The Institutional Biosafety Committee (IBC) has partnered with Michigan Administrative Information Systems (MAIS) in the design of a new registration system for basic recombinant DNA research.

The new system is now ready for use (as of April 6, 2007). A plan is being devised for incrementally rolling out the new system to the nearly 600 researchers who comprise the UM recombinant DNA community with conversion to the new system taking place over a period of three years. However, some investigators may need to complete their registration earlier than their assigned time. We have some specific guidance on when you should complete a registration in relation to the initiation of your recombinant work.

This page provides information about the new registration system and the accompanying fundamental changes in the way recombinant DNA work will be registered at the University. There is also a list of responses to frequently asked questions about the new system.

Table of Contents/Summary

• What is different
• One comprehensive form
• Abbreviated process for exempt-only work
• Access to your registration
• Renewal every 3 years
• New easy amendment process
• Periodic checks
• What is the same
• Registration required for all rDNA work
• Certification for sponsored projects and MTAs
• Lab inspections for BL2 and above
• Importance of training
• Collaborations and registration
• BL3 work reviewed by whole committee
• Frequently Asked Questions

What is different:

One comprehensive form to complete
In the new system there will be one comprehensive registration form for all your rDNA work. Your lab will be approved for a biosafety level based upon this total picture of your recombinant DNA work. (Multiple biosafety levels are possible.) How does this differ from the old system? Under the old system, registration with the IBC was project-specific. This has become a cumbersome way to categorize recombinant research as individual projects could involve rDNA requiring different containment levels and, conversely, different projects could involve identical rDNA use. In addition, registration forms have been vector-specific resulting in investigators needing to complete multiple forms to capture all their recombinant work.

Abbreviated process for exempt-only work
The University still requires recombinant DNA work that is exempt from the NIH Guidelines to be carried out at BL1 containment. Under the new system, however, if you deem all recombinant work in your lab to be exempt as defined by the NIH Guidelines, you will be able to signify this with a significantly shorter form than in the past.

Access to your rDNA registration through eResearch
Investigators will have access to their registration and related IBC correspondence through the eResearch system.

Registration renewal to be required every three years
In the new system, once you register and receive approval from the IBC your registration will be valid for 3 years. The IBC registration renewal mechanism is still to be developed within eResearch, but will include renewal reminders at various intervals.

New amendment process
An amendment to your IBC registration will be required if any aspect of your recombinant DNA is changing so that it has the potential to alter the biosafety profile of your work. We are compiling a list of changes that would necessitate an amendment and will make it available to you. In the new system you will be able to amend the relevant parts of your existing registration without having to complete an entirely new registration form.

Periodic checks to ensure compliance
The IBC will be instituting a system of random checks on laboratories to ensure that recombinant DNA records are kept up to date and Federal regulations are being met.

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What is staying the same:

Importance of registering all recombinant DNA work regardless of funding source or preliminary nature
The University still requires all recombinant DNA work to be registered with the IBC including that which is preliminary or internally funded or otherwise not associated with a sponsored project.

Certification for sponsored projects and materials transfers
If you submit a Proposal Approval Form (PAF) or a Materials Transfer Form to DRDA that indicates use of rDNA in the project, we will still check with you to see if the scope of rDNA research in your lab is changing.

BL2 and higher containments require lab inspections before work begins
OSEH will still be performing regular laboratory inspections as they do now. As always, investigators planning to work at BL2 or a higher containment level must have their lab inspected and approved before any such work may begin.

Importance of training for all staff who will be performing recombinant work
In addition to the basic laboratory safety course offered by OSEH, the IBC strongly recommends the course "Working Safely with Viral Vectors," offered through OSEH and the Vector Core, for individuals who will be performing viral vector work.

Collaborations are encouraged; investigators sharing laboratory space also share registration and training obligations. Recombinant DNA work may be registered either under the investigator in whose lab the work is occurring or under the principal investigator of a project:

• Investigators in charge of labs where recombinant DNA work occurs are responsible for ensuring that there is a registration with the IBC for all the recombinant DNA work occurring in their lab space. In addition, they must maintain documentation of the training status for all the individuals working in the lab with recombinant DNA at BL2 or BL2+ containment.
• Principal investigators who are not themselves registered for BL2 or BL2+ recombinant DNA work, and who are having this work performed in another investigatorŐs lab, are responsible for ensuring that it is occurring in a laboratory that is registered with the IBC for that type of work and that it is conducted by individuals who have received training for the work they are performing.

Work requiring BL3 containment must be approved on a case-by-case basis by the IBC. Furthermore, any work with, transfer or possession, of a Select Agent must undergo a specialized review and approval process including the IBC and coordinated through the University Biosafety Officer (734-747-2318).

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Frequently Asked Questions:

Q: I am already registered with the IBC and my work is staying the same. Do I need to complete a form in the new system?
A: Yes, you will still need to complete a form in the new system. The new form contains slightly different questions and having everyone convert their registration information into the new system will help to ensure that we have a consistent level of information about all the recombinant DNA work occuring on campus.

Q: How soon do I need to complete a registration in the new system?
A: The earliest the new system will be available is April 2007 - but we don't want everyone to register at once! The IBC is dividing up the population of currently registered investigators into small groups and we will be notifying these groups of consecutive three-month windows of time when they should complete the form. However, some investigators may need to complete their registration earlier than their assigned time. We have some specific guidance on when you should complete a registration in relation to the initiation of your recombinant work.

Q: Do I have to wait until my assigned time to register?
A: No. If you do have new recombinant DNA work that you need to register before your assigned time, you are certainly welcome to complete a registration in the new system at any time.

Q: What happens to my old registrations on file with the IBC as of April 9, 2007?
A: Your old registrations with the IBC will still be on file with us and will be considered valid (as long as they are an accurate description of your rDNA work), until you have completed the process of registering in the new system. Then, once your registration in the new system is approved, it will be considered to supercede your old registrations with the IBC.

Q: How long does it take to complete the new form?
A: We will have the answer to this question soon. Please check back with us.

Q: How long does it take for approval and how will I be notified?
A: We anticipate a 2-week turnaround time for registration approvals, which is the same as under our old system. We will be learning the new system too, however, and there will be peaks and valleys in both the influx of registrations and at least initially in our ability to keep up with processing them. We will certainly strive to do our best to approve registrations in a timely manner.

Q: Do I need to register every single project that involves recombinant DNA?
A: The registration that you complete in the new system should be a representation of all your recombinant DNA work. So, it should encompass all your projects that involve recombinant DNA, whether those are sponsored projects, or preliminary work, or projects not associated with a funding source. To put it another way, the registration form does not ask you for tracking information regarding specific sponsored projects, but we do expect that the information you give us in the form covers all the recombinant DNA work you will be doing in all your projects. This is why we consider this to be an investigator-based registration system instead of a project-based system.

Q: How will my sponsored projects be linked to my registration?
A: The IBC will still be receiving information from DRDA from Proposal Approval Forms (PAFs) that are checked "yes" for recombinant DNA, and we will still be writing to you periodically about these proposals to get your certification that the registration you have on record with us encompasses the recombinant DNA work you plan on your sponsored projects. For now these "certification" letters will look like they always have, and we will still be tracking your responses in the same way we have done for a long time.

Q: How long is my new registration valid?
A: Your new registration will be valid for three years from the date of approval.

Q: What if I need a copy of my old registrations with the IBC for reference?
A: You can contact the IBC office (jhoats@umich.edu, or 734-936-3934) to obtain a copy of your old registrations.

Q: What types of changes to one's rDNA work require submission of an amendment?
A: Like always, we require you to update your registration (in the new system: complete an amendment) when your work will be changing in terms of any of the following characteristics:

• cloning different genes than previously registered onto a viral chromosome,
• host-vector system,
• organism studied,
• animal model,
• anything else that might increase the biosafety level of your work.

Q: How do I notify the IBC when my work is changing?
A: There will be an amendment feature in the new system. You can just click on the button for creating an amendment and you will be prompted to complete the relevant questions. This will then be reviewed and approved in the same manner as a regular registration. Your registration renewal date will still remain the same, that is, it will be based upon the approval date of your initial registration.

Q: How will I know when to renew my registration?
A: Your renewal date will be three years from the date of your initial approval in the new system. The IBC will send you a notice prior to your renewal date.

Q: Can I get access to my new registration via eResearch?
A: Yes! You can log in with your kerberos password to view your registration and any amendments.

Q: I am planning a human gene transfer clinical trial? Do I use the new IBC system to register this?
A: No, you will need to go through the Human Subjects component of eResearch to initiate both IBC and IRB review of your human gene transfer clinical trial. Before you begin please look at Appendix M of the NIH Guidelines for Research with Recombinant DNA Molecules regarding the requirements for review and approval of such work.

Q: Are small interfering RNAs included in the definition for recombinant DNA?
A: Not if you are just adding oligos to cells. But if you are expressing the RNAs from a vector, it is rDNA.

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