Review and Approval Process for IBC Protocols

IBC Registration (Protocol) Form
- For new rDNA registration protocols
- For IBC 3-year renewals

Exempt Research

All research utilizing rDNA must be registered with the Office of Research Compliance (ORC). When a principal investigator (PI) requests exempt status on the registration form, the PI must list the appropriate section of the NIH Guidelines on which the exempt status is based. Exempt status, as defined in the NIH Guidelines, shall be determined by the IBC Chair or a designated member of the IBC. The IBC Chair or the designated member may request a review by all members of the IBC. In such a case, the ORC will transmit by e-mail a copy of the registration form to all members. If the IBC Chair, the designated member or a majority of the members (when requested) disagree with the PI’s claim that the research is exempt, the proposed research will be approved only at a convened meeting of the IBC. Under no circumstance may the PI make the final exempt designation. Exempt protocols will be subject to further IBC committee review by the use of the IBC 3 year renewal letter sent by the Office of Research Compliance.

All registered protocols that do not qualify for exempt status must be reviewed by the IBC and acted on at a convened meeting of the committee. A quorum of the committee must be present to vote on a submitted protocol. A quorum shall consist of a majority of the members. Such a convened meeting may take place with the personal presence of the members or by conference call. In either case, minutes shall be recorded and shall include all minority opinions. A protocol must be approved by a majority of the member present at the meeting.
The IBC shall also determine the appropriate biosafety level (e.g. BL1, BL2, BL3, BL4) per the NIH Guidelines. For research that may be conducted under more stringent conditions that minimum required by the NIH Guidelines the IBC has created a BL1+ and a BL2+ containment level section that can be selected on the IBC protocol form. NOTE: Marquette University will only approve BL1 or BL2 protocol requests. Marquette University is not equipped for the facilities for work with BL3 or BL4 projects.

The PI is invited to the meeting when his/her protocol is discussed in order to answer questions that may arise regarding the proposed research. However, the PI cannot be present when a vote is taken by the IBC.

Protocols are approved for a period of three years or until the termination of the project if earlier that the three year period. The PI will be informed of in writing of the IBC decision. Non-Exempt protocols will be subject to further IBC committee review by the use of the IBC 3 year renewal letter sent by the Office of Research Compliance.
If the protocol does not receive initial approval, the PI will be informed of the reasons. If the PI decided to resubmit the protocol, he/she will be expected to make appropriate changes and/or address the items on which the denial was based. When a protocol is submitted by a member of the IBC, he/she may be present during the meeting to answer questions, but must leave the room when a vote is taken on the protocol.

If during the three-year approval period, the PI finds it necessary to change experimental procedures involving rDNA, he/she must file an amended protocol with the IBC. The amended protocol and a copy of the original protocol will be sent to all member of the IBC. If any member considers the changes to be significant and raise the risk level, the amended protocol will be reviewed and voted on at the next convened meeting of the IBC.

The Marquette University IBC committee agreed that a 3 year review cycle was an appropriate time frame for all research involving recombinant DNA (rDNA). Any PI that will continue research with rDNA whether exempt or non-exempt will need to complete the IBC 3-year renewal form. Please note that if your research remains non-exempt by NIH definitions and there is a significant change in operating protocol and/or organisms as originally filed with the IBC you must complete a new IBC Protocol Review Form for submission to the IBC.