Request for Exemption from the NIH Guidelines for Research Involving Recombinant DNA Molecules 2025

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  1. Click ‘Get Form’ to open it in the editor.
  2. Begin by entering your personal information in the designated fields, including your Principal Investigator name, Penn ID Number, Position Title, School, Department, Mailing Address, Telephone, Date of Request, Mail Code, FAX, and E-mail.
  3. Next, specify the location of your lab(s) and provide a clear Project Title along with a brief description of your project. This section is crucial for understanding the context of your exemption request.
  4. Select the appropriate exempt category for your experiments by checking one of the options listed under Section III-F. Ensure that you understand each category to accurately represent your research.
  5. In the final section, briefly explain why you believe your experiments fall within the selected exempt category. This justification is essential for approval.
  6. Finally, sign and date the form. If applicable, have your Faculty Sponsor print and sign their name as well.

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Each organization that conducts research involving recombinant or synthetic nucleic acid molecules, including contractors under grants, must have policies and procedures to ensure compliance with NIH Guidelines and must establish a standing IBC.
Section III-F of the NIH Guidelines describes experiments that are exempt from the requirements. Details on certain other experiments that may be exempt, as well as exceptions to the exemptions, may be found in Appendix C of the NIH Guidelines.
The NIH mandates all research utilizing non-exempt recombinant or synthetic nucleic acid molecules be reviewed and approved by the UAB IBC before initiation regardless of funding agency.
The Institutional Biosafety Committee (IBC) was established to review recombinant DNA research conducted at or sponsored by UNC-Chapel Hill for compliance with the National Institutes of Health (NIH) guidelines and approve those research projects that are found to conform with the NIH Guidelines.
Institutions that receive support from the National Institutes of Health (NIH) for recombinant or synthetic nucleic research are required to establish and register an Institutional Biosafety Committee (IBC) with the NIH Office of Science Policy (OSP) in compliance with the NIH Guidelines for Research Involving

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Institutional Biosafety Committees (IBCs) were established under the NIH Guidelines to provide local review and oversight of nearly all forms of research utilizing recombinant or synthetic nucleic acid molecules.
IBCs must consist of at least five qualified members, including two unaffiliated community representatives. Expertise in plant and animal containment, gene drive organisms, and human gene therapy must be included or accessible. Annual reports to NIH OSP must include rosters, biographical sketches, and committee roles.

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