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- 2. Regulatory Requirements
- 2e. Working with biological materials / organisms
2e. Working with biological materials and organisms
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- 2a. Disclosing financial interests related to research
- 2b. Working with animals
- 2c. Working with human subjects in research
- 2d. Complying with export control regulations
- 2e. Working with biological materials / organisms
- 2f. Working with chemicals
- 2g. Working with radioactive materials / radiation producing machines
- 2h. Disposing of chemical, radioactive and biohazardous waste
- 2i. Serving on committees
- 2j. Working with Drug Enforcement Administration (DEA) materials
Jump to section:
- Whom do I contact?
- What approvals do I need prior to working with biological materials and 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 EHS monitor my laboratory after approval?
- What are other relevant policies, procedures, and links?
1. Whom do I contact?
The Biological Safety section within the Environmental Health and Safety Office (EHS) administers programs for managing biological and infectious agents and other biohazardous materials in research and non-research settings. Program areas include:
General biological safety
Bloodborne pathogens
Recombinant DNA
Select agents and toxins
Stem cell research
Contact information
EHS biological safety officer
319-353-5679
Staff Directory
EHS Biological Safety website
2. What approvals do I need prior to working with biological materials/organisms?
Recombinant DNA (rDNA) research
Authorization
As required by the National Institutes (NIH) of Health Guidelines, the Institutional Biosafety Committee (IBC) must approve all rDNA research covered under the guidelines. To begin the review process, submit an rDNA Registration Document through the electronic IBC (eIBC).
Expiration
Registration documents are valid for three years from the date of IBC approval. You must submit a new application and receive IBC approval before the expiration date to continue the research.
Modification
The IBC must approve any changes to the research as an amendment before implementation. Contact Biological Safety staff for guidance.
Stem cell research
Authorization
The Human Pluripotent Stem Cell Committee (hPSCC) must review and approve a protocol application for research involving the derivation or use of human embryonic stem cells. The hPSCC must also approve research use of human-induced pluripotent stem cells (hiPSCs) designed to yield gametes or integrate cells into the central nervous system of animals.
Expiration
Protocols are valid for three years from the date of approval. You must submit a new application and receive approval from the hPSCC before the expiration date to continue the research.
Modification
The hPSCC must approve changes to the research before implementation. Contact the biosafety officer for guidance.
Select agent and toxin research
Authorization
You must receive Federal Select Agent Program (FSAP) approval before accessing select agents and toxins. The biosafety officer can assist with this process.
Research conducted in Carver College of Medicine Biosafety Level 3 (BSL-3) laboratories also requires review and approval by the Carver College of Medicine’s BSL-3 Oversight Committee (CCOMBOC).
Expiration
For work conducted in BSL-3 facilities, standard operating procedures are reviewed annually. You must submit updated procedures before the expiration date to continue research.
Select agent and toxin research modification
FSAP and/or the oversight committee must approve changes before implementation. Contact the biosafety officer for guidance.
Additional approvals
The use of animals, radioisotopes, or human subjects may require additional approvals. Use of the Carver College of Medicine’s BSL-3 Core Facility may also require additional approvals.
3. How do I get started if my research does require approval? What are the recommended steps?
Contact EHS to set up a site visit to your laboratory.
Review materials provided by EHS staff.
4. What are the training obligations? Are educational resources available?
Mandatory and recommended training courses are available. Review the training requirements for biological safety in the safety training course guide and laboratory-specific training requirements.
EHS staff will help identify training relevant to your research during the site visit. Follow the instructions for university and non-university registration logins.
5. Will EHS monitor my laboratory after approval?
EHS will assign a safety advisor to your laboratory. The advisor conducts safety observations, monitors laboratory practices, and reviews the annual laboratory self-audit to support compliance with safety regulations and university policies.
6. What are other relevant policies, procedures, and links?
Principal investigators working with biological materials or organisms must comply with all applicable federal, state, and local regulations, as well as university policies and guidelines. Depending on your research, consult the following resources:
Biohazardous agents: EHS Biological Safety Manual
Blood and blood products, human tissues or cell lines, certain body fluids: EHS Bloodborne Pathogens Program
Recombinant DNA: EHS Recombinant DNA Program (recombinant DNA is registered through eIBC)
Human embryonic stem cells/human pluripotent stem cells: EHS Human Pluripotent Stem Cell Program
Select agents or toxins: EHS Select Agent Program
Permissible quantities of select toxins: UI Requirements for Possession of Exempt Quantities of CDC SelectToxins
Biohazardous waste disposal: Biohazard Waste Guide
Occupational medical surveillance for research staff: University Employee Health Clinic, 1097-1 BT, University of Iowa Health Care