and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)
Components of Participating Organizations
National Center for Research Resources (NCRR) ( http://www.ncrr.nih.gov/)
National Eye Institute
(NEI) (http://www.nei.nih.gov/)
National Heart, Lung,
and Blood Institute (NHLBI/NIH), (http://www.nhlbi.nih.gov/index.htm
National Institute of Allergy and Infectious Diseases (NIAID) (http://www3.niaid.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS),
(http://www.niams.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
(http://www.niddk.nih.gov/)
Office
of Rare Diseases, NIH (ORD, NIH) (http://rarediseases.info.nih.gov)
Title: Human Tissue and Organ Research Resource (Limited Competition U42)
Announcement Type
New
Update: The following update relating to this announcement has been issued:
Request for Applications (RFA) Number: RFA-RR-07-006
Catalog of Federal Domestic Assistance Number
93.389, 93.846, 93.839, 93.847, 93.867, 93.856
Key Dates
Release Date: October 12, 2007
Letters of Intent Receipt Date: Not applicable
Application Receipt Date: January 30, 2008
Peer Review Date(s): February-April 2008
Council Review Date: May 2008
Earliest Anticipated Start Date: July 1, 2008
Additional Information to Be Available Date (URL Activation Date): Not Applicable.
Expiration Date: January 31, 2008
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
Table of Contents
Part 1: Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
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 Announcement
Section I. Funding Opportunity Description
1. Research Objectives
The National Center for Research Resources (NCRR) requests a limited competition to provide continued support for a human tissue organ research resource (HTOR) at a national tissue and organ procurement and distribution center. The overarching purpose of the research funded by NCRR is to reduce the burden on the society of morbidity and mortality of diverse conditions and diseases and understand normal human tissue and organ function. The resource described by this RFA focuses on access and providing a resource for biomedical research. The Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Bill 2007, Report of the Committee on Appropriations 109-515, indicates that the Committee recognizes that there is still an unmet demand for the use of human tissue specimens in research and encouraged NIH to strengthen the core for the human tissue supply initiative. The existence of a human tissue and organ resource provides the resource for researchers studying normal and diseased tissue and organ systems.
The resource is currently funded as a cooperative agreement (U42) to provide normal and diseased human tissues and organs for biomedical researchers. The HTOR supports the procurement, preservation, and distribution of human tissue and organs for basic and clinical research at research centers, academic institutions, the NIH, and other federal agencies.
1. Mechanism(s) of Support
The administrative and funding instrument to be used for this program will
be a program cooperative agreement (U42), an "assistance" mechanism
(rather than an "acquisition" mechanism), in which substantial
NCRR scientific and/or programmatic involvement with the awardee is anticipated
during performance of the activity. Under the cooperative agreement, the
NCRR’s purpose is to support and/or stimulate the activity of recipient(s),
to generate a high quality resource by involvement in and otherwise working
jointly with the award recipient(s) in a partner role, but it is not to
assume direction, prime responsibility, or a dominant role in the activity.
Details of the responsibilities, relationships, and governance of the study
to be funded under the cooperative agreement are discussed later in this
document under the section "Terms and Conditions of Award." As
an applicant, you will be solely responsible for planning, directing, and
executing the proposed project.
This FOA uses NIH 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 U42 grant is a cooperative agreement award mechanism. In the cooperative
agreement mechanism, the Principal Investigator (PI) 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 PI, as described under the Section VI. 2.
Administrative Requirements, "Cooperative Agreement Terms and Conditions
of Award." It is anticipated that at the termination of this
current U42 award, the RFA will be reissued for continuation of this project
through the U42 mechanism.
2. Funds Available
Participating NIH Institutes, Centers, and Offices expect to provide up
to $4.5 million in direct costs and up to $7.0 million in total costs over
five years for the RFA awardee. The annual budget is capped at the current
level of support (an amount of funding on average experienced in previous
years up to $900.000 per year in the direct costs). One award is anticipated. The
earliest start date will be July 1, 2008.
Although the financial plans of the NCRR provide support for this program,
awards pursuant to this funding opportunity are contingent upon the availability
of funds and the receipt of a meritorious application.
Facilities and administrative (F&A) costs requested by consortium participants
are not included in the direct cost limitation; see NOT-OD-05-004.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
This FOA is a limited competition for continuation of the National Disease Research Interchange Human Tissue Organ Resource (NDRI HTOR). Any application awarded as part of that initiative is eligible to apply for continuation.
The application may involve multiple sites that may be Public/State Controlled Institution of Higher Education; Private Institution of Higher Education; Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education); Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education); Small Business; For-Profit Organization (Other than Small Business); State Government; U.S. Territory or Possession; Indian/Native American Tribal Government (Federally Recognized); Indian/Native American Tribal Government (Other than Federally Recognized); Indian/Native American Tribally Designated Organization; Non-domestic (non-U.S.) Entity (Foreign Organization); Hispanic-serving Institution; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); Alaska Native and Native Hawaiian Serving Institutions; Regional Organizations.
1.B. Eligible Individuals
Any eligible individual with the skills, knowledge, and resources necessary
to carry out the proposed research is invited to work with the eligible
institution to develop an application for support. Individuals from underrepresented
racial and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.
2. Cost Sharing or Matching
There is no cost sharing requirement for this RFA.
The most current NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.
3. Other-Special Eligibility Criteria
An applicant may submit only one application under this announcement.
Section IV. Application and Submission Information
1. Address to Request Application Information
The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in
an interactive format. Applicants must use the currently approved version
of the PHS 398. For further assistance, contact GrantsInfo; Telephone (301)
710-0267, Email: [email protected]. Telecommunications
for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications must be prepared using the 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 application format is to be that of the PHS 398 as customized for the NIH multi-component cooperative agreement U42 mechanism. A complete application must be received by the NIH Center for Scientific Review (CSR) no later than January 30, 2008. If an application is received after that date, it will be returned to the applicant without review. CSR will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. CSR will not accept any application that is essentially the same as one already reviewed. This rule does not preclude the submission of a substantial revision of an application already reviewed, but such an application must include an introduction addressing the previous critique.
Supplementary Instructions
Face page. Name of Principal Investigator (PI)
The PI(s) is (are) the individual(s) designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the grant. The applicant organization may designate multiple individuals as PIs who share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PI is responsible and accountable to the grantee organization or, as appropriate, to a collaborating institution, for the proper conduct of the project or program, including submission of all required reports.
When multiple PIs are proposed, use Face Page (Continued) page to provide items 3a-3h for all PIs. NIH requires one PI be designated as the Contact PI for all communications between the PIs and the agency. The Contact PI must meet the eligibility requirements for PI status in the same way as other PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The Contact PI may be changed during the project period. The Contact PI should be listed in block 3 of Form Page 1 (the Face Page), with additional PIs listed on the Face Page (Continued). All PIs must be registered in the eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
Format Page 2. Key Personnel
List all Key Personnel, giving name, title, and organizational affiliation.
The Research Plan must be organized in the following sections:
A. Overall Aims, Background, and Significance
B. Administrative Structure
C. Research Resource Design and Plan
D. Research Resource Infrastructure
E. Human Subjects
F. Literature Cited
G. Consortium/Contractual Arrangements
H. Budget and Supplementary Documentation
Sections A-F must not exceed a 50-page limit.
A. Overall Aims, Background, and Significance
This application must describe how the overall goals of the program are advanced by the structure of the human tissue and organ research resource, and its specimens, and the topics of research. These plans must address recommendations of an advisory board (including external advisors) and discuss the following key areas:
i. Enhancing the capacity and evaluating processes of human tissue and organ research resource to engage biomedical researchers and address the tissue and organ requests.
ii. Evaluating and continually improving service delivery and communication with the biomedical research community.
iii. Increasing the role of tissue and organ banks, hospitals, research facilities, and tissue and organ procurement organizations affiliated with the applicant s human tissue and organ research resource in the formulation and continued development of human tissue and organ research resource.
iv. Enhancing the capacity to utilize technologies and improving the quality of the resource s procurement, preservation, store, and distribution of specimens.
v. Evaluating and continually maintaining biohazard safety.
vi. Evaluating and maintaining adherence to Health and Human Services and NIH guidelines and regulations on informed consent and research resources, and the implications of the Health Insurance Portability and Accountability Act (HIPAA) regulations Privacy Rule.
vii. Communicating with the government and public on current research and research advancements from the research community it serves.
Briefly describe the purpose and history of the human tissue and organ research resource and the research communities that it serves.
A progress report from the current year must be included
in this section as background to document the development and progress of
the human tissue and organ research resource, including a description of
the interactions that occurred among tissue and organ banks, hospitals,
research facilities, and organ and tissue repositories, and with the researchers
served. The use of Tables to document past HTOR activity is encouraged.
B. Administrative Structure. This section should describe the proposed administrative structure of the project, e.g., PI(s), co-investigators, the Steering Committee, other functional committees or special interest groups, other research support resources, and how these units function to support and maintain the research resource plan of the human tissue and organ research resource, and to maintain communication across tissue and organ banks, hospitals, research facilities, and organ and tissue repositories, participating Federal agencies (i.e., NCRR/NIH and other NIH Institutes and Centers), and the biomedical research community. Only name key personnel and those individuals in the current administration and advisory committee. Also list their term in office, titles, and organization affiliation. Appropriate structures that would oversee procurement, preservation, storage, distribute, and quality control of specimens should be described. Also, the resource’s protocols and systems including advisory committee(s) should be described.
C. Research Resource Design and Plan.
i. Structure and Approach:
The applicant must propose detailed plans describing the design and development of the HTOR, to include current and future capacities of the research resource, procedures for the procurement, shipping, preparation, preservation, confidentiality and informed consent, biohazards and pathogen screening, tissue and organ request application and fulfillment, and distribution of all types of specimens that will be handled by the human tissue and organ research resource. The applicant must describe the design of the quality control, data collection and analysis, and diagnostic verification. The design and development of the database should be such that it provides a user-friendly accounting of the resource’s holdings, including all human tissue and organ specimens for human subject research. The applicant must maintain a core of remote site collection centers.
ii. Customer Service
The applicant must describe the current status and future plans of the customer service and public relations. The applicant must describe plans for a user-friendly customer service interface. This plan needs to provide access for biomedical researchers who search for tissue and organ specimens who have technical questions regarding the search or specification of tissue or organ specimens, or who need assistance with decisions on ordering or obtaining tissue and organ specimens. Moreover, the applicant must outline current status and plans on communication and enhancement of public relations of the research resource with government, and private research facilities.
iii. Milestones
The application must present specific milestones that will need to be met in order to accomplish the work set out above in a five-year time frame.
iv. Principal Investigator
The effective management of a research resource requires a significant commitment by the PI. The PI of a research resource under this FOA must devote at least 10% effort to the project. The applicant should have direct experience, knowledge, and hands-on involvement in daily operations. It is expected that this individual will be an established scientist with a fitting level of seniority within the applicant organization, and with appropriate authority. \
v. Management of Integration plans
The applicant must describe the management plan for the proposed project, and how it will support achievement of the proposed goals and milestones. The application should describe the organization of the proposed research resource effort and its management structure, including integration of the separate components to form an efficient pipeline from request of specimens to the specimens distribution to biomedical researchers, key personnel, expert advisory committee, and reporting relationships. Recruitment and training of personnel should be discussed. The plan should also describe how the various components of the proposed research resource effort will be integrated, and how collaborations or subcontracts, if proposed, will be managed. Coordination of the awardee’s activities with those of the other components of the human tissue and organ research resources, as well as with other national and international programs aimed at producing human tissue and organ specimens, must be described.
D. Evaluation
Procedures should be described for the evaluation of core functioning (e.g., by an advisory board) and for implementing recommendations resulting from such evaluations. The applicant must describe external evaluation review procedures by external advisors and internal evaluation review procedures by internal evaluators, and strategy and implementation processes of action plans which the applicant and evaluators agreed upon.
E. Human Subjects and Biohazards
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). Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.
F. Literature Cited
While this section is not included in the page limitation, it is important to be concise and to select only those literature references pertinent to the research resource. List complete literature citations as directed in the PHS 398 Instructions.
G. Budget and Consortium/Contractual Arrangements
Costs should be budgeted for attendance at scientific meetings, and other key administrative functions. The applicant must outline an overall cost-recovery program that provides a stepwise plan for a charge-back fee for procurement, distribution and restocking that will result in eventual self-sufficiency of the research resource. All proposed costs and projected cost reductions asked for above must be given in terms of the direct, indirect, and total costs, i.e. the fully loaded costs (including overhead). The calculated costs must take into account all of the expenses associated with each component activity including those attributable to informatics infrastructure, quality control, management, and data release. The applicant must present a fully justified budget for the work described above.
If multiple institutions are involved, the project will be administered through a traditional consortium/contractual arrangement, and the usual documentation is required.
H. Supplementary Documentation
Only statements of Institutional Commitment, Letters of Support, letters of collaborations, and other similar documents, if appropriate, should be included in this section. In addition, a letter from the applicant should be included and titled Procedures Related to Materials Obtained from Human Subject and that provides documentation of the following:
- The Resource’s offices which handle or process the tissue and organ specimens for biomedical research are in compliance with the Health Insurance Portability and Accountability Act (HIPAA) as described in the section below labeled Standards for Privacy of Individually Identifiable Health Information.
- The Resource will not accept specimens for the resource’s use from any human subject unless that subject or closest relative has given signed, explicit informed consent.
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
Application Receipt Date: January 30, 2008
Peer Review Date(s): February-April 2008
Council Review Date: May 2008
Earliest Anticipated Start Date: July 1, 2008
3.A.1. Letter of Intent
Not applicable
3.B. Sending an Application to the NIH
Applications must be prepared using 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 delivery; non-USPS service)
And two copies in one package to:
Bonnie B. Dunn, Ph.D.
Scientific Review Administrator
Office of Review
National Center for Research Resources
Democracy Plaza One, Room 1074
6701 Democracy Blvd.
Bethesda, MD 20892
Telephone: (301) 435-0824
FAX: (301) 480-3660
Email: [email protected]
Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
Using the RFA Label: The RFA label available in the PHS 398 application
instructions must be affixed to the bottom of the face page of the application.
Type the RFA number on the label. Failure to use this label could result
in delayed processing of the application such that it may not reach the
review committee in time for review. In addition, the RFA title and number
must be typed on line 2 of the face page of the application form and the
YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.
3.C. Application Processing
Applications must be received on or before the application receipt date(s) described
above (Section IV.3.A.). If an application is received after
that date, it will be returned to the applicant without review. Upon receipt,
applications will be evaluated for completeness by the CSR and responsiveness
by the NCRR. Incomplete and non-responsive applications will not be reviewed.
The NIH will not accept any application in response to
this funding opportunity that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application.
However, when a previously unfunded application, originally submitted as
an investigator-initiated application, is to be submitted in response to
a funding opportunity, it is to be prepared as a NEW application. That is,
the application for the funding opportunity must not include an Introduction
describing the changes and improvements made, and the text must not be marked
to indicate the changes from the previous unfunded version of the application.
Information on the status of an application should be checked by the Principal
Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles,
and other considerations described in the NIH Grants Policy Statement. The
Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
Pre-award costs are allowable. A grantee may, at its own risk and without
NIH prior approval, incur obligations and expenditures to cover costs up
to 90 days before the beginning date of the initial budget period of a new
or competing continuation award if such costs: are necessary to conduct
the project, and would be allowable under the grant, if awarded, without
NIH prior approval. If specific expenditures would otherwise require prior
approval, the grantee must obtain NIH approval before incurring the cost.
NIH prior approval is required for any costs to be incurred more than 90
days before the beginning date of the initial budget period of a new or
competing continuation award.
The incurrence of pre-award costs in anticipation of a competing or non-competing
award imposes no obligation on NIH either to make the award or to increase
the amount of the approved budget if an award is made for less than the
amount anticipated and is inadequate to cover the pre-award costs incurred.
NIH expects the grantee to be fully aware that pre-award costs result in
borrowing against future support and that such borrowing must not impair
the grantee's ability to accomplish the project objectives in the approved
time frame or in any way adversely affect the conduct of the project. See
NIH Grants Policy Statement at 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.
The applicant who is 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). If the applicant
organization chooses to share under its 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.
The applicant should 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.
The applicant responding to this funding opportunity should include a description
of how final research data will be shared.
The reasonableness of the data sharing plan will be assessed by the reviewers.
Reviewers will not factor the proposed data sharing plan into the determination
of scientific merit or the priority score.
Sharing Research Resources
NIH policy expects that grant 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
at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and
at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
The applicant 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.
Processes to enable patient and provider knowledge, interest and understanding
of research performed with the human tissue and organ specimens will be
explored.
Section V. Application Review Information
1. Criteria
The following will be considered in making funding decisions:
2. Review and Selection Process
An application that is complete and responsive to the RFA will be evaluated
for scientific and technical merit by an appropriate peer review group convened
by NCRR in accordance with the review criteria stated below.
As part of the initial merit review, the application will receive a written
critique. The application will receive a second level of review by the National
Advisory Research Resources Council.
The goals of NIH supported research are to advance our understanding of
biological systems, to improve the control of disease, and to enhance health.
In their written critiques, reviewers will be asked to comment on each of
the following criteria in order to judge the likelihood that the proposed
research will have a substantial impact on the pursuit of these goals. Each
of these criteria will be addressed and considered in assigning the overall
score, weighting them as appropriate for each application. Note that an
application does not need to be strong in all categories to be judged likely
to have major scientific impact and thus deserve a high priority score.
For example, an investigator may propose to carry out important work that
by its nature is not innovative but is essential to move a field forward.
Significance: Does this study address an important problem? If the aims
of the application are achieved, how will scientific knowledge or clinical
practice be advanced? What will be the effect of these studies on the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?
Approach: Are the conceptual or clinical framework, design, methods,
and analyses adequately developed, well integrated, well reasoned, and appropriate
to the aims of the project? Does the applicant acknowledge potential problem
areas and consider alternative tactics?
Innovation: Is the project original and innovative? For example: Does
the project challenge existing paradigms or clinical practice; address an
innovative hypothesis or critical barrier to progress in the field? Does
the project develop or employ novel concepts, approaches, methodologies,
tools, or technologies for this area?
Investigators: Are the investigators appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the experience
level of the principal investigator and other researchers? Does the investigative
team bring complementary and integrated expertise to the project (if applicable)?
Environment: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed studies benefit
from unique features of the scientific environment, or subject populations,
or employ useful collaborative arrangements? Is there evidence of institutional
support?
Peer review emphasizes a synthesis of two major aspects of the U42 application: review of the merit of each of the individual research resource and research resource progress compared to a standard of quality in existing broad human tissue and organ research resources. In arriving at an overall merit priority score for the U42, members of the review committee also will consider the likelihood that the proposed research program will have a substantial impact on the scientific field.
A. Review Criteria for the Overall Program
In their written critiques, reviewers will be asked to comment on each of the following criteria and 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.
This application will be reviewed for progress and plans to further the overall objectives of the human tissue and organ research resource and responsiveness to the recommendations of an external evaluation report of the human tissue and organ research resource including specific aspects listed in Section IV.2 (items a-j, under instructions to Section B of the Research Plan).
B. Additional Criteria for Competing Renewal Applications
C. Additional Criterion for Amended Applications
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).
Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.
2.B. Additional Review Considerations
Budget and duration: The reasonableness of the proposed budget and
the requested period of support in relation to the proposed research resource.
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 data.
2.D. Sharing Research Resources
NIH policy expects that grant 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 at http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and
at http://www.ott.nih.gov/policy/rt_guide_final.html).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be
shared or explain why sharing is not possible.
Program staff will be responsible for the administrative review of the plan
for sharing research resources.
The adequacy of the resources sharing plan will be considered by Program
staff of the funding organization when making recommendations about funding
applications. Program staff may negotiate modifications of the data and
resource sharing plans with the awardee before recommending funding of an
application. The final version of the data and resource sharing plans negotiated
by both will become a condition of the award of the grant. The effectiveness
of the resource sharing will be evaluated as part of the administrative
review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.
3. Anticipated Announcement and Award Dates
Not applicable
Section VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed, the PD/PI will be
able to access his or her Summary Statement (written critique) via the eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time"
information from the applicant. For details, applicants may refer to the
NIH Grants Policy Statement, Part II: Terms and Conditions of NIH Grant
Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal notification in the form of a Notice of Award (NoA) will be
provided to the applicant organization. The NoA signed by the grants management
officer is the authorizing document. Once all administrative and programmatic
issues have been resolved, the NoA will be generated via e-mail notification
from the awarding component to the grantee business official (designated
in item 12 on the Application Face Page). If a grantee is not email enabled,
a hard copy of the NoA will be mailed to the business official.
Selection of an application for award is not an authorization to begin performance.
Any costs incurred before receipt of the NoA are at the recipient's risk.
These costs may be reimbursed only to the extent considered allowable pre-award
costs. See also Section IV.5. Funding Restrictions.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy
Statement as part of the NoA. For these terms of award, see the NIH Grants
Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart
A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
The following Terms and Conditions will be incorporated into the award statement
and will be provided to the PI 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 U 42, 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
below.
2.A.1. Principal Investigator Rights and Responsibilities
The PI(s) will have the primary responsibility for the human tissue and
organ research resource effort as a whole, including research resource infrastructure
design, program development, and the actual performance of the human tissue
and organ effort. The PI(s) is (are) expected to make any necessary adjustments
in the overall research strategies to accommodate the changing environment
resulting from improved technologies during the course of the project period.
Awardees will retain custody of and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies. All awardees and NCRR will jointly develop appropriate confidentiality procedures for data collection, processing, storage and analysis to ensure the confidentiality of data on individual health care provider organization patients, health care providers and other institutions involved in human tissue and organ research resource. No identifying information of individual patients or providers should be available through pooled human tissue and organ research resource databases. Encrypted study identification numbers will be used for all pooled data. Awardees will collaborate with the biomedical researchers in government agencies, university, and other research centers.
The PI(s) will attend all annual human tissue and organ research resource meetings and will annually document progress in written reports to the NCRR Program Director and will provide periodic supplementary reports upon request. The PI will also make copies of these reports available for review by the co-funding NIH institute and centers program directors.
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 DHHS, PHS, and NIH policies.
This award is based on the application submitted to, and as approved by, the NIH on the above-titled project and is subject to the terms and conditions incorporated either directly or by reference in the following:
a. The grant program legislation and program regulation cited in this Notice of Grant Award.
b. The restrictions on the expenditure of federal funds in appropriations acts, to the extent those restrictions are pertinent to the award.
c. 45 CFR Part 74 or 45 CFR Part 92 as applicable.
d. The NIH Grants Policy Statement, including addenda in effect as of the beginning date of the budget period.
e. Carry over of an unobligated balance into the next budget period requires Grants Management Officer prior approval.
f. Treatment of Program Income: In accordance with 45 CFR 74.24, program income may be added to funds committed to the project and used to further eligible project objectives approved by the National Advisory Research Resources Council.
g. The funds from the Office of Rare Diseases are to be used for tissue distribution, research recruitment, source and database development and outreach to rare disease patients and advocates, and the medical and research communities engaged in the care and study of rare diseases. The funds from the NIAID are to be used to capitalize on the expertise and infrastructure of the HTOR to obtain tissues and organs from HIV-infected donors for our HIV/AIDS biomedical research community.
h. Written prior approval is required if any of the key personnel individual(s) withdraws from the project entirely, is absent from the project during any continuous period of 3 months or more, or reduces time devoted to the project by 25 percent or more from the level that was approved at the time of award.
i. For each publication that results from grant support provided by the National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH), grantees must include an acknowledgment of support and a disclaimer stating the following:
j. If the grantee plans to issue a press release concerning the outcome of NCRR grant-supported research, it should notify the NCRR Office of Communications at 301-435-0888 in advance to allow for coordination.
k. Award recipients are strongly encouraged to submit to PubMed Central (PMC), upon acceptance for publication, an electronic version of peer- reviewed, original research publications, resulting from research supported in whole or in part, with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process. For additional information, please visit http://publicaccess.nih.gov/.
l. This assistance award is classified as a cooperative agreement. Cooperative agreements are subject to the same administrative requirements as grants in such issuances as Department of Health and Human Services (DHHS) Administration of Grants, Federal Regulations Title 45 Part 74, PHS Grants Policy Statement, OMB Circulars, etc.
m. These 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 Part 74, and other HHS, PHS, and NIH grant administration policy statements.
2.A.2. NIH Responsibilities
NIH/NCRR will assign one staff member and NIH/other co-funding institutes
and centers will assign another staff member to serve as the coordinators
of the project (Project Scientists). The Project Scientists will have substantial
programmatic involvement that is above and beyond the normal stewardship
role in awards, as described below:
An NCRR program official may act as the Project Scientist, as well as be responsible for:
NIH intramural researchers may also be involved in the development of new human tissue and organ scientific collaboration with human tissue and organ investigators and will have similar rights and responsibilities as other non-NIH investigators.
The NCRR reserves the right to terminate or curtail the study (or an individual component of the award) in the event of inadequate progress, data reporting, or insufficient use of this resource.
2.A.3. Collaborative Responsibilities
During the course of the award period, the awardee(s) will be invited to meet with the NCRR, other PIs, and/or other uninvolved experts in Bethesda, MD, to review scientific progress.
The human tissue and organ research resource and NIH staff members will jointly develop methods to make this resource accessible to other investigators. This joint development may occur through trans-NIH events and meetings, publication on the Internet and in print, and other mechanisms, as deemed appropriate.
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.
3. Reporting
Awardees will be required to submit the PHS Non-Competing Grant Progress
Report, Form 2590, annually (http://grants.nih.gov/grants/funding/2590/2590.htm)
and financial statements as required in the NIH Grants Policy Statement.
The NCRR is developing a policy that will require Clinical Terms of Awards
for clinical studies and trials when they are a component of the proposed
research. The policy will require that studies be monitored commensurate
with the degree of potential risk to study subjects and the complexity of
the study. The new policy will be posted in the NIH Guide within a few weeks.
All funded applicants will be expected to adhere to the new policy.
We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:
1. Scientific/Research Contacts:
Institute, Center, or Office |
Contact Program Director |
National Center for Research Resources (NCRR), (http://www.ncrr.nih.gov) |
Rosemarie
Filart M.D. M.P.H. |
National Eye Institute (NEI) |
Jerome R. Wujek, Ph.D. |
National Heart, Lung, and Blood Institute
(NHLBI/NIH), |
Momtaz Wassef, Ph.D. |
National
Institute of Allergy and Infectious Diseases (NIAID), |
Paul Black Ph.D. |
National
Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
Carl C. Baker M.D. Ph.D. |
National Institute of Diabetes
and Digestive and Kidney Diseases (NIDDK) |
Michael C.
Appel, Ph.D. |
Office of Rare Diseases
(ORD), NIH |
Henrietta
Hyatt-Knorr, M.A. |
2. Peer Review Contacts:
Bonnie B. Dunn, Ph.D.
Office of Review
National Center for Research Resources
Democracy Plaza One, Room 1074
6701 Democracy Blvd.
Bethesda, MD 20892
Telephone: (301) 435-0824
FAX: (301) 480-3660
Email: [email protected]
3. Financial or Grants Management Contacts:
Jenelle D. Wiggins
Grants Management Specialist
Office of Grants Management
National Center for Research Resources
National Institutes of Health
One Democracy Plaza, Room 1038
6701 Democracy Boulevard, MSC 4874
Bethesda, Maryland 20892-4874hone: (301) 435-0843
Fax: (301) 480-3777
Email: [email protected]
Section VIII. Other Information
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); and 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 institutional review board (IRB) rules,
as well as local, State, and Federal laws and regulations, including the
Privacy Rule. Reviewers will consider the data sharing plan, but will not
factor the plan into the determination of the scientific merit or the priority
score.
Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised
to provide access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are: (1) first produced in a
project that is supported in whole or in part with Federal funds; and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity
in a public archive, which can provide protections for the data and manage
the distribution for an indefinite period of time. If so, the application
should include a description of the archiving plan in the study design and
include information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
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.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission
(NIHMS) system (http://www.nihms.nih.gov)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole
or in part with direct costs from NIH. The author's final manuscript is
defined as the final version accepted for journal publication, and includes
all modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts resulting from: 1) currently
funded NIH research projects; or 2) previously supported NIH research projects
if they are accepted for publication on or after May 2, 2005. The NIH Public
Access Policy applies to all research grant and career development award
mechanisms, cooperative agreements, contracts, Institutional and Individual
Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural
research studies. The Policy applies to peer-reviewed, original research
publications that have been supported in whole or in part with direct costs
from NIH, but it does not apply to book chapters, editorials, reviews, or
conference proceedings. Publications resulting from non-NIH-supported research
projects should not be submitted.
For more information about the Policy or the submission process, please
visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and
view the Policy or other Resources and Tools including the Authors' Manual
(http://publicaccess.nih.gov/publicaccess_Manual.htm).
Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification
to the "Standards for Privacy of Individually Identifiable Health Information," the "Privacy
Rule," on August 14, 2002. The Privacy Rule is a federal regulation
under the Health Insurance Portability and Accountability Act (HIPAA) of
1996 that governs the protection of individually identifiable health information,
and is administered and enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside
with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information
on the Privacy Rule, including a complete Regulation Text and a set of decision
tools on "Am I a covered entity?" Information on the impact of
the HIPAA Privacy Rule on NIH processes involving the review, funding, and
progress monitoring of grants, cooperative agreements, and research contracts
can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within
specified page limitations. Unless otherwise specified in an NIH solicitation,
Internet addresses (URLs) should not be used to provide information necessary
to the review because reviewers are under no obligation to view the Internet
sites. Furthermore, we caution reviewers that their anonymity may be compromised
when they directly access an Internet site.
Healthy People 2010:
The U.S. 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 2 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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