When we published our first NIH Extramural Nexus two years ago, we envisioned it as a two-way communication portal that would keep you informed of key developments in NIH extramural research policy, program and activities, while offering you a forum to stay engaged in the dialogue that affects our work.

Recently, your feedback has conveyed to me that how and when you receive the information is as important as the content you receive. The Nexus’ new format responds to the lion’s share of your comments by introducing key sections highlighting significant news, events and developments in extramural research that will now be delivered to you monthly.

Many of you have commended the Nexus’ value in providing concise and timely updates—particularly in light of major developments in, for example, the NIH’s peer-review process and public access policy. Our new format not only reflects our continued commitment to keeping you informed, but also to making it easier for you to access important information faster.

NIH’s extramural program is in the midst of changes, and the Nexus remains committed to providing you accurate, timely information. I look forward to hearing from you about the new format, topics for articles or general suggestions. Feel free to email me anytime.

The NIH held a public meeting on Thursday, March 20, 2008, to hear comments on its Public Access Policy. The policy ensures that the public, health care providers, educators and scientists have access to published NIH-funded research. It was made mandatory by the 2008 Consolidated Appropriations Act, and takes effect April 7.

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.

"We believe that public access, after a reasonable embargo period of up to a year to research publications funded by NIH, will help advance science and improve human health while preserving peer review and the value of scientific publishing," Zerhouni said. Improved access will be a "dynamic resource to not only research and display publications, but to link them to all sorts of knowledge that NIH has invested in making research more efficient for all scientists." If the policy remained voluntary, Zerhouni said, about 64,000 new research articles arising from NIH funds would not be available to the public each year.

The meeting was held to ensure the policy's implementation will work as successfully as possible for all involved. "We are all ears," Zerhouni told the audience. "We need to move forward and we are completely open to an interactive process here that will take into account all input."

The NIH received comments from representatives of universities and other NIH grantee organizations, publishers from commercial organizations and professional societies, journal editors, patients, public health advocates and the general public. The NIH received 451 comments in advance of the meeting. Preliminary analysis indicates more than 60 percent of these pre-meeting comments expressed support of the policy as implemented; approximately 15 percent said the 12-month delay period was too long; and 15 percent had concerns that a mandatory policy would be detrimental to scientific publishers.

Twenty-four stakeholders volunteered to speak at the meeting. NIH Deputy Director for Extramural Research Norka Ruiz Bravo closed the meeting with a preliminary analysis of the central themes discussed. These included how author and publisher copyrights would be managed; the speed of the implementation, the impacts of the policy on publishers, science and health; the versions of articles collected; the efficacy of NIH's instructions; and the length of the delay period. Ruiz Bravo said that all of these comments would be analyzed further.

"NIH is committed to making this policy a success for all concerned, and we want to work with all of you to get that done," Ruiz Bravo said in a statement.

VideoCast and pre-meeting comments are available to the public.

The NIH has published a Request for Information (RFI). Comments may be submitted in response to the RFI between March 31 and May 31, 2008. Please see http://publicaccess.nih.gov/comments.htm for more information. NIH's report on the meeting, pre-meeting comments and the RFI will be issued by September 30, 2008.

Please check the Public Access Web site for more information about the RFI and other updates. New training resources are also available.

The January 2008 Nexus highlighted how essential it is that the NIH—in collaboration with grantee institutions and, most importantly, with you—works to maintain the highest standard of objectivity in all our research endeavors.

To this end, the NIH is engaged in a system-wide review of policies, procedures and guidance on financial conflicts of interests (FCOI) and is also reexamining guidance provided to staff in their oversight efforts. We have asked a number of institutions for additional information about how they manage potential FCOIs of investigators conducting various types of research.

These efforts will be important in informing future activities and helping to improve the guidance provided to institutions on this topic. Finally, the NIH is considering how to enhance our education and outreach efforts to raise awareness in the community of the importance of rigorous and thorough management of FCOI issues.

Updated Frequently Asked Questions containing important information about FCOI compliance have been posted on the OER Web site (see news brief in the “Resources” section).

As always, you are welcome to email your comments on this important issue to Dr. Norka Ruiz Bravo. Watch this space for a monthly update of our progress on these activities.

On March 24, 2008, the National Institutes of Health announced the appointments to the NIH Council of Councils (see the roster). The NIH Reform Act of 2006 authorized the Council of Councils and the Common Fund to support trans-NIH initiatives (see November 2007 Nexus).

A major element of the Reform Act of 2006 was the new authority it gave to the NIH director to improve program coordination, assemble accurate data, implement strategic plans based on IC-determined priorities, ensure resources are properly allocated, and further maximize investigator-initiated research.

The Council is made up of 27 members selected from the NIH Institute and Center (IC) advisory councils and advisory committees to the NIH Office of the Director. The Council will advise the NIH director on cutting-edge trans-NIH priorities and matters related to the policies and activities of the Division of Program Coordination, Planning, and Strategic Initiatives, established by the NIH Reform Act 2006, and the Office of Portfolio Analysis and Strategic Initiatives. It also will act as an external advisory panel to the IC directors during the concept approval stage of the review process for trans-NIH initiatives.

The Council's first official meeting was March 31-April 1, 2008, on the NIH campus, Bethesda, MD. It was open to the public; and an agenda is available on the Council's Web site.

The NIH issued a Guide Notice Feb. 11 that details a list of new mandates emanating from the fiscal year (FY) 2008 budget legislation—including the mandatory Public Access requirement. The notice also includes list of mandates that remain in effect from FY 2007. Find additional information about extramural FY 2008 financial operations through a series of NIH Guide notices, listed as resources on the Financial Operations Web site. The Web site provides links to funding strategies for each of the NIH Institutes and Centers.

NIH budget analysts have begun budget planning and justification for FY 2009, even though it is just the mid-point of FY 2008. Access information on the FY 2009 budget activities and other budget developments on the NIH Budget Office Web site and the Financial Operations Web site. If you have additional questions, please write to us at oer@od.nih.gov

The NIH Director's Bridge Award Program, initiated last year, is designed to provide 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. 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.

On March 1, OER’s new “Protecting Human Research Participants” Web-based training officially replaced the National Cancer Institute’s “Human Participant Protections Education for Research Teams.”

The training is intended for individuals involved in the design and/or conduct of NIH-funded human-subjects research. It is specifically designed for extramural investigators and is one of many options for meeting the June 2000 "Required Education in the Protection of Human Research Participants" policy, created in response to federal mandates for increased emphasis on protection for human subjects in research.

Using a graphics-rich and interactive format, the training presents basic concepts, principles and issues related to the protection of research participants. It explains the obligations of researchers and institutions to protect the rights and welfare of subjects in research with up-to-date policies and guidance.

The Office of Extramural Research's Division of Information Services (DIS) recently launched a public prototype of its Reports, Data, and Analyses (RDA) Web site, which will eventually replace the current Award Information and Data page.

The site is designed to provide improved reliability and consistency of reporting and to facilitate access to standardized reports.

DIS, in collaboration with the Office of Portfolio Analysis and Strategic Initiatives' Portfolio Analysis and Scientific Opportunities Branch, developed 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. Also, 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.

Together, the RDA Web site and additional RePORT capabilities will provide the central source for public reporting on NIH-wide research activities.

RePORT will 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, and contracts. The current CRISP system will be sunset in an effort to offer its users enhanced options for searching NIH-funded research.

On March 21, the NIH announced the availability of new "Frequently Asked Questions” (FAQs) on Financial Conflict of Interest (FCOI), now available on the NIH Office of Extramural Research Conflict of Interest Web site. The FAQs are part of NIH’s continuing educational efforts to improve and enhance compliance with FCOI requirements. See the related article in this issue’s “Top Stories” section.

The Office of Laboratory Animal Welfare (OLAW) is encouraging institutions and their investigators to review new FAQs on the OLAW Web site.

The newly posted questions and answers, marked “new” to enable readers to locate and review them quickly among previously posted questions and answers, include:

• Are institutions required by FOIA to release information about their research, animal care programs, and Institutional Animal Care and Use Committee (IACUC) members?
• What are PHS requirements for recording and reporting minority views?
• Is it acceptable to have different individuals named as principal investigator on the grant application and the IACUC protocol?

Other new FAQ topics include answers to questions on whether IACUCs are permitted to authorize the adoption of research animals as pets after the animals are no longer needed for study; what the institution’s responsibilities are in ensuring that animals are shipped safely and reporting adverse events that occur in shipment of animals to or from the institution; and how institutions and their IACUCs can best prepare for a pandemic.

The Office of Laboratory Animal Welfare issued guidance last month to grantee institutions on its revision to the sample Animal Welfare Assurance document.

These changes to the document, detailed Feb. 15 in Guide Notice OD-08-049, clarify essential information and define elements required in the Assurance document, a stand-alone document that describes the animal care and use program of an institution.

The NIH continues to work closely with Grants.gov to be able to receive all grant applications electronically. Currently, about 80 percent of NIH grant applications are submitted electronically.

The Grants.gov move from PureEdge^TM to Adobe forms continues to impact the transition dates for the remaining grant programs. Although the move to forms that require only Adobe Reader will be a positive one for our community, benefiting both Mac^® and PC users, there are many factors to consider when planning the timing of NIH’s switch to Adobe forms.

To reduce the burden associated with form transitions on the applicant community, the NIH is pushing to combine a number of upcoming form changes including:

• The move to the Adobe forms
• Recent changes to the PHS 398 form components [NOT-OD-08-028]
• Form changes resulting from the Federal Funding Accountability and Transparency Act (FFATA)
• Adjustments from the upcoming renewal of the SF424 (R&R) (Federal Register notice due out soon).

NIH is carefully tracking the timing of these changes. We estimate being able to make the transition to Adobe forms towards the end of the calendar year. After that time, NIH will focus on transitioning our Fellowships (F), Career Development (K) and Training (T) mechanisms and finally our complex, multi-project applications. Stay tuned for more information as it becomes available.

As of February, eRA keeps all versions (e.g., 01, A1, A2) of a grant application active and provides an internal “MAA” flag for each application in an active cluster. The cluster allows applicants to identify quickly all versions of one application. If any version in a cluster is awarded, applicants will notice that all other applications within the cluster will be automatically withdrawn without any additional action by applicants or staff.

Having systems permit multiple active applications supports initiatives focused on expediting review and providing quicker feedback to applicants.

Register today while space is still available:

NIH Regional Seminars on Program Funding and Grants Administration Chicago, IL - June 18-20, 2008: Hosted by the University of Illinois at Chicago.

Be sure to register for NCRR’s May workshops that explore various aspects of clinical research. Both are free and open to the public. The first, Clinical Research Networks: Building the Foundation for Health Care Transformation, is on May 8, 2008, from 8:15 a.m. to 6 p.m. in Natcher Auditorium, Bldg. 45.

It will feature experts presenting key accomplishments of the Clinical Research Networks Program and provide a venue for the research community to review and discuss how these accomplishments can be used to advance clinical and translational research. Speakers will include Drs. Elias Zerhouni, NIH director, Barbara Alving, NCRR director, and Isaac Kohane, Harvard Medical School Informatics Program chairman. Please register by April 28, 2008, by visiting www.ncrr.nih.gov/Upenn.asp.

The second workshop, Accelerating the Dissemination and Translation of Clinical Research into Practice, is on May 9, 2008, and will explore collaborative ways to improve and speed research advances into clinical practice. It will be held from 8:00 a.m. to 4:35 p.m. in the Natcher Auditorium of Building 45 on the NIH campus.

The workshop is the first in a series to discuss and share best practices and ways in which researchers can partner with community health care providers to translate clinical research into practice. Participants will develop recommendations for academic-community collaborations and partnerships with other community programs to better facilitate translating science into community-based practice. Please register by April 28, 2008. Registration and more information is available at www.aptrweb.org/workshops.

Individuals with disabilities who need sign language interpreters and/or reasonable accommodation to participate in either event should contact the Federal Relay Service at 1-800-877-8339 at least five days prior to the events.