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Review Process Overview

Types of IRB Review

There are three types (or levels) of IRB Review — full board, expedited, and exempt — determined by the nature of the project, the make-up of the subject population, and the degree of potential risk to human subjects. The IRB determines the applicable level of review, upon receipt of the submission. Regardless of review type, all applications use the same online submission form.

Exempt or Expedited Review

The IRB may conduct an exempt or expedited review if it is determined that the research places subjects at no more than minimal risk, i.e., the risk one experiences in daily living. These reviews are done in the IRB office on an ongoing basis; there are no submission deadlines.

Full Board Review

Full board review (i.e., review conducted by a convened IRB board) is required for studies that involve greater than minimal risk or vulnerable subjects who require special protection by the IRB. Full board reviews are conducted at the next available board meeting, and must be scheduled in advance (see IRB Schedule).

You may review the criteria for determination of review type in the Human Research Protection Program Standard Operating Procedures (SOP): SOP 701, Section 2.1 on expedited review; SOP 601 for exemption from continuing review; studies that do not fit these two categories are reviewed by a full board. If you have questions about level of review, ask the IRB.

Review Timeframe

Time-to-Review

The type of review may affect the time required to conduct a review. Because exempt and expedited reviews are conducted in the office on a continuing basis, turnaround time for these reviews is usually faster than that for full board reviews. Full board reviews require more time because submissions must be prepared and distributed to board members in advance of a meeting. Typically, full board reviews must be calendared two weeks prior to a convened meeting; see IRB Schedule for IRB meeting details.

You should allow additional time for departmental review, prior to submission to the IRB. Upon PI certification, all initial submissions are automatically routed to the department(s) responsible for oversight. Your submission will not be passed to the IRB until all departments have approved. Click here to learn more about routing of online applications.

Submission Deadlines

Deadlines for new submissions only apply to full board reviews. If you think your application will require full board review, heed the deadlines. The IRB will determine review type and if full board review is required, your submission will be placed on the next full board agenda. There may be circumstances when this is not possible, in which case it will be assigned to the next available meeting.

Feedback

Exempt and expedited studies are reviewed once they have been Accepted by the IRB, after which you will receive email feedback. Feedback will be given to applications receiving full board review within one week after the meeting at which it was reviewed.

Communication Following Review

Contingency memo

The IRB often requests changes or clarifications before final approval is granted. Resolution of these contingencies is necessary for approval. If you receive a contingency memo from the IRB, respond to all items in the memo as soon as possible (using the online system, irbis.unc.edu) so that review can continue. Remember that final approval cannot be granted until all requests for information have been answered satisfactorily.

Approval letter

When an application is approved (or determined to be exempt), the PI will receive an email with a link to the Approval Letter and Document List of supporting materials, e.g., consent forms, recruitment scripts, data collection instruments.

Approval Period

All approvals are valid for no more than one year, but may be less than a year if the IRB so designates. The approval letter will include the date of expiration for the IRB approval. The approval of the study must be renewed by the IRB prior to the expiration date or all activities with human subjects must cease until the project has been renewed.

Studies that were determined to be exempt at initial review need not be reviewed again unless substantive changes warrant review at expedited or full board level.

Continuing Review of an Approved Study

Renewal

Conducting human subject research without current IRB approval is a violation of federal and institutional regulations. If IRB approval of a project expires, no new subjects may be enrolled and all ongoing research activities must stop until the renewal has been approved, except for interventions that, if discontinued, would put the subject at risk or have a direct, negative impact upon his/her welfare.

The online application asks questions about the conduct of the study during the past year. If the study was last classified as expedited, it will receive expedited review for the upcoming renewal unless, for some reason, the risk of the study has risen to a level beyond minimal risk. In that case, the study will go to full convened board. If you have questions about review level, ask the IRB.

If the study went to the full board for its last review/renewal, it will again go to the full board unless one of the following conditions applies:

  1. The study has never enrolled subjects (not just since the last review) and there are no additional risks.
  2. The study has transitioned to the follow-up phase and only minimal-risk procedures are involved (note: all x-rays and blood draws, beyond certain parameters, are considered greater than minimal risk and the board must review the renewal).
  3. The study has transitioned into the data-analysis-only phase.
  4. The board determined at last review that the study could be expedited in the future according to category 9 on the expedited review list (see SOP 701, Sections 2.2.2 and 2.6.2.3)—the summary statement for the last approval should state this.

If your renewal can be expedited, the IRB must receive your Renewal application no fewer than 14 days before the expiration date. If it requires full board review, heed the meeting deadlines to make sure it can be reviewed before expiration. The IRB will send reminder notices 30 and 60 days prior to the expiration date, but it is the PI’s responsibility to renew a project on time to avoid a lapse in the approval. Federal regulations permit no grace period for renewals.

Modification

Any modification of a research project must receive IRB approval before the change can be implemented. This includes changes to inclusion or exclusion criteria, recruitment or consent methods, research personnel, the addition of new or revision of previously approved data collection materials. Approval is required for all modifications whether initiated by the investigator or external sponsor. Amendments to projects are submitted as a study modification using the online system (irbis.unc.edu).

Most modifications will be handled through expedited review regardless of whether the original application was reviewed by the full board or an expedited basis. However, modifications that substantially change the study design (e.g., adding or removing a study arm/group) or that change the risk to subjects may require review by the full IRB. The IRB chair will determine the level of review. Approval of a modification does not extend or otherwise change the project’s expiration date.

Updated versions of master protocols and investigator brochures are treated as amendments and should be submitted as study modifications.

Closure

Use the online system (irbis.unc.edu) to report to the IRB Closure of your study.