Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov)
Title: Treatment Response: Linking Genes
With Behavioral Phenotypes of Relevance to Patients, Families, and Policymakers
(R01)
Announcement Type
New
Request for Applications (RFA) Number:
RFA-MH-07-010
Catalog of Federal Domestic Assistance Number(s)
93.242
Key
Dates
Release Date: March 9, 2006
Letters of Intent Receipt Date(s): April 11, 2006
Application Receipt Date(s): May
11, 2006
Peer Review Date(s): July/August 2006
Council Review Date(s): October 2006
Earliest Anticipated Start Date: December 1, 2006
Expiration Date: May 12, 2006
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
This Funding Opportunity Announcement (FOA) from the National Institute of
Mental Health (NIMH) calls for applications that integrate what are currently
two distinct tracks of research -- determining the complex genetic basis of
mental disorders, and creating new strategies and tools for assessing individual
functioning in the real world. By combining these two areas of research,
we aim to characterize the relationship between genetic risk and functional
abilities.
Table of Contents
Part I Overview
Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and Submission
Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and Anticipated
Start Dates
1. Letter of Intent
B. Sending an Application to the
NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Now that new tools (e.g., high throughput genotyping
and array technology) make it possible to ask if we can determine the complex
genetic basis of mental disorders, how shall we decide what are the relevant
phenotypes? Articles about the genetic basis of mental illness
continue to use DSM categories. Behaviors outside the realm of DSM categorization,
when mentioned at all, typically only include co-morbidities such as alcohol
and nicotine dependence.
The definition of mental disorders, as demarcated by the DSM, has limited meaning to someone with a mental disorder. Of more importance to the individual (and his/her family) is how the disorder affects his or her ability to live an independent, productive life on a day-to-day basis. Similarly, of more importance to policymakers is the ability to measure the public health consequences of the research funded by NIMH. Therefore, we need novel behavioral phenotypes (as opposed to, for example, psychophysiological endophenotypes) of more relevance to patients, patient’s families, and policymakers.
This FOA calls for integrating what are currently two distinct tracks of research -- determining the complex genetic basis of mental disorders and creating new strategies and tools for assessing individual functioning in the real world. By combining these two areas of research, we will be able to characterize the relationship between genetic risk and functional abilities.
Currently, there is disagreement on how disorders should be demarcated when establishing genetic profiles. For example, researchers differ on whether they should look for “schizophrenia genes” or “psychosis genes”; “social phobia genes” or “anxiety genes.” The hesitation in including more practical measures and endpoints in psychiatric genetics research has at least two reasons; first, it is easier to study behavior in a lab, and second, many researchers believe that rigorous measures for functioning in the real world are not available.
With this FOA, behavioral researchers are invited to team with psychiatric geneticists to investigate the links between genetic risk and practical measures of day-to-day living. As a result of this FOA, researchers may begin to look for completely different categories of genes – for example, “life-space mobility” genes (genes that are linked with getting out of the bed, or out of the house, or out of the neighborhood). This is an important daily function and relates to frequently observed detrimental behaviors among people with schizophrenia and depression (e.g., sitting all day while smoking and watching TV).
Suicide genetics research provides an example of the ways in which relevant behavioral phenotypes may emerge as a result of this initiative. Because suicide is such a noteworthy event, researchers have looked at it as a discrete category of behavior, rather than simply as a symptom of a psychopathology. Some researchers assert that genetic factors are present in risk for suicide, independent of risk for psychopathology. If researchers had only looked for genetic risk for suicide within DSM categories of depression or other psychopathologies, they would never have noticed that risk for suicide may be independent of these categories. Suicide is but one real-world behavior of considerable interest to patients and their families. Suicide is also one of the most objective measures that policy makers can look to when determining the public health impact of NIMH research.
Therefore, even though the genes for mental disorders discovered to date seem to have a small effect, we don’t know if the same would be true if we looked for genes of functional behavior that is of interest to patients, their families, and policymakers. In other words, it is an empirical question whether genetic variables predict functioning independent of DSM constructs.
This FOA encourages grant applications for research in a number of critical areas including but not limited to:
See Section
VIII, Other Information - Required Federal Citations, for policies related
to this announcement.
Section II. Award Information
1. Mechanism of Support
This funding opportunity will use the Research Project Grant (R01) award
mechanism. As an applicant, you will be solely responsible for planning,
directing, and executing the proposed project.
This funding opportunity uses just-in-time concepts. It also uses the modular
as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, if you are submitting an application with direct costs in each
year of $250,000 or less, use the modular budget format described in the PHS
398 application instructions. Otherwise follow the instructions for non-modular
research grant applications.
2. Funds Available
The National Institute of Mental Health intends to
commit approximately $1,000,000 dollars in FY 2007 to fund 2-6 new grants
in response to this and its related FOAs. An applicant may request a project
period of up to five years. Applications at or exceeding $500,000 in
direct costs in any year must obtain prior permission from the NIMH to submit.
Because the nature and scope of
the proposed research will vary from application to application, it is anticipated
that the size and duration of each award will also vary. Although the financial
plans of the IC(s) provide support for this program, awards pursuant to this
funding opportunity are contingent upon the availability of funds and the
receipt of a sufficient number of meritorious applications.
Facilities and administrative costs requested by consortium
participants are not included in the direct cost limitation, see NOT-OD-05-004.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an) application(s) if your organization
has any of the following characteristics:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.
2. Cost Sharing or Matching
Cost sharing is not required. The most
current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.
3. Other-Special Eligibility Criteria
Not Applicable
Section IV. Application and Submission
Information
1. Address to Request Application
Information
The PHS 398 application instructions are available
at http://grants.nih.gov/grants/funding/phs398/phs398.html
in an interactive format. Applicants must use the currently approved version
of the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
435-0714, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY 301-451-0088.
2. Content and Form of Application Submission
Applications must be prepared using the most current
PHS 398 research grant application instructions and forms. Applications must
have a D&B Data Universal Numbering System (DUNS) number as the universal
identifier when applying for Federal grants or cooperative agreements. The
D&B number can be obtained by calling (866) 705-5711 or through the web
site at http://www.dnb.com/us/. The D&B
number should be entered on line 11 of the face page of the PHS 398 form.
The title and number of this funding opportunity must
be typed on line 2 of the face page of the application form and the YES box
must be checked.
Foreign Organizations
Several special provisions apply to applications submitted
by foreign organizations:
Proposed research should provide
a unique research opportunity not available in the U.S.
3. Submission Dates and Times
Applications must be received on or before the receipt
date described below (Section IV.3.A). Submission
times N/A.
3.A. Receipt, Review and Anticipated
Start Dates
Letter of Intent Receipt Date:
April 11, 2006
Application Receipt Date(s):
May 11, 2006
Peer Review Date: July/August, 2006
Council Review Date:
October, 2006
Earliest Anticipated Start Date: December 1, 2006
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter
of intent that includes the following information:
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed
at the beginning of this document.
The letter of intent should be sent to:
Donna Mayo, PhD
Division of AIDS and Health and Behavior Research
National Institute of Mental Health
6001 Executive Boulevard, Room 6228, MSC 9621
Bethesda , MD 20892
Telephone: (301) 443-1829
FAX: (301) 443-6000
Email: dmayo@mail.nih.gov
3.B. Sending an Application to the NIH
Applications must be prepared using the research grant
applications found in the PHS 398 instructions for preparing a research grant
application. Submit a signed, typewritten original of the application, including
the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS
service)
Personal deliveries of applications are no longer
permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time of submission, two additional copies
of the application and all copies of the appendix material must be sent to:
Jean Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9606
Bethesda, MD 20892-9609
Rockville, MD 20852 (for express/courier service)
Using the RFA Label: The RFA label available in the PHS 398 application instructions
must be affixed to the bottom of the face page of the application. Type the
RFA number on the label. Failure to use this label could result in delayed
processing of the application such that it may not reach the review committee
in time for review. In addition, the RFA title and number must be typed on
line 2 of the face page of the application form and the YES box must be marked.
The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.
3.C. Application Processing
Applications must be received on or before the application receipt date(s) described
above (Section IV.3.A.). If an application is received
after that date, it will be returned to the applicant without review. Upon
receipt, applications will be evaluated for completeness by the CSR and responsiveness
by the National Institute of Mental Health. Incomplete
and non-responsive applications will not be reviewed. If the application is not responsive to the FOA, NIH staff may
contact the applicant to determine whether to return the application to the
applicant or submit it for review in competition with unsolicited applications
at the next appropriate NIH review cycle.
The NIH will not accept any application in response
to this funding opportunity that is essentially the same as one currently
pending initial review, unless the applicant withdraws the pending application.
However, when a previously unfunded application, originally submitted as an
investigator-initiated application, is to be submitted in response to a funding
opportunity, it is to be prepared as a NEW application. That is, the application
for the funding opportunity must not include an Introduction describing the
changes and improvements made, and the text must not be marked to indicate
the changes from the previous unfunded version of the application.
Although there is no immediate acknowledgement of
the receipt of an application, applicants are generally notified of the review
and funding assignment within eight (8) weeks.
4. Intergovernmental Review
This initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants Policy
Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
Pre-Award Costs are allowable. A grantee may, at its
own risk and without NIH prior approval, incur obligations and expenditures
to cover costs up to 90 days before the beginning date of the initial budget
period of a new or competing continuation award if such costs: are necessary
to conduct the project, and would be allowable under the grant, if awarded,
without NIH prior approval. If specific expenditures would otherwise require
prior approval, the grantee must obtain NIH approval before incurring the
cost. NIH prior approval is required for any costs to be incurred more than
90 days before the beginning date of the initial budget period of a new or
competing continuation award.
The incurrence of pre-award costs in anticipation
of a competing or non-competing award imposes no obligation on NIH either
to make the award or to increase the amount of the approved budget if an award
is made for less than the amount anticipated and is inadequate to cover the
pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award
costs result in borrowing against future support and that such borrowing must
not impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
Specific Instructions for Modular Grant applications.
Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.
Specific Instructions for
Applications Requesting $500,000 (direct costs) or More per Year.
Applicants requesting $500,000 or more in direct costs
for any year must carry out the following steps:
1) Contact the IC program staff before submitting
the application, i.e., as you are developing plans for the study;
2) Obtain agreement from the IC staff that the IC
will accept your application for consideration for award; and,
3) Include a cover letter with the application indicating
who agreed to accept assignment of the application.
This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
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.
Applicants requesting more than $500,000 in direct
costs in any year of the proposed research must include a plan for sharing
research data in their application. The funding organization will be responsible
for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).
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.
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 (NIH
Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm
and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan
for sharing research resources 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, http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section VI.3. Reporting.
Section V. Application Review
Information
1. Criteria
The following will be considered in making funding
decisions:
2. Review and Selection Process
Applications that are complete and responsive to the
FOA will be evaluated for scientific and technical merit by an appropriate
peer review group convened by the National Institute of Mental Health
in accordance with the review criteria stated below.
As part of the initial merit review, all applications
will:
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.
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 principal investigator 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 the
Research Plan, Section E on Human Subjects in the PHS Form 398).
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 the Research Plan, Section
E on Human Subjects in the PHS Form 398).
2.B. Additional Review Considerations
Budget: The reasonableness of the proposed budget and 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? The priority score should not be affected by the evaluation
of the budget.
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/part_ii_5.htm#availofrr
and http://www.ott.nih.gov/policy/rt_guide_final.html).
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 will be
considered by Program staff of the funding organization when making recommendations
about funding applications. Program staff may negotiate modifications of the
data and resource sharing plans with the awardee before recommending funding
of an application. The final version of the data and resource sharing plans
negotiated by both will become a condition of the award of the grant. 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
The earliest date that awards can be made is December 1, 2006.
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 Review Results and Summary Statement (written critique)
via the 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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
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
(designated in item 12 on the Application Face Page). If a grantee is not
email enabled, a hard copy of the NoA will be mailed to the 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 Also 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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
3. Reporting
Awardees will be required to submit the PHS Non-Competing
Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm)
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:
Donna Mayo, PhD
Division of AIDS and Health and Behavior Research
National Institute of Mental Health
6001 Executive Boulevard, Room 6228, MSC 9621
Bethesda , MD 20892
Telephone: (301) 443-1829
FAX: (301) 443-6000
Email: dmayo@mail.nih.gov
2. Peer Review Contacts:
David Armstrong, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC 9606
Bethesda, MD 20892-9606
Telephone: 301-443-3534
FAX: 301-443-4720
Email: armstrda@mail.nih.gov
3. Financial or Grants Management
Contacts:
Rita V. Sisco
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6120, MSC 9537
Bethesda, MD 20892-9537
Telephone: (301) 443-2805
Fax: (301) 443-6885
Email: rr46w@nih.gov
Section VIII. Other Information
Required Federal Citations
Human Subjects Protection:
Federal regulations (45CFR46) 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 new PHS Form 398; 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
(http://publicaccess.nih.gov/publicaccess_Manual.htm).
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 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
NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
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
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
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