Research Involving Recombinant DNA Molecules
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.
INSTITUTIONAL BIOSAFETY COMMITTEE
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
PROCEDURES FOR REVIEW OF RESEARCH
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.
APPEALS OF IBC Actions
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.