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IRB-HSR > Protocol Review Process > Potential Outcomes of IRB-HSR Review

 

 

 

 

 

 

Potential Outcomes of IRB-HSR Review

Potential Outcomes of Exempt or Expedited Review

When a protocol is reviewed by exempt or expedited methods, the investigator will receive correspondence detailing requests for revisions, clarification, or additional information. The investigator has 90 days to respond to the revisions requested. If the investigator does not respond in 90 days, the application is deactivated and returned. If the investigator wishes to conduct a study that has been deactivated, the investigator must submit a new application, incorporating comments from the prior IRB review When the modifications are made and submitted to the IRB, they are reviewed by administrative staff and the IRB Chair, Vice Chair or member designee.   If there is disagreement between the IRB and the study team regarding a study- the IRB cannot disapprove a study by expedited review.  The protocol would be sent to the Full IRB for review.  When approved the principal investigator is sent an approval form that includes information on the date of human subject’s expiration of approval. The PI is also sent any additional documents such as approved consent forms.  

Potential Outcomes of Full Board Review

The IRB may come to one of five determinations regarding an application: 

APPROVED:  The PI will be given the original signed IRB Approval Form, the original stamped approved consent form and the original training certificate.  The approval date is the date the protocol was reviewed and approved by the board.   The expiration date is one year minus one day from the date the protocol was reviewed by the full board, unless the board has stipulated an earlier expiration date.  At the time the study is initially approved the IRB will determine the frequency with which this review is to be done. This is normally done at least once a year, but may be required more frequently if the study involves a very new procedure or involves a considerable risk to the subject.  A copy of the IRB Approval Form, the original of the stamped approved consent form and the training certificate will be filed in the protocol file in the IRB office. 

APPROVED PENDING MINOR MODIFICATIONS: The investigator will receive an approval form stating conditions which need to be met in order to be able to enroll subjects in the study.
These conditions include minor changes to the consent and/or protocol and/or approvals from other committee.  After the changes are made the investigator would then submit one copy of the protocol signed by the PI and two copies of the consent form.  The changes should be tracked on the protocol and on one copy of the consent form.  Once these documents are submitted the study does NOT need to go before the full board again.  The modifications would be handled as an expedited event. The PI will be given an original of the approval for the modification- noting that the study status has changed to open to enrollment, the original stamped approved consent form and the original training certificate.  The approval date is the date the full board reviewed the protocol and the expiration date is one year minus one day from the date the protocol was reviewed by the full board, unless the board has stipulated an earlier expiration date.  At the time the study is initially approved the IRB will determine the frequency with which this review is to be done. This is normally done at least once a year, but may be required more frequently if the study involves a very new procedure or involves a considerable risk to the subject.  A copy of the IRB Approval Forms, the original signed protocol, the original of the stamped approved consent form and the training certificate will be filed in the protocol file in the IRB office. 

WITHHELD APPROVAL PENDING MAJOR MODIFICATIONS: The Principal Investigator will receive documentation outlining the general concerns.  The investigator needs to address these concerns and re-submit copies of the revised protocol and consent form per full board requirements. The study will be reviewed again at a future full board meeting.   In addition, the investigator may be asked to attend a future IRB meeting to answer questions.  The investigator has 6 months to respond to the revisions requested. If the investigator does not respond in 6 months, the application is deactivated and returned. If the investigator wishes to conduct a study that has been deactivated, the investigator must submit a new application, incorporating comments from the prior IRB review. 

REJECTED: The board may also decide to reject a protocol if it feels the study has major problems involving risk to participants or other significant concerns.  The investigator may attend a future IRB meeting to defend the protocol if he/she wishes to pursue the study.

TABLED: The Principal Investigator will receive documentation outlining the general concerns.  The investigator needs to address these concerns in written documentation or by attending a future IRB meeting.  The investigator does not need to resubmit a revised protocol and consent.  The study will be reviewed again at a future full board meeting.