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

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 …. Continue reading

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

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. Continue reading

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

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. …. Continue reading

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Implementing a New Human Subject and Clinical Trial Information Form

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 …. Continue reading

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

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. …. Continue reading

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

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. For more information and to register…. Continue reading

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

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 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. …. Continue reading

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

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…. Continue reading

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