RESEARCH INVOLVING RECOMBINANT AND SYNTHETIC NUCLEIC ACID MOLECULES

1. Institutional Biosafety Committee Procedures for Recombinant and Synthetic Nucleic Acid Molecules Research
2. Institutional Biosafety Committee By-laws
3. Schedule of Institutional Biosafety Committee Meetings
4. Roster of Institutional Biosafety Committee Members

Recombinant and Synthetic Nucleic Acid molecules are defined by NIH as:

  1. Molecules that
    a) are constructed by joining nucleic acid molecules and
    b) can replicate in a living cell (I.e., recombinant nucleic acids);
  2. Nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules (i.e., synthetic nucleic acids); or
  3. Molecules that result from the replication of those described in (1) or (2) above.

The University of the Sciences' Institutional Biosafety Committee (IBC) has been established under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules to provide local review and oversight of research utilizing recombinant or synthetic nucleic acid molecules that is conducted at or sponsored by the University of the Sciences, irrespective of the source of funding. The IBC will review, approve, and oversee research protocols in accordance with the responsibilities defined in the NIH Guidelines.

All laboratories working with recombinant or synthetic nucleic acid molecules must comply with the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules. Non-compliance may result in suspension, limitation, or termination of financial assistance for the non-compliant project and other nucleic acid research at the University, or require prior NIH approval of any or all nucleic acid projects at the University.

If research will involve the use of recombinant or synthetic nucleic acids, the Principal Investigator must complete the Research Protocol Form which includes the Recombinant or Synthetic Nucleic Acid Molecules Registration Form. Review the IBC Procedures which includes submission and review procedures and roles and responsibilities of the Principal Investigator.

The NIH Guidelines, from the Department of Health and Human Services, present general requirements for different types of experiments involving nucleic acids.  These guidelines divide research into the following classes:

1. Experiments that require Institutional Biosafety Committee (IBC) approval, Recombinant DNA Advisory Committee (RAC) review and NIH Director Approval before Initiation.  (NIH Guidelines, Section III-A)
2. Experiments that require NIH/OBA (Office of Biotechnology Activities) and IBC approval prior to initiation (NIH Guidelines, Section III-B)
3. Experiments that require IBC and IRB (Institutional Review Board) approvals and RAC review before research participant enrollment. (NIH Guidelines, Section III-C)
4. Experiments that require IBC approval before initiation. (NIH Guidelines, Section III-D)
5. Experiments that require IBC notification simultaneous with initiation. (NIH Guidelines, Section III-E)
6. Experiments that are exempt from the NIH guidelines. (NIH Guidelines, Section III-F) Protocols considered exempt must also be submitted for review to the Institutional Biosafety Committee to verify exemption and to comply with other Federal and State Standards of biosafety that still apply.

Some Examples of Exempt Experiments:

View Section III-F Exempt Experiments and Appendix C (Exemptions under Section III-F-8) for other classes of experiments which are exempt from the Guidelines.

Consult the NIH Guidelines and follow the link to EHRS's IBC Procedures for Recombinant or Synthetic Nucleic Acid Molecules Research for specific project details and to ensure that research is conducted in full compliance with the Guidelines. If you have any specific questions about a particular host-vector not covered by the Guidelines, please call the EHRS Department. (X8925)  Updates to the NIH Recombinant and Synthetic Nucleic Acid Molecules Guidelines are published in the Federal Register. This hyperlink will bring you to the most recent Guidelines.


University of the Sciences in Philadelphia • 600 South Forty-third Street • Philadelphia, PA 19104-4495 • phone: 215-596-8800 • email: safety@usp.edu