Message:
All
Institutional Review Boards must be established and operated in
accordance with the requirements of Federal regulations.
Implication:
Juvenile justice professionals are responsible for complying with
all IRB decisions, conditions, and requirements.
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Institutional
Review Boards are administered at the Federal level by the Office
for Human Research Protections (OHRP), a division of the Department
of Health and Human Services (DHHS). The Common Rule requires that
each institution engaged in human subjects research provide OHRP
with a written assurance of its intention to comply with Common
Rule policies. An OHRP Federalwide Assurance of Protection for Human
Subjects includes the written policies and procedures established
by the organization that ensure human subjects protections. IRBs
are required to register with DHHS.
A Federalwide Assurance (FWA) must be updated every three
years, even if no changes have occurred. Failure to update the information
can result in restriction, suspension, or termination of the institution’s
FWA for the protection of human subjects. Many institutions extend
human subject protection regulations to non-Federally funded research
projects. These organizations require IRB review of all research
projects, regardless of the source of funding.
Most organizations that carry out research with human subjects have their
own IRB to monitor internal research efforts. Some institutions
have more than one IRB, either because of the structure of the institution
or the kinds of human subjects research performed at the institution.
However, an individual or an institution with no registered IRB
(e.g. a juvenile court) may have human subjects research reviewed
by an “outside” IRB. Federal regulations do not require
any IRB to review research proposals beyond the auspices of the
institution. When an IRB does conduct an “outside” review,
the IRB written policies and procedures should authorize and describe
the process. Written arrangements that individuals or non-IRB institutions
have with the IRB must describe the IRB responsibilities for both
initial and continuing review of human subjects research.
Each institution must appoint a qualified individual to have overall responsibility for the agency’s
research and IRB oversight activities. This person, the Authorized
Institutional Official, must have the legal authority to make
decisions for the institution and to ensure that research oversight
is effectively implemented. In many organizations, the Authorized
Institutional Official has the responsibility of selecting
the IRB Chair.
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