Part I Overview Information

Department of Health and Human Services

Issuing Organization
National Center for Research Resources (NCRR) (http://www.ncrr.nih.gov))

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)]

Components of Participating Organizations
This RFA is developed as a Roadmap initiative. All NIH Institutes and Centers participate in Roadmap initiatives. This RFA will be administered by the National Center for Research Resources on behalf of the NIH. http://www.ncrr.nih.gov/.

Title: Limited Competition for Supplements to CTSAs to Plan for Pilot Projects to Apply the National Clinical Research Associates Model in Their Community Engagement Activities (UL1)

Announcement Type
This RFA is affiliated with RFA-RM-06-002, which was released on October 12, 2005.

Request for Applications (RFA) Number: RFA-RM-07-006

Catalog of Federal Domestic Assistance Number(s)
93.310

Key Dates
Release Date: November 28, 2006
Letters of Intent Receipt Date(s): Not applicable
Application Receipt Date(s): January 22, 2007
Peer Review Date(s): March 2007
Council Review Date(s): May 2007
Earliest Anticipated Start Date(s): July 2007
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: January 23, 2007

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

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 and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

The purpose of this limited competition RFA is to solicit applications for competitive supplements from the FY2006 CTSA Program awardees to plan pilot projects to establish a cadre of community-based practitioners trained and qualified to participate in clinical trials supported by NIH or other organizations as part of the Community Engagement Program requirement described in RFA-RM-06-002.

Background to the CTSA Pilot Projects

The NIH Roadmap is a multiyear initiative intended to identify roadblocks to scientific progress and ways to overcome them that require trans-NIH action. A major component of the Roadmap is reinvigorating the clinical research enterprise, of which the Clinical and Translational Science Awards (CTSA) program is a leading activity. Another area of effort has been Clinical Research Workforce Training (CRWT). Roadblocks to progress identified by the scientists considering this area include a) the inadequate training of community-based practitioners in clinical research and the recruitment of research subjects, b) the minimal access of most patients outside of academic health centers to NIH-type clinical studies and trials, c) the consequent inadequate representativeness of the whole U.S. population of the subjects recruited for NIH clinical trials from academic health center patients alone, d) the long recruitment time for clinical trials that is caused by having to start a new network for every multi-site trial, and e) the slow translation to practice of research findings. Many of these roadblocks could be minimized by a establishing a network of qualified community-based recruiter/practitioners who were ready to mobilize research studies quickly and who could make studies available to populations not currently served.

To assess the feasibility and cost of such an approach, the NIH contracted with the RAND Corporation for a study. RAND surveyed potential participants and other stakeholders, developed and tested several conceptual models, and reported to the NIH that the concerns of potential NCRA participants included: a) minimizing the time practitioners would have to spend providing reports to, and interacting with, IRBs and federal agencies, b) the need for practitioners to be compensated for research activity an amount equivalent to what they would have earned in the same time in providing care ( Fair Replacement Value ), c) a need for there to be a steady flow of research studies so there would not be gaps in compensated time, d) that the research questions addressed should be relevant to their practice, so they wanted input into the studies proposed, and e) concerns about their legal liabilities from research as opposed to practice.

The model proposed by RAND included a new, large, and intensive management component at NIH, covering study operations, oversight of the contractor organizations doing the studies (Research Associates Organizations or RAOs), training, data collections, quality assurance, and community relations. RAND proposed that NIH contract with organizations (primary care practice-based networks, HMOs, CROs, community health centers, community hospitals, or academic health centers that incorporate community practitioners). The contracts would provide for recruiting practitioners, providing basic training for them in clinical research (patient recruitment and protection, data and sample collection and submission, follow-up), support for their activities, and credentialing them as NIH Clinical Research Associates. NIH would put clinical studies and trials out for bid to these RAOs and, after negotiations, the best offers would be funded. RAND estimated that it would take approximately 40 RAOs at full strength conducting several billion dollars worth of clinical research annually.

Goals of the CTSA Pilot Projects.

The NIH does not have resources to commit to an enterprise of the magnitude envisaged by RAND at this time, but is eager to pilot test the basic concepts on a smaller scale, believing that the community engagement component of the new CTSA awards may be the ideal place for such pilot testing. This piloting would require a much smaller oversight structure from NIH, and would evaluate the feasibility, methodology, and cost of setting up RAO-equivalent activities at the CTSA sites. If successful, the concept could be expanded to much of the CTSA Network or beyond.

Accordingly, the NIH is issuing this solicitation for competitive supplement grants to the 12 CTSAs awarded under RFA-RM-06-002. The supplements are to provide support for one year of planning for pilot projects, in interaction with NIH staff. These competitive supplements should extend the community engagement component of the institution’s UL1 CTSA award. Applicants for these supplements may build on the activities proposed in the CTSA or may propose new and independent activities, whichever they believe will best meet the intent of the NCRA program.

Information on the CTSA and NCRA is available at: http://nihroadmap.nih.gov/clinicalresearchtheme/.

Scope

In proposing planning for a pilot of the NCRA concept, applicants should address:

Their vision of what an NCRA program would look like and how it would operate in their institution

Characteristics of the community and the practitioners where they would locate their NCRA program with an assessment of the relative benefits of proximate or distant locations for the program.

Previous and existing research interactions with their practice community

Previous efforts to involve community-based practitioners and patients in clinical studies or trials

How they would propose to evaluate the pilot project

Possible solutions for the concerns identified by RAND

Other topics that could be addressed include the potential for: credentialing NCRA candidates in clinical research; linking practitioners electronically in a network for sharing information and securely transmitting data to a central site; the support that would be provided to practitioners for patient scheduling, data and specimen collection, and follow-up and how to promote community-wide knowledge of the results of studies done and promote adoption of treatment advances

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIH UL1 award mechanism.

The NIH UL1 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award."

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" is to be submitted with the application.

2. Funds Available

The NIH intends to commit approximately $1 million in FY 2007 to fund 5 7 competitive supplements in response to this RFA. An applicant may request a project period of up to one year and a budget for direct costs up to $150,000 per award.

The number of competitive supplements recommended for award will depend on the overall scientific merit and relevance to program priorities of the applications reviewed. Although the financial plans of the NIH provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

Eligible institutions or organizations are the current CTSA awardees.

1.B. Eligible Individuals

Eligible PIs are the PIs of current CTSA award. Project Leaders, who will plan and may later conduct the pilot projects, must participate in the Community Engagement component of the CTSA award and have the skills, knowledge, and resources necessary to carry out the proposed activity and should collaborate with the CTSA PI to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

2. Cost Sharing or Matching

Not applicable

3. Other-Special Eligibility Criteria

Competitive supplements are available to these grantees for one year of support to plan pilot projects. A follow-up solicitation for further support will be considered for FY 2008 2010 Roadmap funding.

Planning for the pilot project is to be conducted and performed by the Project Leader, an individual who is not the PI of the CTSA award. The Project Leader may be a co-investigator on the CTSA. The Project Leader may be any individual with the skills, knowledge, and resources necessary to carry out the proposed activity.

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 on line 2 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(s): Not applicable
Application Receipt Date(s): January 22, 2007
Peer Review Date(s): March 2007
Council Review Date(s): May 2007
Earliest Anticipated Start Date: July 2007

3.A.1. Letter of Intent

Not applicable

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-1485
Email: stretchr@mail.nih.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NIH. Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

6. Other Submission Requirements

Application Instructions

The application should follow the standard format of the R01 (PHS 398) application with the exception that the Research Plan must be limited to 10 pages instead of the usual 25 pages.

Special Instructions for Recommended Format:

Key Personnel

The CTSA PI should be listed first and identified as the PI, last name first. The Project Leader for planning the pilot project should be listed next. Other key personnel and consultants for the competitive supplement should then be listed. Provide biographical sketches of the key personnel involved in planning the pilot project.

Budget Instructions

A maximum of $150,000 direct costs may be requested. Follow the instructions for non-modular budget research grant applications. A detailed categorical budget is to be submitted and the budget requested should reflect the total direct costs only of items for which additional funds are requested. Provide a detailed justification for the proposed budget. Note that Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation (see NOT-OD-05-004).

The requested budget start and end dates must coincide with the CTSA budget start and end dates.

Research Plan (10 pages maximum)

A. Specific Aims - Specific aims should include the goals and objectives of the planning for pilot projects (one page recommended).

B. Background and Significance - Provide a description of past experience interacting with the provider and patient communities to be addressed (one page recommended).

C. Feasibility/Preliminary Studies/Progress Report - Describe techniques/approaches that may be used. Preliminary data are not required, but can be provided (one page recommended).

D. Research Design and Methods Describe how you will plan for your proposed pilot project in detail (five pages recommended). Discuss how the aims have the potential to be achieved, such as a discussion of how engagement of practitioners in the community is to be achieved, the metrics that will be used, the partnerships and collaborations proposed, etc. The pilot projects should be suitable for future expansion, and should address how training and credentialing on NIH requirements could be met and how support for office-based research in terms of personnel assistance and electronic linkage could be achieved.

D1. Role of PI of the CTSA and CTSA resources for pilot Describe the roles of the PI and Project Leader of the CTSA on planning this pilot project and the CTSA resources that may be used on planning the pilot project. The Project Leader, who is to lead the planning for the pilot project, must not be the PI of the CTSA. The Project Leader may be a co-investigator of the CTSA parent grant (One page recommended)

E. Human Subjects Research - see instructions in PHS 398 (no page limit)

Plan for Sharing Research Data
Not Applicable

Sharing Research Resources

Not Applicable

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

The following will be considered in making funding decisions:

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Institute of Child Health and Human Development (NICHD) in accordance with the review criteria stated below.

This RFA is developed as an NIH roadmap initiative (http://nihroadmap.nih.gov), in which all NIH Institutes and Centers participate. For administrative purposes, NICHD will be responsible for convening an appropriate review group on behalf of the NIH.

As part of the initial merit review, all applications will:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

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? How well-articulated is the applicant’s vision of what an NCRA program would look like and how it would operate in their institution? How successful have previous efforts been in involving community-based practitioners and patients in clinical studies or trials?.

Approach: Are the conceptual or clinical framework, design, methods, techniques/approaches and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Preliminary data are not required, but can be provided. Does the applicant acknowledge potential problem areas and consider alternative tactics? How will engagement of practitioners in the community be achieved in terms of metrics to be used and proposed partnerships and collaborations? Does the applicant propose community-based participatory research (CBPR) projects that could be considered for future expansion? How well does the applicant address how training and credentialing on NIH requirements could be met and how support for office-based research in terms of personnel assistance and electronic linkage could be achieved? How well does the applicant propose to evaluate the pilot project? How well does the applicant propose to address the practitioners concerns identified by RAND? How well-described are the plans to provide support to practitioners for patient scheduling, data and specimen collection, and follow-up? Are adequate mechanisms provided for determining levels of compensation to practitioners and how they would be provided? How well does the applicant plan to promote community-wide knowledge of the results of studies done and promote adoption of treatment advances?.

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 Project Leader and Project Team appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Project Leader and Project Team? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? Does the applicant adequately describe the roles of the PI and Project Leader of the CTSA on planning this pilot project and the CTSA resources that may be used in planning the pilot project.

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Is there evidence of community support? Are the characteristics of the community and the practitioners where they would locate their NCRA program adequately described? Is there evidence of previous and existing interactions with their practice community?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested one-year period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via 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).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.
The 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 competitive supplements to the cooperative agreement (UL1), 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 to define objectives and approaches of the CTSA. The primary responsibilities of the awardees are to:

Awardees will retain custody of and primary rights to their data and intellectual property developed under the award subject to current government policies regarding rights of access as consistent with current HHS, PHS, and NIH policies and subject to the terms and conditions of this RFA.

Principal investigators and key personnel as appropriate are expected to participate in annual Steering Committee meetings.

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

NIH Science Officers will have substantial scientific involvement during the conduct of this activity, through technical assistance, advice, and coordination above and beyond normal program stewardship for grants. One or more Science Officers will be assigned by the NIH CTSA Program Director to each CTSA Steering Committee, including those constituted to address key functions. A given individual may serve on more than one CTSA Steering Committee. NIH Science Officer(s) will:

To help carry out these duties, Science Officers may consult with non-NIH experts in the field.

NCRR Program Officers will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The Program Officer will:

Additionally, the NCRR CTSA Program Officer will be responsible for normal stewardship of the award and may recommend the termination or curtailment of an investigator or project/program (or an individual award) in the event the partnerships fail to evolve within the intent and purpose of this initiative.

2.A.3. Collaborative Responsibilities

A National CTSA Consortium Steering Committee shall be established and composed of the PIs of each CTSA and appropriate NIH Science Officers. A Chair will be selected by the Steering Committee at an early meeting of the group from among the non-Federal members. The Consortium Steering Committee will enlarge to accommodate new PIs of CTSAs that are funded in future years and to accommodate the NIH Science Officers of key-function-specific Steering sub-committees, as they are established. Each PI will have one vote while the fraction of NIH Staff votes will be adjusted so it does not exceed 33% of the Steering Committee.

The National CTSA Consortium Steering Committee shall be a forum for sharing policies, practices, and resources and for discussion of opportunities, impediments, joint agreement on broad issues impeding clinical research, government policies and practices, and other appropriate topics. The Committee will identify and approve best practices and policies that will advance clinical and translational research as a discipline and facilitate collaboration and sharing among CTSA institutions and with partners in clinical and translational research, e.g., industry, laboratories, hospitals.

Each CTSA institution must agree to work toward adopting and implementing the policies and best practices that are approved by the National CTSA Consortium Steering Committee.

CTSA Steering sub-committees will be established for common themes identified by NIH (e.g., Research Education, Biomedical Informatics, Regulatory Affairs) and additional sub-committees for key resources will be established as required. Membership of these sub-committees will comprise the Directors of the corresponding key functions at each CTSA, one member of the National CTSA Consortium Steering Committee and one or more NIH Science Officers appointed by the NCRR CTSA Program Director. A Chair will be selected by the Steering Committee at an early meeting of the group from among the non-Federal members. Each full member will have one vote with the fraction of NIH Staff votes will be adjusted so it does not exceed 33% of the Steering sub-committee. The Chair will report sub-committee recommendations regarding policies and best practices to the National CTSA Consortium Steering Committee for approval.

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

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:

Anthony Hayward, MD, Ph.D.
Director, Division for Clinical Research Resources
National Center for Research Resources
6701 Democracy Boulevard, Rm. 906
Bethesda, MD 20892
Telephone: (301) 435 0791
FAX: (301) 480 3661
Email: haywarda@mail.nih.gov

2. Peer Review Contacts:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-1485
Email: stretchr@mail.nih.gov

3. Financial or Grants Management Contacts:

Mary Niemiec
Office of Grants Management
National Center for Research Resources
6701 Democracy Boulevard, Rm 1046
Bethesda, MD 20892
Telephone: (301) 435-0842, fax: 301-480-3777
Email:NiemiecM@mail.nih.gov

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).

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:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. 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 PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.

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