Research Involving Recombinant DNA Molecules
Formerly Executive Memorandum 94-107
Initially approved August 15, 1994
Revised: March 9, 2020
Administering Office: Office of Research Administration
I. POLICY STATEMENT
WCU faculty, staff, or students involved in Recombinant or Synthetic DNA (r/s DNA)
molecules research are required to follow established guidelines issued by the National
Institute of Health (NIH). The Guidelines for Research Involving Recombinant or Synthetic
DNA Molecules (NIH Guidelines) are published in the Federal Register and are available
at the NIH Office for Science Policy website (osp.od.nih.gov).
Biosafety Levels (BLs): BLs are categories for biocontainment precautions, based on levels of hazard, not
to be confused with Risk Groups.
- BL1 work involving minimal or no known hazard to laboratory personnel and the environment.
- BL2 work involving agents of moderate potential hazard to personnel and the environment,
requiring a type II biosafety cabinet for containment.
- BL3 work involving indigenous or exotic agents which may cause serious or potentially
lethal disease as a result of exposure by inhalation.
- BL4 work involving viruses that cause severe to fatal disease in humans, that are
easily transmissible by aerosols or contact entry, and for which vaccines or other
treatments are not available
Recombinant and Synthetic Nucleic Acid Molecules:
- Molecules that a) are constructed by joining nucleic molecules and b) that can replicate
in a living cell, i.e., recombinant nucleic acids;
- 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
- Molecules that result from the replication of those described in (i) or (ii) above.
Risk Groups (RGs): NIH categorizes experiments which involve r/s DNA into four RGs on the basis of
hazard, according to their relative pathogenicity for healthy adult humans.
- RG1 agents are not associated with disease in healthy adult humans
- RG2 agents are associated with human disease which is rarely serious and for which
preventive or therapeutic interventions are often available
- RG3 agents are associated with serious or lethal human disease for which preventative
or therapeutic interventions may be available
- RG4 agents are likely to cause serious or lethal human disease for which preventive
or therapeutic interventions are not usually available
III. ROLES AND RESPONSIBILITIES
- Institutional Biosafety Committee (IBC): The IBC is responsible for reviewing and recommending policies and procedures with
the goal of ensuring safe use of r/s DNA in research and compliance with guidelines
established by the NIH and Centers for Disease Control (CDC). The IBC is responsible
for the review, approval, and oversight of activities with r/s DNA conducted at or
sponsored by the University, regardless of source of funding.
The IBC shall consist of faculty, staff and community members with experience and
expertise in r/s DNA technology and biosafety and physical containment. The composition
of the membership of the IBC shall meet all membership requirements in the NIH guidelines.
A chairperson will be appointed by the Chief Research Officer of the Office of Research
Administration. Committee members are appointed for a term of three years and may
be reappointed to additional three year terms without limitation. The WCU Laboratory
Safety Officer and Research Compliance Officer are permanent members of the IBC.
- Office of Research Administration (ORA) and the Research Compliance Officer (RCO): The ORA and RCO provide administrative support to the IBC, maintain appropriate
records, and receive all Request for Review Forms for research involving r/s DNA.
- Office of Safety and Risk Management and Safety Officer: The Office of Safety and Risk Management registers all pathogens and labs, and maintains
a biological inventory of all pathogens on campus. All biohazardous agents used in
research and teaching laboratories on campus must be registered with this office.
The role of the Safety Officer is to assure the use of biohazardous agents conform
to university policy and applicable government regulation, to conduct periodic inspection
of biological laboratories, and provide biosafety training. The Safety Officer provides
an annual report to the IBC of agents on campus.
- Principal Investigator (PI): The PI is responsible for full compliance with NIH Guidelines in the conduct of
r/s DNA research and must register all pathogens and labs with the Safety Office.
The PI shall conduct the initial risk assessment required by NIH Guidelines § 11-A-3.
The PI shall complete and submit a Request to Review research protocol Form, and shall
ensure that r/s DNA research activities subject to the NIH Guidelines are initiated
or modified only after that research or proposed modification has been reviewed and
approved by the IBC. The PI is responsible for training laboratory staff and students
in the practices and techniques required to maintain safety and in the procedures
for handling accidents.
IV. PROTOCOL REVIEW AND APPEAL
- Review of New Protocol
The PI must conduct the initial risk assessment based on the RG of an agent, and shall
submit a protocol application to the Research Compliance Officer (RCO) in the Office
of Research Administration. Research requiring biosafety level 3 or 4 containment
is prohibited at WCU as there are no suitable facilities. The RCO will convene the
IBC to conduct review of new applications and protocol modifications at least biannually,
at which quorum is required. 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.
IBC review of new protocol applications will include:
- independent assessment of the containment levels required by the NIH Guidelines for
the proposed research;
- assessment of the facilities, procedures, practices, and training and expertise of
personnel involved in r/s DNA research;
- implementing appropriate measures with the goal of ensuring compliance with all surveillance,
data reporting, and adverse event reporting requirements set forth in the NIH Guidelines;
- implementing appropriate measures with the goal of ensuring that the research does
not involve human subjects in gene transfer trials as the IBC will not approve this
research at this time.
The NIH Guidelines require that the IBC perform continuing review of all ongoing activities
with r/s DNA approved by the IBC. It is the PI’s responsibility to initiate the request
for continuation, which must include a summary of the protocol and a status report
on the progress to date. The continuing review of activities with recombinant DNA
will be conducted in the same manner as the initial review of the protocol.
B. Appeal of IBC Determination
The IBC does not have to approve any protocol. The PI will be notified in the event
a protocol is not approved by the IBC. Upon notification, the PI may modify and resubmit
the protocol. All notifications will be handled by the Office of Research Administration.
The IBC may terminate or suspend research determined not compliant with NIH guidelines
and WCU IBC requirements. The PI may appeal an IBC determination of suspension, disapproval,
or termination by sending a letter to the Chief Research Officer (CRO) in the Office
of Research Administration. The CRO shall request to convene the IBC for a hearing.
The hearing will allow relevant discussion, documentation, and witnesses on behalf
of the investigator. The IBC will vote to sustain or change its original recommendation.
Should the IBC determine that either unethical behavior or research misconduct occurred,
the Chairperson will initiate action as outlined in WCU Policy 56, Ethics in Research.
V. POLICY REVIEW
This policy shall be reviewed and revised as necessary every two (2) years.
VI. RELATED POLICIES AND RESOURCES
Request for Review Form
Request for Modification or Continuing Review
NIH Citation Table