FAQs now available to clarify our recent guidance on the ability to direct charge personal protective equipment (PPE) costs to clinical trials and clinical research awards (NOT-OD-20-164).
It’s been over eight months since the COVID-19 pandemic crisis struck, changing every facet of life as we knew it. The U.S. biomedical research enterprise was not spared, as lockdowns and severe restrictions on activities took hold across the country. At the time, we offered our perspectives on efforts we could take to cushion the shock. Since that time, much has happened. COVID-19 research has blossomed with impressive results including FDA approval of a therapeutic agent (remdesivir, which was found to have value in a large-scale NIH-funded trial), development of several candidate vaccines that have already made to pivotal Phase 3 trials, and the rapid development of a variety of diagnostic testing platforms. However, research unrelated to COVID has seen a different picture.
Ten years ago, NIH launched the RePORT (Research Portfolio Online Reporting Tools) website to serve as a one-stop shop for reports, data, and analyses of NIH research activities. Well, drum roll please, a new and modernized RePORT site as well as a faster and easier to use NIH RePORTER have now arrived. The updated RePORT site strives to meet the needs of today’s users based on feedback received over the years. It is easier, simpler, and quicker to access the same information you have come to rely upon.
Over the past several years we have heard consistent concerns about the complexity of review criteria and administrative load of peer review. To address these concerns, CSR has convened a working group of our advisory council, charged with recommending changes to research project grant review criteria that will improve review outcomes and reduce reviewer burden. We would like to hear your thoughts on the issue. How might review criteria be modified to obtain the best evaluations of scientific merit?
NIH’s National Library of Medicine has launched an effort to modernize ClinicalTrials.gov to deliver an improved user experience on an updated platform that will accommodate growth and enhance efficiency. Creating a roadmap for modernization requires feedback from a wide array of stakeholders on how to continue serving, balancing, and prioritizing their varied information needs. As ClinicalTrials.gov celebrates its 20th anniversary on February 29, 2020, we’re asking for your input on how it can best continue to serve your needs for many more years to come.
My colleagues within the NIH Office of Portfolio Analysis sought to answer this call. Drs. Ian Hutchins and George Santangelo embarked on a hefty bibliometric endeavor over the past several years to curate biomedical citation data. They aggregated over 420 million citation links from sources like Medline, PubMed Central, Entrez, CrossRef, and other unrestricted, open-access datasets. With this information in hand, we can now take a better glimpse into relationships between basic and applied research, into how a researchers’ works are cited, and into ways to make large-scale analyses of citation metrics easier and free.
Basic research involving humans that seeks to understand the fundamental aspects of phenomena also may meet the NIH-definition of a clinical trial. We refer to these studies as BESH – Basic Experimental Studies involving Humans (see our previous blog). Since this type of research meets the NIH definition However, some researchers have faced challenges in fitting these studies into the data fields for submission in ClinicalTrials.gov. The NIH has determined that more time is needed to address these challenges. Today, NIH published a Guide Notice (NOT-OD-19-126) announcing the extension of delayed enforcement of registering and results reporting of BESH on ClinicalTrials.gov through September 24, 2021.
Applicants should include a rationale for the age range of study participants and justification for age-based exclusion in the Inclusion of Women, Minorities, and Children section of the PHS Human Subjects and Clinical Trials Information Form (Section 2.4). This section will continue to have the heading “Inclusion of Women, Minorities, and Children” until the next forms update. See the instructions under Inclusion of Children in the application guide for additional information.
When conducting clinical trials, NIH funding recipients are required to register their study at ClinicalTrials.gov. To make registration easier, a new feature in the eRA Human Subjects System (HSS) allows applicants and recipients to export study record entries as an XML file, and upload fields that are captured in both systems directly into ClinicalTrials.gov’s Protocol Registration and Results System (PRS).
For your convenience, here is a roundup of recently announced changes impacting grant application submission for due dates on or after January 25, 2019.
