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Biosafety Requirements & Resources
IBC Review/Approval & Meetings
Containment categories for commonly used agents
Human Subject Studies that Require IBC Approval
Human Subjects Studies that Require IBC Approval
The analysis of, or experimentation, with sera, blood products, or other specimens derived from humans in UR research laboratories or those UR labs that are NOT accredited with the College of American Pathologists (CAP) or the Joint Commission on Accreditation of Healthcare Organization (JCAHO).
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UR and IBC regulations require all investigators who plan to collect specimens from human research subjects which are analyzed or used in other experiments to register with the IBC.
The first step in obtaining IBC approval is the completion of the Grant or Project Registration Form (Form G):
- Grant/Project Registration Form (Form G) in PDF format
- Grant/Project Registration Form (Form G) in Word format
In addition, the following supporting documents must be provided for the IBC:
- Laboratory Registration (Form L) for labs used for your study. Many times the document has already been submitted. Contact the IBC to verify the status of Form L (Donna Douglass, X52402, or ddouglass@safety.rochester.edu)
- Laboratory Registration Form (Form L) in PDF format
- Laboratory Registration Form (Form L) in Word format
Additional information may be required at the request of the IBC Chair.
NOTE: One copy of all required documents in both electronic and paper formats must be submitted to Donna Douglass (ddouglass@safety.rochester.edu), IBC Program Coordinator, RC Box 278878.
Follow-up activities by the IBC, upon receipt of complete documentation, will include protocol review/evaluation, as well as, (1) a survey of the facility where the study agent is stored/dispensed/administered, (2) a review of specimen storage unit/facilities, and (3) a review of study personnel training relevant to OSHA compliance.
This page last updated 11/3/09. Disclaimer
