Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov)
National Cancer Institute (NCI), (http://www.nci.nih.gov)
National Center for Complementary and Alternative Medicine (NCCAM), (http://www.nccam.nih.gov)

Title: Global Network for Women's and Children's Health Research

Announcement Type

Update: The following updates relating to this announcement have been issued:

• May 24, 2011 - This RFA has been reissued as RFA-HD-12-200 for (U10) and RFA-HD-12-201 for (U01).
• April 25, 2007 RFA-HD-05-025 has been reissued, see RFA-HD-07-016
• May 5, 2005 RFA-HD-05-025 replaces RFA-HD-00-007 and RFA-HD-01-024, which were previously released March 15, 2000 and October 10, 2001, respectively.

Request for Applications (RFA) Number: RFA-HD-05-025

Catalog of Federal Domestic Assistance Number(s)
93.865, 93.399, 93.213

Key Dates
Release Date: May 5, 2005
Letters of Intent Receipt Date(s): December 19, 2005
Application Receipt Dates(s): January 19, 2006
Peer Review Date(s): June/July 2006
Council Review Date(s): September 2006
Earliest Anticipated Start Date: December 1, 2006
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: January 20, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

• The NICHD, NCI and NCCAM invite applications from investigators willing to participate under a cooperative agreement in an ongoing multi-center international research network designed to perform randomized clinical trials, using common protocols, to reduce the major risk of maternal, neonatal, infant, and early childhood mortality and significant morbidity in resource-poor countries in Africa, Asia, Latin America, and the Middle East.
• The NICHD intends to commit approximately $3.7 million dollars in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2006 to fund four to eight new and/or competing continuation grants in response to this RFA, NCI intends to commit $100,000 and NCCAM intends to commit $225,000 in FY 2006. Additional funds are being sought from other sources.
• This funding opportunity will use the NIH Cooperative Research Project Grant (U01) award mechanism.
• You may submit an application if your institution has any of the following characteristics: For-profit or non-profit organizations, public or private institutions such as universities, colleges, hospitals, and laboratories, domestic.
• Eligible principal investigators (PIs), including any individual with the skills, knowledge, and resources necessary to carry out the proposed research, are invited to work with their institution and senior foreign investigators (SFIs) to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.
• Applicant institutions may apply for (1) only a Data Coordinating Center grant, or (2) only a Research Unit grant, but not both.
• An institution may submit only one application in response to this RFA.
• Background information about the RFA will be available online at http://www.nichd.nih.gov/RFA/HD-05-025.htm.
• Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 09/2004). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, email: [email protected]. Applications must be received by the date listed under Key Dates, above.
• Telecommunications for the hearing impaired is available at: TTY 301-451-5936.

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

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

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

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

Section VIII. Other Information - Required Federal Citations

1. Research Objectives

The NICHD, NCI and NCCAM invite applications from investigators willing to participate under a cooperative agreement in an ongoing multicenter international research network designed to perform randomized clinical trials of interventions to reduce the major risks to maternal, neonatal, infant, and early childhood health in the resource-poor countries in Africa, Asia, Latin America, and the Middle East. The objective of this program is to contribute to the resolution of these problems by establishing a network of Research Units (paired U.S.-based and foreign centers) that will use common protocols to implement randomized clinical trials and thus contribute to the evidence-base for sound clinical, programmatic, and policy decisions. The network will establish the infrastructure necessary to initiate, implement, and evaluate randomized controlled trials in community settings among pregnant women, newborns, infants, and children to the age of three years. The overall goal of the Network is to expand scientific knowledge relevant to improving health outcomes for women and children in developing countries. Other critical goals are to: (1) develop sustainable research infrastructure and public health intervention capabilities in developing countries and (2) strengthen international collaborative research arrangements that focus on the leading causes of morbidity and mortality in pregnancy and early childhood. A key objective for the network Research Units is to design, develop, and conduct multiple simultaneous common clinical trials, as well as implementing and evaluating evidence-based health interventions and pertinent formative and translational research studies collaboratively. These studies must have strong scientific and epidemiologic basis for their use in a foreign country, and should be culturally appropriate. The primary endpoints in these studies must be associated with demonstrable improvement in important public health measures in the population under study. This network will bring the required numbers of subjects into rigorously designed common protocols and thus address pressing research questions in pregnant women and very young children more quickly and efficiently than could individual centers acting alone.

Research that is predominantly epidemiologic, such as observational or surveillance studies, will not be reviewed and will be returned to the PI as unresponsive to the RFA. Applications that only evaluate health care delivery programs or health care utilization and do not evaluate an intervention will also be considered as non-responsive and will be returned without review. The network Data Coordinating Center will assist in protocol development, data collection and management, provide statistical consultation, and logistical support. Program staff will assist the PI and the SFI of the Global Network for Women's and Children's Health Research (GN) to identify research topics of high priority, and to design, implement, and evaluate the impact of common protocols.

Background

According to a report of the Global Forum for Health Research, more than 1.3 billion of the approximately six billion people alive today live in extreme poverty. Nearly three billion people live on less than two dollars a day and 70 percent of these poor are women. Frequently in poor health, they live in unsafe and unsanitary conditions, have the primary responsibility for caring for children and the elderly, and are often expected to perform the major tasks of family sustenance. Despite successes during the past 30 years in improving the health of women and children worldwide, interventions are needed to avert the unnecessary, preventable deaths, illness, and disability that disproportionately affect poor women and children, especially in the developing world.

Problems at the home and community level contribute to maternal, neonatal, and child morbidity and mortality. These include underlying nutritional deficits, limited access to quality medical care, inadequately trained health care workers, lack of adequate health information and resources, social and cultural norms, civil and domestic violence, and the low social status of women and children.

According to World Bank reports, maternal mortality remains the human development indicator that shows the greatest gap between developing and developed countries. The health problems that contribute most to maternal deaths in the developing world include intrapartum bleeding, sepsis, eclampsia, obstructed labor, and postpartum hemorrhage. The World Health Organization (WHO) estimates that every year more than 500,000 women die as a result of pregnancy-related complications, the majority due to postpartum hemorrhage or infection. This represents one in 16 women in developing countries, compared with one in every 2800 women in developed countries, dying of pregnancy-related complications. Seventy percent of these women receive no postpartum care in the six weeks following delivery.

In addition to mortality, for every woman who dies, an estimated 15 to 30 survive but suffer chronic disabilities and morbidities. This includes obstetric fistula, one of the most common, painful, and stigmatizing disabilities. Obstetric fistula affects approximately two million women, with 50,000 to100,000 new cases per year.

Improving maternal health in the developing world is of utmost importance for the woman's own sake, and because the death of a reproductive age woman significantly lowers the chance of survival of her infants and children. The WHO estimates that approximately eight million infants die each year, and of these, more than half (4.4 million) die within the first 28 days of life. Ninety-eight percent of these deaths occur in developing countries and are caused by infectious diseases; pregnancy-related conditions; and delivery-related complications, including intrapartum asphyxia, birth trauma, and premature birth. Birth asphyxia accounts for 21 percent of deaths, followed by pneumonia (19 percent), and neonatal tetanus (14 percent). These deaths are preventable if women and their neonates have access to trained health care workers for delivery, immunizations, and timely treatment of infections.

An estimated 10 million children under the age of five, primarily in developing countries, die each year from infectious diseases, nutrition-related illnesses, and reproductive and perinatal health problems. Seventy percent of deaths among children in developing countries are attributable to vaccine-preventable childhood infections, pneumonia, diarrheal diseases, and malnutrition. These conditions, and others associated with early childhood, are expected to remain the major causes of mortality in young children through 2020. Two-thirds of these illnesses and deaths are preventable, yet they are associated with about half of the disease burden in the poorest regions of the world, including India and sub-Saharan Africa, where the rate of improvement in child mortality is actually slowing.

Infectious diseases account for 63 percent of deaths in children under five, and many such as tuberculosis and malaria have become more difficult to treat due to increased resistance to commonly used and available antimicrobial drugs. Malaria takes a particularly high toll on the lives of women and infants in the developing world. The WHO estimates that 10,000 maternal deaths and 200,000 infant deaths each year are associated with malaria infection during pregnancy. Lower immunity during pregnancy puts women at increased risk for malaria, which can lead to other illnesses, anemia, and death. Over 40 percent of the world's children live in malaria endemic areas. The WHO estimates that malaria causes approximately 20 percent of all childhood deaths in Africa. Despite increased resistance to anti-malarial drugs, many of these deaths are still preventable with appropriate interventions.

Approximately 80 percent of the world's population relies on traditional medicine as its primary source of medical care. The practice of traditional medicine varies greatly by country and region due to culture, history, philosophy, and other influences. In developing countries, where an estimated 63 percent of infants are born at home and an estimated 80 percent of children die at home, advice and assistance concerning reproductive health, birth practices, and infant and child care may be available only from local community health workers, traditional medical practitioners, or members of a woman's extended family. Research is needed to identify potentially valuable traditional practices, and to establish evidence supporting their use and possibly broader dissemination in other settings.

Women comprise more than 200 million of the world's 1.2 billion cigarette smokers. Maternal cigarette smoking is associated with perinatal mortality, low birth weight, premature delivery, and other adverse outcomes, while environmental tobacco smoke exposure (ETS) poses a serious risk to infants and young children as well as to adults. In many developing countries, female smoking prevalence is still quite low. It appears to be increasing, however, and women's use of other forms of tobacco is already common in some regions. Research is needed on interventions to prevent and reduce tobacco use, and on ETS exposure among pregnant and reproductive age women and girls in developing countries.

Given the alarming rates of morbidity and mortality in women and children in the developing world, randomized clinical trials of innovative evidence-based interventions are urgently needed to help improve the health of women and children in these countries. In some instances, the results of efficacy studies have not been translated into feasible interventions for resource-poor settings where the burden of these conditions is the heaviest. In other cases, feasible interventions have been developed, but they are relatively ineffective, or effectiveness has not been assessed. Because economic investment in early intervention is warranted and in many situations relatively inexpensive, rigorously tested health interventions can have enormous impact. A global network of U.S. and developing country scientist teams and institutions will facilitate high quality, sustainable collaborative research that can address many of these problems and issues while simultaneously building the professional capacity and infrastructure in developing country sites.

Scope

Originally funded as diverse individual protocols, the Global Network has moved to the conduct of common research protocols to more efficiently build research capacity and address the major causes of morbidity and mortality among women and young children in the developing world. Grantees will be part of a Global Network that will include clinical Research Units (RUs) and a Data Coordinating Center. The Global Network is intended to strengthen and expand the global infrastructure for women's and children's health research. It will increase opportunities for scientific linkages, interaction, knowledge development and transfer, and collaborative partnerships among U.S. and foreign investigators and institutions.

This initiative calls for a broad array of interventional studies conducted across sites in the developing world. The studies should relate to women and young children, with an emphasis on the perinatal and neonatal periods, but up to and including three years of age. Proposed interventions should emphasize the development, testing, and adaptation of cost-effective, integrated biomedical, behavioral, social, and public health interventions that may reduce causes of premature morbidity and mortality among women of reproductive age and young children. Applications based predominantly in clinical research centers or laboratories in the U.S. will not be considered responsive to the RFA.

The Global Network will function as an affiliated group that fosters communication, innovation, and research excellence. Applications for meritorious common research studies that are relevant to the health needs of more than one locality will be reviewed and funded under the network. Grantees should expect to propose and participate in multiple common protocols that may be conducted in several or all network sites. Grantees must be willing to work collaboratively and with cultural sensitivity.

All research conducted under the auspices of the Global Network must be designed such that health improvements in the study population are meaningful, sustainable, and likely to produce a measurable and significantly improved health outcome. Surrogate or intermediate outcomes must be well defined and scientifically well justified.

The Global Network emphasizes a multidisciplinary, team-based approach. Disciplines may include obstetrics, pediatrics, infectious disease, epidemiology, statistics, environmental science, pharmacology, and the behavioral and social sciences. Global Network teams should be based primarily at the institution of the SFI. It is not the intention of this RFA to support multi-disciplinary teams of investigators in the U.S.

Priority will be given to scientific activities that have the greatest likelihood of improving pregnancy and child outcomes in developing countries. Suitable topics for proposed research projects include, but are not limited to, the following:

• Prevention or reduction of leading causes of maternal morbidity and mortality, including but not limited to, malnutrition, malaria, sepsis, preeclampsia and eclampsia, obstructed labor, and post-partum hemorrhage.
• Studies focused on assessing and improving pregnancy management, birth practices, routine resuscitation, and postpartum care of the mother, neonate, and young infant.
• Prevention and reduction of fetal loss, stillbirths, preterm delivery, and birth defects.
• Prevention and treatment of infectious diseases in infants and young children up to three years, including, but not limited to, sepsis, malaria, diarrheal diseases, acute respiratory tract infections, and vaccine-preventable infections.
• Studies that investigate health enhancing aspects, or the adverse health consequences, of traditional or complementary medicine and its practice as related to women and young children.
• Studies that identify and test potentially promising traditional medicine interventions, with priority for those that are at risk of disappearing, and have potential for broader application to improve the health of women and young children in the developing world.
• Within GN clinical trials, conduct research that describes major individual, social and cultural factors (such as belief systems, affordability, availability, and access) influencing users' choices between traditional or conventional (i.e., western or allopathic) health care.
• Nutritional interventions such as exclusive breastfeeding, nutritional supplementation, improved foodstuffs, and complementary feeding that enhance maternal and infant growth, development, energy, and immunity.
• Interventions to enhance child outcomes, including parental caretaking and parental mental health, and reduction of post-partum depression and domestic violence.
• Interventions to prevent and reduce tobacco use among women and girls.
• Prevention and treatment of environmental exposures in women of reproductive age and young children up to three years, including, but not limited to, tobacco, indoor pollution, toxic chemicals, and water-borne infectious agents.
• Studies to improve methodologies (e.g., verbal autopsy) available for investigations of maternal, infant, and young child morbidity, and/or mortality.
• Development and evaluation of diagnostic methods appropriate to the international setting.

To provide an idea of the capabilities of the applicant Research Units to participate in the development and design of cooperative protocols, each applicant should propose one fully developed common research study to address a current critical or emerging health problem related to the needs of women and/or young children in the foreign collaborator's country and other developing countries. The protocol should be appropriate for the Global Network in that it requires a multicenter design. The application should provide a research plan that includes an evidence-based statement of the health problem (including preliminary data); research hypothesis; specific aims; proposed study population; study design, methodology, and recruitment plans; data collection, analysis, and reporting plans; suggested timelines and staffing plans; plans for enhancing research capacity at the foreign sites; plans for sustaining the intervention after the funding period is over; and a proposed budget for the life of the project. Evidence of collaboration and multidisciplinary expertise should be provided. It is critically important that the proposed intervention be community-based and not place undue burden on the population or cause disruption of local facilities. The quality of the research plan will be an important focus of the peer review of the application. There is no guarantee that the proposed research plan will be accepted as a common protocol by the Global Network. However, Research Units will be invited to submit the protocols from their application to the Protocol Review Subcommittee and Steering Committee for review and consideration. The Global Network Data Coordinating Center will assist in data collection and management, including statistical expertise, and research protocol management.

The NICHD, NCI and NCCAM expect that ongoing common protocols of the currently-funded Global Network may continue into the continuation grant period in existing centers. New common protocols may be developed before the start of the continuation. Research sites that join the network during the next award period (beginning April 1, 2006) may participate in the protocols ongoing at that time, as appropriate.

The NICHD, NCI and NCCAM expect the network to initiate new common protocols in the first year. The topics of these protocols will be decided cooperatively by the Global Network Steering Committee.

Project Organization

This RFA solicits applications for pairs of U.S. and developing country research sites to form a research network to address the major causes of maternal, neonatal, infant, and early childhood morbidity and mortality. This RFA also solicits a Data Coordinating Center. The grantees will form a cooperative network in scientific partnership with NICHD to conduct common randomized clinical trials of evidence-based interventions in resource-poor settings. The catchment populations for the sites will include a diversity of ethnic, linguistic and cultural groups.

Organizational Components

The Global Network will consist of multiple Research Units composed of multidisciplinary teams of collaborating U.S. scientists linked to investigators in developing countries as full and equal partners; a single Data Coordinating Center, that will provide research support services and methodological and statistical expertise for the Global Network; and the NIH (represented by the NICHD Program Scientist and Staff Science Collaborators from NICHD and the other NIH co-sponsors.) The Global Network Research Units may include additional consultants needed at specific time periods.

Steering Committee

The Steering Committee will serve as the Global Network's central point of communication; exchange of ideas; development, review and management of common protocols; research and training activities; and problem resolution. The Steering Committee reviews all presentations and publications. The Steering Committee is composed of the U.S. PI and SFI of each Research Unit, the PI of the Data Coordinating Center, and the NICHD Program Scientist, each of whom have one vote. NICHD will appoint a Chairperson who is not participating as a PI for a minimum term of one year. Representatives of other NIH co-sponsoring Institutes and Centers (ICs) may participate as non-voting members.

The Steering Committee will meet twice annually in person and will participate in telephone or video conferences as needed between Steering Committee meetings. During the meetings, research progress and problems are reviewed for each site.

Data Coordinating Center

The Global Network Data Coordinating Center has the responsibility to provide the Network's organizational, statistical, and financial support, including the funding of staff and site training, and regulatory adherence. In addition, the Data Coordinating Center will financially support specialty consultations, specialty services, and other study needs. It also is responsible for assisting the sites in developing and implementing common protocols, implementing quality assurance procedures, including site monitoring; developing data management systems and databases; and developing analytic capacity. The Data Coordinating Center will be responsible for the creation and integrity of study databases, analytic capacity, and support of and attendance at all Network meetings.

Data and Safety Monitoring Board

A Data and Safety Monitoring Board (DSMB) is established by NICHD to monitor the safety of ongoing clinical trials. It also advises the NIH and the Global Network, including the Data Coordinating Center, on research design issues, data quality and analysis, and ethical and human subject issues. The DSMB members have expertise in clinical trial design and conduct; relevant basic, medical, and behavioral sciences research; and ethics and cultural competency issues, particularly with relevance to developing country populations. The Data Coordinating Center provides coordination, support, travel funding, and logistical arrangements for DSMB meetings and actions.

In addition, the network has established policies and procedures that govern its operations, including publication. These documents are under periodic review, and may be amended and supplemented at the discretion of the NICHD and the Steering Committee.

Advisory Board

An Advisory Board will advise the Steering Committee in the identification and prioritization of topics for network research. The Advisory Board, chosen by the NICHD with the advice of the Steering Committee, will be composed of individuals with expertise in clinical trials; biostatistics; epidemiology; obstetrics; pediatrics; infectious diseases;

social sciences; behavioral sciences; basic sciences; and ethics. Additional members will participate based on the need for specific expertise.

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

1. Mechanism(s) of Support

This funding opportunity will use the Cooperative Research Project Grant (U01) award mechanism(s).

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

The NIH U 01 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award."

2. Funds Available

NICHD intends to commit approximately $3.7 million dollars in total costs [direct plus Facilities and Administrative (F&A) costs] in FY 2006 to fund four to eight new and/or competing continuation grants in response to this RFA. An RU applicant may request a project period of up to five years and a budget for direct costs up to $150,000 dollars per year for RU base costs. An applicant for the DCC may request a project period of up to five years and a budget of direct costs up to $800,000 in the first year. Additional funds for the execution of protocols will be awarded to the RU under "other expenses. Applications for the RUs should also include a request for $140,000 direct costs under Other Expenses as restricted funds to be used for common protocols. Fixed budgets for protocols will be negotiated at a later date. These funds are to be included for NICHD budgetary planning purposes only and may be adjusted upwards/downwards as necessary.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary. Although the financial plans of NICHD, NCI and NCCAM provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application if your organization has any of the following characteristics:

• For-profit organizations
• Non-profit organizations
• Public or private institutions, such as universities, colleges, hospitals, and laboratories
• Domestic Institutions

Foreign institutions are not eligible to apply for these grants, except in partnership with a U.S. applicant. Applicants may apply for (1) only a Data Coordinating Center grant or (2) only a Research Unit grant, but not both.

The NICHD, NCI and NCCAM invite applications both from current members of the Global Network (competing renewal applications) and from prospective members (new applications). Refer to Section IV.6 for minimum requirements for Research Unit applicants.

Global Network Research Unit (RU) Applicants

Applications for a Global Network Research Unit grant must be submitted jointly by collaborating teams of investigators that include the applicant U.S. PI and a developing country scientist resident or senior foreign investigator (SFI) at an established institution in the identified developing country. These collaborating teams are identified as Research Units in the context of this RFA. For the purposes of this RFA, developing countries are defined as the resource-poor nation states of Latin America, the Caribbean, North and sub-Saharan Africa, the Middle East, and South and South East Asia. Investigators from the developing world are expected to function as full and equal partners with the collaborating U.S. investigators.

U.S. and developing country scientists and institutions applying for a network grant must provide strong evidence (e.g., established research collaborations) of their likelihood to succeed and their ability to work in effective international partnership with each other. The roles and responsibilities of collaborating scientists and institutions must be clearly defined. Research Unit applications that do not propose U.S.-foreign scientist collaborations will be considered non-responsive to the RFA and returned to applicants without review. The application must be submitted by the U.S. institution, which is responsible for developing and maintaining affiliation(s) with an established foreign collaborating institution(s), for example a college or university, research institute, or hospital. This affiliation(s) and the appropriate and necessary institutional and governmental endorsements should be clearly specified and well documented in the application. Specifically, applicants must provide evidence that a working agreement has been established with the foreign government to expedite deputation of personnel, equipment, and supplies at the local site, to monitor and verify expenditures, and to manage other legal and procedural matters.

Data Coordinating Center (DCC) Applicants

The Data Coordinating Center applicants are expected to be U.S.-based organizations, and to have a U.S. Principal Investigator with expertise in statistics and/or clinical trials management. The DCC applicant organization must also provide strong evidence of the ability to work within international collaborations. The roles and responsibilities of all components of the DCC application must be clearly defined and described.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and the resources necessary to carry out the proposed research is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

2. Cost Sharing or Matching
Not applicable

3. Other-Special Eligibility Criteria

Research unit applications based predominantly in clinical research centers or laboratories in the U.S. will not be considered responsive to the RFA. Grantees should expect to propose and participate in multiple common protocols that may be conducted in several or all network sites. Grantees must be willing to work collaboratively and with cultural sensitivity. Research must be designed such that health improvements in the study population are meaningful, sustainable, and likely to produce measurable, significantly improved health outcomes. Disciplines may include obstetrics, pediatrics, infectious disease, epidemiology, statistics, environmental science, pharmacology, and the behavioral and social sciences. Global Network RU teams should be based primarily at the institution of the Senior Foreign Investigator.

Domestic organizations with the capacity to maintain close communication with NIH and with prior experience in functioning as a research support services provider, and statistical coordinating and assistance center for multi-center randomized controlled trials, are encouraged to submit an application under this RFA for establishment and operation of the Data Coordinating Center. Data Coordinating Center applicants must be experienced in international clinical trials management, and, like the research unit applicants, show willingness to work collaboratively and with cultural sensitivity. Relevant expertise will include expertise in statistics, research protocol and database management, including data transmission, ethics, information technology, and logistics. Capacity for translation services is a useful function, and the capacity for clinical trials budget planning, procurement, and management is required.

1. Address to Request Application Information

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

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

Further information about the RFA may be obtained from program staff listed under Agency Contacts, below, and on the Internet at http://www.nichd.nih.gov/RFA/HD-05-025.htm.

2. Content and Form of Application Submission

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

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

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

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Date(s): December 19, 2005
Application Receipt Dates(s): January 19, 2006
Peer Review Date(s): June/July 2006
Council Review Date(s): September 2006
Earliest Anticipated Start Date: December 1, 2006

3.A.1. Letter of Intent

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

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

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

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Linda L. Wright, M.D.
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Executive Blvd
Room 4B05, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 402-0830
FAX: (301) 480-7773
Email: [email protected]

3.B. Sending an Application to the NIH

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

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

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

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

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

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by CSR and responsiveness by NICHD. Incomplete and non-responsive applications will not be reviewed.

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

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

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Global Network Research Unit (RU) Applicants

Applications must address the following:

Scientific Productivity

Applicants must demonstrate a capacity to develop and implement studies focused on the health of women and children, and provide evidence of recent research productivity in one or more areas related to the scientific scope and objectives set forth in this RFA. Experience in research in the developing world and evidence of scientific productivity in studies in maternal and child health in the developing world are essential, and must also be demonstrated.

Applicants who are current Global Network members should describe their participation and contribution to the network in detail (e.g., attendance at Steering Committee meetings, active participation in standing subcommittees, mentoring of Global Network scholars, participation in common protocols, etc.), including their particular contribution to Global Network trials and studies, patient enrollment, etc. Relevant research studies should be described and related publications listed.

New applicants must describe their recent experience and participation in randomized clinical trials, preferably of a multicenter nature. Specific roles (PI, participating site, steering committee, writing committee, trial design and development) should be described for each study. Publications should be listed that resulted from participation in the studies.

Organizational Capability

Applicants should describe their research organization, and that of the developing country institutional partner, and include plans, information, and documentation that indicate their institutional or organizational capability to manage funds and to accomplish the proposed research successfully. Details of special administrative strengths or experience as well as participation in administrative aspects of clinical research (Institutional Review Boards [IRBs], Federal Wide Assurance, advisory boards for clinical research, clinical research committees, special consent procedures), the ability to clear research supplies through customs, and to produce drugs in-country should be supplied. A description of aspects of the health system in the developing country that will impact the ability to conduct community-based research should also be provided.

Applicants should also describe how they will utilize membership in the Global Network to enhance the productivity of the network and advance the objectives of the program.

History of Collaboration

Applicants must describe any relevant international collaborative research activity undertaken between the U.S. applicant PI/institution and its developing country partner SFI/institution. Evidence of successful domestic and/or international research network or multicenter research activity also should be provided. Contributions and collaborations in areas such as protocol design, study recruitment, data analysis and interpretation, and publication should be highlighted. Documentation of recruitment and retention rates in clinical trials should be provided. The U.S. PI should clearly document previous time spent, activities, and outcomes at the foreign site.

Evidence of Foreign Institutional Support

Applicants must demonstrate the foreign research partner's institutional commitment to and support for the proposed collaborative research study. Documentation from key administrative personnel at the foreign institution should indicate support for research staff participation in the Global Network and authorize some potential use of institutional resources. Examples of such resources may include administrative staff assistance, equipment, supplies, access to office, clinic or laboratory space, etc. Applicants also should provide evidence of support for their research collaboration from the appropriate foreign government authorities (monetary and non-monetary), as well as any international organization(s), with a regional or country mission or component that is proposed to be involved in the study.

Appropriate Multidisciplinary Expertise and Capability

The application must be submitted by a U.S. applicant institution on behalf of the U.S. and foreign country collaborative partners. Applicants must present evidence of the professional expertise, experience, and capacity of both the U.S. PI and the developing country SFI to develop and implement the research proposed to be undertaken within the Global Network.

Applicants must demonstrate a multidisciplinary approach to the design and implementation of their proposed collaborative study. They should provide a list of available multidisciplinary biomedical and behavioral scientists, physicians, and public health personnel to act as consultants in the design and implementation of common protocols. This team must be capable of conducting the described research, and must be familiar with the clinical services for women and children at the site or in the community where the research will be conducted. Steps to ensure effective communication and cooperation across disciplines should be identified. Prior successful experience of the consultants with multidisciplinary multicenter research activities and implementation of research findings should be indicated.

Population Available for Clinical Trials

Applicant Research Units must describe at-risk populations of pregnant women and children to three years of age who are available to them and their multidisciplinary colleagues to perform community based common protocols described in the scope section. Investigators must be prepared demonstrate the ability to recruit patients from outside their own institutional sites.

Awareness of Ethical and Cultural Issues in Global Research

Applicants must demonstrate an awareness of and describe their experience with any ethical and cultural issues that should be considered in the design, implementation, analysis, and publication of research studies undertaken with women and children in developing countries. This includes issues related to framing of appropriate research questions, recruitment and retention of study populations, informed consent and other human and animal subject considerations, design and use of research methods and instruments, data analyses and interpretation, and dissemination and application of findings to benefit the study populations, sustainability planning, as well as the international and domestic research and healthcare-provider communities. Any relationship of the study topic to national or local health policy should be clearly explained.

Capacity for Communication

Applicants should include a description of existing and anticipated technological and staff resources for the establishment and maintenance of computer-based and other communications linkages to facilitate information and research data sharing between the U.S. and developing country sites. Applicants must provide, at a minimum, assurance of or planning for e-mail capability at all sites. Technological and resource needs and limitations related to communication and data management also should be indicated. This information will help the NIH co-sponsors to assess available and potential technology, and to determine what resources might be needed to support communication among the Global Network Research Units, the Data Coordinating Center, and the NIH.

Travel

It is expected that scientists from the U.S. institutions will travel to the research site's foreign country counterparts for periodic consultations and collaborative work with the resident scientists in research directly related to the objectives of the grant award. It is anticipated that foreign country scientists also might travel to the U.S. for purposes of training or collaborative work related to the grant award. All travel must be justified in detail in the application, including the purpose of any proposed staff travel and proposed duration of stay at the U.S. or foreign research unit site. The terms of award will specify NICHD approval required prior to rebudgeting funds into or out of travel.

Acceptance of the Budgetary Mechanism

Assurance of cooperation with negotiated fixed protocol budgets for each individual protocol, in addition to a base budget, should be provided from the departmental and institutional offices of sponsored research programs. The appropriate Federal cost policies and regulations governing NIH grant programs will be applied.

Data Coordinating Center (DCC) Applicants

Minimum requirements for Data Coordinating Center applicants are as follows and must be addressed in the application:

Evidence of Successful Past Performance

DCC applicants must demonstrate prior experience and provide evidence of successful past performance as a data coordinating center in multi-center studies during the previous five years. Relevant experience in international multi-center randomized clinical trials should be described.

Appropriate Staff Expertise and Capability

The DCC will consist of a Principal Investigator and other staff deemed necessary to carry out its mission. The proposed DCC staff must be prepared to cooperate effectively in all network functions with NICHD and the Research Units. The Principal Investigator and other staff must have appropriate expertise and capability in biostatistics, study development and support, data management, data analysis, and project management, including, but not limited to, staff and site training and quality assurance procedures.

Capacity and Ability to Manage Data and Communications

DCC applicants must have the ability to assist in designing protocols, data collection forms, manuals of operation, and data collection systems, including distributed data entry. Applicants must have experience in developing and maintaining data quality control systems. The applicants must also provide evidence of data management and program support capabilities by describing standard operating procedures that address: 1) plans for data collection, management, analysis, and quality control; and 2) plans for supporting a communications system for participants in the Global Network that will include email, conference calls, and web-based strategies.

Demonstrated Expertise in Developing Research Capacity

DCC applicants must provide evidence of demonstrated expertise and adequacy of plans to develop capacity for independent research among investigators in the developing world.

Demonstrated Ability to Respond to Changing Common Protocols

DCC applicants must have the demonstrated ability to respond to changing common protocol needs of the GN.

Evidence of Reporting and Publications Capabilities

DCC applicants must provide evidence of their capacity to generate monthly reports on subject enrollment for several concurrent studies; quarterly reports on enrollment and RU performance; reports for the use of the DSMB, Advisory Group, Steering Committee, and Subcommittee meetings, and other special reports as required, including prompt conference call reports. The applicants must demonstrate successful experience in assisting investigators to prepare manuscripts for publication.

Experience in Providing Logistical and Other Support Services

DCC applicants must provide evidence of successful experience in arranging logistical support services for multi-center research, for example, meeting and conference support; and assuring and assisting with the appropriate preparation and delivery of study medications and other supplies to research sites participating in common protocols and clinical trials.

Evidence of On-Site Monitoring Capabilities

DCC applicants must have experience and demonstrate capability, including linguistic capacity, in organizing and conducting on-site monitoring of multi-center trials.

Evidence of Technology Transfer and Data Management Training Capabilities

DCC applicants must demonstrate their capability to assist the Global Network RUs to enhance their data management and communication or transmission activities. Evidence of training and technical assistance, expertise, and experience in this area must be provided.

Evidence of Management Capability

DCC applicants must provide evidence of superior ability to 1) estimate appropriate and reasonable resources needed for individual projects; 2) manage those resources efficiently during the trials; 3) adjust the assigned staff and other resources in response to changing work needs as common protocols unfold; 4) report these resource allocations periodically to NICHD; and 5) subcontract with outside organizations or other organizational entities as needed to supplement these resources

Travel

It is expected that scientists from the U.S. institutions will travel to their foreign country counterparts for periodic consultations and collaborative work with the resident scientists on research tasks directly related to the objectives of the grant award. It is anticipated that foreign country scientists might also travel to the U.S. for purposes of training or collaborative tasks related to the grant award. Applicants should indicate the purpose of any proposed staff travel and duration of stay at the U.S. or foreign RU site.

Evidence of Capacity for Database Development

DCC applicants must have the commitment and capacity to develop and implement plans for a future database from all common protocols that is accessible to the public within two years of study completion, in collaboration with the Steering Committee and NICHD.

Budget Request

Research Units

Research Unit applicants should provide separate budgets for the domestic site and the foreign site. The use of budget summary tables and other descriptive tools is strongly encouraged to clarify institutional and research-related expenses. Plans and procedures for monitoring budgetary expenditures at the domestic and foreign sites must be clearly specified. At the time of award, a consortium agreement must be in place between the U.S. grantee and the foreign site(s). Budget requests should include the following:

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

• U.S. PI: 20 percent effort;
• SFI: 25 percent effort (a portion of this amount may be reallocated to a co-SFI)
• U.S. study coordinator/research nurse: 50 percent effort
• SFI study coordinator: 100 percent effort
• SFI data management/information technology coordinator: 25 percent effort
• SFI data entry clerk: 50 percent effort
• Supplies /and small equipment (itemized and justified): not to exceed $5,000
• Travel costs (a total of two PI and two SFI trips to DC metro area and one PI trip to the international site): $10,000, as appropriate
• Expenses related to activities to strengthen research capacity at the foreign site: $2,000, as appropriate
• Expenses related to sustainability planning: $1,000, as appropriate
• Other costs (itemized and individually justified): Not to exceed $3,000.

An RU applicant may request a project period of up to five years and a base budget for direct costs up to $150,000 dollars in the first year. Additional funds for the execution of protocols will be awarded to the RU under "other expenses. Fixed budgets to support recruitment to common protocols will be negotiated at a later date, but for NICHD budgetary planning purposes, applications for the RU's should include a request for $140,000 direct costs under Other Expenses for restricted protocol funds. These funds are to be included for NICHD, NCI and NCCAM budgetary planning purposes only and may be adjusted upwards/downwards as necessary. Once an application has been favorably recommended and is being considered for funding, the RU will be required to complete protocol budgets for those protocols underway in the network. These budgets will consist of specific protocol related allowance and will be negotiated based on the cost of conducting the study, including the number of subjects to be enrolled in the protocol at the RU.

The annual negotiated fixed protocol budgets will consist of specific protocol-related allowances (fixed protocol costs) and will be awarded based on the anticipated number of subjects to be enrolled in the study at the international center. Each RU PI will be required to project patient enrollment for a specific protocol during a specified time frame; continuation and the level of funding will be based on actual enrollment. Each year fixed protocol budgets will be rectified based on actual successful enrollment. Future years' base budgets of the RUs should be limited to the first year base budget costs, with an annual increment of base salary and travel costs not to exceed three percent (the maximum amount available for equipment, supplies, and other costs will not increase). Federal agencies shall use the negotiated rates for F & A costs in effect at the time of the initial award throughout each competitive cycle of the project; F & A costs for the foreign component will be limited to eight percent.

Percent Effort

U.S. PIs of the Global Network Research Units must expend 20 percent effort annually on the award over the entire period of support (as above), with a significant effort expended at the foreign site. The SFIs of the Research Units must be substantially involved, spending 25 percent effort annually on the award over the entire period of support. It is anticipated that this will support the effort of the PI and SFI to conduct at least one common protocol. An additional five percent effort as investigator salary may be awarded annually to the foreign site for each additional common protocol successfully implemented at the sites, as appropriate. The PI of a common protocol may receive an additional five percent effort annually for the duration of the common protocol, as appropriate.

Data Coordinating Center

An application for the Data Coordinating Center is submitted by an institution on behalf of the PI of the Data Coordinating Center who should propose an organization support plan for the GN in the application, clearly outlining the plans for staff and site training, quality assurance procedures, the operation and integrity of the GN study databases, GN study development and support, and analytic capacity. These responsibilities should be presented with plans, processes, and timelines.

The Data Coordinating Center applicant should be able to respond flexibly to the changing needs of the GN as the common protocols unfold, adding and deleting staff as the requirements dictate. The application should reflect an understanding of these processes. The application must provide evidence of data management capabilities by describing standard operating procedures that address: (1) plans for database design and administration; (2) plans for data collection using distributive data entry, data management and analysis, and data quality control; (3) plans for developing capacity for data collection, data management and analysis at the international sites (see Section V.1.).

The budget for the Data Coordinating Center should include, at a minimum, salary and administrative support for the PI, a project director for each common protocol, and staff required to efficiently support open independent GN RU studies, as well as staff to support the development of new common protocols, site visits, training, quality assurance, quality control, drug supply and distribution, and special consultation, as required. It also should provide funds for Data Coordinating Center staff to travel to two GN Steering Committee meetings, and to support travel arrangements for participants attending two DSMB and one Advisory Board meeting per year. An applicant for the DCC may request a project period of up to five years and a budget of direct costs up to $800,000 in the first year. Future years' budget of the Data Coordinating Center will include an annual increment of base salary and travel costs not to exceed three percent.

Plan for Sharing Research Data

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

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

1. Criteria

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

The following will be considered in making funding decisions:

• Scientific merit of the proposed project as determined by peer review
• Availability of funds
• Relevance to program priorities
• Geographic balance and diversity
• Potential site visit observations at most competitive sites
• Willingness to adhere to the terms and conditions of the Cooperative Agreement award

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NICHD in accordance with the review criteria stated below.

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

• Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
• Receive a written critique.
• Receive a second level of review by an appropriate national advisory council or board.

Criteria for Evaluation of Research Unit Applications:

Commitment to the goals of the Global Network, including the collaborative model described in this RFA:

• Commitment to work collaboratively with the NICHD, NCI and NCCAM, the other PIs and SFIs in the Global Network, and the Data Coordinating Center to achieve the goals of this solicitation;
• Adequacy and breadth of understanding of existing global research related to women's and children's health in developing countries and awareness of the ethical and cultural issues and concerns related to the conduct of research within developing countries;
• Evidence of foreign institutional commitment to the research effort and to the Global Network, e.g., letters of support and other documentation of commitment to provide resources, e.g., space, staffing, in kind resources; and
• Evidence of commitment of the foreign government/health care system to implement positive research findings.

Qualifications and Commitment of Key Personnel:

• Experience of PI and SFI in multicenter randomized clinical trials conducted in the developing world;
• Evidence of prior successful scientific collaboration involving the U.S. investigators and foreign researchers in a developing country;
• PI and SFI expertise in obstetrics, pediatrics, maternal-fetal medicine/perinatology, neonatology, infectious disease/immunology, or gastroenterology;
• Availability of other consultants at the U.S. and foreign site with expertise in the above areas as well as environmentalists, epidemiologists, behavioral and social scientists, etc., to assist in the design and implementation of diverse common protocols responsive to this RFA;
• Experience, capacity, and commitment to community-based interventions that go beyond hospital-based community outreach; and
• Demonstrated potential and commitment to initiate common protocols and to participate in jointly-determined research designs and data sharing.

Protocol and Procedures:

• Quality of the RU's participation in the current grant period (current network members) or in similar recent collaborative research (new members);
• Demonstrated willingness and ability to work and cooperate with other Network sites, the Data Coordinating Center, and the NICHD in a manner summarized in this RFA;
• Willingness to work with the Data Coordinating Center on developing and maintaining data management and quality control systems, data monitoring, and recruitment and tracking of participants; and
• Acceptance of negotiated fixed protocol funding of common protocols (see Budget Preparation).

Facilities and management:

• Availability of and access to relevant and sufficient populations for studies related to women and children's health in developing countries;
• Adequacy of administrative, clinical and data organizational management facilities; and
• Institutional assurance to provide support to the RU in such areas as fiscal administration, personnel management, space allocation, procurement, planning and budgeting.

Scientific Review of Concept Proposal:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

1. Significance. Does this intervention address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of this intervention on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

2. Approach. Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the proposed intervention? Does the applicant acknowledge potential problem areas and consider alternative tactics?

3. Innovation. Is the proposed intervention original and innovative? For example: Does the proposed intervention challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the proposed intervention develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

4. Investigators. Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the proposed intervention?

5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

• Quality of the scientific basis for the evidence-based intervention;
• Appropriateness of the proposed protocol for implementation in a network with the goals, structure, organization, and likely enrolled populations of the Global Network;
• Adequacy of plans for implementing the proposed study;
• Plans for the recruitment and retention of subjects;
• Strength and adequacy of plans for study site management, collaboration, and communication;
• Quality of sustainability plan;
• The reasonableness of the proposed budget and its duration in relation to the proposed research; adequacy of plans and procedures for monitoring expenditures at both the domestic and foreign sites.

Criteria for Evaluation of Data Coordinating Center Applications:

• Demonstrated prior experience as a coordinating and statistical center in global multi-center randomized clinical trials and studies;
• Appropriate biostatistical, computational, data management, and coordination expertise and capability of the PI and other staff;
• Demonstrated ability and adequacy of plans to assist in designing protocols, study manuals, and data collection systems, including distributed data entry. Multilingual capability to facilitate document translation and protocol implementation is an advantage;
• Documented ability and adequacy of plans to develop central data collection, management, and analysis for the network;
• Demonstrated experience and adequacy of plans to develop and implement data monitoring and patient tracking systems;
• Demonstrated experience and adequacy of plans to develop and maintain quality control systems, and guarantee the quality and integrity of collected data;
• Commitment to cooperate with the Research Units and NICHD, NCI and NCCAM in all design, collection, and analysis functions;
• Demonstrated expertise and adequacy of plans to develop capacity for independent research among investigators in the developing world;
• Plan to respond to the changing common protocol needs of the GN;
• Documented ability and adequacy of plans to report monthly to the NICHD, NCI and NCCAM and the Steering Committee, as well as prior to each Steering Committee meeting, regarding accumulated data and Research Unit performance;
• Documented ability and adequacy of plans to organize and coordinate the DSMB, and Steering Committee meetings twice a year, and other Network-related meetings as necessary. Commitment to attend all Network meetings;
• Demonstrated ability to assist the NICHD, NCI and NCCAM in securing services of special experts to supplement the expertise of the Steering Committee;
• Commitment and capacity to develop and implement plans for a future database from all common protocols that is accessible to the public within two years of study completion, in collaboration with the Steering Committee and NICHD, NCI and NCCAM.

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

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

2.D. Sharing Research Resources

NIH policy requires that grant award recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

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

3. Anticipated Announcement and Award Dates
Not applicable

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the Notice of Grant Award will be generated via e-mail notification from the awarding component to the grantee business official (designated in Item 14 on the Application Face Page). If a grantee is not e-mail enabled, a hard copy of the Notice of Grant Award will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

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

2.A. Cooperative Agreement Terms and Conditions of Award

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

The administrative and funding instrument used for this program will be the cooperative agreement ( NIH U01), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2.A.1. Principal Investigator Rights and Responsibilities

Research Units

Each Global Network Research Unit will be led by a U.S. PI and a SFI at the developing country site. Specifically, the Research Units will have primary responsibility for:

• Identifying priority areas for research;
• Developing and implementing research protocols, interventions, and evaluation strategies;
• Presenting research concepts, plans, progress, and results to the Protocol Review Subcommittee and Steering Committee;
• Projecting patient enrollment for common protocols during a specified time frame; continuation and level of funding will be based on actual recruitment;
• Implementing any network-approved common study protocols, where feasible, including the recruitment and monitoring of study participants, associated data collection, and study-associated quality control measures at the study sites, in collaboration with the Data Coordinating Center;
• Specifying plans for compliance with all Food and Drug Administration regulations and for working with the Data Coordinating Center to secure any necessary drugs;
• Obtaining institutional assurance from Office of Human Rights Protection (OHRP) and local IRB approval of all study protocols implemented at U.S. or foreign sites and complying with both IRBs' policies and procedures;
• Complying with network policies and procedures;
• Submitting abstracts and manuscripts to the Publication Subcommittee and publication and dissemination of results of both independent and shared research. When common protocols are completed, publication of results in collaboration with other involved Global Network Research Units;
• As a shared activity with the Data Coordinating Center and NICHD, collection, analysis, and interpretation of data, and dissemination of research results from Global Network studies;
• Participating in conference calls, attending network meetings held at least twice annually, and submitting trip reports within four weeks of international travel associated with the Global Network;
• Participating in activities to enhance independent research capacity at the developing world site, including facilitating the identification and mentoring of promising junior investigators, and reporting sustainability planning and benchmarks for Research Units, as described in the terms and conditions of award;
• Working to ensure that the results of network research are implemented in country to improve the outcome of mothers and children;
• Submitting annual progress reports to NICHD and the other co-sponsoring NIH IC(s), as appropriate; and
• Providing study and site performance information.

The Data Coordinating Center

The Data Coordinating Center will provide research support services to the Global Network. These will include establishment and maintenance of a centralized information management system to assist the Global Network Research Units in collecting, editing, storing analyzing, publishing, and disseminating results from their individual projects as well as from shared research. It will assist the program staff of the NICHD and other NIH co-sponsors in monitoring research progress, and will work to ensure data integrity, accuracy, and accessibility among all Research Unit sites. It will offer technical assistance and analytical support for all sites, as needed. The Data Coordinating Center will provide particular attention to the needs of developing country sites, for the purpose of helping develop and enhance their capacity for independent data collection, management, and analysis. Initially, the Data Coordinating Center primarily supported the individual research projects undertaken by Global Network Research Units. However, as the Network undertakes common protocols, the Data Coordinating Center must be prepared to respond to the needs of shared research projects.

All activities of the Data Coordinating Center must be closely coordinated with the Steering Committee Chair and NICHD Program Scientist. In support of all research projects undertaken by the Global Network, the Data Coordinating Center staff will:

• Support the activities of the Steering Committee, DSMB, and Advisory Board through provision of materials/documentation support, meeting planning and logistics, and conference call coordination;
• Provide advice on study design, data collection, data analysis, and publication development to all Global Network research projects;
• Assist in the preparation, design, and dissemination of operations manuals, data collection forms, databases, and results reporting summaries for Global Network research projects;
• Compile site visit reports, monthly and quarterly subject enrollment reports, meeting summaries, quarterly Research Unit performance and progress reports, and other reports as needed for the Steering Committee, DSMB, NICHD, other participating NIH sponsors, and Advisory Board;
• Maintain or assure maintenance of high quality databases resulting from any collaborative research, supervise all data collection procedures, and arrange for the most efficient transfer of study data where indicated;
• Ensure that all Global Network sites and investigators fully comply with Department of Health and Human Services (DHHS) and NIH requirements, including informed consent, reporting of adverse events, human and animal subject safety and welfare provisions, and the requirements of international collaboration;
• Provide training to all Research Unit site personnel as needed on data management and analysis, quality control, and quality assurance;
• In coordination with the NIH co-sponsors, provide periodic on-site monitoring to the Research Units for those studies being performed at that site;
• Participate in regular conference calls and attend network meetings; and

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

2.A.2. NIH Responsibilities

A NICHD Program Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

A number of program staff from the NICHD and from the co-sponsoring NIH ICs also will be involved in the Global Network program, primarily as Staff Science Collaborators. Each research study will have a Staff Science Collaborator involved. Every protocol will be reviewed by NIH according to NIH policies and standard practices.

NICHD Staff Involvement: Program Scientist, Project Officer, and Staff Science Collaborators

NICHD Program Scientist

The NICHD Program Scientist will serve as the principal representative of NICHD and NIH and will have substantial programmatic and scientific involvement that is above and beyond the normal stewardship role in awards and will, in consultation with relevant NICHD program staff and representatives of the other NIH co-sponsors, will provide overall programmatic oversight, coordination, and assistance to the Global Network.

Specifically, the NICHD Program Scientist will:

• Facilitate communication, cooperation, and the exchange of information among network members and between the network components and other existing programs to support collaborative efforts;
• Participate as a voting member of the Steering Committee;
• Consult with NICHD program staff and NIH co-sponsors, who may be designated as Staff Science Collaborators assigned to specific studies, when needed for optimal implementation of study designs;
• Assist the Steering Committee in the selection and approval of important research topics and the development and review of protocols for any specific studies;
• Together with the Steering Committee Chairperson, approve formation and membership of any Steering Committee subcommittees;
• Assist in the development and review of fixed protocol budgets, including the identification of study costs and special institutional needs;
• Assist in the review and evaluation of each stage of the program before subsequent stages are started, in conjunction with the Steering Committee and the Advisory Board
• Assist in the conduct of the trials, including ongoing review of progress; possible redirection of activities to improve performance and cooperation; and frequent communication with other members of the Steering Committee;
• Participate in the Steering Committee and all active subcommittees;
• Oversee site participation and performance with the support of the Data Coordinating Center; and
• Participate in study design, data analysis, interpretation, and publication of study results.

NICHD Project Officer

Additionally, a NICHD Project Officer will be responsible for the normal scientific and traditional programmatic stewardship of the cooperative agreement award and will be named in the award notice. This role is separate from the Program Scientist and will include the following:

• Assurance of scientific merit of the trials, including the option to withhold support to a participating institution if technical performance requirements such as protocol compliance, enrollment targets, or randomization of subjects are not met;
• Continuous review of all activities to ensure that the objectives are being met and that all regulatory, fiscal, and administrative matters are handled according to NIH guidelines;
• Initiation of a decision to modify or terminate a study based on the advice of the Data Coordinating Center, DSMB, and/or Advisory Board with the mutual consent of the Steering Committee and at the direction of the Director, NICHD; and
• Other duties required for normal program stewardship of grants for the Global Network.

NICHD Staff Science Collaborators

Other NICHD staff may be assigned as Staff Science Collaborators for network grants assigned to them in their areas of scientific expertise. They may participate in Steering Committee meetings as non-voting members. Specifically, the NICHD Staff Science Collaborators will, in consultation and collaboration with the NICHD Program Scientist:

• Provide programmatic oversight and assistance to awardees assigned to the NICHD;
• Provide advice, when needed, for optimal implementation of intervention designs;
• Assist in overseeing site participation and performance, as needed, with the support of the Data Coordinating Center;
• Participate, as needed, in study design, data analysis, interpretation, and publication of study results relevant to the research conducted by their respective grantees.

NIH Co-sponsor Staff Science Collaborators

Program representatives of the other NIH co-sponsors may serve as Staff Science Collaborators for grants assigned to their respective NIH Institutes and Centers. They may participate in Steering Committee meetings as non-voting members. Specifically, the NIH Staff Science Collaborators will:

• Provide programmatic oversight and assistance to awardees assigned to their respective NIH Institutes, in consultation and collaboration with the NICHD Program Scientist;
• Provide advice, when needed, for optimal implementation of intervention designs;
• Assist in overseeing site participation and performance, as needed, with the support of the Data Coordinating Center; and
• Participate, as needed, in study design, data analysis, interpretation, and publication of study results relevant to the research conducted by their respective grantees.

2.A.3. Collaborative Responsibilities

In addition to the above specified rights, responsibilities, and involvement, the Global Network components have collaborative responsibilities. These include interaction with the Advisory Board, the DSMB, and membership on the Steering Committee.

Steering Committee

The Steering Committee will serve as the Global Network's central point of communication; exchange of ideas; development, review and management of common protocols; research and training activities; and problem resolution. The Steering Committee reviews all presentations and publications. The Steering Committee is composed of the U.S. PI and SFI of each Research Unit, the PI of the Data Coordinating Center, and the NICHD Program Scientist, each of whom have one vote. NICHD will appoint a Chairperson who is not participating as a PI for a minimum term of one year. Representatives of other NIH co-sponsoring Institutes and Centers (ICs) may participate as non-voting members.

The Steering Committee will meet twice annually in person and will participate in telephone or video conferences as needed between Steering Committee meetings. During the meetings, research progress and problems are reviewed for each site.

The Steering Committee members will:

• Agree to accept the participatory and cooperative nature of the group process and agree to collaborate with other awardees, the Data Coordinating Center, and the NIH;
• Assist in the identification of priority research issues related to women's and children's health in developing countries;
• Approve the direction of joint research efforts and facilitate the conduct and monitoring of these studies;
• Approve all Global Network policies and procedures;
• Approve the research plans based on feasibility and clinical relevance, and provide advice on implementation strategies;
• Identify a need and propose members for Steering Committee subcommittees to undertake specific activities or to review issues, policies, or procedures of particular interest to the Global Network, subject to the approval of the NICHD Program Scientist and the Steering Committee Chairperson; and
• Agree to accept and implement policies approved by the Steering Committee.

Data and Safety Monitoring Board

A Data and Safety Monitoring Board (DSMB) is established by NICHD to monitor the safety of ongoing clinical trials. It also advises the NIH and the Global Network, including the Data Coordinating Center, on research design issues, data quality and analysis, and ethical and human subject issues. The DSMB members have expertise in clinical trial design and conduct; relevant basic, medical, and behavioral sciences research; and ethics and cultural competency issues, particularly with relevance to developing country populations. The Data Coordinating Center provides coordination, support, travel funding, and logistical arrangements for DSMB meetings and actions.

In addition, the network has established policies and procedures that govern its operations, including publication. These documents are under periodic review, and may be amended and supplemented at the discretion of the NICHD and the Steering Committee.

Advisory Board

An Advisory Board will advise the Steering Committee in the identification and prioritization of topics for network research. The Advisory Board, chosen by the NICHD with the advice of the Steering Committee, will be composed of individuals with expertise in clinical trials; biostatistics; epidemiology; obstetrics; pediatrics; infectious diseases; social sciences; behavioral sciences; basic sciences; and ethics. Additional members will participate based on the need for specific expertise. The Advisory Board will meet at least annually.

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

The Data Coordinating Center will compile site visit reports, monthly and quarterly subject enrollment reports, meeting summaries, quarterly Research Unit performance and progress reports, and other reports as needed for the Steering Committee, DSMB, NICHD, other participating NIH sponsors, and Advisory Board. Trip reports will be submitted to NICHD within four weeks on any international travel by network participants.

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

1. Scientific/Research Contacts:

Linda L. Wright, M.D.
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Executive Boulevard
Room 4B05, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 402-0830
FAX: (301) 480-7773
Email: [email protected]

2. Peer Review Contacts:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard
Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email: [email protected]

3. Financial or Grants Management Contacts:

Angelos Bacas
Grants Management Specialist
National Institute of Child Health and Human Development
6100 Executive Boulevard
Room 8A07F, MSC 7510
Bethesda, Maryland 20892-7510
Rockville, Maryland 20852 (for express/courier service)
Telephone: (301) 435-6976
FAX: (301) 451-5510
Email: [email protected]

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of DSMBs is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html). The Global Network will have a DSMB appointed by NICHD.

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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

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

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

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

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

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

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

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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

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

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

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

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