Institutional Biosafety Policy

Purpose

The purpose of the Institutional Biosafety Policy and the Institutional Biosafety Committee (IBC) is to ensure protection of faculty, staff, students who generate, process, and dispose of potentially hazardous biological materials at Lewis & Clark, as well as others who may become exposed to biological hazards within the institutional environment. In addition, Lewis & Clark must comply with guidelines and regulations established by the National Institutes of Health (NIH) with regard to research involving recombinant and synthetic nucleic acid molecules, and those established by the US Government regarding life sciences research with high-consequence pathogens and toxins (“dual use research of concern” or DURC).  This policy provides for compliance with applicable regulations concerning biosafety conducted at or sponsored by Lewis & Clark.

The NIH’s Office of Biotechnology Activities (OBA) develops public policies in three areas: Biomedical Technology Assessment (human gene transfer and human stem cells), Biosafety (recombinant or synthetic nucleic acid molecules), and Biosecurity (DURC). Research involving human gene transfer, human stem cells, and DURC toxins and organisms are expressly prohibited at Lewis & Clark. As such, Lewis & Clark’s responsibilities with regard to Biosafety include but are not limited to establishing and maintaining a compliant Institutional Biosafety Committee (IBC), ensuring adequate expertise and training, filing an annual report with the Office of Biotechnology Activities (OBA), and establishing procedures that the IBC follows with regard to review and approval of applications and compliance with federal regulations.

Policy Statement

1. As indicated in the “United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern” (effective September 2015), “certain types of research conducted for legitimate purposes can be utilized for both benevolent and harmful purposes. Such research is called ‘dual use research.’” Based on this document and the scope of research requiring oversight, it is Lewis & Clark’s policy that the organisms and toxins listed on Schedule A are expressly prohibited at Lewis & Clark.  Schedule A shall be updated by the Sponsored Projects and Research Compliance Office as the list is revised by government agencies.

2.   Institutional Biosafety Committee

The Lewis & Clark Institutional Biosafety Committee (IBC) shall oversee research involving recombinant and synthetic nucleic acid molecules, as defined below and in the NIH Guidelines, as well as infectious agents and toxins, performed at Lewis & Clark in order to protect the health and safety of employees and the public regarding such research. Members and the committee chair shall be appointed by the Dean of the College of Arts and Sciences (CAS), and the committee membership will follow applicable federal guidelines and regulations. A majority of members of the IBC shall constitute a quorum. Appointments shall be for a term of three years. Once a committee member completes his or her term, or resigns from the committee, a replacement will be recommended to the Dean of the College of Arts and Sciences.

3.   Recombinant and Synthetic Nucleic Acids: Definition

In the context of this policy and the NIH Guidelines, recombinant and synthetic nucleic acid molecules are defined as:

(i)  molecules that a) are constructed by joining nucleic acid molecules and b) that can replicate in a living cell, i.e., recombinant nucleic acids;

(ii)  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

(iii) molecules that result from the replication of those described in (i) or (ii) above.

4.   Research Proposals and Protocols; Gene Research

A.  No employee may conduct research involving recombinant or synthetic nucleic acid molecules, infectious agents, toxins, and/or transfer vectors at Lewis & Clark without approval from the IBC and compliance with applicable requirements. This also applies to research sponsored by Lewis & Clark. Participation in research at other institutions by Lewis & Clark faculty or research staff is expected to be approved by that institution’s IBC.

B.  The IBC shall review all research proposals or protocols involving the use of recombinant or synthetic nucleic acid molecules, infectious agents, and/or associated transfer vectors.

C.  Any research involving human subjects and recombinant or synthetic nucleic acid molecules shall be reviewed and approved by both the IBC and the Human Subjects Research Committee (also known as the Institutional Review Board, or “IRB”). This includes any research in which a Lewis & Clark investigator is a collaborator, including work conducted outside of Lewis & Clark.

D.  Any research involving live vertebrate animals and recombinant or synthetic nucleic acid molecules shall be reviewed and approved by both the IBC and the Institutional Animal Care and Use Committee (IACUC). This includes any research in which a Lewis & Clark investigator is a collaborator, including work conducted outside of Lewis & Clark.

E. Faculty and staff who use, possess, store, and/or transport infectious agent(s) (e.g. bacteria, viruses, parasites, fungi, protozoa, prions, etc.), biological toxin(s), and/or recombinant DNA, must register their use with the Institutional Biosafety Committee and complete the required forms.

F. Material Transfer Agreements (MTAs) must be in compliance with this Policy and, where applicable, be reviewed by the Institutional Biosafety Committee. Select agents are not allowed on campus and may not be transferred. The physical transfer of materials must be done in compliance with applicable laws and regulations.

5.   Suspensions

A.  The IBC shall review concerns involving the use of recombinant or synthetic nucleic acid molecules and shall suspend an activity that it previously approved if it determines that the activity is not being conducted in accord with requirements of the National Institutes of Health or other federal regulations. The IBC may suspend an activity only at a meeting of the IBC where a quorum is present.

B.  If the IBC votes to suspend an activity, the Chairperson shall notify the Dean of the CAS of such decision, and the Dean shall notify the Principal Investigator (PI), the appropriate Program Director or Department Chair, and the IRB (if human subjects are involved) or the IACUC (if live vertebrate animals are involved). In consultation with the IBC, the Dean shall review the reasons for the suspension, take appropriate corrective action, and report that action with a full explanation to the NIH Office for Biotechnology Activities in accordance with NIH policy of reporting serious adverse events.

 C. In cases where the IBC cannot be assembled in a timely fashion, the Dean of the CAS, in consultation with the IBC Chairperson, is empowered to act on the IBC’s behalf and immediately suspend any activity that is not, in the Dean’s judgment, being conducted in accord with applicable governmental and institutional regulations and policies including, without limitation, provisions of the National Institutes of Health Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (“NIH Guidelines”).

D.  A suspended activity may be reinstated only after approval by a majority of the quorum present at a meeting of the IBC.

6.   IBC Procedures

The IBC may establish practices, procedures and protocols to ensure compliance with all governmental and institutional regulations, including but not limited to the NIH Guidelines, and requirements that research protocols incorporate all IBC stipulations and requirements; that research designs contain reasonable safeguards necessary to protect research personnel, the public and the environment; and provisions for review of research at intervals appropriate to the degree of risk, including conditions under which the research should be continued or discontinued. All decisions of the IBC concerning research, and recommended practices, procedures and protocols shall be reported to the Dean of the CAS for implementation.

7.   IBC Coordination with Other Reviews

The IBC shall function independently of, but in coordination with, other institutional committees. The IBC may approve, approve with conditions/modifications, or disapprove all research activities that fall within its jurisdiction as specified by both governmental and institutional policies. Approval by the IBC, in and of itself shall not constitute approval for full implementation since a protocol may be subject to review and disapproval by other Lewis & Clark research review bodies. In turn, no institutional officials or committees may approve the conduct of research that has been disapproved by the Lewis & Clark IBC.

NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules