NIH GUIDE, Volume 21, Number 5, February 7, 1992

PA NUMBER:  PA-92-40

P.T. 34


  Infectious Diseases/Agents 




  Disease Model 

National Institute of Neurological Disorders and Stroke


The National Institute of Neurological Disorders and Stroke (NINDS)

encourages the submission of applications for research grants related

to the post-polio syndrome.  The NINDS invites grant applications to

support research in all aspects of the post-polio syndrome including

epidemiology, diagnosis, pathophysiology, immunology, therapy, and the

development of animal models.


The Public Health Service (PHS) is committed to achieving the health

promotion and disease prevention goals of "Healthy People 2000," a

PHS-led national activity for setting priorities.  This program

announcement, Post-polio Syndrome, is related to the priority area of

diabetes and chronic disabling conditions.  Potential applicants may

obtain a copy of "Healthy People 2000" (Full Report:  No.

017-001-00474-0, or Summary Report:  Stock No. 017-001-00473-1) through

the Superintendent of Documents, Government Printing Office,

Washington, DC  20402-9325 (Telephone:  202-783-3238).


Applications may be submitted by foreign and domestic, for-profit and

non-profit organizations, public and private, such as universities,

colleges, hospitals, laboratories, units of State or local governments,

and eligible agencies of the Federal government.  Applications from

minority individuals and women are encouraged.


Support for this program announcement will be the Research Project

Grant (R01), Research Program Project (P01), Research Center Grant

(P50), and First Independent Research Support and Transition (FIRST)

Award (R29).  Prospective applicants are encouraged to communicate with

the NINDS staff contact listed under INQUIRIES regarding the

appropriate funding mechanism.  Both basic science and clinical

investigations are encouraged to address relevant research issues.



Survivors of paralytic poliomyelitis have begun to suffer renewed

neurological and neuromuscular symptoms decades after maximum recovery

from the acute disease.  Symptoms include a form of progressive

muscular atrophy that involves new muscle weakness affecting certain

muscle groups, pain, fatigue, and decreased physical endurance.

Individuals who have fully recovered from the initial episode and those

who still have residual effects are at risk.  A number of terms have

been proposed to describe these late effects including post-polio

syndrome, post-polio motor neuron disease, and post-polio muscular


Estimates of the number of survivors of paralytic poliomyelitis in the

United States vary widely, from about 250,000 to over 1 million.  A

1984 epidemiological study performed by the Mayo clinic found that 25

percent of survivors had renewed symptoms, but a later follow-up of a

sample of the original respondents showed that 66 percent were

experiencing new weakness.

Pathologic mechanisms involved in the post-polio syndrome are not

understood, and there is evidence supporting several etiological

theories.  Changes in the motor neuron have been studied extensively.

After recovery from acute polio, axons of surviving motor neurons

sprout to reinnervate muscles whose original motor neuron did not

survive.  It is hypothesized that this process is ongoing for several

years, after which the capacity of the motor neuron to reinnervate

additional muscles is reached and the nerve terminals begin to


A recent report of IgM antibodies to the polio virus in some patients

with recurring weakness suggests that late effects of the long dormant

polio virus may play a role.  Other hypotheses that have been studied

include neuromuscular changes caused by premature aging in polio

patients, an immunological mechanism, and spinal cord changes affecting

motor neurons.

Research Goals and Scope

Multidisciplinary or collaborative studies of the post-polio syndrome

are encouraged.  Examples are given below, but applications are not

limited to these areas of research:

o   Epidemiological studies to determine the prevalence of post-polio

syndrome and to develop standardized diagnostic criteria.

o   Pathogenetic studies emphasizing the relative stability of

reinnervation following infection with the polio virus, terminal

sprouting, and growth factors.

o   Animal models to study the pathogenesis of the original insult,

reinnervation, possible reappearance of symptoms, and restoration of


o   Use of new molecular biological techniques such as cloned polio

cDNAs and the polymerase chain reaction (PCR) to detect the polio


o   Development of strategies of immunotherapy if it is determined that

an autoimmune mechanism is involved.

o   Development of therapeutic strategies to improve or restore

neuromuscular function.





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 must 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 must 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 must 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 must be provided.

For the purpose of this policy, clinical research is defined as 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


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.


Applications must be submitted on the grant application form PHS 398

according to instructions contained in the application kit.

Applications submitted after May 1, 1992, are to use the 9/91 revision

of the form PHS 398.  Application kits are available from most

institutional business offices and may be obtained from the Office of

Grants Inquiries, Division of Research Grants, Westwood Building, Room

449, National Institutes of Health, Bethesda, MD  20892, telephone


Check "yes" in item two on the face page of the application and type

"Post-Polio Syndrome, PA-92-40."

Applicants for the P01 or P50 must use the application format as

described in the NINDS pamphlet, "Application Guidelines: Program

Project and Clinical Research Center Grants," that may be obtained from

the contacts listed under INQUIRIES.

Deadlines for the receipt of applications are February 1, June 1, and

October 1.  The completed original application and six legible copies

must be sent or delivered to:

Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892


Applications will be assigned on the basis of established Public Health

Service referral guidelines.  Applications will be judged on scientific

merit and program relevance in accordance with NIH policy and

procedures involving peer review.  An initial review will be made by an

appropriate study section of the Division of Research Grants for

research grants and FIRST awards and by an appropriate institute

committee for program projects and centers.  A second level of review

will be made by an appropriate national advisory council.


Applications will compete for available funds with all other approved

applications.  The following will be used 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


For further information regarding this announcement, potential

applicants may write or call:

Paul L. Nichols, Ph.D.

Developmental Neurology Branch

Division of Developmental, Convulsive, and Neuromuscular Disorders

National Institute of Neurological Disorders and Stroke

Federal Building, Room 8C08

Bethesda, MD  20892

Telephone:  (301) 496-5821

For fiscal and administrative inquires regarding this announcement,

potential applicants may write or call:

Dwight H. Mowery, Jr.

Grants Management Specialist

Grants Management Branch

National Institute of Neurological Disorders and Stroke

Federal Building, Room 1004

Bethesda, MD  20892

Telephone:  (301) 496-9231


This program is described in the Catalog of Federal Domestic Assistance

No. 93.853 Clinical Research Related Neurological Disorders and 93.854

Biological Basis Research in the Neurosciences.  Awards are made under

authorization of the Public Health Service Act, Title IV, Part A

(Public Law 78-410, as amended by Public Law 99-150, 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.


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