Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Office of Research on Women's Health (ORWH)

Funding Opportunity Title

Pelvic Floor Disorders Network Data Coordinating Center (U24)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

Reissue of RFA-HD-10-024

Related Notices
Funding Opportunity Announcement (FOA) Number

RFA-HD-16-011

Companion Funding Opportunity

RFA-HD-16-012, UG1 Clinical Research Cooperative Agreements - Single Project   

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.865, 93.313

Funding Opportunity Purpose

This funding opportunity announcement (FOA) invites applications from institutions/organizations willing to participate with the NICHD as the Data Coordinating Center in an ongoing multicenter 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.  Particular attention will be paid to applicants that develop innovative solutions to the challenging problems in women with pelvic floor disorders and reduce the burden of this condition in women.    

Key Dates
Posted Date

July 31, 2015

Open Date (Earliest Submission Date)

October 10, 2015

Letter of Intent Due Date(s)

October 10, 2015

Application Due Date(s)

November 10, 2015, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March 2016  

Advisory Council Review

May 2016

Earliest Start Date

July  2016

Expiration Date

November 11, 2015

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Purpose

This funding opportunity announcement (FOA) invites applications from institutions/organizations willing to participate with the NICHD as the Data Coordinating Center in an ongoing multicenter 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, and any outcomes from the broad array of treatments available, including prevention efforts, among others.  Maximizing the use of the well-defined study populations in innovative translational aims which could contribute to etiology and pathophysiologic knowledge is also important.  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.

Background

Within the mission of NICHD, as part of the topic of reproductive health, the Gynecologic Health and Disease Branch, 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 (NHANES).  The most common condition is urinary incontinence, followed by fecal incontinence and then pelvic organ prolapse. 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 differences has also complicated the development of treatment guidelines.  High quality clinical outcome treatment data for fecal incontinence in particular 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, many treatments are not supported by good quality evidence.  Additionally, the lack of data on failure rates, complications, and cost-effectiveness therapies contributes to the financial burden and the inability of providers and patients to make well informed treatment decisions.  With the aging U.S. population, the number of women with pelvic floor disorders is expected to increase substantially in the future.

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 program area.  The PFDN objectives continue to focus on a robust research agenda which designs and executes high quality randomized trials and translational studies to benefit women with pelvic floor disorders.  Historically, the PFDN has completed approximately 5 large studies per cycle, depending on available funds. 

Key studies completed by the PFDN in the first cycle (2001-2006) were:  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 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; and 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 conducted: 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; 2) a randomized clinical trial to compare 2 year surgical outcomes between sacrospinous ligament fixation and uterosacral vaginal vault ligament suspension which incorporated 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; 3) 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 4) a double-blind randomized trial comparing the change in urge incontinence episodes between women receiving intra-detrusor Botox A® injections and anticholinergic therapy. 

Currently there are eight awarded PFDN clinical sites in the third cycle (2011-2016).  Enrollment has been completed for 3 studies:  1) a random assignment of Interstim compared to Botox A® injections in the bladder for the treatment of refractory urge urinary incontinence; 2) a randomized trial comparing uterosacral ligament suspension and hysterectomy to hysteropexy with the Uphold® LITE vaginal support system; and 3) randomly assigning participants with mixed urinary incontinence already proceeding with a sling procedure to a standardized behavioral/physical therapy program or to regular follow up care. Ongoing studies at the time of this FOA are 1) a factorial design investigating whether loperamide compared to placebo and/or standardized anal sphincter training with manometry-assisted biofeedback compared to usual care is effective to improve fecal incontinence; and 2) a three arm apical suspension trial for post-hysterectomy vault prolapse using sacral colpopexy, transvaginal mesh and native tissue apical repair.  Additional translational studies in the current cycle have focused on 1) characterization and evaluation of the impact of two different treatment modalities (Interstim® and Botox A®) for refractory urgency urinary incontinence on bladder inflammation and tissue remodeling manifested via biomarkers present in urine; 2) characterization of the urinary microbiome in women with mixed urinary incontinence compared with unaffected controls; 3) a comparison of the baseline proportional levels of butyrate and other metabolites in stool samples of women with fecal incontinence to unaffected age-matched controls; and 4) qualitative work to develop a new patient reported outcome measure for anal incontinence. These studies as well as other studies may be continuing or enrolling patients at the initiation of the next award period beginning the summer of 2016.  The DCC and clinical sites selected to join the PFDN should be prepared to participate in ongoing protocols unless otherwise directed by the Steering Committee.

Research Objectives and Scope

There are many controversies in the field of pelvic floor disorder.  The scope of research of this initiative includes clinical problems in urinary incontinence, fecal incontinence, and pelvic organ prolapse, and other emptying and sensory abnormalities of the lower urinary and gastrointestinal tract.  Randomized trials are the preferred approach although other experimental approaches can be considered, especially those that address development and assessment of quality of life instruments and measures, study translational objective, or inform randomized clinical trials.  In all cases, good clinical practice and use of the collaborative process are paramount. Moreover, opportunities in translational research to explore etiology and pathophysiology could be incorporated to maximize the use of the well-defined clinical study populations.

Applicants for the DCC should be familiar with RFA-HD-16-012 announcing the recompetition of the Pelvic Floor Disorders Network Clinical Sites to learn more about the scope, structure, and functions of the PFDN.

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 as well as the NICHD Program Scientist and other participating NICHD and NIH staff in the design and conduct of protocols, analysis of data, and reporting results from the Network research activities.

The NICHD intends to enable the PFDN to initiate new protocols within the first year of the next award period in addition to completion of protocols not completed at the end of the current cycle.  The topics of these new 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 research questions 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 clinical research center.

The functions of the DCC will include developing protocol data management aspects, devising novel comparative study designs, providing sample size calculations and statistical advice, developing data forms and protocol tools, performing data analyses, administering scientific protocol funds for sites, coordinating and providing logistical support for the activities and meetings of the Steering Committee (four times a year) and interim conference calls or webinars 3-4 times per year, Data and Safety Monitoring Board (3-4 conference calls or webinars per year and an annual in person meeting), Advisory Board (3-4 conference calls or webinars per year and one biennial meeting) and overall study coordination and quality assurance. 

While the DCC is not required to have offices in the Washington, DC area, applications without such a resource should provide detailed documentation of how logistical support for the PFDN and its activities will be provided without an office in the Washington, DC area.  Because of the nature of the Network, it is anticipated that a minimum PD/PI time commitment of 50% (6.0 person months) will be needed. 

The Data Coordinating Center will provide support in the following areas:

  • Provide expertise in the design, conduct, data analyses, and data management of collaborative clinical and descriptive research projects.
  • Coordinate multisite IRB submissions and documentation of approvals of PFDN studies.
  • Use informatics and electronic data technologies to design and produce data collection systems; modify and re-design such systems as appropriate for new study protocols.
  • Provide appropriate and capable leadership and expertise in biostatistics, developmental study design, data management, data analysis and project management.  These activities should include, but are not limited to, staff and site training and quality assurance procedures.
  • Provide research support activities in designing data collection modules, operational procedure manuals, quality control systems, and an internet-based communications system for Clinical Site PD/PIs, Research Coordinators, and other Network staff.
  • Manage and distribute patient and protocol funds to participating Clinical Sites on a per protocol capitation basis. The proposed DCC should utilize an automated invoicing system for capitation reimbursements.
  • Provide meeting and conference support for the activities of the Steering Committee, Advisory Board and DSMB through provision of materials and documentation, meeting planning and logistics, and conference call coordination.  Maintain a website to keep materials available continuous and up-to-date both for investigators and NICHD.
  • Organize and conduct multi-site monitoring activities in conjunction with the NICHD Project Scientist.
  • Provide regular reports to NICHD on enrollment, diversity, and the allocation of resources.
  • Respond appropriately to changing work needs, Network prioritization and re-prioritization, and changes in staffing.
  • Provide administrative and scientific assistance in the preparation of manuscripts for publication to the Steering Committee of the PFDN, under the supervision of the NICHD Project Scientist.
  • Provide exploration, technical expertise and management of novel resources to enhance network research.  Examples might include (but are not limited to) establishment of a PFDN biorepository, if feasible within present resources.
  • Prepare and provide publicly utilizable data sets in accordance with NIH data sharing and open access policies.
  • Establish a process for preparing and managing Investigational New Drugs (IND) and Investigational Device Exemption (IDE) reports and other regulatory requirements, such as adverse event reporting.
  • Provide arrangements for data collection and reimbursement of study-related data collection costs at non-Network sites participating in Network studies.

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. 

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New
Renewal

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NICHD and partner components intend to commit an estimated total of $3.55 million in fiscal year 2016 to fund one award.

Award Budget

Applicants may request a budget of up to $1.60 million in direct costs per year for the DCC, excluding capitation expenses.  In addition, a minimum of $1.15 million per year in direct costs must be requested for capitation expenses for distribution to the Clinical Sites.

Award Project Period

An applicant for the DCC may request a project period of five years. 

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
Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or 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
    • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • 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

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her 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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

The PD(s)/PI(s) must possess a doctoral degree in a relevant field such as statistics, biostatistics, or epidemiology and is required to commit at least 6.0 person-months (50 percent) effort to the DCC activities of the NICHD PFDN. The PD/PI must have expertise with clinical trials. Active participation of the PD/PI is expected during all phases of a clinical research study.

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).
Section IV. Application and Submission Information
1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

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.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Lisa Halvorson, MD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-480-1646
Email: lisa.halvorson@nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed. 

Management capability and multidisciplinary expertise must be available depending on the needs of the protocols in development.

One individual must be designated as an Alternate PD/PI who is able to serve in the absence of the PD/PI. The Alternate PD/PI must possess a doctoral degree in a relevant field such as statistics, biostatistics, or other relevant area.  

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

Base Budget

Allowable costs include:

  • The Contact PD/PI must commit a minimum of 50% (6.0 person-months) effort unless special justification is provided
  • The designated Alternate PD/PI will commit 20% (2.4 person-months) effort
  • Research Coordinators or Research Project Assistants
  • Clinical Safety Monitor
  • Statisticians
  • Logistics and support staff
  • Programming and analytic staff (including supervisory staff and software expertise staff)
  • Costs associated with data entry, management, collection and analysis
  • Supplies and small equipment (itemized and justified)
  • Travel for DCC staff, the DSMB, the Advisory Board, and the Steering Committee Chair
  • Travel for two staff members to conduct site and data review visits of network clinical sites as appropriate for the clinical site monitoring plan (up to eight trips for the full cycle)
  • Software
  • Report generation
  • Data analysis, manuscript preparation
  • Data entry, management, quality control
  • Arrangement of logistical services for protocol-specific costs, including subcontracts and supplies
  • Support for the activities of the PFDN Advisory Board, Steering Committee, and the DSMB through provision of materials/documentation support, meeting planning and logistics and conference call/webinar coordination
  • DCC resource management, subcontracting (the DCC will prepare reports and provide coordination, support and funding for travel and logistic arrangements related to DSMB meetings and actions)
  • Administrative management of subcontracts with the clinical sites for disbursement of capitation costs
  • Other costs (itemized and justified)

Capitation Budget

Capitation (Patient and Protocol) costs for studies and trials will be supported with a minimum budget of $1.15M direct costs per year for distribution to the Clinical Sites per Steering Committee direction.  Capitation Costs should be listed on the Other Direct Costs portion of the form. Plans for developing study-specific capitation costs that would be distributed to Clinical Sites from protocol dollars should be described in the budget justification.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.  

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: 

Specific Aims: Include Specific Aims for the Data Coordinating Center.

Research Strategy: The Research Strategy section should address all of the following issues:

  • Evidence of Successful Past Performance:  Applicants must describe prior experience of the organization in the design, conduct, data analysis and management of major collaborative clinical research projects, especially in women's reproductive health or pelvic floor disorders, and provide evidence of successful performance as a DCC for multicenter studies within the past five years.  Further, applicant organizations need to show evidence of monitoring of trials, including the ability to generate monthly reports of enrollment and follow-up for the PFDN Clinical Sites and subcommittees, safety reports for the Data and Safety Monitoring Board, and provision of support of data files.
  • Academic Productivity:  Applications s must describe experience of the proposed DCC with previous or ongoing clinical trials, especially those of a cooperative or multicenter design, in the field of women's reproductive health or 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 that resulted from participating in the studies should be described and related to the proposed DCC structure and function.
  • Staffing Plan:  The application should describe strategies and plans for staffing and accomplishing DCC functions from protocol design through analysis.  The PD(s)/PI(s) will provide overall administrative management as well as provide input on study design, data collection, data analysis, and publication of PFDN studies.  Active participation of the PD(s)/PI(s) is expected during all phases of a research study. Staffing plans should be described for carrying out DCC activities including qualitative study design and quality of life measures, pharmacologic production and placebo development, focus group design and analysis, biostatistics, data management, and data analysis.
  • Research studies on female pelvic floor disorders use both surgical/anatomic findings and quality of life measures as primary outcomes.  The application should demonstrate that the DCC has experience with surgical outcome measures as well as quality of life measures.
  • Logistical staffing for daily functioning of the network must be described and justified, including support staff to manage Clinical Site patient and protocol costs.  The DCC should have some degree of flexibility in staffing to be able to respond to changing needs and variation in work effort of the PFDN. For instance, meeting deadlines, trial startup and completion, and other variables occur which necessitate increases and decreases in staff effort from the DCC. 
  • Data Management and Communications:  The application should describe plans for protocol development with respect to design of standard operating procedures, data collection forms and systems, electronic technologies, data entry systems, and data quality assurance, and public use datasets. Previous experience with Food and Drug Administration IND and IDE (Investigational New Drug/Device) protocols should be documented.  A system to insure availability of patient randomization for studies outside of normal business hours (i.e. nights, weekends, and holidays) is required.  Applicants must include plans for support of electronic mail and communication as well as plans for both public and Clinical Site websites developed by and maintained by the DCC that represents the Pelvic Floor Disorders Network.  Methods to monitor and track serious adverse events consistently among clinical sites must be described.  Mechanisms and procedures must be described for ensuring that federal patient-privacy and data confidentiality requirements are met. 
  • Reporting Capabilities:   Describe plans for generating monthly reports on subject enrollment for multiple concurrent studies, reports for use by the Data and Safety Monitoring Board (DSMB) and the Advisory Board, reports for Steering Committee meetings, and preparation of data and manuscripts for publication.  The DCC PD/PI should provide a report at the quarterly Steering Committee meetings, including a quarterly report of protocol fund distributions and outstanding invoices.  The applicant should delineate previous history of such reporting activities in the application.
  • Logistical and Other Support Services:  Applicants must describe experience and plans with respect to logistical and support services relevant to the PFDN.  The DCC provides arrangements for logistical support associated with: 1) Steering Committee meetings (2 per year in the Washington, DC area and 2 at Clinical Site locations) and interim conference calls or webinars 3-4 times per year; 2)  Data Safety Monitoring Board meetings (3 - 4 conference calls or webinars per year and one annual meeting for 6-8 people in the Washington, DC area); and 3) Advisory Board meetings ( 3-4 conference calls or webinars and one biennial meeting in the Washington, DC area for 6-8 people), as well as support for the Steering Committee Chair as well as other selected consultants as needed by the NICHD.  The DCC should be represented on all Network calls.  Webinar services for calls may be incorporated.  The DCC also provides documentation in the form of minutes for the above mentioned meetings. 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 describe logistics for shipping and distributing materials for multicenter clinical trials and ensuring appropriately prepared and labeled supplies of study medications for the Clinical Sites.  Experience in coordinating sample storage and study drug/equipment assignment is required.  The DCC oversees the patient and protocol funds for the studies and trials and maintains subcontracts with the Clinical Sites for disbursement. 
  • On-Site and Off-Site Monitoring:  Applicants must describe plans for organizing and conducting both on-site and off-site monitoring for research studies.  Generation of data errors and needed edits as queries to sites is required.  The DCC needs to ensure that PFDN Clinical Sites fully comply with NIH regulatory requirements, including Human Subjects Protections, informed consent, reporting of adverse events, human and animal safety and welfare provisions, and FDA requirements as indicated by specific studies. Overall documentation and coordination of IRB approvals at PFDN Clinical Sites are the responsibility of the DCC.
  • Technology Transfer, Data Management, and Protocol Training:  Applicants should describe capabilities and plans for technology transfer, data management, and protocol training.  The DCC must be able to assist the Clinical Sites in data management and communication activities.  Training and technical expertise, as well as experience and resources, must be delineated.  Training sessions for scientific protocols, ongoing yearly certifications necessary for any PFDN studies, and data entry are arranged through the DCC.
  • Administration and Management:  The applicant should propose an operational structure for providing and coordinating all DCC functions for several Network protocols simultaneously (including lines of responsibility/authority for professional staff), and propose an administrative and management structure that would support and enhance the operational structure.  The DCC must provide evidence of the organizational systems necessary to assess the appropriateness and reasonableness of resources required for individual projects and the ability to manage those resources efficiently during the course of the research.  Flexibility among personnel based on effort needed is required.  Prior experience with meeting formal deadlines (e.g., FDA reporting requirements, national meetings, Steering Committee meetings, DSMB meetings, Advisory Board Meetings, and so forth) should be delineated in the application.  Further, the application should describe any modifications in the current processes/operational structure used to provide DCC functions that may be made if the applicant were to be selected as the PFDN DCC.
  • The application must provide evidence of financial administrative capability and plans for managing financial responsibilities of the DCC.  The ability to efficiently process invoices from PFDN Clinical Sites and provide timely distribution of protocol funds is essential and will most likely be accomplished utilizing an automated invoicing system.  Experience with capitation for study subject recruitment by Clinical Sites must be described.  This includes providing and monitoring funds to the Clinical Sites for patient recruitment at regular intervals.  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 Steering Committee quarterly meetings and the NICHD Program Official.  Experience with subcontracts is required, as there is occasional need to supplement resources through arrangements with outside organizations based on individual protocol requirements.
  • Special Strengths of the Institution:  Applicants are encouraged to describe special or unique strengths that may be relevant to the DCC's functions or to PFDN research.  Special administrative strengths or experience, as well as participation in administrative aspects of clinical research (Institutional Review Board, Data and Safety Monitoring Board, Advisory Board for clinical research, clinical research committees, and so forth) should be highlighted.

Letters of Support:   Departmental and institutional commitments to participate in PFDN-supported research must be clearly documented with letters of support from appropriate individuals, including the Chief Executive or Operating Official (or equivalent) of the applicant institution.  Evidence of past support can be cited.  There must be a clearly expressed intent to participate in a cooperative manner with other PFDN Clinical Sites, the NICHD, DSMB and Advisory Board in all aspects of research in a manner consistent with the terms of the award.  The prioritization of PFDN work at the DCC must be expressly stated.  PFDN Clinical Sites are expected to participate in all studies, and the DCC provides logistic and data support for all projects.

Letters of support should describe support in areas of grants management, personnel management, space allocation, data coordination and confidentiality (including electronic data systems, such as hardware, software, maintenance and informatics technology), procurement, and equipment as well as general support of the research..  Letters of support from appropriate leaders of institutional component services must be included in the application.

Applications from institutions that have a Clinical and Translational Science Award (CTSA) funded by NIH or other funded pelvic floor disorders centers as resources for conducting the proposed research should provide a letter of agreement that identifies the level and type of support from the PD/PI or the CTSA program director.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:  Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

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.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information
1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of 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 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 review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific 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(s)/PI(s), 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 application demonstrate the scientific, administrative, statistical and academic qualifications of the PD/PI and the research team at the DCC, as well as the qualifications of the PD/PI and applicant institution to participate fully as the DCC in the Pelvic Floor Disorders Network?

Do the key personnel possess appropriate and adequate knowledge and experience in areas relevant to the conduct of collaborative clinical research, especially randomized clinical trials, including experience in research design, execution, data management and quality control, preferably in pelvic floor disorders?

Does the application demonstrate appropriate expertise and capability in biostatistics, study design, the special needs of pediatric subjects, institutions and institutional review boards (IRBs), study development and support, data analysis, project management, staff site training, and monitoring/quality assurance procedures?

Does the application demonstrate management capability, including the PD(s)/PI(s)' ability to estimate appropriate and reasonable resources for research studies, to manage research resources efficiently during study execution, and to enhance collaboration among Clinical Sites of the Network?

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? 

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?

Does the application demonstrate adequate quality of procedures for communication and dissemination of information relevant to clinical research trials and protocols?

Does the application demonstrate adequate quality of reporting capabilities in multi-center trials with respect to monthly reports, trial subject enrollment, and Data and Safety Monitoring Board experience?

Does the application demonstrate adequate quality of procedures for on-site and off-site monitoring?

Does the application demonstrate adequate quality of protocol training and data entry training capabilities?

Does the application demonstrate the ability for web-based system/website establishment and maintenance?

Does the application demonstrate the ability to administer patient and protocol costs to Clinical Sites, and to budget and administer support for Steering Committee, DSMB, and External Advisory Board meetings?

Does the application demonstrate the ability to enable electronic posting of data, protocols and intra-network communications?

Is there evidence of technology transfer capabilities and of capability and support of publicly utilizable datasets?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?  

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?

Does the application demonstrate adequate administrative, statistical, and data organizational management facilities?

Is there institutional assurance to provide support to the study in such areas as fiscal administration, personnel management, space allocation, procurement, planning, and budgeting?

Does the application demonstrate administrative strengths, such as affiliations with other research units?

Does the application demonstrate the ability to administer patient and protocol costs to Clinical Sites, and to budget and administer support for Steering Committee, DSMB, and External Advisory Board meetings?   

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, 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. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

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 on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Resubmissions

Not Applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Does the application demonstrate the quality of the PD(s)/PI(s)' prior experience in the design, conduct, data analysis, and data management of major collaborative research projects, experience in women's reproductive health or pelvic floor disorders research, and successful performance as a DCC in the previous five years? 

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable 

Select Agent 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; 2) Sharing Model Organisms; and 3) Genomic Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

  • May 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 overall impact score.
  • Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Child Health and Human Development (NACHHD) Council. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.
3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information
1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 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.

The PD(s)/PI(s) will have the primary responsibility for:

  • Cooperating with the clinical investigators at the PFDN Clinical Sites, and with the Project Scientist, Program Official, and other participating NICHD and NIH staff, in the design and conduct of protocols, analysis of data, and reporting of results of Network research.
  • Administration of scientific protocol funds to sites with Steering Committee approval.
  • Systems for data collection, analysis, coordination, and quality assurance are essential.  Required data summaries will be provided to the Network Steering Committee, the subcommittees, the NICHD, the Data and Safety Monitoring Board and others as determined by the Steering Committee.
  • Logistical services, including provision of study drugs, collecting and storing of biological fluids, and other supplies for the conduct of research as may be required.
  • The awardee will agree to accept the coordinating role of the group and the participatory and cooperative nature of the collaborative research process, and the decisions of the Steering Committee.
  • The DCC grant will provide research support services to the Clinical Sites comprising the PFDN.  These will include establishment and maintenance of a centralized information management system to help the Network Clinical Sites, the Steering Committee, and the NICHD to edit, store, analyze, publish, and disseminate results from the shard research.
  • The DCC will serve as a central repository for data on all collaborative Network projects.
  • The DCC will assist the NICHD Project Scientist, Program Official, and the Steering Committee in monitoring research progress, and will work to ensure data integrity, accuracy, security, and accessibility.
  • 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 DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

NICHD Project Scientist - The NICHD Project Scientist will provide technical assistance and participateas one voting member of the Steering Committee.  Specifically, the NICHD Project Scientist will provide:

  • Assistance with the identification of important areas of study.
  • Assistance in the development of study protocols.
  • Assistance in the development and review of capitation-based budgets, including the identification of study costs and special institutional needs.
  • Assistance in the review and evaluation of each stage of the program before subsequent stages are started, in conjunction with the Steering Committee, NICHD Program Official (see below), and the Advisory Board, and make recommendations to enhance the scientific quality of the work.
  • Assistance in the reporting of results in the community of investigators and health care recipients.
  • Assistance with the conduct of the trials and other approved studies, including ongoing review of progress, possible redirection of activities to improve performance and cooperation, and frequent communication with other members of the Steering Committee.
  • Participation on the Steering Committee (voting member) and all active subcommittees.
  • Collaboration with NICHD Program Official in recommending administrative actions to enhance scientific productivity.

NICHD Program Official - 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.  This Program Official role is separate from the Project Scientist, and will include the following:

  • Carry out continuous review activities with the NICHD Project Scientist to ensure that 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, in consultation with the Project Scientist.
  • Initiate a decision to modify or terminate a study based on the advice of the DCC, Steering Committee, DSMB or Advisory Board, and Project Scientist.
  • Work with staff in NICHD Grants Management Branch, who will monitor and evaluate the fiscal concerns and administration, including Facilities and Administrative Fees.
  • Perform other duties required for normal program stewardship of awards.

Areas of Joint Responsibility include:

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 PD/PIs (one from each awarded Clinical Site), the PD/PI of the Data Coordinating Center, and NICHD Staff.  The PFDN Project Scientist will be the only voting NICHD staff member of the Steering Committee.  A member of the NICHD Grants Management Branch advises the Steering Committee on funding matters.  Non-voting members may be appointed to the Steering Committee from other involved Institutes. Subcommittees will be established by the Steering Committee, as deemed appropriate.  An outside chairperson, who is not participating as a PD/PI, will be selected by the NICHD.  Data and Safety Monitoring Boards (DSMBs) will be created at the request of NICHD, and supported by the Data Coordinating Center.   At NICHD discretion, the Project Scientist may serve as executive secretary of the DSMB.

Each full member will have one vote.  All major scientific decisions will be determined by super-majority vote of the Steering Committee.  Awardee members of the PFDN will be required to accept and implement policies approved by the Steering Committee.

Meetings of the Steering Committee will ordinarily be held in the Washington, DC metropolitan area or at the clinical sites or by telephone conference call; logistics of both conference calls and Steering Committee meetings are the responsibility of the DCC. The Steering Committee, with the assistance of the DCC, is responsible for coordinating protocol development and study budget, descriptive study design, protocol submission, study conduct, quality control and study monitoring, trial adjudication, drug ordering, data management, statistical analysis, protocol amendments/status changes, adherence to requirements regarding investigational drug management and Federally mandated regulations, distribution of protocol dollars and performance reporting.  The DCC will be responsible for direct communication with the NICHD Project Scientist.

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.  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 pelvic floor disorders research.  The Advisory Board provides the Network with input into the direction of the science and review of protocols and consents in mid-development stage.  The members of Advisory Board are independent from the Data Coordinating Center and Clinical Sites.  The Advisory Board is selected by the NICHD and consists of individuals with expertise in clinical trials, biostatistics, epidemiology, and pelvic floor disorders.  Additional members with specific scientific expertise may be appointed.

Dispute Resolution - 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 regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: https://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Scientific/Research Contact(s)

Lisa Halvorson, MD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-480-1646
Email: lisa.halvorson@nih.gov     

Lisa Begg, Dr.P.H., R.N.
Office of Research on Women's Health (ORWH)
Telephone: 301-496-3975
Email: beggl@od.nih.gov

Peer Review Contact(s)

Sherry Dupere, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-451-3415
Email: duperes@mail.nih.gov  

Financial/Grants Management Contact(s)

Bryan S. Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

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 Part 52 and 45 CFR Part 75.

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