and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of
Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
Office of Dietary
Supplements (ODS), (http://ods.od.nih.gov)
National Center for Complementary and Alternative
Medicine (NCCAM), (http://www.nccam.nih.gov)
Title: Limited Competition for Dietary
Supplement Research Centers: Botanicals (P50)
Announcement Type
This is a reissue of RFA-OD-04-002 which was previously
released December 22, 2003.
Update: The following update relating to this announcement has been issued:
Key Dates
Release Date: April 6, 2006
Letters
of Intent Receipt Date(s): August 22, 2006
Application Receipt Date(s): September 19,
2006
Peer
Review Date(s): November 2006
Council Review Date(s): January 2007
Earliest Anticipated
Start Date(s): April
2007
Additional Information
To Be Available Date (Url Activation Date): http://ods.od.nih.gov/Funding/DSRCBotanicalsSuppInstr.aspx
Expiration
Date: September 20, 2006
Due Dates for E.O. 12372
Not Applicable
Additional
Overview Content
Executive Summary
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
NIH currently supports
Dietary Supplement Research Centers focused on botanicals, collectively
referred to as the Botanical Research Centers (BRC) Program. ODS and NCCAM
invite renewal applications for Botanical Research Centers. This invitation is
limited to institutions that previously were funded under the BRC Program but
did not apply for renewal under RFA 0D-04-002.
This RFA will use a P50 award mechanism to provide support for a broad interdisciplinary research program consisting of highly integrated research activities and associated research infrastructure. This RFA supports the enhancement of existing research infrastructure to increase interactions among scientists from a variety of disciplines and to provide outstanding training and research environments for future leaders in botanical dietary supplement research. Taken as a whole, a BRC funded under a P50 mechanism is expected to reach a level of achievement exceeding that expected on the basis of the sum of its parts.
BACKGROUND
National surveys indicate that more than half of adults in the U.S. take some form of dietary supplement and about 20 percent take supplements containing botanicals. These products are used by consumers to promote health and wellness, prevent and treat disease. Despite widespread use of dietary supplements with botanical ingredients and promising science, biomedical research in this area has been relatively limited and unfocused. As a consequence, efficacy and safety of many widely used botanical ingredients have not been adequately evaluated. Before these issues can be addressed, high quality basic and mechanistic research and early phase clinical studies are needed.
The purpose of the BRC Program is to support research centers of excellence that will (1) promote interdisciplinary collaborative study of botanicals, particularly those that are found as ingredients in dietary supplements and (2) conduct research of high potential for being translated into practical benefits for human health. This initiative is intended to advance the spectrum of botanical research activities (e.g., plant identification, chemical characterization, bioavailability studies, assessment of bioactivity and mechanism(s) of action, early phase clinical studies). Preclinical research is encouraged as the primary focus.
OBJECTIVES OF THE RESEARCH PROGRAM
1. Build collaborative research teams that will advance the basic science to inform clinical studies; the following activities are emphasized:
2. Cultivate the use of contemporary technologies and innovative approaches (e.g., mass spectrometry, bioimaging, genomics, proteomics, metabolomics, bioinformatics, systems biology) in botanical research
3. Conduct clinical studies such as Phase I/II trials (Optional)
TYPE OF RESEARCH AND EXPERIMENTAL APPROACHES THAT ARE BEING SOUGHT TO ACHIEVE THE OBJECTIVES
For the purpose of this RFA, botanical is defined as plants, plant parts (e.g., bark, leaves, stems, roots, flowers, fruits, seeds, berries), plant exudates, algae, and macroscopic fungus. Bacterial or yeast fermentation products are not included. The definition of botanical is further extended to include botanical extracts and isolated bioactive constituents other than essential nutrients. Synthetic compounds derived from botanical sources are not encouraged as test materials for research conducted under this initiative. If the applicant proposes to study synthetic compounds, their use must be scientifically justified. This RFA is not supportive of applications aimed at new drug discovery.
Botanicals of particular interest include plants commonly referred to as traditional herbal medicines or phytomedicines, many of which are widely available in the U.S. as dietary supplements. This RFA also supports research on foods of plant origin which by virtue of biologically active components may provide health benefits beyond basic nutrition; these bioactive constituents are appearing with increasing frequency as ingredients in dietary supplements. Botanicals as dietary supplements are intended to be ingested. Other intended routes of administration (e.g., topical) are not within the scope of this RFA.
Botanical test materials ranging from whole fresh plants to isolated bioactive constituents are appropriate test materials for the proposed research. There are potential differences in biological effects of and clinical response to a relatively complex extract compared to an isolated bioactive constituent from plants. Thus, applicants proposing to study isolated constituents from plants are advised to consider the potential effects of removing bioactive constituents from their original matrix.
BRC THEMES
Each BRC will be structured around a central scientific theme. Themes provide a focus for center activities. An overarching research theme can be developed in a number of ways. For example, the proposed research may be conducted under the umbrella of a traditional medical system (e.g., Ayurveda); health issues of an under-studied population group (e.g., children); a biological process (e.g., inflammation) with multiple clinical endpoints; potential beneficial effects on an organ system (e.g., digestive); biological effects of a class of bioactive compounds (e.g., flavonoids, saponins, sterols, alkaloids, glucosinolates, terpenes) derived from botanicals with purported health promoting properties or as modifiers of the risk of disease (e.g., cancer, cardiovascular disease, diabetes).
EXPERIMENTAL APPROACHES
The increased need for collaborative and integrated research approaches of multiple disciplines stems, in large part, from the rapid progress in developing new research tools for understanding biology both at a molecular and at a systems level. Research founded on and connected to aspects of human biology may encompass any form of cellular, molecular, structural, biochemical, genetic or other appropriate experimental approach.
Potential research directions might include but are not limited to the following:
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 NIH P50 award mechanism. 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
NCCAM, and ODS intend to
commit approximately 1.5 million dollars in FY 2007 to fund one (1) competing continuation grant
in response to this RFA. Applicants may request a project period of up to three years and a budget for direct
costs up to 1.0
million dollars
per year. The anticipated award date is April 1, 2007.
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 if your organization has any of the following characteristics:
Your institution received a Notice of Award (NoA) to participate as a Botanical Research Center under RFA-OD-99-007 or RFA-OD-00-004 but did not apply for renewal under RFA-OD-04-002.
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.
The PI must be able to
commit at least 25 percent effort to the grant (10 percent Administrative Core
and 15 percent as a Research Project Leader).
2. Cost Sharing or Matching
Not applicable
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
An applicant may submit only
one application under this announcement.
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) 710-0267, Email: [email protected].
Telecommunications for
the hearing impaired: TTY 301-451-5936.
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.
Supplementary Instructions
for preparing the grant application can be found at the following url: http://ods.od.nih.gov/Funding/DSRCBotanicalsSuppInstr.aspx
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: August 22, 2006
Application
Receipt Date(s): September 19,
2006
Peer Review Date(s): November 2006
Council Review
Date(s): January 2007
Earliest
Anticipated Start Date(s): April 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:
Christine A. Swanson, Ph.D.
Director, Botanical Research Centers Program
Office of Dietary Supplements
Office of Disease Prevention/Office of the Director
6100 Executive Blvd., Room 3B01
Bethesda, MD 20892-7517
Telephone: (301) 435-2920
FAX (301): 480-1845
Email: [email protected]
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:
Martin Goldrosen, Ph.D.
Director, Office of Scientific Review
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892-5475 (use 20817 for private courier
services)
Telephone: (301) 594-2014
FAX: (301) 480-2419
Email: [email protected]
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 NCCAM. 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
SPECIAL REQUIREMENTS
This section provides detailed descriptions of required elements of the grant application and post-award conditions. Applications that fail to meet required elements of the grant application will be considered non-responsive to the RFA and will not be reviewed. Non-responsive applications would include but are not limited to the following examples: research projects focused on the isolation of single chemical constituents for the purpose of drug discovery; epidemiologic studies or surveys of dietary supplement use. Applicants with concerns about being responsive to the RFA are encouraged to contact NIH program staff early in the grant preparation process.
Statement of Institutional Commitment
An institution considering applying for a BRC should demonstrate a commitment to the BRC stability and success by incorporating the BRC high within its institutional priorities. The applicant must provide a statement of commitment that includes a plan addressing how the institutional commitment will be established and sustained, how the institution will maintain accountability for promoting scientific excellence, and how the BRC research effort will be given a high priority within the institution relative to other research efforts. The institutional commitment may be in the form of support for recruitment of scientific talent, faculty appointments for BRC investigators, provision of discretionary resources to the BRC Director, assignment of specialized research space, cost sharing for resources, or other ways proposed by the applicant institution. A letter from the Dean or individual of similar rank should be attached confirming this commitment. If the grant application includes research activities that involve institutions other than the applicant organization, the proposed BRC is a consortium effort. In the case of a BRC that involves a consortium arrangement between two or more institutions, the institution that submits the P50 application must include in the application a formal written agreement(s) from the other participant organization(s).
Center Director
Each applicant institution shall name a Center Director as the Principal Investigator (PI) who will be the key figure in the administration and management of the Center grant. The Center Director must be an experienced scientist with leadership and administrative skills commensurate with those required for a P50 or similar award mechanism. The Center Director will be responsible for the organization and operation of the Center and for communications with NIH. The Director is also required to be a Project Leader of one of the R01 level research projects within the Center. The Director’s 25 percent effort (minimum requirement) should be allocated as follows: Leader of the Administrative Core (10 percent) and Leader of a Research Project (15 percent).
The applicant may elect to provide a plan for assignment of administrative responsibilities if the Center Director is on prolonged leave from the institution or otherwise unavailable for administration and/or decision making. The plan could include the appointment of a co-Director of the BRC at the applicant institution.
The Center Director is the only PI for this grant application. The research projects will be headed by Research Project Leaders. A Research Project Leader is equivalent to a PI on a standard NIH R01 grant application. Research cores will be headed by Research Core Leaders.
Administrative Core
The organization of the Administrative Core should encompass a support structure sufficient to ensure accomplishment of the following: coordinating and integrating the Center activities; developing a plan for evaluation of scientific progress; formation and interaction with the two advisory groups (described below); regular evaluation of scientific progress; overseeing the solicitation, review and selection of pilot research studies; overseeing training and career development efforts; and working with the applicant institution to enhance the visibility and effectiveness of the center as a focus for botanical research.
The Center Director is the leader of the Administrative Core. While the final administrative structure of the Center will be left to the discretion of the Center Director, experience demonstrates that effective development of a Center program requires interaction among the Center Director, Research Project Leaders, Research Core Leaders, advisory groups, appropriate institutional administrative personnel, and the staff of NIH.
It is important that a person with institutional management expertise and experience be involved directly with the fiscal aspects of the application and grant. The applicant has the option to include a Project Manger in the Administrative Core. The position should be described and justified. In addition to the Center Director and Project Manager, additional administrative support personnel may be budgeted at one full time equivalent (FTE) which may be divided among one or more positions. This FTE should be fully justified. The Administrative Core may include limited funds for program enrichment activities such as seminars and research workshops. Funds from the center grant cannot be allocated for website development or maintenance, newsletters, consumer information or outreach activities.
Advisory Groups: The Administrative Core includes two advisory groups. A BRC External Advisory Committee (EAC) will provide oversight and assist the Center Director in making scientific and administrative decisions. An Internal Steering Committee (ISC) comprised of the
Research Project and Core Leaders will meet regularly with the Center Director to discuss research progress.
External Advisory Committee (EAC)
The Center shall establish an EAC to provide oversight and assist the Center Director in making scientific and administrative decisions. The EAC will have oversight authority for the research projects submitted in the grant application but will not have the authority to review and modify projects already approved by NIH. In addition to evaluating scientific progress of the Center, the EAC should periodically review Center operations to ensure that resources, especially core resources, are used for the most scientifically worthy projects. The EAC will participate in the review of pilot project applications and may perform other duties deemed appropriate by the applicant. For example, termination of research projects must be discussed with the EAC.
EAC members and the committee chair will be appointed by the Center Director; members may serve on a rotating basis. The Center Director will serve on the EAC in an ex-officio capacity only. The EAC should consist of at least six members in addition to the Center Director. Over the anticipated three year award period, the Center Director is urged to appoint to the EAC a pharmacognosist or ethnobotanist, toxicologist, research clinician, biostatistician, and other individuals with scientific expertise specific to the BRC (e.g., health outcome(s) under investigation, relevant technologies). EAC members may be employees of the grantee institution, participating institutions, or from outside institutions, but they cannot participate directly in the research of the BRC. If an EAC member becomes directly involved in the research of the Center, the resulting committee vacancy must be reported to NIH program staff and a replacement sought in a timely manner.
Please note that APPLICANTS SHOULD NOT IDENTIFY POTENTIAL EAC MEMBERS IN THEIR APPLICATION. However, the process by which members will be chosen must be specified.
The EAC should be established within nine months of the start of first budget period and meet once before the end of that period. Thereafter, the EAC shall meet at least twice a year. Minutes of all (i.e., scheduled and ad hoc) EAC meetings must be kept. Minutes of regularly scheduled meetings shall be sent to NIH staff within 60 days and also be included in the annual Progress Report. At least one of the semi-annual meetings must take place in person; other meetings may be conducted by video- or teleconference. Support for the EAC must be explicitly budgeted in the Administrative Core. If the EAC committee will include individuals who require travel expenses, these costs should be reflected in the administrative budget.
Internal Steering Committee (ISC)
The Internal Steering Committee (ISC) is comprised of the Research Project and Core Leaders. The ISC will meet regularly to discuss research progress and problems, utilization of core resources, new research opportunities, and program development. Regular meetings of the ISC are intended to facilitate internal communication, cooperation, and collaboration among BRC investigators. The applicant should provide a plan for ISC meetings.
Research Projects
The research projects are individual research studies funded through the Center. Each study is headed by a Research Project Leader. Each of the R01 level research projects may request at least three years of support. The research projects should be of a scope similar to the traditional NIH R01 research grant; inclusion of preliminary data is required. The applicant should list grant support of each Research Project Leader in the Biosketch section of the application. (See Supplementary Instructions url http://ods.od.nih.gov/Funding/DSRCBotanicalsSuppInstr.aspx) Applicants with questions regarding eligibility of project leaders are encouraged to contact NIH program staff.
Research projects in the application may be simultaneously submitted to the CSR as investigator-initiated applications (e.g., NIH R01). The dual submission must be clearly documented in the Center application under pending support. If, following review, both the Center application and the R01 application are found to be in the fundable range, the research project investigator must relinquish the R01 and will not have the option to withdraw from the Center grant. This is an NIH policy intended to preserve the scientific integrity of a multi-project grant, which may be seriously compromised if a strong component project is removed from the program. Investigators wishing to participate in a multi-project grant must be aware of this policy before making commitments to the Center Director and applicant institution.
Applications must include at least three, but no more than four, research projects. Collectively, the research projects must show evidence of interdisciplinary collaboration among scientists across the Center. At least three of the submitted projects, must be judged meritorious by the peer-review panel for the application to meet the minimal requirements of a P50 Center. Failure to meet this requirement will remove the application from funding consideration.
At least three R01 level research projects must be active throughout the period of grant support. If this requirement is not met, the grant mechanism may be changed.
Not more than one of the research projects may be a clinical study. Early (Phase I and Phase II) clinical trials can be proposed as part of the application. NCCAM requires all clinical projects to undergo review by the Office of Clinical and Regulatory Affairs (OCRA). http://nccam.nih.gov/research/policies/clinical-considerations.htm
It is the sole responsibility of the applicant to obtain all necessary clearances from the Food and Drug Administration (FDA) as required. Questions regarding IND applications should be addressed to the FDA.
Applicants are strongly encouraged to consult their local Institutional Review Boards (IRB) regarding IND applications. The applicant should present a plan for IND submission, evidence that an IND application is in process or that the FDA has allowed an exemption.
Research Resource Cores
Resource Cores are headed by Research Core Leaders. A research core is defined as a resource that enhances research productivity or in other ways benefits investigators working to accomplish the common research goals of the Center. A Center must establish at least one Research Resource Core. Each core must be utilized by at least two research projects. Applicants must provide a core utilization table showing an estimate of percent effort devoted to each proposed research project in the first year of the grant. (See details included in the section Special Instructions for Preparing a BRC Grant Application below.) Core resources should not duplicate resources already available to Center investigators. However, fee-for-service core components (i.e., Center use of existing facilities) are acceptable with adequate justification.
While the research core should function primarily as a service entity, core scientists can also be involved in conducting original research. Chemistry cores, for example, may need to develop new methods of analysis.
Pilot Research Program
The Pilot Research Program is a required component of a center grant. The primary purpose of this support is to attract promising investigators to Centers and provide an opportunity for them to generate sufficient preliminary data to permit the submission of new applications for peer-reviewed research. The Pilot/feasibility research of the BRC must be relevant to the Center theme and research goals.
The Center must request funds to support pilot projects. The application must describe the process for soliciting, reviewing, selecting and monitoring the pilot projects. The EAC must be involved in the review process for selecting pilot awards, either directly as reviewers or indirectly as part of EAC oversight responsibilities (i.e., approval). Pilot research studies are typically limited to a period of one to two years. No more than $100,000 (direct costs) per year may be devoted to pilot research projects. This is not a per project maximum, but rather an aggregated maximum of all pilot research projects. The first pilot studies should be awarded during the first budget year and new awards are expected in subsequent budget years.
Pilot project funds cannot be awarded to the Center Director, co-Director, Research Project Leaders or Core Leaders. Otherwise, both junior and established investigators from the applicant institution and/or a consortium are eligible to apply for funding. The research must be related to the Center theme and research objectives. Pilot studies may include clinical research. Pilot or other Center funds cannot be used to assess composition of botanical ingredients in products available to consumers solely for the purpose of documenting variability; this activity is not likely to lead to the submission of grant applications for additional research.
NIH program staff must be notified before funds can be expended to initiate pilot projects, to verify (1) EAC approval and (2) approval of animal care and use and human subject assurances. The notification should include the proposal and specific research aims, the pilot research budget, and a biosketch of the pilot study investigator.
Career Development and Training
The establishment of a BRC is expected to provide a rich environment for training and career development. The applicant should include plans for obtaining funds to provide training and career development opportunities. Supplemental funding for training and career development could be sought from NIH Ruth L. Kirschstein National Research Service Awards (e.g., F31, F32), institutional training grants (T32), mentored career development awards (K01, K08) and other sources including, but not limited to, the parent institution and private foundations.
Centers are encouraged to provide interdisciplinary research training and career development opportunities to graduate students, postdoctoral fellows, and physician-investigators and fully integrate the training and career development activities into the research of the BRC.
Annual Meeting of Center Directors
The Center Directors and at least two selected Research Project Leaders shall participate in one meeting per year, alternating between the Washington DC metropolitan area and another site agreed to by the Center Directors and the NIH. The purpose of the meeting is to meet with NIH staff to share scientific information, assess scientific progress, discuss problems, identify new research opportunities, discuss potential collaborations, and review research priorities.
Applications should include yearly travel expenses in the Administrative Core to pay for the Center Director and selected Research Project Leaders to attend one two-day meeting of the Center Directors.
Intellectual Property Rights
A statement of institutional commitment should include written assurance that in its interactions with commercial entities under sponsored research agreements, the BRC will comply with the requirements of the Bayh-Dole Act and NIH funding agreements while upholding basic principles of academic freedom, consistent with NIH policies including the precepts of the NIH Research Tools Policy (http://www.ott.nih.gov/pdfs/64FR72090.pdf). Sponsored research agreements with commercial entities should be entered into by a BRC only upon due consideration of the points outlined in "Developing Sponsored Research Agreements: Considerations for Recipients of NIH Research Grants and Contracts (Federal Register, Vol. 59, No. 215, Tuesday, November 8, 1994, pp. 55674-55679)", a copy of which can be viewed at: https://s-edison.info.nih.gov/Edison/sponsored.html. The statement of commitment should also include a written assurance that the BRC will manage its interactions with third parties so that they do not restrict the ability of a BRC to receive and disseminate biomedical research materials from and to the scientific community. Likewise, applicants must have policies and procedures in place to ensure that any agreements entered into with third parties are consistent with the terms and conditions of this award, including the provision of intellectual property rights to the NIH, and third parties are informed of the NIH requirements [see the NIH Grants Policy Statement for guidance (http://grants.nih.gov/grants/policy/policy.htm)]. Further, applicants will need to revise any agreements with third parties that are inconsistent with the terms and conditions of the NIH award to remain in compliance with the NIH award [see, Developing Sponsored Research Agreements: Considerations for Recipients of NIH Research Grants and Contracts for guidance.] Third party agreements should be identified at the time of grant submission.
Foreign Collaborations
This RFA is not intended
to support international studies or build research infrastructure in foreign
institutions. Funding support for such activities may be available from other
initiatives at the NIH. Foreign collaborations are appropriate if they are
needed to achieve the research objectives of the applicant institution.
Applicants should describe the nature of the collaboration, plans to formalize
a relationship, obtain necessary permits, and establish contract
elements. At a minimum, applicants are advised to consider the following issues:
intellectual property rights, particularly as they pertain to traditional
healing practices; regulations for collection of botanical material from
foreign countries; and rights and responsibilities of both parties if any
patents are developed from the proposed research. Relevant host country,
governmental, non-governmental and community organizations should be consulted
early in the grant planning stage to ensure that research plans are compatible
with national and local policies and to identify potential barriers to
collaboration.
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.
All applicants must
include a plan for sharing research data in their application. The data sharing
policy is available at http://grants.nih.gov/grants/policy/data_sharing.
All investigators responding to this funding opportunity should include a
description of how final research data will be shared, or explain why data
sharing is not possible.
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 expects 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
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 RFA will be evaluated for scientific and
technical merit by an appropriate peer review group convened by NCCAM in accordance with the review
criteria stated below.
As part of the initial
merit review, all applications will:
The following components of the BRC application will be evaluated:
1) Individual Research Projects
2) Research Core(s)
3) Administrative Core
4) Pilot Project Program
5) Principal Investigator
6) Resources and Environment
7) Program Synergy
8) Additional Criteria
9) Overall Program
1) INDIVIDUAL RESEARCH PROJECTS
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? Is the research project
consistent with the thematic focus of the BRC?
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? For clinical
studies, criteria will include the following: Does the proposal include a
trial design and sample size that adequately addresses the objectives?
Does the proposal contain a clear description of interventions, of primary and
secondary endpoints, and ethical considerations including monitoring? Do
the preliminary data support the feasibility and significance of the proposed
research? Are there specific and adequate descriptions to address NCCAM policy
and guidelines on biologically active agents (http://www.nccam.nih.gov/research/policies/bioactive.htm).
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? Information May be Added Here
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)? Information May be Added Here
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? Information May be Added Here
Progress Under Previous Center Award: Reviewers will determine if the original specific aims of each research project have been accomplished and whether the new research goals are logical extensions of that work. They will also evaluate the justification for adding or deleting projects from the original BRC proposal.
Based on the evaluation described above, each project will receive a numerical score from 1.0 to 5.0.
(2)
RESEARCH CORES
Each
research core will receive a merit descriptor (i.e., outstanding, acceptable,
unacceptable) based on the following criteria:
(3) ADMINISTRATIVE CORE
The administrative core will receive a merit descriptor (i.e., outstanding, acceptable, unacceptable) based on the following criteria:
(4) PILOT RESEARCH PROGRAM
The pilot research program will receive a merit descriptor (i.e., outstanding, acceptable, unacceptable) based on the following criteria
(5) PRINCIPAL INVESTIGATOR (Center Director)
The Center Director PI will be evaluated on the following criteria:
(6) RESOURCES and ENVIRONMENT
Each application will receive a merit descriptor for Resources and Environment (i.e., outstanding, acceptable, unacceptable) based on the following criteria
(7) PROGRAM SYNERGY
Each application will receive a merit descriptor (i.e., highly integrated, integrated, not integrated) that reflects the degree of synergy of the projects and cores within the proposed BRC. In particular, program synergy will be evaluated on:
(8) ADDITIONAL CRITERIA
Each application will receive a merit descriptor (outstanding, acceptable, unacceptable) that reflects the progress of the investigators since the initial award, evaluated on:
(9) OVERALL PROGRAM
A single
numerical priority score will be assigned to the BRC application as a whole.
Although primary emphasis will be placed on scientific merit of the research
projects, and past productivity of competing renewals, significant
consideration will also be given to the strength of cores, the pilot research
program, leadership ability of the Center Director, institutional commitment,
resources and environment, and program synergy. In addition, reviewers will
consider the potential for translating the proposed research into practical
benefits for human health (e.g., safety and efficacy of dietary supplement
ingredients) and the use of contemporary technologies. An application in which
the reviewers consider no more than two component research projects to be of
substantial and significant scientific merit will not satisfy the requirements
for this P50 award, and therefore will be recommended for "no further
consideration".
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) 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:
Christine A. Swanson, Ph.D.
Director,
Botanical Research Centers Program
Office of
Dietary Supplements
Office of
Disease Prevention/Office of the Director
6100
Executive Blvd., Room 3B01
Bethesda, MD 20892-7517
Telephone:
(301) 435-2920
FAX
(301): 480-1845
Email:
[email protected]
2. Peer Review Contacts:
Martin Goldrosen, Ph.D.
Director,
Office of Scientific Review
National
Institute for Complementary and Alternative Medicine
National
Institutes of Health
6707
Democracy Blvd., Suite 401
Bethesda, MD 20892-5475
Telephone:
(301) 594-2014
FAX: (301) 480-2419
Email:
[email protected]
3. Financial or Grants Management Contacts:
George Tucker, M.B.A.
Chief Grants Management Officer
National
Institute for Complementary and Alternative Medicine
National
Institutes of Health
6707
Democracy Blvd., Suite 401
Bethesda, MD 20892-5475
Telephone:
(301) 594-9102
FAX: (301) 480-1552
Email:
[email protected]
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. 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
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