In the future, will the rubella virus be under control?
thanx That is like asking when you are gonna die..Who knows..... 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. |
