The Review Process: What to Expect

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Studies determined to involve human subject research, must be reviewed by Research Compliance Services and/or the Institutional Review Board.  There are three types of review: Exempt, Expedited and Full Board.

Upon receipt of an initial study submission, RCS and/or the IRB will determine the appropriate level of review.  At the time of subsequent submission of an amendment or continuing review (if required), the study will be evaluated to determine if the overall study continues to qualify for the originally determined level of review.


Exempt Review

Research that is exempt is no greater than minimal risk and all research activities fall into at least one of the categories for exemption specified in the federal regulations. The activity must fit the description of the exempt category and may not include nonexempt research activities. Exempt does not always mean exempt from all of the requirements of the federal regulations.  Exempt research must be determined to satisfy specific criteria within each category for the research to be eligible for exemption.

An exempt determination does not lessen an investigator’s ethical obligation to subjects as articulated in the Belmont Report and in disciplinary codes of professional conduct.

Ongoing IRB oversight is not required for studies determined to be exempt and the research does not require submission for Continuing Review.  However, investigators are required to submit to RCS the following:

  • Amendments Any changes to the research must be submitted to RCS via an amendment to verify the study continues to qualify for exemption prior to implementing the changes.
  • Event Reports – Any occurrence of an unanticipated problems including those involving risks to subjects or others, protocol deviations, subject complaints, etc. must be promptly reported to the IRB and an Event Report must be submitted to RCS to determine if further action is necessary.

Expedited Review

Research that is expedited is no greater than minimal risk and all research activities fall into at least one of the categories for expedited review specified in the federal regulations.  Under the Expedited review process, the protocol is reviewed by at least one designated IRB member(s).  Expedited research must be determined to satisfy all conditions of the expedited category(ies) as well as all criteria for IRB approval defined within the federal regulations.

Ongoing IRB oversight is required of research qualifying for expedited review:
  • Any changes to previously approved research requires submission of an amendment for IRB review and approval prior to implementing changes. 
  • Studies determined to qualify for expedited review must submit a request for Continuing Review at least 45-days in advance of the expiration date issued by the IRB.
  • Event Reports – Any occurrence of an unanticipated problems including those involving risks to subjects or others, protocol deviations, subject complaints, etc. must be promptly reported to the IRB and an Event Report must be submitted to RCS to determine if further action is necessary.

Full Board Review

Research that does not qualify for exempt or expedited review or that is determined to involve greater than minimal risk to participants must undergo full IRB review.  Full board review requires a study be considered by the fully convened IRB committee.  Full board studies must be determined to satisfy all criteria for IRB approval defined within the federal regulations.

Ongoing IRB oversight is required for full board studies:

  • Any changes to previously approved research requires submission of an amendment for IRB review and approval prior to implementing changes.  In some cases, minor changes to studies previously determined to require full board review may be reviewed by a designated member(s) of the IRB and do not require consideration by the full board.
  • Studies determined to require full board review must submit a request for Continuing Review at least 45-days in advance of the expiration date issued by the IRB.
  • Event Reports – Any occurrence of an unanticipated problems including those involving risks to subjects or others, protocol deviations, subject complaints, etc. must be promptly reported to the IRB and an Event Report must be submitted to RCS to determine if further action is necessary.

What to Expect During the Review Process

  • Study materials submitted to RCS via email to ResearchCompliance@uoregon.edu
  • RCS staff reviews materials for completeness and submission requirements.
  • Once complete, RCS enters protocol into system and generates confirmation email to researcher with assigned protocol number for reference.
  • RCS staff reviews protocol materials to prepare for exempt verification and/or IRB review.
  • If staff identify changes necessary before further review can be conducted, a pre-review revision memo is sent to the researcher outlining changes requested.
  • Researcher provides revised materials (with changes noted in tracked changes) to RCS.
  • RCS staff verifies review readiness, assesses level of review, and sends protocol for review.
  • Exempt Review - protocols are routed for verification of exempt eligibility.
  • Expedited Review - protocols are routed to one or more IRB members for review to determine all regulatory approval criteria are satisfied.
  • Full Board Review - protocols are scheduled for review at  the next available fully convened IRB committee meeting.
  • RCS staff communicates reveiw outcome.
  • RCS staff and/or the IRB verifies the changes satisfy the reviewer's requests.  Once satisfied, approval or exempt determination documentation is issued.
  • If changes and/or clarification are necessary to secure approval or an exempt determination, RCS staff issues a revision memo outlining the information required.
  • Researcher provides revised materials (with changes noted in tracked changes) to RCS.
  • RCS staff and/or the IRB verifies the changes satisfy the reviewer's requests.  Once satisfied, approval or exempt determination documentation is issued.

Timeline

Protocol submissions are processed for review in the order in which they are received. If you do not receive an intake email from us confirming receipt of your protocol submission within one week, please contact RCS by email or phone (541) 346-2510.  For new applications, the intake email will provide the assigned protocol number.  This number will not change during the life of the protocol. Please be sure to reference the protocol number on all correspondence with RCS. 

It is common for RCS and the IRB to request revisions to protocols as part of the review process. Your timely response to requests for revisions or additional information will help facilitate the review. Investigators should communicate in the body of the submission email any time constraints or sensitivities related to their project.

The time it takes from initial submission to approval depends on several factors including the completeness and quality of the application and our current volume of protocol submissions. On average, review times are as follows:

  • Initial protocol review four to six weeks
  • Amendment review - two to four weeks
  • Continuing review submit 45-days in advance of the protocol expiration

Researchers should be mindful that these are average review times – some reviews may require additional time.  Be sure to submit protocol applications well in advance of the anticipated start date for human subjects research activities in order to allow sufficient time to secure approval.  

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