Leveraging Standardized Clinical Data to Advance Discovery

Opportunity knocks for NIH researchers, who will be able to leverage clinical data from electronic health record (EHR) systems with increased frequency and consistency. The recently published final rule, which went into effect on June 30, 2020, and requires electronic health record (EHR) systems to provide the clinical data necessary for nationwide, interoperable health information exchange through the adoption of the U.S. Core Data for Interoperability (USCDI) standard. Continue reading

An Early Look at Applications Submitted During the Pandemic

It has been four months since the COVID-19 pandemic shuttered laboratories and clinical studies across the country and the world. On April 10, only a few weeks into the pandemic, the Congressional Research Service (CRS) published a report describing the consequences of social distancing and other pandemic mitigation measures. These consequences included laboratory closures, de-prioritized projects, cancellation of meetings and conferences, loss of revenue, disrupted personnel processes, supply-chain interruptions, and, overlying all of these, a great deal of uncertainty. Since the CRS report was issued, we have learned more about the pandemic’s effects on non-COVID research and on the research workforce. Continue reading

Useful Flexibilities for Animal Care and Use Programs to Comply with the PHS Policy During the COVID-19 Pandemic

As we continue to address the effects of COVID-19 and as some states and institutions are considering reopening, we would like to share some administrative flexibilities that NIH is providing to research institutions with laboratory animal programs. These flexibilities are meant to assure personnel safety and animal welfare while enabling research personnel to prioritize and preserve research efforts. Some of these can be useful in reducing administrative burden, too. Continue reading

Addressing Foreign Interference and Associated Risks to the Integrity of Biomedical Research, and How You Can Help

On Tuesday, June 23, Dr. Kelvin Drogemeier, the Director of the Office of Science and Technology Policy (OSTP), gave a presentation to the Federal Demonstration Partnership (FDP) on “Enhancing the Security and Integrity of America’s Research Enterprise.” Dr. Drogemeier articulated five “key takeaway” messages. I’d like to take this opportunity to summarize Dr. Drogemeier’s presentation and how it fits within the context of NIH extramural research. Continue reading

How We Handle Allegations of Sexual Harassment

If there are concerns that sexual harassment is affecting an NIH-funded project, we want to know about it. NIH takes the same rigorous approach to addressing allegations involving sexual harassment as we do other integrity issues. We have added a web page that highlights the detailed steps NIH takes when we receive notification of a concern. Continue reading

Help Us Strengthen Rigor of Animal Research: Public Feedback Requested

Ever figured out a clever solution to a vexing challenge that affected the rigor of your work with laboratory animals, and then thought that those solutions could improve the quality and transparency of animal research supported across NIH? Recently found yourself at virtual lab meetings brainstorming ways to facilitate translating the findings from your animal study to human biology and disease? Questioned the status quo on how the research culture drives the choice of animal models and the design of experiments? Well, we want to know more. Continue reading

New Steps to Help Ensure Safe Work Environments for NIH-Supported Research

If an institution requests approval to remove a principal investigator (PI) or other senior key person named in the grant award due to concerns about safety and/or the work environments (e.g. due to concerns about harassment, bullying, retaliation, or hostile working conditions), NIH expects to be notified. If an institution requests a change of recipient institution, and there are concerns about safety and/or work environment involving the PD/PI, NIH expects to be informed. Continue reading

Accepting Preliminary Data as Post-Submission Material and Other COVID-19-Related Application Flexibilities

As our nation looks to begin reopening, NIH continues to track how well our policies are meeting the evolving needs of the research community. In this post we would like to highlight allowance of preliminary data as a new special exception to our post submission materials policy and our guidance for reviewers. Continue reading

Emerging Research Now Available Through New NIH Preprint Pilot

Preprints – complete, public drafts of scientific documents that are not yet certified by peer reviewed – are playing a key role in accelerating dissemination of research on the SARS-CoV-2 virus and COVID-19, highlighting a need for broader discovery and distribution of early research results in literature searches. Responding to this urgent need, the National Library of Medicine (NLM) has launched the NIH Preprint Pilot, which will test the viability of making preprints searchable in PubMed Central (PMC) and, discoverable in PubMed, starting with preprints reporting NIH-supported COVID-19 research. Continue reading

Anonymizing Peer Review for the NIH Director’s Transformative Research Award Applications

NIH is seeking applications for the 2021 Transformative Research awards through a new funding opportunity (RFA-RM-20-013) recently released on Friday, May 21, 2020. And, as a way to address concerns about bias in peer review while also enhancing diversity, this High Risk, High Reward program is going to anonymize the review of Transformative Research Award applications. Continue reading