NEWS FROM NIH

NEWS FROM NIH

NIH revises policy allowing concurrent support from mentored K swards and RPGs

NIH mentored K awards are intended to support a period of mentored career development in preparation for an ongoing role as an independent researcher in biomedical and behavioral science. NIH recently expanded its policy on mentored K awards to allow award recipients to hold concurrent support from their K award and a competing research grant on which they have status as a Principal Investigator (PI). Currently, mentored K award recipients who are in the last two years of their support period may reduce their level of effort on the K award and replace it with effort on an NIH research grant or subproject if they have been successful in obtaining an independent NIH award during their mentored period.

The policy revision expands the list of eligible grants to include research grants obtained from any Federal agency, rather than just NIH, clarifies when the research grant may be obtained relative to the years remaining on the K award, and clarifies that status as a PI on a multiple PI award also confers eligibility. The revised policy is effective for all currently active and all future K mentored career development awards.

NIH recognizes that other Federal agencies are important resources to investigators pursuing biomedical and behavioral research and that funding from such agencies helps sustain research laboratories that are also pursuing research within the mission of NIH. Therefore, NIH is extending the policy of allowing NIH K awardees to reduce effort on the K award in the final two years of the award to all K awardees who compete successfully for peer-reviewed research awards from any Federal agency.

Mentored K award recipients are encouraged to obtain funding from NIH or other Federal sources either as a PI on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award. Requested budgets for a competing research grant or a subproject on a multi-project grant should request appropriate amounts for the salary and associated costs for the K award recipient’s effort. At the time the research grant is awarded the effort required on the K award may be reduced to no less than 6 person-months (50% full-time professional effort at the grantee organization) and replaced by effort from the research award so that the total level of research commitment remains at 9 person-months (75% full-time professional effort) or more for the duration of the mentored K award. This change in policy applies to the following mentored K award activity codes: K01, K07 (developmental) K08, K22, K23, and K25, as well as individuals mentored through institutional K12 awards.

For additional information please visit http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-065.html.

Source: NIH Press Release: NOT-OD-08-065, April 10, 2008.

NIH Public Access Policy is now in effect – PIs must cite PMC ID numbers in submittals starting with May 25 deadline

After issuing a Request for Comments on January 11, 2008, and holding a public forum on March 20, 2008, to hear comments on its Public Access Policy, the National Institutes of Health officially invoked its new Public Access Policy as of April 7. The policy ensures that the public, health care providers, educators and scientists have access to published NIH-funded research, as mandated by the 2008 Consolidated Appropriations Act.
At the meeting, NIH Director Elias Zerhouni described how the NIH is applying 21st-century technology to its investment in research, becoming more transparent and accountable and ensuring that the NIH and the Department of Health and Human Services can better promote the science and health benefits derived from NIH-funded research.

The Public Access Policy requires NIH-funded scientists to submit journal articles that arise from NIH funding to the digital archive PubMed Central (http://www.pubmedcentral.nih.gov/).

Staff members of the MUSC Office of Research and Sponsored Programs and the Health Affairs Library are gearing up to help MUSC investigators make sure their applications, proposals and progress reports include the data where required under the policy.

The NIH Public Policy web site at http://publicaccess.nih.gov/ offers the following tips:

Address copyright – Make sure that any copyright transfer or other publication agreements allow the article to be submitted to NIH in accordance with the Policy.
Submit article – Authors may submit a paper to the journal of their choice for publication
- When submitted to certain journals, author/investigators do not need to do anything special to comply with the submission requirement of the Policy. These journals are listed at http://publicaccess.nih.gov/submit_process_journals.htm
- For journals not included in this list, the author must take the following steps:
  - Inform the journal that the article is subject to the Public Access Policy when submitting it for publication.
  - Make sure that any copyright transfer or other publication agreement allows the article to be submitted to NIH in accordance with the Policy. For more information, see the FAQ Whose approval do I need to submit my article to PubMed Central? and consult with MUSC’s Office of Research and Sponsored Programs.
  - Submit the article to NIH, upon acceptance for publication. See the Submission Process for more information.

Cite article - When citing their NIH-funded articles in NIH applications, proposals or progress reports, author/investigators must include the PubMed Central reference number for each article. Starting with the May 25, 2008, due date, NIH applications, proposals, and progress reports must include the PubMed Central reference number when citing an article that falls under the policy and is authored or co-authored by the investigator, or arose from the investigator’s NIH award.

The NIH Public Access Policy specifically implements Division G, Title II, Section 218 of PL 110-161 (Consolidated Appropriations Act, 2008) which states: SEC. 218. The Director of the National Institutes of Health shall require that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine’s PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law.

Source: NIH Public Policy Web Site, http://publicaccess.nih.gov/

Are you eligible for an NIH Bridge Award?

The NIH Director's Bridge Award Program, initiated in FY2007, provides transitional funding for Research Project Grant (R01) investigators who just miss the nominal payline of a given institute on a renewal application and have limited additional research support (see NOT-OD-08-037).

An institute or center can nominate an investigator for an award of up to $500,000 total costs using the one-year R56 mechanism. PIs cannot apply for a Bridge Award, but can and should discuss the possibility with the Program Officer for their grant.

Only principal investigators with less than $400,000 in other support are eligible for Bridge support. In this year's program, investigators who have submitted a second revision of an application (A2) with a percentile within five points of the institute or 2enter’s payline are also eligible to be nominated.

Source: Extramural Nexus, March 2008

US and Japanese scientists launch pharmacogenomics research alliance

Leaders at the National Institutes of Health and the Center for Genomic Medicine in Japan recently signed a letter of intent creating a Global Alliance for Pharmacogenomics. The effort aims to identify genetic factors that contribute to individual responses to medicines, including rare and dangerous side effects. The results of such work will eventually help doctors optimize the safety and effectiveness of drugs for each patient.

U.S. scientists joining the alliance are members of the NIH Pharmacogenetics Research Network, a consortium of research groups that study how genetic factors influence the way drugs work in and are handled by the body.

Japanese scientists in the alliance represent the newly created Center for Genomic Medicine, a component of the RIKEN Yokohama Institute that conducts high-throughput analyses of human genes involved in diseases and drug responses.

Signers of the agreement include the directors of three of the National Institutes of Health: Jeremy M. Berg, Ph.D., director of the National Institute of General Medical Sciences; Elizabeth G. Nabel, M.D., director of the National Heart, Lung, and Blood Institute; and John E. Niederhuber, M.D., director of the National Cancer Institute.

Initial projects will focus on:

Understanding genetic factors that influence the effectiveness of breast cancer treatments (aromatase inhibitors)
Determining the optimal length of treatment for two drugs used to treat early stage breast cancer (cyclophosphamide and either doxorubicin or paclitaxel)
Discovering new genetic factors linked to serious side effects from certain pancreatic cancer drugs (gemcitabine and bevacizumab)
Exploring how genes contribute to drug-induced long QT syndrome, an irregular heart rhythm that can cause sudden cardiac arrest
Working with the International Warfarin Consortium to tailor initial doses of the anti-clotting drug warfarin based on the genetic profiles of patients

A steering committee will manage the alliance and will meet twice a year to discuss progress, future directions, intellectual property issues, the approval of additional members and communication with the public. Alliance members will share their data and their research results with the scientific community.

The letter of intent is available at http://www.nigms.nih.gov/Initiatives/PGRN/GAP/. This site also includes acknowledgements of the research centers that provided DNA samples essential to perform the work.

Source: NIH Press Release, April 14, 2008

NIH renews focus on protecting sensitive data and information used in research

The recent theft of an NIH employee’s laptop computer containing sensitive data on human subjects has placed renewed focus on data security at NIH as well as at extramural institutions that conduct NIH-supported research to advance the health and well-being of all Americans.

All information systems, electronic or hard copy that contain federal data must be protected from unauthorized access. Congress and the Office of Management and Budget (OMB) have instituted laws, policies and directives that govern the creation and implementation of federal information security practices that pertain specifically to grants and contracts. The current regulations are pursuant to the Federal Information Security Management Act (FISMA), Title III of the E-Government Act of 2002 Pub. L. No. 107-347 (beginning on p. 48) (also see NOT-OD-08-032).

Although FISMA applies to grantees only when they collect, store, process, transmit or use information on behalf of HHS or any of its component organizations, recipients of NIH funds have a vital responsibility to protect sensitive and confidential data as part of proper stewardship of federally funded research, and must take all reasonable and appropriate actions to prevent the inadvertent disclosure, release or loss of sensitive personal information.

NIH advises that personally identifiable, sensitive, and confidential information about NIH-supported research or research participants should not be housed on portable electronic devices. If portable electronic devices must be used, they should be encrypted to safeguard data and information. These devices include laptops, CDs, disc drives, flash drives, etc. Researchers and institutions also should limit access to personally identifiable information through proper access controls such as password protection and other means. Research data should be transmitted only when the security of the recipient’s systems is known and is satisfactory to the transmitter.

For additional information, please contact Dr. Sally Rockey, Deputy Director, Office of Extramural Research, National Institutes of Health. 301-496-1096 or rockeysa@od.nih.gov.

Source: NIH Notice NOT-OD-08-066, April 11, 2006, http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-066.html

NIH grantees can now purchase Lexicon mice with NIH funds under same terms as NIH contract

In November 2005, NIH announced the acquisition of 250 knockout mice from Deltagen and Lexicon and made them available to researchers through publicly funded mouse repositories (see NOT-OD-06-12). The license agreements allowed researchers who received the knockout mice lines through NIH to publish any results from research involving the lines and also to seek patent or other intellectual property protection for any of the inventions or discoveries resulting from such research.

NIH recently announced that Lexicon will now make more than 2,500 knockout mouse strains available for purchase by NIH funded investigators under the same terms as the contract NIH used to acquire knockout mice by using NIH grant money. The list of available mouse lines will be updated on a regular basis as new knockouts strains are added.

Under these terms, an NIH investigator acquiring a Lexicon knockout mouse using his or her grant funds is expected to place the mouse lines in a NIH-supported mouse repository. (Instructions for submitting to the repository are included in NOT-DA-08-015). Universities, medical schools, and research laboratories will have access to mice and germplasm all over the world. Lexicon will send heterozygous mice and materials to the investigator. The investigator and institution will be responsible for coordinating with an NIH supported repository to ensure that banks of cryopreserved embryos, sperm, and embryonic stem cells are archived using state-of-the-art procedures. Mice and cryopreserved germplasm will be available from the central repository for a nominal fee to cover the costs of quality control, archiving, shipping, and restocking the archive.

Investigators acquiring mice are also responsible for ensuring that phenotypic data received from Lexicon is deposited in the Mouse Genome Informatics database or another publicly accessible database. All information provided by Lexicon for each mutant mouse will be made available to researchers worldwide without restriction.

In summary, NIH funded investigators may use grant money to purchase Lexicon mice if it is within the scope of their grants. Those interested in requesting administrative supplements to acquire Lexicon knockout mice should contact their Program Director prior to making a request. When possible, NIH supported investigators are encouraged to pool resources to share the cost of acquiring a mouse with particular null mutation.

Source: NIH Notice NOT-DA-08-015, released April 23, 2008

NIH seeks input for Common Fund/Roadmap trans-NIH strategic initiatives by June 2

The NIH wants input from the scientific community, health professionals, patient advocates and the general public about innovative and cross-cutting initiatives that could be funded through the NIH Common Fund. The NIH Common Fund/Roadmap was created by the NIH in 2004 and enacted into law by Congress through the 2006 NIH Reform Act to support cross-cutting, trans-NIH programs.

Common Fund/Roadmap programs have specific criteria. A primary criterion is that Common Fund programs are expected to have exceptionally high impact and transform the way research is conducted. All Common Fund/Roadmap programs are relevant to multiple diseases. They address common challenges that are faced by investigators working in multiple disease areas. The Common Fund/Roadmap supports programs that address fundamental knowledge gaps, develop transformative tools and technologies, and/or foster innovative approaches to complex problems. These programs are supported for a limited duration of 5–10 years. Long-term support is not consistent with the intent of the Common Fund/Roadmap. A limited duration keeps the fund nimble and able to respond to new opportunities and emerging challenges. It also allows the NIH to regularly test new ways of fostering innovative science.

Common Fund/Roadmap programs use 5–10 years of support to develop tools and technologies and establish new scientific paradigms that can then be adopted by the community through IC-funded awards. Collecting these ideas is an initial step in the process of identifying a new cohort of Common Fund/Roadmap programs for Fiscal Year 2011. The NIH expects to spend $30 – 50 million per year from within the currently projected Roadmap budget for new 5-year initiatives.

Persons, groups, and organizations interested in biomedical research are invited to submit ideas in which a health research problem is identified along with a proposal to resolve it. Responses should address the following elements:

Short Project Title
Problem/Opportunity: What are the specific barriers to basic, translational, or clinical research that need to be addressed, or what is the specific knowledge gap that needs to be addressed? How would addressing these challenges transform the way research is conducted on human health and disease (Response should be approximately 300 words)?
- Sample excerpt from a current program: “…the complex and dynamic set of microbes (microbiome) that is present on and within the human body can have a profound influence on human physiology, nutrition, immunity and development. Disruption of the dynamics may trigger diseases or interfere with normal development. Understanding of the human microbiome is an untapped area of knowledge that may be vital for the prevention and treatment of human diseases. However, to date, the human microbiome remains largely unexplored…”
- ”…the availability of an understanding of the human microbiome could revolutionize our understanding of the dynamics between the human body and the microorganisms that reside in and on it. This, in turn, could accelerate the development of strategies to promote human health and the development of therapeutic drugs to treat a wide range of diseases through microbiome manipulation…”
Approach: What type of program do you propose to address the barrier/knowledge gap (Response should be approximately 300 words)?
- Sample excerpt from a current program:”…the goal of the HMP is to characterize the totality of the human microbiota, and provide a technological and data resource that will enable the study of its variation (with population, genotype, disease, age, nutrition, medication, and environment), its influence on disease, and offer opportunities to improve human health through manipulation of the human microbiome…
Please include 2-3 terms that you would use to classify your proposal.
- Sample excerpt from a current program: “Human Microbiome, Genetics Research, Bioinformatics”

Responses will be accepted through Friday, June 2, 2008. Responses should be limited to one page, and may be emailed to roadmap_ideas@nih.gov.

All ideas submitted will be reviewed to ensure they meet the criteria for Roadmap trans-NIH strategic initiatives outlined above and will be examined in light of existing or planned research. They will then be distributed to the Program Staff of all NIH ICs who will use these ideas to begin crafting proposals for future Roadmap programs. The concepts being proposed will be cleared by the Council of Councils at their Fall 2008 meeting. Those proposals will then be reviewed and prioritized by NIH IC Directors and the NIH Director in February 2009 for a new cohort of initiatives to begin in Fiscal Year 2011.

Source: NIH Notice NOT-RM-08-014, released April 22, 2008