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IBC   

Initial IBC Review and Approval

To harmonize institutional review processes for research involving animals, recombinant DNA, biohazards, human gene transfer, animal gene transfer, or human cell lines please use the following forms for protocol submission:

  1. Exempt Recombinant DNA (rDNA) Research: An Application for Recombinant DNA Exemption describing your current research is required when specific criteria outlined in the NIH Guidelines applies to your research. This application will act as your registration for exempt rDNA research. Exempt protocols do not require submission of Annual Reviews.

  2. Human Source Material - Research in which the ONLY biohazards are human source material require the completion of the Registration for Use of Human Source Material form. Research involving human cell lines plus recombinant DNA, infectious agents, primary human cells, or biological toxins will require an Application for Review of Recombinant DNA and/or Biohazards Research along with corresponding appendices. All work involving human source material must be conducted at a minimum BSL-2 containment level. If applicable, additional strains can be added by submitting an amendment. Registrations for Human Cell Line Use do not require submission of Annual Reviews.

  3. Recombinant DNA Research Involving Generation of Transgenic Rodents: When purchasing, obtaining or creating transgenic rodents, an Application for Rodent Gene Transfer describing the current research is required. This application covers experiments involving the generation of rodents in which the animal’s genome has been altered by stable introduction of recombinant DNA, or DNA derived therefrom, into the germ-line (transgenic rodents). Only experiments that require BSL-1 containment are covered by this application. Additional strains can be added by submitting an amendment. Experiments that require BSL-2 containment or higher require an Application for Review of Recombinant DNA and/or Biohazards in addition to applicable appendices.

  4. Non-exempt Recombinant DNA Research: An Application for Review of Recombinant DNA and/or Biohazards Research along with applicable appendices is required for research that is not exempt from the NIH Guidelines. Each approved protocol will require an Annual Review to update the status of the research. All non-exempt protocols will continue to require the submission of amendments to document changes in personnel, procedures, research location, agents / rDNA host vector systems, and/or changes in containment procedures.

Click below to view an example of a well written Recombinant DNA protocol.
Example of a Recombinant DNA Protocol


Word FormatApplication for Recombinant DNA Exemption version 2.0 - Updated 2/28/08

Word FormatRegistration for Use of Human Source Material version 1.0 - Updated 2/26/09

Word FormatApplication for Rodent Gene Transfer version 2.3 - Updated 3/18/09

Word FormatApplication for Review of Recombinant DNA and/or Biohazards Research version 2.0 - Updated 7/15/08

 

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Last Modified: October 15, 2009