- Protocols not involving human research participants
- Protocols involving human research participants
- For experiments that might be considered “dual use research” (DUR)
- Minutes of IBC meetings
- Copies of approval letters
- All documents relating to the University's regulation of rsNAM.
- Upon receipt of a completed rDNARD, the Biosafety Office will review it for completeness and if necessary request additional information from the PI. If the requested information is provided by the PI in adequate time, the rDNARD will be re-reviewed, and if appropriate, included in the agenda for the next IBC meeting.
- Completed rDNARDs will be moved into the “Committee Review” section of the online registration program. One week prior to the IBC meeting, an automatic e-mail will be generated that includes a hyperlink to each pending completed rDNARD that will be discussed during the next IBC meeting.
- An IBC meeting will be held every two weeks to review all pending completed rDNARDs.
- Each rDNARD requires IBC action by a majority vote of the members attending a meeting in one of the following ways: approved, disapproved or tabled. If an IBC member has a conflict of interest as defined by University policy, he/she must make the conflict known and recuse him/herself from the consideration of that protocol.
- Members unable to attend a scheduled meeting may submit comments or concerns on pending rDNARDs scheduled for consideration to the Biosafety Office prior to the meeting. During the scheduled meeting, comments or concerns so submitted will be read to the members in attendance.
- For each rDNARD approved by the IBC, the Biosafety Office will change the status of the rDNARD to “approved” and an automated e-mail will be sent to the PI (and Co-PIs and authorized users). The approved rDNARD, accessible through the online registration program, will bear the approval date and the expiration date.
- If a majority of IBC members in attendance at a meeting determines that additional information is needed for an rDNARD under consideration and for this reason votes to table the Document, the following procedure will be used:
- The Biosafety Office or the IBC chair will send to the PI a request for the additional information deemed necessary by the IBC no later than two business days after the IBC meeting. The request will indicate the date of the next protocol submittal to the IBC and the PI will be advised to provide a written response containing the additional information at least two days prior to that date. This written response may take the form of a comment or, if appropriate, may take the form of a revised rDNARD that includes the requested additional information.
- Upon receipt of a response from the PI, it will be forwarded to the IBC members at least one week prior to the next scheduled meeting and the rDNARD in question will be included in the table that lists the rDNARDs that will be considered at that meeting.
- If the IBC deems the PI’s response to its request for additional information as inadequate, the committee will request the PI attend the next IBC meeting.
- If the PI does not respond to the request for additional information by the requested date, the Biosafety Office or the IBC chair will send a second request to the PI. This request will indicate the date of the next scheduled IBC meeting at which the rDNARD would be reconsidered and the PI will be advised to provide to the IBC chair a written response at least one week prior to that date.
- Based upon the PI’s written or verbal responses to the request for additional information, the IBC will approve, disapprove, or table the rDNARD by majority vote of the members in attendance at the meeting. If appropriate, the Biosafety Office or the IBC chair will ask the PI in a written comment associated with the rDNARD to revise the rDNARD by inserting the additional information and resubmit it to the Biosafety Office.
- If the PI does not respond to the second request for additional information, the rDNARD will be withdrawn from consideration and will be returned to the PI.
- At any point in the above procedure, an IBC member or the PI may request that the PI appear before the IBC, and such request will be honored.
- PIs must review Appendix M of the NIH Guidelines and submit the required documentation to OBA for review and discussion by RAC.
- After receiving correspondence regarding RAC review, the investigator should submit that correspondence, any response by the PI to recommendations made by RAC (if applicable), along with a completed online rDNA Registration Document for IBC review. NOTE: IRB review will also occur after the PI submits correspondence and recommendations from RAC and all required forms through the HAWK IRB system.
- IBC review will include a review of:
- The informed consent document.
- Safety of the vectors used.
- Risks to the patient, given the vector used.
- PIs will be notified through e-mail when their DNARD is approved by the IBC. PIs will have access to the electronically signed document for their files and to use in providing copies to granting agencies/regulatory agencies.
- Only after RAC review has been completed, the IRB and IBC approvals received, and all applicable regulatory authorizations have been obtained can research participants be enrolled in the human gene transfer experiments.
- No later than 20 working days after enrollment of the first research participant, PIs shall submit the following documentation to NIH OBA:
- A copy of the informed consent document approved by the IRB;
- A copy of the protocol approved by the IBC and IRB;
- A copy of the final IBC approval from the clinical trial site;
- A copy of the final IRB approval;
- A brief written report that includes how the investigator responded to each of the RAC’s recommendations on the protocol (if applicable) and any modifications to the protocol as required by the FDA;
- Applicable NIH grant number(s);
- The FDA Investigational New Drug Application (IND) number; and
- The date of the initiation of the trial.
For experiments that might be considered “Dual Use Research of Concern” (DURC), the following procedure will be used:
- IBC members will evaluate the proposed experiments using the US Government Policy's1 seven classes of dual use experiments involving rsNAM to determine if the experiments proposed meet DURC criteria. Any IBC member may request that a vote be taken on whether the experiments proposed in an rDNARD under consideration meet these criteria.
- If a majority of the members present at a meeting vote that the proposed experiments meet DURC criteria, the following procedure will be used; if a majority of the members present do not vote in this manner, the usual procedure for processing rDNARDs will be followed.
- A completed rDNARD first must be considered and approved by a majority vote of the IBC before the following process takes place.
- As soon as possible (no later than one week) after IBC approval of the completed rDNARD, the IBC Chair will send to the Asst. VPR for further consideration, a copy of the rDNARD and a letter outlining the IBC members’ reasons for deciding that the proposed experiments meet DURC criteria.
IBC meeting minutes will be transcribed by Biosafety Office staff and then will be reviewed, revised and approved by the IBC Chair, distributed to all members, and kept on file in the Biosafety Office.
Copies of approved rDNARDs in which experiments involving human subjects are proposed will be sent to the IRB Office with notification that the protocol was approved.
All documents relating to the University's regulation of rsNAM including but not limited to submitted rDNARDs, IBC meetings, and all correspondence, will be maintained online within the electronic database, and where appropriate, kept on file in the Biosafety Office.
1United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern