Thoughts on How Institutions Can Promote a Culture of Research Integrity

On May 22, I had the privilege of participating in a terrific national conference that focused on what institutions can do to foster a culture of research integrity. I was also given the opportunity to present my thoughts on promoting research integrity, something I have written about before. My talk dealt with approaches institutions may take to foster a culture of research integrity, and I wanted to share it here as a resource for others.

Protecting Participants, Empowering Researchers: Providing Access to Genomic Summary Results

Today, we are updating the way we manage data related to the NIH Genomic Data Sharing Policy to again allow unrestricted access to genomic summary results for most of the studies we support in order to advance health or further research purposes. These summary results are importantly distinct from other genomic research data, most notably in that they do not include individual-level information. Instead, these results come from analyzing pooled genomic data from multiple individuals together to generate a statistical result for the entire dataset. Such information can be a powerful tool for helping researchers determine which genomic variants potentially contribute to a disease or disorder.

A Data Sharing Renaissance: Music to My Ears!

When world famous cellist, Yo-Yo Ma, visited the NIH campus, he shared a story from the history of music, in which the peak of stringed instrument quality occurred in the late 17th century at a time of great collaboration and sharing of knowledge. When instrument makers began to compete, all of that changed: secrets of craftsmanship were held close and the quality of instruments plummeted. This decline lasted, according to Ma, until the 20th century, when again the free-flow of knowledge resumed. NIH Director Francis Collins noted, “There’s a lesson here about science.”

Rigorous Resources for Rigorous Research

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.

Continuing Steps to Ensuring Credibility of NIH Research: Selecting Journals with Credible Practices

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.

4 Questions For Researchers and Institutions Involved In Human Subjects Research

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 opportunity announcements for clinical trials, Good Clinical Practice training, enhanced registration and results reporting on … Continue reading “4 Questions For Researchers and Institutions Involved In Human Subjects Research”

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 ….

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.

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 ….

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.