Under the NIH Genomic Data Sharing Policy, investigators who intend to generate genomic data using research or clinical specimens collected or cell lines created after January 25, 2015 may only do so with consent, even if the data are generated from specimens that are de-identified. Continue reading
Over two years ago, NIH rolled out a policy to enhance reproducibility of its supported research through rigor and transparency. Applicants and reviewers were required to devote more attention to four areas: the rigor of the prior research (scientific premise), the rigor of the proposed research (scientific rigor), consideration of biological variables including sex, and the authentication of key biological and/or chemical resources.
When the 21st Century Cures Act was passed later that same year, we were required, amongst other things, to assemble a working group of the Advisory Council to the NIH Director (ACD). These experts were charged with recommending ways to further enhance reproducibility of the research we fund, while being informed by the current policy.
The scientific community is paying increasing attention to the quality practices of journals and publishers. NIH recently released a Guide notice (NOT-OD-18-011) to encourage authors to publish in journals that do not undermine the credibility, impact, and accuracy of their research findings. This notice aims to raise awareness about practices like changing publication fees without notice, lacking transparency in publication procedures, misrepresenting editorial boards, and/or using suspicious peer review. Continue reading
Last September, and in January of this year, we wrote about a suite of initiatives aimed at improving the quality and transparency of the NIH-supported research that most directly engages human participants – clinical trials. These initiatives include dedicated funding … Continue reading
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
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
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
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
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
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