The Office of
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 two of the three IRBs meet only once a month, full board reviews for these IRBs 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.
All applications and consent materials should be printed on one side only.
Some studies require additional review prior to the IRB submission. Examples include the General Clinical Research Center (GCRC) or the Oncology Protocol Review Committee (PRC). See their web sites for details.
Some schools, departments, institutes and centers also require local review prior to submission to the IRB. These schools include Business, Education, Information and Library Science, Journalism and Mass Communication, Government, and Social Work. These departments include Anthropology, City and Regional Planning, Computer Science, Exercise and Sports Science, Geography, Psychology, and Sociology. These institutes and centers include Center for Developmental Science, Center for Urban and Regional Studies, and the FPG Child Development Institute. Consult these schools and departments for details.
|
Address for all IRBs |
|---|
| CB # 7097, Medical Building 52 Mason Farm Road Chapel Hill, NC 27599-7097 |
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 IRB 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 for new submissions only apply to full board reviews. If you think your application will require full board review, heed the deadlines, especially for those IRBs that meet only once a month (all except Biomedical). The IRB will determine review type and if full board, it will go on the next full board agenda according to the published deadlines for the IRB associated with your department or particular study. The IRB may ask for additional copies.
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.
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 so that review can continue. Always put the IRB study number on any correspondence or forms when communicating with the IRB. Remember that final approval cannot be granted until all requests for information have been answered satisfactorily.
When an application is approved, the PI will receive an approval letter as well as stamped copies of consent forms and any recruitment materials submitted for review. Be sure to keep the stamped copies for your records and for reproducing to use with subjects.
Find detailed information about number of copies of the various components of the application in the instructions on the application form.
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. Additionally, materials that are used with subjects (recruitment letters, consent documents, flyers, etc) will be stamped by the IRB showing the date of expiration.
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.
Prior to expiration you should submit the Request for Renewal of IRB Approval or Study Closure.
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 form asks questions about the conduct of the study during the last year. As noted on the form you will need to provide “clean” (unstamped) copies of all recruitment and consent materials to be used with subjects during the upcoming approval period, which the IRB will review and stamp with the new expiration date. Also at the time of renewal you will need to update your most recently reviewed application/project description to include changes created by modifications approved since the last IRB review of the project.
To determine the level of review a study received on initial review or last renewal, check the approval letter to see whether the study went to full board or was expedited. 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:
If your renewal can be expedited, the IRB must receive the 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.
At the conclusion of the Request for Renewal of IRB Approval or Study Closure form you will check whether you wish the study to be renewed or terminated. If you are terminating a study, please tell us before it expires, and send only one copy.
Send the correct number of copies of your application to the IRB that initially reviewed or last renewed approval for the 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 on the Modification of Approved Human Subjects Research which is self-explanatory in terms of completion and what additional materials need to be attached.
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, other than number of copies for some IRBs. 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.