Research Checklist: Regulatory Requirements

The following checklist is a guide to help inform and instruct PIs in various areas of regulatory research requirements. Please check and complete those that apply to yourself or any person working in the laboratory. If you have any questions or need assistance, please contact the Office of Research Administration at extension 2-2105 or Environmental Health & Safety at extension 2-2185.

Contact: Office of Research Administration I will be using human subjects (see OHRP’s 45 CFR 46) in my research, and: I have contacted the IRB Coordinator in Research Administration to submit a protocol for approval from the Institutional Review Board (IRB) and to schedule human subjects training. I will be using vertebrate animals (see PHS Policy on Humane Care and Use of Laboratory Animals and the Animal Welfare Regulations) in my research, and: I have contacted the IACUC Coordinator in Research Administration to submit a protocol for approval from the Institutional Animal Care and Use Committee (IACUC) and to schedule animal care training. I will be using recombinant DNA (see NIH Guidelines for Research Involving Recombinant DNA Molecules) in my research and: I have contacted the IBC Coordinator in Research Administration to submit a protocol for approval from the Institutional Biosafety Committee (IBC) and to schedule rDNA training. I will possess, use, or transfer select agents or toxins (see CDC Final Rule 42 CFR Parts 72 and 73 and APHIS Final Rule, 7 CFR Part 331 and 9 CFR Part 121) in my research, and: I have contacted Research Administration to initiate the CDC permit/application process and laboratory risk assessment.

Contact: Environmental Health & Safety Office I will be using chemicals and/or generating chemical waste, and: I have contacted EH&S to schedule HazCom/RCRA training. I will be using infectious agents categorized as Biosafety Level 2, 3, or 4 (see CDC’s Biosafety in Microbiological and Biomedical Laboratories “BMBL,” 5 th Edition) in my research, and: I have contacted the Biosafety Specialist in EH&S to initiate a lab inspection/certification and schedule biosafety training. I will be shipping infectious substances or diagnostic specimens, and: I have contacted the Biosafety Specialist in EH&S to schedule shipping training. I will be handling human blood, cell/tissues, or body fluids, and: I have contacted the Biosafety Specialist in EH&S to initiate a lab inspection and schedule Bloodborne Pathogen training. I will be using radioactive material or radiation producing machines, and: I have contacted the Radiation Safety Officer in EH&S to submit a sub-license application to the Radiation Safety Committee (RSC), schedule radiation safety training, and order dosimetry. I will be using lasers, and: I have contacted the Laser Safety Officer in EH&S to add the laser(s) to UTA’s registration and to schedule laser safety training. I will possess, distribute, or dispense controlled substances (see DEA Controlled Substance Schedules), and:

Revised July 2007, Research Administration. All Previous Versions are Obsolete. I have contacted EH&S to find out how to register for controlled substances with the federal Drug Enforcement Administration (DEA).

Revised July 2007, Research Administration. All Previous Versions are Obsolete.