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)

Funding Opportunity Title

Data Coordinating Center for the NICHD Cooperative Multicenter Reproductive Medicine Network (U10)

Activity Code

U10 Cooperative Clinical Research – Cooperative Agreements

Announcement Type

Reissue of RFA-HD-06-008

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HD-14-018

Companion Funding Opportunity

None

Number of Applications

Only one application per institution is allowed as defined in Section III. 3. Additional Information on Eligibility.

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

93.865

Funding Opportunity Purpose

This funding opportunity announcement (FOA) issued by the NICHD invites applications from investigators willing to participate with the assistance of the NICHD under a cooperative agreement as the Data Coordinating Center (DCC) in an ongoing multicenter clinical research program, the Cooperative Multicenter Reproductive Medicine Network, to conduct interventional and observational studies using common protocols designed to facilitate diagnostic and therapeutic solutions to problems in reproductive medicine, gynecology, endocrinology, urology and andrology that affect fertility.

The DCC provides administrative and statistical support to maintain an infrastructure to develop, coordinate, and conduct multiple collaborative clinical trials simultaneously with the goal to improve the health and well-being of infertile couples, individuals with reproductive diseases and disorders and their offspring.

Key Dates
Posted Date

January 7, 2013

Letter of Intent Due Date(s)

March 4, 2013

Application Due Date(s)

April 4, 2013

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June/July, 2013

Advisory Council Review

October, 2013

Earliest Start Date

December 1, 2013

Expiration Date

April 5, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 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. While some links are provided, 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.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of 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) issued by the NICHD invites applications from investigators willing to participate with the assistance of the NICHD under a cooperative agreement as the Data Coordinating Center (DCC) in an ongoing multicenter clinical research program, the Cooperative Multicenter Reproductive Medicine Network, to conduct interventional and observational studies using common protocols designed to facilitate diagnostic and therapeutic solutions to problems in reproductive medicine, gynecology, endocrinology, urology and andrology that affect fertility.

The DCC provides administrative and statistical support to maintain an infrastructure to develop, coordinate, and conduct multiple collaborative clinical trials simultaneously with the goal to improve the health and well-being of infertile couples, individuals with reproductive diseases and disorders and their offspring.

Research Objectives

The NICHD invites applications from investigators willing to participate as the Data Coordinating Center (DCC) for the NICHD Cooperative Reproductive Medicine Network (RMN) under a cooperative agreement in an ongoing multicenter clinical research program designed to perform interventional and observational clinical studies that advance the diagnosis and therapy of diseases and disorders affecting fertility. The objective of this program is to enhance conception, live birth, and the health of children born to women and men with impaired fertility by supporting a network of academic centers that use common protocols in large scale human trials to obtain answers to important clinical problems more rapidly than individual sites acting alone.

The infrastructure is established for development and implementation of rigorously designed randomized-controlled trials as well as longitudinal observational studies and pilot studies. Presently there are 7 RMN clinical sites, and several ancillary collaborating sites.

Current studies include:

Furthermore, data is being collected on behavioral outcomes and quality of life measures of women and men in infertility trials. A bio-specimen repository has been established to enable sharing of de-identified data and samples with investigators outside the network to encourage additional studies to be undertaken with well-characterized data and specimens. Ultimately, the goal of the RMN is to provide the basis for evidence-based, cost effective, clinical care in the evaluation and management of women and men with infertility, to improve conception and live birth rates and clinical outcomes resulting from infertility treatments.

The DCC provides a broad range of support services including data management and analysis, statistical expertise and logistical services for the RMN to accomplish its goals. In support of the activities of the RMN, the DCC:

Scope

Many unresolved issues in reproductive medicine might be elucidated by multicenter collaborative research. The funded DCC will cooperate with the Steering Committee (SC) in identifying high priority areas of research and in designing protocols appropriate to the evaluation of optimal management in these areas. In support of the activities of the RMN, the DCC will have primary responsibility for data management and analysis, providing administrative and statistical support, and maintaining an infrastructure to develop, coordinate, and simultaneously conduct multiple collaborative clinical trials of the RMN.

The NICHD expects the Network to initiate new protocols within the first year of the next award period. The topics of these protocols will be decided cooperatively by the SC with input from the Advisory Board (AB) on the scientific merit and potential impact of the proposed studies. The AB is an external group of experts appointed by the Director of the NICHD with expertise in clinical trial design, biostatistics, epidemiology, reproductive endocrinology and infertility, gynecology and urology/andrology, whose primary purpose is to advise the NICHD and the RMN in the identification and prioritization of topics for RMN research and of overall Network performance.

Topics of potential study may address but are not limited to:

The DCC will provide support in the following areas:

Time Sequence

It is anticipated that the Network will conduct its activities according to this general outline: Initially, the SC will review and identify issues of importance in reproductive medicine. The SC will rank by priority issues that are substantive, lie within the scope of existing technical capability, are suitable for multicenter evaluation, involve sufficient numbers of participants to be of consequence in terms of morbidity, and comprise significant public health need. From the list of important issues, the SC will generate diagnostic or treatment protocols and agree on lead units. Each protocol is to be acceptable to all the participants, adequate for appraisal of the defined research questions, and amenable to data collection in a common format. Protocol subcommittees which include one or more PD/PIs, the PD/PI of the DCC, and the Project Scientist may be constituted to develop protocols more efficiently. The protocols will be reviewed by the AB and the DSMB appointed by the NICHD prior to implementation.

Participating RMUs will recruit, screen and enroll subjects into the trials. The units will supervise the collection of data with adequate attention to the accuracy and quality of records and transcription, providing information in uniform data format for analysis. The mode of data transmission and analysis will be determined by the SC in conjunction with the recommendations of the DCC. Data summaries will be provided to the DSMB on a semi-annual basis, or as indicated by study protocol. Format and content of final reports and the dissemination of information to the scientific community will be determined by the SC.  

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 staff will assist, guide, coordinate, or participate in project activities. 

Application Types Allowed

New
Renewal

The OER Glossary and the PHS 398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NICHD intends to commit $3.3 million in FY 2014 to fund one award.

Future year amounts will depend on annual appropriations.

Although the financial plans of the IC provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Award Budget

Application budgets are not limited, but need to reflect actual needs of the proposed project.

Award Project Period

The maximum period of support is 5 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

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

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 must complete the following registrations as described in the PHS 398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

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.

The PD/PI must possess a doctoral degree in a relevant field such as statistics, biostatistics, or epidemiology and is required to commit 6 person-months (50 percent) effort to the DCC activities of the NICHD RMN. 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. 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 and should commit at least 1.2 person-months (10 percent) effort to the project.

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

  1. To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
  2. Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
  3. Of an application with a changed grant activity code.
Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS 398 Application Guide, 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.

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:

The letter of intent should be sent (email is the preferred method of delivery) to:

Esther Eisenberg, MD MPH
Project Scientist, Reproductive Medicine Network
Fertility Infertility Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Bethesda, MD 20852
Email: eisenbes@mail.nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and 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)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

Sherry Dupere, PhD
Chief, Scientific Review Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development
National Institutes of Health (NIH)
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301-451-3415
Email: duperes@mail.nih.gov

Page Limitations

All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed.

Detailed Budget for Initial Budget Period

Follow instructions in the PHS 398 Application Guide, with the following modifications:

Allowable costs and policies governing the research grants programs of the NIH will prevail. F&A costs will be awarded in the same manner as for research project grants. Budgets will be reviewed on the basis of appropriateness for the work proposed.

Base Budget

The first year budget includes a base budget for direct costs of up to $600,000 per year.

Allowable costs include:

Per Protocol Costs

Annual budgets ($3.3 million total direct and indirect) will support costs for the base budget of DCC and patient care costs for studies and trials to be conducted that will be distributed by the DCC to the clinical sites based on a capitation system, i.e., a flat fee for each subject successfully enrolled and completed for each study.

Budget for Entire Proposed Period of Support

Follow instructions in the PHS 398 Application Guide, with the following modifications:

The DCC budget should be prepared for five 12-month periods. Applicants should submit base budget estimates for all years. Patient care costs for studies and trials should be categorized separately on the budget pages.The budget justification for each year should include a table that apportions the direct costs among the following categories: core costs, costs of protocol initiation, and costs of protocol support.

The total first year budget request should provide for the organization of all administrative aspects of the RMN and for the development of one protocol. Budget requests for the out-years should assume that the DCC should be able to conduct multiple trials concurrently during the grant period. Accordingly, the DCC should request no more than $2 million per year in Years 02 through 05 in the patient care category for the distribution of approved protocols. The final amount will be determined by NICHD. These funds will be managed by the DCC and distributed to each participating clinical site as a fee for service arrangement after a protocol has been approved and the NICHD has released the funds for distribution.

Costs for financial administration to prepare protocol budgets and to distribute and monitor funds should also be addressed. The funds released for DCC operations in each year will be based, in part, on the number of protocols actually executed by the Network and may be more or less than the budget requested in the application.

Research Plan

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Research Strategy

Within the Research Strategy section, applications must address the following items:

Evidence of Successful Past Performance. DCC applicants must describe prior experience in the design, conduct, data analysis and management of major collaborative clinical research projects preferably in reproductive medicine and infertility, and provide evidence of successful performance as a DCC in monitoring multi-site studies within the past three to five years. Applicants need to provide evidence of the ability to generate monthly reports of enrollment and follow up by site for the NICHD RMN Steering Committee and subcommittees, data and safety reports for DSMB; provision of staff training in study procedures, data collection and management, and quality assurance.

Academic Productivity. DCC applicants must provide evidence of research productivity in previous or ongoing clinical trials, especially those of a cooperative or multicenter design in the field of reproductive medicine and female and male infertility. 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 participation in the studies should be listed.

Staffing Plan and Capabilities. The application should describe plans for staffing DCC functions and provide evidence of multicenter collaboration on recent clinical trials, especially those in reproductive medicine and infertility, including publications resulting from these studies. The proposed DCC should have some degree of flexibility in staffing to be able to respond to the changing needs and seasonal variation in work effort of the NICHD RMN. For example, meeting deadlines, trial startup and completion, and other variables occur which necessitate increases and decreases in staff effort from the DCC. Logistical staff for day to day functioning of the network, and support staff to manage clinical site capacitation must be described and justified. The following personnel are needed to insure excellence in the day-to-day activities of the DCC:

Capacity and Ability to Manage Data and Communications. Applications must describe the ability to assist in protocol development with respect to design of procedure manuals, data collection forms, data collection systems, electronic technology, and data entry systems. Prior experience in data quality assurance is required. Applicants should provide evidence of data management and program support capabilities by describing their standard operating procedures for data collection, management, analysis and quality control, as well as central storage, security, processing and retrieval of study results. A system to insure availability of central patient registration and 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 a website system for participants of the NICHD RMN. The website should have public and private access links available. Previous experience in reproductive medicine and infertility studies and FDA IND (Food and Drug Administration Investigational New Drug) procedures are essential. Knowledge of federal patient-privacy and data confidentiality requirements and appropriate experience in ensuring that relevant mechanisms and procedures are in place must be provided in the application. The DCC must develop and maintain a website for both public access and private, secure investigator access.

Evidence of Reporting Capabilities. Applicants must provide evidence of experience with generation of monthly reports on subject enrollment for multiple concurrent studies, reports for use by DSMB and advisory board, and reports for Steering Committee meetings. Documentation and dissemination of meeting minutes and minutes of conference call meetings are required to be performed in a timely manner. The applicant should delineate previous history of such activities in the application. Further, experience in preparing data presentations and manuscripts for publication is to be described in the Research Plan. The DCC PD/PI will report to the Steering Committee on a regular basis at the Steering Committee meetings as necessary.

Logistical and Other Support Services. Applicants must be able to provide meeting and conference support for the activities of the Steering Committee, the AB and the DSMB through the provision of materials and documentation, meeting planning and logistics, and conference call coordination. Applications must describe experience and capabilities with respect to logistical and support services relevant to the RMN. The DCC provides arrangements and documentation in the form of minutes for the Steering Committee meetings (three per year in the DC metropolitan area) and monthly conference calls, DSMC meetings (two per year and as needed) and committee conference calls, and other meetings as needed by the NICHD RMN. On occasion, the DCC handles travel arrangements for selected consultants as needed. The RMN communicates on an ongoing basis via email and teleconference; these activities are supported by the DCC. The DCC is responsible for supporting the infrastructure for meetings and teleconferences. Expertise in coordinating sample storage and study drug/equipment assignment is required.

On-site and Off-site Monitoring Ability. Applicants must provide evidence of experience in organizing and conducting both on-site and remote monitoring for clinical research studies. Generation of data errors and needed edits is required. The DCC needs to ensure that the RMN 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 needed by specific studies.

Technology Transfer, Data Management and Protocol Training Capabilities. Applicants should describe capabilities in technology transfer, data management, and protocol training. The DCC must be able to assist the clinical centers in data management and communication activities. Training and technical expertise as well as experience and resources must be delineated in the Research Plan. Experience with training sessions for scientific protocols, and data management and data entry by the DCC should be described.

Administrative and Management Capabilities. he PD/PI should delineate his/her skills as a manager or administrator for a DCC. The PD/PI must provide evidence of experience and ability to estimate the appropriateness and reasonableness of resources needed for individual projects and ability to manage those resources efficiently during the course of the research. Flexibility of personnel based on needed effort is required. Prior experience with meeting deadlines (e.g., FDA reporting requirements, national meetings, Steering Committee meetings, DSMB meetings, AB meetings, and so forth) should be detailed in the application. Experience with disbursement of patient care costs for study subject recruitment by clinical centers is mandatory. This includes providing and monitoring funding to the clinical centers for patient recruitment at regular intervals. Experience with subcontracts is required as there is need to supplement resources through arrangements with outside organizations based on individual protocol requirements.

Special Strengths of the PD/PI or Institution. Applicants are encouraged to describe special or unique strengths that may be relevant to RMN research. This can include state-of-the art data management systems, which may be shared or may be available to develop and expand the scientific productivity of the RMN. In addition, special administrative strengths or experience as well as participation in administrative aspects of clinical research (IRB, DSMB, AB for clinical research, clinical research committees and so forth) for the PD/PI and additional staff members should be highlighted. Level of support for clinical trials can be described. Applications from institutions that have a Clinical and Translational Science Award (CTSA) funded by NIH or other funded reproductive research centers as resources for conducting the proposed research should provide a letter of agreement that identifies the level of support from the PD/PI or the CTSA program director.

Intent to Participate. The RMN will be a collaborative effort that will require frequent interaction of awardees among themselves and the NICHD. Applicants must explicitly express their willingness to participate in a cooperative manner with RMN clinical centers, the NICHD, DSMB and AB in all aspects of research as outlined in this FOA including participation in Steering Committee meetings (see Section VI, 2, Cooperative Agreement Terms and Conditions of Award) and regular telephone conference calls; cooperate with other awardees in the development and design of research protocols; abide by common definitions, common methods for patient selection and enrollment, and common protocols, procedures, tests, as chosen by majority vote of the SC; comply with data reporting procedures and timelines; comply with study policies and quality assurance measures approved by the SC; agree to oversight of the study by a DSMB; report all adverse events in accordance with procedures established by the SC and NIH policies; and cooperate with other awardees in the publication of study results.

Letters of Support

The departmental and/or institutional commitments to participate in RMN-supported research should be clearly documented with letters of support from appropriate individuals. Evidence of past support can also be cited. Support in areas of grants management, personnel management; space allocation, data coordination and confidentiality, procurement, and equipment as well as general support of the research should be described as well as evidence of past research support.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modification:

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS 398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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 received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

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

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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.

For this particular announcement, note the following:

For the NICHD Reproductive Medicine Network Data Coordinating Center applications, peer review of scientific and technical merit emphasizes experience and capabilities in multi-center, collaborative clinical trials and documentation of expertise in protocol development, staff training, research instrument development, data management, biostatistical expertise as applied to study design, data administration and coordination of multicenter trials.

Overall Impact - Overall

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 - Overall

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?  

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? 

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?   

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?

Additional Review Criteria - Overall

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 Human Subjects Protection and Inclusion Guidelines.

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. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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.

Did the Data Coordinating Center provide high-quality performance with respect to statistical leadership, protocol development, data and safety monitoring plans for executed protocols, site management, data management, and publication record?

Revisions

Not Applicable

Additional Review Considerations - Overall

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) Genome Wide Association Studies (GWAS).

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 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:

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

Applications will be assigned to the appropriate NIH Institute or Center and 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:

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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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 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.

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

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

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

NICHD Project Scientist Roles - The Project Scientist will participate in the overall coordination of the RMN with the Steering Committee. This includes efforts to improve and strengthen cooperation of the RMN Sites and DCC. The Project Scientist will interface with each of the PD(s)/PI(s), the DCC, the Steering Committee Chair, the Committee Coordinator and directly participate in research protocol development, evaluating objectives and research goals of the Network, deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as warranted by participating in the activities of all subcommittees established by the Steering Committee. The Project Scientist will provide progress reports to the Advisory Board and communicate recommendations, as well as assist the research efforts of the RMN by facilitating access to fiscal and intellectual resources provided by industry, private foundations and NIH intramural scientists. The Project Scientist will, as required, help reprogram research efforts, including options to modify or terminate them, by mutual consent between the Steering Committee and NICHD. In the event of disagreements among Program participants, the Project Scientist will assist in forming an arbitration panel.

The Project Scientist will assist and facilitate this process and not direct it, retaining the option to recommend the withholding of support from a research project materially failing to meet the technical performance requirements established by this RMN. This includes identifying jointly with participants of the Steering Committee the need to add additional research projects or to phase out a research project when performance standards have not been met; and participating in data analyses, interpretations, and the dissemination of study findings to the research community and health care recipients including co-authorship of the publication of results of studies conducted by the RMN.

NICHD Program Official Role - An NICHD Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

This role is separate from the Project Scientist and will include the following:

NICHD Committee Coordinator - An NICHD Committee Coordinator will serve as the liason between the Steering Committee, the DCC, Project Scientist and the DSMB and Advisory Board; will convey communications between the Steering Committee and DSMB; and will organize meetings of the Advisory Board and DSMB as needed.

In addition to the above specified rights, responsibilities and involvement, the DCC has collaborative responsibilities involving interactions with the Steering Committee, the Advisory Board, and the Data Safety and Monitoring Board.

Areas of Joint Responsibility include:

Steering Committee - Each of the PD(s)/PI(s) of the RMN clinical units, the PD/PI of the DCC and one staff member from the NICHD, who will be the Project Scientist, will participate on a Steering Committee. A non-NIH Chairperson for the Steering Committee will be selected by the NICHD with the approval of a majority vote of the PD(s)/PI(s). Meetings of the Steering Committee will be convened regularly to be held in-person and by teleconference. The purpose of these meetings is to share scientific information, monitor progress, identify new research opportunities and potential avenues of collaborations such as with other clinical researchers, industry, private foundations and/or NIH intramural scientists, establish priorities that will accelerate the translation of preclinical findings into clinical applications, participate in planning and conduct the business of the cooperative research program.

All major scientific decisions will be determined by the Steering Committee, with each clinical site having one shared vote and all other members of the Steering Committee having one vote. The Steering Committee will review all concepts for scientific merit and feasibility; review all protocols prior to implementation; review all public presentations of the RMN results and manuscripts, posters, and abstracts prior to publication; review compliance with protocol requirements; establish subcommittees; develop Network and study policies; receive and act upon reports of subcommittees, the Advisory Board and the DSMB; and review matters relevant to administrative, financial and medical considerations of studies.

The Chairperson will be responsible for the overall administration of the Steering Committee and provides leadership for all activities described above. The Chairperson, together with the NICHD Project Scientist, will schedule Steering Committee meetings, establish an agenda for those meetings, and monitor the work of subcommittees. The NICHD Project Scientist will convene the first meeting of the Steering Committee. Thereafter, the Committee will meet in person or by teleconference at least six times a year. The Chairperson and NICHD Project Scientist will schedule additional meetings by teleconference as necessary.

The Steering Committee, or a subcommittee, will review the budget and expenditures at least once each year at a face-to-face meeting. Clinical trials will proceed into the implementation stage only with the concurrence of both the Steering Committee and the NICHD Program Official. Each Steering Committee member will be expected to participate in all Steering Committee activities, e.g., meetings, conference calls, subcommittee activities, etc., as necessary. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

The RMN Steering Committee will retain custody and have primary rights to the RMN combined data that is submitted to the DCC from the RMN clinical site awardees, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

Advisory Board - An Advisory Board (AB), convened by the NICHD, will advise the Steering Committee in the identification and prioritization of topics and protocols for the RMN. The AB will be composed of senior scientists, not part of the Network, with expertise in obstetrics and gynecology, andrology, biostatistics, epidemiology, human genetics and clinical trial design. The Chairperson of the Steering Committee and the NICHD Project Scientist will serve as ex officio members of the AB. Additional members will participate as necessary for specific expertise.

Data and Safety Monitoring Board - A Data and Safety Monitoring Board will monitor the safety of ongoing clinical trials and advise on their conduct. This committee will be established by NICHD and consist of individuals with expertise in obstetrics and gynecology, andrology, biostatistics, epidemiology, population genetics, clinical trial design and ethics. This committee will focus on safety, ethics, and scientific and statistical integrity of both proposed and ongoing trials.

Data Coordination and Management - The RMN DCC will carry out data coordination and management. As described, each participating clinical site will be responsible for providing primary study data to the DCC for management, quality control and analysis. Specific analyses to be performed will be directed by the Steering Committee. The results of those analyses will be delivered to the Steering Committee and the Steering Committee is responsible for determining how the results are interpreted, whether the results should influence ongoing data collection, and how the findings should be disseminated. All participating sites will have access to all data originating from their sites.

Publication and Presentation - Timely publication of findings is required. Publications and oral presentations of work performed under this agreement will require appropriate acknowledgement of the participating institutions and NICHD support. Review and approval by the Steering Committee will be required for all analyses prior to publication or presentation according to criteria that will be developed by the Steering Committee.

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 Non-Competing Continuation Grant Progress Report (PHS 2590 or 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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Esther Eisenberg, MD MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 615-343-1082
Email: eisenbes@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Teri Pailen
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Telephone: 301-435-7010
Email: pailent@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 Parts 74 and 92.


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