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NIH Extramural Nexus
Updated: 18 hours 20 min ago

NIH Announces Inclusion Across the Lifespan Policy

Wed, 01/24/2018 - 14:42

Last month, NIH announced a revision (NOT-OD-18-116) to a decades-old policy originally conceived in response to concerns that children were not appropriately included in clinical research. These changes broaden the policy to address inclusion of research participants of all ages, and as discussed at the last Advisory Committee to the NIH Director meeting, will apply beginning in 2019 to all NIH-supported research involving human subjects. Our goal is to ensure that the knowledge gained from NIH-funded research is applicable to all those affected by the conditions under study.

To get here, NIH solicited feedback from experts and the public through a Request for Information and a workshop held over the summer. We heard from many of you, from pediatricians, geriatricians, primary care providers, statisticians, publishers, bioethicists, and people from the general public. Among the concerns raised were that many trials include poorly-justified age-based exclusions (Cherubini 2011, Cruz-Jentoft 2013), and that older adults, who carry a disproportionate burden of disease, are often underrepresented in clinical trials. For example, while nearly a third of US cancer patients are 75 years or older, less than 10% of patients in cancer trials are in this age range (Hurria 2014).

After considering input and in accord with the 21st Century Cures Act, our policy now requires people of all ages, including children under 18 years and older adults, be included in clinical research studies unless there are scientific or ethical reasons not to include them. We outline when certain age groups may be excluded and note that grantees are now required to annually report on the age at enrollment of their participants along with sex/gender, race, and ethnicity.

So, for application due dates on or after January 25, 2019 (yes, one year from now), if you propose a study involving human subjects, you must have a plan describing how participants across the lifespan will be included and justify the proposed age range of participants. Reviewers will consider whether the proposed age range is appropriate in the context of the specific scientific aims. Should the study be funded, keep in mind that your progress reports will include de-identified individual-level participant data on sex/gender, race, ethnicity, and age at enrollment (in units ranging from hours to years). Ongoing NIH-funded research (type 5 awards) are exempt from this policy, but the policy will apply if you are submitting a competitive renewal application on or after January 25, 2019.

We understand that sometimes research should exclude certain participants. For example, if the disease does not occur in the excluded group, or the knowledge sought is already available on the excluded group, then this may be an appropriate justification to limit who is in your study. We also recognize that there are situations where participation of certain groups would be unethical, or laws or regulations bar the inclusion of a specific group in research. The Guide notice describes situations in which exclusion of individuals based on age may be justified. Keep in mind that the age distribution of participants should be appropriate in the context of the science.

We look forward to working with you in the implementation of these high priority inclusion policies, which are designed to assure that our funded research will better help us make informed health and health care choices going forward.

Categories: NIH-Funding

Continuing to Strengthen Inclusion Reporting on NIH-funded Phase III Trials

Mon, 01/08/2018 - 13:34

Much has been learned about how sex and race may contribute to differences in health outcomes and physiologic conditions (Clayton, 2014). We know that, for example, a specific drug used to treat insomnia requires different dosing for women and men.  African Americans with hypertension are more susceptible to stroke than whites with the same blood pressure levels (Howard, 2013). But in many cases, findings from potentially informative stratified analyses may not be widely available. Less than a third of NIH studies required to analyze sex/gender and race/ethnicity have been found to publish sex-stratified results in peer-reviewed journals (Foulkes, 2011).

Last month, we amended our inclusion policy to enhance the public reporting of these sex/gender and race/ethnicity inclusion data (NOT-OD-18-014). With backing from the 21st Century Cures Act, this amendment specifically requires reporting the results of “valid analyses” on sex/gender and race/ethnicity to ClinicalTrials.gov after completing an applicable NIH-defined Phase III clinical trial.

    • Valid analyses” refers to stratified analyses that explore how well the intervention works among sex/gender and racial/ethnic groups. Though they may or may not be powered studies, they can still shed light on important trends informing the direction for future research questions.
    • Applicable clinical trials, in general, study Food and Drug Administration-regulated therapeutics, biologics, and devices. The reporting requirement we are discussing today pertains to a subset of applicable clinical trials that are also known as “NIH-defined Phase III clinical trials,” which are studies that evaluate an intervention in large groups of people by comparing the intervention to other standard or experimental interventions.  NIH funds approximately 600 of these types of trials each year. 

This reporting requirement applies to new and competing awards made on or after December 13, 2017.  Findings from valid analyses based on sex/gender and race/ethnicity from these applicable NIH-defined Phase III clinical trials must now be reported in ClinicalTrials.gov within one year of completion of data collection for the study’s primary outcome measures. This builds on existing requirements for registering and reporting results in ClinicalTrials.gov. If you have an applicable NIH-defined Phase III clinical trial that was already underway before the effective date, the requirement will not affect you for your current award.

When preparing to register your applicable NIH-defined Phase III trial, we encourage you to identify what outcomes relevant to sex/gender and/or race/ethnicity you will need to report in ClinicalTrials.gov.  Keep in mind that most studies will be expected to report results on sex/gender and race/ethnicity for all primary outcomes.

We are in the process of developing additional guidance, so stay tuned for more to come.

Categories: NIH-Funding

Further Refining Case Studies and FAQs about the NIH Definition of a Clinical Trial in Response to Your Questions

Thu, 01/04/2018 - 12:07

In August and September we released case studies and FAQs to help those of you doing human subjects research to determine whether your research study meets the NIH definition of a clinical trial. Correctly making this determination is important to ensure you are following the initiatives we have been implementing to improve the transparency of clinical trials, including the need to pick clinical trial -specific funding opportunity announcements for due dates of January 25, 2018 and beyond.

We have made no changes to the NIH definition of a clinical trial, or how the definition is interpreted.  What we have done is revise existing case studies and add a few new ones to help clarify how the definition of clinical trial does or does not apply to: studies of delivery of standard clinical care, device studies, natural experiments, preliminary studies for study procedures, and studies that are primarily focused on the nature or quality of measurements as opposed to biomedical or behavioral outcomes..

As a reminder, the case studies illustrate how to apply the four questions researchers involved in human studies need to ask, and answer, to determine if their study meets the NIH definition of a clinical trial. 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.

Note that If the answers to the 4 questions are yes, your study meets the NIH definition of a clinical trial, even if…

  • You are studying healthy participants
  • Your study does not have a comparison group (e.g., placebo or control)
  • Your study is only designed to assess the pharmacokinetics, safety, and/or maximum tolerated dose of an investigational drug
  • Your study is utilizing a behavioral intervention

Studies intended solely to refine measures are not considered clinical trials.

The adjustments to the case studies include the following:

  • #7a, #8a, #24, #31a: Clarified whether it meets definition of intervention
  • #18c: Replaced with a more illustrative case study
  • #18d, 24, and 33: Clarified whether study was designed to assess the nature or quality of a measurement, as opposed to the effect of an intervention on a behavioral or biomedical outcome.
  • #18g: New case study about testing procedures
  • #36 a-b: New case studies about standard clinical care
  • #37: New case study about Phase 1 device studies
  • #38: New case study about natural experiments.
  • #39: Proposed case study about preliminary tests for study procedures.
  • New case studies specific to select NIH Institutes and Centers

We recognize that sometimes in an attempt to be helpful we end up providing a lot of material to look through. So to help you quickly find the case studies that are most relevant to your research we have added the ability to filter the case studies by keyword.

We also added two new FAQs on standard clinical care and Phase 1 devices.

Thank you for your continuing dialog on this topic. We look forward to continuing to work with you as we move towards higher levels of trust and transparency with our clinical trials.

Categories: NIH-Funding

Two Years (or so) of “Open Mike”

Fri, 12/29/2017 - 14:25

Last year, as I reflected on finishing my first full year as NIH Deputy Director for Extramural Research, I noted five themes that reflected most of the content of this blog: applicant behavior, activity, and outcomes; peer review; basic science; biomedical research workforce and training; and scientific rigor, transparency, and research impact. Looking back on 2017, which was certainly a busy and active year, many of these themes continue to be at the forefront, though one in particular, the make-up and future of the biomedical research workforce, has been the center of much debate.

On May 2, we posted a blog on “Implementing Limits on Grant Support to Strengthen the Biomedical Research Workforce” in which we proposed using a “Grant Support Index (AKA Research Commitment Index)” to cap the total support going to any one principal investigator. Our goals were to relieve the pressures of hyper-competition, particularly for early and mid-career investigators; we also sought to increase the number of independent early career scientists and to stabilize the career trajectories of those who do high quality work. The blog received 418 comments – by far the most number of comments for any one blog since we started in October 2015. The blog was not the only platform for debate – there were stories in the scientific press  and mainstream media. NIH chose to revise its approach, instead moving to NIH-wide targets for funding early career investigators, and seeking input from an Advisory Committee to the Director (ACD) working group to refine the “Next Generation Researchers’ Initiative (NGRI).” Two blogs on the initiative and policy together received over 200 comments.

The intense attention reflects, I think, high levels of anxiety about the future of American biomedical researchers and their work. We see this discussed in social media conversations and external postings that appeared after we announced the NGRI. For example:

  • Mark Peifer, a senior scientist and member of the NIGMS Advisory Council, published the article, “The Argument for Diversifying the NIH Grant Portfolio.” Peifer argued that the NGRI suffered from two inherent faults: no source for the needed funds and a real possibility that the initiative would jeopardize mid-career investigators who are doing high-quality work by hanging on by only one grant.
  • Yarden Katz and Ulrich Matter, both from Harvard University, posted a working paper “On the Biomedical Elite: Inequality and Stasis in Scientific Knowledge Production.” The authors used NIH data to show that “that funding inequality has been rising since 1985, with a small segment of investigators and institutes getting an increasing proportion of funds, and that investigators who start in the top funding ranks tend to stay there (which results in stasis, or lack of mobility).” Commenting on NIH’s experience with the Grant Support Index proposal, the authors wrote, “In response to criticisms of the highly skewed distribution of funding in biomedical research, the NIH recently proposed a cap on the funds a single investigator can receive, which sparked strong backlash from some elite biomedical scientists and was promptly withdrawn. The selective pressure induced by the maintenance of this concentration of wealth (exerted in part by a small and influential segment of biomedicine that profits from the status quo), coupled with the emphasis on metrics, is likely to exacerbate the lack of diversity within biomedical science.”

We acknowledge these concerns, and through informed discussion with the NIH ACD working group, through feedback and data from NIH’s institutes and centers, and through feedback and recommendations from a National Academy of Sciences (NAS) panel, we will be further refining our approach. We are also pleased to learn of steps that external stakeholders are taking: for example, the presidents and chancellors of nine US research universities and one research institute recently announced a new initiative, the “Coalition for Next Generation Life Science.” The Coalition is engaging in a series of “transparency enhancing efforts,” including providing data to life science trainees on educational and career outcomes.

Alongside the future of the biomedical research workforce, our blog activity also reflects the discussions about efforts to enhance stewardship and transparency of clinical trials. We have cited previous concerns about the under- or delayed-reporting of the main results of NIH-funded trials, a problem that some view as pervasive  and as a serious threat  to the well-being of the scientific enterprise. Much of the discourse over the past few months has focused on the scope of our policies, with critics arguing that our policies should not extend to trials with a primary purpose of basic science. The journal Nature Human Behavior posted essays critical- and supportive of the scope of NIH’s approach. We appreciate the active feedback on the blog, as it has helped us produce, revise, and refine resources that help applicants and grantees.

We look forward to continuing dialogue as we work to maximize the transparency of NIH-funded research, especially research that involves prospective experiments performed on people.

What’s in store for 2018? I’m reminded of a famous quote, attributed to Niels Bohr and to Yogi Berra that “Prediction is very difficult, especially about the future.” There’s scientific evidence that experts, for the most part, are mediocre predictors; along those lines, recent data show that it’s difficult to predict when a scientist will be most productive. I think it’s fair to say that the five aforementioned themes will remain active and salient. We may see even more dialogue about rigor, accountability, and transparency given increasing attention in the news. And we will continue to struggle with figuring out how best to allocate funding resources – how best to balance small science and big science – and how best to deal with long-term hyper-competition and its effects.

As I wrote last year, we are grateful to all our readers for your interest, your feedback, your engagement, and your passion. We wish you all the best for 2018 and beyond.

 

Table 1: Top “Open Mike” posts by page view, Jan 1, 2017 through Dec. 27, 2017 Post Page views Implementing Limits on Grant Support to Strengthen the Biomedical Research Workforce 65,973 Research Commitment Index: A New Tool for Describing Grant Support 26,014 NIH’s Next Generation Researchers Initiative 25,519 NRSA Postdoctoral Stipend Levels for Fiscal Year 2017 22,642 4 Questions For Researchers and Institutions Involved In Human Subjects Research 19,749 Authentication of Key Biological and/or Chemical Resources in NIH Grant Applications 16,547 Outcomes of Amended (“A1”) Applications 16,458 Continuing to Clarify the NIH Definition of a Clinical Trial 14,318 NIH’s Next Generation Researchers Policy Now Posted 13,602 Mid-career Investigators and Shifting Demographics of NIH Grant Recipients 13,457

 

Categories: NIH-Funding

Assuring the Integrity of Peer Review

Fri, 12/22/2017 - 12:49

Eight months ago, CSR Director Dr. Richard Nakamura and I posted a blog on “A Reminder of Your Roles as Applicants and Reviewers in Maintaining the Confidentiality of Peer Review.” We asked you to imagine a scenario: you are a reviewer for an upcoming panel meeting, and shortly before the meeting an investigator associated with an application communicates with you, asking for a favorable review in exchange for an academic favor. We asked what you would do – accept the offer, ignore it, or report it?

We used the blog as an opportunity to remind all of us how important it is that we all do our utmost to assure the integrity of peer review. Failure to do so, we wrote, will “result in needless expenditure of government funds and resources, and erode the public trust in science.” Furthermore, we noted that there are potentially serious consequences for reviewers and for investigators or others associated with applications who engage in behavior that violates the integrity of NIH peer review.

Unfortunately, our blog foreshadowed just such an event. NIH has recently determined that there has been a breach in the integrity of the panel review process of a batch of applications.

NIH takes the integrity of peer review seriously, and we appreciate that the vast majority of individuals also take the integrity of peer review seriously. Accordingly, after much thought and deliberation, we decided we had no choice but to cancel the panel’s review. The consequences are serious: dozens of applications will need to undergo a re-review.

When the integrity of peer review has been breached, it affects everyone. We regret that the dozens of affected applicants who did nothing wrong will face substantial delays in getting their applications reviewed and processed. We appreciate that the panel reviewers spent a great deal of time and effort reviewing dozens of applications, traveling, and participating in meetings. NIH must assure a fair process for everyone and will not stand by when the integrity of our peer review process is compromised.

We are grateful to the tens of thousands of reviewers and applicants who do play by the rules and who take as seriously as we do the critical importance of the integrity of our processes. This case is a reminder for all of us that we must be ever vigilant.

Categories: NIH-Funding

The Importance of Timely Grant Closeout

Thu, 12/21/2017 - 09:19

At any given time, NIH staff are monitoring nearly 50,000 active grant awards. This monitoring happens throughout the grant life cycle, including once the award is over. Just as we strive to award meritorious grants as quickly as we can, it is equally important for us to ensure grant awards are taken off the books in a timely manner.  A grant that slips past its closeout due date is costly and time consuming.

NIH has for years highlighted the impact of discrepancies between final financial reports for grant closeout and the importance of timely closeout. Ideally, we engage in a bilateral closeout with our awardees at the end of an award as described in Section 8.6 of the NIH Grants Policy Statement. This means that the awardee submits acceptable final research progress reports, expenditure reports, cash transaction reports, and invention reports within the required timeframe.

Most NIH grants are closed in a timely manner as required. But, unfortunately, too many grants have payment accounts that remain open beyond the time required for closeout. For each of these grants, we, and by proxy the taxpayer, pays a fee to keep the accounts in the Payment Management System open. This is money better directed elsewhere. We have taken steps to remedy the situation.

NIH recently issued NIH Guide notice (NOT-OD-18-107) alerting the community that we are now strengthening enforcement of the longstanding closeout requirements. The notice informs the community that, in accordance with the Grants Oversight and New Efficiency (GONE) Act and HHS policy, NIH will initiate unilateral closeout—i.e. closeout without receipt of acceptable final reports—for all awards that fail to meet closeout requirements within 120 calendar days.

We can see that this initiative is paying off—as NIH unilaterally closed a backlog of over 5,000 grant payment accounts over the last year.

Occasionally, awardees may have questions on the closeout process or need more time to get their affairs in order. We understand that. In cases seeking an extension past the 120 days, awardees may submit a request for more time from the funding NIH Institute or Center.

Failing to meet the standard closeout requirements may adversely affect future funding decisions. Failure to correct recurring reporting problems may cause NIH to take one or more actions that may include, but are not limited to, corrective actions, withholding of further awards, suspension or termination.

We seek your continued support in managing this important grant function, as scientific and financial monitoring are key components of our role as responsible stewards of taxpayer funds.

Categories: NIH-Funding

When a Country is Open, Do They Have Strong Science Too?

Mon, 12/11/2017 - 12:09

As no scientist is an island, the overall scientific enterprise grows stronger when people work together. But, an interesting question emerges from this concept for us to explore: how can we quantify the effect of collaboration on productivity and impact on science?

In the October 5 issue of Nature, Caroline Wagner, Ph.D. of the Ohio State University and Koen Jonker’s, Ph.D. of the European Commission Joint Research Center

published an interesting analysis of the association of a country’s “openness” and its scientific productivity. The authors assembled data from the Scopus database—a wealth of information on citations from peer-reviewed scientific journals—and data on workforce mobility from the Organization for Economic Cooperation and Development.

Drs. Wagner and Jonkers developed an “openness” measure to look at international engagement. This measure is a composite of “numbers of scientists emigrating from, immigrating to, and returning to a country, plus international co-authorships.” These data encompassed activities in 33 countries and included 3-year citation data for 2.5 million calendar year 2013 publications across all scholarly fields.

Fortunately, because the authors shared their data freely, we could easily download it and dive into the numbers. Figure 1 is a reproduction of the figure the authors published in their paper. It shows a reasonably strong association between a country’s openness and the citation impact of its scientific work; the author’s used a field-normalized citation impact measure here because that allowed them to compare different-sized countries and subjects. In a regression model, a country’s openness “explains” 59% of the variance of citation impact (P<0.0001).

Most countries are either “low-openness and low-impact” – in the lower left quadrant (e.g. China and Japan) – or “high-openness and high-impact” – in the upper right quadrant (e.g. Singapore and Switzerland). The authors note that the United States is one of only 4 countries in the upper left quadrant – with relatively low openness but high citation impact.  They suggest this may be “because of the magnitude of its scientific enterprise and its geographic distance from possible collaborators.”

In their essay, the authors note a strong correlation between levels of government funding for research and development and number of publications. Figure 2 shows a log-log plot demonstrating a near-log-linear association (with funding explaining 89% of the variance, P<0.0001).  We use a log-log plot because both funding and number of publications follow skewed distributions; this also follows standards illustrated, for example, by Geoffrey West in his recently published book Scale. The slope of the log-log line is 0.77, a value less than one, consistent with diminishing marginal returns; that is to say, an increase of funding by 10% is associated with a less-than 10% increase in number of publications.

The authors also note that, even though there is a correlation between government expenditures and the number of publications, there is little correlation between funding and citation impact. Figure 3 is a scatter plot which shows the absence of association (in a regression model, funding explains only 5% of the variance, P>0.10).

These findings offer intriguing insights into research inputs and outputs on an international scale. Taken together, they suggest that funding is strongly associated with quantitative output (i.e. number of publications), but that other factors may play a stronger role in citation output – which the authors describe as a signal of “engagement and recognition .”

We congratulate the authors for their analyses and publication. And, separately, we commend them as well for their willingness to share their data with the wider research community. By facilitating this access, information can eventually lead to ground-breaking findings that will improve the health and lives of all Americans and those around the world too.

Categories: NIH-Funding

Be Careful to Pick the Right Funding Opportunity Announcement (FOA)

Thu, 12/07/2017 - 12:30

Recent policy changes requiring clinical trial applications to be submitted to FOAs that specifically allow clinical trials, first announced in fall of 2016, impact how all NIH applicants choose a FOA, whether you are submitting a clinical trial or not.

Over the last year, each NIH Institute and Center has been carefully evaluating its research funding priorities and strategic goals and using that information to articulate their funding priorities for clinical trials.  They are communicating their priorities through the funding opportunity announcements they issue.

The requirement to respond to clinical trial specific FOAs begins for applications submitted for due dates on or after January 25, 2018. NIH is reissuing any FOA that will accept clinical trial applications after that date. Many of these FOAs have already been issued, others will be published at least 60 days before the first due date for which they will accept applications. How can you tell which FOAs will allow clinical trials?  Reissued clinical trial FOAs make clinical trial allowability clear in both the title and in section 2, and they include clinical trial review criteria.

Responding to the correct type of FOA ensures that you know what information you are expected to include in your application and that you can develop an application that is responsive to the review criteria. It also ensures that reviewers apply the correct criteria and give your application the best review possible.

Before beginning your search for an FOA, if you are doing human subject research you should use our clinical trial tool to determine whether NIH considers any of your studies a clinical trial.

If any study (or component) of your application meets the NIH definition of a clinical trial (even if your application includes other studies that are not clinical trials), you must respond to a FOA that allows for clinical trials.

If none of your specific aims include studies that meet the NIH definition of a clinical trial, be sure to respond to an FOA that does not require clinical trials. Check section II of the FOA; there will be a row entitled “Clinical Trial?” that should say either “Clinical trials not allowed” or “Clinical trials optional”.

We are re-issuing existing parent announcements as “clinical trial not allowed” for due dates on or after January 25, 2018.  Our most recent reminder notice provides a list of all the parent announcements (old and new) and when they will be reissued. .) . The participating organizations may vary between the “clinical trial not allowed” parent FOA and the “clinical trial required” parent FOA for the same activity code. Read the details of each FOA carefully. Note that some institutes that participate on a “Clinical Trial Required” parent may limit their participation to mechanistic studies. Check the Related Notices section of the FOA for any restrictions.

Some IC’s are using different FOAs for different kinds of trials.  We encourage you to visit individual IC’s web pages for guidance.

Note that even for resubmissions, revisions or renewals, you may need to find a new FOA to apply to with the appropriate clinical trial allowability that reflects the research in the application you are submitting.

The upshot of all this?  The FOA landscape is changing. It is important to pick your FOA carefully. We will be reissuing all parent FOAs and all FOAs that will allow clinical trials at least 60 days before the first due date. Before you are ready to apply, check back to be sure you are responding to the latest version of the FOA, and to read any related notices that have been issued since you first looked at the FOA. Learn more about understanding funding opportunities and NIH clinical trial requirements on the NIH Grants and Funding website. And be on the lookout for a new video we will be putting out in the next few weeks on finding and understanding funding opportunities.

Categories: NIH-Funding

Why Project Outcomes Matter in your Interim and Final RPPR

Thu, 11/16/2017 - 14:42

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-Funding

Teaming with ORCID to Reduce Burden and Improve Transparency

Wed, 11/15/2017 - 09:30

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-Funding

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

Wed, 11/08/2017 - 08:54

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-Funding