and Human Services (HHS)
EXPIRED
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/)
Title: Specialized Cooperative Centers Program in Reproduction and Infertility Research (U54)
Announcement Type
This is a
reissue of RFA-HD-07-003,
previously released on December 6, 2006.
Update: The following update relating to this announcement has been issued:
Request for Applications (RFA) Number: RFA-HD-08-001
Catalog of Federal Domestic Assistance Number(s)
93.865
Key Dates
Release Date: October
25, 2007
Letters of Intent
Receipt Date: April 23, 2008
Application
Receipt Date: May 23, 2008
Peer Review
Date(s): October/November
2008
Council Review
Date: January 2009
Earliest
Anticipated Start Date: April 1, 2009
Additional
Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: May 24, 2008
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
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
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
The
National Institute of Child Health and Human Development (NICHD), through the
Reproductive Sciences Branch (RSB) in the Center for Population Research (CPR),
provides funding for a limited number of research centers in the reproductive
sciences. These centers provide an arena for multidisciplinary
interactions among basic and clinical scientists interested in establishing
high quality research programs in the reproductive sciences. The centers
also serve as national resources for the career development of young scientists
electing to pursue research in high priority areas of reproduction and
infertility research. Accordingly, the purpose of this RFA is to announce
the annual re-competition of the Specialized Cooperative Centers Program in
Reproduction Research now called the Specialized Cooperative Centers Program in
Reproduction and Infertility Research. Applications are sought from
investigators willing to participate with the NICHD under a cooperative
agreement in a multi-center cooperative research program. Center
investigators will be expected to work with NICHD staff in facilitating
research collaborations and interactions within and among centers. Such a
cooperative program will form a national network that fosters communication,
innovation and research excellence with the ultimate goal of improving human reproductive
health through accelerated transfer of basic science findings into clinical
practice.
Families, family values, and family planning form the cultural essence and cohesiveness of our existence as human societies. One of the most basic of human rights -- the right to procreate -- is frustrated or denied by the occurrence of infertility in couples desiring children. It has been estimated that infertility affects between 37 and 70 million married couples around the world. In U.S. studies described over 50 years ago, it was stated that up to 10 percent of married couples were sterile, with the remaining 90 percent having varying degrees of fertility. More recent and technically rigorous U.S. survey studies have conservatively identified that there are about 2.3 million infertile couples, which is about nine percent of the domestic married couple population base with wives aged 15-44. In addition, such studies found that about 7.9 million or approximately 13 percent of U.S. women in this age range had an impaired ability to have children. In couples, at least 25-40 percent of infertility is attributable to male factor infertility for which the pathophysiology is either not understood at all or, at best, poorly understood. The prognosis for male infertility treatment outcomes is extremely poor at present. Indeed, whereas 80 percent of infertile women can be successfully treated, male infertility can be treated in only 10-20 percent of such men. However, the widespread use of assisted reproductive technologies such as intracytoplasmic sperm injection (ICSI) and its variants has enabled otherwise infertile men to father children, although possible genetic causes of the infertility are likely transmitted to the progeny.
While analyses of the U.S. population base have not found alarming annual increases in the overall number of infertile couples or the overall prevalence of infertility, significant age-related increases in infertility, coupled with delayed childbearing in the contemporary couple population base, have been found in such studies. Physician office visits reflecting current societal life style requirements for infertility services have markedly increased in the U.S. almost four fold between 1968 (600,000) to 2000 (2,100,000). Indeed, it is estimated that 13 percent of American women will receive infertility services during their lifetime. Of the infertile couples seeking treatment for infertility, it has been estimated that up to one half will be unsuccessful in achieving their desired outcome. In concert with the increased medical assistance sought, U.S. infertility service costs have risen to exceed a billion dollar annual medico-economic impact in the U.S.
Reproductive tract disorders affecting fertility are associated with significant morbidity and a degree of mortality in some specific instances that cannot be ignored. Accompanying the human costs of morbidities of reproductive tract disorders are the attendant substantial costs to the U.S. health care system involving the diagnosis, treatment, and follow-up services provided to the patients, as well as the added costs to the patient and the U.S. economy of lost employment and family service hours. In reproductive-aged couples, the obstructive sequelae of male accessory gland infections account for eight to 12 percent of male partner diagnostic costs for fertility impairment. In reproductive-aged females, it has been estimated that the general incidence of endometriosis is five to 15 percent. The incidence of endometriosis in females being surgically treated for infertility is known to be 30 to 50 percent. Among infertile females with no other known cause of their infertility, the incidence of endometriosis has been reported to be 40 to 70 percent. A diagnosis of severe endometriosis often leads to hysterectomy associated treatment. While the causative role of endometriosis in infertility remains poorly understood and its optimal diagnosis and treatment remain a goal not an accomplishment of contemporary medicine, the morbid impact of the associated pelvic pain has significant human cost as well as national economic costs.
Similarly, the role of dysfunctional uterine bleeding, either in the presence or the absence of uterine leiomyomata (fibroids), is not well understood despite its common occurrence and decades of research. It is a significant factor in noncompliant contraceptive use or discontinuance and, therefore, in the unintended pregnancy problem. Uterine leiomyomata occur in nearly 20% percent of all reproductive-aged women, are the single most common diagnosis in gynecological hospital admissions, may be the only abnormality observed in an infertile couple, and represent the most common medical indication for an unintended and often unwanted hysterectomy that prematurely ends a female’s reproductive options. Fibroids disproportionately affect African Americans with some studies indicating a three-fold higher prevalence in this racial group than in the Caucasian population.
Polycystic ovary syndrome (PCOS) is a major cause of female infertility, as well as other reproductive system and other tissue and organ system morbidities. Identified more than 60 years ago by Stein and Leventhal, the etiology of PCOS remains misunderstood despite 60 years of research. This insidious disease is currently the most common endocrine disorder of reproductive-aged women, affecting between five and 10 percent of women aged 15-44 or more than four million women in the U.S. All PCOS women present with hyperandrogenemia and anovulation. Often, these conditions are accompanied by obesity, polycystic ovaries and insulin resistance. Indeed, the risk of type 2 diabetes mellitus among PCOS patients is five- to 10-fold higher than in the normal population, and the prevalence of the Metabolic Syndrome is nearly two-fold higher in PCOS women then in the general population. Considering the high prevalence of diabetes in PCOS women, a very recent study estimated that the total annualized cost of evaluating and providing care to PCOS women is a staggering $4.6 billion dollars.
Also poorly understood is the pathogenesis of premature ovarian failure that affects one in 100 women by age 40. Interestingly, 16 percent of women carrying the fragile X pre-mutation present with premature ovarian failure. The mechanism(s) underlying pre-mutation-based ovarian insufficiency is not known, but once known could provide critical insights into the basic biological processes regulating ovarian follicular growth, differentiation and atresia.
It is becoming increasingly apparent that some conditions of male and female infertility may be genetically based. In males, there is considerable evidence from breeding studies and gene knockout experiments in animals that mutation of over 100 separate genes results in infertility. More limited studies in humans show that a number of inherited diseases are associated with abnormal sperm morphology and function. These data suggest that a significant number of men with infertility may have one or more mutations that predispose to their condition. However, it is currently not possible to determine which men have genetic infertility. Similarly, it is estimated that 15-20 percent of human pregnancies are chromosomally abnormal as a result of division errors during oocyte meiosis or early embryonic cleavage. Such errors not only are the leading cause of birth defects, but may be the single most important factor contributing to human infertility.
An area of emerging public health interest is the preservation of fertility in individuals undergoing treatments for diseases such as cancer. Currently, there are more than 9 million cancer survivors in the U.S. of whom approximately 5% are under the age of 35. The chemical or radiological consequences of these treatments oftentimes target vital reproductive organs such as the gonads depleting the gamete stem cell pool thereby causing permanent infertility. Therefore, providing options for preserving fertility in men, women and children is not only an important reproductive health issue, but a quality of life issue as well.
The need for the availability of contraceptive options acceptable to diverse populations remains globally unmet. Among the 600 million women of reproductive age in today’s world, as many as 228 million women are at risk of unintended pregnancy. Up to 64 percent of all worldwide pregnancies are unintended (mistimed or completely unwanted). Over 50 million abortions occur worldwide each year, with minimal estimates of at least 100,000 abortion-related deaths annually. In the U.S., more than three million unintended pregnancies, about 60 percent of all pregnancies, occur annually, with half resulting in abortion as an outcome. In half of the abortions occurring in the U.S. each year, a contraceptive method being used failed to prevent pregnancy.
Recognizing that the interactive needs of basic and clinical research necessary to address the above and related problems may be so complex that they cannot be solved by individual investigators working alone, without the intellectual and fiscal resources of a cooperative specialized center program, it is the intention of the RSB, contingent upon the availability of funds, to continue and maintain organized, multi-component reproduction and infertility research programs of high quality that focus on topics of high priority and significance because of their critically important relationship to the mission of the RSB.
ObjectivesThe objectives of this Centers Program are to support specialized reproductive research programs of high quality, and to facilitate and accelerate bidirectional transfer of knowledge between the laboratory and clinic. This process of translating research between the laboratory and clinic is a continuum that encompasses all aspects of knowledge transfer from non-human animal models to humans. For example, application of information from rodent species to non-human primates is considered part of the translational continuum. However, the ultimate goal of supporting translational research through this Centers Program is to improve human reproductive health.
This RFA is specifically designed to stimulate the reproductive sciences research community to organize and maintain research-based centers of outstanding quality that, serving as national research resources, form a cooperative network with NICHD that fosters communication, innovation and high quality reproduction and infertility research. Such networking as afforded by the cooperative nature of this Centers Program will ensure that the reproductive research community remains in the forefront of the development and utilization of new technologies that can be used to diagnose, treat and ameliorate reproductive diseases and disorders, as well as to identify novel leads for fertility regulation.
Research ScopeThe Specialized Cooperative Centers Program in Reproduction and Infertility Research is composed of research-based center grants designed to support interactive groups of research projects and supporting core service facilities. The research activities included in these center grants must comprise, by definition, a multidisciplinary approach to biomedical problems addressing the specific research topic areas announced in this RFA (see below). These centers may have more than one theme, focus or emphasis, but all of the subprojects involved must be responsive to one or more of the specific research areas of reproduction supported by the RSB. Furthermore, the objectives of this Program require that one of the subprojects be entirely or predominantly clinical and that all basic science subprojects be linked to the clinical component(s) of the center.
The following is a list of topics that are considered to be responsive to the research mission areas of the RSB. Additionally, these topics identify areas where research at the basic/clinical interface is deemed essential to the potential development of new leads or approaches to fertility regulation, as well as of diagnostic tools and procedures for the detection, treatment and effective management of reproductive disorders that impact on reproductive competence.
Because this list is not meant to be all inclusive, prospective applicants preparing either a new or competing continuation center grant application are encouraged to discuss program relevance issues with the program staff contact cited below. However, applicants should note that the research scope of this RFA does not include studies in the area of reproductive oncology, reproductive toxicology or reproductive epidemiology, or studies dealing with post-implantation pregnancy and parturition. These topic areas are outside the scope of research supported by the RSB and, therefore, will be deemed non-responsive to this RFA. Further, applications proposing research activities focused exclusively on basic research, or applications or components thereof proposing epidemiological or large-scale clinical trial research, will not be considered responsive to this RFA.
Guidance and Management StructuresOverall coordination of the Centers Program, consistent with the stated objectives set forth in this RFA (see Objectives), will be done by a Steering Committee consisting of all Center Principal Investigators and an NICHD Staff Project Scientist from the RSB, CPR. The Steering Committee will employ a consensus decision process to guide the Centers Program in evaluating the progress of member Center programs, their proposed new research initiatives within the general scope of the approved program, the need to provide the entire Center network with access to new technologies, the need for collaborations either within or outside the Center network, and the need to redirect certain efforts of member Centers due to either sufficient data acquisition to permit conclusion, the acquisition of data supporting an alternative study initiative or experience proving that the proposed research is no longer feasible.
In addition to the Steering Committee, smaller cooperative groups will be formed that consist of research components of member centers having common research interests addressing a specific basic and/or clinical research problem. These research focus groups will perform coordinated research activities as recommended by the Steering Committee, subject to peer review. In turn, progress of the focus groups will further guide the Steering Committee in decision making regarding changes in specific research directions, translational activities, and collaborative research initiatives. The research focus group will consist of an NICHD Staff Project Coordinator from the RSB, CPR, and Key Investigators of the relevant subproject and/or Core Directors.
Further details of the guidance and management structures and processes may be found under Cooperative Agreement Terms and Conditions of Award, below.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism(s) of Support
This funding opportunity
will use the NIH Specialized Cooperative Research Center (U54) 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.
The NIH U54 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". At this time, the NICHD plans to reissue this RFA on an annual basis.
The anticipated award date is April 1, 2009.
2. Funds Available
The NICHD intends to commit approximately $6.0 million in total costs [Direct
plus Facilities and Administrative (F & A) costs] in FY 2009 to fund up to four new and/or competitive
continuation grants in response to this RFA. An applicant for a new center may request a project
period of up to five years and a budget for direct costs up to $1 million for the first year with incremental
increases for recurring costs (i.e., personnel, consultants, supplies, travel
and other expenses) not to exceed three percent in each subsequent year. An
applicant for a competing continuation grant may request a project period of up
to five years and a budget for direct costs of up to $1 million in the first
year or 110 percent of the direct costs awarded for the final competitive
segment of the preceding project period as stated in the Notice of Grant Award,
whichever is higher. Applications exceeding
the budgetary limits specified above will be returned to the applicant without
peer review.
Because the nature and scope of the research proposed may vary, it is anticipated that the size of awards also will vary. Although the financial plans of NICHD provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
In the event that an application submitted in response to this RFA is not funded, two resubmissions of the application may be submitted in response to subsequent RFAs. Requested budgets for resumbitted applications must follow the recommendations of the peer review group who evaluated the previous submission. If a second resubmitted competing continuation application is not selected for funding, the applicant institution may then submit only a new, substantially different application in response to a subsequent RFA that will be subject to the direct cost limit of $1 million.
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:
The policy of the NICHD allows support of more than one Specialized Cooperative Center at a given institution if based in a different department
or unit and if the research areas of the two centers are different (e.g., one
center on female reproduction and one center on male reproduction).
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/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing
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)
710-0267, 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.
Applications
for the U54 grant are to be prepared in a manner consistent with the
information presented in the NICHD U54 Cooperative Specialized Research Center
Grant Guidelines, available from the contacts listed below and at http://www.nichd.nih.gov/funding/u54.htm.
Description of a Center
The minimal requirements for a Center described in this RFA are as follows (see sections on Review Procedures and Award Criteria below):
Optional components of the Center organization include the mix of subprojects and cores to be included in the Center:
Closed Access Structure: In this center structure, administrative and all technical service cores will be utilized by budgeted center subprojects only. Consistent with NICHD guidelines for establishment of core facilities, utilization by three subprojects is required to justify a core technical service facility. Percent utilization by any one of the three subprojects justifying the core may not exceed 50 percent or be less than five percent. The percent utilization of additional subprojects requiring core services may be less than five percent. Costs necessary to use a particular core facility may be incorporated into the budget of the core unit, and not in the budgets of the research subprojects per se. No internal charge-back system would be required.
Open Access Structure: In this center structure, budgeted center subprojects, as well as research projects external to the Center (e.g., R01, R03, R21, P01 subproject), may have access to technical service cores. However, special consideration must be given to justification of a technical service core facility and the formal establishment of an effective charge-back system for all technical service cores. For each core service facility, at least one of the three projects used to justify a core must be a budgeted center subproject, while the remaining project(s) used in justifying the core must be externally funded NICHD projects administered by the RSB. Percent utilization by any internally budgeted center subproject or externally funded RSB project used to justify a particular core facility may not exceed 50 percent or be less than five percent. An additional seven federally funded, peer reviewed external research projects addressing program relevant research areas of the RSB may access the core up to 100 percent of its service capacity. The 50/5 percent utilization requirement applies to this group of external projects. Centers must establish an internal management policy for evaluating the acceptability of proposed RSB program relevant external projects to access the core facilities. Approval of requests for core access privileges for external projects which would replace those described above must be made to RSB Program Staff who then will evaluate the extent to which the project is relevant to RSB mission research areas (see Research Scope), and render a decision accordingly.
If centers choose to operate in an open access format, costs necessary to utilize a particular core facility by budgeted center subprojects must be incorporated into the budget of the subproject and not the core budget in order to accommodate participation in the required charge-back system. Core budgets will be justified and evaluated based on access by budgeted center subprojects and external, program relevant research projects as described above. Above and beyond this arrangement, technology based core units may offer services to additional external projects addressing any area of research regardless of funding source only on a full payback (fee for service or in-kind) basis. However, additional funds necessary to provide services to these external projects (e.g., technical support, supplies, etc.) must come from sources other than the center funding, such as the supply budgets of the external projects wishing to access the core facilities. In choosing to configure a center in an open access center structure, the Principal Investigator must have in place, and adequately describe in the application, management policies that ensure that budgeted center subprojects are given highest priority in receiving services provided by the core.
Centers choosing to configure in an open access center format may propose one or more technical service cores that will be utilized exclusively by budgeted center subprojects. These centers may, therefore, have a mix of open and restricted access technical service cores. On the other hand, administrative cores in open center structures may be accessed only by budgeted center subprojects.
Once an award is made, centers configured as a closed access center structure may, at a later time, choose to convert to an open access center structure by requesting such conversion in writing to the NICHD.
Travel to Meetings
Principal Investigators should request travel funds to support their participation in the annual Steering Committee Meeting as well as one research focus group meeting. Key Investigators of budgeted center subprojects and Directors of technical service cores should request travel funds to support participation in two research focus group meetings.
Training
Although not required in a formal sense, investigators
supported by the center are strongly encouraged to provide training experiences
for students and fellows in their laboratories, particularly those from
under-represented minority groups, those with disabilities and those who wish
to re-enter an active research career after taking time to care for children or
attend to other family responsibilities. The NIH offers supplements to
the parent award to support individuals representing these special populations.
Guidelines on how to apply for these supplements are provided in PA-05-015,
Research Supplements to Promote Diversity in Health-Related
Research (http://grants.nih.gov/grants/guide/pa-files/PA-05-015.html).
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: April 23, 2008
Application
Receipt Date: May 23, 2008
Peer Review Date: October/November
2008
Council Review
Date: January 2009
Earliest
Anticipated Start Date: April 1, 2009
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:
Louis V.
DePaolo, Ph.D.
Reproductive
Sciences Branch
National
Institute of Child Health and Human Development
6100
Executive Boulevard, Room 8B01, MSC 7510
Bethesda,
MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 435-6970
FAX:
(301) 496 0962
Email: ld38p@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 three signed photocopies in one
package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries of
applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At
the time of submission, two additional copies of the application and all copies
of the appendix material must be sent to:
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; non-USPS service)
Telephone: (301) 435-1485
FAX: (301) 402-4104
Email: stretchr@mail.nih.gov
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 NICHD. Incomplete and non-responsive
applications will not be reviewed.
When an unfunded application that had been previously submitted to an earlier version of the RFA is submitted in response to this RFA, it is to be prepared as an AMENDED application. The application must include an introduction describing the changes and improvements made, the text must be marked to indicate the changes from the previous unfunded version of the application, and the previous application number must be indicated.
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/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
Applications
for the U54 grant are to be prepared in a manner consistent with the
information presented in the NICHD U54 Cooperative Specialized Research Center
Grant Guidelines, available from the contacts listed below and at http://www.nichd.nih.gov/funding/mechanism/u54_guide.cfm.
At minimum, an application in response to this RFA should include:
All applicants must document their ability to meet or exceed the minimum requirements as set forth in this RFA. This specifically includes understanding of and commitment to the cooperative nature of this Program, and willingness to meet the Terms and Conditions of Award.
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.
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 expects that
grant 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.
Section
V. Application Review Information
1. Criteria
Only the review criteria
described below will be considered in the review process.
The following will be
considered in making funding decisions:
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:
Individual Research Projects
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.
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?
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 (if applicable)?
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?
Core Units
Center as an Integrated Effort
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:
For competing continuation (renewal) applications:
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 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 expects that
grant 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.
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
Not
Applicable
Section VI. Award Administration Information
1. Award Notices
After the peer review of
the application is completed, the PD/PI will be able to access his or her
Summary Statement (written critique) via the eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH Grants Policy Statement Part II: Terms
and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.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/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 Specialized Cooperative Research Center U54), an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH programmatic
involvement with the awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the NIH purpose is to support and
stimulate the recipients' activities by involvement in and otherwise working
jointly with the award recipients in a partnership role; it is not to assume
direction, prime responsibility, or a dominant role in the activities.
Consistent with this concept, the dominant role and prime responsibility
resides with the awardees for the project as a whole, although specific tasks
and activities may be shared among the awardees and the NIH as defined below.
2.A.1. Principal
Investigator Rights and Responsibilities
The Principal Investigator will have the primary responsibility for participating cooperatively with the Steering Committee in the following activities:
The awardees will agree to: 1) accept the coordinating role of the Steering Committee which includes evaluating objectives and research goals of the Centers Program, and recommending modification, deletion or addition of protocols within the Centers Program; 2) follow any common protocols in which they participate for multicenter projects that are approved by the Steering Committee; and 3) accept the cooperative nature of the group process, including the establishment, where appropriate, of smaller collaborative groups comprised of interacting subprojects and/or cores focused on a particular reproductive research topic area.
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
The NICHD Project Scientist will have substantial
programmatic involvement that is above and beyond the normal stewardship role
in awards, as described below:
The NICHD Program Official will:
2.A.3.
Collaborative Responsibilities
Overall Coordination of the Centers Program consistent with
the stated intent of the RFA will be done by a Steering Committee consisting of
the Principal Investigators from each of the participating Centers and one
NICHD staff member from the RSB, CPR, NICHD, who will be the Project Scientist.
A member of the NICHD grants management staff will serve as a nonvoting advisor
to the Committee. A non-NIH chairperson for the Steering Committee will
be chosen by a majority vote of the Principal Investigators. The Steering
Committee meetings will be convened at least once per year. The purpose
of these meetings is to share scientific information, assess scientific
progress, identify new research opportunities and potential avenues of
collaborations such as with industry, private foundations and/or NIH intramural
scientists, establish priorities that will accelerate the translation of
preclinical findings into clinical applications, reallocate resources and
conduct the business of the cooperative research program. In anticipation
that some centers will have common research interests that address a specific
basic and/or clinical research problem, it is envisioned that research focus
groups will be formed to conduct coordinated research activities recommended by
the Steering Committee. The Steering Committee will approve multicenter
protocols on specific research activities. As needed, the Steering
Committee will develop a publication policy regarding joint authorship of research
reports derived from such collaborative efforts.
Each
full member will have one vote. Awardee members of the Steering Committee will
be required to accept and implement policies approved by the Steering
Committee.
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.
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:
Louis V.
DePaolo, Ph.D.
Reproductive
Sciences Branch
National Institute of Child Health and Human Development
6100
Executive Boulevard, Room 8B01, MSC 7510
Bethesda,
MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 435-6970
FAX:
(301) 480-2389
Email: ld38p@nih.gov
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; non-USPS service)
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email: stretchr@mail.nih.gov
3. Financial or Grants Management Contacts:
Ms. Cecilia Bruce
Grants Management Branch
National Institute of Child Health and Human Development
6100
Executive Boulevard, Room 8A17L, MSC 7510
Bethesda
, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 496-1304
FAX:
(301) 480-4782
Email: cb156n@nih.gov
Section VIII. Other Information
Required Federal Citations
Use of Animals in
Research:
Recipients of PHS
support for activities involving live, vertebrate animals must comply with PHS
Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects
Protection:
Federal regulations
(45CFR46) require that applications and proposals involving human subjects must
be evaluated with reference to the risks to the subjects, the adequacy of
protection against these risks, the potential benefits of the research to the
subjects and others, and the importance of the knowledge gained or to be gained
(http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety
Monitoring Plan:
Data and safety
monitoring is required for all types of clinical trials, including physiologic
toxicity and dose-finding studies (phase I); efficacy studies (Phase II);
efficacy, effectiveness and comparative trials (Phase III). Monitoring should
be commensurate with risk. The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risks to the participants (NIH Policy for
Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research
Data:
Investigators submitting
an NIH application seeking $500,000 or more in direct costs in any single year
are expected to include a plan for data sharing or state why this is not
possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their
institutions, on issues related to institutional policies and local IRB rules,
as well as local, State and Federal laws and regulations, including the Privacy
Rule. 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/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.
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. For
publications listed in the appendix and/or Progress report, internet addresses
(URLs) must be used for publicly accessible on-line journal
articles. Unless otherwise specified in this solicitation,
Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation
to view the Internet sites. Furthermore, we caution reviewers that their
anonymity may be compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health Service
(PHS) is committed to achieving the health promotion and disease prevention
objectives of "Healthy People 2010," a PHS-led national activity for
setting priority areas. This 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.
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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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