Department of Health and Human Services
Participating Organizations
National Institutes of
Health (NIH) (http://www.nih.gov)
Components of Participating Organizations
National Heart, Lung, and
Blood Institute (NHLBI) (http://www.nhlbi.nih.gov)
Title: Longitudinal Studies of HIV-Associated Lung Infections
and Complications (R01)
Announcement Type
New
Request For Applications (RFA) Number: RFA-HL-07-008
Catalog of Federal Domestic Assistance Number(s)
93.838
Key Dates
Release Date: September
14, 2006
Letters of Intent
Receipt Date(s): November 20, 2006
Application
Receipt Dates(s): December 19, 2006
Peer Review Date(s): June-July 2007
Council Review Date(s): September 12, 2007
Earliest Anticipated
Start Date(s): September
28, 2007 http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information
To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: December 20, 2006
Due Dates for E.O. 12372
Not Applicable
Additional
Overview Content
Executive Summary
The 398 forms have been changed. Here is the Link to the recently revised PHS-398 form and instructions (NOT-OD-06-056, "NIH Announces Interim Changes to the PHS398 Application and Instructions"): http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-06-056.html
All PIs /Institutions must be registered in NIH eRA Commons…Must be reflected on Face Page of application; if not, application will not be accepted by the NIH.
For further assistance, contact Grantsinfo at (301) 435-0714, email: grantsinfo@nih.gov.
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(s) 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. Address to 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
Projects that are outside the scope of this announcement are:
See Section
VIII, Other Information - Required Federal Citations, for policies related
to this announcement.
Section
II. Award Information
1. Mechanism(s) of Support
This funding opportunity
will use the regular
research grant (R01) award mechanism(s).
As an applicant, you
will be solely responsible for planning, directing, and executing the proposed
project.
This
funding opportunity uses the just-in-time budget concepts. It also uses the
non-modular budget format described in the PHS 398 application instructions
(see http://grants.nih.gov/grants/funding/phs398/phs398.html).
A detailed categorical budget for the "Initial Budget Period" and the
"Entire Proposed Period of Support" is to be submitted with the
application.
2. Funds Available
HIV infection is an area of
overlapping interest of NHLBI and the National Institute of Allergy and
Infectious Diseases (NIAID). Populations of patients proposed for studies in
this program may also be enrolled in studies supported by NIAID. 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:
Subcontracts
with foreign institutions to study foreign populations are acceptable.
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 support.
2. Cost Sharing or Matching
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
Each applicant may submit
one application for this FOA. An institution may submit more than one
application provided the applications are submitted by different principal
investigators and the applications address different scientific questions.
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.
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
Letters
of Intent Receipt Date(s): November 17, 2006
Application
Submission Date(s): December 19,
2006
Peer
Review Date(s): June-July 2007
Council
Review Date(s): September 12,
2007
Earliest
Anticipated Start Date(s): September 28,
2007
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:
Chief, Review Branch
Division of Extramural Research Activities
National Heart, Lung, and
Blood Institute
6701 Rockledge Drive
Rockledge II, Room 7214
Bethesda, MD 20892-7924
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: NHLBIchiefreviewbranch@nhlbi.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.
The 398 forms have been changed. Here is the Link to the recently revised PHS-398 form and instructions (NOT-OD-06-056, "NIH Announces Interim Changes to the PHS398 Application and Instructions"): http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-06-056.html
All PIs /Institutions must be registered in NIH eRA Commons…Must be reflected on Face Page of application; if not, application will not be accepted by the NIH.
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:
Chief, Review Branch
Division of Extramural Research Activities
National Heart, Lung, and
Blood Institute
6701 Rockledge Drive
Rockledge II, Room 7214
Bethesda, MD 20892-7924
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: NHLBIchiefreviewbranch@nhlbi.nih.gov
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 NHLBI. Incomplete and non-responsive
applications will not be reviewed.
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.
Information on the status of an application should be
checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
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
Grantee Meetings: Upon
initiation of the program, the NHLBI together with the Data Coordinating Center will arrange for up to three meetings in the first year and up to two
meetings in years 2-5 to encourage the exchange of information among the
investigators who participate in this program. In preparation of the budget
for the grant application, applicants should include travel funds for three 1½
day meetings for year one and two 1½ day meetings in years 2-5 to be held in
or near Bethesda, MD for the principal investigators and up to 2 additional key
collaborators. At these meetings awardees will be expected to share their
results, coordinate joint projects and to help evaluate the progress of the
overall program and the individual centers. Applicants should also include a
statement in their applications indicating their willingness to participate in
these meetings.
The Data Coordinating Center should also include funds pay for up to two meetings a year in Bethesda, Maryland of an Observational Study Monitoring Board (OSMB) that would review and follow protocols conducted at the clinical sites in. This would include funds to pay for travel of the Board members (at government rates), and/or to set up teleconferences and to provide honoraria.
Each clinical site must demonstrate that they have access to sufficient HIV-infected patients and any controls that may be needed for the studies they are proposing.
Both the clinical site and staff and the DCC staff must have appropriate training and experience for working safely with biologically hazardous specimens that may contain HIV and other dangerous microbial agents. They must indicate what steps they will take to safely acquire, process, ship, store, and distribute biologically hazardous specimens that contain HIV and other infectious agents.
Each clinical site applicant must propose longitudinal clinical or epidemiological research. In addition, we strongly encourage inclusion of one or more small-scale basic science, hypothesis driven or generating aim(s) that use samples and data obtained from the clinical/epidemiological protocol to elucidate pathogenetic mechanisms associated with the lung condition under investigation.
Each R01 application must be independent. Applicants should propose protocols that can be accomplished at their site alone (their institution and subcontracts or collaborations that they have formed that can be supported by the funds provided in their R01 application budget within the 5 year window of the grant.
Clinical Center applications must include multidisciplinary research collaboration(s) and partnerships between basic and clinical investigators.
Ancillary projects proposed in the applications must be planned in such a way as to be feasible and be able to fit smoothly into the context of the ongoing programs.
Applicants for the centralized Data Coordinating Center (DCC) should present a description of plans to: (1) provide data management, including quality control and development of forms; (2) maintain a common data set; (3) develop needed databases and implement a web-based system to coordinate program activities; (4) provide statistical support (5) provide support in designing and conducting joint protocols; (6) support specimen banking activities; (7) provide support for preparing and submitting joint presentations and joint publications; and (8) provide coordination of meetings and reports as needed (7) provide administrative support services for an Observational Study Monitoring Board (OSMB) for all the clinical R01s (estimate 4-6 grants).
The DCC staff should have appropriate expertise and experience in project management, biostatistics, informatics and expertise in web-based data management. Prior experience in complex collaborative studies is desired. The DCC Principal Investigator and other key staff should have knowledge of HIV/AIDS and pulmonary clinical studies and repositories.
Applications for the DCC may be submitted by individuals located at the same institution as an applicant for a clinical site grant submitted under this FOA, but an individual may not be the Principal Investigator of a research grant and the DCC.
Applicants are encouraged to establish links and utilize existing resources including those listed below, but other resources not mentioned here may also be appropriate:
Multicenter
AIDS Cohort Study (MACS) and Women's Interagency HIV Study (WIHS)
MACS/WIHS
http://www.statepi.jhsph.edu
AIDS
repository
http://www.aidsreagent.org
AIDS and
Cancer Specimen Resource
http://acsb.ucsf.edu/
Centers for AIDS Research (CFAR)
http://www3.niaid.nih.gov/research/cfar/
AIDS Clinical Trials Group (ACTG)
http://www.aactg.org/index.asp
NHLBI shared microarray facilities
http://www.nhlbi.nih.gov/resources/medres/microarray.htm
AIDS information
http://aidsinfo.nih.gov/Guidelines/Default.aspx?MenuItem=Guidelines
Programs for Genomic Applications (PGA) which include resources for animal modeling and phenotyping, clinical and physiological studies, databases and software tools, bioinformatics, expression profiling, mutagenesis, proteomics, SNP’s and genotypes, comparative sequence analysis, educational programs, biomedical topics, and biochemical pathways (http://www.nhlbi.nih.gov/resources/pga/).
Roadmap project http://nihroadmap.nih.gov/
Applicants from institutions that have a General
Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the
proposed research. If so, a letter of agreement from either the GCRC program director
or principal investigator should be included with the application. (http://www.ncrr.nih.gov/clinical/cr_gcrc.asp)
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.
Domestic institutions submitting applications for grant mechanisms that use the modular budget (R01, R03, R15, R21, and R34) that request $250,000 in direct costs or less for all years must continue to use the modular format even if the application includes a subaward with a foreign (non-U.S.) institution.
Additional information on modular budgets is available
at http://grants.nih.gov/grants/funding/modular/modular.htm.
Plan for Sharing Research
Data
All applications responsive to this FOA must include a
plan for sharing research data along with a statement that the plan will be
followed unless it is superseded by an NIH- or NHLBI-wide policy on sharing
research data that is established prior to the date of award, in which case the
NIH- or NHLBI-wide policy will be followed. The precise content of the plan
may vary, depending upon the data being collected and how the data are to be
shared, but elements to consider include: the expected schedule for data
sharing; the format of the final dataset; the documentation to be provided;
what, if any, analytical tools will be provided, whether or not a data-sharing
agreement will be required and, if so, a brief outline of the likely terms of
an agreement that addresses the criteria for determining who can receive the
data and what, if any, conditions will be imposed 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).
For applications requesting more than $500,000 in direct costs in any year of the proposed research, the NHLBI will monitor compliance with the data sharing plan and/or the NIH or NHLBI-wide policy as appropriate.
Although the
reasonableness of the plan for sharing research data will not influence the
determination of scientific merit or the priority score, it may be assessed as
part of the scientific review and will definitely be an important consideration
in selection of applications for funding.
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.
Important
functions of the program will be to conduct studies in such a way that data and
biological samples can be easily shared and to collect data and store
biological specimens for future mechanistic studies of the underlying
pathogenesis of pulmonary complications associated with HIV-infection. The PIs
must provide a written statement agreeing to cooperate, and they must agree to
share samples and data. In addition to sharing the resources during the course
of the program, it is expected that data, specimens, and other resources
generated by the program will be shared with outside investigators (who are not
part of the original program) and that the resources can be easily shared and
integrated into other projects in the future. The NIH-wide policy for sharing
data and biological samples is being updated at this time and once developed
the new NIH guidelines will be applicable to grants funded under this program.
Specimens collected in the course of the lung research protocols may be stored at the NHLBI Biological Specimen Repository, currently managed by the Division of Blood Diseases and Resources through a contractor, SeraCare. It is also possible that specimens or aliquots will be kept in other repositories e.g., those being used by ongoing studies of HIV-infected cohorts.
Section V. Application Review Information
1. Criteria
Only the review criteria
described below will be considered in the review process.
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 NHLBI 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)? Has the investigative team at the
data coordinating center or the clinical site documented specific competence
and their knowledge concerning HIV research and pulmonary research?
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?
Review Criteria for the Data
Coordinating Center (DCC) Facility
For evaluation purposes of DCC Applications, the following technical criteria will be considered:
PERSONNEL: Does the Principal Investigator have the training, expertise, experience, and availability necessary for planning and directing the Data Coordinating Center facility? Does the PI and the other staff members have expertise and previous experience in preparation of data forms, electronic transmission of data, data management, biostatistics, informatics, designing and conducting multi-site clinical studies, consent procedures, and collecting and storing human samples for future use? Does the administrative staff have documented training, experience, competence, and availability? Do the personnel proposed for website development have documented experience in website development and maintenance? Has their availability been documented? Have the PI and professional staff documented specific competence and previous knowledge concerning HIV research and pulmonary research? What is the past experience of the proposed DCC team, as a whole, in supporting multisite clinical studies - including collection and management of data, data analysis and the collection, banking and distribution of biological specimens?
METHODS AND PROCEDURES: Are the proposed plans for coordination and for data collection, processing, entry, transmission, storage, statistical analysis, and reporting meritorious? Are the plans adequately developed? Are the proposed plans for training of Data Coordinating Center personnel in data collection and handling meritorious and adequately developed? Are plans for quality control and quality assurance and plans for monitoring the Data Coordinating Center performance meritorious and adequately developed? Are the proposed plans for collecting, storing, and making human samples available meritorious and adequately developed? Are plans for protecting the privacy of human research subjects adequately addressed?
FACILITIES AND ORGANIZATIONS: Are the facilities and resources necessary to carry out the proposed functions of the Data Coordinating Center available and adequate? How adequate is the organizational and administrative structure, including the means of assuring quality control of data, data entry, confidentiality of data, and plans for day-to-day coordination? What is the institutional commitment to the Data Coordinating Center for the proposed program? Is this adequate?
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).
Care and
Use of Vertebrate Animals in Research: If vertebrate animals are to
be used in the project, the five items described under Section F of the PHS
Form 398 research grant application instructions will be assessed.
Biohazards: If materials or procedures
are proposed that are potentially hazardous to research personnel and/or the
environment, determine if the proposed protection is adequate.
2.B. Additional Review
Considerations
Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. 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 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.
The presence of a data sharing plan will be part of the terms and conditions of
the award. The funding organization will be responsible for monitoring the data
sharing policy.
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
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 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), sent by electronic mail to the principal investigator and
the sponsored projects office of the applicant institution, 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:
Hannah H. Peavy, M.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Rockledge II, Suite 10018
Bethesda, MD 20892
Telephone: (301) 435-0222
FAX: (301) 480-3557
Email: peavyh@nhlbi.nih.gov
For questions regarding NIAID AIDS Programs
Robin E. Huebner, Ph.D., M.P.H.
Epidemiologist, Epidemiology Branch
Basic Sciences Program (BSP), Division of AIDS (DAIDS)
NIAID, NIH, DHHS
6700-B Rockledge Drive, Rm 4104 MSC 7626
Bethesda, MD 20892-7626
(use 20817 zip code for overnight or courier mail)
Telephone: 301-402-4239
FAX: 301-402-3211
Email: rhuebner@niaid.nih.gov
2. Peer
Review Contacts:
Chief, Review Branch
Division of Extramural Research Activities
National Heart, Lung, and
Blood Institute
6701 Rockledge Drive
Rockledge II, Room 7214
Bethesda, MD 20892-7924
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: NHLBIchiefreviewbranch@nhlbi.nih.gov
3. Financial or Grants Management Contacts:
Robert
Pike
Grants Operations Branch
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Rockledge II, Room 7214
Bethesda, MD 20892
Telephone: (301) 435-0171
FAX: (301) 435-480-3059
Emai:piker@nhlbi.nih.gov
Section
VIII. Other Information
Required Federal Citations
Use of Animals in
Research:
Recipients of PHS support
for activities involving live, vertebrate animals must comply with PHS Policy
on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
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.
Sharing of Model
Organisms:
NIH is committed to
support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004, receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
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.
Human Embryonic Stem
Cells (hESC):
Criteria for federal
funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC
line(s)to be used in the proposed research. Applications that do not provide
this information will be returned without review.
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. For
publications listed in the appendix and/or Progress report, internet addresses
(URLs) must be used for publicly accessible on-line journal
articles. Unless otherwise specified in this solicitation, Internet
addresses (URLs) should not be used to provide any other information necessary for 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
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