Public Access Reporting and Resource Sharing

We’ve recently issued an NIH Guide notice to clarify when a grantee should report papers as an output of their grant in their progress reports, and help reduce administrative burden for investigators. Awardees are only required to report papers that directly arise from their award (such as authorship, consulting with authors, preparing manuscripts, and running analyses reported in the publication). In other cases, awardees have discretion in determining whether their contribution …. Continue reading

Enhancing Reproducibility in NIH-supported Research through Rigor and Transparency

Nothing could be more important to our enterprise than research rigor, assuring that the results of our work are reproducible. Our conversation with you on this topic began early last year with a commentary in Nature by Francis Collins and today’s guest blogger, Larry Tabak, on the importance of reproducibility and how NIH plans to enhance it. As described in a follow-up Rock Talk post, the topic of reproducibility is not new. Evidence has shown that too many biomedical-research publications are irreproducible. Thus this topic demanded our community’s immediate attention and we have had continued dialog with and participation by you over the course of the last 18 months to describe the issue, request information, launch pilots, and craft a way forward to enhance reproducibility. Continue reading

A Proposed HHS Regulation and NIH Policy to Further the Impact of Clinical Trials Research

Clinical trials play a vital role in transforming scientific research into medical interventions to improve human health. Transparency about the clinical trials underway and their subsequent results ensure potential participants can make informed decisions about potential trial participation and know how their participation may have helped others. …. Today, the Department of Health and Human Services (HHS) announced proposed regulations to implement the clinical trial reporting requirements established by the Food and Drug Administration Amendments Act (FDAAA) of 2007. …. Importantly, today NIH also announced a proposal to apply these same proposed requirements to all NIH-funded clinical trials, whether subject to FDAAA or not. The proposed policy would require that every NIH-funded clinical trial be registered …. Continue reading

Expanding the Impact of Genomic Data

Genomic research produces incredibly large amounts of valuable data, often more than one lab can feasibly interrogate. Every day, genomic sequencing costs decrease, and high-throughput technologies advance, allowing scientists to generate large-scale genomic data faster than before. Thus the sharing of these data not only is practical and efficient, it also maximizes the scientific potential of valuable data. This is why it’s important for you to know about the release of the final NIH Genomic Data Sharing Policy. Continue reading

NIH Asks for Comments on Genomic Data Sharing

Advances in genetic sequencing and high-throughput technologies, as well as a steep drop in genetic sequencing costs, have resulted in great volumes of genomic data produced with the support of NIH funding. In light of these scientific advances, NIH decided to expand its data sharing policies to encompass a wider range of genomic research. The resulting draft Genomic Data Sharing (GDS) policy, is now available for public comment. Continue reading

NIH and the Lacks Family Announce a HeLa Genome Data Sharing and Use Agreement

In 1951, biomedical research took a leap forward when it was announced that cancer cells taken from a patient, Henrietta Lacks, could not only be grown in a lab, but also grown in perpetuity, creating the first immortal human cell line. This cell line – “HeLa” – is the most widely used human cell line to this day. However, at the time …. Continue reading