PURPOSE: Assist in determining if activities an
institution’s employees or agents perform con-
stitute human subjects research as outlined by the
Office for Human Research Protections (OHRP)*
and thus engage the institution in that research.
When multiple institutions are involved, review
flowchart separately for each institution.
EXPERTISE NEEDED: Ability to assess -
• who is performing activities,
• where the activities are being performed, and
• the relationship of those performing activities
with the institution
LIMITATIONS: Intended only as a tool. Contact
IRB/other human research protection program
(HRPP) office or research administration for final
determination. Consult OHRP resources for
additional information.
Does the research involving human subjects qualify for exemption
under the Common Rule [45CFR§46.104]?
ENGAGEMENT
DOES NOT APPLY.
STOP HERE.
NO
NO
YES
YES
YES
OR
MAYBE
Are employees or agents of the institution involved in the research?*
GO TO PAGE 2
sIRB Flowchart: Determining Engagement of Institutions in Research
STEP 1: Confirm the activity constitutes non-exempt human subjects research and that employees or agents of institution are involved.
Does the activity meet the definition of human subjects research
under the Common Rule [45CFR§46.102(l)]?
NO
*Employee/agent defined as individuals who: (1) act on behalf of the institution; (2) exercise institutional authority or responsibility; or (3) perform institutionally designated activities.
“Employees and agents” can include staff, students, contractors, and volunteers, among others, regardless of whether the individual is receiving compensation.
