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In the future, will the rubella virus be under control?

thanx

2007-03-17 09:55:20 · 2 answers · asked by Anonymous in Health Diseases & Conditions Infectious Diseases

2 answers

That is like asking when you are gonna die..Who knows.....

2007-03-24 13:34:08 · answer #1 · answered by Maureen B 5 · 0 2

Research Objectives and Experimental Approaches

THE FOLLOWING ARTICLE CAN GIVE YOU A CLUE :

Basic research on rubella is now at a low level in the U.S. Our

primary objective is to stimulate research on rubella so that data are

available to develop improved vaccines which would protect women of

childbearing age without causing undesirable side effects and without

fear of fetal infection. Success in this endeavor will require basic

research in virology, immunology, genetics, and pathogenesis. Studies

are needed to identify and characterize rubella virus gene products

required for induction of durable immunity, and those associated with

adverse effects. Research is encouraged to discover the role of viral

components, and the importance of the response of the host, in the

induction of inflammation and symptoms of acute and persistent

arthritis. Studies would include genetic analysis of clinically

characterized vaccine strains to determine if strain-specific variation

leads to a propensity for growth in human synovial cells and

association with persisting joint symptoms in adult vaccinees.

Research in this area also might provide an understanding of the high

female/male incidence ratio of adverse reactions in adults.



Research projects are sought which investigate topics including, but

not limited to those listed below.



o Establishment of the quantitative and qualitative differences

between vaccine-induced and naturally-induced immunity against rubella.



o Determination of which rubella antigens are required to safely

elicit long-lasting protective humoral and cellular immunity.



o Characterization of the viral correlates of virulence and

attenuation.



o Elucidation of those factors contributing to vaccine-induced adverse

events. Analysis of the host and viral factors that contribute to

immune and inflammatory responses associated with arthritis, and

establishment of the molecular and cellular mechanisms causing joint

inflammation.



o Development of an animal model of rubella which parallels human

disease, and allows elucidation of viral and host factors contributing

to immunity and immunization-induced adverse events.



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 are 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 that

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 (rev.

9/91) 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 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

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.

2007-03-17 17:04:53 · answer #2 · answered by Dr.Qutub 7 · 0 1

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