1. A non-UIC site will be determined by the UIC IRB to be engaged in research when
   employees or agents of the site:
   1. Intervene or interact with living individuals for research purposes; and/or
   2. Obtain individually identifiable information from living individuals for research
      purposes; and/or
   3. The site receives direct federal funding for research purposes.
      Please note that employees or agents who perform the activities above must
      have completed the appropriate human subjects protection education.
2. A non-UIC site will be determined by the UIC IRB to be not engaged in research
   when:
   1. No research funding will be received by the non-UIC site;
   2. No employees or agents at the non-UIC site actively participate in the
      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.
   3. No other relationship with UIC, the UIC PI and key research personnel, and/or
      agreements with UIC or the sponsor, indicate that the non-UIC site is
      engaged in research activities.
3. The UIC HSPP follows the OHRP Guidance on Engagement of Institutions in Human
   Subjects Research, dated October 16, 2008, which is provided word for word in this
   procedure section.
4. UIC OPRS applies the guidance re-stated below to non-federally funded research to
   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.
5. Institutions or individuals are considered engaged in an HHS-conducted or
   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).
6. OHRP Guidance
   1. Institutions that receive an award through a grant, contract, or cooperative
      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.
   2. Institutions whose employees or agents intervene for research purposes with
      any human subjects of the research by performing invasive or noninvasive
      procedures.
   3. Institutions whose employees or agents intervene for research purposes with
      any human subject of the research by manipulating the environment.
   4. Institutions whose employees or agents interact for research purposes with
      any human subject of the research.
   5. Institutions whose employees or agents obtain the informed consent of human
      subjects for the research.
   6. Institutions whose employees or agents obtain for research purposes
      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:
      1. Observing or recording private behavior;
      2. Using, studying, or analyzing for research purposes identifiable private
         information or identifiable specimens provided by another institution; and
      3. Using, studying, or analyzing for research purposes identifiable private
         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.
   7. Institutions would be considered not engaged in an HHS-conducted or
      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:
      1. Institutions whose employees or agents perform commercial or other
         services for investigators provided that all of the following conditions
         also are met:
         1. The services performed do not merit professional recognition or
            publication privileges;
         2. The services performed are typically performed by those
            institutions for non-research purposes; and
         3. The institution’s employees or agents do not administer any
            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).
      2. Institutions (including private practices) not selected as a research site
         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:
         1. The institution’s employees or agents do not administer the
            study interventions being tested or evaluated under the protocol;
         2. The clinical trial-related medical services are typically provided
            by the institution for clinical purposes;
         3. The institution’s employees or agents do not enroll subjects or
            obtain the informed consent of any subject for participation in
            the research; and
         4. When appropriate, investigators from an institution engaged in
            the research retain responsibility for:
            1. Overseeing protocol-related activities; and
            2. Ensuring appropriate arrangements are made 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.
      3. Institutions (including private practices) not initially selected as a
         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:
         1. An investigator from an institution engaged in the research
            determines that it would be in the subject’s best interest to
            receive the study interventions being tested or evaluated under
            the protocol;
         2. The institution’s employees or agents do not enroll subjects or
            obtain the informed consent of any subject for participation in
            the research;
         3. Investigators from the institution engaged in the research retain
            responsibility for:
            1. Overseeing protocol-related activities;
            2. Ensuring the study interventions are administered in
               accordance with the IRB-approved protocol; and
            3. Ensuring appropriate arrangements are made for
               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
            4. An IRB designated on the engaged institution’s FWA is
               informed that study interventions being tested or
               evaluated under the protocol have been administered at
               an institution not selected as a research site.
      4. Institutions who employees or agents:
         1. Inform prospective subjects about the availability of the
            research;
         2. Provide prospective subjects with information about the
            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;
         3. Provide prospective subjects with information about contacting
            investigators for information or enrollment; and/or
         4. Seek or obtain the prospective subjects’ permission for
            investigators to contact them.
      5. Institutions (e.g., schools, nursing homes, businesses) that permit use
         of their facilities for intervention or interaction with subjects by
         investigators from another institution.
      6. Institutions whose employees or agents release to investigators at
         another institution identifiable private information or identifiable
         biological specimens pertaining to the subjects of the research.
      7. Institutions whose employees or agents:
         1. Obtain coded private information or human biological specimens
            from another institution involved in the research that retains a
            link to individually identifying information; and
         2. Are unable to readily ascertain the identity of the subjects to
            whom the coded information or specimens pertain because, for
            example:
            1. The institution’s employees or agents and the holder of
               the key enter into an agreement prohibiting the release of
               the key to those employees or agents under any
               circumstances;
            2. The releasing institution has IRB-approved written
               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
            3. There are other legal requirements prohibiting the release
               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.”
      8. Institutions whose employees or agents access or utilize individually
         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.
      9. Institutions whose employees or agents access or utilize identifiable
         private information for purposes of study auditing.
      10. Institutions whose employees or agents receive identifiable private
          information for purposes of satisfying USFDA reporting requirements.
      11. Institutions whose employees or agents author a paper, journal article,
          or presentation describing a human subjects research study.

OHRP Guidance on Engagement of Institutions in Human Subjects Research, dated
October 16, 2008