Levels of Review
LSUHSC-S policy and federal requirements will determine the criteria for approval of human subjects research and the frequency of continuing review. The IRB Office has been delegated the day-to-day authority for determining the level of review needed for each case and for reviewing responses to the IRB’s stipulations for approval.
New research protocols are categorized as one of the following:
New research protocols that clearly meet one of the categories for exempt research, as provided in the federal regulations and as determined by LSUHSC-S policy, are not sent to a convened IRB meeting for review. These research protocols are reviewed and approved by the IRB Chair or their designee only after the IRB application is completed in its entirety by the investigator. The investigator may not make the exemption determination, but must submit a request for exempt status determination. The exemption status must be approved before any research related activities may begin.
Please refer to the Exemption Determination Forms.
Research that is consistent with DHHS guidelines for expedited review may be given an expedited determination by the IRB. An expedited review consists of a review by the IRB Chair or the Chair’s designee. Individual reviewers make their recommendations to the IRB Committee. If the research is approved, the decision will be communicated to the investigator and reported at the next convened IRB meeting. IRB members may ask for discussion of expedited research during any meeting. If the review decision is for disapproval, the research protocol will be placed on the agenda for full IRB discussion at the next available meeting.
Please refer to the Expedited Review Determination Form.
New research protocols that are submitted for initial review that are neither exempt nor expedited are sent to a fully convened IRB Committee for approval. The IRB office assigns these research protocols to both a primary and a secondary reviewer with the appropriate scientific or scholarly expertise. The Primary and Secondary Reviewer present an overview of the research and lead the convened IRB through a discussion of the criteria for approval of the research protocol. All members present at a convened meeting have full voting rights, except in the case of a conflict of interest. In order for the research to be approved, it must receive the approval of a majority of those voting members present at the meeting.
Please refer to the IRB Initial Application Form.
Ongoing research protocols are categorized as one of the following:
Expedited - Minimal Risk
Ongoing minimal risk research protocols receive expedited, continuing review on an annual basis. At the time of continuing review the reviewer will determine if the research continues to meet the criteria for expedited processing. Expedited continuing review is performed by the IRB Chair or a designated IRB committee member. Research protocols that are approved under the expedited continuing review process are listed on the agenda of the next IRB meeting and members may discuss these protocols if necessary.
Full Review - Convened IRB
All ongoing projects of more than minimal risk that do not meet the criteria for expedited continuing review must receive continuing review by a convened IRB committee at an interval appropriate to the level of risk, but not less than once per year. These cases are assigned primary and secondary reviewers which lead the convened IRB through a discussion of the criteria for approval of the research protocol.
Please refer to the IRB Continuing Review Form.
A proposed change in research related activities that does not significantly affect an assessment of the risks and benefits of the study and does not substantially change the specific aims or design of the study is considered a minor modification. All modifications to ongoing research protocols must be submitted to the IRB and approved before they can be implemented. Minor modifications include minor wording changes in a consent form such as typographical errors, addition of procedures that are no more than minimal risk, or change in study personnel. Approval of a minor modification does not change the approval expiration date for a protocol. These protocols modifications are given an expedited review, and the results are communicated to the investigator. Modified protocols that have received approval are listed on the agenda of the next IRB meeting and members may discuss these protocols if necessary.
Major Modification- Convened IRB
Any investigator who proposes a major modification to an approved protocol must submit a modification request and receive approval before involving human subjects in the revised protocol. (The only exception is a change necessary to eliminate apparent immediate hazards to the research subjects. This should be reported promptly to the IRB).Major modifications include significant protocol changes that would cause subjects to engage in activities not previously approved, or involve an increased level of risk to the physical, emotional, or psychological well-being of participants, or change their willingness to participate . These protocol modifications are reviewed by a fully convened IRB. Approval of a major modification does not change the approval expiration date for a protocol.
Please see the Modification Request Form
Notification to Investigators
The IRB Office will provide written notice within fifteen days to each principal investigator or primary contact person following the review of their protocol. If the protocol is approved, the letter will include the approval date and expiration date. If the IRB stipulates changes, or if it disapproves the protocol, the written notification will state the basis for this decision. The investigator will be given the opportunity to respond to these stipulations in person or in writing.
IRB Meetings are run by the Chair, or in their absence, the Vice-chair. Minutes are recorded by the IRB staff. The IRB staff is responsible for maintaining adequate documentation of all IRB activities, including minutes of the IRB meetings. These minutes will be kept in sufficient detail to show attendance at the meetings, actions taken by the IRB, the vote on the actions, the basis for requiring changes in or disapproval of protocols, and a written summary of the discussions of regarding the review of research.