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 Child Health and Human Development (NICHD), (http://www.nichd.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www.niddk.nih.gov/)
Office of Research on Women's Health (ORWH), (http://orwh.od.nih.gov/index.html)

Title: Pelvic Floor Disorders Network

Announcement Type
This announcement for the Pelvic Floor Disorders Network (PFDN) is a reissue of RFA-HD-00-013, released on July 13, 2000.

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

Request For Applications (RFA) Number: RFA-HD-05-019

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

Key Dates
Release Date: August 17, 2005
Letters of Intent Receipt Date(s ): November 18, 2005
Application Receipt Dates(s): December 19, 2005
Peer Review Date(s): February/March 2006
Council Review Date(s): June 2006
Earliest Anticipated Start Date: July 1, 2006
Additional Information To Be Available Date (Url Activation Date): September 21, 2005
Expiration Date: December 20, 2005

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, 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

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

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

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

 Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description

1. Research Objectives

The National Institute of Child Health and Human Development (NICHD), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and the Office of Research on Women's Health (ORWH) , invite applications from both from the current Data Coordinating Center of the Pelvic Floor Disorders Network (competing renewal application) and from prospective investigators (new applications) willing to participate under a cooperative agreement in an ongoing multi-center clinical program designed to investigate problems in women with pelvic floor disorders, including pelvic organ prolapse, urinary incontinence, fecal incontinence, and other sensory and emptying abnormalities of the lower urinary and gastrointestinal tracts. The objective of this program is to facilitate study of these problems by establishing a network of academic centers that, by rigorous patient evaluation using common protocols, can study the required number of patients and can provide answers more rapidly than individual centers acting alone.

The infrastructure is set up for the ideal randomized double-blinded placebo-controlled trial with the ability to follow short term and long term outcomes. The infrastructure is also set up for observational studies, particularly those that will inform the development of randomized trials.

The NICHD program staff will assist the Principal Investigators of the Clinical Sites and the Data Coordinating Center, with input from the Advisory Board, in identifying research topics of high priority and in designing and implementing protocols appropriate to the evaluation of optimum diagnosis and management of pelvic floor disorders.

It is anticipated that 6 to 8 Clinical Sites will be involved in the program, along with the Data Coordinating Center.

Background

Within the mission of NICHD, as part of the broad topic of reproductive health, priority has been given to research on pelvic floor disorders in women. To this end, the Contraception and Reproductive Health Branch (CRHB) of the Center for Population Research (CPR), NICHD, supports research on pelvic floor disorders affecting the reproductive system and other pelvic organs.

The term "pelvic floor disorders" refers to a group of clinical conditions that includes pelvic organ prolapse, urinary incontinence, fecal incontinence, and other sensory and emptying abnormalities of the lower urinary and gastrointestinal tracts. It is estimated that one or more of these conditions affects at least one-third of adult women. Eleven percent of women will undergo surgery for urinary incontinence or pelvic organ prolapse during their lifetime, and 30 percent of those having surgery will have at least 2 surgical procedures to try to correct the problem. With the steady increase in the population of older women, the national cost burden related to pelvic floor disorders is huge in terms of direct health care costs, lost productivity, and decreased quality of life.

In many cases, clinicians caring for women with pelvic floor disorders have adopted principles of care and surgical techniques before rigorous, objective, controlled evaluation has taken place. New devices and materials have had a particularly dramatic influence on surgical practice, with the rapid availability of different techniques, adjunct materials, and devices that have been enthusiastically adopted. However, in some cases, this has been followed by their modification or replacement, after experience has failed to support their usefulness or has shown unexpected consequences or adverse events. Regional differences in surgical practice have also complicated the field.

In an attempt to respond to the need for well-designed clinical trials in pelvic floor disorders, NICHD established the Pelvic Floor Disorders Network in 2001. Seven Clinical Sites and the Data Coordinating Center were selected from respondents to an earlier RFA. The Network Steering Committee, which consists of representatives from each Clinical Site and the Data Coordinating Center, NICHD program staff, and a chairman, evaluated several areas for study. It then selected priority areas to develop randomized trials when possible and observational studies when necessary to provide data needed to design subsequent randomized trials. Completed and ongoing studies include: (1) a randomized trial on the risks and benefits of adding Burch colposuspension to abdominal sacral colpopexy for prevention of stress incontinence in women with prolapse without baseline stress incontinence symptoms; (2) the prevalence and incidence of pelvic floor symptoms in postpartum women after vaginal delivery with and without anal sphincter laceration compared to cesarean delivery without labor, with pelvic MRI and endoanal ultrasound performed in a subset of those postpartum women to correlate imaging with symptoms; (3) cohort study of colpocleisis with various strategies to treat or prevent postoperative urinary incontinence; and others. A Data and Safety Monitoring Board advises NICHD on research design issues, data quality and analysis (including interim results for stopping trials), and ethical and human subject concerns. An Advisory Board reviews scientific protocols during development, and advises the Steering Committee on topics of public health importance that can be optimally studied in a multicenter Network.

This RFA solicits applications for the second cycle of the Pelvic Floor Disorders Network (2006-2011). Previous NIH workshops and literature reviews have identified deficiencies in the current knowledge base regarding pelvic floor disorders for clinicians trying to practice evidence-based medicine. Little evidence exists to support different practices in the management of pelvic floor disorders, particularly surgery. The validity of conclusions from currently available surgical trials is limited by lack of standardization in defining conditions and reporting outcomes, small sample sizes, mostly retrospective study designs, and high rates of loss to follow-up. There is no consensus as to the threshold for intervention, and the rationale for selection of treatment for particular clinical conditions has not been established.

In December 1999, NICHD and other NIH institutes sponsored a Workshop on Terminology for Researchers in Female Pelvic Floor Disorders. During this workshop, recommendations were made for standardization of terminology regarding definitions of the conditions included under the general term "pelvic floor disorders," for definitions of outcomes after intervention, and for minimum data set collection for research studies. All NIH grant applications related to pelvic floor disorders are required to use these standard terms. Interested applicants should obtain a copy of the proceedings of the Terminology Workshop from their local medical library (Int Urogyn J 2001; 12: 178-86).

Use of the cooperative agreement mechanism for this initiative has many advantages. The NICHD staff participant will contribute scientifically to consensus decision-making and to maintaining balance among the participants. Expert statistical consultation in experimental design and analysis is provided by the PI and co-investigators from the Data Coordinating Center during protocol development and data analysis. The Advisory Board provides input on specific protocols as well as the broader objectives of the PFDN. In this way, the research group can identify issues with a high degree of objectivity, develop well-designed protocols, and provide a large patient base, so that tests and treatments can be evaluated more rapidly and with greater statistical validity than would be otherwise possible for individual centers.

Efficiency of communication among investigators and prompt dissemination of information to clinicians and the public leads to more economical use of resources and more effective patient care.

Scope

There are many controversies in the field of pelvic floor disorders that lend themselves to cooperative study. While other study designs will be considered as appropriate to the research question, randomized trials are the preferred approach. The scope includes clinical problems in pelvic organ prolapse, urinary incontinence, and fecal incontinence. The following should by no means be viewed as exhaustive, and are intended only as broad examples of research topics relevant to this RFA:

Because the prevalence of pelvic floor disorders is substantially greater in women than in men or children, and because treatment of pelvic floor disorders is markedly different in men or children compared to women, participation in the clinical protocols planned under this initiative are restricted to adult women.

Since this list is not meant to be all-inclusive, prospective applicants are encouraged to discuss their ideas for applications with the program staff listed under Section VII. Agency Contacts.

The NICHD expects that ongoing clinical studies will continue into the continuation grant period for existing Clinical Sites. New protocols may be implemented before the start of continuation. Centers that join the Network in the next award period (beginning July 1, 2006) will participate in protocols ongoing at that time. The NICHD intends to enable the Network to initiate new protocols within the first year of the next award period. The topics of these protocols will be decided cooperatively by the Steering Committee with advice from the Advisory Board.

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 Cooperative Clinical Research (U10) award mechanism f or the Clinical Sites and the NIH Cooperative Research Project (U01) award mechanism for the Data Coordinating Center.

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 ( U10 and 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

The participating IC(s) NICHD, NIDDK, and ORWH intend to commit approximately $ 3.4 million in FY 2006 to fund six to eight new and/or competing continuation grants in response to this RFA for Clinical Sites, in addition to 1 new or competing continuation grant for the Data Coordinating Center (DCC). An applicant for a Clinical Site may request a project period of up to 5 years and a budget for direct costs associated with base costs up to $125,000 per year. An applicant for the DCC may request a project period of up to 5 years and a budget for direct costs up to $850,000 per year; in addition, the DCC should request not more than $1,000,000 total costs per year in the patient care category for distribution of per-protocol costs to the Clinical Sites for approved protocols.

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 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.

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:

The need for continuous and active communication among sites dictates that only institutions in the United States are eligible to apply.

An institution may apply for both a Clinical Site and the Data Coordinating Center (DCC) grant; however, separate applications with different Principal Investigators are required for each, and the DCC application must include a specific plan for maintaining the independent operation of each unit (e.g., confidentiality of study-wide data).

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 programs.

The Principal Investigator for a Clinical Site must be a practicing clinical urogynecologist in the field of female pelvic floor disorders.

The Principal Investigator for the Data Coordinating Center must have appropriate expertise and capability in biostatistics, data management, data analysis, and project management.

2. Cost Sharing or Matching
Not applicable

3. Other-Special Eligibility Criteria
Not applicable

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 Dun & Bradstreet (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): November 18, 2005
Application Receipt Dates(s): December 19, 2005
Peer Review Date(s): February/March 2006
Council Review Date(s): June 2006
Earliest Anticipated Start Date: July 1, 2006

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:

Anne M. Weber, MD, MS
Contraception and Reproductive Health Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B-13C
Bethesda, MD 20892-7510
(Rockville, MD 20852 for express/courier service, non-US Postal Service)
Telephone: 301-496-4924
FAX: 301-480-1970
Email: webera@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:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7501
Bethesda, MD 20892-7510
Rockville, MD 20852 for express/courier service, non-US Postal Service

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 NICHD. 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.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

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

Scope of Activities: Data Coordinating Center

The following items must be addressed satisfactorily for an applicant to be eligible for consideration as the Network Data Coordinating Center. The Research Plan section of the application should include the following information: (1) Description of relevant capabilities and experience to be used in executing the responsibilities of the Data Coordinating Center; and (2) Concept proposal. The concept proposal is limited to a maximum of 10 pages. Both (1) and (2) must be included within the 25-page limit for the Research Plan as specified in the PHS 398 application instructions.

Minimum Requirements: Data Coordinating Center

Description of Capabilities: Data Coordinating Center

These are examples only of material that may be included in the application to demonstrate the capability of the applicant as a Data Coordinating Center. It is not necessary to address each one; they are suggestions of topical areas to indicate the strength of an applicant.

Concept Proposal: Data Coordinating Center

To provide peer reviewers and the NICHD an idea of the investigators' capabilities, a concept proposal for potential conduct in the Pelvic Floor Disorders Network should be described. The concept proposal should describe one (and only one) study including hypothesis, specific aim(s), background, methods, data analysis (including a consideration of power, sample size, and feasibility), and consideration of potential drawbacks in the study design and how to address them. In addition, the protocol should address relevant ethical issues and the appropriate inclusion of minorities as subjects. The concept proposal is limited to a maximum of 10 pages. The proposed concept will serve as an indicator of the applicant's ability to participate in the development and design of cooperative protocols in the Network. Randomized trials are the preferred study design although other designs will be considered as appropriate to the research question. The concept needs to be appropriate for the PFDN in that it requires a multi-center design. The concept proposal or another study design on the same topic may or may not actually be performed in the Network. It is anticipated that the funded Data Coordinating Center will be invited to submit the concept proposal included in their application to the PFDN Steering Committee.

Clinical Capabilities: Data Coordinating Center

The applicant Data Coordinating Center (DCC) should describe the availability of clinicians for participation in Network activities, such as protocol design, data quality, clinical site monitoring, data analysis, and interpretation of results. Clinical capabilities may be within the applicant institution (as in a university setting) or outside of the applicant institution (as consultants). In either case, it is essential to describe the track record of successful research collaboration between the DCC staff and the clinical staff, and detailed plans for the roles and responsibilities of clinical staff who will be involved in the projected activities of the DCC related to PFDN studies.

Academic Productivity: Data Coordinating Center

Provide evidence of research productivity by the Principal Investigator and the research team that will compose the Data Coordinating Center in previous or ongoing clinical trials of a cooperative or multi-center design. Organizations must have experience in functioning as a statistical coordinating center for multi-center research, including randomized controlled trials and observational studies.

Intent to Participate: Data Coordinating Center

There must be a clearly expressed intent to participate in a cooperative manner with the Clinical Sites of the PFDN and the NICHD in all aspects of research as outlined in this RFA. The application should describe how PFDN research protocols will be prioritized relative to other work being performed at the Data Coordinating Center. The Data Coordinating Center is expected to manage all protocols performed as Network studies.

Departmental and Institutional Commitment: Data Coordinating Center

The departmental and institutional commitments to participate in PFDN research should be clearly documented with letters of support from appropriate individuals. Evidence of past support can also be cited. Support in areas of grants management, personnel management, space allocation, procurement, and equipment as well as general support of the Network's research should be described, along with evidence of past research support.

Clinical Site Applications

The NICHD invites applications both from current members of the Pelvic Floor Disorders Network (competing renewal applications) and from prospective members (new applications).

Scope of Activities: Clinical Site

The following items must be addressed satisfactorily for an applicant to be eligible for consideration as a Network Clinical Site. The Research Plan section of the application should include the following information: (1) Description of relevant capabilities and experience to be used in executing the responsibilities of the Clinical Site; and (2) Concept proposal. The concept proposal is limited to a maximum of 10 pages. Both (1) and (2) must be included within the 25-page limit for the Research Plan as specified in the PHS 398 application instructions.

Minimum Requirements: Clinical Site

Description of Capabilities: Clinical Site

Concept Proposal: Clinical Site

To provide peer reviewers and the NICHD an idea of the investigators' capabilities, a concept proposal for potential conduct in the Pelvic Floor Disorders Network should be described. The concept proposal should describe one (and only one) study including hypothesis, specific aim(s), background, methods, data analysis (including a consideration of power, sample size, and feasibility), and consideration of potential drawbacks in the study design and how to address them. The concept proposal should estimate numbers of patients potentially eligible for the protocol at the applicant's institution. In addition, the protocol should address relevant ethical issues and the appropriate inclusion of minorities as subjects. The concept proposal is limited to a maximum of 10 pages. The proposed concept will serve as an indicator of the applicant's ability to participate in the development and design of cooperative protocols in the Network. Randomized trials are the preferred study design although other designs will be considered as appropriate to the research question. The concept needs to be appropriate for the PFDN in that it requires a multi-center design. The concept proposal or another study design on the same topic may or may not actually be performed in the Network. It is anticipated that funded Clinical Sites will be invited to submit their concept proposals included in their applications to the PFDN Steering Committee.

Clinical Capabilities: Clinical Site

The applicant Clinical Site is expected to have a full range of specialists in female pelvic floor disorders, clinical capabilities, and support staff, including an active full-time research coordinator and additional research staff available to support Network activities.

A detailed description of the clinical attributes of the Clinical Site must be provided. This should include:

Academic Productivity: Clinical Site

Provide evidence of research productivity by the clinical center in previous or ongoing clinical trials, especially those of a cooperative or multi-center design. Contributions in key areas of research development and design, patient recruitment, retention and study completion, data collection and analysis, and track record of publications should be included in the application.

Applicants who are current PFDN Clinical Sites should describe their participation and contribution to the Network in detail including subject enrollment in all studies, involvement in study development and their particular contribution to each study (e.g., Principal Investigator at site, participation on protocol and writing committees), standing committee activities, research presentations, and publications. Participation in research activities outside the Network should also be described.

New applicants must describe their recent experience and participation in randomized clinical trials and other studies, preferably of a multi-center nature. Specific roles (principal investigator, participating site, member of Steering and/or Writing Committees, contribution to study design and development) should be described for each study. Research presentations and publications that resulted from participation in each study should be listed. It is especially important to demonstrate a track record of successful research collaboration across clinical disciplines that provide care for women with pelvic floor disorders. These disciplines may include (but are not limited to): urogynecology, urology, obstetrics and gynecology, gastroenterology, colorectal surgery, physical and occupational therapy, radiology, and geriatrics. It is anticipated that different institutions may have strengths in different departments or divisions; it is not necessary to demonstrate strength or a track record of successful research collaboration in all possible departments, but those that exist should be presented in detail.

Clinician-Investigators in Female Pelvic Floor Disorders: Clinical Site

The Principal Investigator should be a practicing clinical urogynecologist in the field of female pelvic floor disorders. He/She should describe current and planned clinical, research, administrative, and academic commitments. Due to the demands and nature of the PFDN, the identified Principal Investigator should not have extensive departmental duties (e.g., as Department Chairman); rather he/she should be able to devote the required time to the development, implementation, and leadership of PFDN activities.

There must be at least two full-time, academically oriented clinician-investigator specialists in female pelvic floor disorders at each Clinical Site who will receive salary support. At a minimum, this includes the Principal Investigator and at least one other investigator in specialties such as urogynecology, urology, gynecology, colorectal surgery, gastroenterology, geriatrics, radiology, and physical or occupational therapy. The intent is to draw on the strengths unique to that applicant's institution that would serve the PFDN most effectively. The investigators identified must have a successful track record in clinical care and clinical research related to female pelvic floor disorders, with evidence such as:

The time commitment of each funded clinician-investigator would vary depending on the specific Network protocols ongoing at any particular time. However, at a minimum, each funded investigator should make a commitment to attend all Steering Committee meetings and participate on Protocol and Writing Committees as appropriate to the specific protocols and his/her specific area of interest and expertise within female pelvic floor disorders.

In addition, special administrative strengths or experience as well as participation in administrative aspects of clinical research (service on Institutional Review Board, data and safety monitoring board, advisory board for clinical research, clinical research committees, etc.) by clinician-investigators should be highlighted. Level and support for previous or ongoing clinical trials should be described.

Applications from institutions that have a General Clinical Research Center (GCRC) funded by NIH or other funded research centers as resources for conducting the proposed research should provide a letter of agreement that identifies the level of support from the PI or the GCRC program director.

In addition to clinician-investigators who will receive salary support under the Network grant, other clinician-investigators at the applicant institution should be identified who would be available to participate in Network activities on an as-needed basis.

Population Available for Clinical Trials: Clinical Site

In order to provide peer reviewers with the specific populations available for study at the Clinical Site, include information for each year over the 2-year period of 2003-2004 in tabular format. If there have been any significant institutional changes that would affect the estimated number of available patients, provide a detailed explanation (e.g., addition or loss of clinicians). This information should include the number of patients, presented separately for outpatient and inpatient settings, treated for pelvic floor disorders, presented separately for the following conditions: (1) pelvic organ prolapse; (2) urinary incontinence and other relevant lower urinary tract disorders; (3) fecal incontinence and other relevant lower gastrointestinal tract disorders; and (4) other pelvic floor disorders (specify).

Centers that propose to combine institutions or multiple sites must justify the proposed organization and provide a detailed logistical plan for cost-effective and efficient management as a unified Clinical Site. Given the unique challenges that must be overcome to successfully administer a multi-site Clinical Site, the application must include detailed plans for effective coordination of research staff for recruitment, enrollment and follow-up of subjects (including time/distance between the sites) and detailed plans for successful communication between all members of the research team. It is especially important that multi-site Clinical Site applications clearly document their track record of successful research and clinical collaboration. The application should include letters of support from individuals involved, and clear evidence of successful collaboration in research and clinical care. This may include (but is not limited to): joint participation in common research protocols, resulting in scientific presentations and peer-reviewed publications; joint participation in residency and fellowship education between divisions and/or departments; and joint sponsorship of post-graduate courses in pelvic floor disorders.

Research Staff: Clinical Site

A full-time research nurse coordinator must be designated for the coordinator position. Additional research staff should be available, as many protocols are run concurrently with combined requirements that exceed 100% full-time effort (FTE). For each individual named, describe training, experience, qualifications, and previous involvement in multi-center clinical research. Experience in research related to pelvic floor disorders is preferred but not required. In addition, for the research coordinator, describe experience in supervising others and coordinating the efforts of the research team.

Intent to Participate: Clinical Site

There must be a clearly expressed intent to participate in a cooperative manner with the other Clinical Sites of the PFDN, the NICHD, and the Data Coordinating Center in all aspects of research as outlined in this RFA. PFDN research protocols must be given priority at awarded Clinical Sites. Sites are expected to participate in all Network studies (unless applicants describe trials that conflict with ongoing Network studies as part of their application for this RFA).

Departmental and Institutional Commitment: Clinical Site

The departmental and institutional commitments to participate in PFDN research should be clearly documented with letters of support from appropriate individuals. Evidence of past support can also be cited. Support in areas of grants management, personnel management, space allocation, procurement, and equipment as well as general support of the Network's research should be described, along with evidence of past research support.

Acceptance of the Budgetary Mechanism: Clinical Site (see also budget preparation below)

Assurance of cooperation with the policy for capitation of research costs for each individual protocol, in addition to a base budget, should be provided. In addition, the applicant should provide assurance of cooperation with the DCC for appropriate monitoring of enrollment to receive per-protocol funds. The appropriate Federal cost policies and regulations governing NIH grant programs will be applied (see NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).

Budget Preparation: Clinical Site Applicants

The instructions for the budget requests provided with the research grant application (PHS 398) should be followed. F&A costs will be awarded in the same manner as for research project grants. Allowable costs and policies governing the research grants program of the NIH will prevail. In planning the budget section of your application, each Clinical Site applicant should submit the base budget estimate for all years.

The first year budget at the time of application will be limited to a BASE BUDGET with maximum allowances as follows:

Because multidisciplinary collaboration at the investigator level is so critical to the success of the PFDN, base salary support for investigators is provided at a level not to exceed a combined total of 40 percent. The Principal Investigator (PI) must request a minimum of 20 percent effort; it has been our experience that PI effort less than 20 percent is inadequate to meet the needs of the Network for oversight and leadership in Network activities. The PI is responsible for naming at least one other co-investigator and potentially more than one co-investigator, whose combined salary support cannot exceed a total of 20 percent.

Travel estimates should be based on a total of four Steering Committee meetings per year: 2-day meetings (two hotel nights), three held in the Chicago, Illinois area and one in the Washington, DC area for the Principal Investigator, at least one co-investigator, and the research coordinator.

The base budget direct costs are limited to $125,000 for the first year.

Clinical Site applicants should NOT provide a budget for the concept proposal in their application.

When a Clinical Site application has been favorably recommended and is being considered for funding, the applicant will be required to accept protocol budgets for those studies underway in the Network, and participate in the planning of protocol budgets for studies under development in the Network. The protocol budgets will consist of specific protocol-related allowances, capitated per subject enrolled in each study at the applicant Clinical Site. Funding from NICHD at the time of award will consist of the base budget, as described above; the Data Coordinating Center will be responsible for issuing per protocol payments to the Clinical Sites for each study.

Ongoing annual budgets of the PFDN Clinical Sites will be based on individual protocols that will be funded through a capitation system. Each PFDN Clinical Site will be awarded base costs (as listed above) from NICHD, in addition to funding from the Data Coordinating Center that represents per protocol costs, i.e., a flat fee for each subject successfully enrolled and completed for each study. For centers with GCRC funding, applicable capitation funds can be reduced relative to the amount of GCRC support. The Principal Investigator will be required to project subject enrollment for each specific protocol during a specified time frame, although continuation and the level of funding will be based on actual enrollment. The base budgets for future years should be limited to the first year base budget costs, with an annual increment of base salary and travel costs not to exceed 3 percent. Federal agencies shall use the negotiated rates for F&A costs in effect at the time of the initial award throughout each competitive cycle of the project. Award levels for sponsored agreements may not be adjusted in future years as a result of changes in negotiated rates.

Budget Preparation: Data Coordinating Center Applicants

The instructions for the budget requests provided with the research grant application (PHS 398) should be followed. F&A costs will be awarded in the same manner as for research project grants. Allowable costs and policies governing the research grants program of the NIH will prevail.

Since new applicants for the Data Coordinating Center (DCC) will not be aware of detailed Network activities, for the purposes of providing peer reviewers with an example of the applicant's ability to formulate a staffing plan and budget, all DCC applicants (for new and competing continuation grants) should complete a hypothetical staffing plan and budget based on the following information. Assume that two new protocols, including one randomized clinical trial and one observational, descriptive study, were planned but not yet implemented. Assume, for this exercise, that the two studies will generate data on 500 items for each of 300 subjects in the randomized trial, and on 300 items for each of 1000 subjects in the observational study during the first year of the Network. Assume 7 clinical sites will enroll approximately equal numbers of subjects each for both the randomized trial and the observational study and that enrollment is completed in the first year. Using these assumptions, estimate the minimal base costs associated with providing professional and support staffing, and with the preparations necessary to receive and process data from the two studies during the first year, as well as costs associated with distributing and accounting for per-protocol funds to the Clinical Sites for these hypothetical studies.

DCC applicants should NOT provide a budget for the concept proposal in their application.

When a DCC application has been favorably recommended and is being considered for funding, the applicant will be required to complete a budget to support those studies underway and in development in the Network. Therefore, funding levels at the time of award will be negotiated between the grantee institution and the NICHD.

Pre-Application Workshop

An informational pre-application workshop addressing the scientific and administrative issues associated with this initiative will be held on September 16, 2005 in conjunction with the American Urogynecologic Society meeting in Atlanta, Georgia. The purpose of this workshop is to (1) familiarize the potential applicant with established NIH guidelines and criteria for review, (2) discuss the areas of NICHD programmatic emphasis, and (3) facilitate the submission of a well-organized application.

Interested applicants should contact Dr. Anne Weber (see INQUIRIES, below) to request further details. Individuals planning on attending are requested to submit specific questions to Dr. Weber at least one week in advance of the workshop. Attendance of the workshop is not required to submit an application in response to this announcement.

A summary of the workshop will be available online (http://www.nichd.nih.gov/RFA/HD-05-019/Workshop.htm) by September 21, 2005. After the workshop, any additional questions should be directed to Dr. Weber, and the website will be updated accordingly.

Plan for Sharing Research Data

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

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.

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.

Sharing Research Resources

NIH policy requires that grant awardee 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.

Applications recommended by the National Advisory Child Health and Human Development Council (NACHHD) will be considered for award based primarily on scientific and technical merit, as determined by peer review. Program balance, that is, the scope and variety of research strengths to enable a successful collaborative program, will be considered. Final selection of the Clinical Sites for funding may be partly based on the need for diversity including geography and special populations in the study population. Availability of funds will also determine the awards made.

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 NICHD in accordance with the review criteria stated below.

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

The following review criteria will be applied:

Data Coordinating Center (DCC) Applicants

Evaluation of the concept proposal for a randomized interventional trial (preferred) or an observational study for potential implementation in the Pelvic Floor Disorders Network in terms of the quality of proposed hypotheses, specific aim(s), background, methods, data analysis (including a consideration of power, sample size, and feasibility), and consideration of potential drawbacks in the study design and how to address them.

Clinical Site Applicants

Evaluation of the concept proposal for a randomized interventional trial (preferred) or an observational study for potential implementation in the Pelvic Floor Disorders Network in terms of the quality of proposed hypotheses, specific aim(s), background, methods, data analysis (including a consideration of power, sample size, and feasibility), and consideration of potential drawbacks in the study design and how to address them.

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:

Applications will be reviewed based on their ability to meet overall requirements of the RFA and to cooperatively participate as a PFDN Clinical Site or Data Coordinating Center. Review of the concept proposal is one component and is used to demonstrate the applicant's ability to formulate appropriate and timely scientific questions applicable to the Network.

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. Because of the nature of pelvic floor disorders, all protocol recruitment will be restricted to women; most protocols will involve adult women. 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 will be assessed. 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.

2.D. Sharing Research Resources
Not applicable

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 Principal Investigator will also receive a written critique called a Summary Statement.

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 14 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 Notice of Grant Award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

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

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement ( NIH Cooperative Clinical Research [U10] for Clinical Sites; and NIH Cooperative Research Project [U01] for the Data Coordinating Center ), 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 above.

2.A.1. Principal Investigator Rights and Responsibilities

In collaboration with the other awardees and with assistance from the NICHD Project Scientist, the Principal Investigators will have primary responsibility for:

All parties will agree to accept the coordinating role of the group and the participatory and cooperative nature of the group process.

The individual Principal Investigators of each Clinical Site will be required to project subject enrollment for specific protocols during a specified time frame; continuation and level of funding will be based on actual enrollment.

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

NICHD Program Scientist Responsibilities

An NIH Project Scientist will have substantial programmatic involvement, as described below.

The NICHD Program Scientist will provide technical assistance and participate as one voting member of the Steering Committee. Specifically, the NICHD Program Scientist will:

NICHD Project Officer Responsibilities

In addition, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

The NICHD will appoint a Project Officer , apart from the Program Scientist, who will:

2.A.3. Collaborative Responsibilities

The management of the Pelvic Floor Disorders Network includes committees with the following functions:

Steering Committee

The Steering Committee will be the main governing body of the PFDN and will have primary responsibility for developing research protocols by consensus, supervising the conduct of the studies, and reporting results. The Steering Committee will consist of the Principal Investigators (one from each Clinical Site), the Principal Investigator of the DCC, and the NICHD Project Scientist. An outside chairperson, who is not participating as an investigator, may be selected by the NICHD to serve on the Steering Committee; alternatively, the chairperson position may be held by one of the Principal Investigators by consensus of the Steering Committee. Each member of the Steering Committee will have one vote. A member of the NICHD Grants Management Branch advises the Steering Committee on funding matters. Subcommittees will be established by the Steering Committee, as it deems appropriate. The PFDN has established policies and procedures that govern its operations, including publications. These policies and procedures can be amended by the Steering Committee and the NICHD. Awardees will be required to accept and implement the common protocols and procedures approved by the Steering Committee.

Advisory Board

An independent Advisory Board will advise the Steering Committee in identifying and setting priorities for research topics on pelvic floor disorders appropriate for study by the Network. Such topics would be of high public health impact, amenable to rigorous scientific approaches, and clinically feasible. In addition, the Advisory Board will evaluate the overall hypotheses and scope of planned Network protocols, with additional ad hoc scientific and/or clinical experts as needed. The Advisory Board, chosen by the NICHD with the advice of the Steering Committee, will include members with expertise in clinical trial design, biostatistics, epidemiology, obstetrics and gynecology, urology, and urogynecology. Each member of the Advisory Board will have one vote. The Principal Investigator of the Data Coordinating Center and the NICHD Project Scientist will attend Advisory Board meetings as non-voting members.

Data and Safety Monitoring Board

A Data and Safety Monitoring Board (DSMB) will have responsibility for reviewing the safety of ongoing Network studies (including adverse events) and will advise NICHD and the Steering Committee on their conduct. When appropriate, the DSMB will review interim data analyses regarding the potential need to terminate studies, and make recommendations to the Director of NICHD and the Steering Committee. In addition, the DSMB will evaluate planned Network protocols, with additional ad hoc scientific and/or clinical experts as needed, with an emphasis on subject safety. Members of the DSMB will be chosen by the NICHD with the advice of the Steering Committee, and will include one member representing the lay community. Each member of the DSMB will have one vote. The Principal Investigator of the Data Coordinating Center and the NICHD Project Scientist will attend open sessions of DSMB meetings as non-voting members.

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. The three members will include: 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 members of the Arbitration Panel; 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:

Anne M. Weber, MD, MS
Contraception and Reproductive Health Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B-13C
Bethesda, MD 20892-7510
(Rockville, MD 20852 for express/courier service, non-US Postal Service)
Telephone: 301-496-4924
FAX: 301-480-1970
Email: webera@mail.nih.gov

2. Peer Review Contacts:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
(Rockville, MD 20852 for express or courier service, non-United States Postal Service)
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email: stretchr@mail.nih.gov

3. Financial or Grants Management Contacts:

Cecilia Bruce
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A01, MSC 7510
Bethesda, MD 20892-7510
(Rockville, MD 20852 for express or courier service, non-United States Postal Service)
Telephone: (301) 496-1304
FAX: (301) 451-5510
Email: brucec@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.

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://www.nih.gov/about/publicaccess/ and view the Policy or other Resources and Tools including the Authors' Manual (http://www.nih.gov/about/publicaccess/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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to 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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