The General Process for Initial Setup of a Waived Study

The following process applies to initial submissions in which OHSU is the relying IRB and is waiving oversight to an external IRB. Existing studies may be transitioned to an external IRB via a modification in the eIRB using the same process. Studies under external IRB oversight must still be submitted to both the OHSU IRB (in the OHSU eIRB system) and to the external IRB.

Studies must be submitted in the OHSU eIRB system to allow OHSU IRB to conduct a compliance review for local and institutional issues; share study documents and information with departments, committees, and individuals involved in the review and conduct of the study; facilitate emergency care of subjects; and ensure an accurate record of the OHSU research portfolio.

See the Working with Other IRBs section of the IRB FAQs page for further information.

NOTE: This process does NOT apply to NCI-CIRB studies.

The OHSU IRB local compliance review

While the reviewing IRB is responsible for the ethical and regulatory IRB review of the study for each site, the OHSU IRB office must still ensure that all institutional requirements are met. This local compliance review mainly includes, but is not limited to, ensuring that any institutionally required elements and language are included in consent forms and performing any necessary ancillary reviews, like Radiation Safety and Conflict of Interest.

Before the study team submits to the external IRB, the OHSU IRB will pre-review the submission to ensure that all OHSU requirements are met. The study team will then be instructed to submit to the external IRB for review. Once external IRB approval has been obtained, the study should be resubmitted to the OHSU IRB for final verification that all local requirements are met. Afterwards, the study team will be notified via the OHSU eIRB system that research at OHSU can begin. See the Waived Study Initial Setup Checklist or OHSU Local Compliance Review Requirements for Waived Studies for OHSU’s requirements for waived studies.

General initial setup process

These are the basic steps that most studies follow, as applicable, when waiving oversight to an external IRB.

NOTE: The specific steps for this process may vary depending on the external IRB and the particular reliance mechanism used for the study.

  1. Create eIRB study: Create a new study in the OHSU eIRB system (or a modification if transitioning an existing study) and fill out the IRQ as completely as possible.
  2. Title your study: In the Long Study Title on the Basic Information page, indicate the External IRB and reliance agreement/mechanism (see instructions linked above) being used to waive oversight for this study as determined by the Lead PI/study team, the sponsor, or the coordinating center for trial consortiums.
  3. Create Consent Forms: Create the consent/assent form(s) using the model consent/assent template provided by the external IRB/coordinating center/lead PI. OHSU has certain requirements for the consent/assent forms, including OHSU logo, bar code, specific language, etc. For detailed requirements and instructions on how to construct your consent/assent form, see pages 2-5 of OHSU Local Compliance Review Requirements for Waived Studies.
  4. Upload documents: Upload the required minimum set of study documents (protocol, draft consent forms, overall study approval memo, etc.). Typically, the Lead PI/study team or the external IRB will provide study documents or templates for you to revise as necessary to meet OHSU requirements.
  5. Submit draft Consent Forms: Submit the study in the OHSU eIRB system once you have the draft consent/assent forms ready for OHSU IRB Pre-Review. The OHSU IRB will Pre-Review your draft consent/assent forms to ensure it meets all OHSU requirement before you submit to the external IRB. Make all OHSU IRB requested changes to the consent/assent forms or study. The submission can be sent back and forth several times for changes.
  6. Submit to external IRB: Once the OHSU IRB has notified you that the draft documents are acceptable, submit to the external IRB for review.
  7. Resubmit to OHSU IRB for final compliance review: Upload in the OHSU eIRB the external IRB approval memo approving the addition of OHSU as a site to the study along with the external IRB approved version of the minimum set of OHSU required documents. When all OHSU requirements are met, the study team will be notified via the OHSU eIRB system that research at OHSU can begin.

Ongoing waived study maintenance

After initial study approval, the OHSU IRB Office must ensure waived studies have ongoing approval by the Reviewing IRB for the life of the study. For this reason in addition to any submissions required in the reviewing IRB electronic submission system, applicable Modifications (MODs) and Reportable New Information (RNI), as well as continuing reviews (MODCRs) must also be submitted in the OHSU eIRB system.

Applicable modifications requiring an eIRB MOD submission include:

  • Changes to information listed in the eIRB electronic submission form (IRQ).
  • Any changes to OHSU study team members, including the OHSU PI.
  • Changes or revisions to anything included in the "required document set" uploaded in the eIRB submission.

Reportable New Information (RNIs) for waived studies must be submitted directly to the reviewing IRB per their reporting policies. RNIs only need to be submitted to the OHSU IRB office when the reviewing IRB has determined the following has occurred:

  • An unanticipated problem.
  • Serious or continuing noncompliance.
  • Suspension of study approval.
  • Termination of study approval.

If the reviewing IRB has determined any of the above have occurred, then an RNI must be submitted in the eIRB system with the reviewing IRB acknowledgement memo or letter uploaded.

Annual continuing reviews (MODCRs) for applicable research must be submitted in the eIRB to ensure continued compliance with institutional requirements and ongoing reviewing IRB approval. The approval end date in the eIRB system is the same as the reviewing IRB approval end date. It is imperative to submit your continuing review to the reviewing IRB well enough in advance of the expiration date to allow ample time for the local compliance review of the eIRB MODCR submission as well.

NOTE: For studies reviewed and approved under the New Common Rule that do NOT require the submission of annual continuing reviews by the reviewing IRB, the OHSU IRB office will still require an annual, short "check-in" submission in the eIRB submission to confirm institutional requirements are still met.