Author: admin

Seasons Greetings from OSP!

Posted on

‘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!

Blog Roll

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

Posted on

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
Blog Roll

National Biosafety Month: The New Fall Classic

Posted on

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 [email protected].

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.

Blog Roll

The Deep Dish on Institutional DURC Policy: Calling All Stakeholders!

Posted on

If my time in the U.S. government has taught me anything, it is the vital importance of checking in on how the policies we craft are being implemented by our stakeholders.  Policies should not be set in stone, especially when they apply to fast moving areas of science, and we need to hear from the affected community what is or is not working.

When the U.S. government and institutional stakeholders gathered at the NIH in July 2015 to discuss the U.S. Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (DURC), it was still months until the policy would come into effect.  Yet this face-to-face exchange of questions, ideas, perceived challenges, and initial experiences with federal policy implementation was invaluable to providing investigators, institutions, and federal funding agencies with a clearer understanding of their individual and shared responsibilities to identify and manage DURC.  As productive as that meeting was, at that point, it was still impossible to predict the impact of the yet-to-be implemented institutional DURC policy.

To leverage the benefits that come with hindsight, and two years of experiences, the U.S. government is hosting a two day stakeholder workshop on September 25-26, 2017, in Chicago, Illinois to engage with boots-on-the-ground implementers of the institutional DURC policy.  The purpose of this workshop is to learn how the DURC policy is being implemented at different institutions, hear about any challenges encountered and strategies devised and, perhaps most importantly, facilitate the sharing of best practices among research institutions and investigators in order to make compliance with the policy easier.

The safety and security of life sciences research is absolutely dependent upon the shared role of scientists, research administrators, compliance officers, and oversight bodies.  Hearing about the various ways these groups function to achieve the goals of supporting beneficial research while mitigating risks associated with DURC should be a great practical resource to those institutions participating, as well as a great value to NIH and the U.S. government.  I encourage individuals and institutions with a stake in research subject to the DURC policy to register, come share their views, and be active participants in the discussions in Chicago.  I hope to see you there!

Blog Roll