TRAINING IN CLINICAL INVESTIGATION IN KIDNEY AND UROLOGY

Release Date:  October 30, 1998

PA NUMBER:  PAR-99-012

P.T.

National Institute of Diabetes and Digestive and Kidney Diseases

Application Receipt Date:  March 10, 1999

PURPOSE

The Division of Kidney, Urology and Hematology (DKUH) has long been interested
in stimulating more training in clinical research methods in programs related
to Nephrology and Urology.  At the same time, there is a dearth of clinicians
that have advanced training in clinical trial methodology.  The purpose of
this program announcement (PA) is to encourage applications for new training
programs, and to encourage Program Directors of existing Institutional
Training Grants supported by DKUH to collaborate with Schools of Public Health
and Departments of Epidemiology/Statistics/Biostatistics to offer didactic and
practical training in clinical research methodologies.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000," a PHS-led national
activity for setting priority areas.  Potential applicants may obtain a copy
of "Healthy People 2000 at http://www.crisny.org/health/us/health7.html

ELIGIBILITY REQUIREMENTS

For new training programs, only domestic, non-profit, private or public
institutions may apply.  The applicant institution must have the staff and
facilities required for the proposed program.  The research training program
director at the institution will be responsible for the selection and
appointment of trainees to receive National Research Service Award (NRSA)
support and for the overall direction of the program.  Racial/ethnic minority
individuals, women and persons with disabilities are encouraged to apply as
principal investigators.

Positions on NRSA institutional grants may not be used for study leading to
the M.D., D.D.S. or other clinical, health-professional degrees except when
those studies are a part of a formal combined research degree program such as
the M.D./Ph.D.  Similarly, trainees may not accept NRSA support for studies
which are a part of residency training leading to a medical specialty or
subspecialty except when the residency program credits a period of full-time,
postdoctoral research training toward board certification and the trainee
intends to pursue a research career.

Trainees are required to pursue their research training on a full-time basis,
devoting at least 40 hours per week to the program.  Clinical duties must be
confined to those that are an integral part of the research training
experience.

To be appointed to a research training grant, an individual must be a citizen
or a non-citizen national of the United States or must have been lawfully
admitted for permanent residence (i.e., in possession of a currently valid
Alien Registration Receipt Card I-551, or must be in possession of other legal
verification of such status).  Individuals on temporary or student visas are
not eligible.

Additional information concerning trainee eligibility, appointment and payback
requirements may be obtained from National Institutes of Health National
Research Service Award Institutional Research Training Grants, in the NIH
Guide for Grants and Contracts, Vol. 23, No. 21, June 3, 1994, or from the
NIH Research Training Opportunities web site.

MECHANISM OF SUPPORT

Active NRSA Institutional Training Grants (T32) in Nephrology or Urology
supported in DKUH are eligible for this Program Announcement.  They may use
one training position for didactic and practical training in clinical research
methodology without prior approval of the NIDDK.  If such training will incur
costs in excess of current budget allowances, the Program Director must put
together a supplemental budget request with complete justification for the
increased costs and submit it for DKUH review and approval.  Tuition and fees
will be allowed up to $2,000, plus 60% of costs exceeding that amount.

New applications for this program announcement should follow carefully the
guidelines and instructions for NRSA Institutional Training Grant support. 
Necessary tuition and fees should be budgeted keeping costs within the noted
guidelines for maximum allowable.

RESEARCH OBJECTIVES

It is widely acknowledged that there is a need to train more investigators to
design and conduct well-controlled clinical studies, and to make the
epidemiological assessments on which many of these studies depend.  To
accomplish this task, opportunities are needed to enable clinically trained
individuals to obtain didactic and fieldwork training in clinical
investigation and epidemiologic methods.

The goal of this program announcement is to increase the number of well
trained investigators who are capable of conceiving, designing, conducting,
analyzing and presenting the results of clinical research in areas pertaining
to Nephrology or Urology.  Eligible trainees would be enrolled in, or have 
completed clinical training programs in nephrology or urology

Institutions responding to this program announcement should have in place a
formal program for training physicians in clinical research methodology.  An
ideal program would consist of collaboration between the respective clinical
and School of Public Health departments, and would culminate in the granting
of a graduate degree þ e.g., a MPH, DrPH or ScD.  Individuals who complete the
training program should be provided sufficient theoretical and applied
educational experiences to be able to function as independent clinical
research investigators.

The following are important components of an intensive training program in
clinical research:

Training Environment

Structured academic exposure(s) to the basic and applied sciences such that
various scientific methodologies and resources used in the testing of
scientific hypotheses are known.

It is recognized that investigators early in their careers need to have well-
developed associations with more experienced and knowledgeable investigators
whose overall perspective of their fields enable them to provide guidance and
consultation to the student.  Normally, such individuals are present in
universities and  will be responsible for the student's didactic and practical
training.

Course Content

Course work should lead to a graduate degree with a concentration in areas
related to clinical investigative methodology.  The exact course mix will be
determined, in part, by the student's background and particular needs. Courses 
should include exposure to the following subject areas:

o  Research study design: Basic Statistics, Biostatistics, Epidemiology;

o  Analysis of experiments: Advanced Statistics, Advanced Biostatistics;

o  Social Sciences: Public Policy, Economics, Psychology,
Sociology/Anthropology, Health Education.

o  Special topics in Epidemiology: clinical trial þ design, conduct,
recruitment of subjects, implementation.

o  Outcomes analysis.

Practicum

The major intent here is to develop further a career path for nephrologist and
urologists by providing "hands-on" experiences in designing and implementing
clinical research, and in summarizing, analyzing and presenting data by using
statistical methodologies on different sets of data.  The various activities,
settings and/or fieldwork experiences must be within the areas of Nephrology
or Urology.

Specific training in areas of statistical genetic analysis and in genetic
epidemiology with application to the study of risk factors of certain diseases
in Nephrology and Urology also is encouraged.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and
their subpopulations much be included in all NIH supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification is provided 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 research involving human subjects should read the
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research" published in the Federal Register of March 28, 1994 (FR 59 14508-
14513) and NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18,
1994 available on the web:
http://www.nih.gov/grants/guide/1994/94.03.18/index.html.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH 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 I) 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 was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address:
http://www.nih.gov/grants/guide/notice-files/not98-024.html

Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES.  Program Staff may also provide additional relevant
information concerning the policy.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
5/95) and will be accepted on or before the application deadline March 10,
1999.  Application kits are available at most institutional office of
sponsored research, or may be obtained from the Division of Extramural
Outreach and Information Resources, National Institutes of Health, 6701
Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-710-0267,
email: GrantsInfo@nih.gov.

The program announcement title and number must by typed on line 2 of the face
page of the application form and the YES box must be marked.

Mail the signed, original, single-sided application, along with five exact,
single-sided copies and five collated sets of appendix materials 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:

Ann A. Hagan, Ph.D.
Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8886
FAX:  (301) 480-3505

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established Public Health
Service referral guidelines.  An appropriate peer review group convened in
accordance with NIH peer review procedures will evaluate applications that are
complete for scientific and technical merit.  As part of the initial merit
review, all applications will receive a written critique. Only those
applications deemed to have the highest scientific merit, generally the top
half of applications under review, will be discussed, assigned a priority
score, and receive a second level review by the NIDDK National Advisory
Council.

Review Criteria

o  Past research training record for both the program and the designated
preceptors in terms of the rate at which former trainees establish independent
and productive research careers;

o  Past research training record in terms of the success of former trainees in
obtaining individual awards such as fellowships, career awards and research
grants for further development;

o  Objectives, design and direction of the research training program;

o  Caliber of preceptors as researchers including successful competition for
research support;

o  Training environment including the institutional commitment, the quality of
the facilities and the availability of research support;

o  Recruitment and selection plans for appointees and the availability of high
quality candidates;

o  The record of the research training program in retaining health
professional postdoctoral trainees for at least two years in research training
or other research activities;

o  When appropriate, the concomitant training of health-professional
postdoctorates (e.g., individuals with a Ph.D., ScD) will receive special
consideration.

Additional Review Considerations

Minority Recruitment Plan: The NIH remains strongly committed to increasing
the participation of individuals from under represented minority groups in
biomedical and behavioral research.  Additional information on this
requirement is published in the NIH Guide for Grants and Contracts, Volume 22,
Number 25, July 16, 1993

Training in the Responsible Conduct of Research: Every predoctoral and
postdoctoral NRSA trainee supported by an institutional research training
grant must receive instruction in the responsible conduct of research.  For
additional information please consult the NIH Guide for Grants and Contracts,
Volume 21, Number 43, November 27, 1992.  The plan will be discussed after the
overall determination of merit, so that the quality of the plan will not be a
factor in the determination of the priority score.  Plans will be judged as
acceptable or unacceptable.  The acceptability of the plan will be described
in an administrative note.  Regardless of the priority score, applications
with unacceptable plans will not be funded until the applicant provides a
revised, acceptable plan.  Staff within the awarding component of the NIDDK
will judge the acceptability of the revised plan.

AWARD CRITERIA

Applications will compete for available funds with all other approved
applications assigned to the NIDDK.  The following will be considered in
making funding decisions:

o  Quality of the proposed project as determined by peer review;
o  Availability of funds;
o  Program priority.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issue or question
from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Charles H. Rodgers, Ph.D.
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-7717
FAX:  (301) 480-3510
Email:  rodgersc@extra.niddk.nih.gov

Direct inquiries regarding fiscal and administrative matters to:

Kim Law
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8869
Email:  lawk@extra.niddk.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.849.  Awards are made under authorization of the Public Health Service Act,
Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42USC
241 and 285) and administered under PHS grants policies and Federal
Regulations 42 CFR 52 and 45 CFR Part 74.  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and promote the non-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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