As some of you may already know, in November, I will transition as Director of the Office of Extramural Research (OER) and NIH Deputy Director for Extramural Research (DDER) to the role of Special Advisor to the NIH Director.

I personally believe that the leadership of high level positions like that of the DDER should turn over every five or six years to make room for new perspectives and direction, and November marks the completion of my fifth year of service as NIH DDER.  Dr. Zerhouni’s departure makes this an ideal time for my own transition.  From the position of Special Advisor to the NIH Director I can continue to contribute to the NIH mission. 

I am very proud of all that we have been able to accomplish in our five years together.  Much remains to be done, and we have a number of challenges ahead –– such is the nature of biomedical research.  Perhaps our most serious immediate challenge is the financial conflict of interest (FCOI) issues still facing our extramural research community. In this regard, NIH has taken –– and I am sure will continue to take –– necessary action in a thoughtful and measured way to ensure that the integrity of the scientific research that we support is maintained and that we preserve public trust.  I am confident that the NIH-supported biomedical research community is fully engaged and aware of the gravity and complexity of the issues before us.  I know that many of you, scientists, academic leaders, and professional societies are poised to respond to the Advanced Notice of Proposed Rule Making (ANPRM) as soon as it emerges from the clearance process, and I am looking forward to the product of this community discussion.

Dr. Sally Rockey, my deputy since 2005, has agreed to serve as the interim DDER. Prior to arriving at the NIH, she was the Deputy Administrator, Information Systems and Technology Management Unit, Cooperative State Research, Education and Extension Service, U.S. Department of Agriculture. In that role, she provided leadership for and managed all aspects of the agency’s information technology and software applications, spearheading the successful reconstruction of its ailing IT department and bringing the department into compliance with USDA and OMB directives. Sally is also an expert in grants management and the peer review process. I am grateful for her willingness to assume the role, and I am confident that under her leadership the NIH-supported extramural research community will continue to thrive.

It has truly been a privilege to work with you and to serve our extramural research community as the NIH DDER.  I will long remember the friendship, support, and challenges we have shared and look forward to continuing to work with you and serve our community in my new role.

— Norka Ruiz Bravo, Ph.D.
OER Director and NIH Deputy Director for Extramural Research

In his October 17 memorandum to Senior Staff, NIH Director Elias A. Zerhouni had the following to say about Dr. Norka Ruiz Bravo and her tenure as NIH Deputy Director for Extramural Research and Director, Office of Extramural Research:

"Dr. Norka Ruiz Bravo has provided outstanding service to NIH and the biomedical research community in her capacity as NIH Deputy Director for Extramural Research. Her leadership is evidenced by NIH’s continued success in this area. Dr. Ruiz Bravo has made critical contributions to the development and implementation of the NIH Roadmap for Medical Research and many of its initiatives. In addition, she played a leadership role in developing and implementing transforming NIH policies, such as the Public Access and the Multiple Principal Investigator policies, and eSubmission, the NIH transition from paper to electronic submission of applications."

"She initiated the use of mathematical modeling to improve our understanding of the dynamics of the biomedical research workforce, and contributed greatly to the discussion and resulting programs to address the plight of new investigators. She catalyzed the development of the RePort website for NIH data, and led the development of the Animals in Research Project, a proactive agenda to enhance communication about the importance of animal models in research and address the increasing use of violence against NIH-supported researchers who use animal models." We look forward to Dr. Ruiz Bravo continuing to contribute her expertise and experience in her new role and we wish her the very best.

The new NIH policy decreasing the number of amended grant application resubmissions from two to one will help ensure earlier funding of high quality applications and improve efficiencies in the peer review system. For more information on this new policy, please see the relevant NIH Guide Notice. The new policy is part of a continuing series of changes to the NIH peer review system following an in-depth review and a year-long self-assessment that concluded in June 2008. Additional data and information on the policy are available at the Enhancing Peer Review Web site.

The National Institutes of Health (NIH) has issued a Guide Notice on the Financial Conflict of Interest (FCOI) Module, a new feature of the NIH electronic Research Administration (eRA) Commons. The FCOI Module gives institutional users the ability to electronically prepare and submit FCOI reports and other required documents through the Commons, enhancing management of FCOI reports. Currently, the FCOI reports are submitted to the Chief Grants Management Officer of the NIH awarding component. The FCOI Module allows institutional users to:

• initiate and prepare FCOI reports
• electronically submit reports and supporting documents
• search and view FCOI reports previously submitted through the Commons
• edit or rescind submitted reports (with NIH assistance)
• access history of actions

The FCOI Module is part of the eRA Commons, an online interface where grantees and federal staff share information. The current version of the FCOI Module incorporates feedback from a small-scale pilot test performed in the summer of 2008 with nine institutions that are members of the Commons Working Group. Based on feedback from the initial pilot participants, NIH now expands the pilot to all Federal Demonstration Partnership members and a small sample of non-FDP members. Additional information on the FCOI Module can be found on the eRA Commons page.

The first stages of implementation of changes in NIH peer review will begin in January and February 2009. These changes will be timed to apply to all three standard review/award cycles in each fiscal year. Please see the chart below showing the precise timeline by review/award cycle. While many details continue to be worked through, the first set of changes are highlighted below:

Scoring
To improve the transparency of the scoring process:

• Before a review meeting, assigned reviewers and discussants will score applications on the five review criteria using a scale greater than 1-5.
• Each assigned reviewer and discussant will also provide a preliminary overall score using the new scale.
• At the meeting, discussed applications will receive an overall score from each eligible (i.e., without conflicts of interest) panel member and these scores will be averaged, multiplied by 10, and called the priority score.
• The priority scores then will be percentiled against the appropriate base. The new scoring system will necessitate the establishment of new percentile bases. Percentiles will be reported in whole numbers.

Critiques
To improve the quality of the critiques and to focus reviewer attention on the review criteria:

• Before the review meeting, in addition to preliminary scoring, assigned reviewers will provide written critiques of the application through an electronic template that will prompt for strengths and weaknesses for each criterion.
• After the meeting, the critiques will be compiled into a summary statement that will be shorter and more focused than current summary statements due to standardized organization and reporting of strengths and weaknesses.
• Discussed applications also will have a summary of the panel’s discussion at the meeting.
  
  
• Feedback for Streamlined Applications. Currently, applications not considered to be in the more meritorious half are “streamlined.” Streamlined applications are not discussed by the full review committee and are not assigned numerical priority scores, but the applicants do receive the reviewers’ critiques.
• In 2009, streamlined applications will receive scores in addition to the reviewers’ critiques to help applicants assess whether or not they should submit an amended application.

Balanced and Fair Reviews Across Career Stages and Scientific Fields

• The New Investigator Policy was modified to identify Early Stage Investigators (ESIs), see http://grants.nih.gov/grants/guide/notice-files/not-od-08-121.html, and becomes effective beginning with traditional R01 applications received for the February 2009 receipt dates.
• Another notice containing specific guidance for ESIs will be released on October 31, 2008.
• Where possible, NIH will cluster new investigator applications (including ESIs) for review.
• The same clustering approach will be considered for clinical research applications.

Amended Applications:
To speed the funding of meritorious science and minimize reviewer burden:

• NIH has issued a policy announcement decreasing the number of resubmissions (i.e., amendments) permitted from two to one. Beginning with applications intended for the January 25, 2009 due date, all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1).
• To facilitate this transition, original new and competing renewal applications submitted for FY 2009 or earlier, i.e. prior to January 25, 2009, will be permitted two resubmissions.

Enhanced Review Criteria

• The current five scoring criteria will have clearer descriptions, with questions for reviewers to consider in evaluating each criterion.
• The application instructions will be updated to inform applicants of these revised questions.

The full set of application submission dates for each cycle can be found at:
http://grants.nih.gov/grants/funding/submissionschedule.htm

For more information on Enhancing Peer Review and the NIH Guide Notices referenced in this document go to:
http://enhancing-peer-review.nih.gov

Keep abreast of the latest in the Enhancing Peer Review Implementation effort by joining a new Enhancing Peer Review listserv.

The CR applies the terms of the FY 2008 appropriations for the period covered by the CR. When the 111th Congress convenes in 2009, it will need to complete action for FY 2009 funding.

Until the final FY 2009 appropriation is enacted, NIH will issue non-competing research grant awards at a level below that indicated on the most recent Notice of Award (generally up to 90% of the previously committed level). This is consistent with NIH practice during the CRs of FY 2006 - 2008. NIH will consider upward adjustments to these levels after the final appropriation is enacted, but expects institutions to monitor their expenditures carefully during this period.

Additional details are available at http://grants.nih.gov/grants/financial/index.htm.

Starting this month, NIH will be stepping up its efforts to ensure compliance for the Public Access Policy as described in a recent NIH Guide Notice. To ensure compliance with the Public Access Policy, NIH Program Officials will check applications, proposals or progress reports to see if citations of papers appearing to fall under this policy include a PubMed Central Identifier or appropriate alternative. NIH staff will inform the Program Directors/Principal Investigators (PDs/PIs) via an email if citations appear out of compliance and will copy the Institutional Business Official on the email.

The PD/PI will be asked to respond via email to both the Program Official and the Institutional Business Official with confirmation of compliance, or an appropriate explanation. Confirmation is the citation for the paper plus the appropriate identifier as described in the NIH Guide Notice.The NIH Guide Notice also contains a summary of application instructions pertaining to citations, and details on demonstrating compliance through the eRA Commons using eSNAP. For slides, articles, and other training materials and communications about the Policy, please see http://publicaccess.nih.gov/communications.htm.

Results of the Public Access Public Comment Process
Public comment on the Public Access Policy and NIH’s response is now available at http://publicaccess.nih.gov/comments.htm.

Overview of Feedback

In response to an open meeting and request for information on NIH Public Access Policy, NIH received 613 unduplicated comments from a broad cross-section of the public, including NIH-funded investigators, members of the general public, patient advocates, professional organizations, and publishers. These comments and NIH’s response are available at http://publicaccess.nih.gov/comments.htm.

Most comments offered broad support for the policy as written. Many comments requested a reduction in the delay period before papers can be made publicly available on PubMed Central. In some cases, comments expressed concern about the Policy, others asked for clarification, and still others suggested alternatives to NIH’s implementation. These questions and concerns fall into several broad categories:

• The potential administrative burden on Program Directors/Principal Investigators and grantee institutions;
• Details such as applicability, cost reimbursement, compliance monitoring, and enforcement, and publisher support;
• Issues such as submission procedures, tracking submitted papers, version of the paper submitted, and managing and protecting copyrights;
• The relationship of the Policy to copyright law and the Administrative Procedures Act.
• The potential impact of the Policy on publishers and NIH.

NIH also received comments describing implementation efforts by numerous awardee institutions and publishers. In some cases, libraries took the lead on educating their faculty, and supporting them in interpreting publishing agreements and submitting manuscripts to NIH. In other cases, offices of sponsored research provided guidance on the NIH Public Access Policy disseminated to their faculty community via the web, memos, seminars and VideoCasts. Still other institutions described collaborations between libraries, offices of sponsored research, university counsels, and technology transfer offices. Several universities and private groups described the development of new policies on scholarly communications, and new publishing forms and addenda that their faculty could use to ensure compliance with the Policy.

NIH Response

The report details NIH's response to concerns and steps to facilitate compliance with the law.

• In May, July, and September of 2008 NIH updated the Public Access website to clarify the applicability, goals and anticipated impact of the policy, the methods to submit papers, and document compliance.
• In June 2008, NIH updated the NIH Manuscript Submission System (NIHMS), the online mechanism for submission of manuscripts to PMC, to allow Principal Investigators/Program Directors (PDs/PIs) to delegate all aspects of submission tasks to authors, and to allow publishers who submit manuscripts to the NIHMS on behalf of authors to exert greater control over manuscript delay periods.
• In August 2008, the National Library of Medicine issued a new web tool to help the scientific community obtain PubMed Central Identifiers in bulk.
• In September 2008, NIH issued a Guide Notice reminding awardees about the compliance process and providing details concerning NIH’s monitoring plan for Fiscal Year 2008.

Results

These efforts appear to be working. NIH estimates approximately 80,000 papers arise from NIH funds each year, and this total serves as the target for the Public Access Policy. During the voluntary policy, from May 2005 to December 2007, NIH was able to collect a total of 19% of targeted papers, from all sources. Under the first five months of the new Policy (April to August 2008), this rate jumped to an estimated 56% of papers per month.

Conclusions

These first few months show progress in implementing the Public Access Policy requirement due to active support from the academic and publishing communities. However, work still remains, as over 40% applicable papers per month remain unsubmitted.

Implementation and process refinement will continue in the coming months. NIH has established voluntary partnerships with many publishers to facilitate the depositing of manuscripts and final published papers, and expects these partnerships to continue to expand, and the percentage of submitted papers to grow. For example, as of October, approximately 475 journals now directly submit final published articles arising from NIH funds directly to PubMed Central (see http://publicaccess.nih.gov/submit_process_journals.htm). NIH will also continue to engage the community to ensure implementation proceeds in the most efficient and effective manner possible.

The NIH Public Access Policy, mandated by Congress, requires the results of NIH-supported research to be publicly available through the National Library of Medicine’s digital archive, PubMed Central, within 12 months after the official date of publication. The Policy is intended to advance science, provide public access to the published results of NIH-funded research, and improve human health. In order to implement the law in a transparent and participatory manner, NIH formally sought public input through an open meeting and a Request for Information (RFI).

NIH welcomes proposals for 2009 NIH Director's Pioneer Awards and New Innovator Awards. Both programs are part of the NIH Roadmap for Medical Research and support exceptionally creative scientists who take highly innovative, potentially high-impact approaches to major challenges in biomedical or behavioral research.

Pioneer Awards provide up to $2.5 million in direct costs over 5 years and are open to scientists at any career stage. New Innovator Awards provide up to $1.5 million in direct costs over the same period and are for early career investigators who have not received an NIH regular research (R01) or similar NIH grant. NIH expects to make 5 to 10 Pioneer Awards and up to 24 New Innovator Awards in September 2009. To continue its strong record of diversity in these programs, NIH especially encourages women and members of groups that are underrepresented in NIH research to apply.

The Pioneer Award competition begins with a proposal submission period from November 17 to December 17, 2008. See Pre-Application for the 2009 NIH Director’s Pioneer Award Program (X02) (PAR-09-012) for instructions and http://nihroadmap.nih.gov/pioneer for more information. Send questions to pioneer@nih.gov.

The New Innovator Award competition begins with a proposal submission period from December 15, 2008 to January 15, 2009. See Pre-Application for the 2009 NIH Director’s New Innovator Award Program (X02) (PAR-09-013) for instructions and http://nihroadmap.nih.gov/newinnovator for more information. Send questions to newinnovator@nih.gov.

The NIH’s new Transformative R01 Program (T-R01s) will allow highly creative, “out-of-the-box” projects to be supported. The T-R01 Program represents a High Risk/High Reward Demonstration Project in which novel approaches to peer review and program management are to be piloted. The application submission period is from December 29, 2008 to January 29, 2009. See http://nihroadmap.nih.gov/T-R01/ for more information. Send questions to T_R01@mail.nih.gov.

The NIH Roadmap for Medical Research, launched in 2004, is a series of initiatives designed to address fundamental knowledge gaps, develop transformative tools and technologies, and/or foster innovative approaches to complex problems. Funded through the NIH Common Fund, these programs cut across the missions of individual NIH Institutes and Centers (ICs) and are intended to accelerate the translation of research to improvements in public health. OPASI, in collaboration with all NIH ICs, oversees programs funded by the Common Fund. Additional information about the NIH Roadmap and Common Fund can be found at www.nihroadmap.nih.gov.

A May 2008 NIH Guide Notice (NOT-OD-08-075) announced plans to discontinue use of the U.S. Treasury Central Contractor Registration (CCR) system for facilitating electronic disbursement of reviewers’ honoraria and reimbursements for expenses incurred during their participation in NIH peer review meetings (see also NIH Guide Notice NOT-OD-09-009NIH Guide Notice NOT-OD-09-009). Instead, a new, electronic system has been developed to facilitate this process, thanks to the efforts of staff from the Office of Financial Management , NIH Scientific Review and Evaluation Award System, Electronic Research Administration, the Center for Scientific Review, the Office of Extramural Research, and Committee Management Specialists. The new system is undergoing pilot testing, with full implementation planned for early 2009.

Reviewers should do the following during this interim phase:

• Update their residential address information in the eRA Commons now, in preparation for the system conversion.
  
  
• Ignore e-mails from CCR prompting them to renew their CCR registration once it expires.
  
  
• Until further notice, ignore e-mails from the Internet Assisted Review system prompting them to update their banking information in the eRA Commons.

The NIH is committed to ensuring that reviewers receive their disbursements as quickly and efficiently as possible. Additional information will be provided as the transition to the new registration system progresses. Thank you for your continued efforts on behalf of the NIH peer review process.

Questions may be directed to Dr. Sally Amero, NIH Review Policy Officer, Office of Extramural Research, NIH (301-435-1418; ameros@od.nih.gov).

Keep abreast of the latest in the Enhancing Peer Review Implementation effort by joining a new Listserv.

Dr. Norka, Ruiz Bravo, NIH Deputy Director for Extramural Research, has announced that Sherry Mills, M.D., M.P.H., will assume the position of Director, Office of Extramural Programs (OEP), Office of Extramural Research (OER), to be effective November 9, 2008. As OEP Director, Dr. Mills will provide executive scientific leadership for the initiation, coordination, and oversight of NIH policies for extramural program administration, peer review and coordinating resolution of associated human subjects concerns that arise during the process, and the development of human resources for research.

The HHS Office of Human Research Protections (OHRP) has posted on its Web site a finalized guidance document entitled, “Guidance on Engagement of Institutions in Human Subjects Research.”  The public comments submitted on the draft document were very helpful as this guidance document. The finalized guidance is on the OHRP Web site.  This new guidance document replaces two prior OHRP guidance documents on the engagement of institutions in human subjects research:  (1) the January 26, 1999, document on “Engagement of Institutions in Research,” and (2) the December 23, 1999, document on “Engagement of Pharmaceutical Companies in HHS Supported Research.”   The Federal Register notice announcing the
availability of this new guidance document can be found at http://edocket.access.gpo.gov/2008/E8-25177.htm or http://edocket.access.gpo.gov/2008/pdf/E8-25177.pdf.

OHRP has also posted a revised version of the “Guidance on Research Involving Coded Private Information or Biological Specimens” that includes minor changes that were made for consistency with the new guidance document on the engagement of institutions in human subjects research. 

Department of Health and Human Services Assistant Secretary for Health Joxel García, M.D., M.B.A.,has announced the appointment of Jerry A. Menikoff, M.D., J.D. as the director of the Office for Human Research Protections (OHRP), Office of Public Health and Science, Office of the Secretary.

Prior to joining OHRP, Dr. Menikoff served as the director of the Office of Human Subjects Research and as a bioethicist, at the National Institutes of Health. He has written extensively on research and human subject protections, including several books and numerous journal articles, over the past fifteen years.

Before his NIH appointments, Dr. Menikoff served for nine years as the chair of the human subjects committee and the hospital ethics committee at the University of Kansas Medical Center. His educational background includes an M.D. from Washington University and law and public policy degrees from Harvard. In addition, Dr. Menikoff has held academic positions in schools of law at the University of Akron, the University of Chicago, and Hofstra University. He is on leave from the position of associate professor of law, ethics and medicine at the University of Kansas.

Hosted by Rutgers University, the PSI-Nature Structural Genomics Knowledgebase (PSI-SGKB) serves as a continually updated gateway to research data and other resources from the Protein Structure Initiative (PSI). First established in spring 2008, the PSI-SGKB is now re-launched in collaboration with Nature Publishing Group (NPG), with NPG contributing editorial content to help researchers stay informed about developments in structural biology and structural genomics.

Protein structure can tell us a great deal about how living systems function and can help with drug development and in understanding human disease. However, protein structure information is sometimes not easily interpretable by researchers working outside structural biology.

"One of the overarching goals of the PSI is to enable scientists interested in a particular protein family to obtain a relevant structure that can guide functional or disease-related studies," said Jeremy M. Berg, Ph.D., director of the National Institute of General Medical Sciences, the component of the National Institutes of Health (NIH) that developed the PSI. "The PSI-SGKB is a portal to the wealth of resources available for speeding discoveries about these molecules so vital to our health."

The PSI was launched in 2000 by NIH to determine protein structures on a large scale. Over the course of the initiative, PSI-supported research centers have produced more than 3,200 structures, published around 1,000 scientific papers, and developed many techniques now employed in labs around the world.

Institutions often have to walk a fine line between implementing security measures to protect data and ensuring that business flow is not disrupted.

So it was this April at NIH when a directive called for a renewed emphasis on security of information including that on portable electronic devices. At NIH’s electronic Research Administration (eRA), the organization that provides and supports grants systems for NIH and its partner agencies, this meant protecting the grant information on the compact disks containing grant application information given to peer reviewers. Working closely with NIH leaders in the review community, management moved quickly to implement an interim solution. The short-term fix — implemented May 15, 2008 — required a reviewer to enter a password each time a grant application, a summary statement or supplemental material was accessed on the CD.

eRA was not deluged by complaints because reviewers understood the need for the security measure. However, both eRA and the NIH staff who work with the review community realized that the solution was cumbersome. If a CD contained 20 grant applications, it meant that a reviewer had to enter a password at least 60 times to access the applications and related materials. How could one make it less painful for reviewers?

An option to merge all documents into one giant PDF was deemed unsatisfactory because it was too slow to open the PDF on typical laptops used by reviewers. eRA brainstormed the issue with its user community and together, hit upon a more workable solution... Each grant application, along with its summary statement and supplemental material, was bundled into one PDF document that was password-protected. For each bundled grant application, a reviewer will enter the password once and then can then navigate freely within the PDF document. eRA appreciates the time and effort spent by the review community for the sake of ‘appropriate peer review’ and hopes that this change will make their work just a bit simpler.

The new safeguard became effective for CD orders placed on or after Oct. 15, 2008.

You are cordially invited to the NIH campus in Bethesda, Maryland, to speak with RCDC staff about the new RCDC public reporting Web site. During the 90-minute session, RCDC staff will demonstrate the new site and respond to audience questions. These sessions will be held throughout fall 2008 and early winter 2009, and each session will have the same format. Meeting dates are subject to change. Please check back periodically for schedule changes, http://rcdc.nih.gov/RCDC_OHM/Default.aspx.

If you plan to attend, please select a listed date from the Web site that best fits your schedule, and then send an RSVP with your name, organization, and email address to rcdcpublicinfo@mail.nih.gov.