All researchers must secure IBC approval for their activities with recombinant or synthetic nucleic acid molecules (r/sNA) or biohazardous materials by submitting a Memorandum of Understanding and Agreement (MUA) with the IBC.
The MUA is filed through an electronic submission site (e-MUA) and covers r/sNA or biohazardous materials.
- The MUA is overarching of all work in the PI's lab with r/sNA or other biohazardous materials and in most cases each PI will only submit one MUA.
- Research at Biosafety Level -3 does require a separate application.
- The MUA is approved for 3 years with the requirement for an annual review.
- After three years, the application must be resubmitted and reviewed by the full committee.
PIs must submit to the IBC for review and approval of any changes to their MUA. Unless specified otherwise, the proposed changes must not be implemented until the PI receives an electronic approval notice from the IBC. The types of changes that require an amendment to the MUA are:
- Addition or deletion of individuals on the MUA
- Change in facility or use of facility
- Additional objectives to the research
- New sources of nucleic acids (including RNA and DNA)
- New vectors
- Addition of gene editing techniques (CRISPR)
- Recipient organisms
- New biohazardous materials (ex. biotoxins, viral vectors, etc.)
- Change in procedures or use of biohazardous materials
- On PI home page select AMEND button
- Select "My Work has changed…."
- Describe purpose of Amendment and then move through the MUA Table of Contents to make changes.
- Make any additions/deletions within the existing MUA. All changes are visible in "track changes" mode.
- When the amendment is approved this revised MUA becomes the most recent approved MUA
For detailed instructions: Create Amendment
- On the MUA Home Page, under the "IN PROGRESS" bar, click on title of MUA that you wish to submit the Annual Review for. The MUA number will have an AR suffix (e.g. 12345-AR01).
- Review the MUA to make sure that the work described, and the personnel and facilities listed in the MUA accurately reflect your current and planned work. If so, select "Continue" and Submit the Annual Review.
- If you wish to make changes to your MUA, select "Amend. My work has changed, and I would like to amend this MUA". In the text box, briefly describe the purpose of the amendment. Click "Save and proceed" and then move through the Table of Contents to those sections where you need to make a change.
- To see the changes you have made, click "Save" on the page and then on "View Changes". Added and deleted text will show up in a "track changes" mode.
- Submit your Annual Review. You will receive an email confirmation when the Annual Review is successfully submitted.
- When the Annual Review with amendments is approved, your MUA will show with all the changes incorporated in the most recent approved MUA.
- You can see the Annual Review document by going to "History" and clicking on the document with the "AR" suffix.
For detailed instructions: Create Annual Review
PIs need to update their MUA and submit it for IBC review and approval before the three year approval lapses, in order to maintain continuity of approval. The IBC office will contact the PI to remind them of the upcoming expiration date and provide a link to the e-MUA application to start work on the renewal. This renewal will require review by the full IBC.
- On PI home page under IN PROGRESS bar click on the title of MUA.
- Proceed through the Table of Contents and update any applicable sections. All changes are visible in "track changes" mode.
- Changes are made within the existing MUA and not as a separate document
- When the Three Year Renewal is approved, your MUA will show with all the changes incorporated as the most recent approved MUA. The MUA suffix number will increment e.g. 12345-1 will become 12345-2
For detailed instructions: Create Three Year Renewal