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 Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www2.niddk.nih.gov)
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov)
Office of Research on Women’s Health (ORWH), (http://orwh.od.nih.gov)

Title: Multi-disciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network (U01)

Announcement Type
New

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

Request For Applications (RFA) Number: RFA-DK-07-003

Catalog of Federal Domestic Assistance Number(s)
93.849, 93.853, 93.865

Key Dates
Release Date:  September 19, 2007
Letters of Intent Receipt Date: December 17, 2007
Application Receipt Date: January 9, 2008
Peer Review Date(s): February-March, 2008
Council Review Date: May 2008
Earliest Anticipated Start Date: July 1, 2008
Additional Information and Updates May Be Found At: http://www2.niddk.nih.gov/Funding/FundingOpportunities/RFA/RFA_FAQ_MAPP_Research_Network
Expiration Date: January 10, 2008

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

Background

Interstitial cystitis/painful bladder syndrome (IC/PBS) and chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) are syndromes defined by the hallmark symptom of chronic pain in the region of the pelvis or urogenital floor. Lower urinary tract (LUT) symptoms such as urinary urgency or frequency also frequently occur in IC/PBS and CP/CPPS patients. The bladder has been suggested as the origin of IC/PBS symptoms, while the prostate gland has traditionally been believed to be the source of CP/CPPS symptoms, though no organ-specific disease has been conclusively identified for either disorder. Diagnosis of IC/PBS and CP/CPPS is based solely on patient symptoms due to the lack of identifiable pathological findings or defined disease phenotypes or markers and each syndrome may in fact represent a group of related conditions with differing etiologies. Based on their similar symptom profile, IC/PBS and CP/CPPS are here collectively termed urologic chronic pelvic pain syndromes (UCPPS) (this terminology is used solely for the purposes of this funding initiative). Despite intense study the underlying etiology and pathophysiology of disease, as well as risk factors for development of disease, remain unclear and no generally effective clinical therapeutics exist for UCPPS patients.

The impact and burden of UCPPS to patients is enormous. UCPPS patients suffer considerable morbidity throughout their lives resulting in a significant decrease in quality of life for both the patient and his/her partner due to the physical and physiological impact. Epidemiological data for UCPPS prevalence varies substantially based on method of collection. Recent studies involving self-reporting suggest an IC/PBS prevalence of 67 to 865 per 100,000 adult women (IC/PBS occurs at an approximately nine times greater rate in women than in men) while studies of physician-diagnosed IC/PBS assess the prevalence as 197 per 100,000 women. Studies involving a medical diagnosis of disease suggest CP/CPPS affects as many as 9% of men, though like with IC/PBS, prevalence estimates vary significantly based on conditions of the study. Overall patient spending in 2000 for the diagnosis and management of IC/PBS and CP/CPPS (along with prostatitis of a know bacterial origin) exclusive of pharmaceuticals was estimated as $66 million and $84 million, respectively.

To address these debilitating and burdensome disorders, the NIDDK has developed and supported a number of clinical and epidemiological studies of UCPPS. These include the Interstitial Cystitis Database Study (ICDB),  the Interstitial Cystitis Clinical Research Network (ICCRN), the Boston Area Community Health (BACH) Survey, the Rand IC Epidemiology (RICE) Study, the Chronic Prostatitis Clinical Research Network (CPCRN), and the Chronic Prostatitis Clinical Data Base.  In addition, the NIDDK has funded many basic research studies focusing on the biology of the bladder and prostate in attempt to better understand the underlying pathological basis of UCPPS. Despite these efforts much remains to be learned regarding the underlying disease etiology; the natural history of disease, such as an understanding of the associated genetics and risk factors for disease development; and the potential association of UCPPS with other chronic pain conditions affecting urologic and non-urologic systems. Importantly, clinical and basic science efforts have to date not yielded generally effective prevention or treatment options for the clinical care of UCPPS patients.

The clinical and basic research studies developed by the NIDDK and the research community have had a traditional focus on the bladder and the prostate as the origins of disease for UCPPS. However, recent epidemiological studies have shown that other conditions that share chronic pain as a major symptom are often associated with UCPPS, including fibromyalgia, irritable bowel syndrome, chronic fatigue syndrome; vulvodynia and migraine headache may also be associated with UCPPS, but the epidemiological evidence for this relationship is currently less compelling. These findings suggest the possibility of a common underlying pathophysiology in chronic pain disorders. However, these intriguing associations and their implications to disease development have not been adequately addressed in studies of UCPPS. In addition, many traditional urologic-focused research efforts addressing UCPPS have not emphasized novel and innovative approaches or incorporated expertise from related fields of investigation. Also, basic, translational, and clinical researchers have had insufficient formal opportunities for collaboration in addressing common goals. It has become apparent that the traditional concepts and strategies driving UCPPS research are in need of significant redirection, including the introduction of new and novel methodologies and the involvement of related disciplines, in order to address the many long standing deficiencies in our understanding of these disorders.

In light of these insights, the NIDDK proposes that the urologic and LUT centered focus of UCPPS (i.e. IC/PBS and CP/CPPS) research should be broadened to a systemic view of disease in which the interplay between the LUT and other physiological systems is stressed.  The NIDDK is emphasizing that studies of UCPPS be expanded to include new and novel methodologies and approaches involving a diversity of urologic and non-urologic clinical, translational, and basic science disciplines. To promote these ideas in the study of UCPPS, the NIDDK is proposing a multi-disciplinary approach to the study of chronic pelvic pain (MAPP). The MAPP Research Network will adopt multi-site, multi-disciplinary, highly collaborative, and new and novel approaches utilizing traditional urologic and non-urologic expertise to address key questions in our understanding of UCPPS. It is anticipated this effort will lead to critical new insights into the underlying basis and risk for UCPPS, as well as the potential associations of UCPPS with co-morbid disorders, which have the potential for translation into future prevention and treatment strategies for patients.  In addition, in a separate but complementary effort, the NIDDK is working to develop new and more comprehensive research definitions/criteria for UCPPS that will adopt the idea of systemic disease.  It is anticipated that these new definitions/criteria will enable MAPP Network researchers and the research community at large to identify more specific and relevant patient profiles for IC/PBS and CP/CPPS.

The goals outlined in this funding initiative were developed in part through input from the 2007 NIDDK Workshop on Advancing Urologic Science and Career Development, the 2007 NIDDK Prostate Basic and Clinical Science Strategic Planning Meeting, the 2006 NIDDK International Symposium: Frontiers in Painful Bladder Syndrome and Interstitial Cystitis, the NIDDK Interstitial Cystitis Basic Science Investigators Group, and a multi-institutional NIH advisory group of chronic pain experts.

MAPP Network Research Group Goals and Objectives

The goals of the MAPP Research Network are to advance our understanding of disease phenotypes; underlying pathophysiology; natural history; and biologic, genetic, and behavioral risk factors for UCPPS (i.e. IC/PBS and CP/CPPS). An important objective of this program is to better understand the biologic and behavioral relationships between UCPPS and related chronic pain syndromes. Related chronic pain syndromes of primary interest are fibromyalgia, irritable bowel syndrome, and chronic fatigue syndrome.  Other chronic pain syndromes such as vulvodynia and migraine headache may be studied if adequate justification is provided. The MAPP Network will undertake multidisciplinary, multi-site, and highly interactive basic, translational, and clinical science research studies that utilize new and novel approaches to investigate questions of significant clinical relevance. All efforts are expected to provide findings useful for designing future clinical studies of disease prevention and/or treatment. The study of UCPPS as systemic disorders (i.e. expanding the study of these disorders beyond the LUT) and the use of human study materials (e.g. biological specimens) will also be important objectives of the program. Through this effort we hope to encourage the involvement of junior faculty and new and experienced investigators in urological sciences and related fields of study. 

Scientific Priorities

The primary scientific focus of the MAPP Research Network is to investigate the fundamental basis of disease pathophysiology and disease predisposition/risk for UCPPS, as well as assess potential relationships between these disorders and other chronic pain syndromes.

To address important and long-standing deficiencies in the understanding of UCPPS, the MAPP Research Network will focus on the following research areas:

Examples of specific areas of investigation include, but are not limited to, physical/anatomical and physiological studies, including the application of new and novel imaging methodologies for identification of abnormal structural or functional characteristics; studies of neurobiology and organ innervation; identification of cellular defects; analyses of immunobiology of the LUT and other relevant systems; identification of disease markers, including biomarkers at the gene/protein and cell level and anatomical markers; cross-sensitization between urologic and/or non-urologic systems in disease development and symptom severity; sex and gender contributions to disease; the relationship between UCPPS and pathogenic disorders, such as lower urinary tract infections and bacterial prostatitis; analyses of UCPPS as a systemic pain disorder through studies of the peripheral and central nervous system.

Examples of specific areas of investigation include, but are not limited to, identification of early-in-life and later-in-life contributors to disease development or reoccurrence; sex and gender contributions to disease; identification of disease biomarkers for prediction, classification, and prognosis of UCPPS; and genetic studies of disease including predisposition to disease development and progression. 

Examples of specific areas of investigation include, but are not limited to, characterization and comparison of the biology of physiological relevant cell types in disease and normal states, including intracellular signaling/signal transduction pathways, receptor biology, membrane dynamics, cell-cell interactions, and cell interactions with the extracellular environment; studies of neurobiology, organ innervation, and pain cross-sensitization between organ systems; analyses of the immunobiology of the LUT and other relevant systems; identification of cell and molecular biomarkers using patient samples (e.g. serum and urine); assessment of the potential involvement of pathogenic bacteria or viruses in disease development; characterization of mammalian model systems for UCPPS that closely mimic the human disease conditions.

The NIDDK is in the process of developing new research definitions for both IC/PBS and CP/CPPS that will reflect the interrelationship of these disorders with other co-morbid conditions. Applicants should not use definitions for any of these disorders but instead refer to the disease name, such as interstitial cystitis/painful bladder syndrome, chronic prostatitis/chronic pelvic pain syndrome, fibromyalgia, etc.  

MAPP Network Structure and Organization

The MAPP Research Network will include up to six Discovery Sites that share a common goal of improving our understanding of the fundamental basis of disease pathophysiology and natural history, including predisposition/risk for UCPPS, as well as assessing potential relationships between these disorders and other chronic pelvic pain syndromes. While the specific scientific interests of each Discovery Site may differ, they all must demonstrate a dedication to the study of IC/PBS and/or CP/CPPS as a central focus. Applicants for Discovery Sites must describe in their applications at least three but no more than five individual research projects, each headed by a Project Leader. Each of the above three major scientific priorities (i.e. UCPPS phenotyping, targeted epidemiology for UCPPS, and the basic science of UCPPS) must be addressed by at least one research project. Research projects beyond the first three (i.e. projects four or five) may focus on any of the three major scientific priorities at the discretion of the applicant. Applicants must propose at least one research project that will require collaboration with multiple Discovery Sites, such as cohort recruitment and collection of patient data or biologic samples. Final common protocols and research designs for multi-site studies will be established upon initiation of the program. Patient data and samples collected in these efforts will be made available for individual Discovery Site studies and multi-site studies.

The MAPP Research Network will include two separate Core Sites that will serve as common resources:

In addition to providing the above outlined functions, Data Coordinating Core and Tissue Analysis and Technology Core funds will be used to support MAPP Research Network Ancillary Projects beginning in the first year. These projects, which will be designed to enhance multi-site scientific collaborative projects at two or more sites, will be developed by the MAPP Research Network Steering Committee and will be reviewed for scientific merit and feasibility by an external Scientific Advisory Committee. Applicants for Core Sites should describe the process for administering the MAPP Research Network Ancillary Projects program, but should not submit ideas for these projects in their applications. Core Site applicants should propose a process for administration of 10-30% of the site’s overall budget for the MAPP Network Ancillary Projects program. Examples of potential Ancillary Projects include, but are not limited to, pilot testing of disease prevention or intervention concepts, analyses of small and very specific patient cohorts, investigations of chronic pain syndromes beyond those of major focus, and young faculty developmental programs.

Discovery Site and Core Site applicants may also budget resources and personnel for a small site-specific Administrative Core in their application. This site-specific Core would provide administrative support for the Discovery Site or Core Site participating institutions, including organization of site-specific meetings and travel, etc. Applicants may also budget resources and personnel for a small site-specific Scientific Core(s) in their application, if sufficient justification for a unique site-specific need is provided. Functions of site-specific Cores should not overlap with the listed functions of the MAPP Research Network Cores.

MAPP Research Group Leadership

Discovery Sites and Core Sites may utilize the Multiple Principal Investigator (i.e. Multi-PI) concept (see NOT-OD-06-036) to establish a collaborative team of two Principal Investigators who will serve as Co-Directors.  If the Multi-PI concept is used, one Co-Director should be a clinical scientist with a proven track record of research and patient recruitment for clinical research studies of IC/PBS and/or CP/CPPS or one of the frequently encountered co-morbid disorders often associated with IC/PBS, such as fibromyalgia, irritable bowel syndrome, and chronic fatigue syndrome; or, with sufficient scientific justification, vulvodynia or migraine headache.  The second Co-Director should be a basic or translational scientist with prior experience in addressing fundamental aspects of relevant disease pathology. If a Discovery or Core Site chooses not to use the Multi-PI concept, the site’s overall Director may be either a basic, translational, or clinical scientist with the above relevant experience.

Each Discovery Site research project is to be led by a Project Leader who must be a basic, translational, or clinical researcher.  Clinical urology expertise, including a proven track record of patient recruitment for UCPPS, must be represented within each Discovery Site either as a Co-Director or leader(s) of one or more individual research projects.

Investigators from diverse fields and those who have not been traditionally involved in studies of urologic chronic pelvic pain, but who have expertise in relevant disciplines, are strongly encouraged to apply as Discovery Site or Core Site Directors and as Project Leaders on individual Discovery Site projects.  It is anticipated that the MAPP Network will catalyze the involvement of junior faculty and new investigators both in urological sciences and in related fields of study. Investigators may not be listed as participants in more than one application.   

Because all relevant expertise may not be present at a single institution, to achieve the goals of the MAPP Network, applicants are strongly encouraged to establish a multi-disciplinary team for a Discovery Site or Core Site through collaborations with research groups outside their own institution. Sites are encouraged to develop a research synergy through involving novel and varied expertise from multiple institutions both domestic and foreign.

Administration and Meetings

A MAPP Research Network Steering Committee will be established and will be composed of Discovery Site and Core Site Directors and a NIDDK Project Scientist. The Steering Committee will meet regularly in-person and by telephone conference calls to develop and implement multi-site MAPP Network study protocols, review progress of individual projects, discuss results, interpret findings, and develop manuscripts for peer reviewed publications. A Chairman for the Steering Committee will be selected by the NIDDK. The Steering Committee will establish an Executive Committee that will be comprised of the Chairman of the Steering Committee, a representative from each Discovery Site and each Core Site, and NIDDK staff. The Executive Committee will make operational decisions for the MAPP Network between Steering Committee meetings by means of telephone conference calls in order to advance the conduct of the studies.

The NIDDK will assist the Steering Committee in the development of multi-site MAPP Network study protocols; will monitor the progress of multi-site projects, as well as individual Discovery Site research studies; will assist investigators in the analysis and interpretation of multi-site MAPP Network projects and individual Discovery Site research studies; will aid in preparation of manuscripts for publication.

The NIDDK will establish a Scientific Advisory Committee (SAC) to monitor MAPP Network research efforts and advise the Institute on the progress of the individual and multi-site studies.  The SAC will be composed of clinical and basic scientists familiar with the study of UCPPS and general chronic pelvic pain, biostatisticians, physicians with clinical expertise in UCPPS. A Data and Safety Monitoring Board (DSMB) will be assembled in the event that any clinical studies are initiated in the MAPP Research Network. Discovery Site and Core Site applicants should not suggest potential participants for these committees in their applications.

Scope of Research Topics

The scope of appropriate research topics that could be undertaken by MAPP Research Network investigators includes, but is not limited to the following:

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 cooperative agreement (U01) award mechanism(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.

The NIH (U01) 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".

2. Funds Available

Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

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:

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.

Discovery Sites and Core Sites may utilize the Multiple Principal Investigator (i.e. Multi-PI) concept (see NOT-OD-06-036) to establish a collaborative team of two Principal Investigators who will serve as Co-Directors.  If the multi-PI concept is used, one Co-Director should be a clinical scientist with a proven track record of research and patient recruitment for clinical research studies of IC/PBS and/or CP/CPPS or one of the frequently encountered co-morbid disorders often associated with IC/PBS, such as fibromyalgia, vulvodynia, irritable bowel syndrome, and chronic fatigue syndrome or, with sufficient justification, vulvodynia or migraine headache. The second Co-Director should be a basic or translational scientist with prior experience in addressing fundamental aspects of relevant disease pathology. If a Discovery or Core Site chooses not to use the Multi-PI concept, the site’s overall Director may be either a clinical, translational, or a basic scientist with the above relevant experience.

Each Discovery Site research project is to be led by a Project Leader who must be a basic, translational, or clinical researcher with relevant experience. A Discovery Site Director may serve as the leader on no more than one individual project. Clinical urology expertise, including a proven track record of patient recruitment for UCPPS, must be represented within each Discovery Site either as a Director or leader(s) of one or more individual research projects.

Investigators from diverse fields and those who have not been traditional involved in studies of urologic chronic pelvic pain, but who bring expertise from relevant disciplines, are highly encouraged to apply as Discovery Site or Core Site Directors and as Project Leaders on individual Discovery Site projects. It is expected that the MAPP Study Network will catalyze the involvement of junior faculty and new investigators both in urological sciences and in related fields of study. Investigators may not be listed as participants in more than one application.   

Because all relevant expertise may not be present at a single institution to achieve the goals of the MAPP Network, applicants are strongly encouraged to establish a multi-disciplinary team for a Discovery Site or Core Site through collaborations with research groups outside their own institution. Sites are encouraged to develop a research synergy through involving novel and varied expertise from multiple institutions both domestic and foreign.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Investigators may not be listed as participants in more than one Discovery Site or Core Site application.

A Discovery Site Director may serve as the leader on no more than one individual project.

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.

Discovery Site and Core Site applicants should use the relevant portions of Section III of the NIDDK Program Project Grant (P01) Guidelines as a guide for formatting their applications.  The Guidelines are found online at: http://www2.niddk.nih.gov/Funding/Grants/GrantReview/P01Guidelines.htm - III.

Relevant sections include:

B.1. Face Page (reference “MAPP Research Network” and indicate if the submission is for a Discovery Site or a Core Site);

B.2. Description, Performance Sites, and Key Personnel;

B.3. Table of Contents;

B.4. Composite Budget (disregarding the specific budget amounts and caps listed in the P01 Guidelines);

C. Biographical Sketches;

D. Current Sources of Support; 

E. Overall Research Plan;  

F. Research Projects (adhering to all listed page and font limitations).

G. Core Units (here detail and justify any small site-specific Administrative Core or Scientific Core(s), if included in application);

H. Checklist.

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

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
Letter of Intent Receipt Date: December 17, 2007
Application Receipt Date: January 9, 2008
Peer Review Date(s): February-March, 2008
Council Review Date: May 2008
Earliest Anticipated Start Date: July 1, 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:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities, NIDDK
6707 Democracy Boulevard, Room 752, MSC 5452
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: (301) 594-8897
FAX: (301) 480-3505
E-mail: FC15Y@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:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities, NIDDK
6707 Democracy Boulevard, Room 752, MSC 5452
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: (301) 594-8897
FAX: (301) 480-3505
E-mail: FC15Y@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 NIDDK. Incomplete and non-responsive applications will not be reviewed.

If the application is not responsive to the RFA, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle.

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/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements

N/A

Plan for Sharing Research Data

The data collected by the investigators in the MAPP Research Network will be shared by all the investigators within the Network during the conduct of the study. The clinical and basic research data collected by the MAPP Research Network will have two components: (1) Data sets from the individual Discovery Sites will be shared within the MAPP Network and will become part of a common data set that will be maintained and analyzed at the DCC (this data will ultimately be transferred to the NIDDK Biorepository after study completion), and (2) The MAPP Research Network will also publish its research results and will share these findings with the scientific community and the general public.

A Data Sharing Plan will be established by the investigators.  This plan will encompass both sharing within the Network and also outside the Network.  Applicants should indicate in their application that they agree to adhere to the Data Sharing Plan as established by the Steering Committee of the MAPP Network.

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/archive/archive/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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 the NIDDK 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.

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? Is the major focus of the proposed study interstitial cystitis /painful bladder syndrome (IC/PBS) and/or chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS)? If successful, would the study provide new and significant insights into the pathophysiology and natural history of IC/PBS and/or CP/CPPS, as well as other related co-morbid conditions in men and women? Does the study have the potential to identify cellular, molecular, physiological, environmental, and/or other factors that could drive development of future clinical prevention and therapeutic interventions? Are studies designed to address questions of important clinical relevance?

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? Is each of the MAPP Research Network’s three major scientific priorities (i.e. UCPPS phenotyping, targeted epidemiology for UCPPS, and the basic science of UCPPS) addressed by at least one research project? If the study contains more than three research projects (i.e. projects four or five) are they focused on the major scientific priorities? Is at least one research project proposed that will require collaboration with multiple Discovery Sites, such as cohort recruitment and collection of patient data or biologic samples?

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? Does the application address the MAPP Network research priorities through novel, multi-disciplinary, and combined basic, translational, and clinical approaches? Does the research design integrate use of the proposed MAPP Network Core resources? Does the proposed scientific plan, if successful, have the potential to significantly increase and enhance our foundation of knowledge of UCPPS and offer insights that can be directly incorporated into the design of clinical efforts and testing of potential therapies to prevent or treat relevant disorders?

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)? Are basic, translational, and clinical expertise, including relevant urological expertise, represented at the Discovery site and its collaborating institutions (if any)? Do the proposed Discovery Site Director(s), project leaders, and other listed investigators have strong research and/or clinical experience and expertise with a track record of important contributions in the area of UCPPS or other relevant fields? Is a strategy in place to integrate investigators from relevant scientific disciplines, including those who may not have been traditionally involved in the study of UCPPS? Does the applicant(s) describe the integration of promising new and junior basic, translational, and clinical science investigators and trainees? Is clinical urology expertise, including a proven track record of patient recruitment for UCPPS, represented within each Discovery Site either as a Director or a leader of one or more individual research projects?

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?

Proposed plan for collaboration: Is there a suitable plan in place for integration, communication, resource and data sharing, and collaboration between individual projects and investigators within a Discovery Site and between the Discovery Site and its collaborating institutions (if any)? Does the Discovery Site have a stated commitment to multi-site integration, communication, sharing, and collaboration with other MAPP Network Discovery Sites and the MAPP Network Cores? How will the basic, translational, and clinical researchers cooperate in conducting Discovery Site scientific efforts? Is there language in the application indicating willingness to share data and resources within the MAPP Research Network and ultimately provide relevant materials to the NIDDK Biorepository?

Additional Criteria for Data Coordination Core: Does the Core contain sufficient and relevant expertise in multi-site study coordination and in data collection, storage, sample, blinding, distribution, quality control; and analysis? Do the Core Director(s) and other personnel have prior experience and a record of success in conducting a similar Core facility in support of multiple projects and/or multiple sites? Is sufficient expertise and experience present for coordination and execution of MAPP Network statistical analyses in support of all multi-Discovery Site research efforts and, in some cases, efforts at individual Discovery Sites? Does the Core have a commitment to integration, communication, resource and data sharing, and collaboration with other MAPP Discovery Sites and the other Core? Is sufficient expertise in place to address potential operational requirements of the MAPP Network, including the coordination of all meetings, agendas, conference calls, tracking of publications, protocol development, website development and maintenance, preparation of reports and analyses for presentation to the MAPP Research Network investigators, development of computerized system for data sharing, and other operational activities? Does the proposed process for administration of the MAPP Network Ancillary Projects program meet the high standards of NIH review?

Additional Criteria for Tissue Analysis and Technology Core: Does the Core contain sufficient and relevant basic, translational, and/or clinical expertise for conducting both the tissue and technological functions of the Core? Do the Core Director(s) and other personnel have prior experience and a record of success in conducting a similar Core facility in support of multiple projects and/or multiple sites? Does the Core have a commitment to integration, communication, resource and data sharing, and collaboration with other MAPP Network Discovery Sites and the other Core? Is sufficient expertise in place to address potential requirements of the MAPP Network, including the coordination of biosample collection, storage, and distribution (e.g. tissue, serum, and urine)? Is sufficient expertise in place to address potential technological requirements of the MAPP Network, including the development of assay platforms (e.g. genomics, proteomics, and tissue-based methods) and other relevant high-throughput technologies and methodologies and corresponding data analysis/interpretation? Does the proposed process for administration of the MAPP Network Ancillary Projects program meet the high standards of NIH review?

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 will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

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

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

3. Anticipated Announcement and Award Dates

Not Applicable.

Section VI. Award Administration Information



1. Award Notices

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.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 administrative and funding instrument used for this program will be the cooperative agreement (U01), 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 Director(s) will have the primary responsibility for overseeing all the projects within their Discovery or Core Site. They are also responsible for ensuring that their Site is adequately represented at all MAPP Network in-person meetings as well as on specified conference calls.

MAPP Network investigators are expected to work collaboratively and cooperatively with all MAPP Research Network Discovery Sites and Core Sites and all sponsoring organizations in this multi-site study. This includes implementation of and adherence to common protocols, as well as assuring quality control of the data collected and its subsequent analysis.

The DCC will perform analyses as outlined in the study protocols, and as suggested by the members of the Steering Committee, as well as propose original analyses to the collaborative group for their consideration. The DCC will prepare periodic reports as requested by the Steering Committee, the NIDDK and the NIDDK-appointed External Advisory Committee(s). The DCC will establish, maintain and provide appropriate oversight to any subcontracts for external data collection, consultants, and other necessary adjuncts to the study.

The NIDDK has established a central Biorepository for the archival and storage of data and biosamples collected in large, multi-site studies funded by NIDDK. The Cores will work with the NIDDK Biorepository to coordinate procedures for eventual coding, shipping, processing, receipt, and storage of study data and samples that are to be maintained in the Repository for future distribution to the scientific community. All samples and data transferred to the NIDDK Biorepository will be under the custodianship of the NIDDK, although the MAPP Network Steering Committee will have proprietary control of and exclusive access to the samples and data for an agreed-upon period of time. 

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

The NIDDK Project Scientist will be a member of the Steering Committee and the Executive Committee and other selected subcommittees of the MAPP Network. The NIDDK Project Scientist will have substantial scientific involvement in assisting the Steering Committee in the development and refinement of MAPP Network study protocols, monitoring the progress of multi-site projects and individual Discovery Site research studies, quality control, interim data analysis, final data analysis and interpretation, preparation of publications, and assisting in coordination and performance monitoring. The NIDDK will appoint an external Scientific Advisory Committee (SAC) and will assemble a Data and Safety Monitoring Board (DSMB), if needed.

Additionally, an NIDDK Extramural program official will be responsible for the administrative and financial aspects of the cooperative agreements. The NIDDK reserves the right to terminate or curtail any study or any individual award in the event of substantial shortfall in data collection or submission, quality control, or other major breach or a study protocol or MAPP Research Network policy and procedure, or substantive changes in a study protocol that are not in keeping with the objectives of the RFA, and/or a human subject ethical issues that may dictate a premature termination.

2.A.3. Collaborative Responsibilities

A MAPP Research Network Steering Committee will be the main governing board of the study. It will be composed of Discovery Site and Core Site Directors and the NIDDK Project Scientist.  The Steering Committee will meet regularly in-person and by telephone conference calls in its role as the primary body responsible for developing and implementing multi-site MAPP Network study protocols, reviewing progress of individual projects, and discussing results and preparing manuscripts for publication and presentation. The Steering Committee will also be responsible for establishing study policies in such areas as access to patient data and specimens, Ancillary Projects, and performance standards. Each member of the Steering Committee will have one vote (NIDDK will have one vote) and all major scientific discussions will be determined by a majority vote of the Steering Committee. Members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee. The Steering Committee will establish an Executive Committee which will make operational decisions for the MAPP Network between Steering Committee meetings.

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:

Chris Mullins, Ph.D.
Director of Basic Cell Biology Programs
Division of Kidney, Urologic and Hematologic Diseases
NIDDK, National Institutes of Health
2 Democracy Plaza, Room 637
6707 Democracy Blvd.
Bethesda, MD 20892-5458
Telehone: (301) 451-4902
FAX: (301) 480-3510
E-Mail: cm419z@nih.gov

Leroy M. Nyberg, Ph.D., M.D.
Director of Urology Programs
Division of Kidney, Urologic and Hematologic Diseases
NIDDK, National Institutes of Health
2 Democracy Plaza, Room 637
6707 Democracy Blvd.
Bethesda, MD 20892-5458
Telephone: (301) 594-7717
FAX: (301) 480-3510
E-Mail: ln10f@nih.gov

Linda L. Porter, Ph.D.
NIH/NINDS
Program Director, Systems and Cognitive Neuroscience  
Neuroscience Center, Roomm 2115
6001 Executive Boulevard
Bethesda,  MD  20892-9525
Phone:  301-496-9964
Fax: 301-402 2060
Email: porterl@mail.ninds.nih.gov

2. Peer Review Contacts:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities, NIDDK
6707 Democracy Boulevard, Room 752, MSC 5452
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: (301) 594-8897
FAX: (301) 480-3505
E-mail: FC15Y@nih.gov

3. Financial or Grants Management Contacts:

Ms. Carey Beckley
Grants Management Branch
Division of Extramural Activities
National Institute of Diabetes, Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Boulevard, Room 725
Bethesda, Maryland  20892-5456
Telephone:  (301) 594-8833
FAX:  (301) 594-9523
E-mail: cb567c@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).

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.

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/archive/archive/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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