Do I need to complete an Memorandum of Understanding and Agreement (MUA) form?

Find out if your research is exempt by using the link on the homepage

"Is Your Research Exempt?"

What is an MUA?

An MUA is an electronic form that details all information concerning individual research projects. It includes information that outlines the responsibilities of the Principal Investigator of the project. A separate archive is created for all MUA forms and can be retrieved by the user for modification and resubmitted.

To fill out an MUA form:

1. Log on to forms.ibc.arizona.edu/mua
2. Create a log-in for the website
3. Fill out the Profile Section that details your administrative and facilities information.
4. After completing the Profile Section select "New Form" (if you are a first time user). This section allows you to describe the research project. Once you have existing MUA forms you can select "Edit Form" to access an existing form and make relevant changes without having to retype the whole form. The existing form will remain in the data base and a new form will be created from the edit.
5. Fill out a Memorandum of Understanding and Agreement form for each project that involves the use of any of the above mentioned techniques.

What does the Institutional Biosafety Committee look for in an MUA form?

Project Description

Your description should outline research goals, methods to be used and management of biological risk. The description should include identification of biological hazards and how they will be managed.

Recombinant DNA Molecules

Recombinant DNA molecules are defined as either: (i) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or (ii) molecules that result from the replication of those described in (i) above.

Synthetic DNA segments which are likely to yield a potentially harmful polynucleotide or polypetide (e.g., a toxin or a pharmacologically active agent) are considered as equivalent to their natural DNA counterpart. If the synthetic DNA segment is not expressed in vivo as a biologically active polynucleotide or polypeptide product, it is exempt from NIH Guidelines

Source: NIH Guidelines for Research Involving Recombinant DNA Molecules

Cell Cultures

If your cell cultures will be obtained from a repository like American Type Culture Collection (ATCC), it is important that you include ATTC Number and indicate the recommended containment level. Please note that the Institutional Biosafety Committee requires that many cell lines must be handled at Biosafety Level 2 or higher. They include:

All cell lines (primary and established) of human/primate origin

All cell lines dervied from lymphoid or tumor tissue

All cell lines exposed to or transformed by amphotropic packaging systems

All human clinical material (e.g., samples of human tissues and fluids obtained after surgical resection or autopsy)

All cell lines new to the laboratory (until verified to be free of all adventitous agents)

All mycoplasma-containing cell lines

All cell lines (primary or established) of animal origin

Pathogenic Microorganisms

You need to submit an MUA if your research involves material that may harbor infectious organisms from human or primate tissues, fluids or cell cultures.

Biohazardous materials include: bacteria, chlmaydiae, fungi, parasites, prions, rickettsias and viruses which cause disease in humans or signficant environmental or agriculture impact.

Training

It is both good laboratory practice and legally mandated that Principal Investigators (PIs) and research staff be trained on identifying biological hazards and understanding how to reduce risks associated with those hazards. The Department of Risk Management is responsible for conducting educational programs for both Laboratory Safety Training (General Laboratory Chemical Hygiene Training) and Bloodborne Pathogen/Infection Control. Both of these programs are required for Principal Investigators and research staff who are exposed to either chemical hazards and/or biological hazards associated with human bloodborne pathogens. PI's must list all persons who will work on their projects and indicate whether these individuals have completed the necessary training programs.

You must have proper shipping training before shipping/receiving Diagnostic Specimens and/or Dangerous Goods. For more details on how to receive this training contact Mark Grushka, Manager, Biosafety & Biosecurity at 621-5279.

Proposal Routing Sheets (PRS):

If you are applying for a grant where rDNA techniques and/or pathogens are employed, then you must obtain a signature from the Institutional Biosafety Committee on your the Sponsored Projects proposal routing sheet.

• In order to obtain the signature:

1. Log on to forms.ibc.arizona.edu/mua in order to fill out the MUA form that has an EXACT title and sponsor match to the shown on the proposal routing sheet. The IBC staff or Committee member will not sign PRS forms without a MUA form that has a matching title and sponsor to the one on the PRS.
2. Fax the PRS to the Institutional Biosafety Committee office: (520) 621-6159
3. An IBC staff or Committee member will sign your PRS and fax it back to you.

Where can I get additional assistance?

The administrative offices of the Institutional Biosafety Committee are located in 1618 East Helen Street, #115 and #117.

Margaret Stalker, Program Coordinator, Sr., is available to answer procedural questions on form submissions and review processes. Her phone number is (520) 621-3441.

Mark Grushka, Manager, Biosafety & Biosecurity (and part time Biosafety Officer), can provide information on specific research biosafety questions. His phone number is (520) 621-5279 . His office is also at 1618 East Helen Street, #113.

Margaret and Mark are the primary contacts for Proposal Routing Sheet signatures. However, any IBC Committee member can be contacted in the event Margaret or Mark are unavailable. If you have questions regarding University of Arizona IBC forms you can contact the IBC staff at 621-3441 or 621-5279. Office hours are Monday through Friday 8 am - 5 pm.

The IBC FAX number is 621-6159.