EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Library of Medicine (NLM), (http://www.nlm.nih.gov)
Title: Operations Grant for Integrated Advanced Information Management Systems (IAIMS)
Announcement Type
This is a re-issue of PAR-02-081, which was released March 14, 2002.
Update: The following updates relating to this announcement have been issued:
Program Announcement (PA) Number: PAR-05-076
Catalog of Federal Domestic Assistance Number(s)
83.879
Key Dates
Release Date: March 24, 2005
Letters of Intent Receipt Date(s): Not applicable
Application Receipt Dates(s): Standard dates for research grants apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
Peer Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
Council Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
Earliest Anticipated Start Date: Approximately nine months from application receipt date. http://grants.nih.gov/grants/funding/submissionschedule.htm
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: March 2, 2008
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 and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
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
Integrated advanced information systems (IAIMS) are comprehensive trans-organizational information management structures. In an IAIMS environment, organizations apply proven management practices and appropriate expertise about informatics and information services in order to link and relate the published biomedical knowledge base with clinical, research, educational and administrative, information, using computers and networks.
The National Library of Medicine (NLM) provides IAIMS grants to health-related institutions and organizations that seek assistance for projects to plan, deploy, evaluate and sustain a comprehensive information environment that supports organizational mission activities. Implementing an IAIMS information environment that crosses organizational and disciplinary boundaries is a complex task. IAIMS is not a grant program for the selection and installation of an electronic health record system or laboratory reporting system or other single-purpose information tool. IAIMS work usually involves integrating an array of commercial products (which may include electronic health record systems or electronic full-text journals) with local systems, resources and services and Internet-based information to create a single point of access.
Professionals and consumers need ready access to usable, useful, reliable information to guide their decisions and learning. For this reason, NLM's IAIMS grant program has a fundamental area of interest, context-appropriate information. Any IAIMS grant application must focus on this theme. NLM's IAIMS program offers several options for grant support:
This program announcement describes only the IAIMS Operations Grant. For information about other IAIMS grants, see their individual program announcements. Organizations may not apply for more than one type of IAIMS grant at the same time.
Research Objectives
The Internet, advanced computing technologies, and digital information have altered the information landscape. With access to data, information and knowledge no longer time- and place- dependent, new opportunities are emerging to improve health care, education, biomedical research and health administration. To benefit from these advances, health-related organizations must (1) seamlessly integrate their own digital information resources with relevant information obtained from external sources, and (2) bring digital information to health care teams, researchers, teachers, students, patients and the general public in a way that supports sound decisions, efficient research, and effective action.
The long-term goal of NLM's IAIMS program is a comprehensive and convenient information management environment, one that brings useful, usable knowledge to action settings in health care, education biomedical research and health administration. Particular emphasis is placed on organization-wide and trans-organizational mechanisms that enable the easy flow of information between arenas of action, such as between health care and biomedical research, or between organizations, such as from a hospital to a public health department.
Since 1984, NLM has provided IAIMS grants to academic health sciences centers to build networks and organizational mechanisms for information management. In its first two decades, the emphasis of IAIMS program focused on networks in academic medical centers. Twenty-first century technological advances and widespread access to the Internet made it possible to shift the focus of IAIMS from building information networks to exploiting them. The IAIMS challenge for the 21st century confronts all kinds of health-related organizations, academic and non-academic with the challenge of using local and national networks to acquire, manage, and deliver knowledge in a way that binds it to effective action.
Health care, education and research, health administration and personal health decisions take place today in an information space fed by many sources of digital and printed information, some of which are not owned by an organization or individual. Each organization must implement approaches that select the right subset of information from the available sources, and present it in the way most effective for a given problem and person. Examples of context- appropriate information include, but are not limited to:
Three core features are essential for meaningful context-appropriate information:
1. The use of standards. Effective integration of research data, clinical information and published knowledge requires common syntax and semantics. To achieve their IAIMS goals, health organizations must use common vocabularies and adopt information standards that support the integration and exchange of health information. It is expected that applicants for IAIMS grants will use SNOMED, HL7, LOINC, DICOM, XML, components of the Unified Medical Language System (UMLS) or other nationally-recognized health data and information standards. The following examples are aims that would benefit from an IAIMS approach:
2. Appropriate stewardship over information. An IAIMS environment involves the creation and management of a digital library. As used here, the phrase digital library' refers to a collection of information, data or knowledge, stored on a computer and accessible across a network to other local and distributed computers. Probable components in a digital library include published articles and books, electronic personal health records, multimedia curriculum materials, research databanks and data warehouses of administrative or clinical information. Departmental and organizational boundaries can impede the flow of usable, useful information (1) between centers of activity within a single organization (such as between 2 health professions school), or (2) among unaffiliated organizations, (such as departments at different universities or a community consortium of hospitals), making it difficult to build and sustain a digital library. Organizations involved in IAIMS must implement approaches that facilitate the building and use of digital libraries, bringing information acquired in one arena of action, such as clinical care, to people in another arena, such as research or public health.
The phrase information management' can be used to describe the functions of stewardship over the digital library in an IAIMS setting. Methods of stewardship must be in place to assure the availability of useful, usable, reliable information. Examples include:
3. Information management structure. Organizational structures and policies are required in an IAIMS environment to support decisions, deployment, evaluation, enhancement and replacement of appropriate information systems and services. A discussion of the participants' current approach to information management is a required component of all IAIMS applications.
It is expected that IAIMS projects will include more than one institution, and may include organizations of different types such as hospitals, clinics, community centers and local government health departments. Collaborative projects such as these give desirable economies of scale, affect greater numbers of users, and can take good advantage of network infrastructures.
It is expected that applicants for IAIMS grants will demonstrate familiarity with current practice in their area of interest, as expressed in the published literature or activities at other IAIMS organizations. To become familiar with NLM's IAIMS program and its goals, applicants are directed to the following resources:
Next-Generation IAIMS: Binding Knowledge to Effective Practice. Prepared under contract N01-LM 9-3523. Washington, D.C.: Association of American Medical Colleges, September 2001. The full technical report is available in PDF form at http://www.aamc.org/programs/betterhealth/start.htm#iaims.
Operations Grant Objectives
The purpose of an IAIMS Operations grant is to support the implementation of significant aims of an IAIMS Plan.
The IAIMS plan is a written document, adopted by participating organizations, that details their chosen approach to providing context-appropriate information. An IAIMS plan has the following characteristics:
A written IAIMS plan must be submitted as an appendix to an application for an IAIMS Operations grant. Operations grant applications that do not have an IAIMS plan appended will be returned without review. The planning activity that leads to an IAIMS Operations grant proposal need not have been undertaken with NLM funds, but the plan which accompanies the application should adhere to the features of an IAIMS plan, as described in the program statement for that grant.
Because it is not possible for an IAIMS Operations grant to fund all aspects of a comprehensive information environment, applicants should explain which aspects of the IAIMS plan are to be funded by the IAIMS Operations grant and provide a rationale for the choice. Evidence of organizational investment in other aspects of the IAIMS plan should also be provided
An IAIMS environment provides professionals and consumers with usable, useful, reliable information for sound decisions, efficient research and effective action. Implementing an IAIMS plan is a complex and exacting process. Organizational change, technology advances, financial stability, new state and federal regulations, management practices and local conditions all affect an organization's ability to deploy and nourish a comprehensive information environment. An IAIMS Operations grant proposal can include periods of pilot testing and evaluation, and brief planning periods during the course of the work.
An IAIMS Operations project needs careful, insightful management and good communications to meet challenges, respond to changing needs and evaluate the success of the IAIMS work. The grant proposal should include a description of participating organizations and their plan for managing IAIMS implementation, including a discussion of critical success factors and how problems will be addressed.
An IAIMS Operations grant application should cover the following points:
It is expected that all recipients of IAIMS grants will share the fruits of their experience with their peers and interested parties through publications, presentations, open source software banks, and other appropriate means. Applicants should explain their plan for disseminating results of their IAIMS work. Active involvement in the IAIMS Consortium community is strongly recommended.
In addition to regular annual progress reports, successful applicants will be expected to participate in a reverse site visit during second year of an IAIMS Operations Grant. A review of progress, goals, milestones and timeline for completion will be discussed during the visit. The IAIMS Operations Grant is non-renewable.
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 NIH G08 grant 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.
Applicants may request up to $400,000 per year for one, two, three or four years. Only direct costs are covered. Consortium/subcontractual costs will be considered direct costs to the parent grant and, therefore, must fall within the total direct cost cap established for this program. Like the parent grant, consortium costs cannot include funds for facilities and administration. The IAIMS Operations grant is non-renewable.
The IAIMS Operations grant supports direct costs for salary, consultants, equipment and software costs, training costs, travel, supplies and other expenses appropriate to the project. Facilities and administration costs, sometimes called indirect costs, are not provided.
2. Funds Available
Because the nature and scope of the proposed projects 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 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 are not provided for this grant.
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:
Eligible organizations include schools of medicine, dentistry, nursing, allied health, pharmacy, public health and other organizations working toward the promotion of good health and the prevention and treatment of disease. Hospitals, clinics, schools and community health centers, libraries and public health facilities, units of state and local governments among are examples of other organizations that are encouraged to apply. Groups of organizations are eligible to apply, but a single, lead institution must apply on behalf of the group. Foreign institutions are not eligible to apply. Collaboration with foreign organizations is allowed if the foreign organization is a fundamental, necessary feature of the proposed work or provides expertise that is not otherwise available. For-profit organizations and eligible agencies of the federal government may participate as participants or consultants. Applications from ineligible organizations will be returned without review.
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed project 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. It is expected that the Principal investigator will dedicate sufficient time to the project to direct and coordinate all aspects of the work. The Principal Investigator of an IAIMS Operations grant should be positioned within the organization to assure that commitments and communication are maintained.
2. Cost Sharing or Matching
Matching funds or other forms of direct cost participation are not required. However, applicants are expected to cover costs for facilities and administration, also called overhead or indirect costs. Only direct costs are provided in this grant program. This applies to the applicant and any consortium or subcontracting organizations.
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
No continuation applications will be accepted for this grant program. An institution may submit multiple applications at the same grant deadline, but they will compete against one another for funds. An applicant may not apply for more than one type of IAIMS grant at a single deadline.
Section IV. Application and Submission Information1. 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.
Information about specific grant programs and answers to frequently-asked questions about NLM grants are provided at http://www.nlm.nih.gov/ep, along with the program announcement, to assist applicants in organizing the project plan and completing the application form. When special instructions from NLM are provided for completing the application, they take precedence over more general instructions provided with PHS 398.
3. Submission Dates and Times
Applications must be mailed on or before the receipt date described below (Section IV.3.A). Submission times N/A.
3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: Not applicable
Application Receipt Date(s): Same as dates for research grants, see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
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: Approximately nine months from the application receipt date. http://grants.nih.gov/grants/funding/submissionschedule.htm
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.
3.B. Sending an Application to the NIH
Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and five 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)
3.C. Application Processing
Applications must be submitted on or before the application receipt dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm. Upon receipt, applications will be evaluated for completeness by CSR and responsiveness by the NLM.
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. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.
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 (see also Section VI.3. Reporting).
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
Plan for Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.
All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.
The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.
The scope of work determines whether or not a data sharing plan is required for an IAIMS Operations grant proposal. Applicants who are unsure should contact the program official listed on this grant announcement.
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.
The scope of work determines whether or not a resource sharing plan is required for an IAIMS Operations grant proposal. Applicants who are unsure should contact the program official listed on this grant announcement.
Section V. Application Review Information1. Criteria
Applications submitted for this funding opportunity will be reviewed for merit using the criteria below. NLM IAIMS Operations grants are not research grants and reviewers of these applications will take this into account. Additional review criteria are listed below. Applicants are welcome to contact recent recipients of IAIMS Operations grants, whose information is listed at http://www.nlm.nih.gov/ep in the awards section.
2. Review and Selection Process
Applications submitted for this funding opportunity will be assigned to the National Library of Medicine on the basis of established PHS referral guidelines.
An appropriate scientific review groups convened by the National Library of Medicine 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.
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? Does the proposed work support mission goals of the participating organizations? Can the outcome serve as a model for other similar endeavors?
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? Does the proposed work flow logically from the IAIMS plan? Does it fulfill IAIMS program goals? Are management and communication structures well defined 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? ( As IAIMS grants are not research grants, innovation will not be judged in terms of scientific innovation. However, reviewers will give consideration to innovative approaches that address challenging information problems faced by many organizations.)
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)? Is the Principal Investigator appropriately placed, organizationally, to manage the work? Are informaticians, librarians and other information specialists part of the team?
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? Is there evidence of institutional readiness to undertake the work?
6. Critical Review Elements for IAIMS Operations grants:
2.A. Additional Review Criteria:
In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:
Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).
Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).
2.B. Additional Review Considerations
Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. 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 at NLM Extramural Programs will be responsible for monitoring the data sharing plan if one is present.
2.D. Sharing Research Resources
NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible. Program staff at NLM Extramural Programs will be responsible for assessing the adequacy of the resource sharing plan if it is present.
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.
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.
Principal investigators will be notified by e-mail when priority scores and summary statements are available. Each investigator receives a print copy of the summary statement in the mail. All applicants are encouraged to register in the NIH Commons, where they can have access to grant status information, including priority scores and summary statements, as soon as they are available.
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).
2.A. Cooperative Agreement Terms and Conditions of Award
Not applicable
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. A final progress report is required of all awardees. Awardees may exceed the page limit for narrative portion of a progress or final report. In the second year of the project, a reverse site visit will be held.
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:
Dr. Valerie Florance
Extramural Programs Division
National Library of Medicine
Rockledge 1, Suite 301
6705 Rockledge Drive
Bethesda, MD 20892
Telephone: (301) 594-4882
FAX: (301)402-2952
Email: [email protected]
Dr. Arthur Petrosian
Scientific Review Administrator
6705 Rockledge Drive, Suite 301, MSC 7968
Bethesda, MD 20892-7968
Bethesda, MD 20817 (for courier/express service)
Telephone: (301) 594-4933
FAX: (301) 402-2952
Email: [email protected]
3. Financial or Grants Management Contacts:
Dwight Mowery
Extramural Programs Division
National Library of Medicine
Rockledge 1, Suite 301
6705 Rockledge Drive
Bethesda, MD 20892
Telephone: (301) 496-4221
FAX: 301-402-2952
Email: [email protected]
Required Federal Citations
Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.
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.
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/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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