Research Compliance

Principal Investigator's Responsibilities

1. Determine whether or not activities under his/her direction involve rDNA, pathogenic or other infectious agents, viral vectors, or vaccine studies where the structure of the virus is genetically manipulated.
2. Register the experiment(s) with and obtain approval from the Case IBC prior to initiation of proposed experiment(s).
3. Comply with federal, state, local and institutional guidelines for safe handling of biohazardous materials; appropriate safeguards against environmental release should remain in place during the conduction of the proposed experiments.
4. Educate and inform personnel of the risk potential and provide them with adequate training to minimize their exposure.

• If approval is required before initiation of the research, then research shall not proceed until email notification of approval is received.
Allow up to four (4) weeks for approval if your protocol is received by the registration due date for the next committee meeting date.
• After the registration is reviewed you will be notified of the approval status or any changes to the proposed research protocol the Committee requests. If you have any questions or concerns about the status of your registration or changes requested by the Committee, contact the IBC Assistant at mxd4@cwru.edu.

• Once a protocol is approved, an approval letter is sent to the Faculty Principal Investigator. The letter lists the study's Case IBC Protocol number and title, the Biosafety Level and Risk Group set by the IBC, date of approval and the date by which a continuing review is required for continuation of the study, and any additional requirements.

• If at any time during the approved research period you propose to change the containment level for the research, you must notify the IBC immediately for the committee's review and approval of the change or modification before it is implemented.
• Investigators shall report any significant problems, violations of the NIH Guidelines, or any significant research related accidents and illnesses to the Institutional Biosafety Committee, Biological Safety Officer (where applicable), Greenhouse/Animal Facility Director (where applicable) within 14 working days of discovery of the problem, violation or accident, and to NIH/OBA, and other appropriate authorities (if applicable) within 30 days of discovery of the problem, violation or accident.

• For all human studies regardless of the Biosafety Level or projects conducted at BL-3 and BL-4 committee approvals are valid for only one (1) year.
• For projects conducted at BL-1 and BL-2, committee approvals are valid for three (3) years from the date of approval.
• Before the expiration date of each approval period, a continuing review application must be submitted to the Case IBC. Please see the IBC Protocol Forms Page.