and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National
Human Genome Research Institute (NHGRI), (http://www.genome.gov)
Components of Participating Organizations
National
Human Genome Research Institute (NHGRI), (http://www.genome.gov)
Title: Data Analysis and
Coordinating Center For Research Training Activities (U01)
Announcement Type
New
Related Notices
Request For Applications (RFA) Number: RFA-HG-08-006
Catalog of Federal Domestic Assistance Number(s)
93.172
Key Dates
Release Date: August 14, 2008
Letters
of Intent Receipt Date: October
13, 2008
Application Receipt Date: November 13, 2008
Peer
Review Date(s): February/March
2009
Council
Review Date: May 2009
Earliest Anticipated Start Date: July 2009
Expiration Date: November 14, 2008
Due Dates for E.O. 12372
Not Applicable
Additional
Overview Content
Executive Summary
Purpose. This Funding
Opportunity Announcement (FOA) issued by the National Human Genome Research,
National Institutes of Health, solicits grant applications from institutions
and organizations that will collect and analyze data about the career path of
individuals who have participated in short-and long-term research training
activities which are all focused on increasing the number of underrepresented
minorities participating in genome or ethical, legal and social implications
(ELSI) research. From the data collected, a series of reports will be
generated and presentations made periodically to help the NHGRI and its
national advisory council assess whether grantees activities match
anticipated program progress and outcomes.
Table of Contents
Part I
Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and
Anticipated Start Dates
1.
Letter of Intent
B. Sending an Application to
the NIH
C. Application Processing
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Resource Sharing Plan(s)
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
Background: The
NHGRI Plan for Increasing the Number of Underrepresented Minorities Trained in
Genomics and ELSI Research (http://www.genome.gov/10001707/)
was developed in 2002 with the goal of increasing the number individuals from
underrepresented minority (URM) populations who are trained to pursue research in the fields of genomics and ELSI research. The plan was based on five principles: (1) underrepresented communities must be involved; (2) opportunities must be available at all career levels; (3) programs must be anchored in institutions involved in genome and ELSI research; (4) involving and training minority individuals must be a goal for all parts of the NHGRI programs; and (5) the plan must have achievable goals, measurable outcomes, appropriate reviews and undergo evaluation. The Plan was approved by National Advisory Council for Human Genome Research in May 2002. At the same time, a subcommittee of Council, Research Training Working Group, was impaneled to provide oversight of the program and advice to NHGRI regarding progress. The subcommittee includes Council members, as well as additional experts who have track records in training or are interested in the research training of URM populations.
The Action Plan stated that projects in which NHGRI had a significant investment were considered ideal laboratories for this initiative. Thus, it became mandatory for large-scale sequencing centers, Centers of Excellence in Genomic Science (CEGS), and databases to respond to this initiative. Because we were not sure what would work best, grantees were allowed to propose programs that worked well in their research environment. The types of projects ranged from K-12 curriculum development to the support of postdoctoral fellows and faculty. Because training grants represented another opportunity for increasing the number of individuals from URM populations participating in genomic and ELSI research, research training grants were offered supplements to enhance their recruitment and training of individuals from URM populations. This collection of grant activities is considered the Research Training Consortium.
In the Fall of 2003, the Research Training Consortium started meeting annually to review progress, share information and discuss issues of common interest. The members of the Research Training Working Group also attend this meeting to provide feed-back to the grantees and to the NHGRI staff. In February 2007, NHGRI sponsored a meeting of the training coordinators who assist the grantees in implementing their programs. Since they were involved with the implementation of the program activities, it was felt that they could benefit from group discussions of common interests. The second meeting was held in February 2008; it is anticipated that these too will become annual meetings. Summaries of these meetings can be found at: http://www.genome.gov/14514219#2.
The imprimatur of the Research Training Working Group has been evident in their suggestions that research training be encouraged at the undergraduate levels. Because of the concerns expressed by the Working Group regarding cost/benefit of all the programs, the NHGRI has limited all new MAP programs to $300,000 direct cost. The Working Group also strongly recommended that an evaluation program be established to assess whether NHGRI is progressing toward its goal of increasing the number of individuals from URM populations participating in genomics and ELSI research. While the individual programs have always been strongly encouraged to have evaluation and tracking processes in place, this has not been done systematically and it is difficult to compare data among programs. During the last year, the Research Training Consortium has begun discussions about common data elements to be collected on individual participants in order to collectively assess progress and outcomes. Examples of the types of data elements being collected by grantees includes, but is not limited to: contact information of participants; date of degree(s); scholastic records; major(s) in undergraduate and graduate schools; research focus as a postdoctoral fellow; period of support under the MAP; undergraduate and graduate institutions attended; applications applied for; grants/patents received; scientific publications; socioeconomic data of participants; etc; place(s) of employment; etc. In order to rigorously determine progress and outcomes, it is important to monitor the quality of the input data, to have objective assessments of the results, and to develop reports for the overall program for grantees and NHGRI.
Research Scope and Objectives: The Research Training Consortium encompasses the following: (a) National Research Service Awards (NRSA)--eleven institutional training grants and (b) non-NRSAs--three (3) large scale sequencing grants; nine (9) Centers of Excellence in Genome Science; five (5) database resource grants; and one education grant. The NRSA and educations grants are limited to graduate students and postdoctoral fellows and short-term training activities for undergraduate students. The career levels of the non-NRSA grants vary from secondary school students to college faculty. The duration of the activities vary from a few hours (laboratory tours) to long-term activities. Grantees are required to have program evaluation measures in place and be responsible for tracking participants for a minimum of five years beyond the completion of their program. All grantees, to some degree, evaluate their programs, but the data and outcome measures can not be used in a meta analysis that NHGRI can use to track progress and outcomes toward meeting the goal. In preparation for this initiative, the Research Training Consortium has been involved in an exercise in which it has agreed upon the types of data that should be collected on participants to benchmark progress and to demonstrate that participants are on a path that leads to a career in genomic sciences or ELSI.
The proposed Data Analysis and Coordination Center (DACC) would: create a centralized database for deposition of the Research Training Consortium data from grantees that would then be the source of all data analysis; ensure that common data elements are collected on each participant that would result in analyses that would accurately reflect progress and outcomes; ensure the quality, accuracy and completeness of the data; be the central repository for data collected; perform rigorous analyses of the data; generate periodic reports that would assess progress and outcomes; report out the findings at the annual meetings of the Research Training Consortium, training coordinators and periodically to the National Advisory Council for Human Genome Research; and provide written reports to NHGRI periodically. However, in order to have quality reports, it is necessary to have quality assessment and quality control of data collected and entered into the database. It would therefore also be important for DACC personnel to work with grantees to collect complete and accurate records and to develop reliable procedures for tracking participants once they complete the program.
Overview of the DACC responsibilities:
The applicant should describe a broad plan for how the DACC will accomplish the goal of working with grantees to demonstrate that their research training activities are contributing to the goal of increasing the number of underrepresented minorities pursuing genomics and ELSI research. The plan should include working with grantees and NHGRI staff to refine the data elements that are essential to demonstrating progress and appropriate outcomes for the various career levels and working with grantees to ensure that comprehensive and accurate data are collected systematically on individual participants. Grantees will be responsible for collecting data from participants as a requirement for demonstrating that their programs are meeting NHGRI’s MAP goals.
The DACC will obtain data from the grantees and provide feedback to grantees and NHGRI about the quality and utility of the data. The DACC should be prepared to work with data from grantees to produce annual and cumulative reports on program progress and outcomes.
The applicant must have demonstrated prior experience in evaluating and tracking short- and long-term research training activities. Applicants should describe their willingness to be flexible in assuming or relinquishing responsibilities as program needs arise. Since the DACC will have to work closely with grantees, the applicant also must have demonstrated ability to work cooperatively within large, distributed projects where the focus is on research training that results in getting participants to the next phase of their career development.
The activities of the DACC should not overlap, but complement the grantees evaluation and tracking activities. As a reminder, the grantees are already required to incorporate evaluating and tracking components into their programs. The DACC will be funded to develop, house, and maintain a database to track, store, and provide access to all of the participants and different types of research training activities that are funded under the MAP, including NRSA training activities. Applicants for the DACC should make clear that they will avoid duplication of efforts with the grantees evaluation and tracking activities.
In addition to a clear set of goals for the overall DACC, applicants should propose milestones with metrics that will allow assessment of progress towards the achievement of the ultimate goals. Milestones may be negotiated at the time of the award and updated on a yearly basis as described in the terms and conditions of a Cooperative Agreement in section 2.A.2.
The DACC is expected to be a stable resource that will facilitate the analyses of the MAP grantees activities for the purpose of assessing program progress and outcomes. The DACC should use robust, existing analyses tools capable of handling all of the data that will be used in integrative analyses. The DACC is expected to work with the grantees to establish the exact types and formats of data that will be used in integrative analyses along with developing procedures to track and facilitate the analyses.
The awardee funded through this FOA (RFA-HG-08-006) will participate in the annual meetings of grantees and training coordinators and two meetings of the National Advisory Council for Human Genome Research during the course of the award period. Applicants should request funds to attend these meetings. The annual grantee meeting is in the fall of each year and rotates around the country; the training coordinators meetings are held in late winter/early spring and is always held in the Washington Metropolitan area. The national advisory council meetings are always held in the Washington Metropolitan area.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism of Support
This funding
opportunity will use the U01 award mechanism.
The Project Director/Principal Investigator (PD/PI)
will be solely responsible for planning, directing, and executing the proposed
project.
This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
This funding opportunity will use a cooperative agreement award mechanism. In the cooperative
agreement mechanism, the Project Director/Principal Investigator (PD/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 Principal Investigator, as described under the Section VI. 2. Administrative Requirements,
"Cooperative Agreement Terms and Conditions of Award". It is anticipated that this activity will be
continued as a cooperative agreement project beyond the initial period of award.
2. Funds Available
The estimated amount of funds available for support of one project awarded as a result of this announcement is $400,000 for fiscal year 2009. Future year amounts will depend on annual appropriations.
Although the
financial plans of the IC(s) provide support for this program, awards pursuant
to this funding opportunity are contingent upon the availability of funds and
the receipt of a sufficient number of meritorious applications.
NIH grants policies as
described in the NIH
Grants Policy Statement will apply to the applications submitted and awards
made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
The following
organizations/institutions are eligible to apply:
1.B. Eligible Individuals
2. Cost Sharing or Matching
This
program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
Applicants are not permitted to submit a resubmission
application in response to this FOA.
Renewal applications are not permitted in response to this FOA.
Each applicant may submit only one application.
Section IV. Application and Submission Information
1. Address to Request
Application Information
The PHS 398 application
instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
710-0267, Email: [email protected].
Telecommunications for
the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications must be
prepared using the most current PHS 398 research grant application instructions
and forms. Applications must have a D&B Data Universal Numbering System
(DUNS) number as the universal identifier when applying for Federal grants or
cooperative agreements. The D&B number can be obtained by calling (866)
705-5711 or through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS 398
form.
The title and number of
this funding opportunity must be typed in item (box) 2 only of the face page of
the application form and the YES box must be checked.
3. Submission Dates and Times
Applications must be
received on or before the receipt date described below (Section
IV.3.A). Submission times N/A.
3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: October 13, 2008
Application Receipt
Date: November 13, 2008
Peer Review
Date(s): February/March 2009
Council Review Date: May 2009
Earliest
Anticipated Start Date: July 2009
3.A.1.
Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
Although a letter of
intent is not required, is not binding, and does not enter into the review of a
subsequent application, the information that it contains allows IC staff to
estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed
in Section IV.3.A.
The letter of intent should be sent to:
Bettie J. Graham,
Ph.D.
Division of Extramural
Research
National Human Genome Research Institute
5635 Fishers Lane, Ste. 4071, MSC 9306
Bethesda, MD 20892-9306 (U.S Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 496-7531
Email: [email protected]
3.B. Sending an
Application to the NIH
Applications must be
prepared using the forms found in the PHS 398 instructions for preparing a
research grant application. Submit a signed, typewritten original of the
application, including the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries
of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At
the time of submission, two additional copies of the application and all
copies of the appendix material must be sent to:
Rudy
Pozzatti, Ph.D.
Scientific Review Branch
National Human Genome Research Institute, NIH
Phone: (301) 402-0838
FAX: (301) 435-1580
Email: [email protected]
3.C. Application
Processing
Applications must be received on or before the
application receipt date) described above (Section
IV.3.A.). If an application is received after that date, the application
may be delayed in the review process or not reviewed. Upon receipt,
applications will be evaluated for completeness by the CSR and for
responsiveness by the reviewing Institute. Incomplete and/or
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 NIH Grants
Policy Statement.
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 award if such costs: 1) are
necessary to conduct the project, and 2) 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 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 and Information
Applicants should include in their budget the cost of attending the annual grantees and training coordinators meetings and two meetings of the National Advisory council for Human Genome Research.
Awardee must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information".
Research Plan Page Limitations
The standard page limitations as found in the PHS 398 application instructions (http://grants.nih.gov/grants/funding/phs398/phs398.html) apply.
Appendix Materials
All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. (See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Not Applicable.
(b) Sharing Model Organisms: Not Applicable.
(c) Genome-Wide Association Studies (GWAS): Not Applicable.
Section V. Application Review Information
1. Criteria
Only the review
criteria described below will be considered in the review process.
2. Review and Selection Process
Applications that are complete and responsive to
the FOA will be evaluated for scientific and technical merit by
an appropriate peer review group convened by the National Human
Genome Research Institute and in accordance with NIH peer
review procedures (http://grants1.nih.gov/grants/peer/),
using the review criteria stated below.
As part of the scientific peer 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 meritorious 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? Will this application provide information about the progress and
outcome that the participating grant initiatives have made to increase the
number of underrepresented minorities participating in genomics and ELSI
research?
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?
Will the project, as designed, accomplish the goal of rigorously documenting
progress and outcomes?
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)? Do the investigator
and the team have a strong track record in this area as demonstrated by
successful completion of similar long-term evaluation and tracking
projects? Do the investigator and the team have demonstrated experience
in working with groups in different geographic locations.
Environment: Does the scientific
environment in which the work will be done contribute to the probability of
success? Do the proposed studies benefit from unique features of the scientific
environment, or subject populations, or employ useful collaborative
arrangements? Is there evidence of institutional support?
2.A.
Additional Review Criteria:
In addition to the
above criteria, the following items will continue to be considered in the
determination of scientific merit and the rating:
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 on Human Subjects in the PHS
398 instructions).
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 on Human Subjects in the
PHS 398 instructions).
Care
and Use of Vertebrate Animals in Research: If vertebrate animals are to
be used in the project, the five points described in the Vertebrate Animals
section of the Research Plan will be assessed.
Biohazards: If materials or procedures
are proposed that are potentially hazardous to research personnel and/or the
environment, determine if the proposed protection is adequate.
2.B. Additional Review
Considerations
Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.
2.C.
Resource Sharing Plan(s)
When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.
3. Anticipated Announcement and Award
Dates
Applicants
can expect to learn about the outcome of their applications, whether successful
or unsuccessful, by March 30, 2009.
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.
A
formal notification in the form of a Notice of Award (NoA) will be
provided to the applicant organization. The NoA signed by the grants management
officer is the authorizing document. Once all administrative and programmatic
issues have been resolved, the NoA will be generated via email notification
from the awarding component to the grantee business official (designated in
item 12 on the Application Face Page). If a grantee is not email enabled, a
hard copy of the NoA will be mailed to the business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.
2. Administrative
and National Policy Requirements
All NIH grant and
cooperative agreement awards include the NIH Grants Policy Statement as part of
the NoA. For these terms of award, see the NIH Grants Policy Statement Part II:
Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
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 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 Principal
Investigator will have the primary responsibility for defining the details for
the project within the guidelines of RFA HG-08-006 and for coordinating the
evaluation and tracking activities. The P.I. will agree to accept close
coordination, cooperation, and participation of NIH staff in those aspects of
scientific and technical management of the project as described under "NIH
Responsibilities".
The Principal Investigator of the Data Analysis and Coordination Center (DACC) for this project will:
Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
2.
A.2. NIH Responsibilities
An NIH Project Scientist is
a scientist of the NHGRI extramural staff who will have substantial scientific
and programmatic involvement that is above and beyond the normal stewardship
role in awards, including providing technical assistance, advice, and
coordination for the MAP, the NRSA institutional training grants and their
component parts. However, the role of NIH staff will be to facilitate and not
to direct the activities. It is anticipated that decisions in all activities
will be reached by consensus of the Research Training Consortium and that NIH
staff will be given the opportunity to offer input to this process. One NHGRI
Project Scientist will participate as a member of the Research Training
Consortium and will have one vote.
The Project Scientist will:
The Research Training Working Group, a subcommittee of Council was established to evaluate the progress of the MAP and the NRSA institutional grants. This subcommittee provides recommendations to the Director, NHGRI about the progress and direction of all components of the MAP and NRSA institutional training grants. The subcommittee is composed of six to eight senior scientists with relevant expertise in research training programs; two are members of the National Advisory Council for Human Genome Research..
The Research Training Working Group will meet at least twice a year; some meetings may be conducted by telephone conference. At least once a year, there will be a joint meeting with the MAP grantees, NRSA program directors, and NHGRI staff. After the annual meeting with grantees and program directors, the Research Training Working Group will meet with the Director, NHGRI to make recommendations regarding progress of the MAP in meeting the goals of increasing the number of underrepresented individuals pursuing genomics and ELSI research and to provide advice to the Director of NHGRI about changes, if any, that may be necessary in order the Research Training Consortium to accomplish its goals.
Additionally, the NHGRI program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned program director may also serve as an NIH Project Scientist.
Each
full member will have one vote. Awardee members of the Research Training
Consortium will be required to accept and implement policies approved by the
Research Training Consortium.
2.A.3. Collaborative Responsibilities
The principal grantees of the Research Training Consortium will become
the Steering Committee and will serve as the main governing body of the
Research Training Consortium . The Steering Committee membership will
include one NIH Project Scientist and the P.I. from each awarded MAP and NRSA
institutional training grant. The Steering Committee may add additional
members. Other government staff may attend the Steering Committee meetings if
their expertise is required for specific discussions.
The Steering Committee will be responsible for
coordinating the activities being conducted by the Research Training
Consortium. To address particular issues, the Steering Committee may establish
working groups as needed, which will include representatives from the Research
Consortium and the NHGRI and possibly other experts. Minutes of the
Steering Committee meetings will be available to the Steering Committee members
within 30 days after each meeting.
Each full member will have one vote. Awardee members of the Steering
Committee will be required to accept and implement policies approved by the
Steering Committee.
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
The awardees will be
required to submit a progress report every six months in a standard format, as
agreed upon by the Steering Committee and the Research Training Working Group.
Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
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:
Bettie J.
Graham, Ph.D.
Division of Extramural
Research
National Human Genome Research Institute
National Institutes of Health
Email:
[email protected]
2. Peer Review Contacts:
Rudy
Pozzatti, Ph.D.
Scientific Review Branch
National Human Genome Research Institute, NIH
Phone: (301) 402-0838
FAX: (301) 435-1580
Email: [email protected]
3. Financial or Grants Management Contacts:
Ms.
Cheryl Chick
Grants Administration Branch
National Human Genome Research Institute
5635 Fishers Lane, Suite 4076
Bethesda, MD 20892-9305
Telephone: (301) 402-0733
Fax: (301) 402-1951
Section VIII. Other Information
Required Federal Citations
Use of Animals in
Research:
Recipients of
PHS support for activities involving live, vertebrate animals must comply with
PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human
Subjects Protection:
Federal
regulations (45CFR46) require that applications and proposals involving human
subjects must be evaluated with reference to the risks to the subjects, the
adequacy of protection against these risks, the potential benefits of the
research to the subjects and others, and the importance of the knowledge gained
or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and
Safety Monitoring Plan:
Data and safety
monitoring is required for all types of clinical trials, including physiologic
toxicity and dose-finding studies (phase I); efficacy studies (Phase II);
efficacy, effectiveness and comparative trials (Phase III). Monitoring should
be commensurate with risk. The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving interventions
that entail potential risks to the participants (NIH Policy for Data and Safety
Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing
Research Data:
Investigators
submitting an NIH application seeking $500,000 or more in direct costs in any
single year are expected to include a plan for data sharing or state why this
is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators
should seek guidance from their institutions, on issues related to
institutional policies and local IRB rules, as well as local, State and Federal
laws and regulations, including the Privacy Rule. Reviewers will consider the
data sharing plan but will not factor the plan into the determination of the
scientific merit or the priority score.
Policy
for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/
Access
to Research Data through the Freedom of Information Act:
The Office of
Management and Budget (OMB) Circular A-110 has been revised to provide access
to research data through the Freedom of Information Act (FOIA) under some
circumstances. Data that are (1) first produced in a project that is supported
in whole or in part with Federal funds and (2) cited publicly and officially by
a Federal agency in support of an action that has the force and effect of law
(i.e., a regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has provided
guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Sharing of Model
Organisms:
NIH is committed to
support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding pursuant
to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
Inclusion of Women
And Minorities in Clinical Research:
It is the policy of the
NIH that women and members of minority groups and their sub-populations must be
included in all NIH-supported clinical research projects unless a clear and
compelling justification is provided indicating that inclusion is inappropriate
with respect to the health of the subjects or the purpose of the research. This
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43). All investigators proposing clinical research should read the
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b) investigators
must report annual accrual and progress in conducting analyses, as appropriate,
by sex/gender and/or racial/ethnic group differences.
Inclusion of
Children as Participants in Clinical Research:
The NIH maintains a
policy that children (i.e., individuals under the age of 21) must be included
in all clinical research, conducted or supported by the NIH, unless there are
scientific and ethical reasons not to include them.
All investigators
proposing research involving human subjects should read the "NIH Policy
and Guidelines" on the inclusion of children as participants in research
involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education
on the Protection of Human Subject Participants:
NIH policy requires
education on the protection of human subject participants for all investigators
submitting NIH applications for research involving human subjects and
individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem
Cells (hESC):
Criteria for federal
funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov).
It is the responsibility of the applicant to provide in the project description
and elsewhere in the application as appropriate, the official NIH identifier(s)
for the hESC line(s) to be used in the proposed research. Applications that do
not provide this information will be returned without review.
NIH Public Access Policy Requirement:
In
accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators
must submit or have submitted for them their final, peer-reviewed manuscripts
that arise from NIH funds and are accepted for publication as of April 7, 2008
to PubMed Central (http://www.pubmedcentral.nih.gov/),
to be made publicly available no later than 12 months after publication. As of
May 27, 2008, investigators must include the PubMed Central reference number
when citing an article in NIH applications, proposals, and progress reports
that fall under the policy, and was authored or co-authored by the investigator
or arose from the investigator’s NIH award. For more information,
see the Public Access webpage at http://publicaccess.nih.gov/.
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. For publications listed in the appendix and/or Progress report,
internet addresses (URLs) must be used for publicly accessible
on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for 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 FOA 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.
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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