CLINICAL RESEARCH CURRICULUM AWARD

RELEASE DATE:  July 1, 2003 (see NOT-HL-03-016)

RFA:  HL-04-004

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

March 9, 2009 - This RFA has been reissued as (RFA-RR-09-006). 

National Institutes of Health (NIH)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.837, 93.838, 93.839

LETTER OF INTENT RECEIPT DATE: December 16, 2003

APPLICATION RECEIPT DATE: January 16, 2004

THIS RFA CONTAINS THE FOLLOWING INFORMATION:

o Purpose of this RFA
o Training Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Program Directors
o Individuals Eligible to Become Program Faculty
o Individuals Eligible to Become Program Participants/Trainees
o Eligible Competing Continuation Applications
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 Institutes of Health (NIH) invites educational and research 
institutions to apply for the Clinical Research Curriculum Award (CRCA or 
K30).  This program is supported by all NIH Institutes and Centers.  The 
initial and competing renewal awards will be for five years each.   
Applications in response to this RFA may be either new or competitive 
renewals.  
 
The CRCA is an award to institutions and addresses, in part, the NIH's 
commitment to improve the quality of training in clinical research.  The NIH 
recognizes that highly trained clinical researchers are needed in order to 
capitalize on the many profound developments and discoveries in basic science 
and to translate them to clinical settings.  This RFA is intended to 
stimulate the inclusion of high-quality, multidisciplinary didactic training 
as part of the career development of clinical investigators.  The CRCA 
supports the development and/or improvement of core courses designed as in-
depth instruction in the fundamental skills, methodology, and theory 
necessary for the well- trained, independent, clinical researcher.  While 
many NIH programs support research experiences for new clinicians, not all of 
these trainees have the opportunity to receive formal course work in the 
design of clinical research projects, hypothesis development, biostatistics, 
epidemiology, disease mechanisms, medical technology, human genetics, and the 
legal, ethical and regulatory issues related to clinical research.  This 
award is intended to support the development of new didactic programs in 
clinical research at institutions that do not currently offer such programs 
and, in institutions with existing didactic programs in clinical research, to 
support and expand programs or to improve the quality of instruction.  The 
goal of this program is to improve the training of the participants, so that 
upon completion of their training, they can more effectively compete for 
research funding.

For the purpose of this award, clinical research includes: patient-oriented 
research, epidemiologic and behavioral studies, and outcomes or health 
services research.  The NIH defines patient-oriented research as research 
conducted with human subjects (or on material of human origin such as 
tissues, specimens, and cognitive phenomena) that requires direct 
interactions with human subjects.  Patient-oriented research includes study 
of the disease, therapeutic interventions and clinical trials. 

TRAINING OBJECTIVES

Background

This RFA seeks to continue the K30 program in order to attract talented 
individuals to the challenges of clinical research and to provide them with 
the critical skills that are needed.  There is a core of knowledge and skills 
common to all areas of clinical research that should form the foundation of 
clinical research training.  These skills will also serve to improve the 
ability of new clinical investigators to develop hypotheses and draft sound 
research proposals for support.  This initiative is consistent with the 
recommendations of the NIH Director's Panel on Clinical Research 
(http://www.nih.gov/news/crp/97report/index.htm), and those from the 
Institute of Medicine Committee on Addressing Career Paths for Clinical 
Research.

Goals and Scope

The objective of this RFA is to improve the quality of clinical research 
training by providing didactic courses in the fundamental skills needed for 
clinical research.  The long-term goal is to produce clinical researchers who 
are competitive in seeking research support and are knowledgeable about the 
complex issues associated with conducting sound clinical research.  This RFA 
is open to educational and research institutions that do not currently 
provide such a didactic program, as well as to those that have well-
established clinical research training programs.  This award provides 
resources to allow institutions to conduct a comprehensive clinical research 
curriculum.  A curriculum for each group of participants should be designed 
for two years, and the applicant institutions should justify the period and 
describe plans for enrolling a cohort of participants each year.  The 
planning, direction, and execution of the instructional program will be the 
responsibility of the Program Director and the awardee institution, but must 
be consistent with the goals of the CRCA.  The curriculum must span a variety 
of fields of research and encompass a broad range of clinical scientists who 
are interested in the mechanisms of human disease, the genetics of complex 
disorders, and therapeutic interventions.  The core curriculum is to include 
an array of clinical research-related topics of general interest such as 
biostatistics, bioethics, clinical trials design, observational study design, 
Federal policies and regulations that address research with human subjects 
(e.g., 45CFR46, FDA, INDs, inclusion of women and minorities as well as 
children in clinical research projects), scientific writing for publication, 
and preparation of competitive grant applications.  The program may also 
include bioinformatics, human genetics, pharmacokinetics, medical 
applications of new technologies, specialized courses in epidemiology, the 
study of health disparities and other relevant fields.  The scope of the 
curriculum can be flexible to meet the needs of the institution.  Inclusion 
of interdisciplinary approaches is strongly encouraged.

Institutions may propose providing support for candidates to earn a master's 
or a doctoral degree in a relevant area.  The proposed program should also 
have the flexibility to accommodate participants with different levels of 
experience.

Individuals participating in the program should demonstrate a potential for 
the pursuit of innovative clinical research as a major focus in their career 
plan, and plan to enter into a long-term clinical research career.  
Institutions or consortia applying for an award must be able to demonstrate a 
historical record of attracting and producing such individuals.  If not 
already ongoing, new programs should have the faculty and specific plans for 
recruiting participants to enter the didactic program.

MECHANISM OF SUPPORT

This RFA will use the NIH K30 award mechanism.  As an applicant you will be 
solely responsible for planning, directing, and executing the proposed 
project.  The total project period for an application submitted in response 
to this RFA is five years.  The anticipated award dates are between June 1 
and September 30, 2005.  Future years of support will depend on evaluation of 
the program.

This RFA uses just-in-time concepts.  It does not use modular budgeting 
format.

FUNDS AVAILABLE 

The NIH intends to commit approximately $15 million per year for a total of 
five years starting in FY 05 to fund about 50 new and competitive 
continuation grants in response to this RFA.  An applicant should request a 
project period of five years and a budget for total costs of $300,000 per 
year.  Although the financial plans of the NIH provide support for this 
program, awards are contingent upon the availability of funds and the receipt 
of a sufficient number of meritorious applications.  

ELIGIBLE INSTITUTIONS

o For-profit or non-profit domestic, non-Federal organizations 
o Public or private domestic institutions, such as universities, colleges, 
and hospitals.

Foreign institutions are not eligible to apply.
 
Applications will be accepted from organizations that have strong, well-
established clinical research and/or clinical research training programs. The 
applicant institution must have a highly trained faculty that is active in 
clinical research, as evidenced by current research support, and have the 
commitment and capability to provide the core curriculum to individuals in 
the development of a clinical research career.  Institutions with a 
substantial clinical research portfolio along with a sufficiently large group 
of individuals in some aspect of clinical research training and career 
development are eligible to apply.  An institution may submit only one 
application, either new or competitive renewal.  This award is open to both 
current K30 recipients and those without a K30 award.  Applicants are 
encouraged to develop consortia in a common geographic location to enhance 
the depth of their faculty and participant pool, and/or to improve the 
quality of the educational experience.

INDIVIDUALS ELIGIBLE TO BECOME PROGRAM DIRECTORS

The Program Director should possess the clinical research expertise, 
leadership and administrative capabilities required to coordinate and 
supervise an interdisciplinary didactic program of this scope.  The Director 
should also be experienced in the design and management of programs for the 
development of clinical investigators, and should be able to demonstrate a 
superior record of preparing individuals for independent clinical research.  
The Program Director should be the role model for the participants.  He or 
she should be personally engaged in clinical research as well as in the 
mentoring of new investigators.  A minimum of 20% of the Program Director's 
effort is required.  (Combined Program Director and Co-Director's effort 
should be at least 40%.)  Individuals from underrepresented racial and ethnic 
groups as well as individuals with disabilities are encouraged to apply for 
NIH programs. 

INDIVIDUALS ELIGIBLE TO BECOME PROGRAM FACULTY

Faculty involved in the CRCA should have a record of developing and teaching 
the type of curriculum required under this award.  Generally, faculty will 
also be accomplished investigators.  The faculty records of teaching and 
mentoring, as well as the percent of faculty effort planned for the courses 
should be described.  Program faculty members from under-represented minority 
groups or with disabilities are encouraged.

INDIVIDUALS ELIGIBLE TO BECOME PROGRAM PARTICIPANTS/ TRAINEES

All participants must be U.S. citizens, non-citizen nationals or lawfully 
admitted permanent residents of the U.S.  Participants may include those with 
the following degrees: M.D., D.D.S., D.M.D., D.O., D.C., O.D., N.D. (Doctor 
of Naturopathy), doctorally prepared nurses, Ph.D. with clinical 
responsibilities, and others who could benefit from a core curriculum for 
clinical research.  Because clinical research is multidisciplinary, 
participants in this program should represent diverse academic backgrounds.  
Interactions during the early years of career development may serve to 
enhance the team approach necessary to meet the multidisciplinary challenges 
of clinical research.   

Participants may include individuals with NIH support (F32, T32, Ks, etc.) as 
well as those with non-NIH support for training and career development.

The National Heart, Lung, and Blood Institute will administer this program 
for the NIH.  All potential applicants are strongly advised to contact the 
NHLBI/NIH staff listed below to discuss their eligibility and the specific 
provisions of this award.

In all respects, the NIH remains strongly committed to increasing the 
participation of individuals from underrepresented minority groups and 
individuals with disabilities in biomedical and behavioral research.   The 
following groups have been identified as underrepresented in biomedical and 
behavioral research nationally: African Americans, Hispanic Americans, Native 
Americans, Alaska Natives, and Pacific Islanders.  Applicants must describe 
their program plans and efforts to recruit such individuals, as well as their 
success in the recruitment, retention, and graduation of these individuals. 
 All applications must contain plans to demonstrate commitment and proactive 
recruitment efforts.

ELIGIBLE COMPETING CONTINUATION APPLICATIONS 

Competing continuation applications must propose and justify substantial 
changes/modifications/improvements in the K30 curriculum developed during the 
prior funding period. 

SPECIAL REQUIREMENTS

Program: The program award provides five years of support.  Future years of 
support will depend on an evaluation of the success of the program.  The 
award will support a high-quality didactic program in the fundamentals needed 
for independent clinical research.  Institutions applying for competitive 
renewals of existing awards must describe the existing program and include 
plans for enhancement of the programs.  New applicants must provide a 
detailed description of and justification for the program including courses 
offered, frequency and scheduled times of classes, selection criteria for 
participants entering the program, and target goal of enrollment into the 
program.  Both new programs and new components of existing programs must be 
operational within one year of the award.

Environment: The institution must have high-quality clinical research and 
qualified faculty in clinical research.  The proposed faculty should be 
actively engaged in the design and conduct of such research, and also have 
demonstrated a successful record in obtaining peer reviewed federal and non-
federal funding for such activities.  The institution must develop an 
innovative, multidisciplinary program to maximize the available research and 
educational resources.  Applicant institutions must describe the pool of 
participants and must demonstrate experience in preparing individuals for 
careers in clinical research.  Because mentoring, as well as didactic 
coursework, is an integral part of successful training, existing and planned 
mentoring activities should be described.

Advisory Committee: The Program Director must have or establish an Advisory 
Committee for this program to provide ongoing assessment and monitoring.  
Clinical and basic science departments participating in this program should 
be represented on the committee. The committee's responsibilities might 
include: selecting participants, evaluating each participant's progress, and 
monitoring the overall effectiveness of the didactic program and updating it 
as needed. A detailed description should be provided of the committee's 
composition, function, and organizational structure.

Assessment:  Plans for assessment of the Program by the Advisory Committee 
should be described.

Program Evaluation: The success of the overall CRCA program, as well as the 
success of individual awards will be evaluated.  As part of this evaluation, 
NIH will request, as a component of the Annual Progress Report of the grant, 
tables containing the number of trainees, by year; number completing the 
program; number receiving degrees as a result of the program; number of 
trainees submitting applications for research funding; number receiving 
research funding, and number of mentors participating in the program.  An 
assessment of the quality of the didactic training and of the mentoring will 
be requested, as will a description of the overall effect of the program on 
the institutional culture toward clinical research.  

Allowable Costs: Allowable costs may include personnel (support for the 
Program Director, faculty, and administrative support), supplies, travel, 
honoraria and per diem for outside speakers, seminars, development of course 
materials, consultants, and other costs, such as printing, telephone, audio-
visual, postage, recruitment materials, and computer software.

The compensation for the Program Director must not exceed the actual 
institutional salary rates for the effort being devoted to the CRCA.  In 
addition, salary rates must not currently exceed an annual salary level of 
$171,900 plus fringe benefits.  The Program Director must devote at least 20% 
effort and no greater than 50% effort to this award, and may also be a 
principal investigator on other research awards.

Funds may not be requested to directly support the individual trainees.  
Their activities are expected to be supported by other Federal or non-Federal 
sources.  However, in some circumstances, and for trainees supported by non-
governmental funds, tuition is an allowable expense. 

Annual meetings of Program Directors and other staff members to exchange 
information about effective approaches in the training of new clinical 
investigators, including the sharing of course materials, have been initiated 
and will be continued.  Funds to support travel of the Program Director and 
another staff person to these meetings should be included.  For budgeting 
purposes, assume that the meetings will be held in the Washington, D.C. area.

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: programmatic, peer review, and financial or grants management issues:

o Direct your questions about programmatic issues to:

Lawrence Friedman, M.D.
National Heart, Lung, and Blood Institute
Building 31, Room 5A03
Bethesda, MD  20892-2482
Telephone:  (301) 496-9899
FAX: (301) 402-1056
Email: lawrence_friedman@nih.gov

Belinda Seto, Ph.D.
Office of Extramural Research
National Institutes of Health
Building 1, Room 252
Bethesda, MD 20892-0162
Telephone: (301) 402-9128
FAX: (301) 402-2642
Email: setob@od1tm1.od.nih.gov

Direct inquiries regarding review issues to:

Anne Clark, Ph.D.
Chief, Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924
Bethesda, MD 20817 (for express/courier service)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: clarka@nhlbi.nih.gov

Direct inquiries regarding fiscal matters to:

Owen Bobbitt
Grants Operations Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7134
Bethesda, MD  20892-7926
Telephone: (301) 435-0270
FAX:  (301) 480-0422
Email: ob5i@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 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 Anne Clark, Ph.D. at 
the address listed under WHERE TO SEND INQUIRIES.

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.

It is strongly recommended that prospective applicants contact the staff 
person listed under INQUIRIES early in the planning phase of the CRCA 
application.  Such contact will help ensure that applications are responsive 
to the overall intent of this award.

The application must address the following issues:

1.  Didactic Courses:  Describe the content of the proposed courses and their 
potential benefits to the participants.  Describe how continuation and/or 
expansion of an existing program or development of a new program will enhance 
clinical research training at the institution.
2.  Institutional Commitment:  Provide information establishing the 
commitment of the applicant institution, the Program Director, and the 
faculty to providing didactic and mentoring experiences.
3.  Career Development Plans:  Describe how the activities supported by this 
award will advance the career development plans for prospective participants.
4.  Availability of Participants:  Describe the pool of potential 
participants including information about the types of prior clinical and 
research training.  Describe the composition of the selection committee and 
the criteria to be used for selection.  Provide demographic data and the 
number of individuals participating in current training programs, e.g., T32, 
K12, K08, F32, K23, K24, and others eligible for this program.  This 
information will be evaluated to determine whether a sufficient number of 
participants will be available for the CRCA.
5.  Research Environment: Describe to the extent possible the types of 
research experiences that will be available to the participants upon 
completion of the didactic training supported by the CRCA.
6.  Instruction in the Responsible Conduct of Research:  Applicants must 
include plans for instruction in the responsible conduct of research, 
including the rationale, subject matter, appropriateness, format, frequency 
and duration of instruction, and the amount and nature of faculty 
participation. No award will be made if an application lacks this component.
7.  Program Effectiveness:  The applicant institution is to include a 
component to assess the effectiveness of the proposed curriculum, including 
benchmarks against which success of the program can be measured.  Applicants 
submitting renewal applications must include an account of the career 
outcomes of the participants who received training supported by the CRCA.  In 
a text or table format, include participants' names, times spent in this 
program, positions held, research involvement, publications, major 
accomplishments, current status of participants supported by this program and 
other evidence that the institution is meeting the objectives described 
above.

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 plus all 
five collated sets of appendix material must be sent to Anne Clark, Ph.D. at 
the address listed under WHERE TO SEND INQUIRIES.

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 (IC).  Incomplete and/or non-responsive applications 
will be returned to the applicant without further consideration.

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 National Heart, Lung, and Blood Institute 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 an appropriate national advisory council 
or board.
 
REVIEW CRITERIA

The scientific review group will address and consider each of the following 
criteria in assigning your application's overall score:
 
- Quality of the content of courses and adequacy of the syllabus.

- Clinical, scientific and administrative leadership qualifications and 
experience of the Program Director.

- Qualifications of the faculty:  portfolio of on-going funded projects, 
publications and training experience in clinical research.

- Criteria for selecting participants, publicizing the availability of the 
program to potential participants, and demonstration of a sufficient number 
of high quality participants.

- Adequacy and availability of any necessary institutional facilities and 
resources.

- Effectiveness of plans for program oversight and on-going assessment, 
including adequacy of the membership and functions of the program Advisory 
Committee.

- Strength of the institutional commitment to the support of the K30 
curriculum after the end of the funding period of the K30 grant.

The additional review criteria for competing continuation applications for 
the Clinical Research Curriculum Award will include:

- Track record of the previous K30 program in achieving its objectives.
- Effectiveness of the developed K30 curriculum.
- Impact of the K30 program on the institutional culture.
- The justification for continued support of the K30 program, i.e. 
substantial changes/modifications /improvements in the K30 curriculum 
developed during the prior funding period. 

ADDITIONAL CONSIDERATIONS

BUDGET: The reasonableness of the requested budget for the proposed didactic 
program.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: December 16, 2003
Application Receipt Date: January 16, 2004
Peer Review Date: June, 2004
Council Review: October, 2004
Earliest Anticipated Start Date: June 1, 2005

AWARD CRITERIA

Applications will compete for available funds with those submitted and 
reviewed in response to this RFA.  This is a trans-NIH program that is being 
administered and managed by the National Heart, Lung, and Blood Institute.  
An NIH Coordinating Committee has been established to participate in all 
phases of this program.  Funding decisions will be based on the 
recommendations of the initial review group, the National Heart, Lung, and 
Blood Advisory Council and the NIH Coordinating Committee regarding 
scientific and programmatic merit as well as the 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://orhp.osophs.dhhs.gov/humjansubjects/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.



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NIH Funding Opportunities and Notices


H H S Department of Health
and Human Services

 
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