Research Compliance

Human Studies

• All research using recombinant DNA, a vaccine (when the structure of the virus has been genetically manipulated), or other materials derived from rDNA must comply with the NIH Guidelines for Research Involving Recombinant DNA Molecules.
• This research also requires review and approval by the Case Institutional Biosafety Committee.
• Additionally, this research requires review and approval by one of the following biomedical Institutional Review Boards (Case Cancer IRB, MetroHealth Medical Center IRB, Louis Stokes Veterans Administration IRB, and University Hospitals Case Medical Center IRB), which is depended upon where this study will take place.

Required materials to be submitted to the Case IBC with the New rDNA Protocol application:

• Copy of IRB application
• Copy of the Informed Consent Document
• Copy of Appendix M
• Copy of letter from NIH OBA with recommendation of approval or exemption
• Copy of Investigator brochure

Required correspondences between with the Faculty Principal Investigator and NIH OBA that should be submitted to the Case IBC:

Either a letter from the NIH OBA confirming that the human research is covered by the vaccine exemption as explained in the NIH Guidelines for Research Involving Recombinant DNA Molecules Appendix M-IV-A:

"Human studies in which induction or enhancement of an immune response to a vector-encoded microbial immunogen is the major goal, such an immune response has been demonstrated in model systems, and the persistence of the vector-encoded immunogen is not expected, are exempt from Appendix M-I, Requirements for Protocol Submission, Review and Reporting - Human Gene Transfer Experiments."