FROM THE DIRECTOR OF OER: Ensuring Research Is Conducted Objectively and With Integrity—Working Together

Dear Extramural Community Members,

We have a very important problem that threatens the public's perception of the integrity of research. This is a very serious matter, and we must act swiftly to address it.

You may have noticed that the topic of researchers' financial conflicts of interest has been much in the news lately. As I've said on previous occasions (see July 2006 Nexus), NIH and recipients of NIH funds must ensure that the research supported is conducted objectively and in the absence of inappropriate influences.

Maintaining objectivity in research is critical to preserving the public's trust. Only with the public's trust can NIH continue to support the search for new knowledge in the prevention, treatment and cure of human diseases and conditions; promote the development of intellectual property critical to translating this knowledge from bench to bedside; and engender countless new technologies and industries.

Effective oversight and management of the extramural community's financial conflicts of interest necessitates the full participation of researchers, their institutions and the NIH. Given the complexity of the issue, this requires thoughtful and ongoing problem-solving among all the parties in as many forums as possible (this column being just one of them).

For our part, we at NIH will be reviewing our regulations, policies and guidance on financial conflicts of interest in order to determine what changes may be needed to enhance our oversight, provide clarification and promote best practices in the community. In addition to this review, we have already contacted some of your institutions to review their financial conflict of interest policies (see Guide Notice OD-08-010) . We are also expanding our education and outreach efforts to assist institutions and researchers in meeting the requirements related to disclosing and managing financial conflicts of interest, and to emphasize further the critical importance of proper disclosure and management of these conflicts. We will be addressing these issues at our regional seminars over the next few months (See Guide Notice OD-08-022). And soon, we will post on our Web site an updated set of frequently asked questions and answers on financial conflict of interest issues and an online tutorial that will help clarify the responsibilities of researchers, institutions and the NIH. We will continue to communicate with you regularly on our activities in this important area.

As the recipients of funding, you are on the ground at your institutions, knowing what will be most effective in ensuring that the best practices are promoted. Therefore, it is vital that you understand the issues and that you meet your responsibilities in this critical area. I look forward to working with you to find the best way forward to continue to uphold the highest standards of conduct and support the best biomedical research.

— Norka Ruiz Bravo
OER Director and NIH Deputy Director for Extramural Research

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TOP STORIES

NIH Issues New Public Access Policy

The NIH recently announced its new Public Access Policy regarding peer-reviewed publications. The new NIH Public Access Policy will ensure published NIH-funded research is accessible to the public, health care providers, educators and scientists and will help advance science and improve human health.

In accordance with federal law, the NIH now requires the submission of published articles resulting from NIH-funded research to PubMed Central. These articles will be made publicly available on PubMed Central within 12 months of the publication date. The length of this delay period is determined by the copyright holder, which may be the author, their institution or their publisher. NIH will continue to work with all three groups to make this new policy a success.

There are three actions grantees must take to comply with the policy:

1. Address copyright: Beginning April 7, 2008, authors of articles arising from NIH funds are responsible for ensuring that publishing agreements allow for full compliance with the policy.
   
   
2. Submit the article to NIH. Beginning April 7, 2008, authors must submit to PubMed Central an electronic version of every peer-reviewed article arising from NIH research funds, once an article is accepted for publication. NIH has worked with publishers to develop several ways to submit articles:
   
   
   • The author or someone in their organization may deposit a copy of the peer-reviewed manuscript in the NIH Manuscript Submission (NIHMS) system (http://www.nihms.nih.gov/). Author verifies content.
     
     
   • The journal may offer to send the peer-reviewed manuscript files to the NIHMS. Author verifies content.
     
     
   • Publish in a PubMed Central Journal. No additional effort required from the author. See http://publicaccess.nih.gov/submit_process_journals.htm for a list of these journals.
     
     
3. Cite. Beginning May 25, 2008, authors must include PubMed Central ID numbers in NIH applications and reports when citing their articles covered by the policy.

Information for the public

Policy Guide Notice:
NOT-OD-08-033

Public Access Policy Web site:
http://publicaccess.nih.gov/index.htm

FAQs:
http://publicaccess.nih.gov/FAQ.htm

We will keep you posted on the availability of training materials on the policy change and the submission process. In the meantime, there is a submission tutorial at http://www.nihms.nih.gov/web-help/index.html.

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What the New Public Access Requirement Means to the NIH-Supported Investigator

The new Public Access requirement is an important opportunity to make published research funded by NIH and written by you and your colleagues accessible to all - the public, health care providers, educators and scientists, among others. This improved access will help advance science and, ultimately, improve human health.

The Public Access policy becomes a term and condition of award on April 7 (see the related article in our "Top Stories" section). As you take steps to comply with this requirement, consider a few key issues. Please refer to the Guide Notice for the policy requirements.

Have you identified the key players at your institution who can help successfully implement the policy?
Librarians, faculty and offices of sponsored research, the general counsel and technology transfer could all play important roles in implementing the policy.

Does your institution wish to develop or amend a standard copyright transfer agreement for all institutional authors?
A standard copyright transfer agreement may make it easier for faculty, students and employees to comply with the policy, and decrease questions and confusion. Refer to the NIH's FAQs for more information on this topic.

What institutional policies and guidance may need to be modified to implement the Public Access Policy?
Institutions may wish to consider modifying formal guidance for peer-reviewed publications arising from NIH funds. This guidance may include faculty and student handbooks.

Institutions may also wish to consider internal procedures and quality assurance checks for submitting funding-related submissions to NIH (e.g. PHS forms 398, 424, 2590, etc.) in light of changes to the Public Access Policy.

Does your institution wish to develop a plan to inform potential authors about the policy change, its implications and how they can comply?
Institutions may want to announce the policy change internally and incorporate discussions of Public Access into training for institutional staff, faculty and students. NIH has an FAQ on policy and online training on how to submit articles that institutions may want to modify or disseminate.

Do staff who may receive questions from your authors know where to go for help?
NIH has a Web site on the policy. Institutions may also wish to designate internal leads who can answer questions on the policy.

Does your institution wish to designate an individual or department to help investigators submit their own manuscripts?
Many university libraries support the Public Access policy by offering training on the policy and submission, and answering questions about the policy, copyright and the submission process. Other institutional officials, such as grants and contract staff and legal counsel, may receive questions about the policy from faculty. It may be helpful to identify staff likely to receive these questions in advance, and ensure that they have the ability to answer these questions directly or refer authors to the right place.

Does your institution wish to participate in any public resources on compliance?
The research, publishing and medical library communities have developed a number of internet resources to support and understand Public Access.

We welcome your questions and suggestions for information or materials that will help you comply with the policy. Email us at PublicAccess@mail.nih.gov. We will keep you updated on both the Nexus and the Public Access Web page of additional resources as they become available.

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NIH Announces FY 2008 Fiscal Plan

With an FY 2008 budget that increases last year's funding by just 1 percent, NIH set priorities for managing its biomedical research investments, reaffirming its commitment to boosting the pool of researchers by supporting new investigators and sustaining established researchers.

Details are available at NIH Fiscal Policy for Grant Awards – FY 2008. Policy highlights include:

• Non-competing awards that were funded at reduced levels will be restored to comply with the FY 2008 budget action.
  
  
• For competing research awards, the policy requires institutes and centers (ICs) to maintain the number of new investigators comparable to the average of the most recent five years, employing the NIH Director's Innovator Awards, NIH Pathway to Independence Awards, and the NIH Director's Bridge Awards Program.

The policy also directs ICs, within the realm of their specific scientific and programmatic imperatives, to establish fiscal policies consistent with NIH-wide policies. More information on the FY 2008 Fiscal Operations, including specific funding strategies for ICs, will be posted Feb. 6 at http://grants.nih.gov/grants/financial/index.htm.

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FY 2008 Budget Highlights

The President's FY 2008 budget, signed into law on Dec. 26, 2007, increases funding for the Global AIDS Fund and assigns funds to the National Children's Study.

The budget allocates $29.3 billion to NIH, an increase of $328 million (more than 1 percent) above the FY 2007 budget level. This is $606 million (more than 2 percent) above the President's original FY 2008 budget recommendation, but it is $772 million, or 2.6 percent, less than what Congress originally recommended.

NIH's Global AIDS Fund secured $196 million above FY 2007 levels, representing $295 million of NIH's budget. The National Children's Study received $111 million. Overall, NIH spending will increase by $132 million (roughly 0.45 percent) over FY 2007 levels.

The act also includes (in the Department of the Interior appropriations bill) $77,546,000 for NIEHS to carry out Superfund activities and workers' education and training programs on risk assessment and the clean up of hazardous waste sites.

The act also requires the following:

• Transfer of Funds from NIH to HRSA and AHRQ for research training: This provision restores the authority, previously established in the Public Health Service Act, for NIH to take 1 percent of the funds it annually allocates for National Research Service Awards and transfer them to HRSA and AHRQ for training in primary care and health services research.
  
  
• NIH Public Access to Research: The act mandates that NIH-funded researchers submit final peer-reviewed and accepted-for-publication manuscripts to NIH's PubMed Central digital archive within 12 months of official publication date.
  
  
• NIH Facilities: Consistent with the President's budget, the act places a ceiling of $35 million on operating funds within an institute or center that may be used for alteration, repair or improvement.

NIH released its Fiscal 2008 Policy (see story in this issue and the Guide Notice. We will keep you updated as more information on the 2008 budget becomes available.

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FY 2008 Salary Limitation for PIs

The NIH FY 2008 salary cap for principal investigators is again restricted to Executive Level I of the Federal Executive Pay scale, which increased January 1, 2008, from $186,600 to $191,300. Information and questions and answers concerning NIH implementation of the new salary limitation is provided in Guide Notice OD-08-035.

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EYE on PI

New Reporting Web Site Goes Live Next Month, Replaces Awards Info & Data Page

The Office of Extramural Research's (OER) Division of Information Services (DIS) will be releasing a prototype version of a new Reports, Data, and Analyses (RDA) Web site to the public in February. DIS is developing the site, which will replace the current Award Information and Data page, to provide improved reliability and consistency of reporting and to make standardized reports more accessible.

For several months, a prototype of the RDA Web site was available for internal NIH use. DIS highlighted the site's many features in demonstrations to several NIH user communities.

OER is developing a proposal to use the RDA Web site as the foundation for a broader NIH-wide Research Portfolio Online Reporting Tool (RePORT). The goal of RePORT is to improve internal and public access to data on NIH research programs, facilitate evaluation and management of research portfolios and satisfy certain reporting requirements of the NIH Reform Act of 2006. Moreover, RePORT will be used to automate certain aspects of the NIH biennial reporting process.

RePORT is part of a larger initiative that includes an effort to improve OER's reporting business practices, experiment with new ways of reporting and better meet the information needs of NIH's stakeholders. Through RePORT, NIH's stakeholders will have quick access to "Frequently Requested Reports," links to reports on total NIH funding for research in certain areas, conditions and diseases, as well as "Frequently Asked Questions," which will address topics such as:

• How are success rates computed?
• How can I find dollars awarded by specific mechanisms?
• What is the NIH budget?

RePORT will also provide an upgrade to the current Computer Retrieval of Information on Scientific Projects (CRISP) system, which integrates new and existing data sources to allow user-defined querying and reporting on NIH grants, intramural projects, contracts and associated outputs.

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Reminder! Data-sharing Policy for Genome-wide Association Studies Effective Jan. 25

NIH's policy for data sharing under the Genome-Wide Association Studies applies to all grant applications and cooperative agreements submitted for the Jan. 25 and subsequent receipt dates. Look for more information in the Guide Notice.

The Nexus will feature more GWAS information in future editions.

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New Rules for Reporting Clinical Trials

The FDA Amendments Act of 2007 (see Title VIII) expanded the ClinicalTrials.gov registry, run by the National Library of Medicine, to include mandatory reporting of Phase II-IV clinical trials of drugs and devices. The law requires timely registration of clinical trials, and subsequent reporting of results.

Clinical trials for serious and life-threatening diseases that were ongoing as of December 26, 2007, should have been registered in ClinicalTrials.gov by December 26, 2007. All new Phase II-IV clinical trials will need to be registered by September 27, 2008. See NIH Guide Notice NOT-OD-O14 for more details.

Registration of NIH-funded applicable clinical trials (see NOT-OD-014) in the database will need to be certified before funding can be released. As detailed in NIH Guide Notice NOT-OD-O23, competing grant applications submitted to the NIH on or after January 25, 2008, that include applicable clinical trials should include information about registration (i.e. the NCT number, the Brief Title and the name of the responsible party) about any ongoing trials in the Human Subjects Section of the Research Plan.  If a new applicable clinical trial is proposed in the grant, the Human Subjects section of the research plan should include a statement that the application includes a trial that requires registration in ClinicalTrials.gov.

All progress reports for grants that include an applicable clinical trial with budget start dates of April 1, 2008, or later should include information about any ongoing trials in the Human Subjects section.

Who should submit the information? The act defines the "responsible party" who needs to submit the information as the sponsor of the clinical trial or the principal investigator of such clinical trial, if so designated by a sponsor, grantee, contractor or awardee (provided that "the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements" for submitting information under the law).

Nexus Tips on the Rules

Remember! For competing applications: All applications submitted to the NIH on or after January 25, 2008, that incorporate an applicable clinical trial in their proposed project are required to provide the NCT number, Brief Title and name of the responsible party (or parties). The same applies to non-competing progress reports for grants that include an applicable clinical trial with budget start dates of April 1, 2008, or later are required to provide the same information. See NIH Guide Notice NOT-OD-023 for details.

For more information, please consult the Frequently Asked Questions on the Office of Extramural Research Web site.

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NIH: Chartered Reviewers Get New Flexibility Submitting Applications

NIH has just created the incentive of relaxing submission deadlines for scientists who serve as chartered or "permanent" members on its peer review groups.

This change will allow NIH to continue to recruit the most qualified reviewers, while better compensating chartered reviewers, who can be disadvantaged by deadlines that force them to develop their own applications while reviewing those submitted to NIH by others. For more information, see the recent Guide Notices: NOT-OD-08-026 and NOT-OD-08-027.

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Peer Review Advisory Group Reports Early Findings

An external working group reported their preliminary findings on enhancing peer review to the Advisory Council to the Director at the December 14 meeting. NIH Director Zerhouni charged the group to "fund the best science, by the best scientists, with the least administrative burden..."

The scientific community submitted more than 2,500 responses, representing investigators, scientific societies, grantee institutions and voluntary health organizations, holding regional meetings in New York, Chicago, San Francisco and Washington, D.C.

The results of this initiative could have a profound affect how the extramural community operates. Pilots are expected to begin this spring. Details from the peer review working groups may be found at the Enhancing Peer Review at NIH Web site.

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FISMA: Federal Regulations Governing Data Management

The Federal Information Security Management Act (FISMA) governs the creation and implementation of practices related to managing and protecting the information collected by the federal government, including NIH grants and contracts. The regulations require the head of each agency to implement policies and procedures that reduce information-technology security risks to an acceptable level, in a cost-effective manner.

In an October 29, 2007, memo, the Department of Health and Human Services (HHS) addressed the applicability of FISMA to grantees funded by HHS, including the NIH.

The memo stated that FISMA applies to grantees only when they collect, store, process, transmit or use information on behalf of HHS or any of its component organizations. In all other cases, FISMA is not applicable to recipients of grants, including cooperative agreements with grantees. The grantee retains the original data and intellectual property, and is responsible for the security of this data, subject to all applicable laws protecting security, privacy and research.

For more information please see NIH guide notice NOT-OD-032.

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NIH Clarifies New Investigator Definition

NIH has clarified the definition of new investigator and addressed Frequently Asked Questions about eligibility for consideration as a new investigator. In general, a Program Director/Principal Investigator (PD/PI) is considered a New Investigator if he/she has not previously competed successfully as PD/PI for a significant NIH independent research award. See the Resources for New Investigators Web page for this information.

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Pinn Point on Women's Health

NIH researchers and grantees discuss women's health issues with Dr. Vivian Pinn, director of the NIH Office of Research on Women's Health. Join the growing number of people who listen to the podcast every month. Just go to http://orwh.od.nih.gov/ to listen to each episode. For more information, please contact either Calvin Jackson at 301-594-8750 or Joseph Balintfy at 301-496-7246.

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Videocast: Conference on Mentoring Women In Biomedicine

If you missed the National Leadership Workshop on Mentoring Women in Biomedical Careers last November, be sure to view the plenary sessions now available at http://womeninscience.nih.gov/mentoring.

More than 500 registrants from government, academia and industry attended the event, which was sponsored by the NIH Working Group on Women in Biomedical Careers and the Office of Research on Women's Health and included presentations by NIH Director Elias Zerhouni and NIH Deputy Director Raynard Kington.

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NIH Research Radio

NIH Research Radio features in-depth interviews with NIH scientists and grantees discussing the latest research findings, educational campaigns, consumer-orientated features and results from Consensus and State of the Science conferences.

Each program runs approximately 30 minutes. NIH Research Radio, which is currently ranked among iTunes Top 100 Medicine Podcasts, is updated every other Friday. Join the more than 75,000 people who listen to NIH Research Radio each month. Just go to http://www.nih.gov/news/radio/nihpodcast.htm to subscribe to the RSS news feed or listen to podcast via your computer. For more information, contact either Calvin Jackson at 301-594-8750 or Joseph Balintfy at 301-496-7246.

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"i on NIH"

Half an hour, once a month, this video podcast brings you exciting information about medical research advances from all 27 institutes and centers at NIH. Each program runs approximately 30 minutes and features a news update, an in-depth interview with an NIH researcher, and additional segments.

Join the growing number of people who watch "i on NIH" each month. Just go to http://www.nih.gov/news/vodcast/nihvodcast.htm to subscribe to the RSS news feed or view individual video podcasts via your computer. For more information, contact either Calvin Jackson at 301-594-8750 or Joseph Balintfy at 301-496-7246.

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Electronic Emphasis

eRA Introduces Electronic Conflict of Interest Forms

eRA's newly introduced electronic Conflict of Interest (eCOI) form allows NIH peer reviewers to electronically submit any real or apparent conflict of interest with a grant application awaiting study section review.

This new feature, made available through the Internet Assisted Review (IAR) module in December, provides Scientific Review Officers and Grant Technical Assistants with the capability of tracking the signed forms and monitoring signature compliance.

eRA also modified the Committee Management module to show the signed forms via a new 'Meeting Documents' screen, while the Peer Review module displays the signed forms if the forms were signed via IAR. See the Fact Sheet (PDF - 56 KB) on the IMPAC II Review Web page for additional information.

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eRA System to Allow Multiple Active Applications

eRA (electronic Research Administration) will launch a new feature in February that allows multiple applications to be active in the eRA system at the same time. Multiple Active Applications (MAA) offers grant applicants the ability to submit an amended version of an application (marked resubmission on the electronic form) before the previous one has made its way completely through the council/advisory board and funding-decision processes at NIH.

MAA represents a change in the business practice governing how NIH manages grants that was made necessary by initiatives designed to expedite review and provide quicker feedback to applicants. Examples of those initiatives include special deadlines for AIDS applications and new investigators' being allowed to respond to reviewer feedback from the previous round.

The current eRA system software only allows one active application, and automatically withdraws earlier versions when a subsequent version is received. The MAA system addresses this issue, keeping all versions (e.g., 01, A1, A2) of an application active and providing an 'MAA" flag for each application in an active cluster. If any version of an application in a cluster is awarded, all other applications within the cluster will be automatically withdrawn.

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NExus news & events

FDP Seeks Applicants for Next Phase

The Federal Demonstration Partnership (FDP), a cooperative initiative among 10 federal agencies and 98 institutional recipients of federal funds, is accepting applications for institutions to participate in the next phase of the partnership. The primary goal of FDP is to increase research productivity while simultaneously decreasing the administrative burden associated with effective stewardship of federal funds. The application is available at http://www.nsf.gov/pubs/fdp/phasevsol.pdf.

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Opportunities for Senior Science Leaders in OER

The NIH Office of Extramural Research (OER) seeks senior scientific leaders who want to make an impact on NIH grants process and policy. OER is responsible for the establishment, direction and implementation of standards for the program management of all NIH extramural grants activities. Check out the following positions, and consider applying:

Director, OEP (# OD-08-240882-T42)

Director, Division of Scientific Programs, OEP (OD-08-240885-T42)

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Mark Your Calendars!
NIH Faculty To Provide Training in Texas and Illinois

Are you a grants administrator, researcher new to NIH, or a graduate student? Are you looking for an opportunity to interact and learn from the expertise of approximately 25 NIH and HHS policy, grants management, review and program staff? If so, then be sure to register now for one of the upcoming NIH Regional Seminars on Program Funding and Grants Administration:

San Antonio, TX - March 25-27, 2008:
Hosted by the University of Texas Health Science Center at San Antonio. (Only 2 months away - register today!)

Chicago, IL - June 18-20, 2008:
Hosted by the University of Illinois at Chicago.

Held twice a year around the nation, these two-day seminars help demystify the application and review process, provide updates and clarification on federal regulations and policies, as well as highlight current areas of special interest. The seminars promote interaction in a fun learning environment.

In addition, eRA Commons computer labs are scheduled for a third day, offering hands-on training from eRA experts. This year's lab sessions offer a variety of choices for account administrators, principal investigators and delegates, as well as anyone who works with Financial Status Reports (FSRs). Topics include account administration, tracking applications through all phases of a grant's life cycle, xTrain (a new system for managing training awards), the electronic submission of FSRs and so much more!

This is an exciting opportunity for NIH, HHS and the extramural research community to teach, share, learn and grow from one another's expertise and perspectives. Seats are still available for both seminars, but are limited. Reserve your seat, so you don't miss your chance to be a part of this valuable opportunity in 2008!

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