Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)
 
Components of Participating Organizations
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (http://www.niams.nih.gov)
 
Title: Multidisciplinary Clinical Research Centers (P60)
 
Announcement Type
This is a reissue of RFA-AR-05-001 which was previously released on July 19, 2004.

Update: The following update relating to this announcement has been issued:

Request For Applications (RFA) Number: RFA-AR-07-001

Catalog of Federal Domestic Assistance Number(s)
93.846
 
Key Dates
Release Date: March 20, 2007
Letters of Intent Receipt Date(s): May 29, 2007
Application Receipt Date(s): June 29, 2007
Peer Review Date(s): October/November, 2007
Council Review Date(s): January 2008
Earliest Anticipated Start Date(s):  April, 2008
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: June 30, 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
  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

Purpose

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invites new and competing continuation applications for Multidisciplinary Clinical Research Centers (MCRCs) in arthritis and/or musculoskeletal disorders and/or skin diseases.  Each MCRC will be organized around a methodology core and will be expected to include a minimum of three highly meritorious projects encompassing clinical research drawing from different disciplines. The methodology core will be the foundation of the center, providing key support for development and implementation of clinical projects.  Each project must address a critical issue that directly involves prevention, assessment and/or outcomes for patients with chronic diseases within the mission of the NIAMS.

Research Objectives

The goals of the MCRC program are to prevent disease and to assess and improve outcomes for patients with arthritis and other rheumatic diseases, musculoskeletal disorders, including orthopaedic disorders, bone diseases and muscle diseases, and skin diseases. For a comprehensive listing of the disease areas covered in the NIAMS mission, please see http://www.niams.nih.gov/rtac/funding/faq.htm

The key elements of an MCRC will include:

1.  A Center Director, Associate Director and an executive committee with outstanding credentials for promoting clinical research;

2.  A research base that encompasses diseases/disorders within the NIAMS mission and provides professional and patient resources for developing clinical projects using more than one clinical research approach; 

3.  A methodology core that will play a key role in the design and implementation of ALL projects supported through the Center; and

4.  A minimum of three highly meritorious clinical research projects that are synergistic and encompass disease areas e.g. arthritis or skin diseases, but not just one disease, e.g. osteoarthritis or psoriasis, within the NIAMS mission; use the methodology core; and encompass two or more clinical approaches.

Optional elements of an MCRC are (a) one exploratory/feasibility project supported by the methodology core and lasting no more than three years and (b) other core(s) supportive of two or more of the proposed projects.

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 P60 award mechanism(s). An applicant may request a project period of up to 5 years and a budget for direct costs of up to $800,000 per year (excluding F&A costs of

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

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.
 
2. Funds Available

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) intends to commit approximately $3.6 million in FY 2008 to fund 3 new and/or competing continuation grants in response to this RFA. An applicant may request a project period of up to 5 years and a budget for direct costs up to $800,000 per year exclusive of facilities and administrative costs of subcontracts with collaborating organizations. The earliest anticipated start date is April 2008.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NIAMS 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

You may submit (an) application(s) if your organization has any of the following characteristics:

Foreign institutions are not eligible to apply.

 1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
 
2. Cost Sharing or Matching

Cost sharing is not required

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

 None.

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) 435-0714, 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): May 29, 2007
Application Receipt Date(s): June 29, 2007
Peer Review Date(s): October/November, 2007
Council Review Date(s): January 2008
Earliest Anticipated Start Date(s):  April, 2008

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 at the beginning of this document.

The letter of intent should be sent to:

Madeline Turkeltaub, CRNP, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Democracy 1
6701 Democracy Boulevard, Suite 800
Bethesda, MD 20892
Telephone: (301) 594-2463
FAX: (301) 480-4543
Email: mturkeltaub@mail.nih.gov

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:

Yan Wang, M.D., Ph.D.
Chief, Review Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Democracy 1
6701 Democracy Boulevard, Suite 800
Bethesda, MD 20892
Telephone: (301) 594-4952
FAX: (301)402-2406
Email: wangy1@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 NIAMS. Incomplete and non-responsive applications will not be reviewed.

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described
in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
 
Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Guidelines are available for the MCRC program at http://www.niams.nih.gov/rtac/funding/grants/centers_programs.htm#P60

These guidelines are intended to assist the applicant in assembling an application in a manner to facilitate an optimal review of the complex topics covered in the application.

The Director and Associate Director should budget for an annual two-day meeting with NIAMS staff and other MCRC directors. The carryover of an unobligated balance into the next budget period requires Grants Management Officer prior approval.

Support staff requested in the Administrative Core may not exceed 1.0 FTE. 

Each project must discuss recruitment and retention of patients, clinical expertise and facilities needed, and a data safety and monitoring plan.  It is not anticipated that a Data Safety and Monitoring Board will be required for oversight of an MCRC study because multi-site or complex clinical trials are generally not appropriate for the MCRC mechanism.  However, if the patient population is at some significant risk, a Data Safety and Monitoring Board should be proposed.  For most studies, an independent Safety Officer, not affiliated with the institution, will be appropriate. The methodology core should detail support for the data safety and monitoring issues for the projects proposed.  NIAMS has developed guidelines for data safety and monitoring plans:  http://www.niams.nih.gov/rtac/clinical/index.htm. If the application is funded, the investigators will be expected to provide detailed methods of operating procedures, patient consent forms, and updated data and safety monitoring plans.

Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

Plan for Sharing Research Data
 
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

 Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

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 NIAMS in accordance with the review criteria stated below.

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.

Review criteria for Individual Projects:

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and innovative? For example: Des the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score. Additional detail regarding review criteria is provided in the NIAMS Guidelines for Multidisciplinary Clinical Research Centers:

Each project and core (including the administrative unit) will be individually reviewed for scientific merit and a rating assigned by committee consensus.  Merit ratings will also be provided for other center elements, i.e., qualifications of the center leadership, the research base, the institutional environment and resources.  If a competitive renewal is being sought, the progress during the previous funding period will also be evaluated.  To be funded, there must be a highly meritorious methodology core and at least three highly meritorious projects (not including the exploratory/feasibility project, if any) encompassing two or more disease areas within the NIAMS mission.

Review Criteria for MCRC leadership:

Do the Director and Associate Director have the leadership and research qualifications to lead a Center?  Does the leadership team (Director, Associate Director, and executive committee) have the collective expertise to assure focused development and implementation of high quality and meaningful clinical research projects?

Review Criteria for Research Base:

Is there a substantial productive and funded research base?  Is the research base sufficiently broad to foster new multidisciplinary research?  Is there a definition of who will be a Center investigator and what this designation might mean?

Review Criteria for Institutional Environment and Resources:

Is there evidence of a supportive institutional environment for the proposed MCRC?  Will the MCRC add an important multidisciplinary element to the institutional environment?  Does the proposed MCRC utilize available resources well?  Is there support and commitment from the institutional authorities?  

Review Criterion for Applications Seeking Competitive Renewal: 

Does the progress report reflect significant accomplishments?  Has any work been published or are publications likely?

Review Criteria for Administrative Unit:

1. Do the proposed MCRC Director, Associate Director and executive committee have the collective expertise and leadership to identify and focus research projects on clinically relevant issues?

2. Is the management proposed appropriate for scientific administration as well as fiscal administration, procurement, property and personnel management, planning, budgeting, etc.? 

3. Is there a plan for establishment and maintenance of internal communication and cooperation among the MCRC investigators, core leaders and executive committee?  Are there plans for outside review and input? 

4. Is there scientific and administrative leadership, commitment and ability, and adequate time commitment of the MCRC Director and Associate Director for the effective management of the MCRC program?

5. Is there documentation of institutional support for the MCRC by the parent institution?

6. Is a plan for data sharing included?

Review Criteria for Methodology Core:

1.  Does the methodology core serve all projects proposed in the Center (mandatory)?  Have issues relating to data and safety monitoring been addressed?  Is there a plan describing teaching services for the research base?

2.  Are the services offered appropriate and of high quality, especially for the projects directly supported?  How is cost reimbursement proposed?

3.  Will the core likely promote multidisciplinary research?  Are unique services offered?  Is there a plan for prioritizing services to the research base?

4.  Are the qualifications of the professional and support personnel appropriate?  Is there a plan for interactive leadership of the methodology core and the proposed projects?

5.  Are the facilities and equipment adequate?  Is there institutional commitment to the core?

Review Criteria for Other Cores:

1.  Will the core have utility to at least two of the MCRC projects?

2.  Are the services of high quality?  Are there procedures for quality control? Is the core cost effective? 

3.  Do the services offered best fit within a core structure?  If this is an add-on to a preexisting core, what is the benefit to the Center over direct purchase of services from the existing core?  If the core offers new services that may be used by non-MCRC projects, how will the non-MCRC projects purchase these services from the core?

4.  Are the personnel appropriate?

5.  Are the facilities and equipment adequate?  Is there institutional commitment to the core?

Review Criteria for Clinical Research Projects:

Significance:  Does this project address an important clinical issue, especially one not well studied?  Is it likely that the research may have a clinically important impact?  Will these studies influence concepts or methods that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the investigator acknowledge potential problem areas and consider alternative tactics? Does the project utilize the multidisciplinary resources of the Center, especially the Methodology Core?  Is a data safety and monitoring plan included, if appropriate?

Innovation: Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (The quality of the idea or the extent to which the research will advance theory or practice should outweigh an emphasis on technical excellence.)

Investigators: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and collaborators?

Environment: Does the scientific environment of the Center contribute to the probability of success? Do the proposed experiments take advantage of unique features of the Center and employ useful collaborative arrangements?

Review Criteria for Development/Feasibility Project (Optional):

Significance:  Will the proposed work likely yield meaningful preliminary data leading to a research proposal?

Approach; Are the experimental approaches adequate?

Innovation; Is the research topic one that promotes innovative research related to the core center?

Investigator; Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator?

Environment; Is the project appropriate to the research base of the core center?  Does one or more of the cores offer needed materials/assistance?  

After the review of the individual components of the application, the application will be assigned an overall priority score.  This score will reflect not only the individual quality of the projects, cores, and administration, but also how the proposed MCRC will bring together all these elements in a workable unit.  The overall score may be higher or lower than the average of the descriptors based on the assessment of whether the whole is greater than the sum of its parts.  The overall priority score will reflect:

1. The scientific excellence of the Center's research base as well as the relevance and interrelationship of these separately funded research projects to the goals of the Center and the likelihood for meaningful collaboration among Center investigators.  The application must convey how the proposed Center will enhance significantly the established research base of the host institution. (In a competing continuation application, the application should document the impact of the Center.  This includes the qualifications, experience, and commitment of the Center investigators and their willingness to interact with each other.)

2.  The overall environment for a Center.  This includes the institutional commitment to the program, including lines of accountability regarding management of the Center, the institution's partnership with the Center, and the institutional commitment to individuals responsible for conducting essential Center functions. This also includes the academic environment and resources in which the activities will be conducted, e.g., the availability of space, equipment, facilities, and the potential for interaction with scientists from other departments and schools.

3.  The overall priority score assigned to the application will also reflect how well the policies regarding (a) the inclusion of women, minorities and children in study populations, (b) the protection of human subjects from research risks, (c) sharing research data have been addressed.

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).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions 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. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.

All applications are expected to address data sharing. This discussion is to be included in the Administrative Core.

Program staff will be responsible for the administrative review of the plan for sharing research data.

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

N/A

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.

The carryover of an unobligated balance into the next budget period requires Grants Management Officer prior approval.

The grant is excluded from Streamlined Non-competing Award Procedures (SNAP). 

The rebudgeting of funds into or out of the Administrative Core requires Grants Management Officer prior approval.

Rebudgeting of funds within or into the Administrative Core to increase the overall level of support staff above 1.0 FTE requires Grants Management Officer prior approval.

Rebudgeting of funds into or out of the Exploratory and Feasibility Project requires Grants Management Officer prior approval.

Rebudgeting of funds into or out of the Methodology Core requires Grants Management Officer prior approval.

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:

Madeline Turkeltaub, CRNP, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Democracy 1
6701 Democracy Boulevard, Suite 800
Bethesda , MD 20892
Telephone: (301) 594-2463
FAX: (301) 480-4543
Email: mturkeltaub@mail.nih.gov

2. Peer Review Contacts:

Yan Wang, M.D., Ph.D.
Chief, Review Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Democracy 1
6701 Democracy Boulevard, Suite 800
Bethesda, MD 20892
Telephone: (301) 594-4952
FAX: (301)402-2406
Email: wangy1@mail.nih.gov

3. Financial or Grants Management Contacts:

Steve Austin
Grants Management Specialist
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6701 Democracy Boulevard, Suite 800
Bethesda, MD 20892
Telephone: (301) 594-3504
FAX: (301) 480-5450
Email: austins2@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); 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.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

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 RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

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

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

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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