Formerly Executive Memorandum 94-107
Initially approved August 15, 1994
Administering Office: Research and Graduate Studies
WCU faculty, staff, or students involved in Recombinant DNA (r-DNA) molecules research are required to follow established guidelines issued by the National Institutes of Health (NIH). The Guidelines for Research Involving Recombinant DNA Molecules have been published in the Federal Register (May 7, 1986, plus recent amendments). Copies of the documents can be obtained from the Office of Research and Graduate Studies.
The Guidelines define recombinant DNA molecules as either (1) molecules which are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell or (2) DNA molecules that result from the replication of those described in (1).
All research at WCU that involves r-DNA must be registered with and approved by the Institutional Biosafety Committee (IBC) as reviewed in accordance with the section entitled "Procedures for Review of Research" which follows. Where differences between the NIH Guidelines and this policy exist, WCU's policy will be the controlling guide.
NIH categorizes experiments which involve r-DNA into four classes (1 to 4). Currently, WCU's Laboratory Safety Manual states, "There are no facilities on campus for work with dangerous class 3 or 4 viruses so work involving these agents is prohibited." Any faculty anticipating use of either class 3 or 4 agents should contact both the Associate Dean of Research and Graduate Studies and WCU's Safety Officer to discuss such experiments well in advance of research initiation.
Upon the recommendation of the Vice Chancellor for Academic Affairs, the Chancellor will appoint and provide training for an Institutional Biosafety Committee (IBC) that ensures that r-DNA research is carried out in full conformity with the NIH Guidelines. Membership on the IBC will be constituted as outlined by the Guidelines and the IBC shall report directly to the Vice Chancellor for Academic Affairs. The IBC has the authority to recommend policy and procedure changes related to this research activity.
A chairperson will be selected by the VCAA. Committee members are appointed for a term of three years and may be reappointed to additional three-year terms without limitation.
Principal investigators (PI) of any on-campus research or proposals for off-campus r-DNA research funding must submit a Memorandum of Understanding and Agreement (MUA) to the Chairperson of the IBC prior to initiation of the study. Copies of these forms can be obtained from the Office of Research and Graduate Studies. The MUA should be sent to Chairperson, IBC, in care of Associate Dean of the Graduate School. Upon receipt of the MUA the Chairperson shall send copies to all committee members and convene an IBC meeting. A quorum, a majority of the committee members, must be present and the final recommendation made by the majority of the quorum.
No member of the IBC may participate in the review of an application in which the committee member has a conflicting interest, except to provide information if requested. Specialists may be invited to meetings to assist in review of issues beyond or in addition to the expertise available to the IBC.
For approved multi-year projects, the PI will be required to submit an annual update as requested by the IBC.
The IBC has the authority not to approve a research proposal (MUA) and to suspend or terminate research that is not being conducted in accordance with IBC requirements. Any proposal (MUA) not approved by the IBC shall be returned to the PI with reasons for disapproval. The PI may either modify the MUA and resubmit it in accordance with IBC comments or appeal the decision. Any suspension or termination of approved research shall include a statement of the reasons and be reported promptly to the investigator, appropriate institutional officials, and the funding agency.
The PI may appeal a decision that leads to disapproval of an MUA or a suspension or termination of research by sending a letter requesting a meeting of the IBC to the VCAA within ten (10) working days of the receipt of the decision. The VCAA shall request that the Chairperson reconvene the IBC in a timely fashion to consider any additional information from the PI. The hearing will allow relevant discussion, documentation, and witnesses on behalf of the investigator. Based upon the information presented, the IBC may vote to sustain or change its original recommendation.
Should the IBC determine that either unethical behavior or misconduct in research has occurred, the Chairperson will initiate action as outlined in WCU's Policy on Ethics in Research.