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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov)

Title: Pelvic Floor Disorders Network Data Coordinating Center (U01)

Announcement Type
This is a reissue of RFA-HD-05-019.

Related Announcements

• July 31, 2015 - This RFA has been reissued as RFA-HD-16-011.

Request For Applications (RFA) Number: RFA-HD-10-024

Catalog of Federal Domestic Assistance Number(s)
93.865

Key Dates
Release Date: April 9, 2010
Letters of Intent Receipt Date: June 30, 2010
Application Receipt Date: July 30, 2010
Peer Review Date(s): October/November 2010
Council Review Date: January 2011
Earliest Anticipated Start Date: April 1, 2011
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: July 31, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• Purpose. This FOA issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development solicits grant applications from institutions/organizations willing to participate with the NICHD as the Data Coordinating Center in an ongoing multi-center clinical program designed to study clinical and health aspects of pelvic floor disorders in women. Pelvic floor disorders for the purpose of this FOA include urinary incontinence, fecal incontinence, pelvic organ prolapse, and other sensory and emptying abnormalities of the lower urinary and gastrointestinal tracts. Clinical and health aspects of pelvic floor disorders include surgical and nonsurgical treatments, social and behavioral contributions, pharmacologic therapies, any outcomes from the broad array of treatments available, and prevention efforts, among others. Particular attention will be paid to develop innovative solutions to the challenging problems in women with pelvic floor disorders and to reduce the burden of pelvic floor disorders for women and their families.
• Mechanism of Support. This FOA will utilize the NIH Cooperative Research Project (U01) award mechanism and runs in parallel with a FOA of identical scientific scope, RFA-HD-10-002, that solicits applications under the NIH Cooperative Clinical Research (U10).
• Funds Available and Anticipated Number of Awards. The NICHD intends to commit approximately $4.09 million in total costs in fiscal year 2011 to fund one new or competing continuation grant for the Data Coordinating Center in response to this FOA.
• Budget and Project Period. An applicant for the Data Coordinating Center may request a project period of up to 5 years and a budget of $4.09 million in total costs [direct costs plus Facilities and Administrative (F&A) costs] per year. As part of the total cost amount, the proposed budget should include $1.8 million per year in the patient care category for the distribution of per-protocol costs to the Clinical Sites for protocols approved by the Steering Committee.
• Application Research Strategy Length: The U01 Research Strategy section may not exceed 12 pages, including tables, graphs, figures, diagrams, and charts. See Table of Page Limits. Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
• Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization 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.
• Number of Applications. Applicants may submit more than one application, provided they are scientifically distinct. An applicant may apply for both a Clinical Site and the 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).
• Resubmissions. Resubmission applications are not permitted in response to this FOA.
• Renewals. Renewal applications are permitted in response to this FOA.
• Special Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates
• Application Materials. See Section IV.1 for application materials.
  Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: (301) 451-5936.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
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. Dispute Resolution 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

Purpose

This FOA issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development solicits grant applications from institutions/organizations willing to participate with the NICHD as the Data Coordinating Center in an ongoing multi-center clinical program designed to study clinical and health aspects of pelvic floor disorders in women. Pelvic floor disorders for the purpose of this FOA include urinary incontinence, fecal incontinence, pelvic organ prolapse, and other sensory and emptying abnormalities of the lower urinary and gastrointestinal tracts. Clinical and health aspects of pelvic floor disorders include surgical and nonsurgical treatments, social and behavioral contributions, pharmacologic therapies, any outcomes from the broad array of treatments available, and prevention efforts, among others. Particular attention will be paid to develop innovative solutions to the challenging problems in women with pelvic floor disorders and to reduce the burden of pelvic floor disorders for women and their families. The objective of this program is to facilitate resolution of these problems by establishing a network of academic centers that can study the required numbers of patients under rigorous common protocols and then provide answers more rapidly than individual centers acting alone.

Background

Within the mission of NICHD, as part of the topic of reproductive health, the Contraception and Reproductive Health Branch of the Center for Population Research, NICHD, supports research on pelvic floor disorders which affect the reproductive system and other pelvic organs. Pelvic floor disorders affect almost one-quarter of women between ages 20-80 according to the National Health and Nutrition Examination Survey. The most common condition is urinary incontinence, followed by fecal incontinence and then pelvic organ prolapse. According to a recent NIH State-of-the Science Conference on Prevention of Fecal and Urinary Incontinence in Adults (December, 2007), consequences of urinary and fecal incontinence extend beyond physical manifestations. Individuals can withdraw from their social lives and hide the condition from families, friends, and even their physicians. The conference summary also states that these conditions are more common in women and increase with age. With the aging U.S. population, the number of women with pelvic floor disorders is expected to increase substantially in the future.

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 techniques have had a dramatic influence on surgical practice and in some cases, use has dropped off or switched to a newer replacement after experience has failed to support their usefulness or has shown unexpected consequences. Regional and international dissimilarity in surgical practice without good evidence for differennces has also complicated the development of treatment guidelines. A range of treatments, both surgical and non-surgical, exists for these conditions. As an example of surgical treatment outcomes, 11 percent of women will undergo surgery for urinary incontinence or pelvic organ prolapse during their lifetime, and 30 percent of those having surgery will undergo at least 2 surgical procedures to try and correct the problem. Treatment data for fecal incontinence is scarce and incomplete as fecal incontinence is often not identified due to social stigma and therapies have not in general been studied. Thus, although the national cost burden related to pelvic floor disorders is large in terms of direct health care costs, lost productivity, and decreased quality of life, treatments are not supported by good quality evidence. Additionally, failure rates, complications, and lack of data on cost-effective therapies contribute to the financial burden.

The scientific knowledge to be achieved through research supported by the Pelvic Floor Disorders Network will include accumulation of good quality evidence to inform specific rather than empiric methods for prevention, diagnosis, and treatment of pelvic floor disorders. This knowledge will be obtained by incorporating research on standard treatments as well as testing new therapies and approaches to move the research agenda forward in novel directions. Particular attention will be paid to develop innovative solutions to the challenging problems in women with pelvic floor disorders and to reduce the burden of pelvic floors disorders for women and their families.

The infrastructure is set up for the ideal randomized double-blinded placebo controlled trial with the ability to follow both short term and long term outcome measures. 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, to identify research topics of high priority and to design and implement protocols appropriate to the evaluation, diagnosis, prevention, and management of pelvic floor disorders. It is anticipated that 7-9 Clinical Sites will be involved in the program, along with one Data Coordinating Center.

The Data Coordinating Center plays a pivotal role in data management and analysis, statistical expertise, and logistical services required for the Pelvic Floor Disorders Network. In support of the Network activities, the Data Coordinating Center will collaborate in the development, implementation, and monitoring of Network protocols; provide data management and transmission, including preparation of data and safety reports for the Data Safety Monitoring Board, Network committees, public data files, and manuscripts for publication; collaborate in the analysis of data and publication of results of Network studies; provide services for acquisition of study drugs and placebos and other equipment and supplies, and storage, transport and analysis of collected body fluids; and provide logistical support necessary to run an efficient and productive Network. The awardee is expected to collaborate with the Clinical Site Investigators, the NICHD Program Scientist and other participating NICHD staff, in the design and conduct of protocols, analysis of data, and reporting results from the Network research.

The objectives of this research program are to design and carry out high quality studies to benefit women with pelvic floor disorders. The NICHD established the Pelvic Floor Disorders Network (PFDN) in 2001 to support a multicenter network to respond to the need for high quality clinical trials in this area. Seven Clinical Sites and a Data Coordinating Center were selected for the first 5 year cycle. The Steering Committee, consisting of representatives from each Clinical Site, the Data Coordinating Center, the NICHD Program Scientist, and a Chairperson, evaluated several areas for investigation. Some of the studies initiated in the first cycle were: 1) a randomized trial on the risks and benefits of adding Burch colposuspension to abdominal sacral colpoplexy for prevention of stress incontinence in women with prolapse but without baseline stress incontinence symptoms; 2) a cohort study of 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; 3) a cohort study of colpocleisis; 4) development and validation of an instrument to assess the use of adaptive behaviors in women with pelvic floor disorders. In the second 5 year cycle of the PFDN (2006-2011), the following studies were initiated by the time of the preparation of this FOA: 1) a randomized clinical trial with a patient preference arm to determine whether symptom-specific treatment of incontinence after prolapse surgery is equally effective to prophylaxis by adding Tension-free Vaginal Tape mid-urethral sling at the time of prolapse surgery, and 2) a randomized clinical trial to compare 2 year surgical outcomes between sacrospinous ligament fixation and uterosacral vaginal vault ligament suspension which incorporates a 2x2 factorial design to also study the role of perioperative behavioral therapy/pelvic muscle training in women undergoing vaginal surgery for apical or uterine prolapse and stress urinary incontinence. In addition, upcoming studies expected to be initiated by the end of this grant cycle could include: 1) a randomized clinical trial to compare the prevalence of fecal incontinence in women who have sustained an obstetric sphincter laceration who receive either usual care or a behavioral intervention; and 2) a double-blind randomized trial comparing the change in urge incontinence episodes between women receiving intra-detrusor botulinum toxin A and anticholinergic therapy. These and other studies may be continuing or enrolling subjects at the initiation of the next award period beginning July 2011. Clinical Sites that join the PFDN may participate in the protocols ongoing at that time.

The NICHD intends to enable the PFDN 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. A Data Safety and Monitoring Board reviews all protocols before initiation and also advises NICHD on research design issues, data quality and analysis, and ethical and human subject protection matters. In this way, the PFDN can identify issues with a high degree of objectivity, develop well-designed protocols, and with the large patient base, provide quality information on tests and treatments more rapidly and with greater accuracy than would otherwise be possible for an individual center.

Scope

There are many controversies in clinical medicine, and the field of pelvic floor disorders is not immune. The scope of research of this FOA includes clinical problems in urinary incontinence, fecal incontinence, and pelvic organ prolapse. Randomized trials are the preferred approach although other experimental approaches can be considered, especially to address development and assessment of quality of life instruments and measures. In all cases, good use of the multicenter capabilities and collaborative process is paramount.

The funded Data Coordinating Center will have the primary responsibility of supporting the research endeavors of the Network in collaboration with the Steering Committee. The NICHD expects 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 collaboratively by the Steering Committee with advice from the Advisory Board.

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 and children compared to women, participation in the clinical protocols planned under this initiative are restricted to adult women.

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

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the NIH Cooperative Research Project (U01) award mechanism(s).
The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

2. Funds Available

The NICHD intends to commit approximately $4.09 million in total costs in fiscal year 2011 to fund one new or competing continuation grant for the Data Coordinating Center in response to this FOA. An applicant for the Data Coordinating Center may request a project period of up to 5 years and a budget of up to $4.09 million in total costs [direct costs plus Facilities and Administrative (F&A) costs] per year. As part of the total cost amount, the proposed budget should include $1.8 million per year in the patient care category for the distribution of per-protocol costs to the Clinical Sites for protocols approved by the Steering Committee. Future year amounts will depend on annual appropriations.

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.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education
• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• For-Profit Organizations (Other than Small Businesses)
• State Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribally Designated Organizations
• County Governments
• City or Township Governments
• Special District Governments
• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• U.S. Territory or Possession
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Regional Organizations
• Eligible Agencies of the Federal Government
• Faith-based or Community-based Organizations

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her 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 program support.

The Principal Investigator for the Data Coordinating Center must have senior leadership experience with multicenter randomized clinical trials, biostatistics, data management, data transmission, data analysis, and project management and have familiarity with the supportive role of a data coordinating center.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided they are scientifically distinct. An applicant may apply for both a Clinical Site and the 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).

Resubmissions. Resubmission applications are not permitted in response to this FOA.

Renewals. Renewal applications are permitted in response to this FOA.

Section IV. Application and Submission Information

1. Address to Request Application Information

The current PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the PHS 398 application forms and in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).

Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: June 30, 2010
Application Receipt Date: July 30, 2010
Peer Review Date(s): October/November 2010
Council Review Date: January 2011
Earliest Anticipated Start Date: April 1, 2011

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed research
• Name, address, and telephone number of the Principal Investigator
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Susan F. Meikle, M.D., M.S.P.H.
Program Scientist, Pelvic Floor Disorders Network
Contraception and Reproductive Health Branch, Center for Population Research
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)
6100 Executive Boulevard, Room 8B13C
Bethesda, MD 20892
(Rockville, MD 20852 for courier or non-USPS service)
Telephone: (301) 496-0391
FAX: (301)480-1972
Email: [email protected]

3.B. Sending an Application to the NIH

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

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

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

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

Director, Division of Scientific Review
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 496-1485
Fax: (301) 402-4104

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute. Incomplete and/or non-responsive applications will not be reviewed.

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal 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

Data Coordinating Center for the Pelvic Floor Disorders Network

The NICHD invites applications from qualified investigators. Awardees must agree to the Cooperative Agreement Terms and Conditions of Award in Section VI.2.A under Award Administration Information. The following items must be addressed satisfactorily for an applicant to be eligible as the Data Coordinating Center:

• Evidence of Successful Past Performance: Applicants must provide evidence of research productivity as a data coordinating center in previous or ongoing clinical trials, especially those of a multicenter design in fields of women’s health and/or female pelvic floor disorders. Contributions in key areas of research development and design, data collection and analysis, monitoring of trial progress, and track record of publications should be provided. Applicants must provide evidence of successful performance as a data coordinating center in the past 3 to 5 years.

• Clinical Trials and Statistical Expertise: A Principal Investigator with a doctoral degree in a relevant field such as statistics, biostatistics, epidemiology or other relevant area, is required to commit 60 to 75 percent effort to the Data Coordinating Center activities of the Pelvic Floor Disorders Network. The PI applicant must demonstrate multicenter randomized clinical trials experience and statistical expertise. The active participation of the PI is expected during all phases of a clinical research study and at Steering Committee meetings and conference calls. One individual must be designated as an alternate PI who is able to serve in the absence of the PI. The alternate PI should also have a doctoral degree in a relevant field, have demonstrated clinical trials experience, and should commit at least 15 percent effort to the project.

• Staffing Expertise and Capabilities: Biographical sketches should be submitted for key personnel. Personnel involvement and evidence of multicenter collaboration on recent multicenter randomized clinical trials, should be noted, including publications. The Data Coordinating Center should have flexibility in staffing to meet the changing needs and variation in work effort in the Network. For instance, meeting deadlines, trial startup and completion, and other variables occur that require increases and decreases in staff effort from the Data Coordinating Center. A plan for staffing should describe support for computerized randomization at all times and weekend and evening coverage to address unexpected outcomes.

Multidisciplinary expertise must be available depending on the needs of the protocols in development and can include skilled personnel in qualitative study design and quality of life measures, a clinical safety monitor must be available, expertise in pharmacologic production and placebo development, focus group design and analysis, and others. Evidence of management capability to estimate appropriate and reasonable resources needed for individual projects in the role of Data Coordinating Center of multicenter trials, to manage those resources efficiently, to adjust the assigned resources as the work changes qualitatively and quantitatively changes during the research, to report the resource allocations to NICHD, and to supplement resources with subcontracts with outside organization must be provided.

Research studies on female pelvic floor disorders use both surgical/anatomic findings and quality of life measures as primary outcomes. The Data Coordinating Center should demonstrate that personnel have experience with surgical outcome measures as well as quality of life measures.

The following categories of personnel are needed at a minimum to ensure excellence in the day-to-day activities of the Data Coordinating Center: Principal Investigator, Alternate Principal Investigator, Program Manager, Project Managers and Site Monitors, Administrative Assistant, Statisticians, Programmers, Data processing staff, and Logistics and Support Staff. In order to have adequate attention to a plan for distributing and reporting per- protocol costs, a designated accounting staff member is required.

• Capacity and Ability to Manage Data and Communications: Ability to assist in protocol development with respect to design of protocol and manual of operations, data collection forms, study manuals, data collection systems, electronic technology, and state of the art data entry systems, including distributed data entry and computer generated randomization must be demonstrated in the application. Paper based data collection and randomization should not be used. Prior experience in data quality assurance, including internal form checks as well as other methods is required. The applicant must have experience in developing and maintaining data control and transmission systems. Applicants should provide evidence of data management and program support capabilities by describing their standard operating procedures to include data collection, management, analysis, data security, privacy protections, and quality control. Applicants must include plans for support of electronic mail and communication as well as plans for both public and Clinical Site access to a website representing the Pelvic Floor Disorders Network. Previous experience with FDA policies and procedures for investigational new drug (IND) and investigational device exemption (IDE) is preferred. Knowledge of federal patient privacy and data confidentiality requirements and appropriate experience in ensuring that relevant protections and procedures are in place for all studies must be provided. Timely creation of public use datasets under NIH requirements is necessary.

• Evidence of Reporting Capabilities: Evidence of experience with generation of monthly reports on subject enrollment for multiple concurrent studies, real-time reports on enrollment, reports on clinical center performance, appropriate reports for use by the Data Safety Monitoring Board, the Advisory Board, and other reports as needed should be demonstrated in the application. Documentation and dissemination of minutes for meetings and conference calls is required. The applicant must demonstrate successful experience in assisting clinical investigators in the preparation of manuscripts on multicenter research for publication, including rapid turnaround of abstracts for national and international meetings.

• Logistical and Other support Services: The Data Coordinating Center provides logistical arrangements for support of Steering Committee meetings (2 per year in the Washington DC area and 2 at Clinical Site locations) and conference calls, Data Safety Monitoring Board meetings (1 per year for 7 people) and conference calls, Advisory Board meetings (3 per 5 year cycle for 7 people) and conference calls, and the Steering Committee Chair as well as other selected consultants as needed by the NICHD; the Data and Coordinating Center should be represented on all Network calls. Webinar services for calls may be incorporated. The applicant should expect frequent utilization of email and teleconference support services and supportive tasks for the NICHD in terms of reports and presentations. The applicant must have experience arranging logistical services for multicenter clinical trials, such as assuring appropriately prepared and labeled supplies of study medications for the Clinical Sites. Coordinating sample storage and study drug and/or equipment is required.

Additionally, services for the support of phone calls to collect quality of life instrument data or survey data should be discussed. Data collection calls by the Data Coordinating Center can be reimbursed from per protocol patient funds when approved by the NICHD; however, the charges must be all-inclusive and no personnel or personnel funds from the base budget can overlap with these charges.

• Evidence and Experience of On-site and Off-site Monitoring Ability: The applicant must have experience in organizing and conducting both on-site and off-site monitoring for clinical multicenter research studies. Generation of and attention to data errors, needed edits, and protocol deviations is required. The Data and Coordinating Center needs to ensure that the Network Clinical Sites fully comply with NIH regulatory requirements, including Internal Review Board submissions and queries, Human Subjects Protections, informed consent, reporting of adverse events, human and animal welfare provisions, and FDA requirements as indicated by specific studies.

• Evidence of Technology Transfer, Data Management and Protocol Training Capabilities: The application should demonstrate experience assisting clinical sites in data management and communication activities. Training and technical expertise, as well as experience and resources, must be delineated in the Research Plan. Arrangements for carrying out training sessions for scientific protocols, annual certifications necessary for ongoing studies, and data entry should be described.

• Evidence of Management Capabilities: The applicant for Principal Investigator should delineate his/her skills as a manager for a data coordinating center, including provision of the experience and ability to estimate the appropriateness and reasonableness of resources needed for projects and to manage those resources efficiently during the course of the research. Experience meeting deadlines and subcontracting experience should be described. The applicant should demonstrate the ability to manage and distribute per-protocol funds for the participating Clinical Sites as a per-protocol (fee-for-service per subject) arrangement after the protocol has been approved and the NICHD has released the funds for distribution. An accountant should be on staff to prepare, at a minimum, real-time quarterly spending and projection reports in an approved format for protocol funds for the NICHD Program Official. Additional reporting for per-protocol funds may be required.

• Special Strengths of the Principal Investigator or Institution: Applicants are encouraged to describe special or unique strengths that may be relevant to female pelvic floor disorders research. This can include state-of-the-art data managements systems, which may be shared or made available to develop and expand the scientific productivity of the Pelvic Floor Disorders Network.

• Intent to Participate: There must be a clearly expressed intent to participate in a collaborative manner with the Clinical Sites and the NICHD. The applicant must state the intent to cooperate with the NICHD in all aspects of research as outlined in this FOA.

• Departmental and or Institutional Commitment: The departmental and institutional commitments to participate in the Pelvic Floor Disorders Network 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, data coordination and confidentiality, and equipment as well as general support of the Network’s research should be specified. Institutions with a Clinical and Translational Science Award (CTSA) should provide a letter from the program director that describes the level of support and gives specific examples of that support.

• Budget Preparation: The instructions for budget requests provided with the PHS 398 research grant application form should be followed. Budgets will be reviewed on the basis of the appropriateness for the work proposed. Allowable costs and policies governing the research grants programs of the NIH will prevail. The budget is limited to $4.09 million in total costs [direct costs plus Facilities and Administrative (F&A) costs] per year for 5 years. Budgets for the first project year (FY2011-2012) should include funds for computer equipment, training, and software needed to establish a computer-based distributed data entry system at all Clinical Sites. For all budget years, the applicant should request $1.8 million per year in the patient care category for distribution of per-protocol costs to Clinical Sites supported as part of the Pelvic Floor Disorders Network U10 (RFA-HD-10-002).

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

• Principal Investigator, 60-75 percent effort
• Alternate PI, minimum 15 percent effort
• Program Manager, 100 percent effort
• Project Manager and Site Monitor, 100 percent effort
• Statisticians
• Accountant
• Clinical Safety Monitor
• Programmers/analysts/logistics and support staff
• Costs associated with data entry, management, collection, and analysis, software, and establishing a distributed data entry system
• Supplies and small equipment (itemized and justified)
• Travel for Data Coordinating Center staff and the Data and Safety Monitoring Board, the Advisory Board, and the Steering Committee Chair

In addition to a budget request, the applicant should complete a hypothetical staffing, data collection, data management, and budget plan in the Research Strategy section of the application based on the following: assume two new protocols, both randomized clinical trials, were planned. Assume the two studies will generate data on 500 items for each of 300 subjects during the first year. Assume 9 Clinical Sites will enroll approximately equal numbers for each study and that enrollment is completed in the first year. Using these assumptions, estimate the base costs for professional and support staffing, data managements costs, and other appropriate costs for carrying out these tasks as described in this FOA, limited to 2 pages.

When a Data Coordinating Center 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.

PHS398 Research Plan Sections

All application instructions outlined in the PHS 398 Application Instructions are to be followed, with the following additional requirements:

• Specific Aims is limited to 1 page.
• Research Strategy, including tables, graphs, figures, diagrams, and charts is limited to 12 pages. See Table of Page Limits.

Budget

This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information

1. Criteria

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

2. Review and Selection Process

Review Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NICHD and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

• Undergo a selection process in which only those applications deemed to have the highest scientific and technical merit, generally the top half of applications under review, will be discussed and assigned an impact/priority score.
• Receive a written critique.
• Receive a second level of review by the National Advisory Child Health and Human Development (NACHHD) Council.

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the applicant demonstrate extensive experience leading multicenter randomized clinical trials at a senior scientific level? Do the proposed staff have experience with multicenter randomized clinical trials? Are plans presented for responding to the multidisciplinary support needs of pelvic floor disorder studies?

Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Do the hypothetical staffing plan and budget include innovative strategies for data collection and management?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Does the application reflect state-of-the-art data entry, transfer, quality control, management, and analysis? Is there past experience with high quality timely reporting, preparation of manuscripts and abstracts, and successful protocol training? Is there evidence of excellent support for all types of communications (e.g. email, phone, webinar, travel, in person meeting services)?

Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Are there special strengths of the environment that could contribute in innovative ways to the research network? Is the Departmental and Institutional commitment stated?

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmission Applications. Resubmissions are not allowed for this FOA.

Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations. Foreign applications are not permitted for this FOA.

Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Selection Process

The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by peer review
• Availability of funds
• Relevance of the proposed project to program priorities

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.

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 Notice of Award will be generated via email notification from the awarding component to the grantee 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 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 an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2. A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for:

• Assistance with identification of priority areas for research
• Assist in developing and implementing Network protocols
• Supervision and acquisition of data and transfer to Data Coordinating Center
• Data management and quality control monitoring
• Logistical support for the Network
• Preparation of reports as needed
• Analysis of data and publication of results of the Network trials
• Participate as a voting member of the Steering Committee
• Participate on all protocol and other committees

The Clinical Sites are funded through a separate solicitation as a cooperative agreement (U10). All parties will agree to accept the collaborative nature of the group process and the supportive role of the Data Coordinating Center.

The Pelvic Floor Disorders Network will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

2. A.2. NIH Responsibilities

An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

• Assist with identification of priority areas for research
• Assist in developing and implementing Network protocols
• Assist in the development and review of capitation-based budgets, including the identification of study costs and special institutional needs
• Assist in the review and evaluation of all aspects of the program, including incremental evaluations preceding decisions to move studies forward, in collaboration with the Steering Committee, Advisory Board and Data Safety and Monitoring Board
• Assist in the conduct of trials, including ongoing review of progress, possible redirection of activities to improve performance and cooperation which requires frequent communication with other members of the Steering Committee
• Assist in the analysis of data and publication of results of the Network trials
• Assist in the reporting of results to the community of investigators and health care recipients
• Participate on all protocol and other committees
• Participate as a voting member of the Steering Committee
  

Additionally, 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 Program Official, apart from the Project Scientist, will:

• Carry out continuous review of all activities to ensure that the objectives are being met and that all regulatory, fiscal, and administrative matters are handled according to NIH guidelines.
• Have the option to withhold support to a participating institution if technical performance requirements are not met, such as protocol compliance, enrollment targets, or randomization of subjects.
• Have the option to modify or terminate a study based on advice from the Steering Committee, the Data and Safety Monitoring Board, or the Advisory Board.
• Perform other duties required for normal program stewardship of grants

2.A.3. Collaborative Responsibilities

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

Steering Committee: A Steering Committee will be responsible for protocol development, assisted by advice from the Advisory Board and the Data Safety and Monitoring Board. The Steering Committee will have primary responsibility for the conduct of protocols and the preparation of publications.

The Steering Committee will be composed of all Principal Investigators from the Clinical sites, the Principal Investigator from the Data Coordinating Center, and the NICHD Program Scientist. An outside chairperson who is not participating as a Principal Investigator, selected by the NICHD, will serve as Steering Committee Chair.

Each full member (each Clinical Site, the Data Coordinating Center, the NICHD, and the Steering Committee Chair) will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

Advisory Board: The Advisory Board assists the Steering Committee in the identification and prioritization of topics for research. Members are appointed by the NICHD with input from the Steering Committee and their expertise can include clinical trial design, statistics, epidemiology, obstetrics and gynecology, urology, urogynecology, gastrointestinal disorders, and colorectal surgery. 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 Safety and Monitoring Board: A Data Safety and Monitoring Board will have responsibility of monitoring the safety of ongoing clinical trials and reviewing final protocols before initiation. The Data Safety and Monitoring Board is established by the NICHD and reports to the Director of NICHD. The Data Coordinating Center is the liaison with the Data Safety and Monitoring Board. The Data Safety and Monitoring Board is composed of individuals with expertise in clinical trial design and conduct, statistics, urogynecology, urology, a consumer representative, and ad hoc members when dictated by protocol topics.

In addition, the NICHD Pelvic Floor Disorders Network 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 and are consistent with current NIH policies and procedures.

2.A.4. Dispute Resolution 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 Dispute Resolution. A Dispute Resolution 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 dispute resolution procedure does not alter 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 Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Susan F. Meikle, M.D., M.S.P.H.
Program Scientist, Pelvic Floor Disorders Network
Contraception and Reproductive Health Branch, Center for Population Research
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)
6100 Executive Boulevard, Room 8B13C
Bethesda, MD 20892
(Rockville, MD 20852 for courier or non-USPS service)
Telephone: (301) 496-0391
FAX: (301)480-1972
Email: [email protected]

2. Peer Review Contacts:

Director, Division of Scientific Review
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 496-1485
Fax: (301) 402-4104

3. Financial or Grants Management Contacts:

Bryan S. Clark, MBA
Chief Grants Management Officer
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A01A
Rockville, MD 20852
Telephone: 301-435-6975
Fax: 301-402-0915
Email: [email protected]

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.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

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

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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

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

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

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.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.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

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

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

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