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What
qualifies as "Research" requiring IRB review?
What is the definition of "Human
Subject"?
What about research conducted as a class
project?
How long does it take for CHS review?
Do I need to have training before being
eligible to conduct human subject research?
Do I need to apply to any other offices
in
conjunction with or before I apply to the IRB?
What do I need to do if I want to change
something in my research?
Is there someone I can call if I need
assistance or have questions?
Research means a systematic investigation, including research
development, testing and evaluation, designed to develop or contribute
to generalizable knowledge. Activities which meet this definition
constitute research for purposes of this policy, whether or not they
are conducted or supported under a program which is considered research
for other purposes. For example, some demonstration and service
programs may include research activities.
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Human subject means a living individual about whom an investigator
(whether professional or student) conducting research obtains
(1) data through intervention or interaction with the individual, or
(2) identifiable private information.
Intervention includes both physical procedures by which data are
gathered (for example, venipuncture) and manipulations of the subject
or the subject's environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between
investigator and subject. Private information includes information
about behavior that occurs in a context in which an individual can
reasonably expect that no observation or recording is taking place, and
information which has been provided for specific purposes by an
individual and which the individual can reasonably expect will not be
made public (for example, a medical record). Private information must
be individually identifiable (i.e., the identity of the subject is or
may readily be ascertained by the investigator or associated with the
information) in order for obtaining the information to constitute
research involving human subjects.
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Often students at all levels are required to conduct "research" as part
of class responsibilities or activities. Most of this research does not
qualify for CHS review. These are the essential questions to be
answered:
Will this research be published?
If yes, the research is required to be reviewed prior to
implementation.
What will be done with the data / information?
If the information is identifiable to an individual or may be used or
published in the future, the research may require CHS review prior to
being implemented.
If you have any questions about this area please check with CHS staff
before conducting or planning "class project" research.
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Applications / proposals that require full Committee review may take up
to as long as two months for Committee review depending on when the
application is received and the Committee schedule and agenda. Many
applications take longer if the Committee requires amendments /
revisions or additional material.
Federal guidelines allow for some research to be exempt from IRB review
or eligible for expedited review. Please check the Section on Exempt / Expedited
Review. If the research qualifies for exempt or expedited review, this
will normally take about two weeks if all required information and
documents are provided and there are no revisions or additional
information required.
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Currently the University of Hawaii does not require training on human
subject research to be eligible to submit a proposal for research.
However, some federal agencies do require this training and applicants
should check with any funding agency for their requirements. We do
strongly recommend that University courses include human subject
training within their curriculum. We also recommend anyone involved in
human subject research read The Belmont Report
prior to designing their research or applying for CHS review. In
addition the NIH
on-line training is also recommended and may be required by others.
The University does occasionally conduct special training for
investigators and in the future, documentation certifying the
completion of this training may be required to submit a proposal for
CHS review.
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You may need to apply to the UH Bioethics Safety Committee. College of
Education students
conducting "action research", and other investigators working in public
schools may need
to apply to the System Accountability Office of the DOE. Guidelines for
projects conducted
in DOE facilities are here.
If your project involves working with other
Universities, Hospitals,
or similar entities that may have their own IRB's, you may need to
satisfy their requirements as well.
This applies to research conducted outside the United States as
well. If you have questions on this, please contact the CHS
Office for further guidance.
Approval to conduct proposed research is given only on the application
and protocol as presented or amended at the time of approval. If there
are any changes to the research protocol after this approval has been
granted these proposed changes must also be reviewed by the Committee
before being implemented. This includes, but is not limited to, any
changes in the selection of subjects, additional questions or
additional survey items, changes in the approved protocol or any
deletions or additions in the approved consent forms. This applies to
research approved by full Committee review, expedited review, or exempt
approval. To notify the Committee of an amendment to a protocol, use
the status report form. If the protocol was originally approved
as exempt, you may notify the Committee of changes using a letter
detailing the changes, rather than with the status report form.
Bear in mind, if the amendment to an exempt project is sufficient to
alter its exempt status, an expedited or full review may be required.
If you have any additional questions about this, please contact CHS
staff prior to any changes in your research.
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Yes. Please do not hesitate to contact CHS staff at 956-5007 if you
have questions about any aspects of the application requirements,
required forms, or eligibility criteria. You may also use the contact link to send e-mail inquiries.
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