Research involving observation of public behavior is
exempt only if the researcher does not participate in the activities being observed
. … Both exempt and not exempt research must be reviewed by Research Compliance Services and/or the CPHS/IRB.
What makes a research study exempt?
Research can be approved as “exempt”
if it is no more than “minimal risk”
and fits one of the exempt review categories as defined by federal regulation 45 CFR 46. Studies that may qualify for “Exempt” must be submitted to the IRB for review. Exempt reviews are conducted by a member of IRB staff.
Who determines exempt research?
“Exempt” research are
human subjects studies that present no greater than minimal risk to subjects and fit into one or more exempt categories
(as described below).
What is considered exempt research in the context of the IRB?
Exempt research
must be initially reviewed by the IRB, but is then exempt from further review
. Projects that do not meet the criteria for human subjects’ research are excluded from IRB review. Qualified IRB staff or members review applications to determine eligibility for exempt status.
Does exempt research require consent?
For exempt research that involves interaction with subjects, there usually should be a process to ask subjects to participate and confirm their agreement. However,
signed consent is not required for exempt research
, and the consent process and documents can be much simpler than those required for non-exempt research.
Is exempt research considered human subjects research?
The Department of Health and Human Services (DHHS) and FDA regulations apply to research involving human subjects, but there are some categories of research that the regulations consider to be
exempt research
.
Which type of research does not need to get an IRB approval?
Publicly available data
do not require IRB review. Examples: census data, labor statistics. Note: Investigators should contact the IRB if they are uncertain as to whether the data qualifies as “publicly available.”
When would you use an IRB?
IRB review and approval is required for projects that:
Meet the definition of research
.
Involve human subjects and
.
Include any interaction or intervention with human subjects
or involve access to identifiable private information.
Is consent required for exempt research?
Consent Guidance for Exempt Research. … However,
signed consent is not required for exempt research
, and the consent process and documents can be much simpler than those required for non-exempt research. Verbal or implied consent is usually sufficient for exempt research that involves interaction with subjects.
Can research with minors be exempt?
Research involving observation of public behavior is
exempt only if the researcher does not participate in the activities being observed
. … Both exempt and not exempt research must be reviewed by Research Compliance Services and/or the CPHS/IRB.
