Nexus August 2017

Open Mike

NIH’s Next Generation Researchers Policy Now Posted

Today we posted a policy (NIH Guide Notice NOT-OD-17-101) describing current plans for the Next Generation Researchers Initiative.  Since I first blogged about it in June, NIH leadership have reviewed data (see accompanying blog) and deliberated about how best to proceed.  Our goal is to increase the number of NIH-funded early-stage investigators and assure, as best we can, that funded early-stage investigators have a reasonable chance to secure stable funding during the earliest stages of their independent research careers. This new policy will supersede previous notices on new and early stage investigators (NOT-OD-08-121, NOT-OD-09-013 and NOT-OD-09-134).

The Initiative comes against a backdrop of worsening hyper competition that has led to severe challenges for biomedical scientists early in their career. We understand that these researchers worry external link icon about “desperate pursuit of grants,” reduced time for research, dependence on senior scientists, taking on ambitious avenues, and administrative reporting burdens.

The Next Generation Researchers Initiative represents in part implementation of the Section 2021 of the 21st Century Cures Act. The Act states, “The Director of the National Institutes of Health shall … develop, modify, or prioritize policies, as needed … to promote opportunities for new researchers and earlier research independence, such as policies to increase opportunities for new researchers to receive funding, enhance training and mentorship programs for researchers, and enhance workforce diversity.” The Initiative is also consonant with our responsibility to be proper stewards of public funds in alignment with goals set forth in NIH’s Strategic Plan for Fiscal Years 2016-2020.

As described in the policy, NIH institutes and centers (ICs) will prioritize meritorious applications that request funding for Early Stage Investigators (ESIs) and for Early Established Investigators (EEIs) who are at risk for losing all NIH funding or who have only one active NIH award. Here are some key definitions:

  • Early Stage Investigator (ESI): A Program Director / Principal Investigator (PD/PI) who has completed their terminal research degree or end of post-graduate clinical training, whichever date is later, within the past 10 years. Furthermore, these applicants would not have competed successfully as a PD/PI previously for a substantial NIH independent research award. A list of NIH grants that a PD/PI can hold and still be considered an ESI can be found at https://grants.nih.gov/policy/early-investigators/list-smaller-grants.htm.
  • Early Established Investigator (EEI): a PD/PI within 10 years of receiving their first substantial, independent competing NIH R01 equivalent research award as an ESI.

As we implement and monitor the Initiative, the NIH Office of the Director and the ICs will, in consultation with a Working Group of the Advisory Committee to the Director, consider evidence-based strategies to identify, grow, and retain ESIs and EEIs. Effective strategies will likely consider factors such as emerging areas of scientific inquiry, needs of the IC portfolios, and projected needs of the scientific workforce.

We have heard many questions about investigators who are new to NIH, but who are at stages in their career that make them ineligible for ESI or EEI status. In keeping with the 21st Century Cures Act’s call for “earlier research independence,” our focus in this Initiative will be to enhance funding opportunities for ESI’s and EEI’s.  We anticipate that individual ICs will seek to fund other more senior investigators who are new to the NIH system through specific programs as well as select pay.

We recommend that you confirm your dates of terminal degree and post-graduate clinical training is correct in eRA Commons. This will help ensure we can apply your eligibility appropriately to receive funding consideration under the policy. On a case by case basis, NIH will consider requests to extend the ESI or EEI period if you experienced a lapse in your research or research training (e.g. medical concerns, disability, family care responsibilities, extended periods of clinical training, natural disasters, or active duty military service).

We invite you to visit the Next Generation Researchers Initiative web page for more information. We appreciate hearing your ongoing feedback as we implement and develop this mission-critical Initiative.

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Data On Trends According to Career Stage

By the 21st Century Cures Act, the Next Generation Researchers’ Initiative calls on the NIH to develop policies to increase funding opportunities for new researchers seeking to secure early independence. To put the Initiative in perspective and to extend on previous blogs we’ve posted on changing demographics in NIH-funded researchers, we thought it would be useful to explore trends according to career stage.

First, some definitions.  We define “Early Stage Investigators” (ESI) as those who are within 10 years of completing their terminal degree or post-graduate clinical training and who have not yet secured independence as a PI of a substantial NIH research award.  We define “New Investigators (Not ESI)” as those who have not yet secured independence as a PI of a substantial NIH research award but are more than 10 years from completing their terminal degree or clinical training.  We define “Early Established Investigators” as those who are within 10 years of receiving their first substantial NIH award and who received their first substantial NIH award as an ESI.  Finally, we define “Established Investigators” as all others.

Second, for the most part we will focus on competing R01-equivalent applications and awards – these include R01, R23, R29, R37 and RF1 activity codes.

In 2016, NIH received competing R01-equivalent applications from 24,498 unique applicants: these included 3,729 Early Stage Investigators (15%), 4,813 New Investigators who were not ESIs (20%), 3,461 Early Established Investigators (14%), and 12,495 Established Investigators (51%). Figure 1 shows box plots for age distribution by career stage. Age increases as we move from Early Stage Investigators to Early Established Investigators to New Investigators (Not ESI) to Established Investigators. The age distributions are not particularly skewed, as the means approximate medians in all groups.

box plots for age distribution by career stage. Age increases as we move from Early Stage Investigators to Early Established Investigators to New Investigators (Not ESI) to Established Investigators. The age distributions are not particularly skewed, as the means approximate medians in all groups.

Figure 1

Figure 2 shows the number of unique R01-equivalent applicants each year by career stage for each fiscal year since 1995; Figure 3 shows the same data by proportions.  Over time, the proportions of older investigators (New Investigators who were not ESIs and Established Investigators) increased, while the proportions of younger investigators (ESIs and Early Established Investigators) declined. (Note: in 2007, NIH introduced the “New Innovator” DP2 awards, and DP2s were not considered part of the R01-equivalent definition for considering ESI status until 2008. For this reason, there is a notable spike in the number and percent of ESI applicants in 2007, and a proportional decrease in the percentage of established investigators applying for R01-equivalents in 2007.)

number of unique R01-equivalent applicants each year by career stage for each fiscal year since 1995

Figure 2

unique R01-equivalent applicants each year by career stage for each fiscal year since 1995, as proportions

Figure 3

Figures 4 and 5 show analogous data for awardees. The proportion of awardees who were Established Investigators climbed, while there was a marked decrease in the proportion of awardees who were Early Established Investigators.

number of unique R01-equivalent awardees each year by career stage for each fiscal year since 1995

Figure 4

unique R01-equivalent awardees each year by career stage for each fiscal year since 1995, by proportion

Figure 5

Figure 6 shows funding rates by career stage. The funding rate in any given fiscal year is the ratio of unique awardees to unique applicants. Funding rates increased substantially during the doubling (1998-2003) for all career stages, but less so for Early Stage Investigators. Funding rates for all career stages decreased dramatically after the NIH doubling ended in 2003. There were declines in 2013 – the year of sequestration – which were particularly severe for Early Stage Investigators.

funding rates by career stage. The funding rate in any given fiscal year is the ratio of unique awardees to unique applicants. Funding rates increased substantially during the doubling (1998-2003) for all career stages, but less so for Early Stage Investigators. Funding rates for all career stages decreased dramatically after the NIH doubling ended in 2003. There were declines in 2013 – the year of sequestration – which were particularly severe for Early Stage Investigators.

Figure 6

One reason why investigators may leave the NIH grant system is that they are unable to withstand a failed application if they don’t have other active awards to fall back on.  Figure 7 shows the average number of active substantial awards, according to career stage. As expected, Early Stage Investigators and New Investigators who are not ESIs do not have many active awards. Established Investigators have more active awards and this has increased somewhat over time. Thus, Established Investigators may have an easier time staying in the system.

average number of active substantial awards, according to career stage

Figure 7

Established Investigators not only make up a greater proportion of awardees (Figure 5), they also secure, to an even greater extent, a larger proportion of competing award dollars (Figure 8).

proportion of competing award dollars by career stage

Figure 8

Finally, Figure 9 shows the percent of all first-time R01-equivalent awardees who go on to receive at least one more second substantial award within 5 years. For those he received their first award in 1996, over 55% went received at least one substantial award. For first-time awardees in 2011 that value fell to only 38% (and this even accounts for ARRA and the multi-PI policy).

percent of all first-time R01-equivalent awardees who go on to receive at least one more second substantial award within 5 years

Figure 9

In summary, consistent with changes in demographics, we have seen substantial changes in the career stage composition of R01-equivalent applicants and awardees.  As the Next Generation Researchers’ Initiative will focus on increasing funding for Early Stage Investigators and Early Established Investigators, we may see some turning of the curves.

Many thanks to the Statistical Analysis and Reporting Branch of the NIH Office of Extramural Research for their work on this analysis.

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Monitoring the Impact of Hurricane Harvey on Research

The devastating effects of Hurricane Harvey cause deep concern about the health and safety of people and animals, and about the health of the biomedical enterprise in the affected areas. While everyone’s immediate efforts need to be focused on getting through this immediate crisis, we want to assure our applicant and grantee community that NIH will be doing our part to help you ensure your research continues. We issued a Guide notice reminding the community about our natural disaster policy, Reminder: NIH Natural Disaster Policy – Hurricane Harvey. To give you an idea of the ways NIH can help in these situations, our website on Extramural Response to Natural Disasters has a list of available resources, including guidance on animal welfare issues.

A recent National Academies studyexternal link icon, supported in part by NIH, highlighted the importance of the research community working together to build resilience in the face of natural disasters. These recent events underscore their recommendationsexternal link icon to work together to continue this dialog.

Following Hurricane Katrina and Hurricane Sandy, we issued supplemental funding due to the severity and devastating effect of these storms. For major disasters such as these impacting many institutions, NIH coordinates with other Federal agencies (such as HHS, FEMA and OMB), as well as with state, local, and institutional representatives, to develop any additional response.  We consider issues as whether a Federal Disaster is declared; the severity of damage inflicted; the length of time needed for the institutions to recover; the impact on investigators, human research participants, and animal subjects, and the overall impact on the community. We will be continuing to monitor the situation closely, identifying ways we can help as outlined on this page and we will publish additional information in the NIH Guide.

Our thoughts are with all of you affected by this crisis.

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4 Questions For Researchers and Institutions Involved In Human Subjects Research

Last September, and in January of this year, we wrote about a suite of initiatives aimed at improving the quality and transparency of the NIH-supported research that most directly engages human participants – clinical trials. These initiatives include dedicated funding opportunity announcements for clinical trials, Good Clinical Practice training, enhanced registration and results reporting on ClinicalTrials.gov, and required use of single IRBs for multi-site studies. We are now entering the final phases of implementation of these initiatives – so, if you are contemplating research involving human subjects, please read on.

We’ve received queries from members of the research community seeking clarity on whether their human subjects research will be affected by these new policies, and if so, how. So, we want to call your attention to four questions researchers involved in human s studies need to ask, and answer. These questions are:

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

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

The NIH definition of a clinical trial is “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes”. The definition was published in 2014, after extensive public input, and affirmed, after even more public input, in our policy published in September 2016. The clinical trial definition encompasses a wide variety of study types, as shown in figure 1. These range from mechanistic studies to behavioral studies, to pilot/feasibility studies, all the way to large-scale efficacy and effectiveness trials.

Diagram showing that NIH clinical trials span a wide range of studies: mechanistic, exploratory/development, pilot/feasibility, other interventional, behavioral.

Figure 1

The breadth of the NIH definition is intentional, given the nature of the NIH portfolio and imperatives for maximal transparency. Transparency shows respect for the participants who put their trust in us, in the face of unknown outcomes, to help advance science. Our concerns about transparency stem in part from the issues surrounding the reporting of clinical trials data. For both NIH-funded and non-NIH funded trials, unreported data and untimely dissemination of results has been documented over and over again.  Others have expressed concern that the NIH has not collected needed trans-NIH data to enable it to function as proper stewards of clinical trials.

Some have argued that we should not expect trial registration and reporting for small or exploratory trials, for trials that focus on safety, or for trials that fail to meet enrollment targets. As we stated last September, NIH chose to emphasize the value of transparency for these kinds of trials as well, as “the benefits of transparency and the need to fulfill the ethical obligation to participants is as relevant to these types of trials as to any other type.”  We have an ethical obligation to report results, and this is especially true when volunteers contribute their time as study participants in prospective experiments, whether large or small. And, to be effective stewards of precious and constrained taxpayer monies, we need to collect a minimum of standardized data.

This transparency complements existing efforts to promote data sharing, public access to NIH-funded research results, and scientifically rigorous research design, all of which ultimately benefit the research community directly, as well. By developing and sharing robust data, we maximize the value of NIH’s investment in research by allowing scientists to build upon solid results. The definition, and our clinical trial policies, are an integral part of our efforts to enhance scientific stewardship, dissemination of information, transparency, and to excel as a federal science agency that manages for results.

Why is it important to know whether you are proposing to conduct a clinical trial? Correctly identifying whether your study is a clinical trial is crucial to complying with NIH policies, many of which are now in effect,  such as registering and reporting all NIH supported clinical trials in ClinicalTrials.gov and good clinical practice training. Very soon, your answer will be crucial to picking the appropriate NIH funding opportunity for your application, writing your research plan correctly (since some information will be captured in the new human subjects and clinical trials form), and ensuring that your application includes all the information required for peer review.

If you are having difficulty answering the four questions that determine whether a study meets the NIH definition of a clinical trial, we encourage you to consult the case studies and FAQs that are available on our webpage on clinical trial requirements for grants and contracts. We’ll be following up with additional blogs and NIH Extramural Nexus articles that provide more depth on the various initiatives. We strongly encourage you to look at these materials, and share them with your colleagues, to ensure that as an awardee conducting clinical trial research, you are aware of the need to register your trial and report its results.

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Top Stories

Next Generation Researcher Policy Announcement – Coming Soon

In June, NIH announced plans for a new initiative to provide additional support to the next generation of researchers. We will be announcing policy details this month. Stay tuned to the notices published in the NIH Guide for Grants and Contracts. We will also include an announcement here on the NIH Extramural Nexus & Open Mike blog site, when the policy is published.

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Grants Administration & Policy Workshops That Will Have You Asking…”Why Didn’t I Attend Sooner?”

Update: The two day seminar has reached capacity today. However, the following workshops are still available to attend without seminar registration: Human Research Reviews: Mastering the ProcessIntellectual Property – Understanding Requirements and Recipient Responsibilities, and Intellectual Property – A Hands-on Demonstration of iEdison. Further details below.

To register for one of the available workshops above, please email conferences@rippleeffect.com.

Thank you for your interest! – NIH Regional Seminar Staff, August 15, 2017

By now, you’ve hopefully heard about the upcoming NIH Regional Seminar on Program Funding and Grants Administration, October 26 & 27, 2017 in Baltimore, Maryland. (If you’re not familiar this event, see what was said about our 2017 spring seminar in this Open Mike blog post and an article on the Top 5 Reasons to Attend an NIH Regional Seminar.)

Did you know that on the day before the two-day seminar, NIH also offers a variety of optional workshops that will help you delve deeper into specific topic areas? On Wednesday, October 25, 2017, you have the opportunity to participate in one or more of the following workshops:

  • Human Research Reviews: Mastering the Process –  Staff from the Department of Health and Human Services Office of Human Research Protections and NIH will provide you with the information necessary to help you get NIH grant applications and research protocols through the review process. In this full day workshop, experts will focus on providing participants with practical tips and solutions to problems and difficulties commonly encountered during such reviews.  Note: This workshop does not require participation in the 2-day seminar.
  • Administrator’s Boot Camp This introductory level, hands-on workshop for research administrators is designed for those new to applying to NIH. NIH staff will provide in-depth information on the basics of the pre-award process — highlighting key activities, timelines, considerations, and resources. Starting from the very beginning of the pre-award process through the time of award, topics will include registration, identifying funding opportunities, using the application guides, and understanding the Notice of Award.
  • eRA Workshops (2 options):  
    • Grant Application Preparation & Submission: Are you new to the NIH grant application process or overwhelmed by the logistics of submitting a grant application to NIH? Then this NIH eRA Workshop is for you. We will guide the novice user through all the steps in the application submission process from preparing to apply to verifying your application hasbeen successfully received at NIH.
    • eRA Commons Account Administration & Post-Submission Processing: Have you recently started a new position or been given an eRA Commons account and you don’t know what to do with it?  Then this NIH eRA workshop is for you. In this interactive session, we will guide the novice user through key aspects of account administration, maintaining profiles, and post-submission processing in eRA Commons.
  • Intellectual Property – Understanding Requirements and Recipient Responsibilities: This beginner to intermediate-level workshop is designed for sponsored program and technology transfer professionals. Participants will gain an understanding of intellectual property, the Bayh-Dole Act, inventions reporting via iEdison, and other award recipient responsibilities as they relate to intellectual property and federal grant funding.  Note:  This workshop does not require attendance at the  two day seminar.
  • Intellectual Property – A Hands-on Demonstration of iEdison:  Join IP experts in this intermediate to advanced-level workshop which will provide participants with a demonstration of Interagency Edison (iEdison), with an emphasis invention and patent reporting, and administration of the patent rights clauses in Federal funding agreements.  (This workshop does not require attendance at the two-day seminar.)

Registration for the optional pre-seminar workshops requires participation in the two-day seminar (unless noted otherwise.) Space is very limited!  Register today!

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Calendar

August 30: NIH Webinar on Research Performance Progress Reports (RPPRs)…Test your Knowledge!

Did you know there are three types of Research Performance Progress Reports (RPPRs) that are associated with an NIH grant award? Can you name them? If you said “Annual, Interim, & Final RPPRs”…way to go! What does each one include? How and when do you submit each? What changes have been made in 2017 and what are still to come?

On Wednesday, August 30, from 2:00-3:30 p.m. ET, NIH experts are planning to answer these questions, along with sharing the latest updates on RPPR policies and process updates. This webinar is designed for principal investigators, signing officials, and delegated officials responsible for the development and submission of progress reports to the NIH.

Registration is now open at https://attendee.gotowebinar.com/register/8165062792709498114 external link icon.  (**This webinar is limited to 1000 log-ins so act quickly.  We highly recommend group viewing to maximize access.)

Prior to the webinar, check out the NIH RPPR web page with more “Who? What? And Where?” information.

If you have specific questions or topics you’d like covered, send them by Wednesday, August 23 to OPERAall@nih.gov.  These questions and suggestions will be used to help build the presentation content and ensure we’re providing the answers you need.  A recording and transcript will be available approximately 5-7 business days following the event on the NIH Grants YouTube channel.

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