NIH Extramural Research & Funding News

Syndicate content
NIH Extramural Nexus
Updated: 20 hours 8 min ago

Why Project Outcomes Matter in your Interim and Final RPPR

November 16, 2017 - 1:42pm

The next time you are filling out your interim or final Research Performance Progress Report (RPPR) for your NIH grant, pay special attention to writing the project Outcomes section (Section I). That’s because any project outcomes submitted on or after Oct. 1, 2017 will be made available to the general public via NIH’s Research Portfolio Online Reporting Tool (RePORTER).

You may wonder why the scientific community needs to report on outcomes and why we are making the outcomes available to the public. Reviewing reported outcomes is part of our stewardship of the public’s investment in research. Publicly posting grant outcomes provides transparency and lets the taxpayer understand what they have paid for (We informed you that outcomes would be made public in Guide Notices NOT-OD-17-085, NOT-OD-17-037 and NOT-OD-17-022). Therefore, it is important for grantees to write the outcomes for the public appropriately. Keep the description of outcomes concise and crisp, written for the layman in clear and comprehensible language. Do not include any proprietary or confidential information or trade secrets. Aim for Grade 10, so that even a 15 to 16-year-old will be able to understand the results of your research (see our pointers on using plain language to communicate the value of your research).

To help the research community understand what is an acceptable report, I wrote up a specific example from my time at the Cleveland Clinic on the outcome of a R01 funded study from 2001-2004 on ‘Heart Rate Recovery and Mortality.’ It wasn’t easy to break it down into non-scientific speak. I ran my first attempt through a readability checker and it reflected a Grade 12 understanding. I tried again and eventually succeeded in getting it down to a Grade 10 level.

Note that NIH will publish outcomes exactly as they are submitted by the grantee. So, it is critical that this item in the report is written for the lay person. While NIH program officials (POs) will review this item in the Final RPPR or Interim RPPR for elements such as relevancy (i.e. it is a description of project outcome and not unrelated comments that the grantee would not want to see on the Internet), they will not edit the text submitted.  POs may contact PIs to submit revised project outcomes, using the capability in eRA Commons to submit additional materials for interim and final RPPRs (see Guide Notice NOT-OD-18-103). But it is imperative that the PI provide the text (in the web form, not as an attachment) exactly as the PI would like it to appear to the general public on RePORTER. What you write in that web form is what the public will see!

Categories: NIH

Teaming with ORCID to Reduce Burden and Improve Transparency

November 15, 2017 - 8:30am

As you know, our NIH Strategic Plan articulated an objective to “excel as a federal science agency by managing for results,” and to manage by results we must harness the power of data to drive evidence-based policies. Sometimes, however, our world can be complicated by requirements to enter the same types of data repeatedly in one system after another. These situations do have an upside: they provide us the opportunity to look for opportunities to simplify.

If you are a researcher, you may have experienced the need to provide information about yourself, your work, the products of your work, and other basic profile information in one or more university, journal, society, or hospital-based systems. You may also be entering that information into your eRA Commons profile, profile systems for other Federal agencies, systems for non-Federal funders, publisher systems, and more. Each system asks for somewhat different information, making the data fragmented, burdensome to maintain, and hard to use. To address this complex issue, NIH has been exploring ways to better leverage data already available in the research sector.

One organization that may be able to help is ORCID (Open Researcher and Contributor Identification). ORCID is a not-for profit organization that assigns unique persistent identifiers to researchers that supports automated linkages between researchers and their professional activities with the goal of helping people find information and to simplify reporting and analysis. Over 7000 journals use ORCID as part of their workflow, and – with the user’s permission – can automatically populate ORCID user accounts with citations when they publish.

ORCID’s user base has rapidly grown since 2012 (Figure 1) and is now more than ten times larger than the user base for our electronic Research Administration (eRA) system. NIH applicants can already link SciENcv (Science Expert Network Curriculum Vitae) with their ORCID account to simplify the creation of a biosketch.

Graph used with permission from ORCID.

We are excited to announce an expanded integration with ORCID. eRA Commons is establishing a real-time link with ORCID, which allows users to associate ORCID with their eRA account. We encourage investigators who have not done so already to go ahead and create an ORCID profile, which takes about 30 seconds (creating a fully-fleshed out profile will take some more time). Next, link your ORCID profile to your eRA Commons account for continued success of this activity. Those who participate should expect to see additional functionality over time, such as assistance completing NIH applications and reporting requirements as well as allowing public data on NIH grant awards to populate ORCID.

Further, NIH and other funders are collaborating on the ORCID Reducing Burden and Improving Impact Tracking (ORBIT) project. This effort will expand the ORCID data model beyond publications to data elements typically found on a CV, such as grants, courses taught, presentations, and other research products.

ORCID promises to serve as a hub for these data. Users will be able to link their faculty profile, publisher, and funder accounts to ORCID. Moreover, ORCID will be able to verify and exchange data across all these systems, reducing burden for the user.

We also foresee science networking services using these data, leading to more efficient and equitable ways for people to find reviewers, collaborators, and mentors. Moreover, this richer data will make it easier for the scientific community to create measures and incentives for better scientific practices such as openness, rigor, and impact. Combined with other strategies underway and with feedback from the research community, we can further ensure NIH remains proper stewards of taxpayer funds.

Interested in hearing more about the partnership between NIH and ORCID? If so, we invite staff at institutions who manage faculty profile systems to join us for a webinar on Thursday, November 16th.

Categories: NIH

NIH Plans for Issuing Clinical Trial Specific Parent Announcements

November 8, 2017 - 8:42pm

In February NIH announced plans to require clinical trial specific funding opportunity announcements (FOAs) for due dates of January 25, 2018 and beyond. Expect to see clinical trial specific parent FOAs on the streets for select activity codes at least 60 days ahead of the first due date after January 25, 2018. Some NIH Institutes and Centers will join these parent FOAs; others will publish IC-specific Clinical Trial FOAs.

Guide notice NOT-OD-18-010 announces NIH’s plans for clinical trial specific parent R01 and parent R21 funding opportunity announcements.

Guide notice NOT-OD-18-001 provides plans for career development parent clinical trial announcements and explains NIH’s approach to supporting clinical trial research experiences for fellowship, training, and career development awards.

Categories: NIH

Revised NIH Grants Policy Statement

November 8, 2017 - 8:13pm

NIH issues a revised Grants Policy Statement each fall. The latest version, issued in October, introduces no new policies. Rather, it incorporates updates made throughout the year. This revision applies to all NIH grants and cooperative agreements with budget periods beginning on or after October 1, 2017.

Changes in NIH policy made throughout the year are issued as policy notices in the NIH Guide to Grants and Contracts. We aggregate these notices on our Notices of Changes to Grants Policy web page for your convenience. Remember that applicants and grantees are responsible for tracking policy changes as they happen.

You can track publication of policy notices in a number of ways:

  1. Sign up to receive the weekly Table of Contents for the NIH Guide to Grants and Contracts via email or RSS feed.
  2. Get immediate updates on new funding opportunities and notices by following @NIHFunding on Twitter.
  3.  Or set and save a query to receive just the policy notices by email as they are issued (you can cancel any time):
    • Go to the NIH Guide for Contracts
    • Deselect  funding opportunities
    • Select “NIH” under organization
    • Add today’s date for release date
    • Select “save this search” under the top current search box
    • Provide your email
Categories: NIH

Continuing Steps to Ensuring Credibility of NIH Research: Selecting Journals with Credible Practices

November 8, 2017 - 7:54am

The scientific community is paying increasing attention to the quality practices of journals and publishers. NIH recently released a Guide notice (NOT-OD-18-011) to encourage authors to publish in journals that do not undermine the credibility, impact, and accuracy of their research findings. This notice aims to raise awareness about practices like changing publication fees without notice, lacking transparency in publication procedures, misrepresenting editorial boards, and/or using suspicious peer review.

This may not be a big problem for NIH-funded publications now; our colleagues Jennifer Marill, Kathryn Funk, and Jerry Sheehan from the National Library of Medicine note that more than 90% of the 815,000 publicly available journal articles reporting on NIH-funded research are published in MEDLINE indexed journals. Nonetheless, we do know that a problem exists – there are articles reporting NIH-funded research appearing in journals that engage in questionable practices. Ensuring the credibility of NIH funded research is important to maintaining public trust in research.

NIH has taken—and continues to take—many steps to ensure the credibility of the research it supports. From enhancing rigor and reproducibility, to encouraging sharing of data and protocols, to promoting pre-prints, and to requiring timely registration and reporting of clinical trial results, NIH establishes policies to make our funded research as credible, transparent, rigorous, and full of impact as possible.

But what can we do?

Simply put, publish where you cite. If you are not familiar with a particular journal, then consider speaking with your local academic librarian as well as consulting resources from the publishing community (e.g. Think Check Submit) and the federal government (e.g. Federal Trade Commission).

In addition, there are other ways you can enhance the credibility of your research and publications, including: using rigorous practices, such as authenticating cell lines; clearly documenting methodology so others can replicate your work; sharing data; preregistering protocols; and issuing preprints to collect community feedback prior to publication.

All in all, to help convey the credibility of your work, be careful where you publish. We hope that our community publishes only in journals that do what they say they will do. If the rigor of your work is clearly conveyed in writing, and published in journals that maintain high quality standards, then your work will be viewed with respect. By taking these approaches, we can continue ensuring the credibility and trustworthiness of the biomedical and behavioral research findings resulting from public support.

Categories: NIH

Tell Us About Areas of Scientific Opportunity that Would Benefit from the Unique Research Resources of the NIH Clinical Center

November 1, 2017 - 9:20am

The NIH Clinical Center, as the largest biomedical research hospital in the world, is a unique local, regional, and national research resource.  To ensure the Clinical Center is maximizing its potential to support the best possible science, the NIH Director is seeking input regarding needs and opportunities for inpatient clinical research resources. Respond to the request for information by November 24, 2017.

Categories: NIH

What Can We Learn from the Early Outcomes from the NIH Director’s New Innovator Awards?

October 27, 2017 - 9:51am

In earlier posts, like this one, we discussed the importance of moving towards “evidence-based funding.”. NIH seeks to apply data-driven strategies to conceptualize, develop, implement, and evaluate policies, such as those that will affect the NIH-supported biomedical research workforce. Today, we’d like to spotlight a recently published analysis of an award program directed to investigators early in their careers – a population that has received much attention at NIH and beyond in recent years.

For a decade, the NIH Director’s New Innovator Award has sought to support exceptionally creative and innovative early career investigators across the country. To receive an award, applicants must be an early-stage investigator and must not have received a substantial NIH award. No preliminary data are required in the application. As only one component of a wider high-risk, high-reward portfolio, projects supported through this program are meant to be unusually bold and innovative, with the potential for broad impact across biomedicine. But are they?

Since the first three cohorts of awardees recently completed their awards, our colleagues in the NIH Director’s Common Fund, who administer the program, commissioned the Science and Technology Policy Institute to conduct an independent evaluation of early trends related to effectiveness of the program. Namely, did this approach foster higher-risk, higher-reward research compared to the traditional R01 grant? And of interest to our group, did award recipients experience challenges moving forward in their career because they pursued riskier research studies early on, compared to their other early-stage investigator peers?

Multiple characteristics were considered when assessing research Innovativeness. Senior experts rated a study’s application and/or formation of novel, cutting-edge, combinatorial ideas, approaches, techniques, and methodologies; discovery of new phenomena; synthesis of disparate ideas; departure from prevailing wisdom; ability to advance a theoretical concept; and rigorousness.

to cut to the chase…

Our colleagues found that, for the first three years of awardees, the New Innovator program does indeed support research that is more innovative, risky, and impactful than that typically supported by R01s—the standard bearer NIH grant. Further, with most measures used to assess an investigator’s performance (e.g. professional advancement, obtaining new funding, and publications), this award did not significantly impact, either positively or negatively, the careers of the awardees as compared to other early-stage investigator R01 awardees.

Figure 1 highlights how senior experts in the field assessed the innovativeness of the research from New Innovator (black) and their early-stage R01 recipient peers (gray)—using a numeric scale of “Strongly Disagree” to “Strongly Agree.” Overall, the New Innovator awardees rated higher, compared to their peers, on topics such as revolutionizing their field, accessing multiple disciplines, as well as using novel tools, experiments, approaches, and theoretical ideas. Early-stage investigators were rated more favorably on research rigor, likely due in part to the incremental nature of R01 supported research compared to the riskier science supported by this Common Fund program.

According to their data, New Innovator awardees tended to apply for Type 1 (meaning de novo) grants and published in journals, with their articles having higher Relative Citation Ratios, compared to their related awardee contemporaries. Let’s take a moment to look at the Relative Citation Ratio (RCR) data— a metric that uses citation rates to measure the influence of a publication at the article level. Their analysis revealed that, with RCR data from over 3,000 publications published from 1995 to 2014, New Innovator awardees published articles with larger RCRs than other early-stage investigators who received an R01 (Figure 2). This suggests that’ New Innovator awardees publish articles that are likely highly influential in their fields.

New Innovator awardees were also equally successful in obtaining faculty positions and tenure as early-stage investigators supported by their first R01. Interestingly, since they tended to perceive their research as non-traditional and inconsistent with the NIH grant process, New Innovator Awardees felt they could be more successful obtaining funding from non- NIH sources.

…so, what does this mean for new researchers and the NIH-supported workforce?

Though limitations to this evaluation exist, such as only having a small cohort of awardees to study and that perceptions of the program likely changed over time, the data hints at that New Innovator awardees are not at a disadvantage just because they sought to pursue riskier research endeavors early in their careers. That said, we still need additional information and time to assess the true impact of this award on the long-term stability of their career paths and the wider workforce in general.

This New Innovator program provides one way that NIH is assisting early stage researchers towards a pathway of sustained and successful research careers. Though geared towards higher-risk studies, it was encouraging to see that these early stage scientists are productive and continue to pursue successful research careers.

We remain dedicated to helping this population of early-stage investigators and appreciate your feedback, both qualitative and quantitative, to help guide our workforce policymaking decisions. It is encouraging to see what novel insights into public health these, and our entire grantee pool, will uncover as they progress through their professional careers.

Categories: NIH

NIH Loan Repayment Program (LRP) Reminder

October 25, 2017 - 8:59pm

Applying for an NIH Loan Repayment Program (LRP) award? A reminder that applications along with supporting documentation are due on November 15. The NIH Loan Repayment Programs are a set of Congressionally-mandated programs that are designed to recruit and retain highly qualified health professionals into biomedical or biobehavioral research careers. Read more about the programs in this recent Open Mike blog post.

Categories: NIH

New Podcast: “Understanding the Definition of a Clinical Trial and What That Means for You”

October 25, 2017 - 7:13pm

A new “All About Grants” podcast is now available! In “Understanding the Definition of a Clinical Trial and What That Means for You” (mp3, transcript), Dr. Mike Lauer, NIH deputy director for extramural research, discusses the NIH definition of a clinical trial, addresses community questions, and speaks to how changes to clinical trials policies will impact applicants and grantees.

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

A Sampling of Recent Literature on the Scientific Workforce

October 18, 2017 - 10:28am

As NIH continues its work to better understand the many factors that influence the stability of the biomedical workforce, we wanted to take a moment to discuss some recent papers that highlight the need to take new measures to support early and mid-career researchers.

Earlier this year, we discussed a paper by our NIH colleagues who looked at data on the shifting demographics of lead principal investigators (PIs) on NIH and National Heart Lung and Blood Institute (NHLBI) research project grants. One of their findings is a decline in the representation of PIs aged 41-55. A recent paper by Michael Levitt (Stanford University) and Jonathan Levitt (Statistical Cybermetrics Research Groups) published in the Proceedings of the National Academy of Science supports these observations. The authors combined NIH data on R01-funded PIs and Association of American Medical Colleges (AAMC) data on U.S. medical school faculty to examine trends among three age groups: over 55, between 46-55, and under age 46. The number of medical school faculty and NIH R01 grantees over age 55 has increased steadily since 1980. Focusing on faculty in basic science departments, the authors see a similar trend to NIH R01 grantee data, where the representation of younger and middle aged PIs has remained stagnant, or declined, since 2000.

Looking at inflation-adjusted funding data, the authors see further evidence that NIH-supported PIs under age 55 are feeling greater pressure. Funding markedly increased for PIs aged 46-55 and over 55 at the time of the NIH doubling, but for PIs under 46 funding remained comparatively flat.

Levitt and Levitt, Proceedings of the National Academy of Sciences of the United States of America, 2017 Jun 20;114(25):6498-6503. doi: 10.1073/pnas.1609996114.

From 2004 to present, we see that funding to PIs under 46 and 46-55 is declining, while funding to PIs over 55 remains relatively flat. In Panel C the authors present the data in a way that seems to show a large net transfer of funding to R01 grantees over 55.

Levitt and Levitt, PNAS USA, 2017 Jun 20;114(25):6498-6503. doi: 10.1073/pnas.1609996114.

In 2008, NIH implemented the early stage investigator (ESI) policy, and data shown in this paper shows a modest effect of the ESI policy, with younger basic science PIs seeing more success in achieving funding, beginning in 2010. The authors argue that NIH should provide younger investigators with greater support, enough additional support to restore the age distribution of basic science PIs closer to that seen in 1980. Their model proposes that by adding 2,255 basic science PIs in the younger cohort (45 and younger) the enterprise would achieve a steadier distribution of scientists across all ages, now and in the future.

David Blau and Bruce Weinberg (both from Ohio State University) describe in PNAS other factors that influence the age distribution of the scientific workforce. They used National Science Foundation and US Census Data to show that the aging of the scientific research workforce cannot be solely attributed to wider demographic changes; in other words, it’s not just that the population as a whole is aging. In 1993, there was relatively little association between age and the proportion of the general workforce made up by scientists. In 2010, the situation is decidedly different – with scientists over age 55 making up a greater proportion of the general workforce. The authors’ models suggest that the elimination of mandatory retirement in 1994 played a substantive role in these changes.

Blau and Weinberg, Proc Natl Acad Sci U S A., 2017 Apr 11;114(15):3879-3884. doi: 10.1073/pnas.1611748114.

The authors examined other factors – including rate of PhD completion, changes in mortality, and representation of foreign-born PhDs in the US workforce – and found that these factors have little impact on the steady state distribution of the scientific workforce. By determining the rate at which individuals transition from scientific employment to non-employment, and modelling the implications of these rates on the future workforce, they predict an even further, and substantial, increase in the aging of the scientific workforce over the coming years.

Besides stabilizing in the scientific research enterprise, why else might we be interested in the data presented in the Charette, et al., Levitt & Levitt, and Blau & Weinberg papers? There are data that show the benefits of funding investigators of all ages. In a November 2016 Science paper, and February 2017 Science essay, Sinatra et al. present data on the careers and pattern of major discoveries of a broad group of scientists. Among computer science faculty, the most highly productive years – as measured by published papers – occurs within 8 years of starting their laboratory. However, among most scientists, including those in the life sciences, highest impact discoveries are not concentrated in the early-career stage, but rather are randomly distributed across early, mid, and late stage researchers. The authors argue that they “offer empirical evidence that impact is randomly distributed within the sequence of papers published by a scientist, implying that temporal changes in impact during a scientific career can be explained by temporal changes in productivity, luck, and the heavy-tailed nature of a scientist’s individual impact distribution.” This evidence suggests value for policies that offer funding support for scientists across all career stages.

Categories: NIH

New Certificates of Confidentiality Policy in Effect

October 12, 2017 - 9:19am

As discussed in recent Open Mike blog posts, NIH issued a new policy to enhance the privacy protections of individuals participating in NIH funded research studies. The policy eliminates the need for NIH funded investigators to apply for a certificate of confidentiality (CoC). As of October 1, 2017, NIH funded researchers no longer have to request a CoC. The CoC will be issued automatically to awards funded wholly or in part by the NIH that collect or use identifiable, sensitive information.

We encourage you to visit our Certificates of Confidentiality website which we have recently updated to reflect the new CoC policy and the disclosure rules that apply to those that hold CoCs.

Categories: NIH

Guidance for Institutions Impacted by Hurricane Maria, and a Reminder of NIH’s Natural Disaster Resources

October 11, 2017 - 3:29pm

Due to the exceptional impact of Hurricane Maria, we want to assure grantees that NIH will be doing our part to help you continue your research. Recently, we published an NIH Guide Notice that outlines the application and report submission flexibilities available for Puerto Rico and the U.S. Virgin Islands. We have previously published guidance for those affected by other major hurricanes this year (Hurricane Harvey and Hurricane Irma) and we update our Extramural Response to Natural Disasters web page with the most recent guide notices related to natural disasters. This page also has additional helpful resources, including guidance on animal welfare issues.

We will be continuing to monitor the situation closely, identifying ways we can help as outlined on the Extramural Response to Natural Disasters page, and publishing additional information in the NIH Guide.

Categories: NIH

New Video Provides Overview of New NIH Policies on Human Subjects Research and Clinical Trials

October 11, 2017 - 3:05pm

Do you do research with human participants? If so, you play an important role in NIH initiatives to improve accountability and transparency in the human subject research we fund. This 15 minute video Overview of New NIH Policies on Human Subjects Research and Clinical Trials provides a succinct explanation of the various policy changes and what they mean for you.

 

Categories: NIH

Clarifying Percent Effort and Support for Career Development (K) Awardees

October 11, 2017 - 2:46pm

In response to questions about career development (K) award policies, NIH issued a Guide Notice NOT-OD-17-094, to clarify percent effort requirements for K award principal investigators (PIs), and acceptable sources of research support. We’d like to provide some additional details to put the recent Guide Notice in context with existing K award policies on percent effort.

For most K award programs, the K award PI (K awardee) must commit at the minimum 9 person months, equivalent to 75% full-time professional effort, directly to their research project and career development activities. The remaining effort (up to 25%) can be devoted to additional research, teaching, clinical work, or other efforts complementary to career development of the K awardee. NIH provides some salary support as part of the K award, and often institutions will supplement the salary of these K award PIs up to a level that is consistent with the institution’s salary scale.  NOT-OD-17-094 clarifies that salary supplementation for the K awardee’s time spent devoted to the career development award and directly related to the research project is allowable, but must be from non-Federal sources, which can include institutional sources, and must not require extra duties or responsibilities that would interfere with the goals of the K award.  For additional research projects, the effort not directly committed to the K award (commonly up to 25%), K award recipients may devote effort, with compensation, from Federal or non-Federal  research projects as principal investigator, or in another role (e.g., co-Investigator), as long the specific aims of the other supporting grant(s) differ from those of the K award (see Figure 1). K awardees may also be compensated for effort devoted to teaching or clinical activities.

Figure 1: Salary supplementation and compensation during the entire period of K award (up to 5 years)

Most K programs are mentored career development awards, where a faculty mentor provides guidance to support transition of the K award recipient to independence. On mentored K awards of a 3-5 year duration, NIH policy provides a transitional period to permit the K award PI to apply for and if awarded, lead, an independent research project. If the mentored K awardee successfully becomes a PD/PI of a peer-reviewed research award from NIH or any other Federal agency during the final two years of their K award, they are permitted to reduce the effort devoted to the aims of the K award project from a minimum of 75% to a minimum of 50%. As described in NOT-OD-08-065, at the time the new research grant is awarded, this reduced effort on the K award may be replaced by effort and corresponding salary from the research award, so that the combined total research commitment of the PI remains 75% or more for the duration of the mentored K award (see Figure 2).

Figure 2: Reduced effort during the final two years of a mentored K award

Have additional questions about percent effort and K awards for your K award, or for a specific K award PI at your institution? Contact the grants specialist listed on the notice of award for guidance specific to you. General policy questions may be directed to the Division of Biomedical Research Workforce at NIHTrain@mail.nih.gov.

 

[Note: edited text to clarify that “For most K award programs, the K award PI (K awardee) must commit at the minimum 9 person months, equivalent to 75% full-time professional effort, directly to their research project and career development activities.” 10/12/2017 NIH staff]

Categories: NIH

Implementing a New Human Subject and Clinical Trial Information Form

October 11, 2017 - 2:21pm

We have been talking a lot recently about NIH’s efforts to improve transparency and trust in NIH funded clinical trials. One important aspect of this effort is improving our ability to identify and describe the clinical trials we are supporting. In fact, a March 2016 GAO report GAO-16-304, entitled Additional Data Would Enhance the Stewardship of Clinical Trials across the Agency, highlighted the fact that “NIH is limited in its ability to make data-driven decisions regarding the use of its roughly $3 billion annual investment in clinical trials.” Many of the other aspects of this initiative, applying clinical trial specific review criteria, improving oversight, and registering and reporting in ClinicalTrials.gov depend upon our basic ability to identify and describe clinical trial applications and awards.

The new PHS Human Subject and Clinical Trial Information form will flag trials, helping us to achieve a number of goals. The form consolidates into a single location information on human subjects that is currently scattered across a number of forms. It allows us to capture structured and semi-structured descriptive information for each study included in a grant application or contract proposal, which will allow us to clearly identify which funded studies will require registration and timely reporting of results.

Each study record requires a minimum number of requested data elements. This starts with leading the applicant through the four questions that determine whether the study is considered by NIH to be a clinical trial. (See our August 11 post, 4 Questions for Researchers and Institutions Involved in Human Subjects Research for more on the NIH definition of a clinical trial.) The answers to those questions will determine whether or not the applicant will need to complete Section 4 of the form, the “Protocol Synopsis.” The form will help in peer review and will enable NIH to answer important questions, like how many clinical trial studies we are funding, the phase of those trials, and how many have as their primary purpose treatment evaluation or fundamental discovery.

Some information collected in this form is information that you likely would have included in the application elsewhere, either in the protection of human subjects attachment or in the research strategy. Now we are capturing that information in a structured format, which supports better monitoring of the studies by NIH staff after award. It also serves the purpose of leading the applicant or contractor through each of the elements we expect them to consider as they are planning for their grant application or contract proposal, which we expect will make for stronger applications. Collecting the protocol synopsis, study population characteristics, recruitments plans, and plans for statistical design and power in one place will also allow reviewers to more easily locate and evaluate these critical elements. For delayed onset studies, those studies for which the details are not known at the time of application, grantees will submit this information to NIH through the eRA Commons once it is known.

One question we are often asked is whether the information collected in the new form will be duplicative of the information provided in the research strategy. That is not our intent. The form allows you to spell out methodological details in the study record, allowing more space in the research strategy for higher-level descriptions and justifications of your experimental design(s) and methods.

A key element in the design of the form is that we were careful to be consistent with the data elements required for Clinicaltrials.gov reporting, which will help with data reuse and exchange between systems.

If you haven’t seen the new form, we have a 9 minute video  that will guide you through and give you a good idea of how it works. The form will be included as part of the Forms-E application packages, which you will be required to use for all grant applications submitted for due dates on or after January 25, 2018. You will see the form associated with funding opportunity announcements as early as the very end of October/early November.  We expect to make the PHS Human Subjects and Clinical Trial Information form available for Requests for Proposals for contracts posted as of January 25, 2018 as well. We recently published the instructions for FORMS-E (HTML/PDF) if you want to take an early look.

Categories: NIH

New NIH Resource for Studies that Randomize Groups or Clusters or that Deliver Interventions to Groups

October 6, 2017 - 7:25am

Experiments, including clinical trials, differ in the methods used to assign participants to study conditions or arms and to deliver interventions. Thanks to the Office of Disease Prevention, the NIH has a new website that provides resources on research methods related to experiments that randomize groups or clusters or that deliver interventions to groups. The information is relevant for human and animal studies and for basic and applied research. The website includes a calculator to estimate sample size requirements for group- or cluster-randomized trials.

Categories: NIH

NIH Webinar: Single IRB & Exceptions Process – October 18, 2017

September 29, 2017 - 4:48pm

Would you like to learn more about the implementation of the NIH single Institutional Review Board (sIRB) policy and receive guidance on how to effectively request an exception to the policy directly from NIH experts?  If so, then make plans to join the NIH Office of Extramural Research (OER) on October 18 from 2:00-3:30pm ET for a webinar on scope and applicability and the single IRB plan.

Designed for principal investigators, signing officials, research organizations or institutions, and institutional review boards (IRBs), this webinar will help you:

  • Learn how to implement the NIH single IRB policy;
  • Understand the expectations for the NIH single IRB policy;
  • Become familiar with the process to request exceptions to the policy; and
  • Understand the responsibilities of the single IRB, local IRB, the investigator, and the institutions in implementing the NIH single IRB policy.

Registration is now open  !  More info at grants.nih.gov. Following registration, you will receive a confirmation email containing information about joining the webinar. (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 Policy on the Use of a Single Institutional Review Board for Multi-Site Research or the Office of Science Policy (OSP) page for additional information on single IRB and Frequently Asked Questions on implementation and cost.

You may submit advance questions related to the single IRB policy to Petrice Brown-Longenecker, Ph.D. by October 10, 2017. These questions will be used to help build the presentation content and ensure we’re providing the answers you need.

We hope you’ll be able to join us!  If the live event does not work out, a recording and transcript will be available approximately 5-7 business days following the event on the NIH Grants YouTube channel .

Categories: NIH

NIH Webinars on Peer Review Focus on AREA/R15 & SBIR/STTR – October 16 & 18, 2017

September 28, 2017 - 4:57pm

The NIH Center for Scientific Review (CSR) is the portal for receipt and referral of NIH grant applications, and, for the majority of those applications, carries out the peer review process for assessing scientific and technical merit. In October, CSR will host two “online briefings” on peer review focused on the Academic Research Enhancement AREA/R15 program, and NIH small business (SBIR/STTR) programs. The briefings will be approximately one hour long, including a 30 minute question and answer period.

For more information and to register for each webinar, visit the CSR event website.

Briefing Title Date​ ​​​8 Ways to Successfully Navigate NIH Peer Review and Get an AREA/R15 Grant ​Monday, Oct. 16, 2017
2:00 – 3:00 p.m. EDT 8 Ways to Successfully Navigate NIH Peer Review and Get an ​SBIR/STTR Grant ​Wednesday, Oct. 18, 2017
2:00 – 3:15 p.m. EDT
Categories: NIH

Avoid Funding Delays by Ensuring Your Progress Reports are Compliant with the Public Access Policy

September 27, 2017 - 4:36pm

To advance science and improve human health, peer-reviewed articles arising from NIH funds must be made available to the public on PubMed Central. Grantees should ensure their peer-reviewed manuscripts arising NIH funds are deposited into PubMed Central upon acceptance for publication, as well as reported in their annual Research Performance Progress Reports (RPPRs), to be compliant with the NIH public access policy.

As described in NIH Guide Notice NOT-OD-16-079, NIH will not process RPPRs until all papers arising from the award are compliant with the public access policy. That means funding for awards with non-compliant RPPRs could be delayed. The NIH manuscript submission system (NIHMS) is processing papers in about 3 weeks.  We encourage you to ensure compliance well before your RPPR is due to avoid delays processing your RPPR and receiving funding.

For step-by-step instructions on how to bring a particular paper into compliance with NIH’s public access policy, please use the “Show me specific instructions for my publication” link on our public access policy homepage.  Additional training and self-help materials are available on the public access website as well, such as tips specifically for sponsored research offices.

Your papers are important to NIH, and the world. On a typical weekday, approximately 1.5 million unique users retrieve more than 3 million papers from PubMed Central. If you have any questions about posting your papers to PubMed Central or about compliance of your award, please contact PublicAccess@nih.gov.  We are here to help!

Categories: NIH

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

September 18, 2017 - 1:52pm

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