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 Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov/)
Title: Asthma and Allergic Diseases Cooperative Research Centers
Announcement Type
This is a reissuance of RFA-AI-02-007, previously released on April 11, 2002
Update: The following update relating to this announcement has been issued:
Request For Applications (RFA) Number: RFA-AI-05-027
Catalog of Federal Domestic Assistance Number(s)
93.855
Key Dates
Release Date: May 25, 2005
Letters of Intent Receipt Date(s): September 12, 2005
Application Receipt Date(s): October 12, 2005
Peer Review Date(s): January, 2006
Council Review Date(s): May, 2006
Earliest Anticipated Start Date: July, 2006
Additional Information To Be Available Date (Url Activation Date): http://www.niaid.nih.gov /ncn/budget/QA/rfa-05-027.htm
Expiration Date: October 13, 2005
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
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, 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
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
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 Announcement1. Research Objectives
Purpose
The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) invites applications from single institutions and consortia of institutions to participate in the Asthma and Allergic Diseases Cooperative Research Centers (AADCRC) program. The program will support integrated basic and clinical research centers to conduct studies on the immunologic mechanisms underlying the onset and progression of asthma and allergic diseases. The overarching goal of the program is to improve the diagnosis and treatment of asthma and allergic diseases, and to provide a rational foundation for the development of effective prevention strategies.
Background
Allergic diseases, including asthma, are among the major causes of illness and disability in the United States. Asthma affects approximately 8-10% of the U.S. population, and approximately 80% of these asthmatic patients suffer from allergic asthma. The AADCRC program, established more than three decades ago, is the cornerstone of NIAID's efforts to promote innovative, multidisciplinary basic and clinical research on asthma and allergic diseases.
Asthma is a chronic disease of the lungs characterized by reversible airway obstruction and hyperresponsiveness associated with pulmonary inflammation. Research indicates that the pathogenic factors for asthma are linked to an imbalance between T helper type 1 (Th1) and T helper type 2 (Th2) immune regulation, leading to a Th2 dominant state in the airways. As a consequence, an increase in Th2 cytokines is often observed in asthma patients, and is thought to underlie increased IgE antibody responses to house dust mite and other indoor allergens and lung eosinophilia. Numerous factors may contribute to the development of the Th1-Th2 imbalance. These include genetic susceptibility, environmental factors, and the interaction between the innate and adaptive immune systems.
Although not well understood, it is thought that antigen presenting cells and other cells of the innate immune system bias adaptive immune responses in the direction of Th1 or Th2. Research on key receptors whose functions include pathogen recognition, e.g., Toll-like receptors, is beginning to uncover the role of such receptors in inflammation. Understanding the interaction between the innate and adaptive immune systems in asthma and allergic diseases should lead to new approaches for prevention and therapy.
Over the past decade, research on the genetic basis of asthma led to the identification of the specific chromosomal loci that correlate with asthma susceptibility. The range of putative asthma genes identified in these loci, in both humans and mice, includes immune response genes and genes that may confer tissue specificity to the underlying immune responses. Further research is needed to demonstrate the relevance of these novel genes to allergic diseases, understand gene-gene interactions, and determine the potential effects on host responses to environmental influences.
Interactions between environmental and infectious stimuli and various susceptibility genes involved in immunity and respiratory function contribute to the pathogenesis of asthma. It is now believed that specific environmental exposures may have led to the expression of asthmatic phenotypes in previously unaffected, but genetically predisposed individuals. A significant challenge, understanding the precise role of viral and other infections and of environmental agents including pollutants and allergens on the development of asthma and allergy holds considerable promise for improved approaches for disease prevention and treatment.
Although the research solicited by this RFA concerns human allergies and asthma, animal models are of great value in supporting and advancing human research studies. Studies using animal models have helped to define the role of Th2 cells and cytokines in asthma and allergic diseases. Animal models with defined genetic mutations or gene deletions are of growing importance in the study of asthma and allergic diseases, particularly in molecules related to the innate immune system. For example, murine models that are deficient in specific Toll-like molecules are the basis for recent important discoveries in innate immune system signaling in response to CpG and other innate immune system agonists that appear to play key roles in asthma and allergy triggering and control. Integration of new animal models with the recent technical advances such as gene chips for whole genome scanning should permit the development of exciting new programs that combine both human and animal model studies to rapidly advance the molecular understanding of asthma and allergy development, prevention, and treatment.
NIAID currently supports 13 AADCRCs two of which are co-funded by the National Institute of Environmental Health Sciences (NIEHS).
Research Objectives and Scope
Applications considered to be responsive to the RFA must be structured around a central scientific theme that is clearly relevant to the immune mechanisms of, and intervention strategies for, asthma and/or allergic diseases. A minimum of two research projects is required. At least one project must propose a clinical study of individuals with clinically defined asthma and/or allergic diseases or a study involving human specimens. Healthy volunteers may be included in proposed clinical studies. Clinical research projects must meet the NIH definition of clinical research. For the NIH definition of clinical research, please see the NIH Office of Extramural Research Human Subjects Website (http://grants.nih.gov/grants/policy/hs/index.htm). Clinical trials, if proposed, are limited to Phase I or Phase II.
Examples of relevant research include, but are not limited to, the following areas:
This RFA will not support:
Clinical Research Projects
At least one project must propose a clinical study of individuals with clinically defined asthma and/or allergic diseases or a study involving human specimens. Healthy volunteers may be included in proposed clinical studies. These projects may include, but are not limited to: 1) mechanistic studies of human asthma and allergic diseases; 2) Phase I or Phase II clinical trials of preventive and therapeutic interventions including immuno-based therapies; and 3) development of new technologies and biomarkers for diagnosis. Studies using human specimens obtained from completed, ongoing or planned clinical studies or clinical trials may be proposed, but require a sound justification for the anticipated clinical relevance of the proposed study.
Statistical Design and Analysis and Data Management/Quality Control for Clinical Studies
This RFA will not provide support for a centralized statistical and clinical coordinating facility.
The awardee is responsible for providing all support for statistical design, data collection and analysis, and management and quality assurance of the proposed clinical studies funded under this RFA. For responsibilities associated with Investigational New Drug (IND) applications and sponsorship, the awardee is required to comply with NIH and U.S. Food and Drug Administration (FDA) regulatory requirements for clinical monitoring and reporting and the protection of human subjects. See Section VI.2.A. - Cooperative Agreement Terms and Conditions of Award below.
Steering Committee
NIAID, in conjunction with AADCRC Principal Investigators, will establish a Steering Committee within 60 days of award to serve as the governing body for all AADCRC activities. Principal Investigators of all new AADCRC programs awarded under this RFA and continuing AADCRC programs awarded under RFA AI-02-007 must serve on the Steering Committee. Members of the Steering Committee will be required to accept and implement common guidelines and procedures approved by the Steering Committee. Steering Committee responsibilities are further described under Section VI. 2.A.3. Cooperative Agreement Terms and Conditions of Award - Collaborative Responsibilities.
Discretionary Funds
NIAID plans to set aside $1 million per year in discretionary funds to support new clinical research projects and research resource development projects, led by AADCRC members, to capitalize on emerging opportunities, especially clinical trials and/or mechanistic studies of new therapies or preventive approaches as they relate to viral infections, environmental factors, or lung inflammation. Discretionary funds may also be used for the development, production, characterization, and distribution of shared reagents (e.g., viral challenge stocks, gene chips, antibodies, etc.), shared resources (e.g., strengthening or expanding the capabilities of animal, functional testing, genetic, or proteomic core facilities), or access to a unique resource such as funds to support extension of promising projects via access to nonhuman primate facilities. Basic research will not be supported by these funds. The Steering Committee will establish goals, priorities, and evaluation criteria for the use of the discretionary funds to support new clinical research or research resource development. Applicants may include a Discretionary Fund Management Core (DFM Core) to administer this fund, and one awardee will be selected to carry out this function. See Section VI.2.A.3 Collaborative Responsibilities for a detailed description of discretionary fund distribution and management.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section II. Award Information1. Mechanism(s) of Support
This funding opportunity will use the multi-project cooperative agreement (U19) 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.
The NIH (U19) is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".
2. Funds Available
The NIAID intends to commit approximately $11 million in FY 2006 to fund seven to ten new and/or competing continuation grants in response to this RFA. An additional $1 million per year will be allocated in a discretionary fund for new research opportunities that arise in the course of this program. An applicant may request a project period of up to 5 years.
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary. In previous years of this program, the average amount of funding has ranged from $600,000 to $950,000 in annual direct costs. Although the financial plans of the NIAID 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 Information1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an) application(s) if your organization has any of the following characteristics:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.
2. Cost Sharing or Matching
Cost sharing is not required.
The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.
3. Other-Special Eligibility Criteria
An institution may submit only one application.
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.
Applicants for U19 cooperative agreements must follow special application guidelines as described in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS; this brochure is available at: http://www.niaid.nih.gov/ncn/grants/multibron.htm. This brochure presents specific instructions for sections of the PHS 398 application form that should be completed differently than usual. For all other items in the application, follow the usual instructions in the PHS 398.
Essential elements of the multi-project cooperative agreement mechanism (U19) include: 1) a minimum of two interrelated individual research projects organized around a central theme; 2) collaborative efforts and interaction among independent projects and their investigators to achieve a common goal; 3) a single Principal Investigator who will be scientifically and administratively responsible for the group effort; 4) a single applicant institution that will be legally and financially responsible for the use and disposition of funds awarded; 5) an Administrative Core, and 6) where necessary, support for scientific core resources or facilities, each of which shall be utilized by at least two research projects in order to facilitate the research effort. Applicants interested in managing the discretionary fund must include a DFM Core with a proposed administrative structure for disbursement, management and reporting on discretionary fund projects approved by the Steering Committee.
Potential applicants are strongly encouraged to consult with the appropriate NIAID program contact listed in Section VII. Agency Contacts during the early stages of preparation of the application.
3. Submission Dates and Times
Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.
3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): September 12, 2005
Application Receipt Date(s): October 12, 2005
Peer Review Date(s): January, 2006
Council Review Date(s): May, 2006
Earliest Anticipated Start Date: July, 2006
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning of this document.
The letter of intent should be sent to:
Peter Jackson, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3133, MSC-7616
6700B Rockledge Drive
Bethesda , MD 20892-7616
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 496-8426
FAX: (301) 402-2638
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:
Peter Jackson, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3133, MSC-7616
6700B Rockledge Drive
Bethesda , MD 20892-7616
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 496-8426
FAX: (301) 402-2638
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 NIAID. 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.
Current NIH policy permits a component research project of a multi-project grant application to be concurrently submitted as a traditional individual research project (RO1) application. If, following review, both the multi-project application and the RO1 application are found to be in the fundable range, the investigators must relinquish the RO1 and will not have the option to withdraw from the multi-project 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(s) is removed from the program. Investigators wishing to participate in a multi-project grant must be aware of this policy before making a commitment to the Principal Investigator and awarding institution.
Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.
4. Intergovernmental Review
This initiative is not subject to intergovernmental review.
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.
NIAID plans to set aside a $1 million per year in a discretionary fund to support new clinical research projects and/or research resource development projects. Discretionary funds and support for a Discretionary Fund Management Core will be awarded to a single AADCRC institution to be responsible for disbursement, management and reporting on discretionary fund projects approved by the Steering Committee. Discretionary fund expenditures will be restricted until a process for review/ranking of proposals and disbursement of funds is established and agreed upon in writing by the Steering Committee.
6. Other Submission Requirements
Applicants for U19 grants must follow special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS; this brochure is available via the web at: http://www.niaid.nih.gov/ncn/grants/multibron.htm.
This brochure presents specific instructions for sections of the PHS 398 application form that should be completed differently than usual. For all other items in the application, follow the usual instructions in the PHS 398.
Special requirements of this RFA include:
In addition, applicants are strongly encouraged to include one or more investigators who are not currently involved in research on asthma and allergic diseases.
All applications must include:
1. Research Plan
a. Program Overview: A clear and concise plan that depicts the interrelationships among the research groups, their relevant experience and expertise, and the contribution of each to the fulfillment of the objectives of this RFA; an organization chart of the U19 cooperative group showing the name, institution, and scientific disciplines of the Principal Investigator and of all key scientific and technical personnel, as well as a discussion of lines of authority and plans for the coordination of research projects; and a plan to ensure the maintenance of close cooperation and effective communication among members of the U19 group.
b. Applications Proposing Clinical Trials
Concept Proposal: All applications must provide a detailed concept proposal addressing the following aspects of the proposed clinical trial (additional 10 pages will be allowed and will not count against 25-page limit per U19 instructions):
Study Title
Hypothesis to be tested
Study objectives
Population
Clinical sites
Intervention and comparators (if any)
Provision of investigational drugs and/or devices
Regimen
Study design, including:- Eligibility/exclusion criteria
- Randomization/stratification plan
- Number of subjects
- Anticipated duration of recruitment phase
- Total study duration
- Primary endpoints/outcomes
- Secondary endpoints/outcomes
- Study visit schedule and primary evaluations, including laboratory evaluations
- Sample size justification
- Any proposed sub-studies
- Statistical analyses and data analyses planData and safety monitoring plan
The concept proposal also must provide: 1) a plan for the management of the clinical trial that includes collection, storage, management, quality control, and reporting of study data and a system for adverse event reporting; 2) a description of the procedures and timeline for protocol development and implementation, including preparation of the manual of operations; 3) a description of the assistance to be provided in the preparation of Investigational New Drug applications; and 4) a plan for the recruitment and retention of study participants. In addition, the application must describe the overall approaches to overcoming obstacles and limitations with respect to these activities.
c. Applications Proposing Clinical Studies Involving the Use Of Human Samples
For applications proposing a clinical study involving the use of human samples, such samples may be derived from clinical studies or clinical trials that are planned, ongoing or completed and sponsored by any source of support. Applications must include:
1) documentation of the ability to acquire human samples, including written agreements between the Principal Investigator and the applicant institution, the clinical trial sponsor(s), including drug companies, if applicable, and the IND sponsor, if not one of the above, for the conduct of the proposed studies proposed in the application.
2) the complete clinical protocol and informed consent form(s) for the associated clinical study/trial from which samples will be obtained (to be provided as an appendix). NIH will treat as confidential any scientific, pre-clinical, clinical, or formulation data and information that the sponsor deems to be proprietary and confidential.
3) a draft consent form, where necessary, to obtain human samples not provided for in the associated clinical trial/study.
4) a detailed description of the proposed clinical study, including: hypothesis, study objectives, study population, relevance of the proposed study to clinical disease/patient outcome, statistical design and analysis plan, plan for management and quality control of data, and plan for receipt and storage of human samples.
2. Administrative Core: A plan, under the direction of the Principal Investigator, that addresses Program oversight, daily operations, promotion of collaborations, and participation in Steering Committee meetings and other AADCRC activities. The Administrative Core budget request should include funding for: 1) overall administration (e.g. secretarial and other administrative services), expenses for publications for collaborative efforts, and communication expenses; 2) travel funds for the Principal Investigator to participate in annual Steering Committee meetings, and PI and subproject PIs to attend an annual two-day AADCRC scientific meeting to be held in conjunction with the Steering Committee meeting in Bethesda, Maryland.
3. Discretionary Fund Management (DFM) Core (Optional): Applicants proposing to manage the discretionary fund must include in the application a detailed plan to support the responsibilities associated with the disbursement, administration and reporting on the use of discretionary funds. Such applications must include a plan for the DFM Core describing: (1) an administrative structure, including proposed level of effort for all staff; (2) proposed methods/procedures to support the Steering Committee in soliciting, evaluating, prioritizing, selecting and monitoring progress of discretionary fund projects; (3) the experience/qualifications of the PI and all proposed DFM Core staff; (4) proposed procedures, format and timing for reporting on the status of discretionary fund use; (5) documentation of institutional commitment to the administration of the discretionary fund. A separate budget for the DFM Core must be provided and is not to be included in the total budget of the AADCRC. The DFM Core will be evaluated by the review panel, but will not influence the overall score of the application.
4. Documentation of Commitment to the Collaborative Group: A written commitment, signed by the Principal Investigator and the applicant institution, to participate in the cooperative research program, including serving on the Steering Committee, adhering to Steering Committee policies and decisions, and accepting the participation and assistance of NIH staff in accordance with the guidelines described in Section VI. 2. A.2. Cooperative Agreement Terms and Conditions of Award: NIH Responsibilities.
Plan for Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.
Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).
The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.
Sharing Research Resources
NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.
Section V. Application Review Information1. 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 NIAID in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
The goals of NIH-supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.
1. 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?
2. 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? Are the plans for statistical design and analyses of clinical studies, and overall strategy and approaches for data management and quality control sound and appropriate?
3. 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?
4. 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)?
5. 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:
Clinical Research Projects: For clinical studies involving human samples, the scientific merit and soundness of the rationale for the relevance of the proposed clinical study to human asthma and/or allergic diseases. For clinical trials, the scientific merit and feasibility of the concept proposal and the potential for the clinical trial to advance the prevention and/or treatment of asthma and/or allergic diseases.
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.
2.B. Additional Review Considerations
Plan for Discretionary Fund Administration: The adequacy of the experience, level of commitment and availability of the PI and staff to manage the DFM Core. The appropriateness and clarity of plans for administration and fiscal accountability of discretionary funds. The appropriateness and clarity of plans for supporting the Steering Committee and for interacting with investigators applying for or in receipt of discretionary funds. The Plan for Discretionary Fund Administration will not be factored into determining the overall priority score.
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.
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
1. Award Notices
After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.
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 Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the Notice of Grant Award will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Grant Award 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 NGA 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 notice of grant award. 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).
The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.
2.A. Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement (U19 ), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined above.
2.A.1. Principal Investigator Rights and Responsibilities
The Principal Investigator will have the primary responsibility for: the project as a whole, including research design and conduct, data collection, quality control, data analysis and interpretation, preparation of publications, and collaborations with other awardees. Each PI will be a voting member of the Steering Committee, will participate in all Steering Committee activities, and will follow the policies and procedures developed by the Steering Committee.
Awardees will retain primary custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. However, awardees must be committed to making the biological samples, diagnostic products, and other research tools, methods, data, and materials that they develop under AADCRC awards available to the AADCRC and the research community.
Discretionary Fund Management
The awarded institution selected by NIAID to administer the discretionary fund must agree to take responsibility for managing the funds. These responsibilities include the disbursement, administration and reporting on the use of discretionary funds as approved by the Steering Committee.
Monitoring Clinical Studies
If clinical research or clinical trials are a component of the research proposed, NIAID policy requires that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. AN UPDATED NIAID policy was published in the NIH Guide on July 8, 2002 and is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html. The full policy, including terms and conditions of award, is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf.
All clinical research activities performed under this award must be in compliance with all U.S. Federal regulations, guidance and NIH policies applying to the conduct of research involving human subjects and regulatory application for new drug or biological licenses when applicable. These include, but are not limited to, U.S. Code of Federal Regulations (CFR) Title 21, Parts 11, 50, 54, 56, 312, 314, 601 and Title 45, Part 46; ICH guidance for Good Clinical Practice (GCP); and NIH grants policy (refer to http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). In addition, the Awardee must assure that all sites in the U.S. and outside the U.S. comply with the following:
a. Each institution engaged in human subjects research has a current, approved Assurance Number on file with the DHHS Office for Human Research Protections (OHRP).
b. Each protocol and informed consent document is approved by the responsible Institutional Review Board (IRB)/Ethics Committee (EC) prior to subject entry.
c. For Investigational New Drug (IND) studies, each local Investigator of Record has supplied a completed FDA Form 1572 to NIAID for each protocol conducted at each site.
d. Each study investigator and sub-investigator has provided current curriculum vitae to NIAID.
e. Each study participant (or legal representative) will sign an IRB/EC-approved protocol consent prior to entry on study as part of the Informed Consent Process.
All clinical research activities performed outside of the U.S. must, in addition to U.S. Federal regulations, comply with the host country regulations for human subjects.
Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.
The NIH Project Scientist, with the assistance from other NIAID and NIH scientific program staff as determined by research topic and relevant expertise, will have substantial scientific/programmatic involvement during the conduct of this activity through provision of technical assistance, advice and coordination above and beyond normal program stewardship for grants as detailed below.
The NIH Project Scientist will serve as a voting member of the Steering Committee, schedule the first meeting of the Steering Committee, actively assist the Chair in developing the meeting agendas, and ensure coordination of Steering Committee activities and implementation of the its recommendations, decisions and policies.
Clinical Research Responsibilities
The NIAID Division of Allergy, Immunology, and Transplantation (DAIT) will serve as a liaison between pharmaceutical companies, the Food and Drug Administration (FDA), and AADCRC investigators. In accordance with NIH policy, all clinical trials performed through the AADCRC must be conducted in accordance with ICH Good Clinical Practices and applicable Federal regulations.
1. Clinical Trials Agreements (CTA). A CTA, describing the responsibilities and rights of each party, will be negotiated between the NIAID and pharmaceutical or device collaborators who provide an investigational agent or device for a clinical study. The agreement will include, but is not limited to, Investigational New Drug (IND) sponsorship, IND drug supply, safety and data monitoring, publication rights, and access to data. AADCRC PIs will be informed of relevant content of the CTA.
2. Investigational New Drug Applications (IND). For most clinical trials supported under this RFA, either NIAID or the organization supplying the investigational agent or device will serve as the IND/IDE (Investigational Device Exemptions) sponsor. Under certain circumstances, NIAID and an awardee may mutually agree to have the PI serve as the IND/IDE sponsor. If NIAID holds the IND for clinical trials supported by this RFA, DAIT will provide oversight on the development, assembly, and submission of all required regulatory documents, e.g., those regarding the use of investigational drugs, to the FDA or other applicable health authorities.
3. Site Monitoring. If NIAID holds the IND for clinical trials supported by this RFA, DAIT will be responsible for monitoring compliance with good clinical research practices, regulatory compliance, accurate protocol implementation, internal quality assurance, and test agent accountability at the clinical research sites. In studies where NIAID does not serve as the IND sponsor, NIAID will review status and results of clinical trials, and provide oversight of data and safety monitoring.
4. Safety Reports. If NIAID holds the IND for clinical trials supported by this RFA, DAIT will be responsible for reporting of safety information in accordance with FDA requirements. An NIAID Medical Officer will monitor the clinical trials and serve as the Medical Monitor.
Protocol Development, Implementation, and Oversight
1. Protocol Development. DAIT staff will participate with AADCRC Principal Investigators in the development of clinical research protocols for projects supported by this RFA.
2. Protocol Review and Approval. All clinical research protocols must be approved by the DAIT Medical Monitor and the DAIT Clinical Research Committee.
3. Data and Safety Monitoring Board. DAIT requires any protocols deemed to possess more than minimal risks be reviewed by an independent Data and Safety Monitoring Board (DSMB). NIAID will appoint five to seven individuals to an independent DSMB to advise the NIAID on issues pertaining to appropriateness of clinical protocols and the conduct and safety of clinical research and clinical trials supported by this RFA. Information will also be provided to the Principal Investigator , the Project Leader and the Steering Committee. The DSMB will meet at least twice a year, by teleconference or in the Bethesda, MD vicinity. The NIH Project Scientist will be responsible for organizing DSMB meetings and teleconferences.
4. Study Termination. NIAID reserves the right to terminate or curtail a clinical study for any of the following reasons: (1) risk to subject safety; (2) the scientific question is no longer relevant or the objectives will not be met; (3) failure to comply with Good Clinical Practices, federal regulations, or Terms and Conditions of Award; (4) occurrence of unforeseen drug safety issues or data from preclinical studies indicate a presence of unanticipated toxicity; (5) risks that cannot be adequately quantified; (6) failure to remedy deficiencies identified through site monitoring; (7) substandard data; (8) inadequate progress in fulfilling the research agenda; (9) slow accrual; or (10) reaching a major study endpoint substantially before schedule with persuasive statistical significance.
5. Access to Data. The NIH Project Scientist or designee will have access to all data generated under this cooperative agreement, and may review the data as recorded on the case report forms or in a database. Data must be available for external checking against the original source documentation as required by federal regulation and DAIT as the IND sponsor. The NIH may provide public access to selected data sets generated with the use of public funds within a reasonable time after the primary analysis and publication.
Performance Monitoring
The NIH Project Scientist, together with the Steering Committee, will review the performance of each participating AADCRC through consideration of annual reports, site visits, and compliance with Steering Committee procedures.
Additionally, an agency program official of IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The program official will monitor program progress, approve changes, have access to data generated under these awards, and may periodically review the data and progress reports. NIAID staff may use information obtained from the data for the preparation of internal reports on the activities of the study.
2.A.3. Collaborative Responsibilities
A Steering Committee will serve as the governing board for the AADCRCs, its actions and decisions will be determined by majority vote. Membership will include, at a minimum, two NIAID Project Scientists and the Principal Investigators of the awardees under this RFA, as well as the continuing AADRCs awarded under RFA-AI-02-007. Of the two NIAID voting members, one is designated as the asthma scientific coordinator, and one as the allergic diseases scientific coordinator. The Steering Committee will convene its first meeting approximately 90 days after award. A Steering Committee Chair from among non-federal Steering Committee members will be elected by majority vote at the first Steering Committee meeting. Each member will have one vote. Members of the Steering Committee will be required to accept and implement common guidelines and procedures approved by the Steering Committee.
Responsibilities of the Steering Committee include the following:
NIAID plans to set aside a $1 million per year discretionary fund for new projects. These funds will be available for new projects (approved by the Steering Committee) on emerging opportunities, especially clinical trials and/or mechanistic studies of new therapies or preventive approaches as they relate to viral infections, environmental factors, or lung inflammation. Other examples could include development, production, characterization, and distribution of shared reagents (e.g., viral challenge stocks, gene chips, antibodies, etc.), shared resources (e.g., strengthening or expanding the capabilities of animal, functional testing, genetic, or proteomic core facilities), or access to unique resource such as funds to support extension of promising projects via access to nonhuman primate facilities.
The Steering Committee will establish guidelines for the disbursal of discretionary funds. These guidelines will include a process for:
Discretionary funds will be awarded to one AADCRC institution that will be responsible for disbursement, management and reporting on the use of discretionary funds as approved by the Steering Committee. Discretionary fund expenditures will be restricted until a process for the prioritization, solicitation, review and evaluation of proposals and the disbursement of funds is established and agreed upon in writing by the Steering Committee. Once this process is established, funds will be available for distribution.
NIAID intends to support the peer-reviewed studies proposed in the awarded grant applications. However, under special circumstances (e.g. clinical trials or studies that have similar patient populations and/or aims) the Steering Committee will establish guidelines and review procedures to evaluate and determine opportunities for redirection or modification of the peer-reviewed projects. This policy is in keeping with the terms and conditions of the cooperative agreement mechanism.
Meetings
NIAID will arrange quarterly Steering Committee teleconferences, and annual face-to-face meetings in conjunction with the annual AADCRC scientific meeting. All Steering Committee members must agree to participate in quarterly teleconferences, and annual face-to-face meetings. The annual AADCRC scientific meeting is open to the members of AADCRC. The annual scientific meeting is a forum for members of AADCRC to provide the latest update on their research, exchange ideas and information, and discuss collaborations among members of AADCRC. Meeting participants will identify the group's tangible resources, capabilities, and needs to advance the AADCRC's overall goals. The PI of each AADCRC or their designated representative is required to make an oral presentation on current and planned activities and projects. The two-day scientific meeting will be held each year in Bethesda, Maryland.
2.A.4. Arbitration Process
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
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 ContactsWe 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:
Gang Dong, M.D., Ph.D.
Division of Allergy, Immunology, and Transplantation
National Institute of Allergy and Infectious Diseases
Room 3101, MSC-6601
6610 Rockledge Drive
Bethesda, MD 20892-6601
Telephone: (301) 496-8973
FAX: (301) 402-0175
Email: [email protected]
2. Peer Review Contacts:
Peter Jackson, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3133, MSC-7616
6700B Rockledge Drive
Bethesda , MD 20892-7616
Telephone: (301) 496-8426
FAX: (301) 402-2638
Email: [email protected]
3. Financial or Grants Management Contacts:
Heidi Young
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2247, MSC-7614
6700B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 496-7075
FAX: (301) 480-3780
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 the scientific merit or the priority score.
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.
Public 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 public 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 PA 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.
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/ in the following citation: No. 93.855, Allergy, Immunology and Transplantation Research, 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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