When Oregon State University has agreed to be the reviewing site for a study that engages one or more external institutions in research, OSU is considered the IRB of Record. Those external institutions are referred to as the “relying sites”. This information is intended to outline the responsibilities for the investigators at each institution to ensure compliance with all applicable regulations and policies.

Oregon State University’s (OSU) PI will:
  1. Collect information from the relying site required for the IRB application, including but not limited to, the information listed below, and information regarding any local considerations that should be taken into account by the OSU IRB; and provide such information to the OSU IRB.
  2. Include the following information in the OSU application and protocol form:
    1. A list of study team members at the local and relying site(s);
    2. Information pertaining to any financial or nonfinancial COI’s for any study team member at the local and relying site(s).
  3. Ensure that the OSU IRB has received documentation of ethics training for all study team members at the local and relying site(s).
  4. Promptly provide the relying site with:
    1. All approval, exemption, or acknowledgement notice(s), including those issued for initial applications, continuing reviews, and project revisions;
    2. Documents approved and/or acknowledged by the OSU IRB, including, protocol, recruitment materials, test instruments, and informed consent documents, etc.
  5. Notify the relying site PI of the standards and guidelines of the OSU IRB for the reporting of any post-approval events, such as (i) proposed changes in study activities, (ii) adverse events or unanticipated problems, and (iii) protocol deviations. Collect related reports and provide them to OSU IRB within required reporting timeframe.
  6. Collect required information from the relying site that is necessary for the completion of the continuing review application. The OSU continuing review application must include information from all relying sites (e.g. enrolled subjects, complaints, progress, etc.)
  7. Notify the relying site PI immediately if there is a lapse in IRB approval.
The relying site PI will:
  1. Notify the OSU PI about any local considerations that should be taken into account by the OSU IRB.
  2. Provide the OSU PI with any information needed to complete the initial and continuing review of the study.
  3. Assure that research activities at the relying site are not initiated until all OSU and Relying site requirements for the study are finalized.
  4. Adhere to the protocol as approved by the OSU IRB.
  5. If at any time study approval lapses, cease all human subjects research work related to the protocol at the relying site. If the relying site determines that subjects on the study may be harmed if the research is stopped, notify the OSU IRB about the individual subject(s) and provide justification for continuing study activities.
  6. Promptly report all post-approval events to the OSU PI. Review OSU requirement regarding reportable event and cooperate with any OSU or relying site investigation regarding serious or continuing noncompliance or an unanticipated problem.
  7. Cooperate with any OSU or relying site quality assurance/quality improvement or monitoring of the study protocol.
  8. In the event of an audit, allow the OSU PI and the reviewing OSU institutional officials access to research and related records.
  9. Maintain records for all research and related activities conducted under this agreement for at least 3 years post-study termination, and longer if required by regulations, study sponsor, or local site.
  10. Respond promptly to all requests for information from the OSU PI or OSU IRB, including but not limited to the information set forth in this agreement.