Approved by: Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#: 197
AAHRPP Elements: I.I.A, III.1.A.
POLICY
- It is the policy of the UIC IRB to assure that the appropriate approvals, education,
and/or written agreements are completed when human subject research involves
non-UIC performance sites. - UIC OPRS and UIC IRBs ensure that the appropriate approvals and/or written
agreements are completed when human subjects research involves domestic non-
UIC performance sites. (Refer to UIC HSPP policy and procedure UIC IRB Review of Domestic Research Involving Non-UIC Sites, Agencies, Organizations, or Institutions); and - The UIC OPRS, UIC IRBs, and UIC faculty, staff, students, and UIC-authorized
affiliates are required to comply with the terms of the UIC FWA regardless of the
geographic location of the research or the research being conducted. - UIC employees or agents, including faculty, staff, and students, who intend to
conduct activities that may in part represent research with human subjects as
outlined in this policy and procedure are not authorized to determine independently
that the project is subject to the HSPP, except in limited circumstances as a
preliminary suggestion. UIC employee or agent “refers to individuals who (1) act on
behalf of UIC; (2) exercise institutional authority or responsibility; or (3) perform
institutionally designated activities.” (OHRP Guidance on Engagement of Institutions
in Human Subjects Research, dated October 16, 2008). UIC employees or agents
can include staff and students among others, regardless of whether the individual is
receiving compensation. (OHRP Guidance on Engagement of Institutions in Human
Subjects Research, dated October 16, 2008). - If UIC is not engaged as part of adjunct faculty research, UIC IRB approval is not
required. Adjunct faculty may still refer to their UIC credentials in publications
resulting from this research - Individuals engaged in research must complete applicable educational requirements.
Refer to UIC HSPP policy and procedure Investigator and Research Personnel Education Program and Training Requirements.
PROCEDURE
employees or agents of the site:
purposes; and/or
Please note that employees or agents who perform the activities above must
have completed the appropriate human subjects protection education.
when:
research including, but not limited to, consenting subjects, interacting or
intervening with subjects, observing subjects, and/or collecting and
transferring individually identifiable information regarding subjects to the UIC
PI.
agreements with UIC or the sponsor, indicate that the non-UIC site is
engaged in research activities.
Subjects Research, dated October 16, 2008, which is provided word for word in this
procedure section.
determine whether UIC or its agents are engaged in research or not. Refer to UIC
HSPP policy and procedure UIC Review of Domestic Research Involving Non-UIC
Sites for information as to non-federally funded research requirements, as OHRP
FWA requirements differ for non-federally funded research.
supported non-exempt human subjects research project – and, therefore, would need
to hold or obtain OHRP-approved FWAs and certify IRB review and approval to
HHS) when the involvement of their employees or agents in that project includes any
of the following below (refer to OHRP Guidance on Engagement of Institutions in
Human Subjects Research, dated October 16, 2008, for specific examples).
agreement directly from HHS for the non-exempt human subjects research
(i.e., awardee institutions), even where all activities involving human subjects
are carried out by employees or agents of another institution.
any human subjects of the research by performing invasive or noninvasive
procedures.
any human subject of the research by manipulating the environment.
any human subject of the research.
subjects for the research.
identifiable private information or identifiable biological specimens form any
source for the research. It is important to note that, in general, institutions
whose employees or agents obtain identifiable private information or
identifiable specimens for non-exempt human subjects research are
considered engaged in the research, even if the institution’s employees or
agents do not directly interact or intervene with human subjects. In general,
obtaining identifiable private information or identifiable specimens includes,
but is not limited to:
information or identifiable specimens provided by another institution; and
information or identifiable specimens already in the possession of the
investigators. In general, OHRP considers private information or
specimens to be individually identifiable as defined in 45 CFR 46.102(f)
when they can be linked to specific individuals by the investigator(s)
either directly or indirectly through coding systems.
supported non-exempt human subjects research project, and therefore, would
not need to hold a OHRP-approved FWA or certify IRB review and approval to
HHS – if the involvement of their employees or agents in that project is limited
to one or more of the following. The following are scenarios describing the
types of institutional involvement that would make an institution not engaged
in human subjects research; there may be additional such scenarios:
services for investigators provided that all of the following conditions
also are met:
publication privileges;
institutions for non-research purposes; and
study intervention being tested or evaluated under the protocol.
(Refer to OHRP Guidance on Engagement of Institutions in
Human Subjects Research, dated October 16, 2008, for specific
examples).
whose employees or agents provide clinical trial-related medical
services that are dictated by the protocol and would typically be
performed as part of routine clinical monitoring and/or follow-up of
subjects enrolled at a study site by clinical trial investigators.. .
provided that all of the following conditions also are met:
study interventions being tested or evaluated under the protocol;
by the institution for clinical purposes;
obtain the informed consent of any subject for participation in
the research; and
the research retain responsibility for:
reporting protocol-related data to investigators at an
engaged institution, including the reporting of safety
monitoring data and adverse events as required under
the IRB-approved protocol.
research site whose employees or agents administer the study
interventions being tested or evaluated under the protocol limited to a
one-time or short-term basis . . . provided that all of the following
conditions are met:
determines that it would be in the subject’s best interest to
receive the study interventions being tested or evaluated under
the protocol;
obtain the informed consent of any subject for participation in
the research;
responsibility for:
accordance with the IRB-approved protocol; and
reporting protocol-related data to investigators at the
engaged institution, including the reporting of safety
monitoring data and adverse events as required under
the IRB-approved protocol; and
informed that study interventions being tested or
evaluated under the protocol have been administered at
an institution not selected as a research site.
research;
research (which may include a copy of the relevant informed
consent document and other IRB approved materials) but do not
obtain subjects’ consent for the research or act as
representatives of the investigators;
investigators for information or enrollment; and/or
investigators to contact them.
of their facilities for intervention or interaction with subjects by
investigators from another institution.
another institution identifiable private information or identifiable
biological specimens pertaining to the subjects of the research.
from another institution involved in the research that retains a
link to individually identifying information; and
whom the coded information or specimens pertain because, for
example:
the key enter into an agreement prohibiting the release of
the key to those employees or agents under any
circumstances;
policies and operating procedures applicable to the
research project that prohibit the release of the key to the
institution’s employees or agents under any
circumstances; or
of the key to the institution’s employees or agents. (Refer
to OHRP Guidance on Engagement of Institutions in
Human Subjects Research, dated October 16, 2008, for
the definition of the term “coded.”
identifiable private information only while visiting an institution that is
engaged in the research, provided their research activities are
overseen by the IRB of the institution that is engaged in the research.
private information for purposes of study auditing.
information for purposes of satisfying USFDA reporting requirements.
or presentation describing a human subjects research study.
REFERENCES
REVISION LOG
Version (#, date)
Replaces (#, date)
Summary of changes
1.1, 06/18/09
1.0, 03/03/09
Expanded policy title to include individuals as
well as institutions. Linked this policy to the
educational policy and tip sheet. Clarified
information for non-federally funded research.1.2, 03/18/2012
1.1, 06/18/2009
Title and approver change
1.3, 09/13/2016
1.2, 03/18/2012
Updated logo and website links.