Full Text OH-94-001

OCCUPATIONAL RADIATION AND ENERGY-RELATED HEALTH RESEARCH

NIH GUIDE, Volume 23, Number 7, February 18, 1994

RFA:  OH-94-001

P.T. 34

Keywords: 
  Health, Radiation Effects 


National Institute for Occupational Safety and Health

Letter of Intent Receipt Date:  April 1, 1994
Application Receipt Date:  May 18, 1994

PURPOSE

The Centers for Disease Control and Prevention (CDC), National
Institute for Occupational Safety and Health (NIOSH) is soliciting
grant applications for research projects relating to occupational
safety and health concerns associated with occupational exposures to
radiation and other hazardous agents at Department of Energy (DOE)
facilities and in other energy-related industries.  Studies in the
nuclear power industry and deliberate exposure of human subjects in
radiation experiments are outside the scope of this Request for
Applications (RFA).

The purpose of the grant program is to develop knowledge that can be
used in preventing occupational diseases and injuries.  NIOSH will
support the following types of applied research projects:  causal
research to identify and investigate the relationships between health
outcomes and occupational exposure to radiation and other hazardous
agents; methods research to identify early markers of adverse health
effects that are associated with such occupational exposures; and
research related to assessing past occupational exposures.  When this
research is to be conducted at a DOE facility, any DOE data required
will be supplied to the applicant by NIOSH.

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 to reduce morbidity and mortality and
improve the quality of life.  This RFA, Occupational Radiation and
Energy-Related Health Research, is related to the priority area of
occupational safety and health.  A copy of "Healthy People 2000"
(Full Report:  Stock No 017-001-00474-0) or "Healthy People 2000"
(Summary Report:  Stock No. 017-001-00473-1) may be obtained through
the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325 (telephone (202) 783-3238).

ELIGIBLE APPLICANTS

Eligible applicants include domestic and foreign non-profit and
for-profit organizations, universities, colleges, research
institutions, and other public and private organizations, including
State and local governments and small, minority and/or woman-owned
businesses.

MECHANISMS OF SUPPORT

Research support may be obtained through applications for a regular
research grant (R01).  Applicants for R01s may request support for up
to three years.  Because the nature and scope of the research
proposed in response to this RFA may vary, it is anticipated that the
size of an award will vary also.

FUNDS AVAILABLE

For fiscal year (FY) 1994, approximately $500,000 is available to
fund projects ranging in amount from $25,000 to $200,000 in total
costs.

RESEARCH OBJECTIVES

Background

The Secretary, Department of Health and Human Services (HHS) and the
Secretary, Department of Energy (DOE) signed a memorandum of
understanding (MOU) transferring the authority and resources to
manage and conduct energy-related analytic epidemiologic research
from DOE to HHS.  This includes the authority, resources, and
responsibility for the design, implementation, analysis, and
scientific interpretation of analytic epidemiologic studies of the
following populations:  workers at DOE facilities; other workers
potentially exposed to radiation; and workers exposed to potential
hazards resulting from non-nuclear energy production and use.

The Secretary, HHS, delegated responsibility for implementation of
the MOU to the Centers for Disease Control and Prevention (CDC).  The
National Institute for Occupational Safety and Health has
responsibility for the conduct of occupational studies.

Scope

The focus of grants should reflect:  (1) retrospective occupational
exposure assessment, (2) radiation measurement issues, (3) non-cancer
morbidity and mortality outcomes, (4) meta-analysis and combined
analysis methodologies, (5) uncertainty analysis, and (6) effects of
measurement error on risk estimates.

o  Retrospective Exposure Assessment

Epidemiologic studies of occupational cohorts frequently involve, and
can generally benefit from, retrospective exposure assessment to
provide estimates of exposure or categorize groups of workers by
common exposure.  Exposure assessment in energy-related occupational
epidemiology requires evaluating exposures to various hazards
including ionizing and non-ionizing radiation, metals, acids, and
solvents.  Grant opportunities encompass the fields of industrial
hygiene and retrospective exposure assessment of health physics
dosimetry.  Research areas of general interest include:   methods to
use limited data to best advantage;  how to treat censored data in
retrospective exposure assessment; uncertainty analysis techniques
for industrial hygiene exposure data and health physics dosimetry;
insight to sampling strategy design yielding a representative
understanding of exposed groups;  decision logic to select/use the
most appropriate exposure metric for epidemiologic and risk
assessment use;  and, development approaches of "Homogeneous Exposed
Groupings" and the advantages/limitations for epidemiologic use.
Research opportunities of specific interest include:  reconstruction
and dose adjustment of historic film badges; exposure assessment for
acid mists, carcinogenic solvents, exotic metals, and leukemogens;
and evaluation of biomarkers of exposure.

o  Radiation Measurement Issues

This topic will focus on the applicability and utility of radiation
dose data in epidemiological research.  Examples of such issues
include how to use nondetectable values and missing dose data in
historical radiation exposure measurements, the accuracy of
historical external dosimetry techniques (film and pocket
dosimeters), combining external and internal doses into a useful
index, historical bioassay, and radiochemistry techniques.

o  Non-cancer Morbidity and Mortality Outcomes

The majority of analytical epidemiologic research of health effects
of energy-related occupational exposures has focused historically on
the assessment of the association between cancer mortality and
exposure to ionizing radiation.  Although the importance of this
research should not be underestimated, it is essential that other
potential adverse health effects, as well as possibly other
energy-related exposures, be thoroughly evaluated as well.  Among
these would be the possible effects of radiation on the reproductive,
neurologic, and immune systems.  Chemical exposures highly prevalent
in Department of Energy facilities, such as beryllium and mercury,
have also been associated with a variety of disease outcomes,
particularly respiratory and neurologic in nature.  An important
avenue of research is the identification, validation, and use of
biomarkers of both diseases and exposures in energy-related
epidemiologic research.

o  Meta-Analysis and Combined Analysis Methodologies

Many of the cohorts at DOE facilities are not individually large
enough to detect statistically significant increases in mortality or
incidence for rare cancer types.  Methods and/or analyses for
combining data across studies whether in summary form or individual
data are valuable to the NIOSH research effort involving
energy-related health research.

o  Uncertainty Analysis

Measures of occupational exposure are inherently uncertain. Even
though measures of external radiation exposure are generally
available for all workers at DOE facilities, the models used to
estimate organ dose, shallow versus deep dose, neutron dose, etc.,
are subject to error.  Measures of dose derived from biological
monitoring of urine, feces, blood, etc. are even less precise.
Methods for assessing the degree of error in various estimates of
exposure to both ionizing radiation as well as other toxic agents
(i.e., chemicals) are desirable.

o  Effects of Measurement Error on Risk Estimates

Estimation of both bias and imprecision introduced into risk analyses
through exposure measurement error have recently received
considerable attention.  Many of the suggested approaches are very
computer intensive.  Practical solutions to this problem with regard
to the spectrum of epidemiologic designs (cohort, case-control,
cross-sectional, etc.) are needed, with particular attention to the
nature of exposure measurement in radiation epidemiology.

STUDY POPULATIONS

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

NIH policy is that applicants for NIH clinical research grants and
cooperative agreements will be required to include minorities and
women in study populations so that research findings can be of
benefit to all persons at risk of the disease, disorder or condition
under study; special emphasis should be placed on the need for
inclusion of minorities and women in studies of diseases, disorders
and conditions which disproportionately affect them.  This policy is
intended to apply to males and females of all ages.  If women or
minorities are excluded or inadequately represented in clinical
research, particularly in proposed population-based studies, a clear
compelling rationale should be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues should be addressed in developing a research
design and sample size appropriate for the scientific objectives of
the study.  This information should be included in the form PHS 398
in Sections 1-4 of the Research Plan AND summarized in Section 5,
Human Subjects.

Applicants are urged to assess carefully the feasibility of including
the broadest possible representation of minority groups.  However,
NIH recognizes that it may not be feasible or appropriate in all
research projects to include representation of the full array of
United States racial/ethnic minority populations (i.e., Native
Americans (including American Indians or Alaskan Natives),
Asian/Pacific Islanders, Blacks, Hispanics).

The rationale for studies on single minority population groups should
be provided.

For the purpose of this policy, clinical research includes human
biomedical and behavioral studies of etiology, epidemiology,
prevention (and preventive strategies), diagnosis, or treatment of
diseases, disorders or conditions, including but not limited to
clinical trials.

The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.  However,
every effort should be made to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.

For foreign awards, the policy on inclusion of women applies fully;
since the definition of minority differs in other countries, the
applicant must discuss the relevance of research involving foreign
population groups to the United States' populations, including
minorities.

If the required information is not contained within the application,
the application will be returned.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed AND the justification for the
selected study population is inadequate, it will be considered a
scientific weakness or deficiency in the study design and will be
reflected in assigning the priority score to the application.

All applications for clinical research submitted to NIH are required
to address these policies.  NIH funding components will not award
grants or cooperative agreements that do not comply with these
policies.

LETTER OF INTENT

Prospective applicants are asked to submit, by April 1, 1994, a
letter of intent that includes  a descriptive title of the proposed
effort, the name and address of the principal investigator, the names
of other key personnel, and the participating institutions, and the
number and title of this RFA.  The letter of intent is requested in
order to provide an indication of the number and scope of
applications to be reviewed.  This letter of intent does not commit
the sender to submit an application, nor is it a requirement for
submission of an application.

The letter of intent is to be sent to Dr. Fleming at the address
listed under INQUIRIES.

APPLICATIONS PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research; from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone
301/435-0714; and from NIOSH program administrator listed under
INQUIRIES.

The RFA label available in the  PHS 398 (rev. 9/91) application form
must be affixed to the bottom of the face page of the application.
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, Radiation
Studies, OH-94-001, must be typed on line 2a of the face page of the
application form and the YES box must be marked."

Applications submitted in response to this RFA must be received on
May 18, 1994.

Submit a signed, typewritten original of the application, including
the Checklist, and five photocopies of the PHS 398, in one package
to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

The timetable for receiving applications and awarding grants in
fiscal year 1994 is:

Letter of Intent Receipt Date:  April 1, 1994
Application Receipt Date:       May 18, 1994
Initial Review:                 August 1994
Secondary Review:               September 1994
Earliest Possible Start Date:   September 30, 1994

Applications must be received on the above receipt date.  To guard
against problems caused by carrier delays, retain a legible
proof-of-mailing receipt from the carrier, dated no later than one
week prior to the receipt date.  If the receipt date falls on a
holiday, it will be extended to the following work day.

REVIEW CONSIDERATIONS

The applications will be reviewed by an initial review group convened
by NIOSH.  The initial (peer) review is based on scientific merit and
significance of the project, competence of the proposed staff in
relation to the type of research involved, feasibility of the
project, likelihood of its producing meaningful results,
appropriateness of the proposed project period, adequacy of the
applicant's resources available for the project, and appropriateness
of the budget request.

In the secondary (programmatic importance) review, the following
factors will be considered:

o  The results of the initial review;
o  Magnitude of the problem in terms of numbers of workers affected;
o  Severity of the disease or injury in the worker population; and
o  Usefulness to applied technical knowledge in the identification,
evaluation, and/or control of occupational safety and health hazards.

Applicants will compete for available funds with all other approved
applications.  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 balance among research areas of the announcement

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.

Direct inquiries regarding programmatic issues and address the letter
of intent to:

Roy M. Fleming, Sc.D.
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road, NE
Building 1, Room 3053, Mail Stop D-30
Atlanta, GA  30333
Telephone:  (404) 639-3343

Direct inquiries regarding fiscal matters to:

Ms. Lisa Tamaroff
Grants Management Branch, PGO
Centers for Disease Control and Prevention
255 E. Paces Ferry Road, NE
Room 300, Mail Stop E-13
Atlanta, GA  30305
Telephone:  (404) 842-6796

AUTHORITY AND REGULATIONS

This program is authorized under the Public Health Service Act, as
amended, Section 301 (42 U.S.C. 241); the Occupational Safety and
Health Act of 1970, Section 20 (a) (29 U.S.C. 669[a]); and the
Federal Mine Safety and Health Amendments Act of 1977, as amended,
Section 501 (30 U.S.C. 951).  The applicable program regulations are
in 42 CFR Part 52.  The Catalog of Federal Domestic Assistance number
is 93.262.  This program is not subject to the Public Health System
Reporting Requirements.  Applications are not subject to review as
governed by Executive Order 12372, Intergovernmental Review of
Federal Programs.

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