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HPTN Scientific Management
The HPTN
Scientific Committees (SCs) are the scientific foundation for the Network. They function
for each of prevention research areas -- antiretroviral therapies, STD control, and substance use.
Membership in the groups includes recognized experts in HIV prevention,
site investigators, and community representation. Each SC is
responsible for:
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developing an
area-specific research strategy to contribute to the overall HPTN
research agenda
-
continually
reassessing research priorities in light of new ideas and research
opportunities
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overseeing the
formulation and review of concept plans based on the priorities in
the research plan
-
designating (by
the SC Chair) and recommending to the Prevention Management Group
(PMG) a Protocol Chair for each approved concept plan/protocol
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monitoring the
status of protocol development and implementation and reporting
semiannually to the EC (SC Chair)
The SCs integrate non-HPTN
scientific expertise into the development of the research agenda
established by the committees through the inclusion of leaders in their
respective fields (who are not affiliated with the HPTN) as group
members. The SCs also participate in interactions with industry
regarding development and evaluation of new products.
SCs meet routinely via
conference call and, at a minimum, annually at a face-to-face meeting.
SC chairs attend semiannual EC meetings to report on activities of the
committees and to discuss research priorities.
The
Behavioral Science Working Group (BWG)
is a cross-cutting working group that provides behavioral science
expertise and guidance into the development and implementation of
studies in each of the research areas. The goals of the BSWG are to
ensure high-quality behavioral science components in each Network study
as appropriate, and to contribute to the design of study concepts,
protocols, data collection instruments and manuscripts as needed, by
having representatives participate as members of protocol teams and SCs.
The BSWG’s scope of work includes ensuring and providing appropriate
behavioral science expertise in the development, review and
implementation of HPTN protocols by serving as members of the HPTN EC,
Science Review Committee (SRC), protocol teams and ad hoc resources to
SCs.
The
Community Working Group (CWG) is the leadership voice for
community issues within the HPTN. The CWG shapes the overall HPTN Community
Program and promotes information exchange among the six
scientific working groups, the EC and the HPTU Community Advisory Boards
(CABs). The
Ethics Working Group (EWG)
ensures inclusion of ethical review in the development process of all HPTN
concepts, protocols and manuscripts.
The
Science Review Committee (SRC) is
responsible for providing the HPTN Leadership (EC and PMG) with a
thorough scientific, ethical, and operational assessment of study
concept plans and protocols. The SRC ensures that study protocols are
statistically, operationally, and ethically sound as well as accurate,
consistent, complete and, to the extent possible, standardized relative
to other HPTN protocols. The Study Monitoring Committee
(SMC)
functions as an arm of the EC to provide a peer
review of the conduct of all HPTN studies. Active HPTN studies are
typically reviewed by the SMC within the first four to six months of
study implementation and thereafter, approximately every six months
including prior to DSMB reviews. The SMC also assists the
PMG in analyzing and responding to
problems identified in study implementation.
The Study
Operations Group monitors the implementation of HPTN studies,
focusing on crosscutting operational issues and challenges encountered
in specific studies or sites. The Study Operations Group is
consultative and has no decision-making authority but refers issues and
makes recommendations on policy to protocol teams,
PMG, DAIDS, and/or other Network groups for
further discussion, direction, and resolution.
The
Domestic Prevention Working Group
oversees the network's domestic prevention research portfolio, develops
relevant bridging studies, and enhances collaboration with other
research groups and with public health agencies. |