A Match Made in Science Policy Heaven

Everyone knows someone who has dived fearlessly into the world of online dating and found the perfect match.  But did you know that the American Association for the Advancement of Science (AAAS) plays matchmaker between federal agencies and scientists who are interested in getting their feet wet in the science policy arena?

Here at NIH, we host up to 40 AAAS Science and Technology Policy Fellows each year.  This one-year fellowship provides the opportunity for scientists from a wide range of disciplines and career levels to experience the (science policy) sausage making process à la NIH, while at the same time bringing a wealth of scientific and analytical expertise to the table.  Since this is the time of year when all the action happens, it seemed like an ideal time to tell you about how this program works.

As you can imagine, the whole operation requires considerable coordination, and OSP is responsible for managing NIH’s involvement in the program.  In February and March, the Fellowship cycle begins, and we work to recruit offices from across NIH who are interested in potentially hosting a Fellow. One of the most challenging parts of our job comes next during April’s placement week.  During that week, Fellowship finalists converge on Washington en masse, and dash from agency-to-agency to participate in interviews with potential host offices (think of a cross between speed dating and a steeple chase!).  This all culminates in a matching process, where we work with AAAS to place finalists within NIH host offices.As you might imagine, only the best matches are placed across NIH’s Institutes and Centers, as well as within the Office of the NIH Director.  Fellows find homes in a range of different NIH offices that are engaged in policy, planning, communication, outreach, legislative affairs, program administration, and evaluation, to name but a few.

Once matching has concluded, the real work can then begin.  OSP works with the host offices, AAAS and the incoming Fellows, to begin the onboarding process in preparation for the Fellow’s first day in September.  When the Fellows arrive, OSP provides an NIH orientation to bring everyone up-to speed and then assists throughout the year in making the Fellows and host offices aware of the various AAAS and NIH program requirements.

Having worked closely with many of the AAAS Fellows (as well as having several OSP staff as alumni of the program) I see the Fellowship as a valuable tool in advancing NIH’s mission by fostering productive relationships between federal policy makers and scientific professionals.  I like to look at the OSP role in this as making sure that the relationships forged through this program begin and remain strong!  For more information about our involvement with the program please visit the OSP website.

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.