NIH Extramural Research & Funding News

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NIH Extramural Nexus
Updated: 7 hours 34 min ago

Announcement of Childcare Costs for Ruth L. Kirschstein National Research Service Award (NRSA) Supported Individual Fellows

March 2, 2021 - 11:39am

We recognize that the high cost of childcare impacts the ability of graduate students and post-doctoral fellows in many ways, including successfully completing their training and fully participating in the extramural research workforce. Pieces like these from Scientific American in 2019 and 2020, Science, and Nature Cancer as well as this recent report underscore the reality faced by some early-career researchers when balancing professional and personal responsibilities.

NIH is dedicated to fostering a well-trained and diverse biomedical research workforce, which involves supporting family-friendly policies and initiatives that balance work and family life for all biomedical researchers. Trainees and fellows supported by National Research Service Awards (NRSAs), for instance, are eligible for up to 60 calendar days (equivalent to 8 work weeks) of parental leave per year for the adoption or the birth of a child.

As part of our on-going efforts to develop programs which support family-friendly research environments for the NIH-supported workforce, NIH will begin providing an option for NRSA fellows to request support for childcare costs in new and continuation applications or as administrative supplements to existing awards effective April 8, 2021.

The NRSA childcare costs apply to full-time NIH-NRSA supported fellowship positions. Each fellow is eligible to receive $2,500 per budget period to defray childcare costs. The NRSA childcare costs are not tied to any payback obligations.

NRSA fellows are encouraged to carefully review this Guide Notice for more information, and contact relevant NIH staff with any questions if needed. Please stay tuned as related guidance is expected for NRSA supported trainees in Phase 2 of this initiative (anticipated in early fiscal year 2022).

Categories: NIH

NIH Stands Against Structural Racism in Biomedical Research

March 1, 2021 - 1:15pm

I am proud to join my NIH colleagues today in reaffirming our commitment to fostering a diverse biomedical research workforce and ending structural racism at NIH, the institutions we support, and anywhere where NIH research activities take place. Working together, we can continue identifying and dismantling any policies, practices, or other impediments that may harm our supported workforce and science.

We encourage you to join us in this effort. Please take a moment to read the statement below from the NIH Director on achieving racial equity in biomedical research and visit our new webpage, which includes more on the UNITE initiative. You are also welcome to share your thoughts and ideas to our Request for Information directly with us here.

—-

Although addressing the COVID-19 pandemic has been front and center for NIH over the past year, we have not forgotten another significant challenge confronting the health of our nation — systemic and structural racism. The events of 2020 highlighted the reality of our nation’s racial injustices that have been allowed to endure over four centuries and that significantly disadvantage the lives of so many. The time for upholding our values and taking an active stance against racism, in all its insidious forms, is long overdue.

As a science agency, we know that bringing diverse perspectives, backgrounds, and skillsets to complex scientific problems enhances scientific productivity. NIH has long supported programs to improve the diversity of the scientific workforce with the goal of harnessing the complete intellectual capital of the nation. These efforts, however, have not been sufficient. To those individuals in the biomedical research enterprise who have endured disadvantages due to structural racism, I am truly sorry. NIH is committed to instituting new ways to support diversity, equity, and inclusion, and identifying and dismantling any policies and practices that may harm our workforce and our science.

Toward that end, NIH has launched an effort to end structural racism in biomedical research through a new initiative called UNITE. The initiative has already begun to identify short-term and long-term actions to address structural racism at NIH, the institutions we support, and anywhere where NIH research activities take place, with the overall goal of ending racial inequities across the biomedical research enterprise. The UNITE initiative’s efforts are being informed by five committees with experts across all 27 NIH institutes and centers who are passionate about racial diversity, equity, and inclusion. NIH also is seeking advice and guidance from outside of the agency through the Advisory Committee to the Director (ACD), informed by the ACD Working Group on Diversity, and through a Request for Information (RFI) issued today, seeking input from the public and stakeholder organizations. The RFI is open through April 9, 2021, and responses to the RFI will be made publicly available. You can learn more about NIH’s efforts, actions, policies, and procedures via a newly launched NIH webpage on Ending Structural Racism aimed at increasing our transparency on this important issue.

We cannot underestimate the challenges before us. Identifying and dismantling racist components of a system that has been hundreds of years in the making is no easy task. This is just the beginning of an effort that has a concrete goal of achieving racial equity but has no scheduled end point. Our intention is to apply what we learn from this initiative to all future actions centered on diversity, equity, and inclusion for other groups who have been marginalized. Our resolve must be unflinching – it must not waver in the face of difficulties or tire at the magnitude of the problem. I have faith that as a people and as an enterprise, we are up to the task. We are reliable, capable, and resilient because of our many races, ethnicities, cultures, faiths, gender identities, sexual orientations, ages, abilities, talents, and backgrounds. Collectively, our diversification fuels our creativity and drives innovation.

At the most fundamental level, the NIH mission is about the respect of human life and dignity, which should permeate all aspects of our lives and work. The National Institutes of Health is also known as the National Institutes of Hope. With optimism, I invite you to join NIH in our efforts to bring health and hope to all people — because together we’re stronger.

Francis S. Collins, M.D., Ph.D.
Director, National Institutes of Health

 

Categories: NIH

Reminder: Switch Early to the New Secure Two-Factor Authentication Required to Access eRA Modules

February 24, 2021 - 1:08pm

Users of eRA Commons, ASSIST, Internet Assisted Review (IAR) and Commons Mobile are encouraged to begin their switchover to the new two-factor authentication (2FA) login method (via login.gov) required to access eRA modules before the mandatory deadline of September 15, 2021 for all users. The authentication will help ensure the security of your personal and confidential information in these systems.

Resources

Categories: NIH

Ever Wondered What Happens During the Scientific Review of an NIH Grant Application?

February 23, 2021 - 4:19pm

Understanding how peer review works is key to writing a good grant application.  In this 44-minute video, NIH Peer Review: “Live” Mock Study Section, scientists have gathered virtually to review three fictional applications in response to a fictional Request For Applications (RFA).

Watch their discussion to learn how applications are scored, what questions are commonly asked, and what mistakes to avoid in your application.

This video was originally recorded on October 28, 2020 during the 2020 NIH Virtual Seminar on Program Funding and Grants Administration. Find other presentations from the Seminar here.

Categories: NIH

All About Grants Podcast: Considerations for a Research Plan

February 22, 2021 - 1:23pm

Dr. Kentner Singleton, NIAID

Dr. Lillian Kuo, NCI

Thanks to a suggestion from a listener, in this NIH All About Grants episode (MP3 / Transcript) a duo of NIH program officers, Drs. Lillian Kuo from the National Cancer Institute and Kentner Singleton from the National Institute of Allergy and Infectious Diseases, share their advice and experience on developing a research plan for a grant application.

They discuss the relationship between the specific aims and research strategy, provide suggestions for when you sit down to start writing, and share common pitfalls. More helpful advice on writing your application is available from the NIH Grants and Funding site.

Have an idea for a future podcast? Email ExtramuralNexus@mail.nih.gov and tell us all about it. We appreciate the feedback!

Categories: NIH

Changes in the Review Criteria for Applications Submitted for NIH Support for Scientific Conferences (R13 and U13)

February 22, 2021 - 1:20pm

As we discussed in a recent Open Mike blog post, applications for conference grants now require a diversity plan. A recent Guide Notice announced that reviewers will be asked to evaluate the plan and factor it into the overall impact score.

The diversity plan will be evaluated as an additional review criterion and will not receive a separate criterion score. The new parent conference grant funding opportunity announcement, published February 10, reflects the new review criteria. Applicants are encouraged to carefully follow the instructions for developing the diversity plan.

Categories: NIH

Keeping on Top of NIH-Funded Research You Care the Most About Just Got Easier

February 16, 2021 - 12:29pm

Last fall, we launched our newly revamped RePORTER site which made it easy to find information about specific NIH supported grants, investigators, and institutions. Today, we are adding to RePORTER’s functionality with a modernized version of MyRePORTER so you can stay on top of the research you care the most about.

With MyRePORTER, you can save searches and set customized weekly email alerts that are sent when new projects are funded or new publications are linked to projects in your search. Email alerts will provide a summary listing of the new items, with hyperlinks to bring you back to MyRePORTER to get more information about the projects and publications.

Here is how it works (check out this short tutorial video too).

Users outside NIH will need a login.gov account to access MyRePORTER (Figure 1). The system will allow you to create a new account with login.gov if you do not have one, or to use your existing login.gov credentials, as you can now do with eRA systems. Of note, please clear your browser’s cache if you do not see the sign-in option on initial launch.

Figure 1

Once logged in, you can create a saved search after conducting either a Quick Search (which is new to modernized RePORTER) or an Advanced Search. A “Save” button appears on pages with search results, which opens a save window when clicked (Figure 2), allowing you to name the search, add detailed notes, and select desired email alerts. These alerts include newly funded projects, new publications, or related news.

Figure 2

Saved searches are automatically added to the MyRePORTER dashboard, found just below your email address (Figure 3). The dashboard provides intuitive access to saved searches and alert settings, allowing them to be run, monitored, edited, or deleted (Figure 4). There is no limit on the number of searches that you can create; they will all be displayed on the dashboard for easy reference. As the list of saved searches grows, the alternate table view shows the same information in a more compact form. And, for any saved searches created using the original MyRePORTER, they will automatically migrate to the modernized version if the same email address is use for both the existing MyRePORTER and login.gov accounts.

Figure 3

Figure 4

We welcome you to check out MyRePORTER today and take advantage of the many other features available via RePORTER to remain up to date on the biomedical and behavioral research NIH funds.

If you have any feedback or questions, please contact the RePORT team by email at RePORT@mail.nih.gov.

Categories: NIH

Progress Towards a Modernized ClinicalTrials.gov

February 16, 2021 - 8:13am

Guest post by Rebecca Williams, PharmD, MPH, acting director of ClinicalTrials.gov at the National Library of Medicine, National Institutes of Health. Originally released on the Musings from the Mezzanine blog

Rebecca Williams, PharmD, MPH

In 2019, NLM introduced a multi-year effort to modernize ClinicalTrials.gov, the world’s largest publicly accessible database of privately and publicly funded clinical trials. This effort was launched with a commitment to engage with and serve the millions of users who rely on this essential resource — with a focus on delivering an improved user experience on an updated platform that will accommodate growth and enhance efficiency.

In keeping with that promise, NLM has embarked on several stakeholder activities as part of the roadmap for modernization that we want to highlight in this post. We will also continue to share opportunities for involvement and invite you to join us for an upcoming webinar on February 18, 2021 at 3 pm ET to learn more about our modernization efforts.

Starting Out

Early in the process, our modernization team reached out to stakeholders through a request for information (RFI) to solicit input on topics around website functionality, information submission processes, and use of data standards. We received nearly 270 responses, which were summarized and discussed during a virtual interactive public meeting held in April 2020, and attended by nearly 400 participants. This robust feedback from the stakeholder community, along with input gathered from leaders and stakeholders across the NIH, provided the foundation to identify high-impact user-driven goals and set priorities. Currently, to advance the crucial next step of setting modernization goals and priorities, the team is working closely with NLM’s Board of Regents Public Service Working Group on ClinicalTrials.gov Modernization. Members in this group represent a range of stakeholder perspectives and provide input to ensure the continued integrity and utility of ClinicalTrials.gov.

Serving Stakeholders

Feedback received in response to last year’s RFI revealed several themes for modernizing ClinicalTrials.gov including ways to improve the management of search results, study records, and plain language information for the website, as well as enhancements to support structured and unstructured data, the quality control review process, and workflow management for information submission.

Three key external stakeholder groups were identified and consist of diverse individuals that share common interests and goals, but also have unique circumstances and needs. Feedback received from our engagement efforts, as well as the working group, reinforce the importance of being able to serve all stakeholders, including:

  1. Data providers, who are responsible for submitting, updating, and managing clinical trial registration and results information through the ClinicalTrials.gov submission system, also known as the Protocol Registration and Results System (PRS). The clinical trial information provided by this stakeholder group is listed on ClinicalTrials.gov for use by others.

2.Patients and their advocates, who find and use information about clinical trials for themselves or others through ClinicalTrials.gov.

3. Data researchers, who use clinical trial information to study the clinical research enterprise, such as detecting trends in research and gaps in medical knowledge, identifying trials for use in systematic reviews and meta-analyses, and validating reported outcome measures and study design through ClinicalTrials.gov or its application programming interface, or API.

 

We aim to ensure that:

  1. Clinical trial information is current, complete, and reliable.
  2. All users can easily find and use information about clinical trials.
  3. Clinical trial information, resources, and tools provide value to the research ecosystem.

Looking Ahead

NLM is employing a user-centered design approach to modernization. This includes user feedback loops and prototypes to elicit user input on new features in an iterative manner. A new version of the ClinicalTrials.gov website will be released first, in parallel to the current website, to obtain maximum user input. Work on the website began with extensive planning and research and has since shifted into implementation that includes building the technical foundation in a cloud-based platform; designing key elements for the homepage, search results, and study records; and testing approaches for the continuous improvement of search results. We expect to release the new website for broad user testing by Fall 2021. Work related to the PRS is in the planning and research stage, with prototype development underway.

As ClinicalTrials.gov and the PRS undergo “construction,” be assured that one of the core principles guiding NLM’s ClinicalTrials.gov modernization effort is to minimize disruption to our users while continuing to deliver improved services to maximize the value of this resource to the people who rely on it.

We are also developing continuity approaches for the PRS, management portal, and website to ensure a smooth transition to updated features. We will continue to provide stakeholders with updates and a timeline of activities as they become available.

Stay Informed and Involved

NLM is committed to keeping you informed throughout this modernization effort. We invite you to join us for an upcoming webinar on February 18, 2021 at 3 pm ET where you will receive additional updates on our modernization efforts and learn about future opportunities for you and your communities to be involved. To register, please visit the ClinicalTrials.gov webinar registration page.

 

Categories: NIH

Extensions for Early Career Scientists Whose Career Trajectories Have Been Significantly Impacted by COVID-19

February 8, 2021 - 12:48pm

The COVID-19 pandemic, along with extensive mitigation measures, has adversely affected progress in many biomedical research settings. Evidence from multiple sources, including a survey NIH issued to its supported extramural research workforce last fall, indicates legitimate concerns about career trajectory for early career scientists, including those with caretaker responsibilities. An article by Dr. Erin Gibson and her colleagues argued for a “reset” with focus on early career investigators. One point I took away from this paper is that a reset does not necessarily mean for us to go “back to normal” after the pandemic is over, because that time may have favored certain investigators and disfavored others (something I reflected on in this video and this blog).

Hearing your concerns, NIH issued a Guide Notice last week detailing our approach to support early career scientists whose career trajectories may have been significantly affected by the pandemic as funding will allow). Specifically, NIH is providing an opportunity for recipients in their last year of NIH Fellowship (“F”) and NIH Career Development (“K”) awards who have been impacted by COVID-19 to request extensions. Such extensions will be considered on a case-by-case basis, within the existing constraints of available funding. We encourage you to read the Guide Notice and, if appropriate, reach out to NIH staff as directed.

We hope these opportunities will provide some help for some of our researchers whose careers have been adversely affected by the effects of the pandemic. If you are in the last year of an F or K award, consider whether an extension would be helpful.

Categories: NIH

Help Us Understand How You Use Common Data Elements in NIH-Supported Research

February 8, 2021 - 7:42am

The  NIH Data Science Strategic plan drives us towards having accessible, well-organized, secure, and efficiently operated data resources to maximize the value of data generated from NIH funding. To meet the mark as we move forward, data need to be interoperable, interconnected, harmonized, standardized, and shared where and when appropriate. One way we hit the mark is through encouraging researchers to adopt Common Data Elements (CDEs).

CDEs foster rigor, facilitate data sharing, and allow multiple datasets to be integrated. They also help make data more FAIR (Findable, Accessible, Interoperable, and Reusable). Many different CDEs are currently in use and can vary across research disciplines, so we would encourage researchers check out databases like the NIH CDE Repository   for examples, tools, and other related resources.

Through a recently released Request for Information (NOT-LM-21-005), we seek your thoughts on how you use CDEs, potential challenges to their adoption, and how NIH might facilitate and incentivize their use to help us plan future CDE-related efforts.

Do you use CDEs? How have they benefited your work? Did you face any barriers, and how were they overcome? What resources or tools would make it easier for you to use CDEs? Can the NIH CDE Repository be enhanced? Please tell us.

We seek general feedback on CDEs regardless of the research topic or disease area. That said, we are especially interested in their use in COVID-19 research. Systematic and consistent data on study participants, for instance, could be collected across multiple COVID-19 sites with CDEs. And since CDEs allow data to be pooled, strengthen their statistical power, and facilitate reuse, we might learn more about coronavirus disease as a result.

We look forward to hearing your thoughts. Comments are being accepted electronically here until May 10, 2021.

Categories: NIH

FY 2021 Fiscal Policies for Grant Awards: Funding Levels, Salary Limits, and Stipend Levels

February 2, 2021 - 11:06am

NIH issued guidance for NIH Fiscal Operations for FY 2021 including the following policies:

  • FY 2021 Funding Levels: Non-competing continuation awards made in FY 2021 will generally be issued at the commitment level indicated on the Notice of Award.
  • Ruth L. Kirschstein National Research Service Awards (NRSA): NIH will increase NRSA stipends by approximately two percent for predocs and two percent for postdocs.
  • Next Generation Researchers Initiative Policy: NIH will prioritize meritorious R01-equivalent applications from Early Stage Investor (ESI) PD/PIs.
  • Salary Limits: Salary limit is set at $199,300.

For additional guidance and details, see NOT-OD-21-058.

Categories: NIH

Friendlier Format for Key Dates in Funding Opportunities

February 2, 2021 - 9:32am

We have begun posting research opportunities with a new, friendlier table format for the Key Dates section. The table format allows readers to easily identify the available due dates in each review and award cycle. As shown in the first row of this example (partial table pulled from the Key Dates section of PA-21-110), New applications received for the February 16, 2021 due date, Resubmission applications for the March 16, 2021 due date, and AIDS applications for the May 7, 2021 due date will all go to Scientific Merit Review in July 2021 and Advisory Council Review in August 2021. The Earliest Start Date for those applications is in December 2021.

A few important points to keep in mind when reading these tables

  • Applications are still due by 5:00 PM local time of applicant organization as indicated beneath the table.
  • Note the “as allowed” in the Renewal / Resubmission / Revision column header. Section II of each funding opportunity announcement (FOA) specifies the Application Types Allowed for that specific opportunity.
    • In our example, Section II. Award Information of PA-21-110 indicates only New and Resubmission applications are allowed. So, even though the column header includes “Renewal” and “Revision”, the dates provided in the “Renewal / Resubmission / Revision (as allowed)” column in the PA-21-110 key dates table only apply to Resubmission applications.
  • Due dates that correspond to Standard Due Dates are marked with an asterisk.
    • Some NIH policies (e.g., Continuous Submission) only apply to applications submitted on “Standard Due Dates”. Going forward, either Due Dates that state “Standard dates apply” or Due Dates in the table marked with an asterisk will both meet that criteria.
  • If a Request for Application (RFA) does NOT allow late applications, the statement “No late applications will be accepted for this Funding Opportunity Announcement” will appear beneath the table (found in due date field for FOAs that do not use the table format.)

Currently, you’ll find the new table format in new, single-project research opportunities. We hope to roll out the table format for key dates in other opportunities (e.g., training, fellowship, career development, multi-project) soon. With many FOAs remaining on the streets for several years, we can expect a mix of key dates formats in our FOAs for the foreseeable future.

Categories: NIH

Office of Laboratory Animal Welfare Webinar – 21st Century Cures Act: Update on Implementation

February 1, 2021 - 2:28pm

The NIH Office of Laboratory Animal Welfare (OLAW) will be releasing their prerecorded quarterly webinar titled “21st Century Cures Act: Update on Implementation” on March 11, 2021, featuring Drs. Patricia Brown (NIH), Betty Goldentyer (USDA), and Brianna Skinner (FDA). No registration required!

In this webinar, the speakers will provide updates on the agencies’ progress in implementing the recommended measures of the 21st Century Cures Act. The 21st Century Cures Act, Section 2034(d), directed NIH, USDA, and FDA to “complete a review of applicable regulations and policies for the care and use of laboratory animals and to make revisions, as appropriate, to reduce administrative burden on investigators while maintaining the integrity and credibility of research findings and the protection of research animals.” In response to this directive, a working group from NIH, USDA, and FDA identified regulations and policies that contribute to the administrative burden. It released a report in 2019 detailing the planned actions of the three agencies.

If you have any questions for Drs. Brown, Goldentyer, and Skinner, please submit them to olawdpe@mail.nih.gov before February 19, 2021.

Subscribe to the OLAW listserv to get the notification sent directly to your email when the webinar is published.

Categories: NIH

NIH R01 Grant Outcomes of T32 Postdoctoral Participants: Associations with Demographics, Cohort, Degree, and Career Development (K) Awards

February 1, 2021 - 12:11pm

Introduction

Postdoctoral NIH T32 programs aim to provide select trainees with experience to enable successful career and research development. Here we present data on NIH career development, or K award, and R01 equivalent research grant outcomes of participants in post-doctoral T32 programs.

Cohorts

These analyses are based on the outcomes of 35,528 T32 post-doctoral participants (including 18,671 men and 16,857 women) who matriculated between 1995 and 2009, for whom we had data on age and gender, and who had received MD, MD-PhD, or PhD degrees. We followed them for designation as principal investigator (PI) on subsequent K and R01-equivalent awards (which we’ll refer to as R01 going forward) through 2017. Table 1 shows characteristics and high-level outcomes according to matriculation cohort. Over time, a greater proportion of matriculants were women.

Among all participants, 4,299, or 12%, served as PI on an R01-equivalent award during follow-up. Among the 4,236 who served as PI on a K award, 1,769, or 42%, later supported later served as PI on an R01-equivalent award. Conversely, among the 31,292 who were not PI’s on a K award, only 2,530, or 8%, later served as PI on an R01-equivalent award.

Table 2 shows characteristics according to gender. Men appointed to T32 programs were more likely to have MD or MD-PhD degrees. A greater proportion of men submitted K and R01 applications and received K and R01 awards during follow-up.

Time to First Competing R01 Award

Figure 1 shows Kaplan-Meier event rates for time from T32 matriculation to time to serving as a PI on a first competing R01 award according to cohort. Those in the 2005-2009 cohort (meaning after the end of the NIH doubling) were less likely to eventually be a PI on an award. Figure 2 shows that recipients with MD-PhD degrees were PI’s on awarded grants at greater rates than those with PhD degrees, whereas those with MD degrees were PI’s on awards at the lowest rate. Figure 3 shows that men were supported as PI’s at a greater rate than women. Figures 4 and 5 show that for both men and women, those who matriculated into post-doctoral programs after age 35 had a lower rate of serving as PI on an R01 award.

Table 1: T32 Participant Characteristics According to Matriculation Cohort

Characteristic/Cohort 1995-1999 2000-2004 2005-2009 Total N (%) 11622 (32.7) 11768 (33.1) 12138 (34.2) Age (years) at Matriculation 30 or less 3607 (31.0) 3982 (33.8) 4298 (35.4) 31 to 35 5166 (44.5) 5181 (44.0) 5517 (45.5) 36 or more 2849 (24.5) 2605 (22.1) 2323 (19.1) Degree MD 3559 (30.6) 4161 (35.4) 4243 (35.0) MD-PhD 1327 (11.4) 1241 (10.5) 1130 (9.3) PhD 6736 (58.0) 6366 (54.1) 6765 (55.7) Gender Men 6440 (55.4) 6271 (53.3) 5960 (49.1) Women 5182 (44.6) 5497 (46.7) 6178 (50.9) Submitted K Application Yes 1898 (16.3) 2423 (20.6) 2602 (21.4) PI on K Award Yes 1313 (11.3) 1512 (12.8) 1411 (11.6) Submitted R01 Application Yes 3315 (28.5) 2932 (24.9) 2047 (16.9) PI on R01 Award Yes 1844 (15.9) 1546 (13.1) 909 (7.5)

Table 2: T32 Participant Characteristics According to Gender

Characteristic/Gender Men Women Total N (%) 18671 (52.6) 16857 (47.4) Age (years) at Matriculation 30 or less 5774 (30.9) 6113 (36.3) 31 to 35 8752 (46.9) 7112 (42.2) 36 or more 4145 (22.2) 3632 (21.5) Degree MD 6750 (36.2) 5213 (30.9) MD-PhD 2530 (13.6) 1168 (6.9) PhD 9391 (50.3) 10476 (62.1) Submitted K Application Yes 3846 (20.6) 3077 (18.3) PI on K Award Yes 2386 (12.8) 1850 (11.0) Submitted R01 Application Yes 4845 (25.9) 3449 (20.5) PI on R01 Award Yes 2662 (14.3) 1637 (9.7)

Figure 1: Time to first award according to cohort

Transition Time from First K to First R01 Award

Figure 6 shows corresponding Kaplan-Meier event rates for time from first K award to first competing R01 award according to matriculation cohort. Participants in later cohorts became PI’s on R01 awards more quickly. Figure 7 shows that those with PhD and MD-PhD degrees served as PI’s on R01 awards sooner than those with MD degrees. Figure 8 shows that men were more likely to be a PI on an R01 award sooner.

Multivariable analyses

Table 3 shows a Cox proportional hazards model for time to R01 award. The analyses show adjusted associations of age, gender, degree type, matriculation cohort, and K-award (as a time-dependent covariate) with time to award. Men, recipients with MD-PhD degrees, and recipients of K awards were more likely to become PI’s on R01 awards in less time. The model focuses on those 35,079 participants with at least 7 years of follow-up (since few R01 awards were issued earlier, leading to a violation of the proportional hazards assumption). By bootstrap validation the model performed well with an optimism-corrected concordance statistic of 0.784 (where a value of 1 would imply perfect discrimination and a value of 0.5 would imply that the model performs no better than chance).

Figure 2: Time to first award according to degree

Figure 3: Time to first award according to gender

Figure 4: Time to first award according to age among men

Figure 5: Time to first award according to age among women

Figure 6: Time to first R01 award from first K award according to cohort

Figure 7: Time to first R01 award from first K award according to degree

Figure 8: Time to first R01 award from first K award according to gender

Table 3: Cox Proportional Hazards Model for First Competing R01 Award among T32 Post-doctoral Matriculants for Those with at Least 7 Years of Follow-up

Predictor HR (univariable) HR (multivariable) Age (years) at Matriculation 30 or less – – 31 to 35 0.96 (0.89-1.03, p=0.240) 0.84 (0.78-0.91, p<0.001) 36 or more 0.49 (0.44-0.55, p<0.001) 0.46 (0.41-0.52, p<0.001) Degree MD – – MD-PhD 2.33 (2.10-2.60, p<0.001) 1.78 (1.60-1.99, p<0.001) PhD 1.34 (1.23-1.45, p<0.001) 2.05 (1.89-2.24, p<0.001) Post-Doctoral Cohort 1995-1999 – – 2000-2004 1.02 (0.95-1.11, p=0.558) 0.97 (0.90-1.05, p=0.458) 2005-2009 0.89 (0.81-0.99, p=0.025) 0.84 (0.77-0.93, p=0.001) Gender Women 0.69 (0.64-0.74, p<0.001) 0.68 (0.64-0.74, p<0.001) K Award (Time-Dependent) Yes 9.42 (8.79-10.10, p<0.001) 10.27 (9.54-11.05, p<0.001)

Summary

In these analyses of the outcomes of T32 post-doctoral trainees with MD, MD-PhD, and PhD degrees, we find that men with MD-PhD degrees had the highest rates for R01 application submission and award receipt (as PI). Women comprised a greater proportion of trainees over time. Serving as PI on a K-awards predicted a substantially higher rate of later support as PI on R01 awards.

I am grateful to my colleagues in the NIH Office of Extramural Research (OER) Division of Biomedical Research Workforce and Division of Statistical Analysis and Reporting for their help collecting these data and conducting these analyses.

Categories: NIH

Writing An Effective “K” Application: A Video Guide

January 28, 2021 - 3:32pm

Do you need some guidance on preparing a K Award application for the NIH? Dr. Kay Lund, Director of Division of Biomedical Research Workforce, gives some great tips in a 25-minute YouTube video, “Writing an Effective ‘K’ Application,” originally presented at the Fall 2020 NIH Virtual Seminar on Program Funding and Grants Administration.

” It is designed for junior investigators and those who assist in the preparation of the scientific portions of an application.

The video covers points including:

  • Currently active K award funding opportunity announcements & where to find them
  • A breakdown of the different K awards
  • Planning tips
  • Application requirements
  • Review criteria

You will also learn how to avoid the most common mistakes in writing K applications, as well as some typical misconceptions about the review process.

Categories: NIH

How Do I Submit Preliminary Data as Post-Submission Material Under the Special Exception During the COVID-19 Pandemic?

January 28, 2021 - 3:20pm

You may submit data as post-submission material under the special exception for the COVID-19 pandemic if:

  1. The timing is after submission of your grant application but before peer review.  Unless stated otherwise in the Funding Opportunity Announcement, the deadline for post-submission materials is 30 days before the review meeting.
  2. The data material is not intended to correct oversights or errors discovered after submission of the application.
  3. The Funding Opportunity Announcement (FOA) used for submission allowed preliminary data in the application. If this applies to you, see NIH Will Continue to Accept Preliminary Data as Post-Submission Material Through August/October 2021 Councils for more details, including deadlines.

For videos, please follow the directions in NOT-OD-18-093 and NOT-OD-20-061.

Remember:

  • You must demonstrate concurrence of your Authorized Organization Representative.
  • You must send the post-submission materials directly to the Scientific Review Officer who is managing the review of your application.

For step-by-step directions for all other materials, please refer to our previous post, “How Do I Submit Post-Submission Materials for My Application?

Still have questions? Please reach out to NIH for assistance.

Categories: NIH

February 15 (Monday), 2021: NIH Closed for the Federal Holiday

January 28, 2021 - 8:32am

NIH (including help desks) will be closed on Monday, February 15, 2021, for the federal holiday (Washington’s Birthday). If a grant application due date falls on a federal holiday, the application deadline is automatically extended to the next business day.

Categories: NIH

Enhancing Diversity at NIH-Funded Conferences

January 22, 2021 - 1:05pm

A recent Harvard Business Review article noted that the gap between awareness and action when it comes to gender equity is ‘gender fatigue’ – a “phenomenon of simultaneously acknowledging that gender inequality exists in general while denying that it exists in one’s immediate work environment.” And the article questions why organizations are not making more progress towards gender equity, while making recommendations to avoid the mismatch.

At NIH, we have and continue to focus not just on gender equity but on ensuring greater diversity in all aspects of the biomedical workforce. This means, that along with women, members of racial and/or ethnic minority groups, people with disabilities, and those from disadvantaged backgrounds are also included. To help ensure that the nation remains a global leader in scientific discovery and innovation, NIH needs the richness and breadth of varied perspectives that comes from having a pool of highly talented scientists from diverse backgrounds.

In that spirit, today we released a guide notice (NOT-OD-21-053)  that updates guidance for NIH R13/U13 Conference Grant applicants and recipients. These new requirements are part of a wider series of initiatives at NIH aimed at diversifying the biomedical workforce (something we frequently discuss here). You may recall, for instance, that in 2019 we expanded the definition of socio-economically disadvantaged background in our Notice of NIH Interest in Diversity (see this related blog and podcast).

Conferences’ ability to bring people together expressly to share perspectives can have a large effect. Diversity in thought, expertise, perspective, and experience add noticeable value to what is discussed at a meeting. In 2019, the NIH Director issued a bold statement announcing that he will decline to take part in speaking invitations where inclusiveness is not evident in the agenda. Too often, groups underrepresented in science are conspicuously missing in speaking slots at scientific meetings and other high-level conferences.

The new conference grant policy describes plans to enhance diversity by increasing the participation of individuals from diverse backgrounds in all aspects of the conference. Such plans will be required, as a separate attachment, for applications received beginning for the April due date (the revised FOA coming soon, see active funding opportunities here). If a plan to enhance diversity is not included, the application will not be reviewed. Applicants can also outline, in the biosketches for their key personnel, past experiences in enhancing diversity in the biomedical sciences.

We encourage conference grant applicants to consider the following points when putting together a Plan to Enhance Diversity:

  • Identify ways to increase participation from underrepresented groups throughout the entirety of the conference, including selection of organizing committees, speakers, panelists, attendees, and other participants
  • Consider the geographical area where participants will come from and expected size and composition of the conference
  • Develop strategies (with appropriate data) to monitor effectiveness
  • Highlight success at enhancing diversity at previous conferences, especially for those which reoccur

Peer reviewers will take an application’s diversity plan into consideration as part of the overall impact score (see R13/U13 reviewer guidance here). They will assess how well it demonstrates efforts to enhance diversity by increasing the participation of individuals from different backgrounds in all aspects of the conference. Reviewers will also consider experiences enhancing diversity when assessing the investigators’ suitability for organizing and fulfilling the goals of the conference. Recipients, following award, must report on their progress and outcomes implementing the plan.

Lastly, the guide notice also reminds organizers of NIH-supported research conferences are expected to maintain an inclusive, safe, and respectful work environment for all attendees (see also NOT-OD-15-152). Various effective strategies exist to prevent or mitigate harassment at conferences and applicants should explore those that are most appropriate. Examples include establishing conference codes of conduct, eliminating barriers to participation, conducting harassment climate surveys, providing resources for individuals who report incidents of harassment, be it sexual or otherwise, all the way to expelling offenders. More recommendations are available from the Advisory Committee to the NIH Director and their 2019 working group report on changing the culture to end harassment in science (see recommendations 1.7 and 3.2 as examples).

We look forward to seeing your R13/U13 application and your specific plans for incorporating diversity.

Questions? Please reach out to R13/U13 program and grants management staff at the NIH Institute or Center that best fits your research.

 

Categories: NIH

Check Out NIH’s New COVID-19 Research Website

January 19, 2021 - 12:10pm

We are pleased to announce that the new NIH COVID-19 website launched last week. The site provides a central location for trusted, up-to-date, accurate information about NIH research and our strategic role in COVID-19 research. The site complements information made available on our COVID-19: Information for NIH Applicants and Recipients of NIH Funding webpage.

The new site includes information about key programs such as the Accelerating COVID-19 Therapeutic Interventions and Vaccines public-private partnership and the Rapid Acceleration of Diagnostics initiative to develop state-of-the-science diagnostic tests for COVID-19. Users are also able to search information on funded research by state, institution, Congressional district, and more.

To support ongoing efforts to direct the public to critical information on COVID-19, the website also includes links to information on:

  • Vaccines, treatments, and testing
  • Clinical trials and how to participate
  • How to donate plasma

Resources from NIH’s Community Engagement Alliance Against COVID-19 Disparities and Federal agencies such as the Centers for Disease Control and Prevention and Department of State

Categories: NIH

What You Read in 2020

January 19, 2021 - 10:42am

Looking back on 2020 includes seeing how well we have done to capture your interest with our Open Mike blog posts.  Did we hit the mark?

Here we analyze page views on the Open Mike blog. Similar to what we did for 2018, below we show the top ten blog posts from 2020 based on overall page views pulled from Google Analytics. We issued 43 blogs last year on many different subjects. Posts on topics that are directly related to grant funding were the ones that were viewed the most.

Rank Title Page Views 1 COVID-19 Funding and Funding Opportunities 51,295 2 COVID-19 Resources for Applicants and Recipients of NIH Funding 31,076 3 Introducing the Stephen I. Katz Early Stage Investigator Research Grant Program 24,388 4 An Early Look at Applications Submitted During the Pandemic 17,591 5 New NIH Resource to Analyze COVID-19 Literature 17,100 6 Accepting Preliminary Data as Post-Submission Material and Other COVID-19 Flexibilities 13,637 7 What’s Happening with At-Risk Investigators 12,814 8 Temporary, Emergency Situations Due to COVID-19 and Application Scores Received During Peer Review 12,250 9 Institute and Center Award Rates and Funding Disparities 11,366 10 Case Study in Review Integrity: Asking for Favorable Treatment 9,809

Not surprisingly, posts about COVID-19 were heavily read. This attention extended to our coronavirus webpages too. They received record-high web traffic with more than 650,000 views over the year—with most coming early on.  since we do not know how this story is going to end, expect more on COVID-19 to come.

The workforce was also popular. Our focus on early-stage investigators, on at-risk investigators, and on workforce diversity are areas we will focus on in 2021 and beyond. We were pleased to see that one of the peer review case studies made it into the top ten. These case studies are important learning opportunities to cover the rules and integrity of the peer review process.

I would also like to thank everybody who has taken the time to share your ideas, suggestions, and concerns in the comments section. We read each one that comes in, so keep them coming. And if there are topics that you think we should be covering that we haven’t been, please let us know.

 

Categories: NIH