Plan for Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data
being collected and how the investigator is planning to share the data. Applicants
who are planning to share data may wish to describe briefly the expected schedule
for data sharing, the format of the final dataset, the documentation to be
provided, whether or not any analytic tools also will be provided, whether
or not a data-sharing agreement will be required and, if so, a brief description
of such an agreement (including the criteria for deciding who can receive
the data and whether or not any conditions will be placed on their use), and
the mode of data sharing (e.g., under their own auspices by mailing a disk
or posting data on their institutional or personal website, through a data
archive or enclave). Investigators choosing to share under their own auspices
may wish to enter into a data-sharing agreement. References to data sharing
may also be appropriate in other sections of the application.
The reasonableness of the data sharing plan or the rationale for not sharing
research data will be assessed by the reviewers. However, reviewers will not
factor the proposed data sharing plan into the determination of scientific
merit or the priority score.
Sharing Research Resources
NIH policy requires that grant
awardee recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after publication
(See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The effectiveness
of the resource sharing will be evaluated as part of the administrative review
of each Non-Competing
Grant Progress Report (PHS 2590). See Section VI.3., Reporting.
Section V. Application Review Information
1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
Only the review criteria described below will be
considered in the review process.
2. Review and Selection Process
Applications submitted for this funding opportunity
will be assigned to the ICs on the basis of established PHS referral
guidelines.
Appropriate scientific review groups convened in accordance
with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm)
will evaluate applications for scientific and technical merit.
As part of the initial merit review, all applications
will:
- Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
- Receive a written critique.
- Receive a second level of review by the appropriate national advisory council or board.
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
- Scientific merit of the proposed project as determined by peer review.
- Availability of funds.
- Relevance to program priorities.
The NIH R21 exploratory/developmental grant is a mechanism for supporting novel scientific ideas or new model systems, tools, or technologies that have the potential to significantly advance our knowledge or the status of health-related research. Because the Research Plan is limited to 15 pages, an exploratory/developmental grant application need not have extensive background material or preliminary information as one might normally expect in an R01 application. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.
- Significance
- Approach
- Innovation
- Investigator
- Environment
- Additional Review Criteria
Note that an application does not
need to be strong in all categories to be judged likely to have major scientific
impact and thus deserve a high priority score. For example, an investigator
may propose to carry out important work that by its nature is not innovative
but is essential to move a field forward.
Significance: Does this study address an important problem? If the aims of
the application are achieved, how will scientific knowledge or clinical practice
be advanced? What will be the effect of these studies on the concepts, methods,
technologies, treatments, services, or preventative interventions that drive
this field?
Approach: Are the conceptual or clinical framework, design, methods,
and analyses adequately developed, well integrated, well reasoned, and appropriate
to the aims of the project? Does the applicant acknowledge potential problem
areas and consider alternative tactics?
Innovation: Is the project original and innovative? For example: Does the
project challenge existing paradigms or clinical practice; address an innovative
hypothesis or critical barrier to progress in the field? Does the project
develop or employ novel concepts, approaches, methodologies, tools, or technologies
for this area?
Investigators: Are the investigators appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the experience
level of the PD/PI and other researchers? Does the investigative team bring
complementary and integrated expertise to the project (if applicable)?
Environment: Does the scientific environment in which the work will be done
contribute to the probability of success? Do the proposed studies benefit
from unique features of the scientific environment, or subject populations,
or employ useful collaborative arrangements? Is there evidence of institutional
support?
2.A. Additional Review Criteria:
In addition to the above criteria, the following items
will continue to be considered in the determination of scientific merit and
the priority score:
Protection of Human Subjects from Research Risk:
The involvement of human subjects and protections from research risk relating
to their participation in the proposed research will be assessed. See item
6 of the Research Plan component of the SF424 (R&R).
Inclusion of Women, Minorities and Children in Research: The
adequacy of plans to include subjects from both genders, all racial and ethnic
groups (and subgroups), and children as appropriate for the scientific goals
of the research will be assessed. Plans for the recruitment and retention
of subjects will also be evaluated. See item 7 of the Research Plan component
of the SF424 (R&R).
2.B. Additional Review Considerations
Budget and Period of Support: The reasonableness of the proposed budget
and the appropriateness of the requested period of support in relation to
the proposed research may be assessed by the reviewers. Is the percent effort
listed for the PD/PI appropriate for the work proposed? Is each budget category
realistic and justified in terms of the aims and methods?
2.C. Sharing Research Data
Data Sharing Plan: The reasonableness of the
data sharing plan or the rationale for not sharing research data may be assessed
by the reviewers. However, reviewers will not factor the proposed data sharing
plan into the determination of scientific merit or the priority score. The
funding organization will be responsible for monitoring the data sharing policy.
http://grants.nih.gov/grants/policy/data_sharing.
2.D. Sharing Research Resources
NIH policy requires that grant awardee recipients
make unique research resources readily available for research purposes to
qualified individuals within the scientific community after publication (See
the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff will be responsible for the administrative
review of the plan for sharing research resources.
The adequacy of the resources sharing
plan and any related data sharing plans will be considered by Program staff
of the funding organization when making recommendations about funding applications.
The effectiveness of the resource sharing will be evaluated as part of the
administrative review of each Non-Competing Grant
Progress Report (PHS 2590), See Section VI.3.,
Reporting.
3. Anticipated Announcement and Award Dates
Not Applicable.
Section VI. Award Administration
Information
1. Award Notices
After the peer review of the application is completed, the PD/PI will be able
to access his or her Summary Statement (written critique) via the NIH eRA
Commons.
If the application is under consideration
for funding, NIH will request "just-in-time" information from the
applicant. For details, applicants may refer to the NIH Grants
Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart
A: General.
A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via
email notification from the awarding component to the grantee business official.
Selection of an application for award is not an authorization
to begin performance. Any costs incurred before receipt of the NoA are at
the recipient's risk. These costs may be reimbursed only to the extent considered
allowable pre-award costs. See Section IV.5., Funding
Restrictions.
2. Administrative and National
Policy Requirements
All NIH grant and cooperative agreement awards include
the NIH Grants Policy Statement as part of the NoA. For these terms
of award, see the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General and Part II:
Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions
for Specific Types of Grants, Grantees, and Activities.
3.
Reporting
When multiple years are involved, awardees will be
required to submit the Non-Competing Grant
Progress Report (PHS 2590) annually and financial statements as required
in the NIH
Grants Policy Statement.
Section VII. Agency Contacts
We encourage your inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
Inquiries may fall into three areas: scientific/research, peer review, and
financial or grants management issues:
1. Scientific/Research Contacts:
General Inquiries regarding the scope and content of this program announcement
should be directed to:
National Institutes of Health
G. Stephane Philogene, Ph.D.
Assistant Director for Policy and Planning
Office of Behavioral and Social Sciences Research
Office of the Director
National Institutes of Health
31 Center Drive, Room B1C32
Bethesda, MD 20892-2248
Telephone: (301) 402-3902
Fax: (301) 480-7555
E-mail: [email protected]
Direct inquiries regarding research interests and topics of Specific Institutes and Centers to:
National Cancer Institute
Suzanne Heurtin-Roberts, Ph.D., M.S.W.
Basic and Biobehavioral Research Branch
Behavioral Research Program,
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Blvd., MSC 7326
Executive Plaza North, Room 4054
Bethesda, MD 20892-7326
Phone: (301) 594-6655
Fax: (301) 435-7547
Email: [email protected]
National Heart, Lung and
Blood Institute
Susan Czajkowski, Ph.D.
Behavioral Medicine and Prevention
Scientific Research Group
Clinical Applications and Prevention
Program
Division of Epidemiology and Clinical
Applications
National Heart, Lung, and Blood
Institute
National Institutes of Health
6701 Rockledge Drive, Room 8114
Bethesda, MD 20892
Phone: (301) 435-0406
Fax: (301) 480-4773
Email: [email protected]
National Institute on Aging
Sidney M. Stahl, Ph.D.
Chief, Individual Behavioral Processes Branch
Behavioral and Social Research Program
National Institute on Aging/National Institutes of Health
7201 Wisconsin Ave., #533
Bethesda, MD 20892-9205
Phone: (301) 402-4156
Fax: (301) 402-0051
Email: [email protected]
National Institute on
Alcohol Abuse and Alcoholism
Peggy Murray, M.S.W.
Chief, Health Sciences Education Branch,
Office of Research Translation and Communications, NIAAA
5635 Fishers Lane, Room 3105, MSC 9304
Bethesda, MD 20892-9304
Ph: (301) 443-2594
Fax: (301) 480-1726
Email: [email protected]
National Institute on
Child Health and Human Development
V. Jeffery Evans Ph.D., J.D.
DBSB, CPR, NICHD
Room 8B07 6100 Executive Blvd
Bethesda, MD 20892
Phone: (301) 496-1176
FAX: (301) 496-0962
E-Mail: [email protected]
Jerry Flanzer, Ph.D.
Services Research Branch
Division of Epidemiology, Services and Prevention
National Institute of Drug Abuse, Room 5185
6001 Executive Blvd
Bethesda, MD 20892
Telephone: (301) 443-6504
FAX: (301) 443-6815
Email: [email protected]
National Institute of Mental Health
Ms. Denise Juliano-Bult, M.S.W.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7146, MSC 9631
Bethesda, MD 20892-9631
Telephone: (301) 443-3364
FAX: (301) 443-4045
Email: [email protected]
National Institute of Mental Health (AIDS)
Andrew D. Forsyth, Ph.D.
Chief, Primary HIV Prevention & Behavior Change Program
Center for Mental Health Research on AIDS
National Institute of Mental Health
6001 Executive Boulevard, RM 6201, MSC 9619
Bethesda, MD USA 20892-9619
Phone: (301) 443-8403
Fax: (301) 443-9719
E-mail: [email protected]
National Institute on Nursing Research
Martha L. Hare, Ph.D., R.N
National Institute of Nursing Research
6701 Democracy Boulevard
One Democracy Plaza, Room 710
Bethesda, MD 20892-4870 Courier: 20817
Phone: (301) 451-3874
Fax: (301) 480-8260
Email: [email protected]
Martina Vogel-Taylor
Senior Advisor for Disease Prevention
Office of Disease Prevention
Office of the Director
National Institutes of Health
Office of Disease Prevention, OD, NIH
phone: (301) 496-6614
Fax: (301) 480-7660
email: [email protected]
Office of Research on Women's Health
Eleanor Z. Hanna, Ph.D.
Associate Director for Special Projects and Centers
Office of Research on Women’s Health
Office of the Director
National Institutes of Health
Executive Plaza South 150A
6120 Executive Boulevard
Bethesda, Maryland 20892-7116
Phone: (301) 435-1573
Fax: (301) 402-0005
E-mail: [email protected]
2. Peer Review Contacts:
Not Applicable.
3. Financial or Grants Management
Contacts:
National Cancer Institute
Crystal Wolfrey
Team Leader, DCCPS Team
Grants Administration Branch
National Cancer Institute
National Institutes of Health
6120 Executive Blvd., Suite 243
Bethesda, MD 20892 (for regular mail)
Rockville, MD 20852 (for hand delivered mail)
Phone:(301) 496-8634
Fax: (301) 496-8601
Email: [email protected]
National Heart, Lung and
Blood Institute
Tanya McCoy
Grants Management Specialist
DEA, GOB, ECAGMS
National Heart, Lung, & Blood
Institute
National Institutes of Health
6701 Rockledge Drive, Room 7154
Bethesda, MD 20892
phone: (301) 435-0171
e-mail: [email protected]
National Institute on
Aging
Linda Whipp
Chief, Grants and Contracts Management Office
National Institute on Aging
Gateway Building, Room
2N212
7201 Wisconsin Ave.
Mailstop Code: 2292
Bethesda, MD 20892
Telephone: (301) 496-1472
Email: [email protected]
National Institute on
Alcohol Abuse and Alcoholism
Judy Fox
Chief, Grants Management Branch, NIAAA
5635 Fishers Lane, Room 3023, MSC 9304
Bethesda, MD 20892-9304
Ph: (301) 443-4704
Fax: (301) 443-3891
E-mail: [email protected]
National Institute on
Child Health and Human Development
Victoria Connors
GMB, NICHD
Room 8A17P 6100 Executive Blvd
Bethesda, MD 20892
Phone: (301) 496-5482
FAX: (301) 451-5510
E-Mail: [email protected]
Gary Fleming, J.D., M.A.
Grants Management Branch
6101 Executive Boulevard, Suite 242, MSC 8403
Bethesda, MD 20892-8403
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: [email protected]
National Institute of Mental Health
Rebecca Claycamp, CRA
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6122, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2811
Email: [email protected]
National Institute on
Nursing Research
Brian Albertini
Chief, Office of Grants and Contracts Management
National Institute of Nursing Research
6701 Democracy Boulevard
One Democracy Plaza, Room 710
Bethesda, MD 20892-4870 Courier: 20817
Phone: (301) 594-6869
Fax: (301) 402-4502
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications
and proposals involving human subjects must be evaluated with reference to
the risks to the subjects, the adequacy of protection against these risks,
the potential benefits of the research to the subjects and others, and the
importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The establishment
of data and safety monitoring boards (DSMBs) is required for multi-site clinical
trials involving interventions that entail potential risks to the participants
( NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and
Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include
a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their institutions,
on issues related to institutional policies and local IRB rules, as well as
local, State and Federal laws and regulations, including the Privacy Rule.
Reviewers will consider the data sharing plan but will not factor the plan
into the determination of the scientific merit or the priority score.
Access to Research Data through the Freedom of
Information Act:
The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are (1) first
produced in a project that is supported in whole or in part with Federal funds
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity
in a public archive, which can provide protections for the data and manage
the distribution for an indefinite period of time. If so, the application
should include a description of the archiving plan in the study design and
include information about this in the budget justification section of the
application. In addition, applicants should think about how to structure informed
consent statements and other human subjects procedures given the potential
for wider use of data collected under this award.
Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members
of minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators
proposing clinical research should read the "NIH Guidelines for Inclusion
of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new
OMB standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R) application; and updated roles
and responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description
of plans to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b) investigators
must report annual accrual and progress in conducting analyses, as appropriate,
by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical
Research:
The NIH maintains a policy that children (i.e., individuals
under the age of 21) must be included in all clinical research, conducted
or supported by the NIH, unless there are scientific and ethical reasons not
to include them.
All investigators proposing research involving human
subjects should read the "NIH Policy and Guidelines" on the inclusion
of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject
Participants:
NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key personnel.
The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to
the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole
or in part with direct costs from NIH. The author's final manuscript is defined
as the final version accepted for journal publication, and includes all modifications
from the publishing peer review process.
NIH is requesting that authors submit manuscripts
resulting from 1) currently funded NIH research projects or 2) previously
supported NIH research projects if they are accepted for publication on or
after May 2, 2005. The NIH Public Access Policy applies to all research grant
and career development award mechanisms, cooperative agreements, contracts,
Institutional and Individual Ruth L. Kirschstein National Research Service
Awards, as well as NIH intramural research studies. The Policy applies to
peer-reviewed, original research publications that have been supported in
whole or in part with direct costs from NIH, but it does not apply to book
chapters, editorials, reviews, or conference proceedings. Publications resulting
from non-NIH-supported research projects should not be submitted.
For more information about the Policy or the submission
process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view
the Policy or other Resources and Tools, including the Authors' Manual.
Standards for Privacy of Individually Identifiable
Health Information:
The Department of Health and Human Services (DHHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the "Privacy Rule", on August
14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and enforced
by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/) provides
information on the Privacy Rule, including a complete Regulation Text and
a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and research
contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must
be self-contained within specified page limitations. Unless otherwise specified
in an NIH solicitation, Internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Furthermore, we caution reviewers that their anonymity
may be compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health Service (PHS) is committed to achieving
the health promotion and disease prevention objectives of "Healthy People
2010," a PHS-led national activity for setting priority areas. This PA
is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the
Catalog of Federal Domestic Assistance
at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements
of Executive Order 12372 or Health Systems Agency review. Awards are made
under the authorization of Sections 301 and 405 of the Public Health Service
Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part
52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants Policy
Statement.
The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early childhood
development services are provided to children. This is consistent with the
PHS mission to protect and advance the physical and mental health of the American
people.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment
from qualified health professionals who have made a commitment to pursue a
research career involving clinical, pediatric, contraception, infertility,
and health disparities related areas. The LRP is an important component of
NIH's efforts to recruit and retain the next generation of researchers by
providing the means for developing a research career unfettered by the burden
of student loan debt. Note that an NIH grant is not required for eligibility
and concurrent career award and LRP applications are encouraged. The periods
of career award and LRP award may overlap providing the LRP recipient with
the required commitment of time and effort, as LRP awardees must commit at
least 50% of their time (at least 20 hours per week based on a 40 hour week)
for two years to the research. For further information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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