THE DIRECTOR OF OER: Ensuring
Research Is Conducted Objectively and With Integrity—Working
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
said on previous occasions (see July
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
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
And soon, we will post on our
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
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
There are three actions grantees must take
to comply with the policy:
- 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.
- 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.
- Cite. Beginning May 25,
2008, authors must include PubMed Central
ID numbers in NIH applications and reports
when citing their articles covered by the
Information for the public
Policy Guide Notice:
Public Access Policy Web site:
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.
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
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
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
Do staff who may receive questions
from your authors know where to go for help?
NIH has a
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?
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?
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.
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.
FY 2008 Budget Highlights
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
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
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
- 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
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.
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.
EYE on PI
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.
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
The Nexus will feature
more GWAS information in future editions.
Rules for Reporting Clinical Trials
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
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
||For more information, please consult the Frequently
Asked Questions on the Office of Extramural
Research Web site.
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.
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
FISMA: Federal Regulations Governing Data Management
The Federal Information Security Management
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
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.
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
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.
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.
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.
"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.
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
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.
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.
NExus news & events
FDP Seeks Applicants for Next Phase
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.
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
OEP (# OD-08-240882-T42)
Division of Scientific Programs, OEP (OD-08-240885-T42)
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
Antonio, TX - March 25-27, 2008:
by the University of Texas Health Science Center
at San Antonio. (Only 2 months away - register today!)
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
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