- Whom do I contact?
- What approvals do I need prior to working with biological materials/organisms?
- How do I get started if my research does require approval? What are the recommended steps?
- What are the training obligations? Are educational resources available?
- Will I be monitored after my approval?
- Relevant policies, procedures, and links.
http://ehs.research.uiowa.edu/biological-safety Biological Safety staff: Haley W Sinn, Ph.D., CBSP, Biological Safety Officer; 335.9553
Rachel White, Ph.D., Associate Biological Safety Officer; 353-5679 Deborah Kratz, Sr. Biosafety Specialist; 353.5678
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 UIRIS (under the “Forms” section).
- Expiration: Registration Documents are valid for three years from the date of IBC approval; a full application must be submitted 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 Chair 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 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) is approved by the hPSCC Chair through submittal of an iPSC Informational Form; please contact the Biosafety Officer to obtain the Information Form.
- Expiration: Approval is granted for the length of the award period; a full application must be submitted 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 Chair. Contact the Biosafety Officer for guidance.
Select Agent and Toxin Research
- Authorization: You must have prior Center for Disease Control (CDC) 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 CDC and/or CCOMBOC as an amendment to your research proposal prior to implementation. Contact the Biosafety Officer for guidance.
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.
- Contact the Biological Safety Staff to set up a site visit to your lab.
- Review the handbook that will be provided by the Biological Safety staff.
Mandatory and recommended training sessions are available. Review the training requirements for Biological Safety in the Safety Training Course Guide and follow the instructions below to access the courses online.
- Login to Employee Self Service.
- On the Personal tab, under the heading Learning and Development, click on My Training.
- Click on Available Online ICON Courses
- Select the applicable courses below.
Additional training resources are listed on the EHS website.
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.
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:
- Biohazardous agents: refer to EHS’s Biological Safety Manual
- Blood and blood products, human tissues or cell lines, certain body fluids: refer to EHS’s Bloodborne Pathogens Program
- Recombinant DNA: refer to EHS’s Recombinant DNA Program Recombinant DNA is registered through UIRIS.
- Human Embryonic Stem Cells/Human Pluripotent Stem Cells: refer to EHS’s Human Pluripotent Stem Cell Program
- Select Agents or Toxins: refer to EHS’s Select Agent Program
- Exempt quantities of Select Agent Toxins: refer to the UI Requirements for Possession of Exempt Quantities of CDC Select Agent Toxins
- Biohazardous Waste Disposal: refer to the Biohazard Waste Guide
- Occupational medical surveillance for research staff: University Employee Health Clinic, 1097-1 BT, UIHC
- Centers for Disease Control and Prevention (CDC)
- CDC's Biosafety in Microbiological and Biomedical Laboratories
- CDC’s Select Agent Program: National Select Agent Registry
- Infectious Substance MSDS's from Canada's Laboratory Centre for Disease Control
- National Institutes of Health Recombinant DNA Guidelines
- National Institutes of Health Guidelines for Research Using Human Stem Cells
- USDA/Animal and Plant Health Inspection Service’s Select Agent Program
- Carver College of Medicine BSL3 Laboratory Facilities