1. Whom do I contact?

  2. What approvals do I need prior to working with biological materials/organisms?

  3. How do I get started if my research does require approval?  What are the recommended steps?

  4. What are the training obligations?  Are educational resources available?

  5. Will I be monitored after my approval?

  6. Relevant policies, procedures, and links.

1.  Whom do I contact?

The Biological Safety Section in Environmental Health & Safety Office (EHS) is responsible for the administration of programs in the research and non-research community regarding the management of biological or infectious agents and biohazardous materials. Program areas include: general biological safety, bloodborne pathogens, recombinant DNA, select agents and toxins, and stem cell research.

 

EHS Biological Safety Officer: (319) 353-5679

Website:  http://ehs.research.uiowa.edu/biological-safety

 

2.  What approvals do I need prior to working with biological materials/organisms?

Recombinant DNA (rDNA) Research 

  • Authorization:  As required by the NIH Guidelines, all rDNA research covered under the Guidelines must be approved by the Institutional Biosafety Committee (IBC).  To start the review/approval process, submit an rDNA Registration Document, available through the electronic IBC (eIBC).
  • Expiration: Registration Documents are valid for three years from the date of IBC approval; a full application must be submitted and approved prior to the expiration date in order to continue the research.
  • Modification:  Any modification you wish to make to your research must be approved by the IBC as an amendment to your Registration Document prior to implementation.  Contact Biological Safety staff for guidance.  

Stem Cell Research 

  • Authorization:  If your research protocol involves the derivation and/or use of human embryonic stem cells, you must complete a Protocol Application for review and approval by the Human Pluripotent Stem Cell Committee (hPSCC). Research use of human induced pluripotent cells (hiPSC) that is designed to yield gametes or integrate cells into the central nervous system of animals is also approved by the hPSCC.
  • Expiration: Protocols are valid for three years from the date of approval; a full application must be submitted and approved prior to the expiration date in order to continue the research.
  • Modification:  Any modification you wish to make to your research must be approved by the hPSCC.  Contact the Biosafety Officer for guidance.  

Select Agent and Toxin Research

  • Authorization:  You must have prior Federal Select Agent Program (FSAP) approval to access select agents and toxins (non-exempt quantities), and the Biosafety Officer can provide guidance in obtaining this approval.  If you will be using the Carver College of Medicine’s Biological Safety Level III Laboratories (BSL3), your protocol will need to be reviewed and approved by the College of Medicine’s BSL3 Oversight Committee (CCOMBOC).
  • Expiration: For work that is performed in CCOM BSL3 facilities, standard operating procedures are reviewed annually and amended procedures must be submitted to the CCOMBOC prior to the expiration date in order to continue the research.
  • Modification:  Any modification you wish to make to your research must be approved by the FSAP and/or CCOMBOC as an amendment to your research proposal prior to implementation.  Contact the Biosafety Officer for guidance.

Additional approvals: 
Additional approvals will depend upon your use of biological materials/organisms with animals, radioisotopes, and/or human subjects.  Use of the Carver College of Medicine’s BSL3 Core Facility will also require additional approvals.

3.  How do I get started if my research does require approval?  What are the recommended steps?

  1. Contact the Biological Safety Staff to set up a site visit to your lab.
  2. Review the handbook that will be provided by the Biological Safety staff.

4.  What are the training obligations?  Are educational resources available?

Mandatory and recommended training sessions are available. Review the training requirements for Biological Safety in the Safety Training Course Guide and follow the instructions provided here for paid or non-paid registration logins.

Additional training resources are listed on the EHS website.

5.  Will I be monitored after my approval?

A member of the safety advisor team within EHS will be assigned to your laboratory.  Your safety advisor will  conduct safety round observations, monitor the laboratory, and review the annual lab self-audit to assist lab staff with complying with safety regulations and University policies.  

6.  Relevant policies, procedures, and links.

Principal Investigators working with biological material/organisms at the University will have to abide by all Federal, State, and local regulations in addition to University policies and guidelines.  Depending on the material/organisms handled in your laboratory, your research may fall into one or several of the categories referenced below: