NIFA Director Meets With
Stakeholders To Seek Input And Address Concerns
National Institute of Food and Agriculture (NIFA) Director, Dr. Roger Beachy, addressed concerns of the agricultural research community and asked for additional input at a stakeholder meeting on July 29th. During the meeting, Dr. Beachy stated he hoped to reach a broad audience beyond the scientific societies that participated in previous NIFA listening sessions.
In response to worries that the number of individual investigator-initiated grants will be reduced in favor of large awards to multidisciplinary teams, Dr. Beachy explained that multi-institutional awards are especially appropriate due to the regional nature of agricultural research. However, he renewed his commitment to allocate 30 percent of NIFA’s Agriculture and Food Research Initiative (AFRI) budget to individual investigator-initiated grants. Since this issue is inherently tied to the way in which university faculty are evaluated, he suggested that the tenure system be revised to better encourage collaborative research. Dr. Beachy also expressed his concern that AFRI grants to new investigators might be used primarily to obtain future awards from the National Institutes of Health (NIH) and the National Science Foundation (NSF), thereby enabling scientists to abandon agricultural research for the biomedical or physical sciences.
Regarding the scientific community’s warning that request for applications (RFA’s) targeting specific societal challenges would exclude vital areas of agricultural research, Beachy stressed that NIFA must focus on making large impacts with limited resources. He acknowledged that previous stakeholder input helped identify research areas in danger of being neglected, and he specifically cited food science as an important area of nutrition research with implications beyond obesity prevention. There will also be flexibility within NIFA’s five RFA “challenge areas," and the agency is willing to help researchers determine the appropriate category for their specific research project.
Concerns that large initial awards will limit future grant availability are based on the assumption that NIFA funding will remain flat, something seen as unlikely by Dr. Beachy, who remains confident that Congress appreciates the importance of agricultural research. Recognizing the role coalitions have played in garnering support for NIFA, the director hopes stakeholders will unite to identify common areas of key research that would benefit the broadest range of stakeholders while producing significant scientific advances. NIFA will also establish partnerships with NIH and NSF to coordinate agency goals and meet the needs of the research community.
FASEB submitted a
statement regarding fiscal year (FY) 2011 AFRI RFA’s at a NIFA stakeholder meeting held on June 2nd. NIFA Deputy Administrator Dr. Deborah Sheely, who was in attendance at the July 29th meeting, said comments from the June 2nd meeting are being analyzed and compiled into written reports which will be considered during the preparation of FY 2011 RFA’s.
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House Holds Hearing on
Status of Open Access
On July 29, 2010, the Information Policy, Census, and National Archives Subcommittee of the House Oversight and Government Reform Committee convened a hearing entitled “Public Access to Federally-Funded Research.” Subcommittee Chairman William Lacy Clay explained that the purpose of the hearing was to examine the current level of accessibility to federally-funded research and discuss increasing access.
Panel one, which was comprised of Allan Adler, Vice President for Government Affairs at the Association of American Publishers; Steven Brecker, PhD, Executive Director for Science at the American Psychological Association; and Ralph Oman, Professorial Lecturer in Intellectual Property Law Fellow at the George Washington University Law School, cautioned the subcommittee on the dangers of pursuing public access policies without fully appreciating the potential effects
on scholarly publication and the scientific enterprise. The key argument put forth was that publishers invest significant resources in the production of peer reviewed, scientific literature. Any model, whether subscription-based or “open access,” must allow publishers to recoup the costs associated with value added. Later, Chairman Clay asked “whose investment means more…American taxpayers or publishers?”
Further, the first panel emphasized that federal public access policy must be responsive to the heterogeneity of scientific publishing characteristics across academic disciplines. As a follow-up, Representative Judy Chu (D-CA) asked specifically about the unique challenges facing publishers of psychology research under the current National Institutes of Health (NIH) policy. She also asked how the government could facilitate patient access. Panelists, as well as a Representative Jason Chaffetz (R-UT), also highlighted the National Science Foundation policy of making final grant reports available to the public instead of journal articles.
The second and third panels consisted of a total of seven witnesses: among them were Richard Roberts, PhD, Chief Scientific Officer of New England Biolabs; Catherine Nancarrow, Managing Editor of the Public Library of Science (PLoS) Community Journals; and David Lipman MD, Director of the National Center for Biotechnology Information, NIH. Collectively, these witnesses emphasized the viability of an open access business model, citing the recent first two quarters of profitability for PLoS, and the potential benefits of expanded access for scientists, patients and their families, and students. Here, Representative Carolyn Maloney (D- NY) emphasized the importance of peer-review and her concern that public access efforts could jeopardize the quality of science. The testimony and associated materials from all witnesses and Subcommittee Chairman Clay can be viewed
here.
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HHS and CDC Solicit
Input on Select Agents and Toxins List
The Department of Health and Human Services (HHS) and the Centers for Disease Control (CDC) are undertaking their biennial review and republication of the HHS list of select agents and toxins.
An Advance Notice of Proposed Rule Making (ANPRM) was published in the July 21st
Federal Register seeking comments on the revision. HHS and CDC are interested in input on
several issues including the content of the list (i.e., should agents be added or removed), whether the list should be tiered or stratified based on the risk posed by the agents, the criteria that should be used to designate high-risk and low risk agents, and the security measures that should be in place for those agents. Stratification of the list was recommended by the National Science Advisory Board for Biosecurity and the National Research Council. In a May 2009
letter to the U.S. Working Group on Strengthening the Biosecurity Security of the United States, FASEB and the Association of American Medical Colleges recommended that careful consideration be given to this idea. FASEB’s letter stated that “it may make sense to have stricter security measures…for extremely high risk agents…while allowing greater access to less pathogenic and ubiquitous agents.” Comments on the ANPRM are due to HHS on August 20, 2010.
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HHS Proposes Modifications to HIPAA Research Provisions
On July 14th, the Department of Health and Human
Services (HHS) released a
Notice of Proposed Rule Making (NPRM) on
“Modifications to the HIPAA Privacy, Security,
and Enforcement Rules Under the Health
Information and Technology for Economic and
Clinical Health (HI-TECH) Act.” The Notice
proposes modifications to the Health Insurance
Portability and Accountability Act (HIPAA) in
order to: implement recent statutory amendments
enacted through the HI-TECH act, strengthen the
privacy and security of protected health
information (PHI), and improve the workability
and effectiveness of HIPAA. Numerous changes to
the HIPAA Privacy, Security, and Enforcement
rules are recommended in the draft regulation.
Of particular relevance to clinical researchers
are three proposals to modify the research
provisions of the Privacy Rule. These would
allow covered entities to combine conditioned
and unconditioned authorizations for research;
enable research participants to authorize the
use and disclosure of their Personalized Health
Information (PHI) for unspecified, future
research (currently each authorization must be
research project specific); and modify the
definition of PHI such that the individually
identifiable health information of a person who
has been deceased for more than 50 years would
not be considered PHI. Comments are due to HHS
on September 13, 2010.
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