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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.

A streamlined IBC registration has been developed specifically for investigators who are proposing a clinical study which meets the following criteria:

  1. Study does NOT involve infectious agents, recombinant DNA, or genetically-engineered micro-organisms.
  2. Study does involve the analysis of, or experimentation, with sera, blood products, or other specimens derived from humans in UR research laboratories or in those UR labs that are NOT accredited with the College of American Pathologists (CAP) or the Joint Commission on Accreditation of Healthcare Organization (JCAHO).

The first step in obtaining IBC approval is the completion of the Human Subjects Study Registration Form (Form HS):

In addition, the following supporting documents must be provided for the IBC:

  1. Summary or abstract of study

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 Patty Bardeen (pbardeen@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 5/08/08. Disclaimer