Common Data Elements foster rigor, facilitate data sharing, and allow multiple datasets to be integrated. They also help make data more FAIR (Findable, Accessible, Interoperable, and Reusable). Many different CDEs are currently in use and can vary across research disciplines, so we would encourage researchers check out databases like the NIH CDE Repository for examples, tools, and other related resources. Through a recently released Request for Information (NOT-LM-21-005), we seek your thoughts on how you use CDEs, potential challenges to their adoption, and how NIH might facilitate and incentivize their use to help us plan future CDE-related efforts.
Learn more about the planning process and ask questions at one of the upcoming webinars (3/9, 3/16) hosted by NIH, registration required. Continue reading
Have suggestions to improve the American research environment? The National Science and Technology Council’s (NSTC’s) Joint Committee on the Research Environment (JCORE) wants to hear from you! Make your voice heard in response to JCORE’s Request for Information (RFI), seeking input on actions that Federal agencies can take, working in partnership with private industry, academic institutions, and non-profit/philanthropic organizations, to maximize the quality and effectiveness of the American research environment. Continue reading
NIH is currently accepting public comments on the use of standards for capturing, integrating, and exchanging clinical data for research purposes (NOT-OD-19-150). This is a great opportunity to hear more from the community on ways to strengthen approaches that find, share, and access high-quality patient data, while also making it more interoperable and reusable. Such goals align with long-standing NIH data sharing policies and what was also called for in a related NIH strategic plan on data science. Continue reading
Promoting scientific environments that can encourage and benefit from a full range of talent is necessary in biomedical research today. The NIH Common Fund is conducting strategic planning for a potential new program exploring ways to create a route of entry and advancement for talent from diverse backgrounds into independent academic faculty positions. NIH is seeking broad input on this approach from academic institutional leadership, biomedical faculty, and interested members of the public. Continue reading
NIH has long been committed to transparency into who and what we fund. We have previously discussed the value of freely-available web tools that allow you to gain insight into NIH funding decisions. Award data available via RePORT and RePORTER, for instance, include non-sensitive information such as awardee institution, principal investigator, funding levels, research abstracts, as well as associated publications, patents, and other project outcomes. The data available through RePORT are quite powerful in their own right. However, compelling arguments exist for why researchers outside NIH should have access to even more information associated with the grants process. Continue reading
The 21st Century Cures Act requires federal agencies to “review applicable regulations and policies for the care and use of laboratory animals and make revisions, as appropriate, to reduce administrative burden on investigators while maintaining the integrity and credibility of research finding and protection of research animals.” This past March we requested feedback from the public on ways to reduce regulatory burden while also maintaining the highest standards for protecting animal welfare and scientific integrity. You responded with constructive and helpful feedback with more than19,000 comments. Generally, many responses supported the actions initially proposed in the request, but they were balanced with concerns from animal advocacy and other groups. Continue reading
Last December, NIH announced a revision to its Inclusion of Children Policy to expand the policy to individuals of all ages. The revised policy, now called the Inclusion Across the Lifespan policy, requires individuals of all ages (including children and older adults) be included in clinical research studies unless there are scientific or ethical reasons to exclude them.
A recent Viewpoint Essay published in the Journal of the American Medical Association (JAMA), co-authored by Drs. Marie Bernard (National Institute on Aging), Janine Clayton (NIH Office of Research on Women’s Health), and Michael Lauer, highlights the need for such a policy. The essay summarizes efforts by NIH to implement 21st Century Cures requirements to publish data on the age of research participants, to convene a workshop on age grouping and exclusions, and to make a determination on whether to revise inclusion guidelines on age.
We have written several blogs and articles over the past two years about our efforts to enhance stewardship and transparency in clinical trial research. Indeed, earlier this year Congress applauded our efforts thus far and reaffirmed its commitment to ensuring public access to the results of the NIH-funded clinical trials through timely registration and results information reporting on ClinicalTrials.gov. However, we have heard concern about how the NIH’s Policy on the Dissemination of NIH-Funded Clinical Trial Information applies to fundamental studies involving human participants. Continue reading
I’d like to call your attention to an opportunity to provide comments on a proposed clinical trial protocol template, developed by the FDA and NIH, and informed by the guidance set forth by the International Conference on Harmonisation (ICH) E6 Good Clinical Practice. The template provides a standard format, and corresponding instructions and sample text, for… Continue reading