Part I Overview Information

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: GrantsInfo@nih.gov.

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: bettie_graham@nih.gov

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: rp7s@nih.gov

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.

Section VII. Agency Contacts

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: bettie_graham@nih.gov

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: rp7s@nih.gov

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.

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