Public Affairs
FY 2006 Research Budgets
NIH Issues Conflict of Interest Rules for Intramural Scientists
USDA to Phase in E-FOIA Inspection Reports
The policy establishes a voluntary program in which funded investigators will be asked submit to the National Library of Medicine’s PubMed Central (PMC) an electronic copy of the author’s final manuscript of articles based upon NIH-funded research. The policy will go into effect on May 2, 2005 and will apply only to primary research articles based upon NIH-funded research that have been accepted for publication in peer reviewed journals after that date. The purpose of the policy is to create a permanent archive of NIH funded research that can be used to improve portfolio management. Once in the archive, however, manuscripts will be made accessible to the public 12 months after publication, or sooner if the author agrees. It is the access provision of the policy that has provoked controversy.
Despite NIH claims to the contrary, its new policy has copyright implications. Although copyright practices differ among publishers, when articles are accepted for publication in an APS journal, authors (unless they are government employees) assign their copyright interest to the journal. This means that the author grants the journal exclusive publication rights in exchange for the services the journal has provided to peer review, copy edit, format, publish, and disseminate the article. Acquiring exclusive publication rights permits the journal to sell the article and thus recover its investment in the article. This arrangement has shown to be an effective way to ensure rapid dissemination of high quality peer reviewed research.
Once copyright transfer has taken place, the NIH must have the permission of the journal as copyright holder to disseminate the manuscript. It should be noted that the APS and many other not-for-profit publishers already provide free public access to their content after 12 months or whatever period of subscription sales makes it possible to recoup publication related costs. The APS does not believe that the NIH Policy offers better public access than what the Society already provides. Moreover, since half the manuscripts APS publishes could be subject to the policy, the Society is justifiably concerned about the potential financial implications for its journals.
Nevertheless, the APS has decided to modify its copyright agreement to grant NIH-funded authors permission to submit their manuscripts to PMC for public dissemination after 12 months. Providing access after 12 months is consistent with the existing APS free public access policy and would enable authors to comply with the funding agency’s request without violating their copyright agreement with the journal.
Since the policy was announced, questions have arisen about whether or not participation is truly voluntary. On the day the policy was published, NIH Director Elias Zerhouni sent a letter to all extramural scientists and their research institutions describing the policy and urging them to participate. Although Zerhouni stated that the policy is a request, many researchers as well as university offices of sponsored programs and even some NIH program officers have interpreted it as a mandate for grantees. However, in public statements, Zerhouni and other NIH officials have repeatedly underscored that it is voluntary and there will be no repercussions for those who choose not to participate. Funded investigators can still fulfill their progress report requirements by providing print copies of their publications with their annual progress reports.
The APS has been at the forefront of online publishing. The Society began putting its journal content online as early as 1994 and developed one of the first online manuscript submission and review systems. The APS has also underwritten the scanning of its journal content back to 1898 and was an early adopter of the policy of making all final content freely accessible to the public 12 months after publication. These were costly efforts that the Society undertook to enhance access to physiological research in the Internet age. Although the APS still has reservations about the NIH approach to public access, if authors who choose to participate would select public access after 12 months as specified in the revised copyright agreement, this will fulfill NIH’s request while still protecting the viability of the APS journals.
FY 2006 is the third consecutive year in which lawmakers will try to keep non-defense discretionary spending flat in order to restrain rising deficits, and this is reflected in the proposed budgets for federal science agencies. The current budget season not only promises tight budgets, but also a potentially more complex approval process in Congress. Appropriations Subcommittees have reorganized in both houses of Congress, placing the NSF, NASA and VA in new subcommittees for funding allocation. Although both the House and Senate have reduced the number of subcommittees, the configuration of subcommittee responsibilities are no longer the same, and this has the potential to complicate approval of individual funding bills.
The National Institutes of Health
For the second year in a row, the proposed NIH’s budget increase fails to keep pace with the rate of biomedical research inflation index, which is currently 3.3%. For FY 2006, the NIH is slated to receive an increase of $196 million, which would increase its budget by 0.7% to $28.845 billion.
Of that increase, $50 million is designated for research into biological and chemical countermeasures as part of the Public Health and Social Services Emergency Fund. This would leave only $146 million for the rest of NIH, an overall increase of just 0.5%. This increase is well below the $30.07 billion recommended by FASEB and other research advocacy groups. If enacted, it would result in 402 fewer research project grants (RPGs) in 2006. Most individual institutes and centers can expect a budget increase of 0.3-0.7%. The largest percentage increase would go to the Office of the Director, which would receive 7.6% increase of $27 million over its FY 2005 of $358 million to fund high-risk basic research and the NIH Roadmap.
In the current environment, prospects for NIH are grim because although the NIH continues to be a priority for some in Congress, others on Capitol Hill say they want to see the results of a doubled NIH budget along with increased transparency from an agency plagued with negative reports about conflict of interest.
The National Science Foundation
On the heels of a budget cut in FY 2005, the administration’s proposal for NSF would give the agency a 2.4% increase to $5.61 billion. However, this sum still falls below NSF’s FY 2004 funding and is short of the FASEB recommendation of $6.4 billion. The NSF budget is also subject to a $48 million transfer to the US Coast Guard to cover the cost of icebreakers to provide access to NSF facilities in Antarctica.
Within the NSF, Research and Related Activities will receive an increase of 2.7%, with the Biological Sciences Directorate receiving an increase of 0.9%. The grant funding success rate is expected to remain steady at approximately 21%, down from 30% in the late 1990’s. NSF Director Arden Bement plans to increase success rates while maintaining grant size and duration by sharply focusing solicitations for proposals, which will have the effect of attracting fewer applicants. Education and Human Resources will be cut by a proposed 12.4% overall, with a 24% reduction in the Math and Science Partnership Program and 12% cut in undergraduate programs. While some of these programs have received increases within the Department of Education, attention in Congress has focused on finding a way to maintain these exemplary education programs at the NSF.
Department of Veterans Affairs
The recommended funding level total VA R&D budget is up slightly in FY 2006 to $786 million, an increase of 0.3%. This represents a proposed consolidation of accounts, and thus is not comparable to the Medical and Prosthetic Research Account for FY 2005. Of the $786 million, $452 million would be designated for biomedical laboratory science and is intended for investigator-initiated research projects.
National Aeronautics and Space Administration
The FY 2006 budget proposal includes a 2.4% increase in the overall NASA budget to $16.456 billion. The recent NASA reorganization created the Human Systems Research and Technology theme (HSR&T), which has a proposed budget of $806.4 million. This represents a 20% decrease over FY 2005 levels. The new HSR&T theme focuses on ensuring the health and safety of humans in the course of solar system exploration, with an emphasis on advancing knowledge and technology necessary to support human survival and performance in space. Included in this theme are physiology-based initiatives exploring bone, cardiovascular, and renal function.
NIH Issues Conflict of Interest Rules for Intramural Scientists
The APS understands the need for an organization such as the NIH to have ethics rules that serve to protect the integrity of this important research institution. Rules concerning conflict of interest must protect the public, NIH employees and the integrity of the science they produce. At the same time, the rules should not be so onerous as to deter government service, or to restrict participation of government employees in research activities sponsored by universities and scientific societies. The rules cover three broad areas: outside activities, financial holdings, and awards.
Outside Activities
The new regulations have prompted considerable uncertainty in the scientific community, and there are concerns about how NIH investigators will maintain meaningful relationships with non-NIH scientists and professional organizations.
Under the new conflict of interest rules, NIH employees are prohibited from compensated or uncompensated consulting, teaching, speaking, editing and writing for an outside organization. Outside organizations include pharmaceutical and biotechnology companies, health care providers and insurers, educational institutions that receive NIH funds and trade and professional organizations.
Ethics officials at NIH have indicated that scientists will be allowed to maintain interactions with their scientific societies if they obtain exceptions on a case-by-case basis. The NIH anticipates that many of these activities will be exempted from the rules based on being classified their classification as part of an employee’s official duties. Employees will still be required to seek approval from ethics officials for each such activity, and anything performed as an official duty will be ineligible for compensation. Examples include activities such as speaking about their research, teaching as part of a course, editing for their society’s journal, and writing book chapters. In certain cases, an employee’s interaction with a society may be considered an outside activity instead of an official duty. For example, as part of an NIH employee’s official duties, they may not hold a leadership positions that where they would have requires fiduciary responsibility to a scientific society. However, the NIH employee may might still be able to hold that position if it is were approved as an outside activity.
Financial holdings and awards
In addition to limiting outside interactions, the conflict of interest rules also impose restrictions on employees’ financial holdings and awards they are allowed to accept. Under the new regulations, senior employees are no longer allowed to own stock in “substantially affected organizations,” such as pharmaceutical companies. Non-senior employees are limited to $15,000 worth of stock in such companies. Employees are required to divest any prohibited financial holdings within 150 days of the rules taking effect.
Newly imposed restrictions on awards include a ban on senior scientists accepting any award worth more than $200, and require case-by-case approval for acceptance of all awards. Awards are subject to a two-step approval process. The first step evaluates the award and certifies that it is a bona fide award for meritorious service. The second compares the individual award recipient’s job description with the award to ensure that there is no potential conflict.
The impact of the rules
Prior to the new conflict of interest rules being issued, the NIH did have ethics rules in place. It appears now that the existing system was inadequate to protect the integrity of the institution. While the new rules are meant to delineate what is known as a “bright line” to prevent even the appearance of conflict of interest, it will be critical to evaluate how the rules affect the NIH. With new restrictions on outside activities, awards and financial holdings, it is possible that retention and recruitment at the NIH will be negatively impacted.
The Interim Final Rule was published in the Federal Register on February 3, 2005 with a 60-day window for comments to be submitted. The APS will submit comments strongly urging the exemption of scientific societies from the conflict of interest rules.
It is important to note that while the regulations issued on February 1 apply only to intramural NIH employees, there have been calls to extend similar policies to NIH reviewers and grantees in the future. Members of the House of Representatives Government Reform Committee have written to NIH raising concerns about controlling conflicts of interest for grant recipients and reviewers. NIH Director Zerhouni has indicated that conflict of interest in the extramural community is an issue that needs to be addressed.
The complete rule and related documents are available at: http://www.nih.gov/about/ethics_COI.htm.
The USDA inspects research facilities, zoos, circuses, breeders, and dealers of animals whose use is regulated under the AWA. Animal activist organizations often request FOIA inspection documents to determine whether these facilities are in compliance with the AWA and to obtain information about the use of the animals. Even before the implementation of E-FOIA, these inspection reports were available upon written request.
In an Email message to stakeholders, APHIS Deputy Administrator for Animal Care Chester Gipson indicated that the agency intends to review every inspection report to ensure that personal and confidential information is removed. This is expected to include the redaction of identifying information such as the names of individuals and where animals are housed or procedures are conducted. APHIS is also developing a new database that will enable the APHIS FOIA staff to review and redact information electronically, but it is not expected to be fully operational until FY 2006.
“While initially only regularly requested reports will be accessible, the goal is to eventually make all inspection reports available,” Gipson said in his message.
Due to the potential threat from extremists remains if sensitive information is disclosed, research institutions are encouraged to obtain a copy of their own inspection report through E-FOIA to verify what it contains.