What are the three levels of review that the Institutional Review Board provides for different types of research select all that apply?

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.

IRB oversight is not required for studies determined to be exempt and the research does not require submission for Continuing Review; however, RCS does maintain intuitional oversight for research determined exempt. With an exemption determination, RCS grants an approval period based on anticipated project dates. 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.
• Progress Reports 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period you must request either an extension of the approval of the project period or to notify RCS the project is no longer active.

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 Progress Report and providing a revised anticipated end date.

At least 45-days in advance of the study expiration, a Continuing Review Application or Progress Report will need to be submitted to RCS. For studies that do not require Continuing Review, the Progress Report will be used to request a revised project end date. 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 , 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
• 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 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. 

If you have questions, please contact Research Compliance Services.