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.
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).
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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 over and over again in one system after another. These situations do have an upside: they provide us the opportunity to look for opportunities to simplify.
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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.
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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.
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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.
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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 ….
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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). …. 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….
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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. ….
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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. …
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