INDIVIDUAL POSTDOCTORAL NRSA FELLOWSHIPS IN EPIDEMIOLOGY /CLINICAL TRIALS 
RESEARCH /OUTCOMES RESEARCH IN SKIN DISEASES
 
RELEASE DATE:  February 19, 2002
 
RFA:  RFA-AR-02-007 (See Modification PAR-06-536)

PARTICIPATING INSTITUTES AND CENTERS (ICs):
 
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
 (http://www.niams.nih.gov/)
 
LETTER OF INTENT RECEIPT DATE:  None

APPLICATION RECEIPT DATE:  April 17, 2002
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
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

Progress in the treatment of skin diseases has been hampered by a lack 
of baseline data concerning prevalence and the effectiveness of 
therapeutic interventions in all but the most common skin diseases.  
Part of this problem is the lack of trained individuals within the skin 
disease community capable of designing and carrying out these studies. 
This RFA is designed to begin to address this problem. 
 
RESEARCH OBJECTIVES

The NIAMS, along with the Herzog Foundation, announces the availability 
of individual NRSA postdoctoral fellowships to support the training of 
physicians with expertise in clinical dermatology to supplement that 
knowledge with training in epidemiology/clinical trials/outcomes 
research.  These fellowships are intended to support up to two years of 
advanced training in the relevant methodologies which is to be used to 
obtain a Master"s of Public Health (or similar relevant area of study 
such as biostatistics, etc) and or a Ph.D. in epidemiology to qualify 
the fellow to pursue a career in these areas as they relate to skin 
diseases.  Therefore, a special feature of this award is the inclusion 
of tuition and fees for the necessary course work which is to be taken 
at a School of Public Health or as part of an appropriate degree 
granting program within a graduate school.  Applicants to this RFA may 
request activation at any time between July 1, 2002, and July 1, 2003, 
inclusive. An additional unique feature is the cooperation of the 
Herzog Foundation which will provide supplementation of approximately 
$30,000.00 per year per fellow to supplement the stipend and any other 
expenses involved in the training.  The intent of this announcement is 
to begin to train a cadre of investigators who will be both experienced 
clinicians in dermatology as well in the sciences underpinning 
epidemiology/clinical trials/outcomes research so that in the future 
this data will be available to the skin disease community. 
The overall goal of this research training initiative is to increase 
the number of clinically trained dermatologists who have the 
appropriate training in epidemiology/clinical trials/outcome research 
to pursue a career focused on this combined area of investigation.  The 
secondary goal is to enhance the visibility of this discipline at U.S. 
academic health centers.    
 
MECHANISM OF SUPPORT
 
This RFA will use the National Institutes of Health (NIH) Individual 
Postdoctoral NRSA Fellowship Award (F32) mechanism.  The total project 
period for an application submitted in response to this RFA may not 
exceed a total of two years.  The requested project period should be 
reduced by the amount of time a fellow has received support on any 
prior NRSA post-doctoral fellowship including Institutional NRSA 
training grants (T32s) so that the total NRSA  support does not exceed 
3 years.  For further information refer to the NIH Guidelines for the 
NIH National Research Service Awards for Individual Postdoctoral 
Fellows (F32) published in the NIH Guide for Grants and Contracts 
(PA-00-104) http://grants.nih.gov/grants/guide/pa-files/PA-00-104.html.

FUNDS AVAILABLE

The NIAMS intends to fund up to 5 new applications responding to this 
RFA in FY 2002 and/or FY 2003 subject to the availability of resources 
and receipt of sufficiently meritorious applications.  The estimated 
funds (total costs) available for the first year of support of this 
program are $300,000.   
 
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 

INDIVIDUALS ELIGIBLE TO BECOME FELLOWS   

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

Candidate:  The candidate must have an M.D. degree and have completed at 
least two years of clinical dermatology training in an accredited 
program prior to the commencement of the fellowship.  Clinical 
dermatology training may not have been completed more than five years 
prior to submission of the application.  The individual must also meet 
the criteria for NIH National Research Service Awards for Individual 
Postdoctoral Fellows (F32) described in Program Announcement PA-00-104 
available in the NIH Guide for Grants and Contracts (Release date 
December 11, 1998, available at 
http://grants.nih.gov/grants/guide/pa_files/PA_00_104.html).  
Racial/ethnic minority individuals, women, and persons with 
disabilities are encouraged to apply.  By the time of award, 
individuals must be citizens or non-citizen nationals of the United 
States, or have been lawfully admitted to the United States for 
permanent residence (i.e., possess a currently valid Alien Registration 
Receipt Card I-551, or other legal verification of such status).  Non-
citizen nationals are generally persons born in outlying possessions of 
the United States (i.e., American Samoa and Swains Island).  
Individuals on temporary or student visas are not eligible.   

Sponsorship: Before submitting a fellowship application, the applicant 
must identify a sponsoring institution and an individual who will serve 
as a sponsor (also called mentor or supervisor) who will supervise the 
training and research experience.  The sponsoring institution may be 
private (profit or nonprofit) or public, including the NIH Intramural 
Programs and other Federal laboratories.  The applicant"s sponsor 
should be an active investigator in either skin disease research or 
epidemiology/clinical trials/outcomes research.  In some instances, it 
may be advisable for a secondary sponsor to complement the primary 
sponsor"s expertise.  The sponsor must document the availability of 
staff research support, didactic training and facilities for high 
quality research training.   
 
SPECIAL REQUIREMENTS

As didactic work in a degree granting program are a requirement of this 
award, candidates must indicate the relevant degree granting program in 
which they intend to enroll, and provide information on tuition and fees.

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:

Alan N. Moshell, M.D.
Skin Disease Program Director
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Room 5AS25L, MSC-6500
Bethesda, MD  20892-6500
Telephone:  301-594-5017
FAX:  301-480-4543
Email:  alan_n_moshell@nih.gov
 
o Direct your questions about peer review issues to:

Tommy L. Broadwater, Ph.D. 
Scientific Review Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Room 5AS25U, MSC-6500
Bethesda, MD  20892-6500
Telephone:  301-594-4952
FAX:  301-480-4543
Email:  Broadwat@mail.nih.gov

o Direct your questions about financial or grants management issues to:

Melinda Nelson
Grants Management Officer 
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Room 5AS49F, MSC-6500
Bethesda, MD  20892-6500
Telephone:  301-594-3535
FAX:  301-480-5450
Email:  melinda_nelson@nih.gov

LETTER OF INTENT
 
No letter of intent is required for this RFA.

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 416-1 (rev. 1/98) 
application. To obtain application kits with instructions and forms, 
please contact your institutional office of sponsored research. If 
application kits are not available at the institution, they may be 
downloaded from the NIH website at 
http://grants.nih.gov/grants/funding/416/phs416.htm or it may be 
requested from the: 

Division of Extramural Outreach and Information Resources 
National Institutes of Health 
6701 Rockledge Drive, Room 6207, MSC 7910 
Bethesda, Maryland  20892-7910 
Telephone:  ( 301) 435-0714
FAX:  (301) 480-0525

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten 
original of the application, including the Checklist, and one signed, 
photocopy, 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, one additional copies of the application 
must be sent to:

Tommy L. Broadwater, Ph.D. 
Scientific Review Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Room 5AS25U, MSC-6500
Bethesda, MD  20892-6500
 
APPLICATION PROCESSING: Applications must be received by 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.
 
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.  The CSR will not accept any application that is 
essentially the same as one already reviewed. This does not preclude 
the submission of substantial revisions of applications already 
reviewed, but such applications must include an Introduction addressing 
the previous critique.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the NIAMS. 

Incomplete applications will be returned to the applicant without 
further consideration.  And, if the application is not responsive to 
the RFA, CSR 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 NIAMS in accordance with the review 
criteria stated below.  As part of the initial merit review, all 
applications will:

o Receive a written critique
o Receive a second level review by the National Arthritis and 
Musculoskeletal and Skin Disease Advisory Council.
 
REVIEW CRITERIA

The review criteria focus on four main components: 

Candidate: An assessment of the candidate"s previous academic and 
research performance and the potential to become an important 
contributor to biomedical, behavioral, or clinical science. 

Sponsor and Training Environment: An assessment of the quality of the 
training environment and the qualifications of the sponsor as a mentor 
for the proposed research training experience. 

Research Proposal: The merit of the scientific proposal and its 
relationship to the candidate"s career plans. 

Training Potential: An assessment of the value of the proposed 
fellowship experience as it relates to the candidate"s needs in 
preparation for a career as an independent researcher.

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

o PROTECTIONS:  The adequacy of the proposed protection for humans, 
animals, or the environment, to the extent they may be adversely 
affected by the project proposed in the application.

o INCLUSION:  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 included in the section on Federal Citations, below)

o OTHER REVIEW CRITERIA: 

Likelihood that the training described will prepare the applicant for a 
career in epidemiology/clinical trials research/outcomes research in 
skin diseases and that the individual will pursue a career in these areas.
 
RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:    None
Application Receipt Date:         April 17, 2002
Peer Review Date:                 June, 2002
Council Review:                   September 26,2002
Earliest Anticipated Start Date:  July 1, 2002

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
 
REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND 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 Safety and 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 AMENDMENT 
"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://grants.nih.gov/grants/stem_cells.htm 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 RFA 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.

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 No. 93.846 and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or 
Health Systems Agency review.  Awards are made under authorization of 
Sections 301 and 405 of the Public Health Service Act as amended (42 
USC 241 and 284) and administered under NIH grants policies described 
at http://grants.nih.gov/grants/policy/policy.htm and under Federal 
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 

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


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.