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
As part of a wider initiative to shape the future direction of research training for the biomedical workforce as a whole, we at the NIH are actively pursuing ways to examine the physician-scientist workforce and to optimize training for clinicians seeking research careers. Physician-scientists face some challenges and career transition pathways unique to being in a clinical career track, hence the need for a specific focus on this workforce. Continue reading
Understanding what you need to know and do to apply for a grant can be a challenge. NIH’s application instruction guide is long, with lots of background information that you may only occasionally need. On top of that, funding opportunity announcements have instructions that often add to those in the application instruction guide. …. Continue reading
NIH is beginning the process of developing a 5-year strategic plan, at the request of Congress. NIH developed a framework to identify crosscutting areas of research …. Continue reading