Month: December 2015

‘Twas the night before Christmas, and at NIH,

There were still policy issues, keeping us wonks awake.

The sIRB comments have been read with care,

Soon a final policy will be ready to share.

The Common Rule comments are still flowing in,

Thoughts on consent forms for biospecimens.

NSABB staff are busy, organizing fora to discuss,

The Gain of Function studies that have raised such a fuss.

And I at my computer, and staff at theirs, too,

Are pushing along the CT.gov final rule.

Precision medicine and chimeras are both front of mind,

Biosafety compliance is not far behind.

The new Strategic Plan raised a small clatter,

As everyone read it to find what really matters.

Data sharing policy, don’t forget about that,

Even as we update our disease burden stats.

The Biennial report is soon to emerge,

Full of good info – read it, we urge!

The RAC staff is ready, FR comments in hand,

To implement the streamlined process we planned.

Then what to our wondering eyes should appear,

But an omnibus bill for this fiscal year!

And as OSP Director, true policy geek,

I keep policy wheels rolling, week after week,

“Now, consent! Now, DURC! Now, gametes and eggs!

On NPRM! On agencies and regs!

To extramural and intramural, and all in between,

To new science policy in 2016!”

The Office of Science Policy (OSP) has added technology transfer and innovation policy to its scope of advice and support to the NIH Director on issues affecting the biomedical research community, the NIH, and the public.  As described previously, OSP participates in the development of new policies and programs in a variety of arenas that span the research continuum from basic laboratory science, through translational and clinical research, and from domestic to global public health.   With the addition of tech transfer policy to our portfolio, OSP staff now collect data and assess activities involving the commercialization of technologies based on NIH funded research.  Ongoing research programs invariably require the application of policies related to technology transfer. In addition, the advent of new technologies and collaboration paradigms raises questions and may merit application of new policies.

For example, in receiving a material from a third party, what level of restrictions, if any, is NIH willing to accept on its use, the publication of research results, and ownership of newly developed materials?  If a new inventive technology arises, will it be patented, what institution(s) owns the patent, and who has rights to use it for research or commercial use?  These are typically fact-specific questions made by NIH Institutes and Centers (ICs) and grantees.   However, policy guidance shapes where the lines are drawn and when.  Access to new technologies and creative collaborative arrangements may require creative applications of existing policies or the development of new ones.

While taking on a leading role within the Office of the Director, OSP works closely with the Office of Intramural Research (OIR), the Office of Extramural Research (OER), and ICs on policy issues within their respective domains.  In the past, technology transfer policy issues have included arrangements for the receipt and distribution of approved stem cell lines, patenting of genomic technologies, and the restrictions under which samples of pandemic flu strains would be distributed internationally to researchers and organization preparing vaccine seed strains.  The reorganization of technology transfer at NIH and the introduction of staff focused on technology transfer in OSP have led to the newly created Technology Transfer and Innovation Policy Division.   Among our areas of current interest: the evolving nature of complex prognostic tests requiring greater clinical development prior to commercialization and an analysis of drugs and biologics approved for precision medicine applications.

This staffing of expertise within OSP will benefit the OD and the NIH community in strengthening the management and oversight of policy functions and the programs that provide vital support to the NIH community on matters involving technology transfer and innovation policy.