Certificates of Confidentiality for NIH Grants

Earlier this year I wrote a post about the 21st Century Cures Act and its changes that directly affect the NIH. One part of this new legislation contains provisions to improve clinical research and privacy through certificates of confidentiality.

Currently, certificates of confidentiality (or “CoCs”) are provided upon request to researchers collecting sensitive information about research participants. Soon, CoCs will be automatically provided for NIH-supported research, as set forth in the 21st Century Cures Act. …. Continue reading

Status of Our Initiatives to Strengthen Clinical Trials

In September Dr. Carrie Wolinetz and I blogged about our policy reforms to build a more robust clinical trials enterprise through greater stewardship and transparency at each phase of the clinical trial journey from conception to sharing of results. We discussed how these efforts promise to improve the quality and efficiency of clinical trials, translating into more innovative and robust clinical trial design, and accelerated discoveries that will advance human health.

Over the past months we have continued to partner with the community to work through the implementation of these new policies, developing responses to frequently asked questions and even reconsidering the timing of our single IRB policy to give our grantees time to work through how to operationalize the change. …. Continue reading

Accelerating Clinical Research by Streamlining Multi-site Review of Human Subjects Research

Research involving human participants is key to improving public health and advancing medicine. Oversight of such research by institutional review boards (IRBs) both protects research participants and promotes ethical science. IRB review and approval is a critical step in initiating the start of a research project and for multi-site studies, NIH is taking an important step to help streamline the process. Today, NIH is issuing the NIH Policy on the Use of a Single Institutional Review Board (IRB) for Multi-Site Research (sIRB Policy) …. Continue reading

Proposed Changes to Human Subjects Regulations Are Open for Comment

As many in the research community know, the “Common Rule” refers to current regulations to protect individuals who participate in research as human subjects. The regulations, which have been in place since 1991, are followed by 18 federal agencies that support research – hence the name. Today I’d like to give you some background on how these regulations – and the conversation around these regulations – have evolved since 1991, and let you know about an opportunity to provide feedback on the modernization of these important rules. …. 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

Streamlining IRB Review of Multi-Site Clinical Research Studies

For many decades now the Department of Health and Human Services (HHS), and consequently NIH, has required institutional review board (IRB) review of research involving human subjects. …. as the clinical research landscape evolves, so should our policies to assure that NIH-funded research can more quickly generate research results without compromising protections for those who volunteer to participate in clinical studies. …. Today, NIH released a draft policy proposing that all NIH-funded multi-site clinical studies carried out in the US should use a single IRB’s review, rather than working through the IRB approval process of each participating institution. …. Continue reading

Credit Where Credit’s Due: Human Subjects Training for Physicians

NIH supports critical research that advances human health, while protecting the rights and welfare of the research participants who are integral to research success. NIH’s human subjects protection policies ensure the conduct of quality research and provide the proper stewardship of NIH funding. Some of you may have taken human subjects training offered at your home institution, but did you know NIH offers free online training as well? ….. Now we have even more good news for physicians interested in this training! Beginning March 3 2014, physicians who successfully complete the course will be able to earn up to 3 American Medical Association Physician’s Recognition Award (AMA PRA) Category 1 Credits™ continuing medical education (CME) credits. …. Continue reading