Today Science published our letter “Safeguarding integrity and collaborations,” which summarizes our perspectives on NIH efforts to address long-standing foreign interference threats, many stemming from foreign malign talent recruitment programs. We are grateful to Science for publishing our letter and for endorsing our efforts to “talk more openly.”
We described our concerns in this venue on July 8, 2020; we have also assembled a content-rich foreign interference web site which includes case studies, disclosure requirements, processes for handling allegations, data, and a compilation of notices, statements, and reports.
The main points we make in our letter are:
I encourage those of you who are interested in learning more to read the letter and to look at our web site. We are posting a longer version of our essay as well as a summary sheet that includes general principles, case studies, information about select publicly known cases, and findings of others (Congress, Office of the Inspector General, Government Accountability Office) who have scrutinized our work. We are continuing to work closely with Federal government colleagues to, as we write, “envision a framework that secures trust and integrity while enhancing all that robust international collaborations have to offer.”
Did you know there are NIH programs that support small-scale research projects at educational institutions that provide baccalaureate or advanced degrees, and which have not received significant NIH support? If not, it’s time to get to know the NIH Research Enhancement Award (R15) programs during a virtual event on June 15 at 2:30 PM ET.
The NIH R15 programs include:
Prospective grant applicants and research administrators are invited to learn more about these valuable programs during this one-hour, virtual event. Join your peers as NIH experts share an overview of the R15 programs and insight into key components of the application process, followed by a Q&A. Register today!
Resources following the webinar:
A recording and transcript will be available approximately seven days after the event concludes. An email will be sent to all registrants with additional information.
Reasonable Accommodations:
This webinar will be closed-captioned and will include an ASL interpreter. Any questions about the format or requests for reasonable accommodations should be submitted at least five days prior to the event to NIHGrantsEvents@nih.gov.
We look forward to having you join us!
Do you work with human subjects in your research? Our Division of Human Subjects Research team put together a handy one-page resource to help you find the information you need as you develop your grant application and beyond. In it you’ll find useful tips like how to use the participant-level data template, an infographic on exempt human subjects research, a decision tool to determine if your study is considered a clinical trial, and more!
The UNITE E Committee recently updated the research community on their progress towards creating a “multipronged strategy to advance racial equity and create the most inclusive biomedical research environment possible.” We wanted to briefly share a few of their efforts here.
As a reminder, NIH launched the UNITE initiative in March 2021 to end structural racism in biomedical research. Their inaugural progress report was released last October. One of five committees, UNITE E continues to focus attention on promoting and sustaining diversity, equity, and inclusion in the NIH extramural research ecosystem.
In the recent UNITE Director’s Corner message, the co-chairs Drs. John Lorsch, Ericka Boone, and Anna Ordóñez spotlighted several new UNITE-E led programs centered around:
The following research areas were also recently cleared:
UNITE E was also instrumental for leading policy changes in requirements that recipient institutions have behavioral codes of conduct. These internal controls help us further assure safe, respectful, and healthful working conditions for their employees and foster work environments conducive to high-quality research, free from harassment and discrimination.
We encourage you to read the full UNITE Co-Chairs’ Corner post for more on UNITE E’s efforts.
This blog has been co-authored with Noni Byrnes, Director, Center for Scientific Review, NIH. Originally posted on the Review Matters blog.
Mike Lauer, Deputy Director for Extramural Research, NIH Noni Byrnes, Ph.D., Director of NIH Center for Scientific ReviewAs discussed in the blog, “Update on Simplifying Review Criteria: A Request for Information (RFI),” NIH issued an RFI—from December 8, 2022, through March 10, 2023—seeking feedback on its proposed plan to revise and simplify the framework for the first level of the peer review of research project grant (RPG) applications.
NIH received more than 800 responses to the RFI: 780 from individuals, 30 from scientific societies, and 30 from academic institutions. The vast majority were supportive of the proposed changes, although a minority were in favor of Factor 3 (Investigator, Environment) being scored, and a smaller minority advocated for a blinded or partially blinded review process. Most of the respondents highlighted the need for strong training resources for reviewers, study sections chairs, and scientific review officers.
One question that often arises is how investigator and institution will be weighted in arriving at the Overall Impact score, if they themselves are not individually scored. Since 2009, when scoring was added to the review criteria, reviewers have been free to weight these as they see fit in the Overall Impact score. This score has never been an average of criterion scores. This is no different in the setting of the simplified framework.
Although fully blinded review may be conceptually favorable, NIH is required by statute to assess investigator and environment. Thus, at best, only a multi-staged, partial blinding process would be possible. However, as the Nakamura et. al publication showed (eLife 10:e71368, 2021), anonymization of research proposals is difficult to achieve with those familiar with a given field, with about 20% of the reviewers correctly identifying the principal investigator despite extensive redaction. In addition, while NIH is conducting a partially blinded, three-stage review process for its Transformative Research Awards, which receives fewer than 200 applications per year, attempting to scale the process up to the more than 80,000 applications is not feasible. Piloting the changes would involve designing a multi-year study, since the NIH cannot “carve out” a subset of applications submitted to the agency for potential funding and review them using a different set of criteria.
A trans-NIH committee has been established for implementation of the changes for simplifying review criteria. This committee is developing a timeline as well as designing rollout and trainings. The evaluation of these changes—the effects of which would be evident only over several years—will include surveys and data analysis. For the simplified review criteria framework changes, we hope to see a broader range of institution types across the scoring ranges and an increase in the diversity of the pool of R01 applicants, as well as more career stages and PI funding levels represented (meaning those with no grants or only 1 other grant).
If we do see improvements, however, it will be important to place them in the context of all the actions that NIH’s Center for Scientific Review (CSR) is taking to improve peer review, which also include diversifying our review committees, deploying bias awareness and mitigation and review integrity trainings, and establishing a direct channel for the extramural community to report instances of bias in peer review. These actions are, of course, in conjunction with NIH’s overall efforts to break down structural barriers and advance equity in all aspects of NIH’s activities, particularly by way of its UNITE initiative, which has recently reached its second anniversary.
We thank all who took the time to work with us in this effort to simplify the review criteria framework for RPGs and provide feedback through the RFI and in other ways. We also thank those involved in the other aspects of improving peer review at NIH, which is an ongoing process as more data are generated and analyzed, new questions are asked, and fresh insights are established and shared. The engagement of our community partners is critical to the success of this continued endeavor. We believe these current changes will go a long way in helping us to better identify the science with the greatest potential impact.
We often recommend NIH RePORT (Research Portfolio Online Reporting Tools) site to applicants & awardees because it publicly provides reports, data, and analyses of NIH research activities, including information on NIH expenditures and the results of NIH-supported research. The RePORT suite includes:
This NIH All About Grants podcast episode also shares ideas on how you may use RePORT throughout the grants process.
Though these tools provide a wealth of information about NIH biomedical research funding, RePORT does not provide information on sub-awards or non-R&D contracts. Moreover, only limited data are available in the RePORTER database for other federal funders. In these situations, we encourage users to explore the following resources:
Except for RePORT and World RePORT, NIH is not involved with managing the other funding databases. If you have questions, please contact them directly.
NIH is launching a pilot on May 15, 2023, to improve the quality, accuracy, and transparency of project data for awarded NIH R&D contracts to promote the highest level of public accountability (see NIH Guide Notice NOT-OD-23-115).
Six contract vendors have been selected to participate in the pilot. These vendors will directly enter select project data for their awarded R&D contracts in eRA systems, replacing the process of sending the information on a PDF form 1688 for manual entry by NIH staff. The data, once approved by the NIH Contract Project Officer, will be displayed to the public through RePORTER and the Categorical Spending page.
The vendors will directly enter the following information in eRA Commons for projects associated with new contract awards and new task orders during the pilot, within 15 days of the request from NIH staff:
The pilot will run from May 15 through October 2023 and is scheduled for evaluation from November to December 2023. The full rollout is tentatively planned for early 2024, pending results of the pilot. For resources and background, please see the Submitting Data on R&D Contracts webpage.
Several resources are on hand for xTrain users to navigate the redesigned xTrain module that was launched March 30. xTrain allows program directors/principal investigators, university administrators, and trainees to electronically prepare and manage appointments and terminations for trainees and fellows.
NIH (including help desks) will be closed on Monday, May 29, 2023 for the federal holiday (Memorial Day). If a grant application due date falls on a federal holiday, the application deadline is automatically extended to the next business day.
NIH provides stipends to NRSA fellows and trainees as a subsistence allowance to help defray living expenses during the research training experience. NIH does not provide stipends as a condition of employment with either the Federal government or the sponsoring institution. While stipends are not provided as a condition of employment, this policy is not intended to discourage or otherwise prevent recipient institutions from hiring NRSA trainees and fellows as employees or providing them with benefits consistent with what the institution provides others at similar career stages.
For more information, see the full Guide Notice. Please direct all inquiries to NIHTrain@mail.nih.gov.
Would you benefit from feedback on your NIH grant application? Or are you seeking advice on NIH funding and how it can support your career progression? Sometimes help is closer than you think! It can be very helpful to tap NIH-funded researchers at your own institution to provide feedback on your application or to serve as mentors. NIH RePORTER is a super easy way to identify NIH-funded investigators at your institution (or elsewhere) who may be willing to help.
RePORTER is an electronic tool that allows users to search a database of NIH-funded research projects and access publications and patents resulting from NIH funding. This means you can find funded researchers at your institution through a simple search of your organization name or using the Organization filter in the Advanced Search. You could also use it to find potential NIH funded collaborators in your field.
Enter just about anything in the RePORTER Quick Search box, text, PI names, project numbers, fiscal year, agency, whatever criteria you want to explore NIH’s database of funded research.
NIH is deeply concerned for the health and safety of people and animals, and about the biomedical enterprise in the areas in Mississippi affected by these natural disasters. Due to the exceptional impact of these storms, NIH wants to assure our recipient community that we will be doing our part to help the extramural community continue its research. NIH has issued a notice identifying policy exceptions for impacted organizations to relieve short-term administrative, financial management, and audit requirements.
Our website on Extramural Response to Natural Disasters has a list of available resources, including guidance on animal welfare issues.
Do you want more tools to understand good experimental design when reviewing animal use protocols? Watch this informative webinar hosted by the NIH Office of Laboratory Animal Welfare on approaches for the Institutional Animal Care and Use Committee (IACUC) to effectively evaluate study design, animal numbers, and statistical descriptions in animal protocols. By focusing on concepts rather than mathematical equations, this webinar is for all IACUC members regardless of scientific or statistical background.
This blog has been co-authored with Noni Byrnes, Director, Center for Scientific Review, NIH. Originally posted on the Review Matters blog.
Mike Lauer, Deputy Director for Extramural Research, NIH Noni Byrnes, Ph.D., Director of NIH Center for Scientific ReviewNIH is recommending changes to the peer review of Ruth L. Kirschstein National Research Service Award (NRSA) fellowship applications by restructuring the review criteria and modifying some sections of the PHS Fellowship Supplemental Form that are specific to NRSAs. The goal of this effort is to facilitate the mission of NRSA fellowship peer review – to identify the most promising trainees and the excellent, individualized training programs that will help them become the outstanding scientists of the next generation. The proposed changes will 1) allow peer reviewers to better evaluate the applicant’s potential and the quality of the scientific training plan without undue influence of the sponsor’s or institution’s reputation; and 2) ensure that the information provided in the application is aligned with the restructured criteria and targeted to the fellowship candidate’s specific training needs. The RFI requests public input on this proposal. To comment, go to the RFI, which contains additional background and links to submit your thoughts. Most of that background follows:
The first stage of NIH peer review serves to provide expert advice to NIH on assessment of the likelihood that the fellowship will enhance the candidate’s potential for, and commitment to, a productive independent scientific research career in a health-related field. The criteria for the review of NRSA fellowship applications derive from the NRSA regulation 42 CFR 66.106, with four pertinent factors: (1) the scientific, technical, or educational merit of the particular proposal; (2) the availability of resources and facilities to carry it out; (3) the qualifications and experience of the applicant; and (4) the need for personnel in the subject area of the proposed research or training.NIH currently organizes these criteria into the following categorical labels: Applicant, Sponsors and Collaborators, Research Training Plan, Training Potential, and Institutional Environment and Commitment. By NIH policy, peer reviewers are also required to evaluate Training in the Responsible Conduct of Research, Biohazards, Resubmissions, Foreign Organizations, Select Agents, Resource Sharing Plans, Budget and Period of Support, and Authentication of Key Biological and/or Chemical Resources.
NIH gathered input from many sources in forming this proposal. Unsolicited comments over a period of years, reflecting persistent concerns that the NRSA fellowship review process disadvantages some highly-qualified, promising applicants led the Center for Scientific Review (CSR) to form a working group to the CSR Advisory Council. To inform that group, CSR published a Review Matters blog which was cross-posted on the Office of Extramural Research blog, Open Mike. The blog received more than 1,500 views by unique individuals and numerous comments. The working group presented interim report to the CSR Advisory Council, which adopted the recommendations, at public CSR Advisory Council meetings (March 2022 video, slides; September 2022 video, slides). Final recommendations from the CSR Advisory Council (report) were considered by the CSR Director, as well as major NIH extramural program, review, and policy committees that included leadership from across NIH. Recommendations were presented to the NIH Advisory Committee to the Director in December 2022 (video, slides).
Improving NRSA Fellowship Review
Recommendation 1: Revise the Criteria Used to Evaluate NRSA Fellowship Applications
An Overall Impact Score (scored 1-9) will reflect the scientific and educational merit of the proposal and an assessment of the likelihood that the fellowship will enhance the applicant’s potential for, and commitment to, an independent, productive research career in a health-related field. Reviewers will take into account their assessments of the three criteria in determining an Overall Impact Score. Each of the three criteria will receive an individual score. The “additional review criteria” below are unchanged, will not receive individual scores, but will be considered in arriving at the Overall Impact Score. Two “additional review considerations”, also unchanged, will be evaluated but have no effect on the Overall Impact Score. Review the full text of the proposed changes.
Review Criteria
I. Scientific Potential, Fellowship Goals, and Preparedness of the Applicant
II. Science and Scientific Resources
III. Training Plan and Training Resources
Additional Review Criteria (not scored, but affecting Overall Impact; no changes proposed, see current language):
• Protections for Human Subjects
• Inclusion of Women, Minorities, and Individuals Across the Lifespan
• Vertebrate Animals
• Biohazards
• Resubmission
Each of the Additional Criteria except the last will be rated as “Appropriate”, with no comments required, or as “Concerns”, which must be briefly justified. Resubmission will be given brief written evaluations.
Additional Review Considerations (not scored and having no effect on Overall Impact) no changes proposed, see current language):
• Training in the Responsible Conduct of Research
• Authentication of Key Biological and/or Chemical Resources
• Budget and Period of Support
• Applications from Foreign Organizations
• Select Agents
• Resource Sharing Plans
Recommendation 2: Revise the PHS Fellowship Supplemental Form
Changes to the application instructions are needed to better align the information applicants provide with the revised review criteria. The PHS Fellowship Supplemental Form currently includes the following four sections: Fellowship Applicant; Research Training Plan; Sponsor(s), Collaborator(s), and Consultant(s); Institutional Environment and Commitment to Training. The NIH proposes to revise the Fellowship Applicant section and the Sponsor(s), Collaborator(s) and Consultant(s) section. NIH also proposes to change the instruction for Letters of Reference. An additional proposed change would allow an optional Statement of Special Circumstances from the fellowship applicant. Review the full text of the proposed changes.
Through the RFI, NIH continues to seek public comment on the proposed changes before moving forward with implementation. The RFI will be open for a 60-day period, until June 23, 2023. We look forward to your comments.
Guest post by Chuck Dunn, Associate Director, Office of Communications and Outreach, NIH Center for Scientific Review, and Lamont Williams, Associate Director, Office of Communications and Outreach, NIH Center for Scientific Review. Originally posted on the Review Matters blog.
Lamont Williams, Associate Director, Office of Communications and Outreach Chuck Dunn, Associate Director, Office of Communications and OutreachNIH has a vested interest in receiving proposals from a wide range of investigators, from a wide range of applicant institutions. However, data on funding of research project grants (RPGs) and a recent analysis done by the Center for Scientific Review (CSR) on applicant institutions for National Research Service Award (NRSA) fellowship applications indicate some disparities among institutions in terms of funding and application rates. In Fiscal Year (FY) 1985-2020, the top 10% of organizations received approximately 70% of RPG funding (Open Mike, Jan 18, 2022;Lauer and Roychowdhury, 2021). An analysis of NRSA fellowship applications in 2021 found skewed application rates; 15 institutions submitted more than 100 applications, while 106 institutions submitted one or two applications (Final report of the CSR Advisory Council Working Group on Peer Review of NRSA Fellowship Applications).
To assist investigators/institutions that are submitting fewer applications, we’ve developed this resource to help clarify the process, highlighting institution- and investigator-specific information, including key actions that must be taken well in advance of application submission. We hope this makes the process easier for those with relatively less experience submitting NIH grant applications and that it is useful for the broader research community, as well.
We will be sharing this resource through direct email to offices of sponsored research at a wide range of institutions. Please share with others.
An image of the Resources and Programs for NIH Grant Applicants infographic.We are pleased to share our annual snapshot of how many researchers NIH supports. These fiscal year (FY) 2022 data are also available in the NIH Data Book (see report #303) and represent awards made with traditional and supplemental coronavirus appropriations. Please keep in mind that these data are distinct from success rates, however, which are application-based metrics (see this post).
Our cumulative investigator rate is an NIH-wide person-based metric. The metric is calculated as the number of unique principal investigators who were designated on an NIH research project grant (RPG), activity or mechanism, divided by the number of unique principal investigators who were designated on applications over a five-year period. For simplicity, we will refer to those investigators as either “awardees” or “applicants” in this post. And, we focus on a five-year timeframe because most research grants last for more than one year, and applicants submit applications with the goal to secure multiple years of funding. We also only count someone once if they are designated on separate applications from the same or multiple NIH Institutes or Centers in a particular five-year timeframe.
Figure 1 shows cumulative investigator rate data for RPGs between FYs 2003 and 2022. Applicants are in blue bars, awardees in orange bars, and the funding rate itself is the gray line. NIH supported 36,594 awardees in FY 2022, out of 92,465 applicants. This is an increase of 4.0% and 0.5%, respectively, over FY 2021, and the cumulative investigator rate was 39.6%.
Figure 1. Cumulative Investigator Rate: Research Project Grants: FY 2003 to 2022
The table below highlights FY 2022 data for R01-equivalent, R21, and P01 grant types. As noted earlier, please see report #303 in the Data Book for more details.
Grant TypeApplicantsAwardeesCumulative Investigator RateR01-equivalent69,56830,41143.7%R2139,5954,78912.1%P011,23144636.2%The cumulative investigator rate for R01-equivalent grants rose to 43.7% in FY 2022, 0.9 percentage points over the previous year (Figure 2). There were 30,411 awardees out of 69,568 applicants, which is more awardees as well as applicants than in FY 2021.
Figure 2. Cumulative Investigator Rate: R01-equivalent Grants FY 2003 to 2022
The R21 cumulative investigator rate did go up in FY 2022 (Figure 3). Out of 39,595 applicants, there were 4,789 awardees, for a 12.1% Cumulative Investigator Rate. Though the rate did inch up compared to FY 2021, it has been markedly low for over a decade. Thus, as we mentioned last year, we still encourage applicants consider other NIH grant types (such as R01-equivalents), especially since R21s are shorter and smaller grants and do not necessarily increase success for a future larger award.
Figure 3. Cumulative Investigator Rate: R21 Grants FY 2003 to 2022
Though there were more P01 program applicants in FY 2022 compared to 2021, nearly the same number of awards were made (Figure 4). This resulted in the cumulative investigator rate decreasing to 36.2%.
Figure 4. Cumulative Investigator Rate: P01 Grants FY 2003 to 2022
We are pleased that the cumulative investigator rate for RPGs and R01-equivalent grants continued to increase over recent years.
I would like to thank my colleagues in the Office of Extramural Research Division of Statistical Analysis and Reporting for their work on these analyses.
Have questions about funding opportunities, developing an application, or managing a grant award? Unsure who to contact for help? Don’t be scared to reach out to NIH staff – it’s literally our job!
You may be able to find answers to your questions through your institutional contacts or our online resources (Grants & Funding, Policy & Compliance, How to Apply, FAQs). If you’ve checked these sources and still need help, our Need Help page is a great place to start finding contacts for NIH grants administration questions. If you want a refresher on the ins and outs of what to do when seeking assistance from extramural staff, check out the NIH All About Grants podcast episode on How to Find Help. Sheri Cummins, with the NIH Office of Extramural Research’s communications group, explains where to find answers to many frequently asked questions and other information online, deciphering program, review, and grants administrative staff roles at NIH, when to reach out and when not to, and much more.
With the expiration of the Public Health Emergency on May 11 comes the end of the special exception that allowed applicants to submit a one-page update of preliminary data as post-submission materials. However, going forward, NIH is revising our standard post-submission material policy to allow a one-page update with preliminary data to be submitted as post-submission material for Type 1 R01, R21, or R03 applications, including resubmissions, as long as the funding opportunity used for submission allows preliminary data in the application. For applications submitted for the May 25, 2023 receipt date and beyond, the special exception is ended and applicants should follow the new policy.
NIH recently updated its annual categorical information with fiscal year (FY) 2022 actual spending data and estimates for FY 2023 and 2024. Available on the Research, Condition, and Disease Categorization (RCDC) page, you will find the annual support level for various research, condition, and disease categories. The data are based on grants, contracts, and other funding mechanisms used across NIH.
There were 215 public categories when RCDC information began being reported in 2008. Now in our fifteenth year, there are a total of 315 categories. The following new categories were added in FY 2022:
There were also several existing categories that were renamed including:
For more background on RCDC, please see this NIH Open Mike blog and the RCDC process here.
Anna M. Fine, PharmD, MS, Acting Director, ClinicalTrials.gov
Guest post by Anna M. Fine, PharmD, MS, Acting Director of ClinicalTrials.gov at the National Library of Medicine (NLM), National Institutes of Health. Originally posted on the Musings from the Mezzanine blog.
ClinicalTrials.gov is the world’s largest database of privately and publicly funded clinical trials. It provides easy access to clinical trial information for millions of users every month—from patients and their advocates to data submitters, data researchers, and the broader public. NLM is in the midst of a multi-year effort to modernize ClinicalTrials.gov to deliver an improved user experience on an updated platform that will accommodate future growth and enhance efficiency.
In June 2023, we will reach an important milestone: replacing the current website with the modernized ClinicalTrials.gov website. This modernized site will implement the innovations we have designed based on user feedback, including an updated look and feel and improved functionality for searching, viewing, and downloading information about clinical trials.
In advance of this launch, NLM will host a virtual public meeting on April 25 to provide a detailed look at the modernized website, a summary of our overall progress, and a look ahead to the final phases of and expectations for the modernization effort. Attendees will have the opportunity to hear from and interact (both via chat and during two simultaneous breakout sessions) with the ClinicalTrials.gov modernization team members and other stakeholders. For more information about this public meeting, please visit the ClinicalTrials.gov Modernization webpage.
In the meantime, we wanted to share key highlights of our progress and provide insight into where we’re going.
What’s Been DoneNLM announced the launch of the beta versions of the modernized ClinicalTrials.gov website and its clinical information submission and management portal, the Protocol Registration and Results System (PRS), in December 2021. Throughout 2022 and into early 2023, we made available a series of additional beta releases with new features and enhancements based on user testing and feedback.
A closer look at some of these features is available in demonstration videos for ClinicalTrials.gov Beta and PRS Beta. We will continue to make available additional beta releases of the modernized PRS into 2024, which will be summarized in the PRS Beta Release Notes.
What’s to ComeIn addition to switching over to the new ClinicalTrials.gov in June, we will continue to make additional enhancements to the system:
All the engagement activities we conducted over the last three years to identify stakeholder needs—including the modernization request for information, user surveys, and usability research, as well as our work to iteratively develop user-centered designs—will come together in these final years of the effort. Beyond 2025, we will continue to engage with users across stakeholder groups, with the aim of helping everyone reap the full benefits of the modernized ClinicalTrials.gov website and PRS.
We Want to Hear from You!Because the ultimate success of the modernization effort is best measured through feedback, all stakeholders are encouraged to become involved by sharing their comments and suggestions via the feedback buttons on the ClinicalTrials.gov Beta and PRS Beta sites.
For additional information about modernization-related events and resources, visit the ClinicalTrials.gov Modernization webpage.
We thank you for your patience as we work to provide these updated features and improved functionality to serve our millions of users around the world. We hope you’ll join us on April 25 to hear directly from the modernization team members and stakeholder representatives who are behind this substantial effort.
