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
National Center for Complementary and Alternative Medicine (NCCAM), (http://nccam.nih.gov)
National Cancer Institute (NCI), (http://www.nci.nih.gov/)
Office of Dietary Supplements (ODS), (http://dietary-supplements.info.nih.gov/)
Title: Basic And Preclinical Research On Complementary And Alternative Medicine (CAM) (R15)
Announcement Type
This is a reissue of PA-05-141 which was released on July 15, 2005, for R15 funding mechanism.
Updates: The following updates relating to this announcement have been issued:
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance for submission dates on or after February 25, 2006 must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 (R&R forms and Application Instruction Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This (FOA) must be read in conjunction with the application guidelines included with this announcement in Grants.gov Apply for Grants (hereafter called Grants.gov/Apply
A registration process is necessary before submission and should be started at least two weeks in advance of the planned submission. See Section IV.
Two steps are required for on time submission:
1) The application must be submitted to grants.gov by the submission date (see Key Dates below)
2) Applicants must complete a verification step in the eRA Commons within two business days of notification from NIH. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check the Commons.
Program Announcement (PA) Number: PA-06-064
Catalog of Federal Domestic Assistance Number(s)
93.213, 93.393, 93.394, 93.395, 93.396
Key Dates
Release Date: November 9, 2005
Opening Date: January 17, 2006 (Earliest date an application may be submitted to Grants.gov)
Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
Letters of Intent Receipt Date(s): Not required.
Application Submission Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Receipt Dates(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council Review Date(s): see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Earliest Anticipated Start Date: see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Expiration Date: September 2, 2008
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
This funding opportunity will utilize the R15 mechanism, but will be run in parallel with a program announcement of identical scientific scope (PA-06-065) that will utilize the traditional research project grant (R01) or the exploratory/developmental (R21) grant mechanism.
Table of ContentsPart I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission 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
1. Research Objectives
The National Center for Complementary and Alternative Medicine (NCCAM) invites applications for funding of basic, mechanistic, and/or preclinical research in all domains of CAM, in order to elucidate the underlying mechanisms of action of CAM therapies and to provide a stronger foundation for ongoing and planned clinical studies. NCCAM encourages outstanding CAM and conventional researchers to focus on opportunities in CAM research and to employ cutting-edge technologies to strengthen the knowledge bases needed to improve clinical practice. The National Cancer Institute (NCI) and the Office of Dietary Supplements (ODS) share programmatic interests in some areas of CAM research with NCCAM. NCCAM and NCI areas of interest are described below. For ODS research interests, please visit http://dietary-supplements.info.nih.gov/Research/research.aspx/.
NCCAM is dedicated to studying CAM practices in the context of exacting science. NCCAM desires to encourage outstanding CAM and conventional researchers to focus on the opportunities in CAM research, and to employ the most current and emerging technologies. Chemists, physicists, psychologists, neuroscientists, endocrinologists, immunologists, geneticists, pharmacologists, and others in relevant fields of inquiry who are interested in applying their expertise and powerful contemporary technologies to help advance the science of CAM are encouraged to apply.
In order to strengthen the knowledge bases needed to inform CAM clinical practice, more basic, mechanistic, and preclinical research is needed across the broad spectrum of biomedical science underlying CAM practices. These practices may be grouped into four major domains of mind-body medicine, biologically based practices, manipulative and body-based practices, and energy medicine. In addition, NCCAM also studies whole medical systems (Please see NCCAM's Strategic Plan 2005-2009 at http://nccam.nih.gov/about/plans/2005/index.htm). The individual systems and treatments within each category of CAM are numerous. It is therefore necessary for NCCAM and other sponsors of this FOA to prioritize the research areas according to the prevalence of a modality, the evidence supporting its value and safety, gaps in knowledge, and opportunities to advance the relevant science. These areas of special interest are subjects of research for this FOA.
NATIONAL CENTER FOR COMPLEMENTARY AND ALTERNATIVE MEDICINE (NCCAM)
NCCAM constantly reviews its research portfolios in setting its research priorities. All CAM modalities, disease areas, as well as special populations are evaluated to identify opportunities for research. These areas of special interest are posted on the NCCAM website at: http://nccam.nih.gov/research/priorities/index.htm#5. Applicants are encouraged to respond to these areas of special interest. Since this list is regularly revised, investigators are encouraged to visit the website before they submit an application.
NATIONAL CANCER INSTITUTE (NCI)
The National Cancer Institute is interested in basic, mechanistic, and preclinical research as it relates to the prevention, diagnosis and treatment of cancer as well as management of cancer symptoms and side effects due to conventional cancer treatment. Areas of interest include interactions between conventional cancer treatment and CAM modalities.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section II. Award Information1. Mechanism of Support
This funding opportunity will use the NIH Academic Research Enhancement Award (R15) award mechanism.
As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.
This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement: http://grants.nih.gov/grants/policy/policy.htm#gps). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium F&A costs), use the Modular Budget Component provided in the SF424 (R&R) Application Package and Instructions Guide (see specifically Section 5.4). Otherwise, follow the instructions for non-modular research grant applications.
2. Funds Available
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. For funding strategies and pay line, please see visit IC specific websites. For NCCAM, please see http://nccam.nih.gov/research/strategy/2005.htm.
Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an) application(s) if your organization has any of the following characteristics:
The NIH has published Program Guidelines for Academic Research Enhancement Awards (AREA; R15 grants) which include a list of schools/components that are ineligible for this Program; see http://grants.nih.gov/grants/funding/area.htm for detail.
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.
2. Cost Sharing or Matching
This program does not require cost sharing, matching or cost participation as defined in the current NIH Grants Policy statement.
The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.
3. Other-Special Eligibility Criteria
Not applicable
To download an Application Package and Instructions for completing the SF424 Research and Related (R&R) Forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that site.
Several additional separate actions are required before an applicant can submit an application through Grants.gov. See "Preparing for Electronic Receipt" at http://era.nih.gov/ElectronicReceipt/preparing.htm.
Several of the steps of the registration process could take up to two weeks. Therefore, applicants should immediately check with their business official to determine whether their institution is already registered in both Grants.gov and the Commons.
1. Request Application Information
Applicants must download the SF424 (R&R) application forms and instructions for this FOA through the Grants.gov Apply http://www.grants.gov/Apply Web site.
Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.
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
Prepare all applications using the SF424 (R&R) application forms and instructions in accordance with the Application Guide. The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this announcement in Grants.gov APPLY will include all applicable components, required and optional. A completed application in response to this announcement will include the following components:
Required Components:
SF424 (R&R) (An application cover component)
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Project/Performance Site Locations
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment Form
Foreign Organizations
Several special provisions apply to applications submitted by foreign organizations:
Proposed research should provide a unique research opportunity not available in the U.S.
3. Submission Dates and Times
See Section IV.3.A for details.
3.A. Submission, Review and Anticipated Start Dates
Letter of Intent Receipt Date: not required
Application Submission Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Receipt Dates(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date: http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date: http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: http://grants.nih.gov/grants/funding/submissionschedule.htm
3.A.1. Letter of Intent
A letter of intent is not required for this funding opportunity.
3.B. Sending an Application to the NIH
To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted electronically
PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C. Application Processing
Applicants are reminded to follow the submission dates cited in this FOA. Applications must be submitted to Grants.gov on or before the application submission date(s) described above (Section IV.3.A.) If an application is received after that date, it will not be reviewed.
Upon receipt applications will be transferred from Grants.gov to the NIH Electronic Research Administration process for validation. Both the Project Director/Principal Investigator (PD/PI) and the Signing Official for the organization must verify the submission via Commons within 2 business days of notification of the NIH validation.
There will be immediate acknowledgement of receipt of applications via both Grants.gov and the Commons. Information related to the assignment of an application to the Scientific Review Group is also in the Commons.
Upon receipt applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 R&R.
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 (http://grants.nih.gov/grants/policy/policy.htm).
Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.
The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
Specific Instructions for Use of Biologically Active Products.
NCCAM has special requirements for research on biologically derived substances. Practitioners of CAM believe that the polypharmacy of complex natural products has advantages over single-ingredient drugs in providing greater therapeutic benefit and less overall toxicity. In pursuit of its mission, NCCAM supports research to determine safety, efficacy, and mechanisms of action of complex biologically derived substances. NCCAM will support research characterizing single constituents extracted from complex biologically derived products if the purpose is to identify and standardize whole products, compare the actions of single constituents with the complex product, or identify the mechanisms of action for the whole product. NCCAM will not accept applications to isolate the active constituents of complex natural products for the purpose of developing these constituents as discrete drugs. Funding support for applications to develop active constituents as drugs may be available from other Institutes and Centers at NIH.
Applications involving biologically derived substances should adhere to the policy and guidelines published in the NIH Guide (http://grants.nih.gov/grants/guide/notice-files/NOT-AT-05-003.html, and http://grants.nih.gov/grants/guide/notice-files/NOT-AT-05-004.html) and/or the NCCAM website at http://nccam.nih.gov/research/policies/naturalproducts.htm.
Note: While each section of the Research Plan needs to eventually be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits.
Specific Instructions for Modular Grant applications.
Applications requesting direct costs in each year of $250,000 or less (excluding consortium F&A costs), must be submitted in a modular budget format using the Modular Budget Component provided in the SF424 (R&R) Application Package and Instructions Guide (see specifically Section 5.4). 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.
Plan for Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.
Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).
The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.
1. Criteria
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.
Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.
As part of the initial merit review, all applications will:
The following will be considered in making funding decisions:
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.
Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?
Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?
2.A. Additional Review Criteria:
In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:
Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see item 6 of the Research Plan component of the SF424 (R&R).
Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see item 7 of the Research Plan component of the SF424 (R&R).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under item 11 of the Research Plan component of the SF424 (R&R).
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 may be assessed by the reviewers. Is the percent effort listed for the PI appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims and methods?
Period of Support: The appropriateness of the requested period of support in relation to the proposed research.
2.C. Sharing Research Data
Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.
3. Anticipated Announcement and Award Dates
Not applicable
1. Award Notices
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.
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.
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:
The National Center for Complementary and Alternative Medicine (NCCAM)
Please contact the appropriate NCCAM program officer listed at
http://nccam.nih.gov/research/contact/index.htm.
The National Cancer Institute (NCI)
Dr. Wendy B. Smith
Program Director
Office of Cancer Complementary and Alternative Medicine
National Cancer Institute
6130 Executive Blvd, EPN
Suite #102, MSC 7302
Bethesda, Maryland 20892-7302
Telephone: 301-435-7980
FAX: 301-480-0075
Email: [email protected]
Or
Dr. Cindy Davis
Division of Cancer Prevention
National Cancer Institute
6130 Executive Blvd, EPN
Suite #3160, MSC 7308
Bethesda, Maryland 20892-7308
Telephone: 301-594-9692
FAX: 301-480-3925
Email: [email protected]
The Office of Dietary Supplements (ODS)
Dr. Joseph M. Betz
Director, Dietary Supplement Methods and Reference Materials Program
Office of Dietary Supplements
National Institutes of Health
6100 Executive Blvd., MSC 7517
Suite 3B01
Bethesda, MD 20892-7517
Phone: 301-435-2920
Fax: 301-480-1845
Email:
[email protected]
2. Peer Review Contacts:
Dr. Martin Goldrosen
Chief, Office of Scientific Review
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892 (for express/courier service use 20817)
Telephone: (301) 594 2014
Fax: (301) 480 2419
Email: [email protected]
3. Financial or Grants Management Contacts:
Mr. George Tucker
Grants Management Branch
National Center for Complementary and Alternative Medicine
6707 Democracy Boulevard, Suite 401
Bethesda , MD 20892 (for express/courier service use 20817)
Telephone: (301) 594-9102
FAX: (301) 480-2419
Email: [email protected]
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 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 SF424 (R&R); 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.
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NIH Funding Opportunities and Notices
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