and Human Services (HHS)
EXPIRED
NINR MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD FOR MINORITY INVESTIGATORS
RELEASE DATE: June 4, 2003
RFA: NR-04-003 (This RFA is being reissued as a PA, see PAR-05-135)
(see NOT-NR-04-001)
National Institute of Nursing Research (NINR)
(http://www.ninr.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.361
LETTER OF INTENT RECEIPT DATE: October 1, 2004 (extended, see NOT-NR-04-001)
APPLICATION RECEIPT DATE: October 29, 2004 (extended, see NOT-NR-04-001)
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The National Institute of Nursing Research (NINR) invites applications to
support the research career development of doctorally prepared minority nurse
investigators in tenure-earning positions at Traditionally Minority Based
Institutions (TMBIs) and at majority academic institutions in the biomedical
and behavioral scientific mission areas of the NINR. The purposes of this
program initiative are to: 1) foster the development of independent
investigators in nursing research on the faculties of TMBIs and majority
academic institutions; 2) stimulate nursing research and nursing research
training at these institutions; and 3) encourage the development of qualified
minority nurse investigators in academic research settings who can become
effective role models for minority students.
RESEARCH OBJECTIVES
Background
The striking underrepresentation of racial/ethnic minority groups in
biomedical and behavioral research in the United States has been underscored
in many studies. There are existing programs at the NIH designed to improve
this situation. These include: the Minority Biomedical Research Support
Program, the Minority Access to Research Careers (MARC) Program, the
Individual Predoctoral Fellowship for Minority Students Program, and the
Research Supplements for Underrepresented Minorities Program. The NINR has
been an active participant in these trans-NIH minority research training
programs.
NINR has had a long-standing interest in increasing the number of minority
investigators in nursing research. Based on the recommendations from groups
of minority health experts, NINR has developed a variety of outreach
strategies that assist individuals at TMBIs and other majority institutions
in obtaining support for research training, career development, and research
funding from NINR. The NINR Mentored Research Scientist Development Award for
Minority Investigators is one approach that NINR has taken to strengthen the
participation of TMBIs, where there are few graduate schools of nursing, and
majority academic institutions by addressing the needs of minority nurse
investigators for additional research training with financial support.
NINR also recognizes that the paucity of qualified minority nurse
investigators in academic research settings has created a shortage of role
models for minority students. This RFA seeks to address this problem by
enhancing the research capabilities of minority nurse faculty members so
these individuals may establish research laboratories and research programs
in nursing at their institutions. In this fashion they will serve as role
models for minority undergraduate and graduate students, stimulating them to
consider research career opportunities in nursing research.
The purposes of the present RFA are to: 1) foster the development of
independent investigators in nursing research on the faculties of TMBIs and
majority academic institutions, 2) stimulate nursing research and nursing
research training at these institutions, and 3) encourage the development of
qualified minority nurse investigators in academic research settings who can
become effective role models for minority students. This is the seventh
consecutive year NINR has issued this RFA. The NIH Office of Research on
Minority health (ORMH), now the National Center on Minority Health and Health
Disparities, has been a co-sponsor of this initiative.
Research Areas
The research career development plan must address a research area consistent
with the NINR mission. Descriptions of relevant research areas may be found
on the NINR website at http://www.ninr.nih.gov/ResearchAndFunding/DEA/OEP/AreasofscienceFile.htm.
Minority nurse investigators are encouraged to develop their innovative
research career development plans in areas relevant to underserved minority
populations and in priority areas of NINR's scientific research mission,
particularly research on health disparities. Applicants are encouraged to
review NINR's Strategic Plan on Reducing Health Disparities located at:
http://www.ninr.nih.gov/research/diversity/mission.html.
Environment
The applicant TMBI or majority academic institution must demonstrate in the
application a firm commitment to the development of the candidate as a
productive, independent investigator in nursing research and to the pursuit
of the research career development plan described in the application. The
candidate should describe a career development program that will maximize the
use of relevant research and educational resources available in the TMBI or
the majority academic institution and in the mentor's institution.
Program
The award provides three consecutive 12-month appointments to pursue a
mentored research experience and specialized study in nursing research that
are tailored to the individual needs of the candidate. At least 75 percent
of the recipient's full-time professional effort must be devoted to the
program, and the remaining 25 percent devoted to other research-related
and/or teaching or clinical pursuits consistent with the objectives of the
award. The program must consist of both a research plan and a research
career development plan that will develop knowledge and research skills
relevant to his or her career goals.
Mentor(s)
The candidate must receive appropriate mentoring throughout the three-year
program. Where feasible, women and minority mentors should be involved as
role models. If the mentor (and/or a co-mentor, if desired) is
geographically distant from the candidate, a detailed communication plan must
be provided to document the mentor-candidate relationship and level of
commitment for the successful implementation and completion of the proposed
research and career development program.
Allowable Costs:
1. Salary: The NINR will provide salary for the recipient of this award up
to a maximum of $50,000 plus fringe benefits per year. The institution may
supplement the NINR contribution up to a level that is consistent with the
institution's salary scale; however, supplementation may not be from Federal
funds unless specifically authorized by the Federal program from which such
funds are derived. In no case may PHS funds be used for salary
supplementation. Institutional supplementation of salary must not require
extra duties or responsibilities that would interfere with the purpose and
provisions of this research career development award. Under expanded
authorities, institutions may rebudget funds within the total costs awarded,
but may not rebudget funds involving the salary component of the budget.
The total salary requested must be based on a full-time, 12-month staff
appointment. It must be consistent both with the established salary
structure at the institution and with salaries actually provided by the
institution from its own funds to other staff members of equivalent
qualifications, rank, and responsibilities in the department concerned. If
full-time, 12-month salaries are not currently paid to comparable staff
members, the salary proposed must be appropriately related to the existing
salary structure.
2. Research Development Support: The NINR will provide up to $20,000 per
year for the following expenses: (a) tuition, fees, and books related to
career development; (b) research expenses, such as supplies, equipment, and
technical personnel; (c) travel to research meetings or training; and (d)
statistical services including personnel, research and computer time. These
funds must be expended solely for the support of the candidate's research
career development plan.
3. Ancillary Personnel Support: Salary for mentors, secretarial and
administrative assistance, etc., is not allowed.
4. Facilities and Administrative (F&A) Costs: F&A costs will be reimbursed
at eight percent of modified total direct costs.
Evaluation
In carrying out its stewardship of human resource related programs, the NINR
or NIH may request information essential to an assessment of the
effectiveness of this program. Accordingly, recipients are hereby notified
that they may be contacted after the completion of this award for periodic
updates on various aspects of their employment history, publications, support
from research grants or contracts, honors and awards, professional
activities, and other information helpful in evaluating the impact of the
program.
MECHANISM OF SUPPORT
This RFA will use National Institute of Nursing Research (NINR) Mentored
Research Scientist Development Award (K01) mechanism. This mechanism is
described in program announcement PA-00-019 (NIH Guide, December 3, 1999;
http://grants.nih.gov/grants/guide/pa-files/PA-00-019.html.) Although all
general guidelines of PA-00-019 will apply, this RFA is written as a stand-
alone document and contains provisions that are unique to this initiative.
As an applicant you will be solely responsible for planning, directing, and
executing the proposed project. This RFA is a one-time solicitation. Future
unsolicited, competing-continuation applications based on this project will
compete with all investigator-initiated applications and will be reviewed
according to the customary peer review procedures. The anticipated award date
is July 1, 2004. Applications that are not funded in the competition
described in this RFA may be resubmitted as NEW investigator-initiated
applications using the standard receipt dates for NEW applications described
in the instructions to the PHS 398 application.
This RFA uses just-in-time concepts.
FUNDS AVAILABLE
NINR intends to commit approximately $360,000 in FY 2004 to fund 3 to 4 new
grants in response to this RFA. An applicant may request a project period of
up to 3 years. Salary support for each recipient will be for a maximum of
$50,000 plus fringe benefits with a minimum of 75% effort committed. Each
year up to $20,000 may be requested for research development support.
Although the financial plans of the NINR 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.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories
o Traditionally Minority Based Institutions
Foreign institutions are not eligible to apply.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Awards will be limited to citizens or non-citizen nationals of the United
States or to individuals who have been lawfully admitted for permanent
residence (i.e., in possession of an Alien Registration Receipt Card) at the
time of application.
SPECIAL REQUIREMENTS
Candidates must be from ethnic/racial groups determined by the applicant
institution to be underrepresented in biomedical or behavioral nursing
research. Candidates for this award must be full-time nursing faculty
members in tenure-earning positions at Traditionally Minority Based
Institutions or majority academic institutions who:(1) have a research or
health-professional doctorate (e.g., PhD or DNSc), or its equivalent; (2)
have demonstrated the capacity or potential for productive independent
research career; (3) have a Registered Nurse license; and (4) have secured
the commitment of an appropriate research mentor actively involved in
research relevant to the mission of NINR.
The candidate must identify an appropriate mentor or co-mentors with
extensive research experience in the research area proposed in the
application. The candidate must be willing to spend a minimum of 75 percent
of full-time professional effort conducting research and career development
activities for the period of the award. The remaining 25 percent time should
be devoted to other research-related and/or teaching or clinical pursuits
consistent with the objectives of the award.
Candidates who have served as principal investigators on PHS research grants
or have been supported by a research career award in the past, are eligible
to apply, provided the proposed research career development program is in a
fundamentally new area of scientific endeavor for the candidate or there has
been a significant hiatus in his/her research career because of family or
other personal obligations. Current principal investigators on PHS research
grants are not eligible.
Applicants are encouraged to call the program director listed in the
Inquiries section to discuss any aspects of this program that need
clarification.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA 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:
o Direct your questions about scientific/research issues to:
Dr. Janice Phillips
Office of Extramural Programs
National Institute of Nursing Research
6701 Democracy Blvd, Room 710, MSC 4870
Bethesda, MD 20892-4870
Telephone: (301) 594-6152
FAX: (301) 480-8260
Email: [email protected]
o Direct your questions about peer review issues to:
Dr. Jeffrey M. Chernak
Office of Review
National Institute of Nursing Research
6701 Democracy Blvd, Room 712, MSC 4870
Bethesda, MD 20892-4870
Telephone: (301) 402-6959
FAX: (301) 480-8260
Email: [email protected]
o Direct your questions about financial or grants management matters to:
Ms. Cindy McDermott
Chief Grants Management Officer
National Institute of Nursing Research
6701 Democracy Boulevard, Room 710
One Democracy Plaza
Bethesda, MD 20892-4870
Telephone: (301) 594-6869
FAX: (301) 402-4502
Email: [email protected]
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
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 NINR 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:
Dr. Jeffrey M. Chernak
Office of Review
National Institute of Nursing Research
6701 Democracy Blvd, Room 712, MSC 4870
Bethesda, MD 20892-4870
Telephone: (301) 402-6959
FAX: (301) 480-8260
Email: [email protected]
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: [email protected].
SUPPLEMENTAL INSTRUCTIONS:
The application must address the following issues:
Candidate
o The candidate's commitment to a nursing career in biomedical or behavioral
research.
o The candidate's potential to develop into a successful independent nursing
investigator.
o The candidate's immediate and long-term career objectives, and how the
award will contribute to their attainment.
o Letters of recommendation. Three sealed letters of recommendation
addressing the candidate's potential for an independent nursing research
career must be included as part of the application.
Career Development Plan
o The career development plan, incorporating consideration of the
candidate's goals and prior experience. It should describe a systematic plan
to obtain any necessary basic biomedical or behavioral science background and
research experience to launch or reinitiate an independent nursing research
career.
o The candidate must describe plans to receive instruction in the
responsible conduct of research. These plans must detail the proposed
subject matter, format, frequency, and duration of instruction as well as the
amount and nature of faculty participation. No award will be made if an
application lacks this component. Additional information is available at:
http://ori.hhs.gov/education/ed_rcr.shtml
Research Plan
The candidate must describe the research plan and the use of a basic or
clinical approach to a biomedical or behavioral problem. The candidate must
describe the research plan as outlined in form PHS 398, including sections on
the Specific Aims, Background and Significance, Progress Report/Preliminary
Studies, Research Design and Methods.
Mentor's Statement
The application must include a biographical sketch and information on the
mentor(s) including research qualifications and previous experience as a
research supervisor. The application must also include information that
describes the nature and extent of supervision that will occur during the
award period. A letter of support from the mentor (and co-mentor, if
appropriate) must be included in the application delineating the match with
the candidate's research and development plan and willingness to provide the
necessary assistance.
Environment and Institutional Commitment
The sponsoring TMBI or majority academic institution must provide a statement
of commitment to the candidate's development into a productive, independent
investigator in nursing research. This statement must indicate that the
candidate will be provided with sufficient release time from other duties to
accomplish the research and career development goals stated in the
application.
Budget
Individuals applying for the K01 award must comply with the JUST-IN-TIME
procedures announced in the NIH Guide on March 29, 1996 and May 17, 1996.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001)
application form 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/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: 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
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application must be
sent to:
Dr. Jeffrey M. Chernak
Office of Review
National Institute of Nursing Research
6701 Democracy Blvd, Room 712, MSC 4870
Bethesda, MD 20892-4870
Email: [email protected]
For express/courier service: Bethesda, MD 20817
ATTN: Minority Investigator MRSDA
Telephone: (301) 402-6959
FAX: (301) 480-8260
APPLICATION PROCESSING: Applications must be received on or before the
application receipt date listed in the heading of this RFA. If an
application is received after that date, it will be returned to the applicant
without review.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within 8 weeks.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA 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 an RFA,
it is to be prepared as a NEW application. That is the application for the
RFA must not include an Introduction describing the changes and improvements
made, and the text must not be marked to indicate the changes. While the
investigator may still benefit from the previous review, the RFA application
is not to state explicitly how.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NINR. Incomplete applications will be returned to the
applicant without further consideration. And, if the application is not
responsive to the RFA, NIH staff may contact the applicant to determine
whether to return the application to the applicant or submit it for review in
competition with unsolicited applications at the next appropriate NIH review
cycle.
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 NINR in accordance with the review criteria stated below. As
part of the initial merit review, all applications will:
o Receive a written critique
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications under
review, will be discussed and assigned a priority score
o Receive a second level review by the National Advisory Council for Nursing
Research.
REVIEW CRITERIA
The following criteria will be applied:
Candidate
o Commitment to an independent research career in nursing research;
o Potential to develop (or evidence of the capacity to develop) as an
independent nurse investigator; and
o Quality and breadth of prior scientific training and experience,
including, where appropriate, the record of previous research support,
publications, and other scholarly activities.
Career Development Plan
o Likelihood that the plan will contribute substantially to the scientific
development of the candidate and the achievement of research independence;
o Appropriateness of the research plan to the career goals of the candidate;
o Appropriateness of the research plan to develop new nursing knowledge;
o Consistency of the career development plan with the candidate's prior
research and academic experience and stated career goals;
o Clarity of the goals and scope of the plan and the need for the proposed
research experience; and
o Quality of the proposed training in the responsible conduct of research.
Research Plan
A sound research plan that is consistent with the career development plan and
the candidate's level of research development must be provided:
o Usefulness of the research plan as a vehicle for enhancing existing
research skills as described in the career development plan;
o Scientific and technical merit of the research question, design and
methodology, judged in the context of the candidate's previous training and
experience;
o Relevance of the proposed research to the candidate's career objectives;
and
o When human subjects are involved, adequacy of plans to include both
genders and minorities and children and their subgroups as appropriate for
the scientific goals of the research. Plans for the recruitment and
retention of subjects will also be evaluated.
Mentor
o Appropriateness of mentor's(s') research qualifications in the specific
areas of the application;
o Quality and commitment of the mentor(s) to supervise and guide the
candidate throughout the award period;
o Previous experience in fostering the development of independent nurse
investigators; and
o History of research productivity and support.
Institutional Environment and Commitment
o Applicant institution's commitment to the scientific development of the
candidate and assurances that the institution intends the candidate to be an
integral part of its research program;
o Adequacy of research facilities and training opportunities at the
sponsoring institution;
o Quality of environment for scientific and professional development; and
o Applicant institution's willingness to develop an appropriate balance of
research, teaching and administrative responsibilities for the candidate.
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 criteria included in the
section on Federal Citations, below).
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. Plans for the recruitment and retention of subjects will also be
evaluated. (See Inclusion Criteria in the sections on Federal Citations,
below).
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
398 research grant application instructions (rev. 5/2001) will be assessed.
ADDITIONAL CONSIDERATIONS
DATA SHARING: The adequacy of the proposed plan to share data.
BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the career development and research aims and plans.
RECEIPT AND REVIEW SCHEDULE (see NOT-NR-04-001 for new dates)
Letter of Intent Receipt Date: October 17, 2003
Application Receipt Date: November 14, 2003
Peer Review Date: February 2004
Council Review: May 2004
Earliest Anticipated Start Date: July 1, 2004
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Responsiveness to the purpose of this request;
o Quality of the proposed research career development program, as determined
by peer review; and
o Availability of funds.
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
MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components
involving Phase I and II clinical trials must include provisions for
assessment of patient eligibility and status, rigorous data management,
quality assurance, and auditing procedures. In addition, it is NIH policy
that all clinical trials require data and safety monitoring, with the method
and degree of monitoring being commensurate with the risks (NIH Policy for
Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12,
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
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 -
Amended, October, 2001," published in the NIH Guide for Grants and Contracts
on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-
02-001.html); a complete copy of the updated Guidelines are 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 RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported
by the NIH, unless there are scientific and ethical reasons not to include
them. This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998.
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 that is available at
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 proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, 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 (see http://escr.nih.gov).
It is the responsibility of the applicant to provide the official NIH
identifier(s)for the hESC line(s)to be used in the proposed research.
Applications that do not provide this information will be returned without
review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The
Department of Health and Human Services (DHHS) issued final modification to
the "Standards for Privacy of Individually Identifiable Health Information",
the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal
regulation under the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 that governs the protection of individually identifiable
health information, and is administered and enforced by the DHHS Office for
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified
under the Rule as "covered entities") must do so by April 14, 2003 (with the
exception of small health plans which have an extra year to comply).
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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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