MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD IN MOLECULAR EPIDEMIOLOGY

Release Date:  December 15, 1998

PA NUMBER: PAR-99-027

P.T.

National Institute of Environmental Health Sciences

PURPOSE

The National Institute of Environmental Health Sciences (NIEHS) announces the
availability of support for Mentored Research Scientist Development Awards that
will develop research scientists in the field of  molecular epidemiology of
environmentally induced diseases.  The program is intended to allow individuals
trained in a basic science that is relevant to the study of the effects of
environmental exposures to gain research and training experience in epidemiology,
or to allow individuals with training in epidemiology to gain experience in a
basic science that could be applied to the development of biomarkers of exposure
or of effect in humans, or to studies aimed at understanding the genetic basis
for differing susceptibilities to environmentally-associated diseases.  These
research career development opportunities will be supported through the Mentored
Research Scientist Development Award (K01), which will provide an intensive,
supervised career development experience in molecular epidemiology of
environmentally induced diseases.

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 of setting priority areas.  This Program Announcement (PA), Mentored
Research Scientist Development Award in Molecular Epidemiology, is related to the
priority area of human resource development.  Potential applicants may obtain a
copy of "Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0 or Summary
Report: Stock No. 017-001-00473-1) from the Superintendent of Documents,
Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800).

ELIGIBILITY REQUIREMENTS

The candidate must have a research or health-professional doctorate or its
equivalent, and must have demonstrated the capacity or potential for highly
productive independent research in the period after the doctorate.

The candidate must identify a mentor with extensive research experience, and must
be willing to spend a minimum of 75 percent of full-time professional effort
conducting research and research career development activities for the period of
the award.

Applications may be submitted on behalf of candidates by domestic, non-Federal
organizations, public or private, such as medical, dental, or nursing schools or
other institutions of higher education.  Minorities and women are encouraged to
apply.  Candidates must be U.S. citizens or noncitizen nationals, or must have
been lawfully admitted for permanent residence and possess an Alien Registration 
Receipt Card (I-151 or I-551) or some other verification of legal admission as
a permanent resident. Noncitizen nationals, although not U.S. citizens, owe
permanent allegiance to the U.S.  They are usually born in lands that are not
states, but are under U.S. sovereignty, jurisdiction, or administration. 
Individuals on temporary or student visas are not eligible.

Candidates may be or may have been principal investigators on PHS research grants
provided the candidate can demonstrate that the new field of study is
fundamentally different from their past research or research training experience
and the candidate has a commitment to pursue a research career in molecular
epidemiology at the conclusion of the support period.

MECHANISM OF SUPPORT

Awards in response to this Program Announcement will use the K01 mechanism.
Planning, direction, and execution of the program will be the responsibility of
the candidate and his/her mentor on behalf of the applicant institution. The
project period may be for three, four, or five years and will depend upon the
justification of the need for particular additional experiences to achieve
independence in the field of molecular epidemiology.  Awards are not renewable.

RESEARCH OBJECTIVES

Background

It is established that exposure to environmental agents may adversely affect many
aspects of human health.  However, because human exposures to environmental
agents are generally inadvertent, uncontrolled, confounded with other exposures,
and often low dose and chronic, it has often been difficult to link a given
exposure with a disease or disease process. Because of these limitations,
research strategies have included the development and validation of biomarkers
that reflect specific exposures and predict disease risk in individuals.  In
addition, rapid advances in molecular genetic technologies are providing new
opportunities to study individual differences in susceptibility and response in
environmentally responsive diseases, and to understand the underlying genetics
and genetic-environmental interactions involved.

It is also recognized that the development of biomarkers and the application of
genetic principles to epidemiological research require individuals whose
background includes experience and training in both epidemiology and a basic
science discipline. Ph.D. and postdoctoral training programs in these areas have
traditionally run in parallel tracks, and only rarely have offered specific
didactic training in both epidemiological methods and in laboratory sciences
which would provide background in these new approaches. However, it is becoming
clear that chronic diseases are multi-factorial, and multiple exposures, as well
as variability in susceptibility based on polymorphisms in numerous genes,
interact in disease etiology.  Increased communication between the disciplines
and the formation of multidisciplinary work teams are now needed to approach
environmental health problems in humans and to understand the complex molecular
and cellular disease cascades resulting from adverse environmental exposures. 
It is intended that this Research Scientist Development award will increase the
pool of researchers who have the multidisciplinary training and research
experience to conduct research in molecular epidemiology, and who can maximize
collaborative opportunities.

Given that there has been some success to date in the development of biomarkers
and in the elaboration of susceptibility genes for cancer endpoints,  the
development of research personnel who will pursue molecular epidemiology studies
with non-cancer endpoints is particularly encouraged.

Environment

The institution must have a well-established research career development program
and qualified faculty to serve as mentors.  The institution must be able to
demonstrate a commitment to the development of the candidate as a productive,
independent investigator.  In addition, the candidate, mentor and institution
must be able to describe a career development program that will maximize the use
of relevant research and educational resources.

Program

The award provides three to five consecutive 12 month appointments.  At least 75
percent of the recipient's full-time professional effort must be devoted to the
program and the remainder devoted to other research-related and/or teaching
pursuits consistent with the objectives of the award.  The candidate must develop
knowledge in both a relevant basic science and the principles of epidemiology
with a goal to becoming an independent investigator conducting research in
molecular epidemiology of environmental exposures.  The candidate may find it
appropriate to include relevant didactic and laboratory or field research
experiences, and if the training program is for an individual with a background
in a basic science, the candidate is encouraged to pursue an advanced degree in
epidemiology.

Mentors

The recipient must receive appropriate mentoring throughout the three to five
year program.  Where feasible, women and minority mentors should be involved as
role models.

Allowable Costs

Salary:  NIEHS will provide salary for the K01 recipient of up to $75,000 per
year plus commensurate fringe benefits or a minimum of 75 percent effort. 
Although a greater effort may be proposed, the maximum allowable salary is
$75,000.  The institution may supplement the NIH 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 of the award. 
Under expanded authorities, however, institutions may rebudget funds within the
total costs awarded to cover salaries consistent with the institution's salary
scale.

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.

Research Development Support:  The NIEHS 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; (d) statistical services
including personnel and computer time.

Ancillary Personnel Support:  Salary for mentors, secretarial and administrative
assistance, etc., is not allowed.

Indirect costs:  Indirect costs will be reimbursed at eight percent of modified
total direct costs, or at the actual indirect cost rate, whichever is less.

Evaluation

In carrying out its stewardship of human resource related programs, the NIH may
begin requesting 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.

Other Income

Fees resulting from clinical practice, professional consultation, or other
comparable activities required by the research and research-related activities
of this award may not be retained by the career award recipient. Such fees must
be assigned to the grantee institution for disposition by any of the following
methods:

o  The funds may be expended by the grantee institution in accordance with the
NIH policy on supplementation of career award salaries and to provide fringe
benefits in proportion to such supplementation. Such salary supplementation and
fringe benefit payments must be within the established policies of the grantee
institution.

o  The funds may be used for health-related research purposes.

o  The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks
must be made payable to the Department of Health and Human Services, NIH and
forwarded to the Director, Division of Financial Management, NIH, Bethesda,
Maryland 20892.  Checks must identify the relevant award account and reason for
the payment.

o  Awardees may retain royalties and fees for activities such as scholarly
writing, service on advisory groups, or honoraria from other institutions for
lectures or seminars, provided these
activities remain incidental and provided that the retention of such pay is
consistent with the policies and practices of the grantee institution.

o  Usually, funds budgeted in an NIH supported research or research training
grant for the salaries or fringe benefits of individuals, but freed as a result
of a career award, may not be rebudgeted.  The awarding component will give
consideration to approval for the use of released funds only under unusual
circumstances.  Any proposed retention of funds released as a result of a career
award must receive prior written approval of the NIH awarding component.

Special Leave

Leave to another institution, including a foreign laboratory, may be permitted
if directly related to the purpose of the award.  Only local, institutional
approval is required if such leave does not exceed three months.  For longer
periods, prior written approval of the NIH funding component is required.  To
obtain prior approval, the award recipient must submit a letter to the NIH
describing the plan, countersigned by his or her department head and the
appropriate institutional official.  A copy of a letter or other
evidence from the institution where the leave is to be taken must be submitted
to assure that satisfactory arrangements have been made.

Support from the career award will continue during such leave.

Leave without award support may not exceed 12 months.  Such leave requires the
prior written approval of the NIH funding component and will be granted only in
unusual situations.  Support from other sources is permissible during the period
of leave.  Such leave does not reduce the total number of months of program
support for which an individual is eligible.  Parental leave will be granted
consistent with the policies of the NIH and the grantee institution.

Termination or Change of Institution:  When a grantee institution plans to
terminate an award, the NIH funding component must be notified in writing at the
earliest possible time so that appropriate instructions can be given for
termination.  If the individual is moving to another eligible institution, career
award support may be continued provided:

o  A new career award application is submitted by the new institution.

o  The period of support requested is no more than the time remaining within the
existing award period; and

o the new application is submitted far enough in advance of the requested
effective date to allow the necessary time for review.

o  The funding component may require a review by an initial review group and/or
the appropriate National Advisory Council or Board. Alternatively, review may be
carried out by staff within the NIH funding component, depending upon the
circumstances.

The Director of the NIH may discontinue an award upon determination that the
purpose or terms of the award are not being fulfilled.  In the event an award is
terminated, the Director of the NIH shall notify the grantee institution and
career award recipient in writing of this determination, the reasons therefore,
the effective date, and the right to appeal the decision.

A final progress report, invention statement, and Financial Status Report are
required upon either termination of an award or
relinquishment of an award in a change of institution situation.

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 must 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," which have been published in the Federal Register of March 28, 1994
(FR 59 14508-14513), and in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18,
1994, Volume 23, Number 11, available on the web at the following URL address:
http://www.nih.gov/grants/guide/notice-files/not94-105.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.

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 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 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.
4/98; use the instructions in Section IV as appropriate) and will be accepted on 
February 1, October 1 and June 1.  Applications should be organized using the
Research Career Award portion of the PHS 398.  Application kits are available at
most institutional offices of sponsored research and from the Division of
Extramural Outreach and Information Resources, National Institutes of Health,
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, Phone (301) 435-0714,
FAX: (301) 480-0525, Email: GrantsInfo@nih.gov.  Forms are also available on the
NIH Website at http://www.nih.gov/grants/forms.htm

It is strongly recommended that prospective applicants contact the staff person
listed under INQUIRIES early in the planning phase of the application
preparation.

To identify the application as a response to this program announcement, check
"YES" on item 2 of page 1 of the application and enter "PAR-98-027, Molecular
Epidemiology Mentored Scientist Development Award."

Three sealed letters of recommendation addressing the candidate's potential for
the research career must be included as part of the application.

Submit a signed, typewritten original of the application, reference letters,
current curriculum vitae with complete bibliography, 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 same time, send two additional copies to:

Dr. Ethel Jackson
Scientific Review Branch  MD EC-24
National Institute of Environmental Health Sciences
P.O. Box 12233
Research Triangle Park, NC 27709

REVIEW CONSIDERATIONS

Applications will be reviewed assigned on the basis of established PHS referral
guidelines.  Applications will be evaluated for scientific and technical merit
by an appropriate peer review group convened in accordance with the standard NIH
peer review procedures.  As part of the initial merit review, all applications
will receive a written critique and may undergo a process in which 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 appropriate national advisory council or
board.

Review Criteria

The following review criteria will be applied:

Candidate

o  Commitment to an independent research career;

o potential to develop (or evidence of the capacity to develop) as an independent
investigator; and

o quality and breadth of prior scientific training and experience, including,
where appropriate, the record of previous research support and publications.

Career Development Plan

o  Likelihood that the plan will contribute substantially to the scientific
development of the candidate and the achievement of scientific independence;

o appropriateness of the research plan to the career goals of the candidate;

o appropriateness of the plan to update conceptual and theoretical knowledge, and
the proposed award duration;

o consistency of the career development plan with the candidate's prior research
and academic experience and the 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

All candidates for this award will have had previous research
experience and in some cases will have been Principal Investigators in other
scientific fields.  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  adequacy of plans to include both genders and minorities 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 research qualifications in the area of this
application;

o quality and commitment of the mentor to supervising and guiding the candidate
throughout the award period;

o previous experience in fostering the development of researchers; 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;

o quality of environment for scientific and professional
development; and

o applicant institution's willingness to develop an appropriate mix of research,
teaching and administrative responsibilities for the candidate.

Budget

o  Justification of budget requests in relation to career development goals and
research aims and plans.

Review Criteria

Candidate

o  Establish the candidate's commitment to a career in biomedical or behavioral
research;

o establish the candidate's potential to develop into a successful independent
investigator; and

o summarize the candidate's immediate and long-term career
objectives, explaining how the award will contribute to their
attainment.

o  Letters of recommendation.  Three sealed letters of recommendation addressing
the candidate's potential for a research career must be included as part of the
application

Career Development Plan

o  Describe the career development plan, incorporating consideration of the
candidate's goals and prior experience.  It should describe a systematic plan to
obtain the necessary basic biomedical or
behavioral science background and research experience to launch or reinitiate an
independent research career.

o  Candidates 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.

Research Plan

o  Describe the research plan and the use of a basic or clinical approach to a
biomedical or behavioral problem.  The candidate and mentor together 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

o  The application must include information on the mentor(s)
including information on  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 proposed award period.

Environment and Institutional Commitment

o  The sponsoring institution must document a strong, well-
established research program related to the candidate's area of interest
including a high-quality research environment with staff capable of productive
collaboration with the candidate.  The
sponsoring institution also must provide a statement of commitment to the
candidate's development into a productive, independent
investigator.

Budget

o  Budget requests must be provided according to the instructions in form PHS
398.  The request for tuition and fees, books, travel, etc., must be justified
and specified by category.

AWARD CRITERIA

Funding decisions will be made based on the recommendations of the initial review
group and council/board, the need for research personnel in specific program
areas, and the availability of funds.

INQUIRIES

Written and telephone inquiries concerning this PA are encouraged, especially
during the planning phase of the application.

Inquiries regarding programmatic issues may be addressed to:

Carol A. Shreffler, Ph.D.
Training and Education Programs
National Institute of Environmental Health Sciences
P.O. Box 12233 - MD EC-23
Research Triangle Park, NC  27709
Telephone:  (919) 541-1445
FAX:  (919) 541-5064
Email:  shreffl1@niehs.nih.gov

Direct inquiries regarding fiscal matters should be addressed to:

Ms. Jackie Russell
Grants Management Branch
MD EC-22
Research Triangle Park, NC 27709
Telephone:  (919) 541-0751
Email:  russell@niehs.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.121.  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, 42 USC 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, and 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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