When Oregon State University has agreed to cede oversight for a study that engages the institution in research, OSU is considered the relying site. The external institution’s IRB is referred to as the “reviewing site”. This information is intended to outline the responsibilities for the investigators at each institution to ensure compliance with all applicable regulations and policies. It is the responsibility of the OSU investigator to ensure that the OSU file for this study matches the external IRB file by providing OSU’s HRPP office with pdf versions of all approval documents issued by the reviewing IRB within 30 days of approval for all submission types (i.e., initial, revisions, annual reviews, adverse events).

The Principal Investigator at the Reviewing IRB will:
  1. Identify OSU as a collaborating institution in the documents to be submitted to the IRB of Record and describe the role of the OSU researcher(s).
  2. Promptly provide the OSU PI with:
    1. All approval, exemption, or acknowledgement notice(s), including those issued for initial applications, continuing project reviews, and revisions;
    2. Documents approved and/or acknowledged by the IRB of Record, including, protocol, recruitment materials, test instruments, and informed consent documents, etc.
  3. Notify the OSU PI of the standards and guidelines of the IRB of Record 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 IRB of Record within required reporting timeframe.
  4. Notify the OSU PI immediately if there is a lapse in IRB approval.
The Principal Investigator at OSU will:
  1. Notify the IRB of Record PI about any local considerations that should be taken into account by the IRB of Record.
  2. Provide the IRB of Record PI with any information needed to complete the initial and continuing review of the study.
  3. Assure that research activities at OSU are not initiated until all IRB of Record and OSU requirements for the study are finalized.
  4. Adhere to the protocol as approved by the IRB of Record.
  5. If at any time study approval lapses, cease all human subjects research activities related to the protocol at OSU, including data analysis and receipt of new samples or data. If the OSU PI determines that subjects on the study may be harmed if the research is stopped, notify the OSU IRB and the IRB of Record PI and provide justification for continuing study activities. The OSU IRB will contact the IRB of Record.
  6. Promptly report all post-approval events to the IRB of Record PI. Review IRB of Record requirements regarding reportable event and cooperate with any IRB of Record or OSU investigation regarding serious or continuing noncompliance or an unanticipated problem.
  7. Cooperate with any IRB of Record or OSU quality assurance/quality improvement or monitoring of the study protocol.
  8. In the event of an audit, allow the institutional officials at the IRB of Record 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 external site.
  10. Respond promptly to all requests for information from the IRB of Record PI or OSU IRB, including but not limited to, the information set forth in this agreement.