As of July
1st, 2010, a process for administrative screening
of research that qualifies in
the regulations as not requiring review has been implemented.
The pertinent sections of the regulations have been highlighted
on the second page of this copy
of the regulations: OHRP
Regulations. There are six categories of research
that can qualify but note that there are conditions
on the use of these exemptions in parts B, C, and D of
the
regulations that address vulnerable population issues.
Many of these conditions have been incorporated into
the
Miami
application
process.
"Administrative screening" means
that there is still an application, but the application
is
not submitted to the Institutional Review Board (IRB)
for review,
rather, it is submitted to the Research Compliance
Office (RCO).
A representative of the RCO reads the application
to determine if the research qualifies for exemption.
Subject
protection
issues must still be addressed, but less detail is
required for Miami to meet it's obligations. The screener
may ask for clarification on some issues if
insufficient
information is provided. If the screener suspects
that the researcher is not fully forthcoming about the
nature
and
extent of activities, the researcher will be asked
to submit an application to the IRB. If the research
simply
does not qulaify for exemption, the screener will direct
the researcher to submit an application to the IRB.
The application consists of
a series of check-box based descriptors that incorporates
the categories your research may fit into as well as the
subject population
limitations. In addition there are three narrative responses
to describe your research. The first narrative
is a basic
description
of the projects and the subject population. The second narrative
is a description of the consent process. The third narrative
is the materials used for gathering data, e.g. survey questions.
Both the first and the third narratives should be materials
that have already or will need to be produced regardless
of the review process. All three of the narratives can
be copied
to a regular IRB application if it is determined the research
does not qualify for exemption.
If you submit an application
to the IRB that qualifies for exemption, the IRB chair
may transfer your application to the exemption screening
process. You may subsequently request an application
be reviewed by the IRB nonetheless (receive comments).
Ultimately, if the application is determined to qualify
for exemption, that classification will be assigned as
this invokes an appropriate level of records maintenance.
If you think your research may
fit into an exemption category but you are not sure, or have
any other questions, please feel free to contact Neal Sullivan,
the Research Compliance Officer (neal.sullivan@muohio.edu;
(513) 529-2488)
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