NIH Extramural Research & Funding News

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NIH Extramural Nexus
Updated: 18 hours 21 min ago

RCDeCade: 10 Years and Still Counting

June 12, 2018 - 12:57pm
Remember hearing those stories about how your grand-PIs had to walk five miles, in the snow, uphill, with no shoes just to learn how NIH spent its research budget? Well, believe it or not, but that was just ten years ago. Today, we have the Research, Condition, and Disease Categorization (RCDC) webtool to do this in a blink of an eye. Now, following the official release of Fiscal Year (FY) 2017 data and updated estimates for FYs 2018 and 2019 last month, we wanted to celebrate a successful decade of service.

 

With origins stemming from the NIH Reauthorization Act of 2006, and now available via NIH RePORT, RCDC is a helpful resource for investigators, advocacy groups, Congress, and the public to easily see how much NIH spends on certain research areas year by year. Since 2008, we have made regular enhancements to make the system more beneficial to all. Project listings published. Data cleansed. Quality enhanced. Disease burden information added. And, today, 285 categories reported online.

 

Consistency in RCDC is critical for accurate NIH budget reporting. To achieve this, NIH experts defined boundaries for each RCDC category—akin to a biomedical thesaurus—using an automated text mining tool. Based on the importance of a scientific concept to a category topic, a definition is agreed to by the experts, a match score calculated, and a list of projects produced. Once the experts agree, a final budget report is developed accounting for all obligated dollars in each category and the NIH Institute or Center who obligated those dollars.  It’s also important to acknowledge that the process is not perfect – there is some misclassification.  Just like with diagnostic tests, a tension exists between sensitivity (i.e. are we finding all the projects that fit into a category) and specificity (i.e. are the projects linked a certain category truly linked to that category). Want more on the categorization process? Go here.

 

Many astute RCDC users know, as additional research areas are added, the overall total reported by RCDC will also increase. If you do that now, the total is a whopping $186 billion. That number is obviously much higher than NIH’s budget. This occurs because the same project can be reported in multiple categories in one year. RCDC categories are by their nature overlapping (for example, Brain Disorders, Neuroscience, and Mental Health). Further, we cannot partially parse project funding in a meaningful and consistent way, for example, deciding that 40% of the monies went to one category, 30% went to another, and 30% went to a third.

 

Categories are also limited to those requested by Congress and Executive Branch leadership. This means that RCDC categories do not encompass all types of biomedical research. Thus, some NIH-funded projects might fall into several of the reported categories, whereas others may not be captured at all.

 

Even with those caveats, the beauty of using the RCDC method is that it gives us consistent annual reporting and the ability to see any potential trends in spending. But, how can we truly know if the RCDC coding process is consistent over time and not artificially inflating the reported amounts?

 

To answer this, we started with the publicly available RCDC topics in fiscal year (FY) 2008 that used an automated coding process. In other words, we focused on 207 of the original 215 categories available in FY 2008—the remaining eight were excluded because they were manually coded (e.g. Women’s Health and Health Disparities). We followed what happened with these topics through FY2017.

 

Let’s start with actual (nominal) appropriations to NIH. As a point of reference, since each fiscal year is compared back to it, the 2008 figures will always begin at the zero percent change mark (Figure 1). NIH’s nominal appropriations, as we know, steadily increased most years over the past decade (landing at about 12 percent higher in 2017), with the notable exception of 2013, the year of sequestration (green line).

 

We can next see that the percent change in the fraction of NIH projects assigned to the 207 categories is within 2 percent between FY 2008 and 2016 (gray line)—note, we introduced a better categorization engine in FY 2017, one that still allows for comparable observations to be made. Nevertheless, the percent change in the sum of spending in the 207 categories trends upward more strongly, when compared back to FY 2008 (orange line). The increase from 2008 to 2017 was about 35 percent more during that span of time and is a result of the increases in average project costs.

 

 

The average cost per project drove the reported increase. When looking at the percent change in average project cost (red line) as well as the Sum of the percent changes in both the average project cost and average number of projects (light blue line) in the original 207 categories, we see they both trend upward over time. Many factors may lead to this outcome, among them being the rising cost of doing biomedical and behavioral research in general.

 

What about the changes we made to the RCDC algorithms themselves? Could that also contribute to the noticeable changes in average project counts of categorized and reported funding amounts we see here? Well, yes, but the change was negligible. As mentioned earlier, the normal % change attributed to refining the categorization process was at most 2 percent each year, with the notable exception for FY 2017.

 

These findings suggest that the automated RCDC categorization does contribute to a consistent reporting process over the past decade. Most of changes seen in project funding are due instead primarily to increases in the average cost of research projects—not the algorithms.

 

When combined with other tools, these resources are a quite powerful means to assess the research enterprise. Our staff and stakeholders can trust that RCDC can help them get a quick, accurate, and consistent look into how NIH spends its funds in many different research areas. We’re excited to see where this tool will take us going forward, especially as its consistency and transparency will help us better forecast future trends in biomedical and behavioral research spending.

 

I would like to thank Rick Ikeda, Judy Riggie, and Andrei Manoli within the NIH Office of Extramural Research for their dedicated and hard work on this project.

 

 

 

Categories: NIH

If You Run Into SAM Registration Processing Delays, We’ve Got Your Back

June 8, 2018 - 10:56am

GSA now requires entities who are updating or renewing their SAM registration  to provide an original, signed and notarized letter stating that the organizational official registering the organization is the authorized administrator. The new process is slowing processing time for registrations and GSA is unable to provide estimated  processing time frames. NIH encourages applicants and recipients with existing SAM accounts to review their account information and begin the renewal process well in advance of the expiration date, to ensure all renewals are competed on time. But if you started early and the registration process isn’t complete by the application deadline, don’t fret, we recognize this could be due to reasons beyond your control.

Under normal circumstances the NIH late application policy does not allow late submissions due to failure to complete or renew required registrations. But because this is a system issue impacting all applicants and recipients across the Federal government NIH has issued a notice that makes an exception to our late application policy until the issue is resolved. If an entity has submitted all SAM renewal documentation before the application due date, but the renewal is not completed prior to the application due date, NIH will accept late applications within the two-week late window, so long as all other aspects of the application are compliant and consistent with the funding opportunity announcement requirements. Requests for accommodations beyond the two-week late window will be considered on a case-by-case basis. NOT-OD-18-188 provides further details.

Categories: NIH

New Podcast: Data Privacy, Access, and Security of the Personal Data NIH Collects on Grantees, Applicants, Investigators, and Trainees

May 31, 2018 - 3:43pm

NIH takes the security and privacy of data of people supported by NIH grants seriously. Some of this information is made public if we make an award—such as name and contact information. Other data is protected by the Privacy Act.  If you have ever wondered how NIH protects these data, then take a few minutes and listen to the discussion on a new All About Grants podcast (MP3 / Transcript).

Categories: NIH

NIH Fiscal Policies in Effect for Fiscal Year 2018

May 31, 2018 - 10:30am

NIH Guide notice NOT-OD-18-180, issued on May 16, 2018, provides NIH policy on:

  • FY 2018 Funding Levels – We are generally restoring non-competing continuation awards already made in FY 2018 and making remaining non-competing continuing grants at the commitment level indicated on the Notice of Award.
  • Ruth L. Kirschstein National Research Service Award (NRSA) Stipends – We are increasing NRSA stipends by approx 2%.
  • Next Generation Researchers Initiative Policy – We are prioritizing meritorious R01-equivalent applications from early stage investigator (ESI) principal investigators.
  • Salary Limits – Salary limits increased to $189,600 effective January 7, 2018.
  • Other Legislative Mandates – These mandates limit or condition the use of funds on NIH grant, cooperative agreement, and contract awards for FY 2018.

Read the details in the full announcement.

Categories: NIH

Register Early & Save for Fall 2018 NIH Regional Seminar in San Francisco, CA

May 30, 2018 - 2:34pm

Could you benefit from learning more about applying to NIH and our policies, processes, and resources?  Do you know colleagues, whether they be faculty, research administrators or trainees at your institution who might also benefit?  If so, then spread the word about the NIH Regional Seminar on Program Funding and Grants Administration taking place in San Francisco, California – October 17 -19, 2018.  Register by June 22 and save while Early Registration rates are still available.

The 2-day seminar offers a unique and valuable opportunity to interact with hundreds of your peers, while spending time learning the latest NIH grants policy and process information first-hand from over 65 NIH & HHS program, grants, review and policy officials. In addition to choosing from 6 concurrent sessions during the seminar, you will be able to make appointments with presenters for 15 minutes chats during a time we call, “1:1 Meet the Experts”.

If you’re looking for even more learning opportunities, consider the variety of optional pre-seminar workshops available on Wednesday, October 17 (the day prior to the seminar).  These workshops provide an in-depth look at topics, such as electronic Research Administration (eRA), human subjects research protections, intellectual property & iEdison, as well as an administrator’s boot camp.

For more information on the 2-day seminar, optional pre-seminar workshops, and special room rates, visit the conference website.  Act soon, as we often sell-out weeks before the event!

Categories: NIH

Wait…It’s Not MY Grant?

May 29, 2018 - 10:51am

Remembering back to my days as a PI, I can recall myself saying something like “yea, on my NIH grant…” when discussing my research. This may have been okay over coffee, but it is technically incorrect. We hear this confusion a lot. So, we thought it would be worthwhile to remind you about some of the respective roles of institutions and investigators working on an NIH award.

For the most part, NIH makes awards to institutions, not people. This may seem counterintuitive since the idea for the research may have come from the investigator. Why do we do it this way? The rules for all Federal awards- including uniform administrative requirements, cost principles, and audit requirements anticipate that an institution/organization carries out a Federal award as the “recipient” of the award. The institution designates individuals, including an “authorized organization representative” (AOR) the program director/principal investigator (PD/PI), to assume the responsibilities described below, in fulfilling the terms and conditions of their award. The NIH Grants Policy Statement (NIH GPS), which is a term and condition of all NIH awards, summarizes these responsibilities and the respective roles of the institutions and individuals.

Among other obligations, the applicant organization must certify, and in some cases submit assurances, that they comply with the public policy requirements provided in the NIH GPS.  These requirements are intended to ensure fairness, equity, fiscal stewardship, and other protections in activities that receive NIH support. They include measures to promote objectivity in research, civil rights protections, human subjects protections, consideration of environmental impacts, animal welfare, compliance with PHS policies on research misconduct, maintaining a drug-free workplace, prohibitions on lobbying with Federal funds, and many others. While NIH maintains oversight of our awards, we entrust our recipient organizations with the responsibility and accountability for successfully administering their grant award, including prudent fiscal management and other requirements spelled out in the NIH GPS. The NIH Welcome Wagon letter also provides a concise overview of institutional responsibilities..

NIH staff work with designated AORs for compliance matters related to the award. Also known as the Signing Official within the eRA Commons, the AORs are pivotal partners with us, as they are the persons authorized to act for the institutions. They assume the obligations imposed by Federal laws, regulations, requirements, and conditions that apply to grant applications and awards. Further, they assure the materials submitted to NIH are the original work of the PD/PI as well as certify that the institution is accountable for the appropriate use of federal funds and performance of the grant-supported project.

We rely on our recipient institutions to be responsible stewards of taxpayer funds and to ensure the same of the PD/PIs identified on an application to intellectually and logistically direct the proposed research. The qualifications of the investigators are evaluated during peer review to ensure they have the appropriate expertise and skills to serve on the leadership team and execute the project before any funding is awarded. Key among their responsibilities, consistent with those of the institution, is fostering trust and transparency in the research enterprise. Generally achieved through ethical scientific conduct as provided in the NIH GPS, the investigators foster research integrity when they uphold shared values, adhere to requirements and policies for scientific practices,  and maintain high standards of scientific rigor and transparency when proposing, conducting,  and reporting research.

The designated PD/PIs closely partner with their institutional officials to ensure appropriate responsibility and accountability for the proper conduct of research. They collaborate when creating and maintaining technical and administrative reports, preparing justifications, as well as ensuring compliance with the financial and administrative aspects of the award. Importantly, the PD/PIs must appropriately acknowledge Federal support of their research in publications, announcements, news programs, and other media, including when they or their institutions issue statements, press releases, requests for proposals, bid invitations, and other documents describing projects or programs funded in whole or in part with Federal money.

The key to success in grants management is a close working relationship between institutional officials and investigators, and communication and coordination with NIH. If an investigator has questions about their roles and responsibilities on an NIH grant, their first stop should be the sponsored programs office at their institution. If there are questions about a specific grant award, we encourage you next to reach out to the assigned NIH program official for scientific and technical questions, or the grants management staff for issues related to its business and administrative aspects.

Interested in learning more about what happens when the status of a PI changes?  See our Nexus post  on Changing the Status of a PD/PI: Clarifying the NIH Prior Approval Policy.

 

Categories: NIH

Changing the Status of a PD/PI: Reminder of the NIH Prior Approval Policy

May 29, 2018 - 9:04am

Have you wondered what happens when a program director/principal investigator (PD/PI) is no longer available to serve on an NIH grant? Maybe they have accepted a position at another institution? Or perhaps they are unable to carry out their duties for some other reason?

NIH recently issued a Guide Notice (NOT-OD-18-172) to remind the community about the NIH’s prior approval policy requirements when an institution seeks to change the status of a PI or other senior/key personnel as designated  in the Notice of  Award. This Notice also helps clarify the situations in which NIH’s prior approval is required.

NIH, for the most part, awards grants to institutions (see accompanying blog post). In the case of a PI getting a new position elsewhere, the recipient institution may seek NIH’s prior approval to relinquish the grant to the new employer, so the PI can continue to work on the project. Alternatively, the recipient institution could decide to keep the award and replace the PI with someone else who is qualified to take over the responsibilities of the original PI, as long as the NIH agrees. This is well within the rights of the recipient organization.

There are many scenarios where an institution could replace a PI or reduce a PI’s effort on an award with prior approval from NIH. Scenarios include, but are not limited to, situations where the PD/PI withdrew from the project, has been absent for at least three or more consecutive months, or the time the PI has available to dedicate to the project has reduced by 25 percent. Other scenarios may involve restrictions that the institution imposes on such individuals after the time of award, including but not limited to any restrictions on access to the institution or to the institution’s resources, or changes in the individuals’ (employment or leave) status at the institution.  In summary, prior approval is required any time there is a change in status of the PD/PI or other senior/key personnel designated on the award, where that change will impact his/her ability to carry out the approved research at the location of, and on behalf of, the recipient institution on the terms specified in the application and award.

You can learn more about the prior approval policy and requirements in the NIH Grants Policy Statement 8.1.2.6. If you have any further questions about the need for prior approval, contact the Grants Management Officer named in your Notice of Award.

 

Categories: NIH

Working with Human Subjects? New Human Subjects System Replaces NIH’s Inclusion Management System

May 21, 2018 - 4:26pm

On June 9, 2018, a new Human Subjects System will replace the Inclusion Management System (IMS) currently used for reporting participant sex/gender, race, and ethnicity information for NIH grants. The new system consolidates human subject information submitted in applications and progress reports and will be used for all human subject-related post-submission updates as of its release on June 9.

Recipients will be able to access the system through the Human Subject link that will be on both the eRA Commons Status page and in the RPPR. Investigators and signing officials will be able to make study updates or corrections (including just-in-time or off-cycle updates) through the new system.

Be prepared! Complete any in-progress enrollment records to ensure their migration to the new system. Note that if you are working on your RPPR on or before June 8, you will be unable to submit any in-progress inclusion data until the entire RPPR is submitted.  In this situation, you should plan to submit your entire RPPR by June 8 or wait until June 9 to enter your inclusion data in the new system. Records that have not been submitted by June 8, 2018 will not be available in the Human Subjects System and will need to be re-entered.

The new system also supports submission of participant-level sex/gender, race, ethnicity and age data using a CSV file to populate the Inclusion Enrollment Report.

Learn more about the transition to the Human Subjects System by reading the guide notice, checking out the website, or by watching a video or viewing other resources on our system training page.

Categories: NIH

Now Available: Delegate Tasks When Working on Interim or Final RPPRs

May 21, 2018 - 2:36pm

The interim Research Performance Progress Report (I-RPPR) and final RPPR (F-RPPR) are submitted online through eRA Commons in the same format as the annual RPPR.  We’ve often been asked if working on I-RPPR and/or F-RPPR be delegated to an Assistant (ASST) role. We are happy to announce that, yes, it is now possible to delegate working on I-RPPR and F-RPPR to anyone with the Assistant (ASST) role.

 

Read more in the eRA Items of Interest.  Want more updates on NIH electronic submission and eRA Commons straight to your mailbox? Subscribe today!

Categories: NIH

NIH Announces Stipend and Benefit Increases for National Research Service Award Recipients

May 16, 2018 - 7:44am

We are pleased to announce that stipends will be increased for those supported by Ruth L. Kirschstein National Research Service Awards (NRSAs). As a result, approximately 15,000 NRSA training grant appointees and fellows spanning career stages from undergraduates, graduate students, and postdoctoral researchers will receive a two percent stipend increase for Fiscal Year 2018. Please see the recently released NIH Guide Notice NOT-OD-18-175 for the specific new stipend levels.

Advisory groups at NIH, including those focused-on physician scientists, recommended that NIH adopt a practice of regular stipend increases. They also recognized that post-doctoral researchers on research project grants, such as those on R01 awards, for example, typically receive better benefits than postdoctoral trainees or fellows receiving NRSA support. It was also noted that inadequate benefits may deter postdocs from applying for fellowships or accepting a slot on a training grant.

In addition to the stipend increases for postdocs, NIH will support increases in Training Related Expenses provided with Institutional Training grants. Institutional Allowances awarded with fellowships will also be increased to support enhanced benefits, particularly health insurance.

To this end, we have noted recommendations from the National Academies of Sciences, Engineering, and Medicine regarding NRSA stipend increases for post-docs. We are currently reviewing these and other recommendations from their recently released report which recommends ways in which NIH may continue enhancing the future of the biomedical workforce.

Please continue to monitor the NIH Research Training website for more information as it becomes available on this and related policies.

Categories: NIH

Reach Out to NIH Staff – We’re Here to Help

May 9, 2018 - 3:25pm

We had the pleasure of interacting with over 900 applicants and grantees at last week’s NIH Regional Seminar on Program Funding and Grants Administration in Washington, DC. A recurring theme in many presentations was the importance of reaching out to NIH staff throughout the grant application and award process.

Most folks know to call the eRA Service Desk when they run into issues with ASSIST or eRA Commons. But, do you know where to go for other support? The best people to talk with about the scientific or administrative information in your particular application or award are in the NIH institute or center that may fund the grant. Our resource on Contacting Staff at the NIH institutes and Centers will help you understand the roles of NIH program officials, scientific review officers, and grants management officials, when to contact them, and where to find their contact information.

Categories: NIH

The Issue that Keeps Us Awake at Night

May 4, 2018 - 11:49am

The most important resource for the successful future of biomedical research is not buildings, instruments, or new technologies – it’s the scientists doing the work. But by now, it’s no longer news that biomedical researchers are stressed – stressed by a hypercompetitive environment that’s particularly destructive for early- and mid-career investigators. But those are the researchers who, if we don’t lose them, will comprise the next generation of leaders and visionaries. Almost 10 years ago, the National Institutes of Health (NIH) took steps to improve funding opportunities for “early stage investigators”, those who were 10 years or less from their terminal research degree or clinical training. Those steps helped, but many stakeholders have concluded that more is needed. Stakeholders include members of Congress, who included a “Next Generation Researchers’ Initiative” (NGRI) in the 2016 21st Century Cures Act. This act asked NIH to support a comprehensive study by the National Academies of Sciences, Engineering, and Medicine (NASEM) on policies affecting the next generation of researchers and to take into consideration the recommendations made in their report. The National Academy began their study in early 2017 and completed it in April 2018. The NIH has initiated steps to fund more early stage investigators to improve opportunities for stable funding among investigators who, while funded, were still beset by unstable prospects. The NIH also convened a special Advisory Committee to the Director (ACD) Working Group, focused on the Next Generation Researchers Initiative (NGRI) with members included from all career stages – from a graduate student through senior faculty.

The NASEM NGRI panel recently released a long-awaited report, “The Next Generation of Biomedical and Behavioral Sciences Researchers: Breaking Through.” The report includes a detailed summary of previous reports and their recommendations, along with a data-driven description of the biomedical research workforce “landscape.” The report offers a number of recommendations that deserve close attention. The NASEM report presents its assessment and recommendations within a multi-actor systems context: “Many stakeholders tend to hold the federal government responsible for this system, placing blame for failures at the feet of NIH, the principal funder of biomedical research. Doing so, however, obscures the important role that other organizations, particularly universities, must play in developing and implementing solutions.” We welcome the chance to work with other stakeholders to find those solutions.

The NASEM panel also calls for greater degrees of data transparency and communications from all stakeholders. It notes that “a lack of comprehensive and easily available data about the biomedical research system itself has impaired progress.”  Therefore, “biomedical research institutions should collect, analyze, and disseminate comprehensive data on outcomes, demographics, and career aspirations of biomedical pre- and postdoctoral researchers using common standards and definitions.” Last December, in a welcome development, the recently formed “Coalition for Next Generation Life Science” announced that 10 major institutions would disseminate data that would help students and early-career researchers make better-informed decisions. These data include information on admissions, enrollment, degree completion rates and time, time spent in post-doctoral research fellowships, and jobs held by former graduate students and postdoctoral researchers.

Like the NASEM NGRI committee members, the ACD Working Group on NGRI is thinking in a systems-oriented data-driven manner. The Working Group is also wrestling with the issue that keeps us awake at night – considering how to make well-informed strategic investment decisions to nurture and further diversify the biomedical research workforce in an environment filled with high-stakes opportunity costs.  If we are going to support more promising early career investigators, and if we are going to nurture meritorious, productive mid-career investigators by stabilizing their funding streams, monies will have to come from somewhere. That will likely mean some belt-tightening in other quarters, which is rarely welcomed by the those whose belts are being taken in by a notch or two.

The NIH looks forward to integrating the recommendations of the NASEM NGRI report with the preliminary recommendations of the ACD NGRI Working Group in June, and their final report in December. We pledge to do everything we can to incorporate those recommendations, along with those of the NASEM panel, in our ongoing efforts to design, test, implement, and evaluate policies that will assure the success of the next generation of talented biomedical researchers.

Categories: NIH

Open Mike Perspective: Healthy Skepticism when Focusing Solely on Surrogate Endpoints in Clinical Research

May 3, 2018 - 5:29am

I recently wrote an essay for the NIH’s Science, Health, and Public Trust series to encourage a healthy bit of skepticism about clinical studies that solely involve surrogate end-points (e.g. changes in “biomarkers” like blood cholesterol levels or findings on an electrocardiogram).

To make my point, I described experiences with a well-known cardiovascular trial — one that focused on the risk of sudden death among heart attack survivors. I encourage readers in this essay to not just assume that treating a surrogate endpoint will automatically treat the underlying condition. Sometimes it does.  But sometimes it may not and may even cause more harm than good.

As I mention in the essay, one way to deal with this problem is to conduct more trials that focus on clinical endpoints. We should consider conducting them in innovative, efficient, cost-effective wayssuch as using pre-existing large-scale databases or “registries. I am open to hearing other thoughts and approaches which have the potential to address this challenge.

The NIH’s Science, Health, and Public Trust series is intended to provide perspectives, tools, and resources to improve the quality and usefulness of information about science and health for the public. It seeks to share strategies and best practices that might contribute to public understanding of the nature of biomedical research and its role in health.

Categories: NIH

Looking for a NIH Program Official in Your Research Area?

April 16, 2018 - 12:03pm

For years researchers have used the Matchmaker feature in NIH RePORTER to identify NIH-funded projects similar to their supplied abstracts, research bios, or other scientific text. Matchmaker was recently enhanced to make it just as easy to identify NIH program officials whose portfolios include projects in your research area.

After entering your scientific text (up to 15,000 characters), Matchmaker will analyze the key terms and concepts to identify up to 500 similar projects. Those projects will continue to show on the Projects tab with handy charts to visualize the results and quickly filter identified projects by Institute/Center, Activity Code, and Study Section. A new Program Official tab identifies the program officials associated with the matched projects and includes its own filters for Institute/Center and Activity Code. From the list of program officials you are one click away from their contact information and matched projects in their portfolios. Never before has it been so easy to answer the question “Who at NIH can I talk to about my research?”

Categories: NIH

“Cover Letters and their Appropriate Use” Podcast Now Available

April 16, 2018 - 11:52am

Ever wonder what you should and shouldn’t put in a grant application cover letter? Dr. Cathleen Cooper, director of the Division of Receipt and Referral in NIH’s Center for Scientific Review, explains just that in the latest addition to our “All About Grants”  podcast series – “Cover Letters and Their Appropriate Use” (MP3, Transcript).

All About Grants podcast episodes are produced by the NIH Office of Extramural Research, and designed for investigators, fellows, students, research administrators, and others just curious about the application and award process. The podcast features NIH staff members who talk about the ins and outs of NIH funding, and provide insights on grant topics from those who live and breathe the information. Listen to more episodes via the All About Grants podcast pagethrough iTunes, or by using our RSS feed in your podcast app of choice.

Categories: NIH

Impact of Teams Receiving NIH Funding

April 4, 2018 - 12:31pm

Almost 11 years ago, Stefan Wuchty, Benjamin Jones, and Brian Uzzi (all of Northwestern University) published an article in Science on “The Increasing Dominance of Team in Production of Knowledge.”  They analyzed nearly 20 million papers published over 5 decades and 2.1 million patents and found that across all fields the number of authors per paper (or patent) steadily increased, that teams were coming to dominate individual efforts, and that teams produced more highly cited research.

In a Science review paper published a few weeks ago, Santo Fortunato and colleagues offered an overview of the “Science of Science.”  One of their key messages was that “Research is shifting to teams, so engaging in collaboration is beneficial.”

I thought it would be worth exploring this concept further using NIH grants. For this post, data were acquired using a specific NIH portfolio analysis tool called iSearch. This platform prvides easy access to carefully curated, extensively-linked datasets of global grants, patents, publications, clinical trials, and approved drugs.

One way of measuring team size is to count the number of co-authors on published papers. Figure 1 shows box-and-whisker plots of author counts for 1,799,830 NIH-supported papers published between 1995 and 2017.  The black diamonds represent the means.  We can see from these data that the author counts on publications resulting from NIH support have steadily increased over time (mean from 4.2 to 7.4, median from 4 to 6).

Figure 2 shows corresponding data for 765,851 papers that were supported only with research (R) grants. In other words, none cited receiving support from program project (P), cooperative agreement (U), career development (K), training (T), or fellowship (F) awards.   We see a similar pattern in which author counts have increased over time (mean from 4.0 to 6.2, median from 4 to 5).  Also, of note is a drifting of the mean away from the median, reflecting an increasingly skewed distribution driven by a subset of papers with large numbers of authors.

Next, let’s look at corresponding data for papers that received support from at least one P grant (N=498,790) or at least one U grant (N=216,600) in Figures 3 and 4 respectively. As we can see, there are similar patterns emerging that were seen for R awards.

Figure 5 focuses on 277,330 R, P, or U-supported papers published between 2015 and 2017 and shows author counts for papers supported on R grants only (49%), P grants only (11%), U grants only (8%), R and P grants (16%), R and U grants (7%), and P and U grants (9%).  The patterns are not surprising – author counts are higher for papers supported by P and U grants—likely as these are large multi-factorial activities inherently involving many researchers—but even for R grant papers the clear majority involve multiple authors.

Finally, in Figure 6 we show a scatter plot (with generalized additive model smoother) of relative citation ratio (RCR) according author count for NIH-supported papers published in 2010. As a reminder, RCR is a metric that uses citation rates to measure influence at the article level. Consistent with previous literature, an increased author count is associated with higher citation influence – in other words, the more authors on a paper, then the more likely it is to be influential in its field.

Summarizing these findings:

  • Consistent with prior literature, we see that NIH-funded extramural research, including research funded by R grants, produce mostly multi-author papers, with increasing numbers of authors per paper over time.  These findings are consistent with the growing importance of team science.
  • Mechanisms designed to promote larger-scale team science (mainly P and U grants) generate papers with greater numbers of authors.
  • There is an association by which greater numbers of authors are associated with greater citation influence.

It is important to understand that, even in this competitive funding environment, research is shifting to teams. And when we look more closely at the impact of the shift, we see that collaboration is proving to move science forward in important ways. How big should teams be? Some recent literature suggests that small teams are more likely than large teams to produce disruptive papers. A few years ago, my colleagues published a paper on the NIH-funded research workforce; they found that the average team size was 6. Is this optimal? We don’t know.

There is much more for us to look at in terms of the role of team science in NIH supported research. In the meantime, it’s great to see more confirmation that scientific collaboration is truly beneficial to moving science forward.

Categories: NIH

Do Reviewers Read References? And If So, Does It Impact Their Scores?

March 30, 2018 - 9:33am

In March 2017, we wrote about federal funders’ policies on interim research products, including preprints. We encouraged applicants and awardees include citations to preprints in their grant applications and progress reports. Some of your feedback pointed to the potential impact of this new policy on the peer review process.

Some issues will take a while to explore as preprints become more prevalent. But some we can dig into immediately. For example, how do references cited in an application impact review?  To start to address this question, we considered another one as well: do peer reviewers look at references – either those cited by applicants or others – while evaluating an application?  We had heard anecdotes, ranging from “Yes, I always do,” to “No, I don’t need to,’ but we didn’t have data one way or the other. And if reviewers do check references, how does it impact their understanding and scoring of an application?

So, together with colleagues from the NIH Center for Scientific Review (CSR), we reached out to 1,000 randomly selected CSR reviewers who handled applications for the January 1, 2018 Council Round. There were an equal number of chartered (i.e. permanent) and temporary reviewers solicited to participate (n=500 each) over a three week period from November 16 to December 8, 2017.

Our survey focused on the last grant where they served as primary reviewer. Specifically, we asked if they looked up any references that were either included in the application (i.e. internal references), and if they also looked up any that were not included in the application (i.e. external references). Depending on their answers to each of these questions, we also proceeded to ask certain respondents follow-up questions to better understand their initial feedback. We felt it would be interesting to know, for example, how reading the paper or abstract impacted their understanding of the application and their score.

We received 615 responses (62% of total), including 306 chartered members and 309 temporary members.  Figure 1 shows the responses related to if they looked up references, either internal or external to the application.  Most reviewers answered yes – particularly for internal references.

Figure 2 goes a bit deeper – as a secondary question, we asked whether the references affected reviewers’ understanding of the applications.  The clear majority said yes. Figure 4, shows that most reviewers (~85%) found the references improved their understanding.

Next, we learned that of those reviewers that checked references, about 2/3 reported that the references affected their scoring for the application (Figure 3). References reviewers found on their own (external references) seemed slightly more influential.  Figure 4 shows references could impact the score in either direction.  References cited in the application were slightly more likely to improve scores than worsen them, and external references were slightly more likely to make scores worse than improve them.

Nearly half of the respondents even provided additional comments for us to consider.  Here is a sampling of their thoughts:

  • “References are of immense value.”
  •  “I look up references to judge the quality of the [principal investigator’s] work in relation to the rest of the field, to learn about the field in general, and to delve into specific questions that might be key to evaluation of the application.  This could result in changes to the score in either direction.”
  • “References are useful and sometimes critical.”

This experience was very enlightening. We were pleased to learn that most reviewers do look up references as part of their work in the peer review process, but preprints, at least for now, are too rarely cited in applications to have a clear impact. Further, both chartered and temporary reviewers shared similar perspectives on looking up references, which they noted often affects their understanding of the applications and resulting scores. Finally, they indicated that references internal to applications often lead to reviewers’ improving their scores.  We may need to revisit this survey as preprints and other interim products become more common.

Overall, this survey demonstrates, yet again, the time and care NIH reviewers spend on applications. They work hard for all of us-  NIH, applicants and the American public, and I am personally grateful to all of them.

I would like to acknowledge Neil Thakur with the NIH Office of extramural research as well as Mary Ann Guadagno, Leo Wu, Huong Tran, Cheng Zhang, Lin Yang, Chuck Dumais, and Richard Nakamura with the NIH Center for Scientific Review for their work on this project.

Categories: NIH

Celebrating Women’s History Month: Scientist Spotlight

March 27, 2018 - 8:07am

Women’s History Month quiz question (and no “Googling” allowed): Who was Joan Procter?

I didn’t know either until a few months ago when I learned that my colleague, Dr. Patricia Valdez, wrote a children’s book, called “Joan Procter, Dragon Doctor.”  Alfred A Knopf published Patricia’s and her illustrator Felicita Sala’s book a few weeks ago, on March 13, 2018.  Critics have already acclaimed the work: Publisher’s Weekly in a starred review wrote, “Valdez paints a portrait of a unique woman whose love for reptiles developed into a gratifying career.”

So, who was Joan Procter?  She was born in London in 1897 and had a rather unusual childhood.  By age 10 she had developed a fascination for reptiles – she read voraciously about them and kept a pet lizard.  At age 16 she brought a pet crocodile to school.  And when she was ready to graduate high school, she worked for Dr. George Boulenger, a curator at the British Museum.  Intestinal ailments prevented her from going to college, but fortunately Dr. Boulenger recognized her dedication and genius, taking her under his wing.

Procter presented her first scientific paper by age 19 (later published as Procter JB, On the variations of the pit viper Lachesis atria.  Proc Zool Soc London 1918:163-182), and in her early 20s she took over as curator when Dr. Boulenger retired.  Later she became reptile curator at the London Zoo, where she oversaw the building of a new reptile house and conducted internationally recognized scientific work on reptile and amphibian taxonomy.  She developed many innovative veterinary procedures.

Perhaps she is best known for her work with two Komodo Dragons — Sumba and Sumbawa, the first live dragons to come to a European zoo.  She demonstrated that in many respects these “fierce lizards” could be quite gentle; she was famous for taking Sumbawa to tea parties with children, to scientific conferences, and on walks around the zoo, steering him with his tail.

Sadly, Procter died at age 34 of her intestinal ailments.  Shortly before she passed away, the University of Chicago granted her an honorary Doctor of Science.

I thoroughly enjoyed Patricia’s book – and I already know of a number of children and parents in my neighborhood who have too. This book is the first of what may well be a series by Dr. Valdez highlighting the achievements of female scientists. I certainly hope the follow-on books come to fruition. We can all benefit from hearing these stories, and inspiring our children to fulfill their dreams.

Categories: NIH

Make Your Voice Heard! We want Your Ideas to Reduce Administrative Burden in Research with Laboratory Animals

March 15, 2018 - 8:27am

NIH has, for many years, been concerned about the increasing burden of applying for, reporting on, and the costs faced by researchers when complying with requirements on  federally-funded research grants— so much so that it is even called out in our strategic plan as an area to address. Today, as we continue to implement the 21st Century Cures Act, NIH is requesting public feedback on some proposed approaches to reduce administrative burden on investigators use of laboratory animals in biomedical research (NOT-OD-18-152 and Federal Register Notice 2018-05173). Together with our colleagues at the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA), we are looking for constructive and thoughtful feedback on this topic from individuals, research institutions, professional societies, animal advocacy organizations, and other interested parties. Input will be accepted electronically during a 90-day comment period, that is until June 12, 2018.

Through your participation, we hope to gain insights into how we can best improve the coordination and harmonization of regulations and policies with respect to research with laboratory animals. This call will help shed further light on where the community feels that regulations and policies are inconsistent, overlapping, or unnecessarily duplicative.

Using animals in research is critical to scientific understanding of biomedical systems leading to useful drugs, therapies, and cures. It is important to note that, even as we strive to identify ways to reduce administrative burden on our supported investigators, we simultaneously aim to maintain the highest standards of integrity and credibility within the biomedical research enterprise. This further extends to NIH continuing to ensure the greatest commitment to the welfare of laboratory animals involved in our supported research endeavors.

As part of examining existing regulations, staff within the NIH, USDA, and FDA have conducted listening sessions on the topic and diligently reviewed published materials aimed at reducing burden faced by investigators within the research community. Such resources span findings from a workshop held last April, National Academies of Science recommendations from 2016, the National Science Board’s considerations from 2014, and a survey about faculty workload published in 2012.

Ideas have been collected and analyzed for their relationship to existing statutes, regulations, and policies, as potential approaches to implement in support of the 21st Century Cures Act requirements to reduce regulatory burden on investigators in their use of animals. Some examples include:

  • Allow investigators to submit protocols for Institutional Animal Care and Use Committee continuing review using a risk-based methodology.
  • Allow institutional annual reporting to the NIH Office of Laboratory Animal Welfare (OLAW) and USDA on the same reporting schedule and as a single report through a shared portal.
  • Harmonize the guidance from NIH and USDA to reduce duplicative considerations of alternatives to painful and distressful procedures.
  • Provide a minimum 60-day comment period for new OLAW policy guidance.

We hope to hear from you during this process. Insights from the community are critical to helping us refine and ensure the final recommendations and implementation plans are appropriate to reducing administrative burden while maintaining our long-standing commitment to the humane care and use of animals in research.

Categories: NIH

Principal Investigators, Delegate!

March 12, 2018 - 1:26pm

Did you know that the eRA Commons allows principal investigators the ability to grant permission to have others at their institution help with some grants administration tasks?  You might want to consider whether delegating any or all of the following tasks is right for you:

All you need is another Commons user with the right role. Learn how!

Categories: NIH