“We conclude the plaintiffs are unlikely to prevail because Dickey-Wicker is ambiguous and the NIH seems reasonably to have concluded that, although Dickey-Wicker bars funding for the destructive act of deriving an ESC [embryonic stem cell] from an embryo, it does not prohibit funding a research project in which an ESC will be used. We therefore vacate the preliminary injunction.”

As you might recall, last August, U.S. District Court Judge Royce Lamberth had ruled in favor of two scientist plaintiffs and issued a preliminary injunction that briefly blocked federally funded embryonic stem cell research on the grounds that NIH’s 2009 hESC guidelines violated Dickey-Wicker. Today’s decision vacating that injunction can be viewed here.   There is still the possibility of an appeal. 

Also in the news today, Dr. Roger Beachy, the current Director of the National Institute of Food and Agriculture (NIFA) at USDA, will resign as Director effective May 20, 2011 to spend more time with his family. In the interim, Dr. Chavonda Jacobs-Young will be named as Acting Director of NIFA.

                          

National Institutes of Health- $31.8 billion, an increase of 3.3% over the FY10 level of $30.8 billion

White House/Office of Management and Budget HHS FY12 Budget Summary

National Science Foundation- $7.77 billion, an increase of 13% over the FY10 level of $6.87 billion –keeping the agency on track for a 10-year (FY08-FY17) doubling that is authorized in last year’s America COMPETES Act

NSF FY12 Budget Materials

Department of Energy, Office of Science- $5.4 billion, an increase of 10.2% over the FY10 level of $4.9 billion –keeping the agency on track for a 10-year (FY08-FY17) doubling that is authorized in last year’s America COMPETES Act. $550 million is also included for the Advanced Research Projects Agency-Energy (ARPA-E) to continue support for the promising early-stage research projects that could deliver game-changing clean energy technologies.

DoE FY12 Budget Materials

Department of Defense, Science and Technology- $12.2 billion for science and technology programs, which includes a 2% real growth in basic research

National Oceanic and Atmospheric Agency- $5.5 billion, an increase of 14.3% over the FY10 level of $4.85 billion

White House/Office of Management and Budget Department of Commerce FY12 Budget Summary

Department of Education-

• Continues support for a $5,550 maximum Pell Grant award, $819 above the level in 2008, largely paid for by eliminating the year-round Pell Grant and the in-school interest subsidy for graduate and professional student loans
• Invests $26.8 billion, an increase of 6.9 percent, in a reformed Elementary and Secondary Education Act (ESEA) focused on raising standards, encouraging innovation, and rewarding success, while allowing States and districts more flexibility to invest resources where they will have the greatest impact. The new ESEA directs funds to reform-oriented competitive initiatives, consolidates dozens of programs, and cuts programs that do not demand results.
• Provides $1.4 billion for new competitions, modeled on the Race to the Top initiative, to strengthen and reform early childhood education, improve district performance in elementary and secondary education, and improve outcomes in higher education

Department of Education FY12 Budget Materials

National Endowment for the Humanities- $146 million, a decrease of 13% from the FY10 level of $168 million

NEH FY12 Budget Summary

Additional information on President Obama’s FY12 budget request will be posted as it becomes available. The release of the President’s Budget Request (PBR) is the first step in appropriations process for the coming year. After Congress and the President settle on a path forward for FY11 — which began on October 1, 2010 — the FY12 process will begin to move forward.

                          

 “We need to out-innovate, out-educate, and out-build the rest of the world,” he said. “We have to make America the best place on Earth to do business. We need to take responsibility for our deficit, and reform our government. That’s how our people will prosper. That’s how we’ll win the future.”

The promise of technology heavily underpinned the President’s address, as he emphasized the importance of clean tech, broadband, and science education in achieving his goal. He made the case for continued investment in research funding, and a renewed commitment to immigration reform that’s designed to keep talented foreign workers in the country.

While this all sounds encouraging for the research and higher education communities, the President proposes to pay for those investments by cutting other domestic programs.  He is proposing a five-year freeze on non-security discretionary spending, which he said would save more than $400 billion over 10 years and bring discretionary spending to the lowest level as a share of the economy since the Eisenhower administration. It remains to be seen whether the President can actually motivate Congress into acting on his proposals, some of which appeared in Obama’s prior State of the Union addresses. It was in 2010 that the president sounded similar notes on innovation, taxes and trade, but those reforms often lagged in a Congress more focused on other big-ticket items like healthcare.

One surprise in the President’s address was his threat to veto any legislation that includes earmarks, essentially closing the door on any earmarks for FY12. Democrats in the Senate denounced the President’s call as a power grab that will have little-to-no impact on the federal budget deficit.

But the reality is that Democrats face a political climate that makes it virtually impossible to get any earmarks through this Congress if Obama and Republicans in congress maintain their opposition. Speaker John Boehner (R-OH) has already said that no appropriations bills with earmarks will pass the House, and Senate Republicans have also embraced a moratorium on the pet projects. That means House Republicans, Senate Republicans, and the President would have to cave in if any earmarks are to become law this year.

In other budget news, the House Republicans on Tuesday moved forward in their push to sharply reduce spending and draw contrasts with President Obama’s budget priorities. They adopted a resolution calling for non-security discretionary spending to be cut to FY08 levels or less for the last seven months of FY11. House Republican leaders also announced that they are planning to bring a government funding measure to the floor the same week the president is expected to release his budget (week of February 14^th). During that same week, the House will also consider another stopgap spending measure to fund the government for the remainder of FY11. The current stopgap funding expires March 4th.

The Office of Federal Relations is closely monitoring all of these events and will provide additional information on this site as it becomes available. In the meantime, we are anticipating major programmatic cuts in the President’s FY12 Budget and are currently developing materials to defend those federal programs that the UW works with the most.

                          

NIH Director Francis Collins provided details of the impact of the ruling, based on an interpretation by the Department of Justice. According to Dr. Collins, ongoing research (totaling around $131 million) that has already been funded will continue, undisrupted, until it reaches the point of renewal. Projects that are in review, even if they have been scored, or that are up for renewal, will be halted immediately, and applications will no longer be reviewed. NIH has also ceased reviewing applications for new embryonic stem cells lines. It remains unclear whether no-cost extensions of existing ESC projects would be allowed.

In addition to the problem presented by Dickey-Wicker, AAU is concerned about the findings related to the competitive status of the two adult stem cell researchers serving as plaintiffs in this case. The researchers were granted standing on the basis that they must compete for funds with ESC researchers. Judge Lamberth’s ruling goes a step further by declaring that these researchers suffer irreparable harm due to this competition. (He also determined that blocking federal funding would not do irreparable harm to ESC researchers.) This could have far-reaching – although not immediate – implications for all federally-funded peer-reviewed research, as it could effectively empower any researcher to sue a research agency over “unfair competition”.

Read the entire decision made by the Court

                          

There are substantive and significant changes being proposed by NIH.  Some of those changes have been anticipated by the research community; others have not.  Some of the changes will require changes in how many research organizations have designed and implemented the current NIH requirements; others will not.  It is important to remember that the proposed policy is NIH’s requirement and sets a minimum set of standards.  Organizations can implement policies the meet and exceed these requirements.  The reference to “minimum standards” is not to suggest that the current NIH policy is insufficient in achieving the goal of objectivity.  Rather, it is to remind organizations of how NIH views the reporting requirements – for purposes of reporting to NIH and – under the proposed rule – posting to public websites, organizations must report on financial conflicts of interest (FCOI) according to the organization’s standards, if they are different.   For example, the proposed rule lowers the threshold for a “significant financial interest” from $10,000 or equity interests of 5% to $5,000 total value in remuneration and/or equity in a publically traded company.  If the organization sets a $0 value, the organization must report and post interests from $0.  

General Outline of Important Changes

Small Business Innovation Research (SBIR) program Phase I projects are no longer exempt.

Definitions: The definitions have been clarified and expanded as necessary to support the proposed changes to the policy.  For example, there are new definitions of the investigator’s “Institutional Responsibilities,” “Manage,” and “Financial Interest.”    NIH makes a distinction between “Disclosure” – by an investigator to the institution – and “FCOI report” – from the institution to NIH. 

The most significant modification to a definition is the meaning afforded “Significant Financial Interest” which describes the changes in thresholds (noted above) and what is and is not included in the definition.  With regard to the thresholds, any equity interest in a non-publically traded company is considered significant.  There are additional modifications to the exclusions, notably income from for seminars, lectures, etc., from non-profit entities other than higher education institutions are no longer excluded.

Subrecipients: NIH clarifies the responsibility of the prime awardee organization to manage the compliance of its sub-recipients including the requirements to articulate the relationship between prime/sub in the subaward document, a written certification and reports to the prime awardee of any FCOI and the prime awardee’s timely reporting to NIH.    

Determining Conflicts: The investigator is required to disclose all significant financial interests to the organization annually, updating their disclosure when the information changes.  The organization is given the responsibility to determine whether the disclosed interests are related to the NIH-funded research and whether the disclosed interest is a conflict of interest.    NIH has outlined criteria for that determination.  The organization must develop a management plan and report on the FCOI to NIH. 

Training: The institution must provide training for the investigator prior to engaging in funded research and, thereafter, at least every two years. 

Managing, Mitigating and Reporting: There is a new section on management and reporting of financial conflicts of interest.  Prior to expending funds, the organization will review disclosures, determine if a conflict exists, and develop and implement a management plan.  The proposed rule outlines “examples of conditions or restrictions” that might be a part of the plan.   Reduction or elimination of the financial interest is included as an example of such a condition or restriction.   The proposed rule describes how the organization should conduct the review of those investigator’s disclosures who join a project after its initiation and when the organization identifies an interest not disclosed by an investigator.   In the latter case, in addition to managing the recently identified conflict, the organization must implement a mitigation plan to determine if the research has been biased. 

The single most significant addition – not discussed in the Advance Notice – is the requirement for organizations to post to publically accessible web site information concerning the identified financial conflict of interest.  This information, to be posted before the expenditure of funds, includes the investigators name, position on the project, nature of the interest, and approximate dollar amount.  This information must be updated annually and on the disclosure of new conflicts of interest and must remain on the web site for five years from the most recent update. 

The reports to NIH would be more comprehensive and include elements of the management plan and the organization will be required to provide annual FCOI reports addressing the status of the conflict and any changes to the plan as well as other assessments. 

Institutional Conflicts of Interest: NIH does not address institutional conflicts of interest in the proposed rule but welcomes further comments.  They acknowledge the creation of regulations governing this area is complex based, in part, on the extensive differences in administrative structure among institutions receiving PHS funding.

Costs: In describing the proposed rule, NIH acknowledges that there will be a burden but, in assessing the costs, NIH concludes:

“The cost of implementing the amended regulations is an allowable cost eligible for reimbursement as a Facilities and Administrative cost on PHS supported grants, cooperative agreements, and contracts.  This generally offsets the cost burdens of implementation of the regulations to the investigators.”

COGR members are invited to participate in the discussion of this proposed rule at the June 3-4 COGR meeting Thursday, June 3, morning session (10-11:45).  We will outline the key elements (as above) and invite a wide-ranging discussion/reaction to the proposal.   We look for this discussion to serve as the basis for building COGR’s comments on the new regulation.

                          

President Obama requested $32 billion for NIH in his FY11 budget, an increase of 3.2 percent. The boost matches the inflationary index for biomedical research. While several members of the committee voiced strong support for the agency’s request they also said the challenging fiscal environment would make it difficult to secure a larger increase than is called for under the President’s proposal.

Senator Arlen Specter (D-PA), a long-time champion for NIH funding, pressed for more funding and called the proposed 3.2 percent boost “disgraceful.”  Specter suggested that scientists should become stronger advocates for NIH funding by highlighting how the stimulus funding has helped spark more interest in biomedical research.  Senator Harkin (D-IA), Chair of the Senate Appropriations Subcommittee on Labor, HHS, and Education, also expressed support for NIH funding but reminded committee members that finding additional funding will be difficult this year.

                          

The purpose of these two programs is to provide support for cutting-edge, visionary research, only possible through cross disciplinary research. Breakthroughs such as x-ray crystallography, CAT scans, and magnetic resonance imaging have had an enormous and important effect on biology. These discoveries were funded by sources, such as the Bell Labs, which are no longer in existence. Thus, it is very difficult for researchers to work on similar breakthrough technologies today.

Both programs will provide grants of varying sizes and lengths to accommodate a variety of research, encourage young investigators with novel ideas to apply, and will be reviewed by special review panels that include reviewers from the physical, mathematical, and computational sciences selected by NSF.  Applications will be accepted once a year in May through 2012.  The first deadline is May 18, 2010.

                          

Governors’ Letter on FY11 NIH Funding