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Human Subjects

Policies & Guidance

Co-Investigators

Any individuals who interact with subjects or have access to identifiable subject information should be considered investigators and listed on the Personnel Tab in KC IRB.

Notes:

  1. Investigators who are receiving only de-identified samples or data are NOT engaged in research.
  2. For a list of IU affiliates, see Affiliated Institutions.
  3. Investigators responsible for the conduct and/or reporting of research may include:
    • Investigators making critical decisions regarding eligibility of subjects
    • Investigators obtaining consent for a study that is greater than minimal risk (full Board)
    • Investigators listed on Form FDA 1572 or the investigator agreement
    • Students who have designed a research project and are conducting it in order to complete an educational requirement and who are conducting the research under the mentorship of a Principal Investigator

OHRP Exceptions to Engagement

Exception Instructions

OHRP Engagement Exception #1:
Institutions whose employees or agents perform commercial or other services for investigators, provided that all the following are true:

  • Services performed do not merit professional recognition or publication privileges;
  • Services performed are typically performed by those institutions for non-research purposes; and
  • The institution’s employee’semployees or agents do not administer any study intervention being tested or evaluated under the protocol.
Example procedures: performing analysis of samples as a commercial service; obtaining blood through a blood draw or collecting urine and providing specimens to investigators as a service; radiology clinic performing xX-rays and sending results to investigators as a service.
No further action.

OHRP Engagement Exception #2:
Investigator(s) at an institution not selected as a research site:

  • Performs protocol-dictated services/procedures
  • Procedures would typically be performed as part of routine clinical monitoring or follow-up of subjects enrolled at a study site

All of the following must be true:

  • Investigator(s) will not administer study inventions interventions being evaluated under the protocol.
  • Investigator(s) typically provide the services/procedures as part of clinical care.
  • Investigator(s) will not enroll or consent any subjects.
Example procedures: medical history, physical examination, assessment of adverse events, blood test, chest X-ray, or CT scan
Notify the IRB that study interventions will be administered at an institution not selected as a research site via a memo to the IRB (general information item). 

OHRP Engagement Exception #3:

Investigator(s) at an institution not selected as a research site:

  • Administer the study interventions being evaluated under the protocol
  • Limited to a one-time or short-term basis

All of the following must be true:

  • Local PI determines it is in the subject’s best interest to receive the study interventions
  • External investigator(s) do not enroll or consent any subjects.

Example:  an oncologist at the institution administers chemotherapy to a research subject as part of a clinical trial because the subject unexpectedly goes out of town, or is unexpectedly hospitalized

Notify the IRB that study interventions will be administered at an institution not selected as a research site via a memo to the IRB (general information item). 
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