Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit cc.nih.gov. Updates regarding government operating status and resumption of normal operations can be found at OPM.gov.

A Seat at the Table: Behind the Scenes of the NIH-FDA-CMS Leadership Councils

One of the questions (or more accurately, lamentations) that I frequently hear when I am out amongst our stakeholder community is “Hey, wouldn’t it be great if you and other federal agencies got together and actually talked?”  Personally, I couldn’t agree more with this sentiment, and I wanted to take the opportunity to say unequivocally in response “YES!!  We actually do this pretty regularly.”  I want to highlight two successful and ongoing relationships that NIH has with some of its most important federal partners, the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS).

Let’s start with the NIH-FDA Joint Leadership Council.  As broad opportunities in translational research have come to the fore, it became clear that better coordination between agencies was necessary to fully take advantage of those handoffs from research to medical advancement.  As a result, the Joint Leadership Council was created, co-chaired by the NIH Director and FDA Commissioner, with senior staff from NIH Institutes and FDA Centers comprising the rest of the committee.  While the public perception of such interagency discussions might be “all talk and no action”, I am pleased to say that this effort has resulted in tangible products and improvements.

Some examples of what has come out of the leadership council include the BEST Resource and the NIH-FDA Protocol Template for Phase 2 and 3 IND/IDE Clinical Trials.   The BEST Resource came from the council’s recognition that a lack of consensus on terms used in translational science and medical product development was impeding research progress.  A working group of NIH and FDA leaders created a living glossary of important biomedical terms to ensure everyone was speaking the same language. As for the NIH-FDA template, that was developed with the goal of making it easier for investigators to prepare consistently organized protocols that can be easily reviewed by the FDA.  As a further extension of that, NIH then turned the template into the Clinical e-Protocol Writing Tool, which has been a huge success, drawing almost 2,000 visitors last month alone!

Another successful example of idea sharing between agencies is the NIH-CMS Leadership Council, which is of similar composition to the NIH-FDA council and is led by the NIH Director and CMS Administrator.  With CMS as the largest purchaser of health care in the United States, and NIH as the largest source of public funding for medical research in the world, it makes perfect sense for these agencies to work together.

NIH and CMS have used this forum to think about how to move NIH research results on evidence-based care into practice. As result of these discussions, a joint informational bulletin was sent out by CMS, NIH, and the Substance Abuse and Mental Health Services Administration (SAMHSA) to State Medicaid Directors regarding coverage of early intervention services for initial episodes of psychosis.  This was an important event because NIH research has shown that coordinated specialty care is a better treatment option, and this approach is more likely to be available to patients if it is covered by Medicaid.  Some of the other topics that this council has discussed include coverage of ancillary clinical care costs, physician reimbursement in clinical trials, and genomic medicine resource sharing.

NIH is always looking for ways to coordinate and collaborate with our partners to identify common problems and come up with solutions that will benefit the research community.  Leadership level councils are not the only such vehicle – truthfully, interaction between agencies takes place on a nearly daily basis between subject matter experts – but they do represent an effective way to ensure our agencies are working together to achieve our missions. The best news is, since these councils are still active and sharing ideas, I am confident that there will be more positive examples in the years to come.

Seasons Greetings from OSP!

‘Twas the middle of Hanukkah, and across OSP,

We’re thinking deep thoughts on NIH policy.

Talented experts working on the agency’s behalf,

While their Director’s moonlighting as Acting Chief of Staff…

There’s clinical trials, a suite of to-dos,

Designed to work together, stewardship to improve.

If you’ve got a trial, use our new FOA,

Or try the protocol template developed with FDA!

Gain of function research, now where did time go?

That term’s so last year, now we’ve P3CO!

As sIRB, finally goes into effect.

Certificates of confidentiality, our participants protect.

We celebrated 40 years since forming the RAC,

Results from research, how to give them back?

As for data sharing, in the New Year you’ll find,

A request for feedback, to help us draw policy lines.

On CRISPR! On HeLa! On emerging tech!

To transforming research, built on participant respect!

On stem cells! On rigor! On validated LDTs!

To solving the opioid crisis and burden of disease!

From privacy to march-in, from chimeras to gene drives,

Science policy to support research, that extends all our lives…

So to scientists and policy wonks, we wish you good cheer!

Happy holidays to all, and a healthy New Year!

Accessing Genomic Summary Results: We Want to Hear From You!

Enabling the secondary use of research data to advance scientific discoveries while respecting participant privacy has been a priority for both NIH and the public. How can we strike the right balance of maximizing public benefit from research while remaining consistent among the many important scientific and ethical considerations?

NIH has been evaluating the best way for researchers to access genomic summary results (GSR), which, as the name implies, are ‘aggregated’ summary statistics from all participants in a genomic research study or set of studies. GSR have an important distinction from some other types of genomic research data. This is because GSR do not include individual-level information, in contrast to individual genome sequences. Instead, GSR come from pooling genomic data from multiple individuals together, yielding information like genotype frequencies and other statistics. This information can help researchers determine which genomic variants might or might not contribute to a disease or disorder.

Before 2008, these types of GSR were publicly available in the NIH Database of Genotypes and Phenotypes (dbGaP). However, in 2008, an article was published showing that statistical methods using GSR could possibly be used to determine if an individual participated in a specific research study (if they also had access to that individual’s  genomic data). Because of this concern, NIH decided that until it had a better appreciation of the state of the science and the actual risks to research participants, it was best to have GSR available through controlled-access.

Since that time, NIH has convened two workshops to bring together leaders in the field to consider a wide range of issues, including those directly related to GSR. One of the workshops, held in 2016, focused specifically on the risks and benefits of different levels of access to GSR. NIH also solicited broad input in a Request for Information earlier in 2017. Based on the recommendations from the workshops and public comments received through the RFI, NIH has come to realize that many stakeholders believe that there is little risk when GSR are maintained through unrestricted access (i.e., in an open and public way). However, they also suggested that additional protections should be in place for sensitive studies where there might be additional concerns, such as studies that include populations from isolated geographic areas or with rare or stigmatizing traits.

Based on this input, NIH has developed a proposed update to the access process for GSR under the NIH Genomic Data Sharing Policy, and is now seeking public comment.  This update would allow GSR from most studies to be provided via a public, rapid-access model. GSR from sensitive studies would remain in controlled-access.

To view the request for comments and for instructions on how to comment, please visit: Previously Compiled Public Comments.

NIH encourages comments from all stakeholders, and is especially interested in hearing from members of the general public, research participants, and the broader patient community. Comments will be accepted until October 20, 2017.  In addition, during the comment period, experts from both OSP and NHGRI will also be hosting a webinar on GSR on October 4.  More details on this webinar will be provided shortly.

NIH is committed to maximizing the value of government-funded research while ensuring that participant privacy is protected, and we want to take all stakeholder thoughts into account.  We look forward to hearing from you!

This blog was co-authored by Dr. Eric Green, Director of the Human Genome Research Institute.  More information about NHGRI can be found at https://www.genome.gov/.

Dr. Mike Lauer
NIH Deputy Director for Extramural Research

National Biosafety Month: The New Fall Classic

What do you think of when you think of fall? Back to school? Pumpkin spice lattes? Raking leaves? That first chilly nip in the air?

Here at NIH’s Office of Science Policy, our thoughts turn to National Biosafety Month! This year’s annual event will feature an important new resource and additional opportunities for stakeholders to engage in a dialogue with NIH about biosafety. During National Biosafety Month, we encourage institutions to highlight the importance of biosafety and to undertake activities to strengthen their biosafety programs.  In past years during National Biosafety Months, NIH has promoted themes such as transparency, laboratory accountability, and public engagement. This year, our theme is “promoting biosafety through good governance.”

A recent activity of the Federal Experts Security Advisory Panel (FESAP) has been the development of a document articulating guiding principles and best practices for biosafety and biosecurity governance.  Just in time for National Biosafety Month, this document, “Guiding Principles for Biosafety Governance”, is now available.  A wealth of other resources that institutions may also find useful can be found, on the S3: Science, Safety, Security website.  I encourage you to take a look at these resources and determine what best practices might benefit your institution.

OSP has also been very active of late with respect to the future direction of biosafety oversight. This past July, we held a workshop  to examine the current biosafety oversight framework, and discuss the future direction of biosafety oversight given the emergence of new technologies in the life sciences and the evolution in our understanding of risk and safety.  In addition, OSP staff will be participating in a town hall meeting with biosafety professionals at the ABSA International 60th Annual Biological Safety conference in Albuquerque in October to follow-up on some of themes that were raised at the workshop. Stakeholders are also encouraged to share their thoughts with us at any time by emailing NIHGuidelines@od.nih.gov.

Finally, all throughout National Biosafety Month, I will be sending out biosafety-themed tweets.  Please make sure to follow me @CWolinetzNIH.  I encourage everyone to use #NBM2017 to keep the conversation going.

Effective biosafety oversight needs cooperation and commitment from all levels – from Federal to institutional to the individual scientists who are conducting vitally important research. Hopefully, National Biosafety Month will help strengthen that commitment to biosafety, not just in the fall, but throughout the year.