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To fully benefit from the exponentially growing body of biomedical data, we need cutting-edge approaches that foster data access, analysis, sharing, and collaboration so novel scientific questions can be pursued. But the sheer volume, sometimes siloed nature, along with the costs and time associated with analyzing large datasets, can be difficult for some researchers. Recognizing these concerns, NIH is helping by hosting large data sets and bringing together computational tools and cloud technologies in ways that support open access, interoperability, and collaborative analyses. We encourage you to explore how these resources may help accelerate your research in ways not possible before.
In recent years, NIH has invested in cloud computing and other platforms to create shared environments enabling opportunities for better data access and novel analyses. These investments are positively shifting how researchers interact with COVID-19, genomic, imaging, proteomic, and other NIH-supported large datasets.
The NIH Strategic Plan for Data Science suggests fostering data access and use through investing in cloud computing will have many benefits. Researchers, for one, can retrieve data quicker than before, without needing to copy and store any data locally. They can also leverage existing high compute environments to scale up analyses and improve efficiencies, without needing to build or maintain the underlying infrastructure. And working in the cloud may ease collaboration between government, academia, industry, and other partners to facilitate the translation of basic discoveries into novel treatments.
An NIH initiative that brings together computational tools and cloud technologies for our recipient institutions and supported investigators is the Science and Technology Research Infrastructure for Discovery, Experimentation, and Sustainability (STRIDES) Initiative. Launched in 2018, the STRIDES Initiative is a vehicle for NIH and NIH-funded researchers to access cloud resources through partnerships with commercial cloud providers—making it easier and more cost-effective to access large datasets and computing power. More than 60 NIH research institutions are currently taking advantage of the favorable pricing, training, and technical support available. We encourage you to learn how others are leveraging these services and explore the available opportunities too.
What does the STRIDES Initiative offer? Researchers supported by NIH awards can receive cost-effective access to state-of-the-art, cloud-based data storage and computational capabilities, tools, and expertise. Shared tools, data hosting, and curation help reduce the costs for participants. They also offer learning and development opportunities and customized guidance from experts, all to help you better connect with biomedical datasets, tools, resources, and fellow scientists in new ways.
STRIDES also partnered with the National Library of Medicine’s (NLM’s) Sequence Read Archive (SRA) in continued efforts to ease data access. The partnership made over 36 petabytes of “next generation” (raw and SRA-formatted) sequencing data accessible to anybody via two cloud service providers. Now, you can search their entire catalog of genomic data in the cloud, and even use the computational tools for your analyses.
Before, researchers who wanted to use this archive effectively had to have efficient means to search and retrieve large datasets, sometimes to the scale of 6 petabytes (or 6,000,000 gigabytes), which could take days to download and was only possible for those with access to large-scale storage systems. This led to substantial obstacles and delays, given that timely results could help address public health emergencies (see COVID-19 datasets publicly available here).
These cloud computing services should make using data from NIH-funded research more accessible to researchers in a more timely and cost-effective way. We also hope that, working together with the research community, a robust, interconnected ecosystem can be created that reduces barriers to generating, analyzing, and sharing research data. By moving data to the cloud, we can maximize our investment in research, while also strengthening the transparency, rigor, and reproducibility of our supported science.
As announced in March, updated biosketch and other support format pages and instructions are available for use in applications, Just-in-Time (JIT) Reports, and Research Performance Progress Reports (RPPRs). Use of the new format pages is preferred immediately and required for due dates and submissions on or after January 25, 2022 (NOT-OD-21-110). This represents a change from the original May 25, 2021 requirement date for the updated formats and other support signatures. Applicants and recipients can use this time to align their systems and processes with the new formats and instructions. Failure to follow the appropriate formats on or after January 25, 2022 may cause NIH to withdraw applications from or delay consideration of funding.
Applicants and recipients remain responsible for disclosing all research endeavors regardless of the version of the forms used, including:
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Under normal circumstances, individuals must have no more than four years of postdoctoral research experience to be eligible to apply for a K99/R00 Pathway to Independence award. Due to disruptions caused by the COVID-19 pandemic, NIH will be extending the two-receipt cycle extension (roughly eight additional months) of eligibility for prospective, eligible candidates for a K99/R00 application. Individuals whose final due date eligibility based on a 48 month eligibility window was either the June/July 2021 or October/November 2021 will have a 2 cycle extension of eligibility (to February/March 2022 and June/July, 2022, respectively).
For more details, see the full Guide Notice.
The revised NIH Grants Policy Statement (NIHGPS) has been published, replacing the December 2019 version as standard terms and conditions of award. This revision applies to all NIH grants and cooperative agreements with budget periods beginning on or after October 1, 2020.
For more details, see the full Guide Notice.
The 8th joint symposium, titled “Pandemic Driven Advances,” organized by the Johns Hopkins University Center for Alternatives to Animal Testing (CAAT), NIH’s Office of Laboratory Animal Welfare, USDA’s Animal Welfare Information Center, and Johns Hopkins Department of Molecular and Comparative Pathobiology is scheduled for June 3rd and 4th, 2021. Join us as we bring together experts and practitioners to focus on the challenges faced during the pandemic and the successes in effectively using animal models to maximize both biomedical discovery and the 3Rs goal.
Visit CAAT now to view the preliminary agenda and register. Discounts are available for some attendees and the organizers have applied for 9 RACE credits.
Want more on proposing alternatives to animals in NIH grant applications? Check out this NIH All About Grants podcast episode.
NIH (including help desks) will be closed on Monday, May 31, 2021, 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 awardees must report individual-level study participant data on: 1) Sex/Gender, 2) Race, 3) Ethnicity, and 4) Age at Enrollment in annual progress reports. This individual-level data must be de-identified and submitted using the required .csv template file.
Important: do not modify the format of the template. The categories set in the columns should not be deleted or edited; the data for each participant can be entered on rows.
This requirement is effective for competing applications for due dates January 25, 2019 or later (NOT-OD-18-116).
Working on a study that might meet both the definition of basic research and the NIH definition of a clinical trial? Check out our new webpage on Basic Experimental Studies involving Humans (BESH). This webpage contains new resources to help investigators:
We have also updated our library of clinical trial case studies, designed to help you identify whether your study would be considered by NIH to be a clinical trial.
You likely know that for human-participant research funded wholly or in part by NIH, we automatically issue Certificates of Confidentiality (CoCs) as a term and condition of award. CoCs protect identifiable, sensitive information of people who participate from being disclosed to others not associated with the study. More about the CoC policy can be found on this blog and podcast. But, for human-participant research funded by an entity other than NIH, did you know that you can reach out to us to request a CoC as well?
We offer this service for certain non-NIH funded projects to strengthen the privacy protections afforded to people involved in research studies. As with all CoCs, the protections for data or biospecimens collected under an active CoC issued for a non-NIH funded project also continue in perpetuity.
To obtain a CoC for a non-NIH funded project, investigators may request one through the eRA CoC System. NIH will ensure the research meets a number of requirements, including ensuring that the activity is actually research, that it falls within the mission of NIH or HHS, and that at least one institution or performance site is within the U.S or some of the data will be maintained within the U.S. On average, it takes about two days to process requests, though some can take longer. See our FAQs on Certificates for Non-NIH, Federally Funded Research and Certificates for Non-Federally Funded Research to learn more.
CoC requests come in for projects supported by many different funders. Non-federal sponsors, like research institutions, non-profit organizations, and pharmaceutical companies, consistently represent the bulk of approved requests. Figure 1 shows a breakdown by quarter last year. The remainder of requests issued come from human-participant research projects supported by other HHS funding sources, as well as the Department of Defense, Department of Veterans Affairs, the National Science Foundation, and other federal departments.Figure 1
We have seen a steady increase in CoCs issued for non-NIH funded research over the last five years (Figure 2). Last year, NIH approved 744 CoCs, an 85% increase over 2016.Figure 2
The growth of CoCs requested and approved continuing into 2020 was surprising. We expected the number of CoCs issued would decrease with pandemic shutdowns. The 2020 rate was more than what was seen for previous years, even when excluding the 126 CoCs approved for COVID-19 related research studies (16.2 percent of the total).
The delays resulting from pandemic shutdowns could extend a project beyond the approved CoC expiration date. This could cause investigators to spend additional time and resources reapplying for new Certificates and put participants’ privacy at risk. Therefore, NIH informed the 1,356 active CoC holders who found themselves in this situation that they were issued an automatic one-year extension on the expiration date (see this FAQ for more). To prevent this issue going forward, NIH removed the language about an Expiration date on CoCs issued on or after January 12, 2021 to non-NIH funded projects.
We are proud to offer this service to the biomedical research community. If you are interested to learn more, please review our CoC webpage and email any questions to NIH-CoCfirstname.lastname@example.org.
I would like to thank my colleagues with OER’s Division of Human Subjects’ Research for their work on this service.
Is your NIH grant coming to an end soon? Here’s a refresher on reporting deadlines, timeframes for drawing funds from the Payment Management System (PMS), and the process for amending a Federal Financial Reports (FFR).
Recipients must submit a final FFR, Final Research Performance Progress Report (RPPR), and Final Invention Statement and Certification within 120 calendar days of the end of the period of performance (see NIHGPS Section 8.6). In the event that additional time is needed to fulfill the closeout requirements (e.g. prepare, revise, or amend financial reports), a no-cost extension should be requested.
Recipients may request payments from PMS up to 120 days past the period of performance end date, to liquidate obligations incurred during the period of performance. Per the NIH Grants Policy Statement, a term and condition of every NIH award, recipients must submit timely, accurate final grant expenditure reports, and reconcile cash transaction reports submitted to the PMS with expenditure reports submitted to NIH.
In rare cases, a recipient may need to revise or amend previously submitted expenditures more than 120 days past the period of performance end date in order to revise a previously submitted FFR. In these cases, the AOR must notify the IC Grants Management Specialist listed in the NoA for additional guidance (see NIHGPS Section 126.96.36.199.3).
For more details, see the full Guide Notice.
For due dates on or after January 25, 2022, NIH, AHRQ, FDA, and ORD/VA are targeting a requirement that all individuals listed on the R&R Senior/Key Person Profile (Expanded) Form have an eRA Commons username (Commons ID) listed on grant applications. Extension of the existing eRA Commons ID requirement to include all senior/key personnel will facilitate better data collection for individuals contributing to federally funded research as well as assist in disambiguating data on applications and facilitating the identification of conflicts of interest in peer review.
To get applicants accustomed to this change, applicants will receive a warning if a valid eRA Commons username is not provided for senior/key Personnel.
For more details, see this eRA news item.
As you begin your journey in search of NIH grant funding, it is important to understand the structure of NIH to find the best fit for your research.
NIH is made up of 27 institutes and centers (often referred to as ICs), 24 of which can make grant awards. Each IC has a separate appropriation from Congress, and the director of each IC decides which grants it will fund, taking into consideration input from their staff, the results of the scientific peer review of the grant application, public health need, scientific opportunity, and the need to balance its scientific portfolio. NIH only funds research that has been judged highly meritorious in the peer review process.
Each IC has a distinct mission that focuses on a specific disease area, organ system, or stage of life. The mission and priorities of each IC are stated on their individual websites. Prospective grantees should do their research to identify the ICs that might be interested in their research idea. Many research topics may be of interest to multiple ICs, so reach out to different scientific program officials around NIH. They can guide you to the best IC home for your idea.
Our Matchmaker tool in RePORTER can help you determine which IC may be interested in your idea (see our video demonstration of Matchmaker). Simply enter your abstract or other scientific terms to see which ICs have funded research in that area. Your query result may also be useful for finding NIH program official contacts at NIH. Click on the details tab for individual grants in the search result to find the program official responsible for that area of research.
Why is it so important to identify an IC that may be interested in your work? As you start looking for funding opportunities, ensure that the IC potentially interested in your area of science is listed as a participating organization on the funding opportunity announcement that you use to submit your application. If they are not listed as participating on the funding opportunity announcement you use to submit your application, they will not be able to consider your application for funding.
When in doubt, reach out – NIH staff are here to help you navigate the grants process and find the right fit for your research.
Back in August of last year, Microsoft announced that it would be discontinuing its support of Internet Explorer (IE) 11 by August 17, 2021. As a result of that announcement, eRA is phasing out the use of IE for all eRA systems due to security concerns. By July 19, 2021, eRA systems will no longer be available when using the IE browser.
Please switch to one of the other supported browsers such as Mozilla Firefox, Google Chrome, Safari (and Microsoft Edge once IE is phased out), when using eRA systems (see eRA’s Browser Compatibility statement).
Each year around this time we look back on NIH’s investment in research. Similar to previous fiscal years (FYs), this post focuses on grant funding and success rates for research supported through our traditional annual appropriations.
Grants data related to special coronavirus appropriations are excluded here to be consistent with prior “By The Numbers” posts. For more on that spending, please review these posts and use the advanced search functionality available in RePORTER.
NIH received $ 41.6 billion in FY 2020 (see our Appropriations history here ). Of this amount, $30.8 billion was awarded to 56,169 new and renewed meritorious extramural grants (excludes research and development contracts). This investment was up $1.3 billion from FY 2019 (4.4 percent increase), with 1,157 more grants funded (2.1 percent increase). The awards were made to 2,650 academic universities, hospitals, small businesses, and other organizations throughout the U.S. and internationally.
Table 1 – All Extramural Research (competing and non-competing, excluding contracts)2019 2020 2020 % Change from 2019 Number of Awards 55,012 56,169 2.1% Total Amount (in billions) $29.466 $30.761 4.4%
NIH awarded 11,332 competing Research Project Grants (RPGs) in FY 2020, 297 more than FY 2019. We spent $22.6 billion on RPGS, an additional $1.0 billion (4.9 percent) over the previous year, with the average size per award increasing by $13,065 (2.4 percent). The RPG success rate in FY 2020 was 20.6 percent (55,038 competing applications and 11,332 awards).
Table 2 – Research Project Grants (RPG)2019 2020 2020 % Change from 2019 Number of research project grant (RPG) applications: 54,903 55,038 0.3% Number of new or renewal (competing) RPG awards: 11,035 11,332 2.7% Success rate of RPG applications: 20.1% 20.6% 2.4% Average size of RPGs: $553,679 $566,744 2.4% Total amount of NIH funding that went to RPGs (both competing and non-competing): (in billions) $21.589 $22.636 4.9%
The application success rate for R01-equivalent grants, which make up the majority of RPGs, was 21.4 percent. We received 36,250 applications and funded 7,767 of them. The average grant size and overall total spending for R01-equivalents increased in FY 2020, compared to the previous year, to $559,680 (2.1 percent increase) and $17.4 billion (5.9 percent increase), respectively.
Table 3 – R01-equivalent Grants*2019 2020 2020 % Change from 2019 Number of R01-equivalent grant applications: 35,085 36,250 3.3% Number of new or renewal (competing) R01-equivalent awards: 7,366 7,767 5.4% Success rates for R01-equivalent applications: 21.0% 21.4% 2.1% Average size of R01-equivalent awards: $548,390 $559,680 2.1% Total amount of NIH funding that went to R01-equivalents (both competing and non-competing): (in billions) $16.435 $17.412 5.94%
*R01-equivalent grants are defined as activity codes DP1, DP2, DP5, R01, R37, R56, RF1, RL1, U01 and R35 from select NIGMS and NHGRI program announcements (PAs). Not all these activities may be in use by NIH every year.
I would like to thank my colleagues within the NIH Office of Extramural Research’s Division of Statistical Analysis and Reporting for their work on this analysis.
Imagine this scenario. In the hustle to publish a paper, you accidently forgot to cite the underlying NIH support. Or, the opposite, you opt to include that other grant in the acknowledgements that did not have anything to do with the work. No problem, right?
Well, it could be. Accurately and precisely acknowledging NIH funding allows us to properly assess award outputs and make recommendations for future research directions. It is also a term and condition of award outlined in the NIH Grants Policy Statement. Since the Stevens Amendment passed in 1989, recipients have been required to acknowledge federal funding when publicly communicating projects or programs funded with HHS funds.
NIH relies on proper acknowledgements to link publications to awards, and reviewers rely on it to help assess award productivity. Citing awards that did not directly support the work described in a paper adds to the burden on reviewers, who must then determine which grants were actually related to the reported research. In addition, Congress and the public may use this information to better understand progress resulting from the investment in biomedical research. Improperly citing awards not directly connected to the publication (over-citing) and failing to properly acknowledge NIH-funding on publications (under-citing) may also distort the true effect of NIH funding
So how does one determine when to acknowledge NIH awards on publications? Recipients should only acknowledge NIH awards on publications and other statements when:
So, ask yourself, did the personnel activity supported by the award contribute to the publication? Did the authors consult with each other, help prepare the manuscript, conduct experiments, or analyze data reported in the paper? Is there a clear and apparent link between the work described in the publication with the aims and objectives of the grant? If so, then cite the appropriate NIH support.
In some cases, it may be difficult to identify which award(s) directly support a specific activity, especially in situations such as for large program projects with multiple components. We have FAQs on our Communicating and Acknowledging Federal Funding web page that may help, or you can also consider reaching out to NIH program staff identified on the award notice for guidance.
We hope this information will help recipients better understand when to link federal dollar amounts to projects. By precisely and accurately acknowledging NIH awards in publications, we all help to ensure proper stewardship of taxpayer funds.
Developing your application and wondering how reviewers will assess the vertebrate animal section (VAS)? If so, we encourage you to check out these two new resources, a training module and cheat sheet, which are available on the Consolidated List of Reviewer Documents webpage. The training module highlights what reviewers need to know about the information that must be included in the VAS and assists reviewers in evaluating the VAS. The cheat sheet provides an overview of the criteria required in the VAS including justifications for animal use and interventions to minimize pain, discomfort, and injury.
Want to know more about the VAS? Listen to this NIH All About Grants podcast with the Director of the Office of Laboratory Animal Welfare, Dr. Patricia Brown.
NIH has extended the deadline for your organization to respond to NIH’s Request for Information (RFI) to receive feedback on our effort to end structural racism in biomedical research through the UNITE initiative. Comments can be submitted through the submission website and must be received by 11:59 pm on Friday, April 23, 2021. Please share this information with your networks as we would like to hear from as many organizations as possible on this important effort. If you have questions about the RFI, please direct them to UNITEInitiative@nih.gov.
If you are interested in additional information, we invite you to sign-up to receive updates on the UNITE effort, including the latest news, announcements, and funding opportunities regarding this effort.
Interest in sex and gender in research—and resources to help investigators—is growing. In the 5 years since NIH enacted its pioneering Policy on Sex as a Biological Variable (SABV) (see our progress report here), there has been a lot of activity, including increased attention on sex differences and influences and many questions and requests for assistance. I’m pleased to announce the NIH Office of Research on Women’s Health (ORWH) has issued two new courses, Sex as a Biological Variable: A Primer and Bench to Bedside: Integrating Sex and Gender to Improve Human Health, to our suite of free e-learning offerings.Janine Clayton, MD, NIH Associate Director for Research on Women’s Health
Before discussing these e-learning opportunities, I would like to invite you to a related symposium where we will explore current gaps or barriers within different sectors of the biomedical research enterprise, introduce areas of scientific opportunity that the study of sex and gender presents, and underscore its impact on science and public health. Our Fifth Annual Vivian Pinn Symposium: Integrating Sex and Gender into Biomedical Research as a Path for Better Science and Innovation will be held virtually on May 11-14, 2021. Registration information can be found here. I look forward to seeing you at the symposium.
To enhance transparency, researchers should consider the potential influence of sex on the disease, condition, or phenomenon being studied, whether there is already a proven influence or not. Investigators should design research that studies both sexes whenever possible, collecting data in a way that allows for disaggregation of data by sex. Even when a study isn’t sufficiently powered to detect a sex-based difference in analysis, data can be reported separately for each sex, to facilitate meta-analyses and inform future studies.
Developed with funding support from ORWH, the NIH Office of the Director, and the National Institute of General Medical Sciences (NIGMS), one of the new e-learning courses, called the SABV primer, provides guidance for researchers seeking to enrich research by making SABV a routine part of it.
Jon R. Lorsch, Ph.D., Director of NIGMS, explains, “Despite being a central part of biology, the sex of research organisms has too often been ignored as an important variable to consider in experimental design and interpretation. NIGMS was very pleased to help support development of the SABV primer. We hope that it will allow researchers to explore the role that sex plays in a wide variety of important biological processes and disease states.”
The SABV primer consists of four independent, interactive modules designed to help the research community—including trainees and researchers at all career stages, NIH grant applicants, and those engaged in peer review—account for and appropriately integrate SABV across all phases of biomedical and biobehavioral research.
Our Bench to Bedside course helps researchers apply a sex-and-gender lens to clinical research. Developed in partnership with the Food and Drug Administration Office of Women’s Health, the course explores sex- and gender-related differences in key disease areas. The six modules provide biomedical researchers, clinicians, and students in the health professions with knowledge they can apply in designing and conducting research and/or interpreting evidence for clinical practice.
Scientific journals are making strides in the incorporation of SABV. Many have adopted the Sex and Gender Equity in Research guidelines or similar standards for the reporting of sex and gender information in study designs, analyses, and results. During her illuminating keynote address at the Specialized Centers of Research Excellence on Sex Differences Annual Meeting in December 2020, Lancet Executive Editor Jocalyn Clark, Ph.D., said that most medical journals will enter 2021 with a great appetite to see the broader effects of COVID-19, including how sex and gender play a central role.
Journalists are taking note of these changes and research findings and exploring the impact of inclusion of women in scientific research, including pregnant women and lactating women, and how sex differences and gendered behaviors can influence health and disease for everyone.
Making science work for everyone is a worthy charge.
The effects of sex at the cellular, molecular, and organism levels are so prevalent, so measurably different, and so biologically and clinically meaningful that it is an ethical responsibility to study and report them. Be a part of the movement to enhance and ingrain the use of a sex-and-gender lens in the research process. Gaining a greater understanding of sex and gender influences and applying it to your research will help you produce better science and garner new insights. You will be contributing to an expanded knowledge base. Join the more than 1,100 people who have already enrolled in this educational experience and register for ORWH’s free e-learning courses today.
For decades, NIH has collected and curated information on the schools and departments associated with the grants awarded to domestic higher education academic institutions to provide statistics on the fields contributing to advances in biomedical research. This information appears in NIH RePORTER (Figure 1), NIH Awards by Location and Organization, and other reports issued by NIH. To facilitate uniform reporting, NIH aligns the schools and department names used by institutions to standard lists of school types and department types.
Signing officials can ensure the accuracy of their institution’s assignment through tools in the eRA Commons (Figure 2). They can also edit this information for awards themselves or request manual corrections through the eRA Service Desk. To help facilitate review by signing officials, we send annual reminders towards the end of each fiscal year, such as this Guide Notice from 2020, reminding our recipients verify the accuracy of the grant assignments.Figure 2
NIH uses automated procedures to propose a school and department assignment based on information from the SF424 (R&R) grant application. The Division field is used to determine a school or major component (e.g. School of Public Health) and the Department field is used to determine the academic department.Figure 3
Our systems follow this order of operations when making school and department assignments:
If no information is available, NIH assigns either “UNIVERSITY WIDE” or “NONE” for the major component or department, respectively. Finally, the specific institution’s schools and departments are rolled up into standard reporting categories of school types and department types.