Submission Instructions

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Time-to-Review

The type of review required by a given study may affect the turnaround time. Understanding the criteria for review type will help the PI assess the amount of time a review might take. “Full board” reviews are those that require consideration at a scheduled meeting of the convened IRB. Other reviews are done in the IRB office on a continual basis. Since the Non-Biomedical IRB (Committee E) meets only once a month, full board reviews for this IRB can be a schedule consideration. This is less of a concern for submissions to the Biomedical IRB, which has four committees and meets nearly every week. See dates and deadlines for IRB meeting details.

Upon PI certification, all initial submissions are automatically routed to the department(s) responsible for oversight.  In addition, some schools, departments, institutes and centers require local review as part of this departmental approval process. Your submission will not be passed to the IRB until all departments have approved.  Check with your department or school for details regarding local review.  Click here to learn more about routing of online applications.

Types of Review

There are three types of IRB Review (full board, expedited, and exempt), determined by the nature of the project, level of potential risk to human subjects, and the subject population. The determination of level of review applicable to a particular study is made by the IRB. Regardless of the kind of review, all applications use the same submission form.

Exempt and expedited reviews can be given to studies that constitute no more than minimal risk to the human subjects, i.e., the risk one experiences in daily living. These reviews are done in the IRB office on a continual basis; there are no submission deadlines.

Full board review is required for studies that involve greater than minimal risk or vulnerable populations that require special protection by the IRB. These require review by the convened IRB at the next scheduled meeting.

You can review the criteria for determination of review type in the Human Research Protection Program Standard Operating Procedures (SOP) (SOP 13 on expedited review; SOP 15 for exempt from continuing review; anything not fitting these categories is a full board review). If you are not sure, ask the IRB.

Deadlines

Deadlines for new submissions only apply to full board reviews. If you think your application will require full board review, heed the deadlines, especially for the Non-Biomedical IRB that meets only once a month. The IRB will determine review type and if full board review will be required, it will generally go 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.

Submission and Feedback Time Frame

Exempt and expedited studies can be submitted at any time and will be, typically, reviewed within a 7-10 working day period, after which you will receive feedback from the review. Full board studies must be submitted by a deadline that is usually 2 weeks before the next scheduled IRB meeting for your specific IRB. Check meeting dates and submission deadlines for details. Feedback will be given to applications receiving full board review within one week after the meeting during which it was reviewed.

PI – IRB Communication Following Review

The IRB often requests changes or clarifications before final approval is granted. Resolution of these contingencies is necessary for approval. If the investigator receives a contingency memo from the IRB, s/he should 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 Documents

When an application is approved, 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.

Information for New IRB Approvals

Approval Period and Need for Renewal

All approvals are valid for no more than one year, and 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.

The IRB will send reminder notices prior to the expiration date of a project, but it is the PI’s responsibility to renew a project on time to avoid a lapse in the approval.

Information for Continuing Review (Renewal) of an Approved Study

Prior to expiration you should apply for Renewal using the online system (irbis.unc.edu).

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 directly negative impact upon his/her welfare.

The online application asks questions about the conduct of the study during the last year. Studies that were determined to be exempt at initial review need not be reviewed again unless substantive changes have changed the level of review for the project to expedited or full board review. 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 committee. If you are not sure 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 committee 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 committee must review the renewal).
  3. The study has transitioned into the data-analysis-only phase.
  4. The committee determined that the study could be expedited in the future according to category 9 on the expedited review list (see SOP 13)—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. Federal regulations permit no grace period for renewals.

Information for Modification of an Approved Study

Any change to a project must receive IRB approval before the change can be implemented. This includes modifications to the protocol, inclusion or exclusion criteria, recruitment methods, research personnel, or any new or revised study materials. Approval is required for all modifications whether initiated by the investigator or external sponsor. Changes to projects are submitted to the IRB using the online system (irbis.unc.edu).

Determining whether a modification request should receive expedited or full convened committee review can be difficult. Most modifications will be handled through expedited review regardless of whether the original application was reviewed by the full board or expedited. 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 make the decision about the type of review. In terms of submission materials, there is no difference between full committee and expedited 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 according to the above guidelines.

Information about closure of an approved study

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