Levels of Review

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 a modification 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.

• What to Expect during the Review Process
• Project Approval Periods
• Timeline

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. We have an exempt self-assessment tool which can help you determine if you should apply for an exempt level review. 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.

Although the regulations do not require a regulatory Continuing Review; RCS maintains intuitional oversight for research determined exempt and requests a continuing review to keep the study open past the expiration date. With an exemption determination, RCS grants an approval period based on anticipated project dates. Approval periods for exempt studies can be up to 5 years. Investigators are required to submit to RCS the following:

• Modifications: Many changes to the research must be submitted to RCS via a modification to verify the study continues to qualify for exemption prior to implementing the changes. Review this information to identify what changes require review.
• Event Reports: Any occurrence of 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.
• Continuing Review and Study Closure: Prior to a project reaching expiration of the approved project period you must request either an extension of the approval of the project period or to notify RCS the project is no longer active. These are submitted through the Continuing Review submission type in the RAP. 

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 study 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 a modification 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 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 a modification 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 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

Project Approval Periods

At the time of initial review requirements for continuing review will be determined. For studies that require continuing review, IRB approval will be issued based on the frequency determined appropriate by the IRB but will be no greater than one year.

For studies under the Revised Common Rule that do not require continuing review, a project approval period will be issued with an expiration date based on the researcher’s stated anticipated end date for working with human subjects. We will solicit the projected project start and end dates on the initial review form. This date may be extended if necessary by submitting a Continuing Review and providing a revised anticipated end date.

At least 45-days in advance of the study expiration, a Continuing Review Application will need to be submitted to RCS. F All researchers are required to submit a Study Closure Application when the study is closed.

Timeline

Study submissions are processed for review in the order in which they are received. If you have questions or would like to check in on the status of your study please contact RCS by email at researchcompliance@uoregon.edu, submitting a study comment through the RAP, or phone at (541) 346-2510. Please take notice of the study number generated by the RAP system. This number will not change during the life of the study. Please be sure to reference the study number on all email and phone correspondence with RCS. 

It is common for RCS and the IRB to request revisions to studies 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 study submissions. On average, review times are as follows:

• Initial study review: four to six weeks (however, exempt reviews can take less time if a complete submission is provided) 
• Modification review: two to four weeks
• Continuing review: submit 45-days in advance of the study expiration

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

Tips to Minimize Review Time:

• Provide a complete submission (see our Forms and Guidance page, FAQs and Guidance Library for additional resources)
• Don't forget to click the Submit button (projects in "pre-submission" state are not in the queue for review). Only the PI or PI proxy can see and use the Submit button. Make sure you submit your project using that Submit button. The diagram at the top of a project will move from pre-submission to pre-review after you have successfully submitted. If revisions are needed, the button to resubmit it called "Submit Response". See our Submit Study Instructions in the RAP section of the Guidance Library for details and screenshots.
• Avoid making additional unrequested changes during review if possible. When a project is sent back for specific changes, researchers sometimes make additional changes that were not requested and this may require additional clarifications or rounds of revision. Sometimes this is unavoidable. However, if it can be avoided, especially during the later stages of the review, it may make the review quicker. 
• If you don't understand what is being asked for in terms of changes/clarifications, contact the person assigned as IRB Coordinator for your project in the RAP to get clarity. 
• Resubmit revisions as soon as possible after addressing all requested revisions. Often times, the turnaround time is impacted by how long it takes researchers to address the required changes. If researchers need a substantial amount of time to make changes or if they resubmit without addressing all the changes and an additional round of revisions is required, that will increase the overall review time. The RAP sends out automatic reminders if revisions are not resubmitted within 14 days. 
• For complex studies, consider contacting RCS before submission to discuss your options. Email researchcompliance@uoregon.edu to request a consult. 
• Check the box for IRB Coordinator under "Who should receive an e-mail notification?" when asking questions in the RAP using "Add Comment". If you do not check that box, the IRB Coordinator may not know you had a question. 

If you have questions, please contact Research Compliance Services.