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Updated: 10 hours 53 min ago

Patents and the Relative Citation Ratio: Correlations to Assess NIH Impact

September 18, 2017 - 2:52pm

We previously referenced Ioannidis’ and Khoury’s “PQRST” mnemonic for describing research impact: “P” is productivity, “Q” is quality, “R” is reproducibility, “S” is sharing, and “T” is translation.  We wrote several blogs about “P,” productivity, focusing on publications, citations, and more recently the Relative Citation Ratio.  Now we’ll focus on a different kind of “P” for productivity, namely patents (which arguably are also related to “T” for translation).  We’ll also take a brief look at “S” for sharing.

In the April 7, 2017 issue of Science, Danielle Li [now with the Massachusetts Institute of Technology (MIT)], Pierre Azoulay (MIT), and Bhaven Sampat (Columbia University) published an investigation on the patent productivity of NIH grants. They identified over 365,000 grants NIH funded between 1980 and 2007, and linked them to patents. Two kinds of links were identified: “direct” links in which a patent cited an NIH grant, and “indirect” links, in which a patent cited a paper which in turn acknowledged support from an NIH grant.

The authors found that close to 10% of grants directly generate a patent. That’s remarkable!  But perhaps even more so, nearly 30% of grants generate a paper that is later cited by at least one patent. Even more remarkable, grants directly and indirectly generated patents whether they were “disease-targeted” or not, “patient-oriented” or not, or linked to a Request For Application or not. And, large proportions of grants assigned to different models directly and indirectly generated patents – models including humans, primates, rodents, invertebrates, multicellular eukaryotes, unicellular eukaryotes, prokaryotes, and viruses.

Another noteworthy feature of this paper is that the authors freely shared their data and statistical code. We took advantage of this to ask a question: do NIH-supported papers that are cited by patents have a higher Relative Citation Ratio than those that are not cited by patents? As a refresher, the Relative Citation Ratio uses citation rates to measure the influence of a publication at the article level

We identified 119,674 unique NIH grants that were funded between 1995 and 2007 and that generated at least one publication. Of these grants, 46,002 (38%) generated at least one publication that was later cited by at least one patent. The grants generated 1,241,307 publications that appeared between 1995 and 2015; of these, 103,421 (8%) were cited by at least one patent.

Figure 1 shows a box plot of the Relative Citation Ratio of papers that were or were not cited by at least one patent.  The Y-axis (Relative Citation Ratio) is log-transformed to reflect the log-normal distribution. Papers cited by a patent had a higher Relative Citation Ratio (median 1.75, IQR 0.85-3.62 compared to papers not cited by a patent median 0.97, IQR 0.46-1.91). For convenience, we drew a dotted line through the median value of RCR among the papers cited by a patent. The large dots represent the mean RCR values.

Figure 1

Figure 2 shows the Relative Citation Ratio of papers according to the number of patents citing them.  There is a gradient, with Relative Citation Ratio increasing as papers are cited by zero, one, two, three, or more than three patents (median values of 0.97, 1.46, 1.66, 1.87, and 2.40).  For convenience, a dotted line goes through the median RCR (1.46) for papers citing one patent.

Figure 2

Taken together, the data presented here suggest that the number of publications cited by a patent positively correlates with a higher relative citation ratio. In other words, when patents cite a publication, that article is also likely to be highly influential in its field.

These preliminary findings show one way we are continuing to explore research impact beyond bibliometrics. Though helpful, focusing on bibliometrics alone does not completely capture productivity and impact of our funded research programs. The analysis we present here attempts to build upon prior work by adding yet another instrument to our toolbox.

We recognize that this correlation between patent citation and relative citation ratio may be correlative, not causal. With that noted, both measures do still provide us with a glimpse into the influence of the NIH research portfolio. Our findings are consistent with prior findings showing that the relative citation ratio also correlated with post-publication peer review.

And finally, the “S,” sharing that is…

We are pleased to hear about ways researchers use our data to empirically analyze the productivity of NIH-supported research. We congratulate the authors of the Science article, and commend their willingness to share their data. We progress towards our goal of enhanced transparency and stewardship when researchers share data with each other and when funding agencies share administrative data. Ultimately, sharing information this way is how we, together, improve human health and reduce illness and disability.

Categories: NIH

Reminder to Review Accuracy of Your Institution’s Grant Award Data before October 9

September 11, 2017 - 4:35pm

Now that we are in the closing stretch of the fiscal year, we remind research institution officials to review whether your awarded grants are accurately assigned to the correct department/school within eRA Commons. This ensures that the grants are reported correctly in tools like RePORT for year-end reporting, and displayed under the right division/school in eRA Commons. On October 9, data for the government’s fiscal year will be frozen, and cannot subsequently be changed in our year end reports, so we encourage you to review your information now and avoid the end-of-fiscal-year rush.

Signing Officials at institutions of higher education can make corrections and update the reassignment of a grant to the correct division/department directly in eRA Commons (see steps to Reassign Grant). Once the data is updated in eRA Commons, it appears immediately on the eRA Commons Status screen as well as on the Reassign Grants screen. Updated data will be reflected in RePORT, when the data is refreshed weekly.

Categories: NIH

Important News for Applicants Using Downloadable Forms Packages

September 11, 2017 - 1:11pm

Do you submit using downloadable forms packages? If so, be sure to read an important message from the NIH eSubmission Items of Interest listserv: “Grants.gov to Retire Legacy PDF Application Packages at end of 2017“.

In brief, of the four application submission options currently available to NIH applicants, the option to use legacy PDF application packages will retire at the end of this year. Those who normally use these offline PDF packages will need to choose another submission method.

Read the Items of Interest article for more details!

Categories: NIH

Spreading the Word About Policies Impacting Human Subjects Research and Clinical Trials

September 11, 2017 - 12:45pm

Understanding the impact of the new human subject and clinical trial policies on selecting a funding opportunity announcement, developing an application, the review of applications, and reporting on grant awards will be critical in the upcoming months. We need all hands on deck to help us communicate these changes. To this end, we have made a variety of resources available to the research community to assist with institutional training and outreach. Our clinical trial training page has presentations, a flier, and more, available for your use.

Feel like there is something else we can provide that would be helpful?  Let us know! Or if you have developed outreach materials that work better than what we have, please share them with us so we can potentially share them with others.

Categories: NIH

Continuing to Clarify the NIH Definition of a Clinical Trial

September 8, 2017 - 2:47pm

A few weeks ago we released some case studies and FAQs to help clarify for our research community whether their human subjects research study meets the NIH definition of a clinical trial. These resources prompted a number of follow-on questions and thoughtful suggestions from the community that have helped us refine both the FAQs and the case studies. We are grateful for your thoughtful and constructive comments and suggestions, many of which we have incorporated into our revised documents and communications.

In addition to providing additional rationale for our conclusions in the case studies, we made a number of changes, to include clarifying: what it means to be “prospectively assigned”; what we consider to be a “health-related biomedical and behavioral outcome”; how to classify “ancillary studies”; in what circumstances we would consider a mechanistic study to be a clinical trial; the use of surveys, questionnaires and user preferences; and more.

One of the key clarifications is the distinction between an observational study and an interventional study. There was a lot of very productive discussion around case study 18, which resulted in our breaking the one case study into 6 variations on a theme. The new case studies 18 a-f should help the community understand the nuances of when a measurement is a measurement, and when a measurement tool or task is considered an intervention.

The case studies and FAQs are living documents. We fully expect them to evolve as we work together to think through various scenarios. Unsure whether your human subjects study meets the NIH definition of a clinical trial? Ask the NIH program official (scientific contact) listed in the funding opportunity announcement or on NIH’s website who is responsible for your area of research.

It is important that we get this right. We have an ethical mandate to assure the public that the results of all NIH-funded trials will be made available in a timely manner. We know that under the current state of affairs, over half of all completed NIH-funded trials are not reported out within 2.5 years of completion; the problem is widespread and pervasive. This is an unacceptable state of affairs; it should not be optional to report results. We look forward to continuing to work with you as we move towards higher levels of trust and transparency.

Categories: NIH

NIH’s Certificates of Confidentiality Policy Enhances Confidentiality of Participants Enrolled in Clinical Research Studies

September 7, 2017 - 5:59pm

A few months ago we blogged about our plan to release an updated Certificate of Confidentiality (CoC) policy. Today, we are pleased to announce that we have published the new policy (NOT-OD-17-109), which will go into effect on October 1, 2017. The new policy both enhances the privacy protections of individuals participating in NIH funded research studies and eliminates the need for NIH funded investigators to apply for a CoC.

To help protect the privacy of research participants, NIH has for many years issued CoCs, upon request, to researchers collecting sensitive information about research participants. The CoCs protect researchers and institutions from being compelled to disclose information in response to legal demands that would identify their research subjects.  Section 2012 of the 21st Century Cures Act authorized new provisions governing the authority of HHS to protect the privacy of research subjects.  The new policy implements the new CoC statutory requirements.

Under the new policy, as of October 1, 2017, NIH funded researchers will no longer have to request a CoC, nor will they receive an actual certificate. The CoC will be issued automatically to NIH funded grants, cooperative agreements, contracts and intramural research projects research funded wholly or in part by the NIH that collects or uses identifiable, sensitive information. Compliance with the requirements of the law will become a term and condition of award. All research that was commenced or ongoing on or after December 13, 2016 and is within the scope of this policy is issued a Certificate through this policy.

The CoC protects the privacy of subjects by limiting the disclosure of identifiable, sensitive information. Under the new policy, disclosure is not up to the discretion of the investigator. Disclosure is only permitted in the following circumstances:

  • if required by other Federal, State, or local laws, such as for reporting of communicable diseases
  • if the subject consents; or
  • for the purposes of scientific research that is compliant with human subjects regulations.

The restrictions on disclosures apply to all researchers or research institutions previously issued a CoC who are engaged in research.

A point that is important to understand is that if your research is covered by a CoC, you are required to ensure that any investigator or institution with whom you share a copy of the identifiable sensitive information that is protected by the policy understands that they are they are also subject to the disclosure restrictions, even if they are not funded by NIH.

If you have non-Federal funding,  NIH will continue to consider applications for CoCs for applicable non-federally funded research submitted to our institutes and centers through our existing online CoC application system.

We have noted the changing policy on our CoC website and will be overhauling the page to align with the new policy for the October 1, 2017 policy implementation date.

Categories: NIH

Small Businesses Gather in Milwaukee for 19th Annual HHS SBIR/STTR Conference on Federal Research Funding

September 7, 2017 - 4:23pm

The Department of Health and Human Services (HHS) is pleased to present the 2017 Annual SBIR/STTR Conference: In The Heartland of BioHealth Innovation.

The National Institutes of Health (NIH), Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), Administration for Community Living (ACL), and the Office of Inspector General (OIG) will be present to demonstrate and discuss research funding opportunities with interested entrepreneurs and innovators.

The Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) programs are federal sources of support for U.S.-based small businesses developing life science technology to enhance health and life for all people. This year’s conference will be hosted by our partner, the Clinical & Translational Science Institute of Southeast Wisconsin at the Medical College of Wisconsin, in Milwaukee, WI from November 7 – 9, 2017.

A draft of the agenda and registration information is now available online.  Save on registration with early bird rates though September 28, 2017.

This conference is relevant to a diverse audience, including biomedical entrepreneurs, principal investigators, grants and contracts administrators, and industry partners and investors. We are also committed to reaching and collaborating with Woman-Owned and Socially Disadvantaged Business owners, as well as professional organizations that support them.

You will network with potential partners and learn how to successfully participate in federal seed funding programs from HHS during an interactive three-day conference. Session topics will include:

  • Strategies for developing competitive SBIR/STTR applications
  • Understanding grant and contract solicitations and funding opportunities
  • What you need to know about Human Subjects and Animal Research
  • Discuss specific questions one-on-one with HHS SBIR/STTR subject-matter experts
  • Leveraging NIH’s Technical Assistance Programs to support commercialization

We look forward to meeting you #InTheHeartland! Follow us on Twitter to keep up with news and updates: @NIHsbir.

Categories: NIH

Have You Seen the Loan Repayment Program Recently? Here’s What You Missed

September 5, 2017 - 4:43pm

As I reflect on the research training I received during and after medical school, I recall how lucky I was that I did not have much resulting debt and severe financial constraints that could interfere with my research career. Unfortunately, today’s aspiring physician scientists are often mired in debt. The Association of American Medical Colleges estimates that two-thirds of medical students graduate with debt, with 80% of those students owing at least $100,000.

How can we alleviate the rising debt accrued during biomedical training for those investigators seeking a foothold in the lab? The NIH loan repayment programs (LRPs), managed inside the Office of Extramural Research, is one approach the NIH is utilizing to stabilize career trajectories for talented investigators. My predecessor, Dr. Sally Rockey, understood and also championed the impact of the LRPs, and I share her enthusiasm.

Congress established the first NIH LRPs nearly a quarter century ago to recruit and retain highly qualified health professionals into biomedical or behavioral research careers. If a researcher is awarded this opportunity and commits to studying diseases and conditions important to the NIH mission, the agency will repay up to $35,000 annually, over a two-year contract, towards their qualified educational debt. Individuals can also reapply for and receive LRP support if they continue conducting qualifying research and making significant strides in their career.

As you can imagine, we are motivated to share the successes and impact of these opportunities. NIH recently assessed career outcomes, as an example, of recipients of LRPs in 2003-2009. Preliminary results suggest that many awardees, for example, apply for and receive more peer-reviewed research grants as well as publish in scholarly journals, when compared to those who did not receive an LRP. These data suggest that individuals are remaining in active research careers and contributing to the advancement of biomedical knowledge and discovery long-term – just as the programs intended.

I’d like to highlight a few other recent updates that will help further promote this program with researchers and supportive stakeholders across the country.

First, to further support increased transparency and reporting of NIH data, we recently launched a new feature to provide access to a wealth of data regarding the NIH LRPs. The LRP dashboard allows users to easily access, visualize, and export trend data about the programs via a bold, new interface.

Figure 1 – LRP Dashboard widget showing the number of LRP applications and awards by degree category for FY 2013-2016. Data can be filtered by year and by LRP or award type within the dashboard by utilizing the pulldown and slide features.

The dashboard provides information regarding program funding (total and by IC), program success rates, the number of annual program applications and awards (by program and degree status, e.g. M.D., Ph.D., M.D./Ph.D., etc., as shown in Figure 1), and an interactive map highlighting the number of awardees by state (Figure 2).

Figure 2 – LRP dashboard widget showing distribution of LRP awardees by state FY 2013-2016. Data can be filtered by year and by LRP or award type within the dashboard by utilizing the pulldown and slide features.

Second, just like when diplomats foster relationships between the United States and other countries, LRP ambassadors serve as a personalized link between the NIH LRPs and investigators in the extramural community. Consisting of a nationwide network of current and former LRP recipients, these talented individuals share their personal experiences, provide advice on the application process, and support the perspective within their local scientific community. We invite you to search the directory to locate a nearby LRP ambassador if you are interested in applying.

Already an awardee and wish to serve your community further as an Ambassador? Feel free to visit the Directory as well for more information on the process and resources. There are currently already over 500 individuals like you across the country energized and committed to extolling the benefits of these invaluable NIH programs.

The LRP online application is open each year from September 1 to November 15. We recommend potential applicants begin by first engaging with LRP program officers within the NIH institutes and centers (ICs) before submitting their application. These individuals can help you understand the potential benefits of these programs to your career, explain eligibility criteria, as well as discuss the research and funding priorities for LRPs at their IC. These staff regularly attend scientific conferences as well to interact directly with the community and address any questions you may have.

We continue to spotlight these important programs facilitating career stability for investigators struggling with high levels of educational debt. Instead, our awardees can spend their time building a stable research career and making important biomedical contributions to improve public health – ultimately benefiting us all in the long run.

Categories: NIH

NIH’s Next Generation Researchers Policy Now Posted

August 31, 2017 - 3:23pm

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  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.

Categories: NIH

Data On Trends According to Career Stage

August 31, 2017 - 3:12pm

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.

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.)

Figure 2

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.

Figure 4

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.

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.

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).

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).

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.

Categories: NIH

Monitoring the Impact of Hurricane Harvey on Research

August 31, 2017 - 10:09am

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 study, 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 recommendations 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.

Categories: NIH

Next Generation Researcher Policy Announcement – Coming Soon

August 15, 2017 - 4:44pm

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.

Categories: NIH

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

August 13, 2017 - 9:48am

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 .  (**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.

Categories: NIH

4 Questions For Researchers and Institutions Involved In Human Subjects Research

August 11, 2017 - 1:01pm

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.

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.

Categories: NIH

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

August 11, 2017 - 12:24pm

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!

Categories: NIH

Fiscal Policy and Salary Cap Guidance for 2017

July 25, 2017 - 12:58pm

Now that the NIH fiscal year 2017 budget is signed into law, NIH published its final fiscal policy and salary cap guidance for this year.

In general, NIH will restore reductions to non-competing continuation awards made this year while we were operating under a pending budget (continuing resolution).  Additional details on fiscal operations, including specific funding strategies for ICs and any exceptions, will be posted at the NIH funding strategies page.

The salary cap remains unchanged from the interim guidance published in March. The direct salary limitation follows Executive Level II of the Federal Executive pay scale, which was previously set at $185,100, and increased to $187,000 effective January 8, 2017. This means that for awards issued in previous years that were restricted to Executive Level II, including competing awards already issued in fiscal year 2017, grantees may rebudget to accommodate the current Executive Level II salary level as long as:

  1. adequate funds are available in active awards; and
  2. the salary cap increase is consistent with the institutional base salary.

See NIH Guide Notice NOT-OD-17-087 for details on the salary cap, and NOT-OD-17-086 for guidance on NIH fiscal policy.

Have questions about your specific award(s)? Contact the Grants Management Specialist identified on your Notice of Award.

 

Categories: NIH

Keep Current with News from the Office of Laboratory Animal Welfare

July 21, 2017 - 1:24pm

If you are a researcher who works with animal models, or are involved in IACUCs (Institutional Animal Care and Use Committees), you’ll want to stay on top of news, training opportunities, and resources from the NIH Office of Laboratory Animal Welfare (OLAW). These include:

  • A fact sheet to get you (or your newer faculty/colleagues) up to speed on principal investigator responsibilities
  • ICARE Academies (Training for IACUC members and animal program personnel) and Train the Trainer Institutes (Training for institutional IACUC trainers)
  • OLAW Online Seminars (A free webinar series to help IACUCs and institutional officials with responsible oversight of research involving animals)

Want to know when new resources are created, articles are published, or new training dates are announced? Stay connected through the NIH OLAW email LISTSERV and follow OLAW on Twitter (@NIH_OLAW ).

Categories: NIH

Available Now: Legislative Mandates for the Use of NIH Funding

June 30, 2017 - 11:51pm

NIH’s fiscal year 2017 budget was signed into law on May 5. As we do every year, we have posted a list of the current statutory limits on the use of NIH grant, cooperative agreement, and contract awards. Read NIH Guide Notice NOT-OD-17-075 for more information about these legislative mandates.

Categories: NIH

Receiving NIH Funding? Don’t Forget Your Responsibilities in Reporting Progress and Financials

June 30, 2017 - 10:49pm

If you are a recipient of NIH funding, then you are required to report on scientific progress and financial expenditures. Submitting timely, accurate, and complete reports are an essential part of the stewardship of federally-supported research, and maintaining the public’s trust in science.

We recently reminded all NIH recipients of their reporting responsibilities in an NIH Guide notice published June 5. The Guide notice summarizes the required information, and due dates, for Research Performance Progress Reports (RPPRs) and Financial Expenditure –Federal Financial Reports (FFRs).

We encourage you to share this information with your colleagues at your research organization. Failure to submit complete and accurate reports doesn’t just affect one individual – it can affect future funding to the entire organization, and can result in a delay of continued support. Read more in NIH Guide Notice NOT-OD-17-074.

Categories: NIH

Making Institutional Training Tables Easier Through XTRACT

June 30, 2017 - 9:23pm

A feature within eRA Commons called the xTRACT module is available to help applicants create training data tables for institutional training grant applications, and to help grantees update these tables for their progress reports (RPPRs).

xTRACT is available to all institutions through eRA Commons. If you or your institution works with institutional training grant applications or progress reports, and are not taking advantage of this tool yet, consider the time-saving features the module provides.

Highlights include:

  • Using Commons IDs and xTrain appointment data, xTRACT allows users to populate the tables from data already available in the NIH database, including trainee names, selected characteristics, institutions, grant numbers and subsequent NIH and other HHS awards.
  • After completing and reviewing your data entries, xTRACT produces a PDF file for you to attach to your grant application or RPPR.
  • Training table data can be reused for future submissions, rather than re-entered manually.
  • Faculty data can now be bulk uploaded, instead of the previous requirement to add one at a time.
  • xTRACT validates table entries so that errors can be corrected as the table is being populated.

We’ve received great feedback since xTRACT’s launch in October 2015. xTRACT users say that the system is very helpful in saving time preparing training table information. As of June 2017, xTRACT has been used by more than 160 institutions, with over 110 new applicants using xTRACT for their initial application, and over 1,000 existing grantees using xTRACT for RPPRs and renewals.

While using the xTRACT module is an option, and not yet a requirement, it can save research administrators and principal investigators time when creating and completing data tables for new applications for institutional training grants (T32, TL1, T90/R90, and T15), progress reports, and most types of renewal applications.

Applicants for renewal T90/R90s and other predoctoral, postdoctoral, and career-level training, education, and career development activities that use training data tables (e.g., T35, R25, K12/KL2 awards) can also use xTRACT, but the system does not yet include features tailored to their specific types of awards. Programs targeted to undergraduates (e.g., T34 awards) should not use the xTRACT system at all at this time, but should instead use the fillable tables designed for undergraduate programs available on the NIH website.

Want to learn more? Visit the eRA web page on xTRACT for more information. Looking for help in using the module? Check out the xTRACT user guide, instructional videos, and FAQs for additional help using the system.

Categories: NIH