As a condition for NIH funding of recombinant DNA research, the Institution is required to ensure that such research conducted at or sponsored by the Institution, irrespective of the source of funding, complies with the NIH Guidelines. The Principal Investigator must make an initial determination whether the subject research is Exempt or Non-Exempt under the NIH Guidelines. If the research is Non-Exempt , the investigator must submit a completed IBC Protocol form for review and approval.It is the Principal Investigator’s responsibility to be knowledgeable of and abide by the provisions of the NIH Guidelines when making this determination.
IBC Protocol Form. All Non-Exempt recombinant DNA research must be reviewed and approved by the IBC. All Non-Exempt recombinant DNA research protocols and any subsequent changes (e.g., changes in the source of DNA or host-vector system), if covered under Sections III-A, III-B, III-C, III-D, or III-E (Experiments Covered by the NIH Guidelines), must be submitted to the IBC for review and approval using the IBC Protocol Form. Approval is for a three (3) year period, after which a new application must be submitted for review.
Amendment Form. Modifications of approved Non-Exempt research protocols require IBC review and approval before implementation of the changes. Amendments should be submitted by e-mail to firstname.lastname@example.org. The IBC Chair and BSO will perform an initial review of the modification. Some modifications may require full committee review and/or a separate approval by the IBC prior to initiation of such experiments.
Exempt Questionnaire: Answering this questionnaire will help investigators determine whether their research is Exempt or Non-Exempt. Please send the questionnaire to the IBC Office (email@example.com) for our records. For further assistance determining if experiments are covered under the NIH Guidelines, please contact the IBC office.
Office of Biosafety, Tulane University, New Orleans, LA 70112 504-988-0300 firstname.lastname@example.org