Review Types, Processes, and Timeline

All research projects involving rDNA, SNAMs, and/or other biological materials must be registered and may require approval from the IBC before initiation. The submitted protocols will undergo an administrative check and screening to determine the applicable Category(ies) (A1, A2, or B) and Section(s) of the NIH Guidelines , as well as the necessary containment level. This determination will be based on the table below:  

Category A1: Research protocols involving either handling recombinant organisms (RG2 and RG3 infectious agents, human-derived materials, and arthropods), work falling under Sections III-A through III-D of the NIH Guidelines will require approval of the IBC, using the Full Committee Review (FCR) process, and/or other relevant regulatory bodies ( e.g., IACUC and IRB) before the research can begin.  

Category A2: Research protocols involving procedures under Section III-E of the NIH Guidelines must be approved by the IBC but may begin upon submission of an IBC Protocol Application Form and acknowledgment by the IBC analyst.  At UTEP, these lower-risk protocols must be reviewed for approval using the FCR process.  

Category B: Protocols that fall under Section III-F of the NIH Guidelines, any teaching activities involving BSL-1 rDNA or SNAMs, and any research or teaching activities involving non-recombinant BSL-2 or higher biological agents, biological samples (e.g., animal tissues, fluids, etc.) known or highly suspected to be contaminated with BSL-2 or higher agents, non-human primate or human-derived materials (including work with human stem cells), or biological toxins must be registered with, reviewed, and approved by the IBC before initiation. The IBC Chair may assign the protocol to a committee member or an ad hoc reviewer with the relevant expertise, utilizing the Designated Member Review (DMR) process.  

All IBC protocol submissions, appendices, and supporting documents must be submitted electronically through the submission platform.  Applications and procedural amendments requiring FCR must be submitted by the first business day of each month to be considered for the next meeting. Renewals should be submitted at least eight to ten weeks before the expiration date. These periods are necessary for pre-review and allow the committee members sufficient time to review the submission before the meeting. Due dates are available on the UTEP IBC website. If you have questions about submission, please contact the IBC office by e-mail at ibc@utep.edu.  

For a new project, procedural amendment, or renewal (triennial), the PI must ensure that all the listed personnel have completed or are at least completing training requirements ( e.g., GLS, BBP, BSL-3) and OHP, whenever applicable. Additionally, revised submissions going to FCR must be received no later than the published receipt deadline to be placed on the agenda for that month's meeting.  Once a PI submits a protocol through the submission platform to the IBC, the IBC analyst conducts a pre-review within two days to ensure the submission is complete. After the administrative pre-review, protocols are either sent for FCR or polled by  the IBC Chair for potential assignment to a designated member review (DMR). The IBC analyst will notify the PI that if their protocol only falls under category A2, work  may begin while FCR reviews it.  

Assigned reviewers have seven days from the IBC analyst’s notification to submit their comments/questions. Both the FCR and DMR process include the consideration of the following:  

• Assessing the containment levels A/BSL1, A/BSL2, or A/BSL3, as required by the NIH Guidelines ), and ACL1 or ACL2 for work with arthropods.  

• Assessing the facilities, procedures, practices, training, and expertise of personnel included in the PI protocol, including using rDNA or SNAMs and biohazardous materials, agents, and toxins.   

• Determining the physical and biological containment for rDNA or SNAMs, biohazard material, agents, toxins, and containment levels as necessary.    

• Assessing the possession and procedural usage of rDNA or SNAMs, biohazard material, agents, and toxins.    

FCR    

All new and renewal protocols and procedural amendments falling under Category A1 and A2 must be reviewed by the full committee. The IBC Chair will designate primary and secondary IBC reviewers who are regular members of the IBC and have the necessary expertise to review the protocol. The Biosafety Officer and IBC Chair typically act as secondary reviewers on all protocols.  If necessary, the IBC chair will appoint an expert as an ad hoc reviewer. This protocol will be reviewed at an upcoming convened meeting of a quorum of the full committee. Comments and questions received at least ten days prior to the meeting will be sent back to the principal investigator for potential response and protocol revision.  The protocol must be revised and submitted one day prior to the meeting for consideration. This protocol will be reviewed at an upcoming meeting with a quorum of the full committee.  

 At the meeting, the committee will review the protocol, hear reviewers' comments, and decide if any revisions are necessary.  

Motions  

A member must call for a motion after discussing and reviewing a submission. A motion should be one of the following regarding the outcome of the vote on the proposal:  

• Approved  

• Approved with contingencies: To complete approval, the PI must complete the modifications requested by the IBC for the proposed work at the indicated containment level.  

• Modification requested: Send the submission back to the PI with significant modifications to be reviewed and approved by FCR.  

• Not approved  

After the IBC meeting, the investigator will receive a notification informing them of the committee’s decision. If the motion is approved with minor modifications, the motion must include how those modifications will be reviewed: 1) DMR assigned or 2) IBC analyst.  When the motion is to review the modifications by DMR, the IBC Chair then assigns up to two reviewers.  The assigned designated reviewers are authorized to approve or require further modification(s) to secure approval, and their decision must be unanimous. If the motion is for modifications requested, the investigator must submit all revisions back to the submission platform, to be reviewed by a quorum of the full committee.   

DMR    

New protocols and procedural amendments that fall under Category B submitted to the IBC are reviewed by the IBC committee using the DMR process. Each eligible DMR protocol is distributed to the entire IBC with specific instructions regarding the designated member review process and a three-day (72-hour) deadline from the IBC analyst’s notification to call for potential FCR. Affirmation from all IBC members is not required. Written rationale to the IBC analyst must accompany a call for FCR.  If no one calls for FCR, the protocol is sent through the DMR process.  At that point, the chair will assign one or more qualified members to review the category of new protocol or procedural amendment submissions. The designated member(s) can approve, request modifications (to secure approval), or send the submission to an FCR.  

The Designated Reviewer(s) will have seven days from the IBC analyst’s notification to evaluate the documents and submit comments on the PI’s submission via the submission platform.  The IBC analyst will share the reviewer's comments with the PI via the submission platform.  If the designated reviewer has not completed the review in the required period, the Chair can reassign another reviewer. Upon sharing the reviewer’s comments, the PI will be granted access to the protocol and will have fourteen days from the IBC analyst’s notification to address any additional comments and submit revisions. The PI may ask for an extension via email if the revisions cannot be completed in fourteen days. Any extensions must be approved by the IBC Chair. If the submission is not revised and resubmitted and an extension is not requested and granted, the protocol or amendment will be withdrawn. Following assessment of the PI revisions, the DMR can either:    

1. Approve: The submission for the proposed research is approved.   

1. Request Information/Modification: The reviewer may request additional information or modifications from the PI before making a final decision.   

1. Bring the Submission for FCR: If the reviewer believes further discussion or evaluation by the entire committee is necessary, the submission is escalated to the FCR.   

Once the DMR process is complete, the IBC analyst will notify the PI of the designated reviewer’s decision and recommendations for approval.  

Administrative Review    

Personnel amendments without changes to the protocol may be reviewed and approved administratively.  Administrative approval can be performed outside a convened IBC meeting.   

IBC Meeting  

Meeting Time and Quorum

The IBC meets at scheduled times and votes on the protocols, provided there is a quorum.  A quorum is established with one more than 50% of the voting members. Members may attend the IBC meeting by video conference or by telephone. IBC Members with a potential conflict of interest with the activities under review must be recused from the vote and will not be counted as part of the quorum. See Conflict of Interest for additional information below.   

Conflict of Interest

The NIH Guidelines state that no member of an IBC may be involved (except to provide information requested by the IBC) in reviewing or approving a project in which he/she has been or expects to be engaged or has a direct financial interest.  If an IBC member is a Principal Investigator of a protocol undergoing review or has a personal or financial interest, they must abstain from voting.  The minutes of the meeting will contain a record of this action.    

Voting

Each member is allowed one vote, and proxy votes are not permitted. Members must vote in favor of, against, or abstain from voting on a motion. If a member decides to vote against the motion or abstain, they may request that their reason be recorded in the minutes.  

Meeting Minutes

Meeting minutes summarize the committee's business and discussions. The IBC analyst prepares them, and the minutes from the previous meeting are reviewed at the next meeting.  

Approval of Suspension and Termination

The IBC can suspend or terminate activity approval based upon non-compliance with regulatory obligations or University policies and programs. Typically, the IBC Chair and/or IBC analyst will work with the PI to resolve any issues. The IBC must vote on a suspension or termination of approval at a convened meeting and suspension can carry with a simple majority of votes.