Not scholarly and journalist activities (e.g. oral history, journalism, biography, literary criticism, legal research, historical scholarship), including the collection and use of information that focuses directly on the specific individuals about whom the
information is collected.
EXEMPT RESEARCH CATEGORIES REVISED/NEW CATEGORIES
A1-Research conducted in established or commonly accepted educational settings, that specifically involves normal educational that are not likely to adversely impact students' opportunity to learn required educational content or the assessments of educators who provide
instruction.
A2-Research that only includes interactions involving educational tests, survey
procedures, interview
procedures, or observation of public behavior.
A3-(NEW)-Research involving benign behavioral interventions in
conjunction
with
collection of
information from an adult subject through verbal or written responses or
audiovisual
recording if
the subject prospectively agrees to the intervention and information of
collection.
A4-Secondary research for which consent is not required: secondary
research
uses of
identifiable
private information or identifiable bio- specimens.
A5-Public benefit and service programs research and demonstration
projects.
EXPEDITED REVIEW
No continuing review of expedited research unless the IRB has a reason to
require it and
can justify
that reason
No continuing review for projects conducting data analysis only
Expedited categories of IRB review will be annually evaluated by the
Research
Integrity
Office
CONTINUING REVIEW
Continuing Review no longer required* for:
Research approved by expedited review
Research interventions completed and only involving:
Data analysis, including identifiable private information
or
identifiable
biospecimens
Accessing follow‐up clinical data from clinical care procedures
INFORMED CONSENT
New required element of consent required for collection of identifiable
info
or
identifiable
specimens. Whether or not identities are removed, the consent must
state:
unspecified future research may occur without additional consent;
or
that the
information or
biospecimens will not be used for future research
New required section of consent:
"key information" must be presented first with
sufficient
detail for
subjects
understanding of reasons to participate – a revised FAU
consent template
will be
provided
For clinical trials supported by federal funding, one
IRB‐approved
consent form
used to
enroll participants must be posted on publicly available website
Waiver of documentation of consent — new additional
exception
for subjects
for whom
signing documents is not the cultural norm
SINGLE IRB REVIEW
Single IRB review will be required for all federally funded cooperative
research studies
effective
January 2020
Reviewing IRB must be identified by funding department or agency or
proposed
by the lead
institution
NEXT STEPS
Complete the new CITI course "Revised Common Rule"
