21 PA). You would definitely want to talk with a PO there to see if they would be interested in your work.

NEI will also have specific priorities for what they will fund, so, again, I would suggest you check their FOAs (not parent, though they do participate) and communicate with a PO there.

These are all ICs with small appropriations, so they will be more concerned with using their limited funding to address key programmatic priorities. Establishing a relationship with a PO who is interested in your science will be very beneficial, though.

Categories: NIH-Funding

By: XIANGRONG KONG

WriteEdit-Grant Questions Blog - Thu, 01/04/2018 - 22:19

Dear Writeedit,
I am submitting a R21 that fits a specific PA that only NINR participates. The grant potentially could also be of interest to FIC and NEI. In this case, shall I submit the grant under the specific PA or better under the parent PA? For grants submitted to a specific PA, would non-participating ICs be considering them?

Thank you very much, and Happy New Year!
Best,
Talaci

Categories: NIH-Funding

Notice of Correction for PAR-18-464: Clinical and Translational Science Award (U54 Clinical Trial Optional)

NIH Funding Announcements - Thu, 01/04/2018 - 12:41
Notice NOT-TR-18-015 from the NIH Guide for Grants and Contracts
Categories: NIH-Funding

Further Refining Case Studies and FAQs about the NIH Definition of a Clinical Trial in Response to Your Questions

Rock Talk: NIH Extramural News - Thu, 01/04/2018 - 12:07

In August and September we released case studies and FAQs to help those of you doing human subjects research to determine whether your research study meets the NIH definition of a clinical trial. Correctly making this determination is important to ensure you are following the initiatives we have been implementing to improve the transparency of clinical trials, including the need to pick clinical trial -specific funding opportunity announcements for due dates of January 25, 2018 and beyond.

We have made no changes to the NIH definition of a clinical trial, or how the definition is interpreted.  What we have done is revise existing case studies and add a few new ones to help clarify how the definition of clinical trial does or does not apply to: studies of delivery of standard clinical care, device studies, natural experiments, preliminary studies for study procedures, and studies that are primarily focused on the nature or quality of measurements as opposed to biomedical or behavioral outcomes..

As a reminder, the case studies illustrate how to apply the four questions researchers involved in human studies need to ask, and answer, to determine if their study meets the NIH definition of a clinical trial. These questions are:

  1. Does the study involve human participants?
  2. Are the participants prospectively assigned to an intervention?
  3. Is the study designed to evaluate the effect of the intervention on the participants?
  4. Is the effect that will be evaluated a health-related biomedical or behavioral outcome?

If the answer to all four questions is yes, then we consider your research a clinical trial.

Note that If the answers to the 4 questions are yes, your study meets the NIH definition of a clinical trial, even if…

  • You are studying healthy participants
  • Your study does not have a comparison group (e.g., placebo or control)
  • Your study is only designed to assess the pharmacokinetics, safety, and/or maximum tolerated dose of an investigational drug
  • Your study is utilizing a behavioral intervention

Studies intended solely to refine measures are not considered clinical trials.

The adjustments to the case studies include the following:

  • #7a, #8a, #24, #31a: Clarified whether it meets definition of intervention
  • #18c: Replaced with a more illustrative case study
  • #18d, 24, and 33: Clarified whether study was designed to assess the nature or quality of a measurement, as opposed to the effect of an intervention on a behavioral or biomedical outcome.
  • #18g: New case study about testing procedures
  • #36 a-b: New case studies about standard clinical care
  • #37: New case study about Phase 1 device studies
  • #38: New case study about natural experiments.
  • #39: Proposed case study about preliminary tests for study procedures.
  • New case studies specific to select NIH Institutes and Centers

We recognize that sometimes in an attempt to be helpful we end up providing a lot of material to look through. So to help you quickly find the case studies that are most relevant to your research we have added the ability to filter the case studies by keyword.

We also added two new FAQs on standard clinical care and Phase 1 devices.

Thank you for your continuing dialog on this topic. We look forward to continuing to work with you as we move towards higher levels of trust and transparency with our clinical trials.

Categories: NIH-Funding

Update: Notice of NIH's Interest in Diversity

NIH Funding Announcements - Wed, 01/03/2018 - 03:01
Notice NOT-OD-18-122 from the NIH Guide for Grants and Contracts
Categories: NIH-Funding

By: writedit

WriteEdit-Grant Questions Blog - Tue, 01/02/2018 - 21:28

Your PO won’t know about funding likelihood until the federal budget passes, which could be in a few weeks – or the CR could be continued again (timeline unknown). Without knowing NCI’s appropriation for FY18, he won’t have any new information for you. If your PO did not indicate whether you should prepare a new application (resubmission of your A1), assuming you are still eligible, then you might ask him if you should submit an application in February for insurance. If he says yes, that doesn’t mean the A1 won’t be funded but that he agrees you should not lose time waiting for Congress to pass a budget … if he says no, then you can feel more positive about getting an award (though no guarantees).

Categories: NIH-Funding

By: JW

WriteEdit-Grant Questions Blog - Tue, 01/02/2018 - 19:12

Hi writedit, happy new year!

I got an impact score of 25 for my revised K99 for NCI, checked with PO in November, and he told me “somewhat good chance”. No updates from him, any advice what I can do now? Is it proper to send another email to followup? Thanks!

Categories: NIH-Funding

By: writedit

WriteEdit-Grant Questions Blog - Tue, 01/02/2018 - 13:01

Happy new year to you, too – best wishes for a productive 2018 to everyone!

You can change the font (e.g., Arial for changes, Georgia for unchanged text) or typeface (italic, underlined, bold) of the updated text, but this makes reading less pleasant for reviewers. Instead, you should simply note in the Introduction that changes have not been marked and summarize your changes/additions. Often this is a better strategy so as not to have reviewers focus on whether they like the changes vs whether they like the science overall. And in fact, current OER guidance says the same thing: “individual changes do not need to be identified within other application attachments (e.g., do not need to bold or italicize changes in Research Strategy)” (https://grants.nih.gov/grants/policy/amendedapps.htm)

Categories: NIH-Funding

NIDCD Clinical Research Center Grant (P50 - Clinical Trials Optional)

NIH Funding Announcements - Tue, 01/02/2018 - 12:05
Funding Opportunity PAR-18-556 from the NIH Guide for Grants and Contracts. The National Institute on Deafness and Other Communication Disorders (NIDCD) invites applications for Clinical Research Center Grants designed to advance the diagnosis, prevention, treatment, and amelioration of human communication disorders. For this announcement, Clinical Research is defined as research involving individuals with communication disorders or data/tissues from individuals with a communication disorder. Examples of such research include but are not limited to, studies of the prevention, pathogenesis, pathophysiology, diagnosis, treatment, management or epidemiology of a disease or disorder of hearing, balance, smell, taste, voice, speech, or language. Proposal of clinical trial research is allowed but not required (optional) for this FOA
Categories: NIH-Funding

By: Mika 6787

WriteEdit-Grant Questions Blog - Tue, 01/02/2018 - 11:17

@writedit, happy new year, I am working on the revised application for resubmission, question is how to mark the”track changes” Thanks

Categories: NIH-Funding

Understanding and Modifying Temporal Dynamics of Coordinated Neural Activity (R01) and Clinical Trial Optional

NIH Funding Announcements - Tue, 01/02/2018 - 10:44
Funding Opportunity PAR-18-555 from the NIH Guide for Grants and Contracts. A rich body of evidence suggests that optimal cognitive, affective, and social processes are associated with highly coordinated neural activity. These findings suggest that oscillatory rhythms, their co-modulation across frequency bands, spike-phase correlations, spike population dynamics, and other patterns might be useful drivers of therapeutic development for treatment of cognitive, social, or affective symptoms in neuropsychiatric disorders. This funding opportunity supports projects that test whether modifying electrophysiological patterns during behavior can improve cognitive, affective, or social processing. Applications must use experimental designs that incorporate active manipulations to address at least one, and ideally more, of the following topics: (1) in animals or humans, determine which parameters of neural coordination, when manipulated in isolation, improve particular aspects of cognitive, affective, or social processing; (2) in animals or humans, determine how particular abnormalities at the genomic, molecular, or cellular levels affect the systems-level coordination of electrophysiological patterns during behavior; (3) determine whether in vivo, systems-level electrophysiological changes in behaving animals predict analogous electrophysiological and cognitive improvements in healthy persons or clinical populations; and (4) use biologically-realistic computational models that include systems-level aspects to understand the function and mechanisms by which oscillatory and other electrophysiological patterns unfold across the brain to impact cognitive, affective, or social processing. This FOA uses the R01 grant mechanism, whereas its companion funding opportunity seeks shorter, higher-risk R21 grant applications.
Categories: NIH-Funding

Understanding and Modifying Temporal Dynamics of Coordinated Neural Activity (R21 Clinical Trial Optional)

NIH Funding Announcements - Tue, 01/02/2018 - 10:44
Funding Opportunity PAR-18-554 from the NIH Guide for Grants and Contracts. A rich body of evidence suggests that optimal cognitive, affective, and social processes are associated with highly coordinated neural activity. These findings suggest that oscillatory rhythms, their co-modulation across frequency bands, spike-phase correlations, spike population dynamics, and other patterns might be useful drivers of therapeutic development for treatment of cognitive, social, or affective symptoms in neuropsychiatric disorders. This funding opportunity supports projects that test whether modifying electrophysiological patterns during behavior can improve cognitive, affective, or social processing. Applications must use experimental designs that incorporate active manipulations to address at least one, and ideally more, of the following topics: (1) in animals or humans, determine which parameters of neural coordination, when manipulated in isolation, improve particular aspects of cognitive, affective, or social processing; (2) in animals or humans, determine how particular abnormalities at the genomic, molecular, or cellular levels affect the systems-level coordination of electrophysiological patterns during behavior; (3) determine whether in vivo, systems-level electrophysiological changes in behaving animals predict analogous electrophysiological and cognitive improvements in healthy persons or clinical populations; and (4) use biologically-realistic computational models that include systems-level aspects to understand the function and mechanisms by which oscillatory and other electrophysiological patterns unfold across the brain to impact cognitive, affective, or social processing. This FOA uses the R21 grant mechanism, encouraging shorter, higher-risk applications, whereas its companion funding opportunity seeks R01 grant applications.
Categories: NIH-Funding

Research on Comparative Effectiveness and Implementation of HIV/AIDS and Alcohol Interventions (R01 - Clinical Trials Optional)

NIH Funding Announcements - Tue, 01/02/2018 - 09:56
Funding Opportunity PAS-18-557 from the NIH Guide for Grants and Contracts. HIV+ alcohol users remain at high risk for medication non-adherence and rapid disease progression, medication toxicities, organ failure, and poor viremic control, leading to increased risk of transmission and premature death. Recent advances in technology and biomedical science (e.g., new pharmacological agents, alcohol and inflammation biomarkers, internet and mobile technology) open new opportunities for strengthening the quality of HIV/alcohol-related implementation research through utilization of novel technology and biomarkers. This initiative seeks to advance knowledge on implementation and comparative effectiveness of alcohol-focused interventions among HIV+ individuals. Multiple factors need to be investigated, including potentially important patient and provider characteristics, and the organizational, financial, and structural factors that facilitate or inhibit the delivery of evidence-based services for HIV+ individuals with a range of severity of alcohol use problems. The overall goal is to inform clinical decision-making to implement effective interventions that will improve prevention, care, and outcomes across the continuum of HIV and alcohol problem severity and patterns of alcohol use. This solicitation is divided into two major topics. An application may choose to address one or both. These topics include: 1) comparative effectiveness research focused on understanding factors related to early detection, patient engagement and retention in appropriate alcohol and HIV care, and achieving and maintaining optimal treatment responses in diverse settings, and 2) modeling and testing alternative implementation approaches to improve uptake and scaling-up of effective interventions and reduce HIV disease transmission and progression.
Categories: NIH-Funding

Two Years (or so) of “Open Mike”

Rock Talk: NIH Extramural News - Fri, 12/29/2017 - 14:25

Last year, as I reflected on finishing my first full year as NIH Deputy Director for Extramural Research, I noted five themes that reflected most of the content of this blog: applicant behavior, activity, and outcomes; peer review; basic science; biomedical research workforce and training; and scientific rigor, transparency, and research impact. Looking back on 2017, which was certainly a busy and active year, many of these themes continue to be at the forefront, though one in particular, the make-up and future of the biomedical research workforce, has been the center of much debate.

On May 2, we posted a blog on “Implementing Limits on Grant Support to Strengthen the Biomedical Research Workforce” in which we proposed using a “Grant Support Index (AKA Research Commitment Index)” to cap the total support going to any one principal investigator. Our goals were to relieve the pressures of hyper-competition, particularly for early and mid-career investigators; we also sought to increase the number of independent early career scientists and to stabilize the career trajectories of those who do high quality work. The blog received 418 comments – by far the most number of comments for any one blog since we started in October 2015. The blog was not the only platform for debate – there were stories in the scientific press  and mainstream media. NIH chose to revise its approach, instead moving to NIH-wide targets for funding early career investigators, and seeking input from an Advisory Committee to the Director (ACD) working group to refine the “Next Generation Researchers’ Initiative (NGRI).” Two blogs on the initiative and policy together received over 200 comments.

The intense attention reflects, I think, high levels of anxiety about the future of American biomedical researchers and their work. We see this discussed in social media conversations and external postings that appeared after we announced the NGRI. For example:

  • Mark Peifer, a senior scientist and member of the NIGMS Advisory Council, published the article, “The Argument for Diversifying the NIH Grant Portfolio.” Peifer argued that the NGRI suffered from two inherent faults: no source for the needed funds and a real possibility that the initiative would jeopardize mid-career investigators who are doing high-quality work by hanging on by only one grant.
  • Yarden Katz and Ulrich Matter, both from Harvard University, posted a working paper “On the Biomedical Elite: Inequality and Stasis in Scientific Knowledge Production.” The authors used NIH data to show that “that funding inequality has been rising since 1985, with a small segment of investigators and institutes getting an increasing proportion of funds, and that investigators who start in the top funding ranks tend to stay there (which results in stasis, or lack of mobility).” Commenting on NIH’s experience with the Grant Support Index proposal, the authors wrote, “In response to criticisms of the highly skewed distribution of funding in biomedical research, the NIH recently proposed a cap on the funds a single investigator can receive, which sparked strong backlash from some elite biomedical scientists and was promptly withdrawn. The selective pressure induced by the maintenance of this concentration of wealth (exerted in part by a small and influential segment of biomedicine that profits from the status quo), coupled with the emphasis on metrics, is likely to exacerbate the lack of diversity within biomedical science.”

We acknowledge these concerns, and through informed discussion with the NIH ACD working group, through feedback and data from NIH’s institutes and centers, and through feedback and recommendations from a National Academy of Sciences (NAS) panel, we will be further refining our approach. We are also pleased to learn of steps that external stakeholders are taking: for example, the presidents and chancellors of nine US research universities and one research institute recently announced a new initiative, the “Coalition for Next Generation Life Science.” The Coalition is engaging in a series of “transparency enhancing efforts,” including providing data to life science trainees on educational and career outcomes.

Alongside the future of the biomedical research workforce, our blog activity also reflects the discussions about efforts to enhance stewardship and transparency of clinical trials. We have cited previous concerns about the under- or delayed-reporting of the main results of NIH-funded trials, a problem that some view as pervasive  and as a serious threat  to the well-being of the scientific enterprise. Much of the discourse over the past few months has focused on the scope of our policies, with critics arguing that our policies should not extend to trials with a primary purpose of basic science. The journal Nature Human Behavior posted essays critical- and supportive of the scope of NIH’s approach. We appreciate the active feedback on the blog, as it has helped us produce, revise, and refine resources that help applicants and grantees.

We look forward to continuing dialogue as we work to maximize the transparency of NIH-funded research, especially research that involves prospective experiments performed on people.

What’s in store for 2018? I’m reminded of a famous quote, attributed to Niels Bohr and to Yogi Berra that “Prediction is very difficult, especially about the future.” There’s scientific evidence that experts, for the most part, are mediocre predictors; along those lines, recent data show that it’s difficult to predict when a scientist will be most productive. I think it’s fair to say that the five aforementioned themes will remain active and salient. We may see even more dialogue about rigor, accountability, and transparency given increasing attention in the news. And we will continue to struggle with figuring out how best to allocate funding resources – how best to balance small science and big science – and how best to deal with long-term hyper-competition and its effects.

As I wrote last year, we are grateful to all our readers for your interest, your feedback, your engagement, and your passion. We wish you all the best for 2018 and beyond.

 

Table 1: Top “Open Mike” posts by page view, Jan 1, 2017 through Dec. 27, 2017 Post Page views Implementing Limits on Grant Support to Strengthen the Biomedical Research Workforce 65,973 Research Commitment Index: A New Tool for Describing Grant Support 26,014 NIH’s Next Generation Researchers Initiative 25,519 NRSA Postdoctoral Stipend Levels for Fiscal Year 2017 22,642 4 Questions For Researchers and Institutions Involved In Human Subjects Research 19,749 Authentication of Key Biological and/or Chemical Resources in NIH Grant Applications 16,547 Outcomes of Amended (“A1”) Applications 16,458 Continuing to Clarify the NIH Definition of a Clinical Trial 14,318 NIH’s Next Generation Researchers Policy Now Posted 13,602 Mid-career Investigators and Shifting Demographics of NIH Grant Recipients 13,457

 

Categories: NIH-Funding

Assuring the Integrity of Peer Review

Rock Talk: NIH Extramural News - Fri, 12/22/2017 - 12:49

Eight months ago, CSR Director Dr. Richard Nakamura and I posted a blog on “A Reminder of Your Roles as Applicants and Reviewers in Maintaining the Confidentiality of Peer Review.” We asked you to imagine a scenario: you are a reviewer for an upcoming panel meeting, and shortly before the meeting an investigator associated with an application communicates with you, asking for a favorable review in exchange for an academic favor. We asked what you would do – accept the offer, ignore it, or report it?

We used the blog as an opportunity to remind all of us how important it is that we all do our utmost to assure the integrity of peer review. Failure to do so, we wrote, will “result in needless expenditure of government funds and resources, and erode the public trust in science.” Furthermore, we noted that there are potentially serious consequences for reviewers and for investigators or others associated with applications who engage in behavior that violates the integrity of NIH peer review.

Unfortunately, our blog foreshadowed just such an event. NIH has recently determined that there has been a breach in the integrity of the panel review process of a batch of applications.

NIH takes the integrity of peer review seriously, and we appreciate that the vast majority of individuals also take the integrity of peer review seriously. Accordingly, after much thought and deliberation, we decided we had no choice but to cancel the panel’s review. The consequences are serious: dozens of applications will need to undergo a re-review.

When the integrity of peer review has been breached, it affects everyone. We regret that the dozens of affected applicants who did nothing wrong will face substantial delays in getting their applications reviewed and processed. We appreciate that the panel reviewers spent a great deal of time and effort reviewing dozens of applications, traveling, and participating in meetings. NIH must assure a fair process for everyone and will not stand by when the integrity of our peer review process is compromised.

We are grateful to the tens of thousands of reviewers and applicants who do play by the rules and who take as seriously as we do the critical importance of the integrity of our processes. This case is a reminder for all of us that we must be ever vigilant.

Categories: NIH-Funding

Analytical Validation of Candidate Biomarkers for Neurological Disease (U01 Clinical Trial Optional)

NIH Funding Announcements - Fri, 12/22/2017 - 12:45
Funding Opportunity PAR-18-550 from the NIH Guide for Grants and Contracts. The purpose of this Funding Opportunity Announcement (FOA) is to support rigorous analytical validation of candidate biomarker measures or endpoints in a manner that is consistent with FDA guidelines. Analytical validation establishes that the performance characteristics of the biomarker measurement or endpoint are acceptable for its intended use.
Categories: NIH-Funding

Clinical Validation of a Candidate Biomarker for Neurological Disease (U44 - Clinical Trial Optional)

NIH Funding Announcements - Fri, 12/22/2017 - 12:44
Funding Opportunity PAR-18-548 from the NIH Guide for Grants and Contracts. The purpose of this Funding Opportunity Announcement (FOA) is encourage applications from Small Business Concerns (SBCs) to support rigorous clinical validation of a candidate biomarker using retrospective and/or prospective methods in a manner that is consistent with the purpose of the biomarker. This FOA assumes that: 1) a candidate biomarker has already been identified, 2) an analytical method has been developed and validated that is consistent with the purpose of the biomarker and 3) a working hypothesis regarding context of use is in place. The goal of this FOA is to facilitate the advancement of robust and reliable biomarkers of neurological disease for use in multi-site clinical trials and clinical practice.
Categories: NIH-Funding

Analytical Validation of a Candidate Biomarker for Neurological Disease (U44 - Clinical Trial Optional)

NIH Funding Announcements - Fri, 12/22/2017 - 12:44
Funding Opportunity PAR-18-549 from the NIH Guide for Grants and Contracts. The purpose of this Funding Opportunity Announcement (FOA) is to support applications from Small Business Concerns (SBCs) to perform rigorous analytical validation of candidate biomarker measures or endpoints in a manner that is consistent with FDA guidelines. Analytical validation establishes that the performance characteristics of the biomarker measurement or endpoint are acceptable for its intended use.
Categories: NIH-Funding