Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (www.nih.gov)

Components of Participating Organizations
Office of Research on Women's Health (ORWH) (http://www4.od.nih.gov/orwh/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (http://www.niams.nih.gov/)
National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov/)
National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov/)
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/)
Food and Drug Administration (FDA) (http://www.fda.gov/womens/default.htm)

Title: Specialized Centers Of Interdisciplinary Research (SCOR) On Sex And Gender Factors Affecting Women’s Health (P50)

Announcement Type
This is a reissue of RFA-OD-02-002, previously released December 18, 2001

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

Request For Applications (RFA) Number: RFA-OD-06-003

Catalog of Federal Domestic Assistance Number(s)
93.846

Key Dates
Release Date: June 12, 2006
Letters of Intent Receipt Date(s): August 14, 2006
Application Receipt Date(s): September 14, 2006
Council Review Date(s): May, 2007
Earliest Anticipated Start Date(s): September, 2007
Expiration Date: September 15, 2006  

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research Objectives

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

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

Section IV. Application and Submission Information
  1. Address to Request Application Information
  2. Content and Form of Application Submission
  3. Submission Dates and Times
    A. Receipt and 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
  3. Reporting

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

PURPOSE

The Office of Research on Women's Health (ORWH) serves as a focal point for women's health research at the NIH.  The ORWH promotes, stimulates, and supports efforts to improve the health of women through biomedical and behavioral research. ORWH works in partnership with the NIH Institutes as well as the Food and Drug Administration (FDA) to ensure that women's health research is part of the scientific framework at NIH and throughout the scientific community.

The ORWH announces the Specialized Centers of Interdisciplinary Research on Sex and Gender Factors Affecting Women's Health (SCOR) program.  These centers will provide new opportunities for interdisciplinary approaches to advancing studies on how sex and gender factors affect women's health.  Each SCOR should develop an interdisciplinary research agenda bridging basic and clinical research on sex/gender factors underlying a priority women’s health issue. 

The ORWH has published "An Agenda for Research on Women's Health for the 21st Century" that provides at outline of research needs identified through national taskforces.  The executive summary of this report is available at the following URL:  http://www4.od.nih.gov/orwh/research.html.  This web site also provides the FY 2006 research priorities identified by the Institutes and Centers at NIH working with the ORWH. http://orwh.od.nih.gov/research/FY06research_priorities.pdf

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) will be the service center for the administration of this program.

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

RESEARCH OBJECTIVES

Background

The Office of Research on Women's Health (ORWH) and cosponsors seek to promote interdisciplinary research in sex/gender factors through Specialized Centers of Interdisciplinary Research (SCOR).   Each SCOR will promote interdisciplinary collaborations and develop a research agenda bridging basic and clinical research on sex/gender factors underlying a priority women’s health issue.  The SCOR program will complement other Federally supported programs addressing women's health issues.  Such programs include the Building Interdisciplinary Research Careers in Women's Health (BIRCWH, see http://orwh.od.nih.gov/interdisciplinary/bircwhmenu.html, The Women's Reproductive Health Research Career Development Centers (http://www.nih.gov/news/pr/sept99/nichd-13a.htm) and numerous NIH RFAs and PAs. 

Description of a SCOR

The objective of the SCOR program is to expedite interdisciplinary development and application of new knowledge to human diseases that affect women, to learn more about the etiology of these diseases, and to foster improved approaches to treatment and/or prevention.

Each SCOR should have a central theme related to the disease area to which individual projects relate and which serves as an integrating force.  The SCOR must provide an interdisciplinary approach utilizing both laboratory and clinical research to focus on a particular health problem and provide for a mutually supportive interaction between basic scientists and clinical investigators. Emphasis in proposed projects should be on interdisciplinary development of innovative approaches, elaboration of new and significant hypotheses, and generation of improved strategies for approaching current issues relating to the disease area addressed.  Collaboration among institutions is encouraged within a given SCOR to share scarce resources.

A SCOR consists of at least three individual, but interrelated, research projects, each with high scientific merit and clear research objectives and, in the aggregate, devoted to a specific major health area.  Both basic and clinical research must be present.  An administrative core must be proposed to coordinate the research program, providing intellectual leadership as well as basic management functions. Funding may also be requested for one or more core resources.  A core is defined as a resource shared by multiple investigators that enhances research productivity and increases the functional capacity of the SCOR.

NIH defines human clinical research as: (1) Patient-oriented research.  Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects.  Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual.  Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies, (2) Epidemiologic and behavioral studies, (3) Outcomes research and health services research.

Although the focus of the SCOR is on sex/gender factors, it is not required to have both a male and female cohort.  For example, the background section can include the current state of knowledge and review of the literature of studies related to men that can justify studies that will include cohorts of women only, consistent with NIH inclusion policies.

Support for large clinical trials or for applications that contain exclusively clinical or exclusively basic studies will not be provided within this SCOR program.

Applicants from institutions which have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research.  Details of the interactions of the SCOR staff with the GCRC staff and research personnel may be provided in a statement describing the collaborative linkages being developed.  A letter of agreement from the GCRC Program Director must be included with the application.

In summary, a SCOR must include:

1.  a broad interdisciplinary theme capturing an important issue in sex/gender factors in a priority women’s health issue (See sections on Research Scope and Required Overarching Themes, below);

2.  two overarching themes that are an integral part of the research plan: Sex/Gender Determinants and Interdisciplinary Research;

3.  an Administrative Core with a Center Director, Associate Director and executive committee with outstanding interdisciplinary credentials for advancing the research theme;

4.  a minimum of three interdisciplinary research projects, representing both basic and clinical research; and

5.  an established research program in areas related to the SCOR theme.

Additional core(s) supportive of two or more of the proposed projects may also be requested.

RESEARCH SCOPE

The research scope for the SCOR program derives from three sources:

1.  The Institute of Medicine report, "Exploring the Biological Contributions to Human Health, Does Sex Matter?" defined the use of  "sex" and "gender" (p. 8 and 176) as follows.  In the study of human subjects, the term "sex" should be used as a classification, generally as male or female, according to the reproductive organs and functions that derive from the chromosomal complement. In the study of human subjects, the term "gender" should be used to refer to a person's self-representation as male or female, or how that person is responded to by social institutions on the basis of the individual's gender then move presentation.  In most studies of nonhuman animals, the term "sex" should be used.  (See http://www.nap.edu and http://www.iom.edu/CMS/3740/5437.aspx.

2.  The intellectual background for establishing SCORs in sex/gender factors is also presented in the ORWH publication, "An Agenda for Research on Women's Health for the 21st Century."  This outline represents the recommendations from three national topic meetings examining research needs for women's health: (1) Scientific Areas, (2) Sex and Gender Perspectives Throughout the Life Cycle; and (3) Differences Among Populations of Women Throughout the Life Cycle.  The executive summary of these outcomes is available at the following URL:  http://www4.od.nih.gov/orwh/research.html.  The research areas identified through these meetings overlap and the SCOR program will address them through the perspective of sex/gender factors. 

3.  Current research priorities have been identified by the Institutes and Centers at NIH working with the ORWH and are found at the following URL:http://orwh.od.nih.gov/research/FY06research_priorities.pdf. The NIH is especially interested in fostering research in women’s health in the high priority areas of prevention and treatment, and the biological and behavioral basis of sex and gender differences. Research may relate to acute and chronic diseases and disorders including but not limited to, metabolic, inflammatory, endocrine, autoimmune, gastrointestinal, liver, urologic, ophthalmic, oral, reproductive, musculoskeletal, neurological, psychiatric, addictive and cardiovascular diseases.  These research priorities are not an exclusive list of research areas important to women’s health; therefore other innovative or significant research areas should also be considered.  The sections below on Sex/Gender Determinants, and Interdisciplinary Research are of particular interest to the SCOR program and are required elements for the SCOR application.

I. OVERARCHING THEMES

a. The following two overarching themes are required to be an integral part of the research plan: Sex/Gender Determinants and Interdisciplinary Research:

Sex/Gender Determinants: Women are characterized by both sex and gender as highlighted in the Agenda for Research in Women ’s Health for the 21st Century and the Institute of Medicine report, entitled Exploring the Biological Contributions to Human Health: Does Sex Matter? In this context, the term sex refers to being male or female according to reproductive organs and functions assigned by chromosomal complement. Sex factors that contribute to the biological differences include chromosomes, reproduction, and hormones. Gender refers to socially defined and derived expectations and roles rooted in biology and shaped by environment and experience. Gender and sex are important considerations in most areas of research, including psychological, social, and behavioral studies. Consideration of these variables is critical to the accurate interpretation and validation of research affecting women’s health. Moreover, these variables determine how similar or different health or disease processes may be among women or between men and women.

Interdisciplinary Research: Research integrating knowledge from disparate sources and research teams with multiple areas of scientific expertise (for example, physicians, statisticians, epidemiologists, dentists, pharmacologists, nurses, biotechnologists, social scientists, and geneticists) are needed in women’s health.  Interdisciplinary research can facilitate the integration of basic science, clinical research, translational research, population studies, behavioral and social research, and outcomes research.  An additional focus on bioengineering and biomedical informatics, genomics, proteomics, imaging, and metabolomics is increasingly relevant to research on women’s health.

Programs must ensure that research projects are interdisciplinary in nature. With increasing understanding of the inter-relatedness and complexity of disease, the nature of scientific investigation is shifting to an interdisciplinary collaborative approach.  Advances in our understanding of sex and gender factors in health and disease can be enhanced through scientific progress across biological, physical and social science disciplines.  Interdisciplinary approaches can integrate knowledge from multiple perspectives, resulting in more complex definition of underlying common normal or pathologic processes.  Collaborations among research scientists in academia, private industry, and federal settings, could also provide access to the latest scientific tools and technologies for women’s health and sex/gender research.

b. Other overarching themes of priority for sex /gender research which may be included in the application are:

Lifespan: The health of girls and women is affected by developmental, physiological, and psychological age. Women’s lives are marked by a continuum from intrauterine life to the elderly years: infancy, childhood and adolescence, menarche, reproductive life, the menopausal transition, postmenopausal years, the elderly, and frail elderly. Many women’s lives and health status are influenced by factors such as work inside and outside the home, care-giving such as childcare and elder care responsibilities, reproductive status, marital status, and chronic illness. Each of these may influence health, disease, treatment choices, and response to therapy. Researchers should consider these variables in designing studies related to women’s health.

Health Disparities/Differences and Diversity: Projects must also address sex/gender determinants. Women are affected by some conditions and diseases in terms of incidence, diagnosis, course, and response to treatment. Some populations of women may be at higher risk for adverse disease outcomes because of factors such as: biology, genes, culture, education, access to care, quality of care, and access to opportunities for inclusion as research subjects in clinical trials and studies. Thus, clinical research should include, but not be limited to, population-specific characteristics such as cultural diversity, race/ethnicity, immigrant status, rural or inner city residency status, effects of poverty or low socioeconomic status, sexual orientation, and physical or mental disabilities.

II. AREAS OF RESEARCH INTEREST

Basic, clinical and translational research should be considered in addressing priority areas in sex/gender research.  Some examples may include, but are not limited to:

Increased investigation into methods to prevent conditions and diseases, to better detect, or to better treat them, can result in significant improvements in the quality and length of life. Prevention research spans the continuum from the most basic biological studies to understanding the basis and effects of risk behaviors across the lifespan and the interventions to change them, including a focus on wellness and healthy behaviors. Examples of needed prevention, detection, and treatment research studies include, but are not limited to:

•Research to identify and validate biomarkers, including genetic polymorphisms, of disease risk, pathogenesis, progression, and their applications to disease prevention, early detection and treatment, including the development, evaluation and validation of novel tools and technologies;

•Studies of the impact on health of diet, nutrition, hormones, exercise, weight patterns, toxin exposures, obesity, eating disorders, sex practices, tobacco, alcohol and drug use or abuse, occupation, violence or trauma including the impact of the above on concomitant disease detection and treatment;

•Studies of the factors that are involved in disease initiation and progression, both biologic and behavioral, in order to develop effective preventive and treatment strategies;

•Development, testing, and validation of preventive, early detection, and treatment strategies for conditions and diseases including, but not limited to: sexually transmitted diseases, coronary artery disease, stroke, obesity, diabetes, musculoskeletal disorders, pain syndromes, addictions, and chronic multi-systemic diseases;

•Studies of the effect of biological, behavioral, cultural, social, economic, and environmental factors on susceptibility to, or protection from, disease and response to treatment;

•Determination of sex differences that may modify the role of known cellular pathways and gene defects in disease;

•Sex and gender differences in prevention, pathogenesis, course, response to treatment, and prevention, using basic, translational, behavioral, and clinical research approaches;

•Mechanism of sex effects on gene expression and cellular and signaling pathways in healthy women, including the impact of puberty, the menstrual cycle, pregnancy, and menopause;

•Genetic, molecular and cellular basis of action of pharmacologic agents in women, including differential effects between males and females;

•Development of novel methods of analysis to assist in discerning impact of sex in mechanisms of disease initiation, course, and response to treatment or other interventions;

•Effect of biologic and behavioral sex and gender difference on quality of life and quality opportunities for inclusion as research subjects in clinical trials and studies. 

Other examples of selected research areas are included below.  They should by no means be viewed as exhaustive, and are intended only as examples of those that may be most amenable to a theme relating to sex/gender factors:

SPECIAL REQUIREMENTS

The director and co-director should budget for an annual two day meeting in Bethesda, MD with ORWH staff. The director should be prepared to devote at least 25 percent total effort as both the director and as the PI on a Center project. Each project and core PI should be prepared to devote at least 15 percent effort.

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the National Institutes of Health (NIH) P50 award mechanism.
As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

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

2. Funds Available

The participating IC(s) (NIAMS, NICHD, NIDA, NIDDK, NIEHS, NIMH), the Office of Research on Women’s Health and the FDA intend to commit at least 10 million dollars in FY 2007 to fund approximately 10 new and/or competing continuation grants in response to this RFA. An applicant may request a project period of up to 5 years   and a budget for direct costs of up to $750,000 in the first year, excluding indirect costs of subcontracts.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.  ORWH will decide whether the SCOR Program will be renewed after the five year funding period.  Individual partnering NIH institutes and centers will also evaluate their continued participation at that time.

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

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

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

Established research programs in areas related to the SCOR theme must be present.

1.B. Eligible Individuals

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

2. Cost Sharing or Matching

Cost sharing is not required.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

N/A

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a 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): August 14, 2006
Application Receipt Date(s): September 14, 2006
Peer Review Date(s):  February-March, 2007 
Council Review Date(s): May, 2007
Earliest Anticipated Start Date: September, 2007

3.A.1. Letter of Intent

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

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

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

The letter of intent should be sent to:

Madeline Turkeltaub, RN, PhD, CRN,FAAN
ORWH SCOR Program Coordinator
Deputy Director, Extramural Program
NIH/NIAMS
6701 Democracy Blvd.  Suite 800
Bethesda, MD  20892
Phone:  301-451-5888
FAX:     301-480-4543
mturkeltaub@mail.nih.gov

 3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and five 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).

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

3.C. Application Processing

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at 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/archive/grants/policy/nihgps_2003/index.htm.

To be funded, a SCOR must include at least three highly meritorious projects approved for five years. One of these must have the SCOR director as the principal investigator, and the highly meritorious projects must include both basic and clinical research.  Guidelines have been developed to assist in developing a SCOR application. These guidelines are available at the following URL: http://www.niams.nih.gov/rtac/funding/grants/scor/orwhscorguidelines.htm

Administrative support personnel may be budgeted in at no more than one full time equivalent (FTE) which may be divided among one or more positions. This FTE must be fully justified.

Since the ORWH is interested in funding only the best research, individual projects or cores of lesser quality may not be funded, even if approved, under the “umbrella” of the SCOR mechanism

6. Other Submission Requirements

N/A

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

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

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/archive/archive/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

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

 Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.  The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application 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 the 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.

The following will be considered in making funding decisions:

Since the ORWH is interested in funding only the best research, individual research projects of lesser quality may not be funded, even if approved under the “umbrella” of the SCOR mechanism.  For this reason, each project will be assigned a separate priority score.  A SCOR must include at least three highly meritorious interdisciplinary research projects representing both basic and clinical research.

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 the Center for Scientific Review in accordance with the review criteria stated below.

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

Review Criteria for Individual Projects:

Significance: Does this study 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 these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? Does the project incorporate sex/gender determinants and interdisciplinary research as parts of the research plan? Does the project advance the theme of the SCOR and contribute to the interaction of basic research and clinical investigation?

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 project?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Does the proposed study benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Are the facilities adequate to perform the proposed research?

Review Criteria for the Administrative Core:

Is there scientific and administrative leadership, commitment and ability, and adequate time commitment of the SCOR Director for the effective management of the SCOR program? Does the SCOR director have a minimum time commitment of at least 10 percent effort to the overall administration of the program plus 15 percent effort as a principal investigator of a SCOR project?

Is there a clinical investigator named in the Administrative Core who will be responsible for the translation of basic research to clinical research? Is there a plan to promote patient based research?

Does this Core include internal and external procedures for monitoring and evaluating the proposed research and for providing ongoing quality control and scientific review? Has the role of an Advisory Committee been described? Are there plans for outside review and input?

Is the management proposed appropriate for scientific administration as well as fiscal administration, procurement, property and personnel management, planning, budgeting, etc.?

Is there a plan for the establishment and maintenance of internal communication and cooperation among the SCOR investigators?

Review Criteria for additional proposed cores:

Does the core have utility to at least two of the SCOR projects? Is the relationship of the core to each project addressed?

Are the procedures to provide quality control for the core services clearly described and appropriate?

Do the services offered best fit within a core structure?

Are the personnel functions addressed and are the personnel appropriate to the intent of the core?

Are the facilities and equipment adequate? Is there institutional commitment to the core?

Review criteria for SCOR leadership:

Review Criteria for Environment and Resources:

Review Criteria for the overall application:

Review criteria for Applications Seeking Competitive Renewal:

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.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

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

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing

2.D. Sharing Research Resources
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 (See the NIH Grants Policy Statement http://grants.nih.gov/archive/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.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

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

N/A

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. 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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.htm).

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.  An electronic copy of the Progress Report should also be sent directly to Office of Research on Women’s Health SCOR Program Coordinator.

An annual non-competing continuation application, which includes a progress report, is due two months before the anniversary date of the award. The progress reports are used by the ORWH, partnering NIH institutes and centers, and the SCOR advisory committees to review the SCOR Center and its progress. They serve to document in detail the achievement of the objectives outlined in the initial application and award; they also serve as an important source of data for program staff in preparing annual reports, planning programs, and communicating scientific accomplishments. These progress reports should include the following:

Section VII. Agency Contacts  


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

1. Scientific/Research Contacts:

Madeline Turkeltaub, RN, PhD, CRNP, FAAN
Deputy Director, Extramural Program
NIAMS
6701 Democracy Blvd.  Suite 800
Bethesda, MD  20892
Phone:  301-451-5888
FAX:     301-480-4543
mturkeltaub@mail.nih.gov

Contact information for program staff in participating Institutes:

Madeline Turkeltaub, RN, PhD, CRNP, FAAN
Deputy Director, Extramural Program
NIAMS
6701 Democracy Blvd.  Suite 800
Bethesda, MD  20892
Phone: 301-451-5888
FAX:     301-480-4543
mturkeltaub@mail.nih.gov

Estella Parrott, M.D., M.P.H.
Program Director, Reproductive Medicine Gynecology
Reproductive Sciences Branch, Center for Population Research
National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 8B01
Bethesda, MD 20892-7510
Telephone: (301) 496-6515
Fax: (301) 496-0962
Email: parrotte@mail.nih.gov

Debuene Chang, M.D.
Director of Women’s Urology
Division of Kidney and Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza, Room 637
6707 Democracy Blvd.
Bethesda, MD 20892-2560
Telephone: (301) 594-4733
Fax: (301) 402-4874
Email: changtd@mail.nih.gov

Cora Lee Wetherington, Ph.D.
Women & Gender Research Coordinator
National Institute on Drug Abuse (NIDA)
6001 Executive Boulevard, Room 4282, MSC 9555
Bethesda, MD 20892-9555
Telephone: (301) 435-1319
Fax: (301) 594-6043
Email: cwetheri@mail.nih.gov

Jerrold (Jerry) Heindel, Ph.D.
Scientific Program Administrator
National Institute of Environmental Health Sciences
Division of Extramural Research and Training
Cellular, Organ and Systems Pathobiology Branch
POB 12233
Research Triangle Park, NC, 27709
(919) 541-0781(P)
(919)541-5064(F)
heindelj@niehs.nih.gov

Catherine Roca, M.D.
Chief, Women's Mental Health Program
National Institute of Mental Health (NIMH)
6001 Executive Blvd. Rm. 8125, MSC 9569
Bethesda MD 20892-9659
Telephone: (301) 443-3488
Fax: (301) 443-3553
Email: croca@mail.nih.gov

Kathleen Uhl, M.D.
Director, Office of Women's Health
Food and Drug Administration (FDA)
5600 Fishers Lane, HF-8
Rockville, MD 20857
Telephone: (301) 827-0350
Fax: (301) 827-0926
Email: Kathleen.uhl@fda.hhs.gov

2. Peer Review Contacts:

Bob Weller, Ph.D., Chief
Health of the Population (HOP) Integrated Review Group
Center for Scientific Review, NIH
6701 Rockledge Drive, Room 1104, MSC 7770
Bethesda, MD 20892 (20817 for overnight mail)
301-435-0694
301-480-1056 (fax)
wellerr@mail.nih.gov

3. Financial or Grants Management Contacts:

Melinda Nelson
Chief Grants Management Officer
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institutes of Health
6701 Democracy Blvd.Suite 800
Bethesda, Maryland  20892
Phone:  (301) 594-3535
Fax:  (301) 480-5450
E-mail:  mn23z@nih.gov

Section VIII. Other Information


Required Federal Citations

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

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

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

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

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/archive/archive/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.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

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

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

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

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA  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.


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