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:  Janice.phillips@nih.gov

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: chernak@nih.gov

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: cindy_mcdermott@nih.gov

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: chernak@nih.gov

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) 435-0714, 
Email: GrantsInfo@nih.gov.
 
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: chernak@nih.gov
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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Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
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Bethesda, Maryland 20892
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and Human Services (HHS)
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