Public Affairs

106th Congress Grants NIH 14% Increase 
NIH to Create New Bioimaging Institute 
Congress Provides a 9% Increase for VA Medical Research 
NIH Increases Training Stipends 
Outgoing Administration Pursues Research Ethics Initiatives 
107th Congress Faces Organizational Hurdles 
NIH Notices: Protocol Review Procedures and Animal Care Policy Materials 
President Signs Chimpanzee Retirement Law 
Porter Donates Campaign Funds to Endow Research Chair 
Activist Organizations Continue to Grow 
“Communicating About Science”: EB Public Affairs Symposium 

As originally printed in The Physiologist,
February 2001, Volume 44, Number 1
Page 37

106th Congress Grants NIH 14% Increase 
    The NIH budget for FY 2001 was finally approved on December 21 when President Clinton signed into law a bill providing $20.3 billion for the NIH for the fiscal year that had begun on October 1, 2000. 
    Between October 1 and that date, the NIH had been forced to operate at its FY 2000 spending level under a series of continuing resolutions. Congress, which had been unable to complete FY 2001 legislation prior to the election, had to return for a lame duck session that dragged out until the outcome of the presidential election was resolved.
    Although short-term continuing resolutions have become routine in recent years, the lengthy delay interfered with NIH’s ability to provide full funding for new grants and to begin new programs. There had also been also growing concern that Congress might decide to save money by leaving the remaining agencies at their FY 2000 levels for the rest of the year. This would have jeopardized efforts to achieve a doubling of the NIH budget over five years.
    The difficulty in reaching a final agreement on FY 2001 funding was symptomatic of the contentious atmosphere that was also played out in this year’s electoral impasse. The post-election congressional session was also overshadowed by the presidential contest because Members of Congress were unwilling to finish their work until the election was decided. Then, even though the spending legislation itself was ready to go, a last-minute dispute over Alaskan fishing seemed to threaten yet another delay. Finally, late in the day on Friday, December 15, the House and the Senate approved the final “must pass” legislation and the 106th Congress adjourned.
In the end, Congress provided the NIH with a $2.5 billion increase or 14.2% more than its FY 2000 budget. Final passage of the bill was greeted with profound relief within the medical research community. “We are so grateful to the Administration and to the lawmakers who, in a bipartisan spirit, supported the third year of significant increases to the NIH’s budget, continuing the momentum to double the agency’s budget by 2003,” said Mary Hendrix, president of the Federation of American Societies for Experimental Biology.
    The final figure for the NIH was $200 million below the figure that House-Senate conferees had agreed to in November. That agreement would have given the NIH its third 15% increase. However, some congressional leaders and even Senate Labor-HHS-Education Subcommittee Chairman Arlen Specter (R-Pa.) repudiated the conferees’ agreement as too costly, and it seemed likely that some cuts would be made. At one point, there was concern that the NIH might lose as much as $500 million in the efforts to reduce the overall spending total of the legislation. However, NIH’s congressional champions remained steadfast in their efforts to secure the third installment in the five-year doubling of the NIH budget. 
    The Labor-HHS-Education spending bill containing the NIH budget was combined with the other remaining spending bills and various provisions lawmakers wanted to see enacted in the 106th Congress. The NIH portion of the legislation contains some new programs and some technical modification of existing laws. These provisions include:

As originally printed in The Physiologist,
February 2001, Volume 44, Number 1
Page 37

NIH to Create New Bioimaging Institute 

    Among the final actions taken by the 106th Congress in its post-election session was approval of legislation establishing a new institute to house bioimaging and bioengineering research. The bill passed the Senate on Friday, December 15. President Clinton signed the bill into law on December 29, 2000. 
    The bill had passed the House in October but languished in committee after it went to the Senate. NIH, which recently established an office devoted to bioengineering, bioimaging and bioinformatics, had private expressed concerns about the legislation. However, Senate Majority Leader Trent Lott, who sponsored the Senate version of the bill, brought the bill to the floor on the last day of the session, and it was passed by voice vote.
    The legislation had strong support from American Institute for Medical and Biological Engineering and the Academy of Radiology Research, which have been working with NIH to build bioimaging and bioengineering research and to raise the visibility of their disciplines within the scientific community.

As originally printed in The Physiologist,
February 2001, Volume 44, Number 1
Page 38

Congress Provides a 9% Increase for VA Medical Research 
     The Department of Veterans Affairs (VA) medical and prosthetics research program received a $30 million increase. The additional 9.3% brought its budget to $351 million for FY 2001.
    In its budget submission a year ago, the Clinton administration had requested only $321 million for FY 2001, the same as the FY 2000 funding level for this program. Furthermore, the FY 2000 budget represented only a $5 million increase over FY 1999. However, VA medical research supporters in the House added a $30 million increase when the bill was brought to the floor of that chamber. The Senate Appropriations Committee recommended only $331 million, but agreed to $351 million in the House-Senate conference agreement.
    Report language accompanying the House version of the bill addressed the issue of how the VA should allocate VERA administrative funds associated with research, a contentious issue at many VA Medical Centers. The House report encouraged the VA to “align the VERA research allocation with designated time for clinician-investigators to conduct research.” The House report language also directed VA to extend through FY 2001 its policy assigning administration of the VERA research allocation to medical centers, and also to evaluate new accounting systems in terms of their effectiveness in ensuring adequate support for research salaries, facilities and administration. The Senate report language supported these recommendations.
    The FY 2001 appropriation does not contain any disease-specific spending earmarks but the accompanying reports “encourage” the VA to increase its efforts in particular areas, including prostate cancer, diabetes, Hepatitis C, neurofibromatosis, and lymphoid malignancies, as well as to explore the possibility of establishing a nursing research program. 

As originally printed in The Physiologist,
February 2001, Volume 44, Number 1
Page 38

NIH Increases Training Stipends 
     NIH has announced stipend increases for National Research Service awards (NRSA) to pre-doctoral and postdoctoral trainees. 
    These levels are a 9.6 percent increase in the predoctoral stipend an an average increase of 5 percent for the postdoctoral rates. The budgetary changes will take effect for NRSA Awards made with FY 2001 funds. 

Table 1. New Stipend Levels for NIH awards
Years Postdoctoral Experience  Stipend
Predoctoral 
0 
1 x
2 x
3 x
4 
5 
6 
7 or more 		 16,500
$28,260
$29,832
$35,196
$36,996
$38,772
$40,560
$42,348
$44,412

As originally printed in The Physiologist,
February 2001, Volume 44, Number 1
Page 39

Outgoing Administration Pursues Research Ethics Initiatives 
 Government-Wide Research Misconduct Policy Issued
    A government-wide Federal Policy on Research Misconduct was issued during the closing days of the Clinton administration, nearly five years after the National Science and Technology Council began trying to develop a uniform policy. 
    In announcing the policy, the White House Office of Science and Technology Policy (OSTP) noted that “Advances in science, engineering, and all fields of research depend on the reliability of the research record.” It also noted that “Sustained public trust in the research enterprise also requires confidence in the research record and in the processes involved in its ongoing development.”
The policy applies to “research conducted by the Federal agencies, conducted or managed for the Federal government by contractors, or supported by the Federal government and performed at research institutions, including universities and industry.” It consists of a definition of research misconduct as well as basic guidelines for the response of federal agencies and research institutions to allegations of research misconduct. The goal is to achieve a uniform standard for dealing with research misconduct. Federal agencies must bring their own regulations, policies, and procedures into conformity within one year of December 6, 2000, the date it was issued.
    The final policy defines research misconduct as “fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.” It then provides definitions of fabrication, falsification, and plagiarism, adding that “research misconduct does not include honest error or differences of opinion.” It further stipulates that a finding of research misconduct also requires that:

The “Federal Policy on Research Misconduct” is available on the Office of Science and Technology website at http://www.ostp.gov/html/001207_3.html. The notice announcing and describing the policy is posted at http://www.ostp.gov/html/001207_2.html.

Office of Research Integrity Finalizes Policy on Instruction in the Responsible Conduct of Research
    On Dec. 1, 2000, the Office of Research Integrity (ORI) published the final PHS Policy on Instruction in the Responsible Conduct of Research for extramural institutions receiving PHS funds for research or research training. The policy requires research staff at extramural institutions to “complete a basic program of instruction in the responsible conduct of research.” It also defines which research staff members are covered and what the instruction program must cover.
    The draft policy had been announced in July and was followed up in early August with a meeting convened by ORI and the PHS agencies with representatives from extramural institutions to discuss the draft policy. The ORI also received about a hundred written comments from individual scientists and extramural institutions, which raised a number of concerns. These included that the mandate to provide training was excessively broad, and that it would be both difficult and financially burdensome to implement within the two-year phase in period proposed.
    For the text of the policy and additional information such as instructional materials on the Responsible Conduct of Research and a set of Frequently Asked Questions, go to the ORI website at http://ori.hhs.gov/html/programs/rcrcontents.asp

Human Subjects Protection Efforts Advance 
    On December 14, 2000, Department of Health and Human Services Secretary Donna Shalala appointed a twelve member National Human Research Protections Advisory Committee (NHRPAC) to advise the Office of Human Research Protection (OHRP). The committee was created to serve as the department's “principal advisory body on issues pertaining to human subjects protections and responsible conduct of human research,” according to a press release issued by Shalala’s office. 
The establishment of the advisory committee had been announced in June 2000 when the new HHS Office for Human Research Protections (OHRP) was created to replace human subjects oversight function previously housed within the NIH’s Office for Protection from Research Risks. All these steps are part of an HHS initiative to further strengthen protections of human research subjects in clinical trials, including those involving gene transfer, according to Shalala's office.
    Meanwhile, an IOM committee established to create guidelines for the evaluation of institutional human subjects review programs requested public comment on a set of draft standards at a January meeting. The Committee on Assessing the System for Protecting Human Research Subjects scheduled a January 22 meeting to enable the public to comment on the draft report on accreditation of human subjects review programs (HRRPs). 
    In addition to providing an opportunity for comment on the draft standards, the meeting was also intended to enable the committee to “obtain information and perspectives on accreditation as a mechanism to improve the protection of human research subjects as provided by HRRPs.” 

HHS Proposes Whistleblowers Protection Plan
    On November 28, 2000, the Department of Health and Human Services published a Federal Register Notice of Proposed Rulemaking concerning the establishment of “Public Health Service Standards for the Protection of Research Misconduct Whistleblowers.” The proposal would require institutions receiving PHS funds to “follow certain requirements for preventing or otherwise responding to occurrences of retaliation against whistleblowers.” 
    The notice stated that the proposed regulation will give institutions “wide latitude in the types of administrative proceedings they may choose to offer.” However, it added, “The proceeding must meet certain minimum standards such as allowing the whistleblower an opportunity to be represented by counsel and having a qualified, objective decision-maker.” The terms “qualified” and “objective” were not defined, although it suggested that decision-makers should have “significant training, experience, or expertise in adjudicating disputes.’ Comments on the proposal were due in January. 

As originally printed in The Physiologist,
February 2001, Volume 44, Number 1
Page 40

107th Congress Faces Organizational Hurdles 
     Significant organizational issues confronted both the House and the Senate when the 107th Congress convened in January. On the House side, many Committee chairmanships were open because of a rule adopted in 1994 by the newly installed Republican majority. The Republicans agreed to limit committee chairs to a maximum of six years in order to avoid the entrenchment in power that occurred while Democrats held the majority. However, the fallout from this was a sometimes-bruising game of musical chairs 2001.
    The House term limit rule for chairs was also a key reason why Labor-HHS-Education Appropriations Subcommittee Chairman and NIH champion John Porter decided to retire last year. Rep. Ralph Regula (R-Ohio) was expected to succeed Porter as head of the House panel responsible for NIH funding, although that still had to be finalized. Rep. Henry Bonilla (R-Texas) was expected to become the chairman of the House Appropriations Subcommittee that oversees funding for the USDA, including Animal Welfare Act enforcement. Rep. Bonilla is also a member of the Labor-HHS subcommittee. Rep. James Walsh (R-NY) was expected to remain as head of the VA, HUD and Independent Agencies Subcommittee, which oversees funding for the NSF, the VA and NASA.
On the Senate side, a 50-50 split between Republicans and Democrats was yet another quirk of election 2000, and the challenge was to devise with operating procedures acceptable to both parties. Democrats held the effective majority for the first 17 days of the 107th Congress while the Clinton administration was still in power and Al Gore wielded the tie-breaking 51st vote. However, this was a transient oddity. The more substantive question was, how would the Senate govern itself, and in particular, what would be the ratios of Republicans to Democrats on committees. 
    The number of seats each party gets on committees depends upon how many seats they hold overall. This ratio can be crucial in getting legislation out of committee to bring it to the floor. Since Republicans and Democrats were evenly split in the Senate, the Republicans did not have the votes make this determination without the concurrence of the Democrats. Although many Republicans argued that they should have a one-seat majority on committees since they will be the majority party when Vice President-elect Dick Cheney is the one casting the tie-breaking vote, both parties finally agreed to a power-sharing arrangement. Each side will have equal representation on committees, but in the event of a tie vote in committee, legislative matters or nominations can be brought to the floor at the request of either party.
    In terms of key committee posts, despite some uncertainty, it seemed likely that Sen. Arlen Specter (R-PA) would return to chair the Senate Appropriations Subcommittee on Labor-HHS-Education. Last October after efforts to achieve compromise seemed likely to result in an unacceptably costly bill, Specter announced in frustration that he would no longer chair the subcommittee. However, a number of biomedical research advocacy organizations subsequently urged him to reconsider his decision because of the strong support he has shown for the NIH, and there were indications that he might remain as head of that panel. 

As originally printed in The Physiologist,
February 2001, Volume 44, Number 1
Page 41

NIH Notices: Protocol Review Procedures and Animal Care Policy Materials 
     The NIH published a notice in the NIH Guide for Grants and Contracts reminding researchers that IACUC of research protocols involving animal studies must be completed prior to peer review. Notice OD-01-008 states that IACUC approval for all such applications should be provided either when the application is submitted, or within 60 days thereafter. Otherwise, the application cannot be peer reviewed. The notice is available online at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-008.html
    This policy stands in contrast to a change in policy with respect to Institutional Review Board (IRB) approval of research protocols involving human subjects. In notice OD-01-031, dated December 6, 2000, the NIH reiterated that beginning with applications submitted for the January 2001 Council round, “IRB approval is no longer required prior to NIH peer review of an application which covers human participants.” The change in policy “is intended to provide flexibility at the institutional level to reduce the workload burdens that many IRBs are currently facing, while still ensuring full protection of participants in human studies.’ This is posted at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-031.html
The Office of Laboratory Animal Welfare (OLAW) has announced that it has copies available of a reprinted version of the PHS Policy on Humane Care and Use of Laboratory Animals. The reprint is an updated version in a smaller format of the original Policy promulgated in 1986 to implement the Health Research Extension Act of 1985. Updated elements include revised citations and addresses. In addition, language that was clarified in a 1996 reprint to eliminate common areas of confusion has been retained. To request a copy of the reprint, contact OLAW at olaw@od.nih.gov or call 301-594-2506. 

As originally printed in The Physiologist,
February 2001, Volume 44, Number 1
Page 41
President Signs Chimpanzee Retirement Law 
     On December 20, President Clinton signed into law a bill to provide for the long-term care of chimpanzees previously used in biomedical research. However, he issued an unusual statement outlining his reservations of “flaws in the bill that the next administration and the Congress should correct to ensure the viability and effectiveness of the proposed sanctuary system.”
    The legislation, known as the Chimpanzee Health Improvement, Maintenance, and Protection Act, would establish a system of privately operated “sanctuaries” for federally-owned chimpanzees that are no longer needed for biomedical research. It was approved by unanimous consent in the Senate on December 6 after House approval on October 24. 
    In signing the bill, Clinton noted that the legislation “is a valuable affirmation of the Federal Government’s responsibility and moral obligation to provide an orderly system to ensure a secure retirement for surplus Federal research chimpanzees and to meet their lifetime needs for shelter and care.” However, he noted that the legislation “puts severe constraints on the use of a chimpanzee for further research once it has been declared ‘surplus.’” The President also noted “concerns” with the administrative structure and funding of the sanctuary system authorized by the legislation. 

As originally printed in The Physiologist,
February 2001, Volume 44, Number 1
Page 41

Porter Donates Campaign Funds to Endow Research Chair 
     Retiring Congressman John Porter, the former chair of the House Labor-HHS-Education Appropriations Subcommittee, announced that he would donate his unused campaign funds—approximately $325,000—to finance a professorship in biomedical research at Northwestern University Medical School. Porter, a Republican who represented Illinois’ 10th district, was one of the NIH’s staunchest champions on Capitol Hill. According to a Northwestern University press release, Porter’s donation will be used as a “leadership gift” to fund a Professorship of Biomedical Research that Northwestern University Medical School will establish in his name. Northwestern hopes to raise a total of $2 million to endow a perpetual professorship in Porter’s name.
    “This nation must continue to place the highest priority on basic research to battle the war we face against disease,” Porter said in announcing the professorship. “I can think of no better use for this campaign money than to invest it in health research that will benefit the needs of society.” Porter, who served 11 terms in the US House of Representatives, before retiring at the end of 2000, earned an undergraduate degree from Northwestern University in 1957. In 1999, the university honored him with an Honorary Doctor of Laws Degree in recognition of his “legislative leadership on behalf of biomedical research.” 
    Stephen D. Miller, professor of microbiology-immunology and director of the Interdepartmental Immunobiology Center at the Northwestern University Medical School, has been named to the professorship. 

As originally printed in The Physiologist,
February 2001, Volume 44, Number 1
Page 42

Activist Organizations Continue to Grow 
     The monthly activist newspaper Animal People recently published its annual report on the finances of animal-related charities. Animal People compiled the report using copies of IRS Form 990 that it requested from nonprofit organizations that claim to work on behalf of animals. Financial data from the Form 990 filings of 130 such charities was compiled and presented along with an overview of their programs. The report also included notes about anomalies or controversies associated with programs or financial management, such as violations of the standards that nonprofits are expected use in allocating costs between programs and administrative overhead. In November 2000, Animal People published its report on 1999 financial data.
    The report included many of the major animal activist groups that conduct campaigns against medical research. Notable absences included the Liberation Collective, the National Activist Network, Protecting Our Earth's Treasures, and the Physicians Committee for Responsible Medicine. PCRM data appeared in the 1998 report but the organization declined to supply its 1999 IRS Form 990. 
Eleven major organizations included in the 1999 report ac-counted for combined budgets totaling more than $90 million. The two largest organizations by far are the Humane Society of the United States (HSUS) with a staggering $51,560,147, and People for the Ethical Treatment of Animals (PETA) with $16,487,851. In contrast, in 1998, twelve major organizations (the same eleven along with PCRM) had combined budgets of $75 million. 
    A supplemental note concerning the HSUS said that in 1999 it had transferred $5,434,566 to affiliated organizations including the National Association for Humane & Environmental Education, Humane Society International, Center for Respect For Life & Environment, Earthvoice International, Wildlife Land Trust, Worldwide Network, Inc., and Meadowcreek Inc., which is an Arkansas-based organic vegetable-growing project. “Most and perhaps all of these affiliates are controlled by the board and senior staff of HSUS,” according to Animal People. The note went on to say that “Technically, HSUS did not end 1999 with more than twice its annual budget in cash and securities reserves—but only because of the payments to affiliates, whose reserves may be used in connection with HSUS projects, yet do not appear on the HSUS filing of IRS Form 990.”
    A note concerning PETA said that it had “ascribed to program services $309,546 spent in connection with the sale of fundraising merchandise, and at least $4,252,855 spent for ‘campaigns’ which appear to have consisted chiefly of direct mailing, beyond the $551,284 which PETA acknowledged spending on fundraising mailings in the name of education.”
    Highlights of the report are provided in the table below. The complete report is available on line at http://www.animalpeoplenews.org/watch-1.html. Additional financial information about nonprofit organizations is available at http://www.guidestar.org/, which is a project of Philanthropic Research, Inc. 

Table 1. 1999 Budgets and Programs for Animal Activist Organizations
Organization  1999 Budget  1999 Programs 1998 Budget
American Anti-Vivisection Society   
Animal Legal Defense Fund   
Doris Day Animal League   
Friends of Animals   
Fund for Animals   
Humane Society of the US   
In Defense of Animals   
Last Chance for Animals   
National Anti-Vivisection Society   New England Anti-Vivisection Society 
People for the Ethical Treatment of Animals  
Physicians Committee for Responsible Medicine* 		 $1,088,433
$2,929,360
$2,298,227
$4,289,534
$6,383,888
$51,560,147
$1,707,270
$657,946
$2,153,309
$1,052,240 
$16,487,851
 $1,012,233
$1,924,092
$1,871,898
$3,768,089
$5,311,129
$29,746,546
$1,390,001
$441,895
$1,535,661 
$643,263 
$14,417,787 
 $1,087,241
$2,363,019
$2,405,903
$4,514,292
$5,445,455
$36,633,759
$1,491,213
$629,404
$2,012,888
$1,392,009
$14,543,860
$2,160,634 
     *The Physicians Committee for Responsible Medicine declined to provide 1999 data.


As originally printed in The Physiologist,
February 2001, Volume 44, Number 1
Page 42
“Communicating About Science”: EB Public Affairs Symposium
    The APS Public Affairs Committee has organized a public affairs symposium to be presented on Saturday, March 31, at the EB 2001 meeting in Orlando. The event will be cosponsored by FASEB and the other FASEB societies that are participating in the meeting. The program is entitled “A Call to Activism: Communicating about Science.” Featured speakers will include FASEB President Mary Hendrix, Kim Cavendish of the Orlando Science Center, Kawanza Griffin of The Milwaukee Journal, and Hyman Field, of the National Science Foundation. The program will take place from 3-5:30 pm in Room 311GH of the Orange County Convention Center on Saturday, March 31, and will be chaired by Public Affairs Committee Chair William Talman. 

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