Subject: NIH GUIDE - V20(19) 05/17/91 - P2/2
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Wed, 15 May 91 15:05 EST

Hi Paul ,
This is part 2 of 4. Please post to the list server as :
   NIHGUIDE2.910517
                   Dottie
 ---------------------------- Text of forwarded message -----------------------
various types; economic and other stresses in rural areas and
health-related behavior of rural populations; mental health problem
prevention in rural populations; economic and financing issues
concerning mental health related services in rural areas; special
problems of distinctive rural subpopulations such as migrants, ethnic
and cultural minorities, the elderly, persons with Alzheimer's disease,
children and adolescents, the homeless mentally ill, and persons with
co-occurring mental health and other types of disorders such as
substance abuse and physical disorders; and distinctive methods needed
for research in rural areas.
 
Applications for research demonstration projects must involve the
transfer and application of interventions derived from a solid
theoretical or research base, be designed to test effectiveness through
a rigorous research design that measures the project's impact, and
generate conclusions that are generalizable to other sites.
 
Applications may be submitted by any nonprofit or for-profit
organization, including units of State and local governments.
 
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS
 
NIH and ADAMHA policy is that applicants for NIH/ADAMHA 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 Section 2,
A-D of the Research Plan AND summarized in Section 2, E, Human Subjects.
Applicants/offerors 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.
 
Preference will be given to projects consistent with the National
Institute of Mental Health Public-Academic Liaison initiative (bringing
together public sector service providers and academic researchers),
those involving high-risk populations (e.g. homeless and severely
mentally ill persons), and those that include females and minorities in
study populations.
 
Support for research on rural mental health that does not include funds
for demonstration services may be requested through applications for a
regular individual research grant (R01), the First Independent Research
and Transition (FIRST) award (R29), and a small grant (R03).
 
Support for research demonstration awards that include funds for
services necessary for the conduct of the research may be requested
through applications for research demonstration grants (R18).  Research
demonstration applications will be subject to review and comment by
States, through procedures that may be obtained from the State's single
point of contact (SPOC).  Criteria for the various grant mechanisms
should be requested from the contact listed below.
 
Applications may request support for up to 5 years for research and
research demonstration projects.  Small grants are limited to 2 years
and may not be renewed.  FIRST awards may be made for up to 5 years, but
are not renewable.  Annual awards will be made, subject to continued
availability of funds and progress achieved.  During Fiscal Year 1990,
the National Institute of Mental Health funded approximately $8 million
for rural mental health research through all mechanisms.
 
The earliest receipt date is June 1, 1991.  Applications submitted by
that date, if complete at time of submission, will be eligible for an
expedited review so that funding in September, 1991, is possible.
Thereafter, the usual receipt dates of Oct. 1, Feb. 1, and June 1 and
the usual review schedule apply.
 
Staff consultation to applicants during proposal development is
available.
 
For further information and to request a copy of the full announcement,
prospective applicants should contact:
 
Charles Windle, Ph.D.
Acting Director
Office of Rural Mental Health Research
Division of Applied and Services Research
Parklawn Building, Room 18C-14
National Institute of Mental Health
Rockville, MD  20857
Telephone:  (301) 443-4233
 
Inquiries pertaining to grants management should be directed to:
 
Steven Hudak
Chief, Grants Management Section
Grants Management Branch
Parklawn Building, Room 7C-23
National Institute of Mental Health
Rockville, MD  20857
Telephone:  (301) 443-4456
 
This program is described in the Catalog of Federal Domestic Assistance
No. 93.242, Mental Health Research Grants.  Under the authority of
Section 301 of the Public Health Service Act (42 U.S.C. 241) and subject
to availability of funds, the National Institute of Mental Health will
accept applications in response to this announcement.
 
$$P4 END ***************************************************************
 
$$P5 BEGIN PA-91-53 ****************************************************
 
RESEARCH ON THE EFFECTS OF POWER FREQUENCY ELECTRIC AND
MAGNETIC FIELDS
 
PA:  PA-91-53
 
P.T. 34; K.W. 0725015, 1013026
 
National Institute of Environmental Health Sciences
 
The National Institute of Environmental Health Sciences (NIEHS), the
National Institute of Neurological Disorders and Stroke (NINDS), and the
National Institute of Child Health and Human Development (NICHD) invite
grant applications through a joint Program Announcement (PA) for basic
studies on the effects of electric and magnetic fields.  This
solicitation is issued to encourage investigator-initiated research
projects in areas of special programmatic interest to the National
Institutes of Health (NIH).  Applicants funded under the PA are
supported through traditional research grants in accordance with Public
Health Service (PHS) policies applicable to research grants.  It is
noted that only Research Project (R01, R29) grant applications will be
considered to be responsive to this PA.
 
Grant applications in response to this announcement will be reviewed in
accordance with the usual Public Health Service Peer Review Procedures.
 
BACKGROUND
 
The NIEHS is the principal NIH component for support of basic research
on environmental factors that contribute to human health problems and
disease.  Major emphasis by NIEHS is placed upon research examining
those physical and chemical substances to which humans are exposed in
their general environment as a result of human activities such as modern
technologies and industrial and commercial processes.  In addition to
the NIEHS, the NINDS also supports research on those factors that
impinge on the nervous and sensory systems.  The NICHD is interested in
factors such as EMF that may affect reproduction and development.
 
As a result of electrification of our homes and work places, people from
all walks of life and of all ages are now exposed to power frequency (60
Hz) electric and magnetic fields.  Increasingly scientists, regulators
and lay people are asking whether human exposure to these fields
involves risks to human health.  Electromagnetic fields (EMF) cause
biological effects in human beings, in laboratory animals, and in cells
and tissues from humans and animals.  However, the extant literature
does not provide a basis for assessing the risks, if any, from exposure
to these fields.  Thus there is a need for additional research on the
biological effects of EMF exposure particularly at the frequencies of
power lines and electrically powered devices.
 
The results of studies on the biological effects of EMF are
controversial.  One reason for controversy is the finding of positive
and negative effects in some similar studies.  Also, there are
scientists who believe that power frequency fields cannot cause
biological effects other than the well known hazards of electrical shock
and burn.  This position is based on two points.  One, the energy of a
60 Hz electromagnetic wave is too weak to break chemical bonds.  Two,
natural electric fields in the body are orders of magnitude greater than
those induced by common EMF exposure.
 
On the other hand, there are reports of biological effects of EMF at
many levels of biological organization.  These studies have examined a
wide range of endpoints but, for the most part, have been
phenomenological rather than hypothesis based.  For example, in vitro
studies report effects on the cell membrane, DNA synthesis, RNA
transcription, ornithine decarboxylase activity, calcium-ion efflux,
cellular response to hormones and cancer cells.  These responses to EMF
at the cellular level display a considerable complexity including
resonant responses in frequency and field strength, complex time
dependencies, and dependence on the ambient DC magnetic field created by
the earth.
 
Animal systems have been used for studies under a range of electric and
magnetic field intensities for varied exposure conditions and durations.
A few examples are studies of animal behavior with and without drugs,
melatonin synthesis in the pineal gland, and circadian rhythms.  In
general, research is needed to determine if in vivo EMF exposure has a
deleterious effect on animals and to define exposure conditions that may
be effective.
 
The results of epidemiological studies are controversial because some
studies report no association between residential EMF exposure and
cancer while other work suggests a possible association.  For example, a
study published in 1979 reported increased incidence of leukemia and
brain tumors in children exposed to EMF.  Criticisms of the report led
to a second study that addressed many of the study design problems.
This work also found a weak association between EMF exposure and
leukemia and brain tumors.  However, another epidemiological study in
1980 failed to demonstrate an association between residential EMF
exposure and childhood leukemia.  In addition, some but not all studies
of occupational exposure of electrical workers have suggested an
increased incidence of leukemia and brain cancer; however, the causative
agent for this pattern remains unknown.
 
RESEARCH OBJECTIVES AND SCOPE
 
This announcement is issued to encourage and foster
investigator-initiated basic and applied research on the possible health
effects of EMF.  Because of the limited data on EMF biological effects
it is anticipated that some projects may be more focused on
identification of EMF effects than on the possible mechanisms of EMF
actions.  Such applications must state the means by which the
information generated will be useful in risk assessment and/or
developing mechanistic hypotheses.  Collaborative research efforts among
toxicologists, physicists, engineers, and scientists in closely related
disciplines are encouraged to ensure quality in all aspects of the
proposed study.
 
Research interests include, but are not limited to studies designed to:
 
A. Determine the effects/mechanisms of action of EMF on cellular
responses such as DNA synthesis, modulation of ion binding, and
interaction with hormones and growth factors.  B. Determine the effects
on cancer processes in vivo and in vitro.  C. Determine the effects of
EMF on reproductive/developmental and nervous systems in vivo and in
vitro.  D. Development of well-characterized EMF exposure systems for
assessing biological effects.
 
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.  This Program
Announcement, Research on the Effects of Power Frequency Electric and
Magnetic Fields, is related to the priority area of environmental
health.  Potential applicants may obtain 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) through the Superintendent
of Documents, Government Printing Office, Washington, D.C. 20402-9325
(telephone 202-783-3238).
 
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDIES.
 
NIH and ADAMHA policy is that applicants for NIH/ADAMHA 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, together with a rationale for
its choice.  In addition, general 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 Section 2, A-D of the Research Plan AND
summarized in Section 2, E, Human Subjects.  Applicants are urged to
assess carefully the feasibility of including the broadest possible
representation of minority groups.  However, NIH recognize 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
review will be deferred until the information is provided.
 
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.
 
MECHANISM OF SUPPORT
 
The mechanism of support for this activity will be the individual
research grant (RO1) or First Independent Research Support and
Transition (FIRST) Award (R29) as applicable.
 
APPLICATION AND REVIEW PROCEDURES
 
Applications will be accepted in accordance with the usual receipt dates
for new research grant applications; i.e., February 1, June 1, and
October 1.  The earliest possible award dates will be approximately nine
months after the respective receipt dates.  Applications received too
late for one cycle of review will be held until the next receipt date.
 
Applications will be received by the NIH's Division of Research Grants
(DRG) and referred to an appropriate study section for scientific and
technical merit review.  Institute assignment decisions will be governed
by the normal programmatic considerations as specified in the NIH
Referral Guidelines.  The review criteria customarily employed by the
NIH for regular research grant applications will prevail.  Following the
initial scientific review, the applications will be evaluated by an
appropriate advisory council.
 
METHOD OF APPLYING
 
Applications must be submitted on form PHS 398 (revised 10/88) which is
available in the business or contracts offices at most academic and
research institutions and from the DRG.  To identify the application as
a response to this announcement, check "yes" in Item 2 on the face page
of the application and enter the title "Research on the Effects of Power
Frequency Electric and Magnetic Fields, PA-91-53."
 
The original and six (6) copies of the application must be directed to:
 
Applications Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
Inquires related to this Program Announcement should be directed to:
 
Dr. Michael J. Galvin
Program Administrator, Scientific Programs Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233
Research Triangle Park, NC  27709
Telephone:  (919) 541-7825
 
Dr. Eugene Streicher or Dr. W. Watson Alberts
Division of Fundamental Neurosciences
National Institute of Neurological Disorders and Stroke
Federal Building, Room 916
Bethesda, MD  20892
Telephone:  (301) 496-5745
 
Dr. Felix de la Cruz
Chief, Mental Retardation and Developmental Disabilities Branch
National Institute of Child Health and Human Development
EPN, 631
Bethesda, MD  20892
Telephone:  (301) 496-1383
 
Grants management inquiries should be directed to:
 
David L. Mineo
Chief, Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P. O. Box 12233
Research Triangle Park, NC  27709
Telephone:  (919) 541-1373
 
This program is described in the Catalog of Federal Domestic Assistance
Numbers 93.112, Characterization of Environmental Health Hazards, and
93.113, Biological Response to Environmental Health Hazards.  Awards are
made under the authority of Section 487, Public Health Service Act as
amended (42 USC 288) and administered under PHS Grants Policies and
Title 42 of the Code of Federal Regulations, Part 66.  This program is
not subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review.
 
$$P5 END ***************************************************************
 
**THE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE DIVISION OF
RESEARCH GRANTS OR CONTACTING PROGRAM STAFF IN THE WESTWOOD BUILDING IS
THE CENTRAL MAILING ADDRESS FOR THE NATIONAL INSTITUTES OF HEALTH.
APPLICANTS WHO USE EXPRESS MAIL OR A COURIER SERVICE ARE ADVISED TO
FOLLOW THE CARRIER'S REQUIREMENTS FOR SHOWING A STREET ADDRESS.  THE
ADDRESS FOR THE WESTWOOD BUILDING IS:
 
5333 Westbard Avenue
Bethesda, Maryland 20816

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