I. Preamble
The University of Maine
acknowledges and accepts responsibility for ensuring that research using
recombinant DNA or infectious agents is carried out in a safe and responsible
manner.
Appended to and made a part of this
Policy is the Department of Health and Human Services, National Institutes of
Health, Guidelines
for Research Involving Recombinant DNA Molecules, April 2002 and amendments thereafter.
For the purpose of this Policy, the University of Maine has defined "infectious
agents" as all bacterial, parasitic, fungal, viral, rickettsial, and
chlamydial agents included within Class 2 or higher classes. (See Appendix B of Federal Regulations.)
II. Responsibilities
of the University
of Maine
A. Establish, implement, and maintain
policies that provide for the safe conduct of research involving recombinant
DNA or infectious agents, and that ensure compliance with federal
guidelines. The University may also establish
whatever additional precautionary steps it deems appropriate.
B. Maintain an Institutional Biosafety
Committee (IBC) that meets the requirements set forth in Section III of this
Policy.
C. Appoint a Biosafety Officer (BSO) who
shall be a member of the IBC and carry out the duties specified in Section VI
of this Policy.
D. Appoint an Authorized Institutional
Official (AIO) who shall carry out the duties specified in Section VII of this
Policy.
E. Ensure that investigators responsible for
research covered by this Policy comply with the provisions of Section IV of
this Policy and assist them in doing so.
F. Ensure appropriate training for the IBC
Chair and members, the BSO, Principal Investigators (PI), and laboratory staff
regarding this Policy, its implementation, and laboratory safety. Responsibility for training IBC members is
carried out through the IBC Chair.
Responsibility for training laboratory staff is carried out through the
PI. The University of Maine
is responsible for seeing that the PI has sufficient training.
III. The
Institutional Biosafety Committee (IBC)
A. Responsibilities and Authority of the IBC:
1. Review
and approve, require modifications in, or withhold approval of new research
protocols involving the use of recombinant DNA or infectious agents (or
significant changes in previously approved protocols).
This
review shall include:
a. Assessing
independently, the containment levels required by federal guidelines for the
proposed research.
b. Judging whether the Principal
Investigator has sufficient training to provide for the safe conduct of the
proposed research.
c. Assessing the adequacy of facilities,
procedures, and practices.
d. Notifying the Principal Investigator of
the results of their review.
Protocols receiving IBC approval may be
subject to further administrative review by the AIO or by another officer of
the University appointed to that purpose by the President. This review may result in limitations and restrictions
on the use of recombinant DNA or infectious agents beyond that required by the
IBC. In extreme cases, the use of
recombinant DNA or infectious agents may be denied. Under no circumstances can the administration
approve a project not approved by the IBC or ease any restrictions imposed by
the IBC.
2. Review
annually research approved by or reported to the Committee involving the use of
recombinant DNA and approved projects involving infectious agents, and report
to the AIO any instances in which the requirements of this Policy are not being
fulfilled.
3. Determine, in connection with each
project, the necessity for a health surveillance program for research
personnel, and notify the AIO if such a health surveillance program is needed.
4. Adopt emergency plans covering accidental
spills and/or personnel contamination resulting from research with recombinant
DNA or infectious agents.
5. Report at once to the AIO suspensions
of research activity, significant problems with or violations of this Policy,
and any significant research-related accidents or illnesses.
6. Review suspensions of research activity
ordered by the BSO and determine whether the activity shall:
a. proceed without changes; or
b. proceed only with changes; or
c. terminate.
7. Perform
additional functions as may be assigned to the IBC.
B. Membership of the IBC:
1. The
IBC shall recommend to the AIO, and the President of the University shall
appoint, members of the IBC to three-year terms. Members may be reappointed to further
terms. The President may also appoint
alternates when desirable. Such
alternates shall have the same voting privileges as the member for whom they
substitute.
2. The President shall appoint one member
of the IBC to serve as Chair for a term of two years. The Chair shall normally be a member of the
University’s tenured faculty who engages in research with recombinant DNA or
infectious agents and who has substantial experience in the review of research
with recombinant DNA or infectious agents.
At the beginning of the Chair's second year of service, the President
shall appoint a Chair-Elect to succeed the current Chair. The Chair-Elect's role is to provide a
back-up to the Chair and to become familiar with the responsibilities of the
Chair. The Chair-Elect shall perform the
duties of the Chair in the absence or incapacity of the Chair, and shall serve
as Chair during the remainder of the term should the position of Chair become
vacant.
3. The IBC shall comprise no fewer than
five members, so selected that they collectively have sufficient experience,
expertise, and technical capability to assess the safety of research
experiments involving the use of recombinant DNA or infectious agents and any
potential risk to public health or the environment. The IBC shall include:
a. At least
two members who are not affiliated with the University (apart from their
membership on the IBC) and shall represent the interest of the surrounding
community with respect to health and protection of the environment. Members meet this requirement if, for
example, they are officials of State or local public health or environmental
protection agencies, members of other local governmental bodies, or persons
active in medical, occupational health, or environmental concerns in the
community.
b. The
BSO of the University.
c. Persons with expertise in the
technology, biological safety, and physical containment of recombinant DNA or
infectious agents, in order to ensure the competence necessary to review
research activities involving recombinant DNA or infectious agents.
An individual who meets the requirements
of more than one of these categories may fulfill more than one
requirement. However, the IBC may not
consist of fewer than five members.
In addition, the AIO, to whom this
committee reports, shall be available as a consultant in matters concerning
institutional commitments and policies, applicable law, standards of
professional conduct and practice, community attitudes, and the environment.
4. No
member of an IBC may be involved (except to provide information requested by
the IBC) in the review or approval of a project in which he or she has been or
expects to be engaged or has a direct financial interest.
IV. Responsibilities of the Principal
Investigator
On
behalf of the University
of Maine, the Principal
Investigator (PI) is responsible for complying fully with this Policy in
conducting any research using recombinant DNA or infectious agents.
A. General Responsibilities of the PI:
1. a)
Initiate or modify no research involving infectious agents until that research
or the proposed modification has been approved by the IBC and all other
requirements of this Policy have been met; b) initiate or modify no research
involving recombinant DNA that requires reporting to the IBC until that research
or the proposed modification has been reported to the IBC and all other
requirements of this Policy have been met; or c) initiate or modify no research
involving recombinant DNA that requires approval by the IBC until that research
or the proposed modification has been approved by the IBC and all other
requirements of this Policy have been met.
2. Determine whether experiments involving
recombinant DNA are covered by Section III-C of the Federal Regulations and
follow the appropriate procedures.
3. Report to the BSO and the IBC Chair
immediately all significant problems with and violations of this Policy and all
significant research-related accidents and illnesses.
4. Report to the IBC new information
bearing on this Policy.
5. Be adequately trained in good
microbiological techniques and lab safety.
6. Adhere to IBC-approved emergency plans
for dealing with accidental spills and personnel contamination.
7. Comply with shipping requirements for
recombinant DNA molecules. (See Appendix
H of the Federal Regulations for shipping requirements.)
B. Responsibilities
of the PI to the IBC:
1. Make
the initial determination of the required levels of physical and biological
containment in accordance with this Policy.
2. Select appropriate microbiological
practices and laboratory techniques to be used in the research.
3. Submit the initial research protocol
and also subsequent changes (e.g., changes in the source of DNA or host-vector
system) to the IBC for review and approval or disapproval.
4. Remain in communication with the IBC
throughout the conduct of the project.
C. Responsibilities
of the PI Prior to Initiating Research:
1. Be
adequately trained in good microbiological techniques and laboratory safety to
provide for the safe conduct of the proposed research.
2. Make available to the laboratory staff
copies of the protocols that describe the potential biohazards and the
precautions to be taken.
3. Instruct and train staff in the
practices and techniques required to ensure safety and in the procedures for
dealing with accidents.
4. Inform the staff of the reasons and
provisions for any precautionary medical practices advised or requested, such
as vaccinations or serum collection.
D. Responsibilities of the PI During the Conduct of the
Research:
1. Supervise
the safety performance of the staff to ensure that the required safety
practices and techniques are employed.
2. Investigate and report in writing to
the IBC any significant problems pertaining to the operation and implementation
of containment practices and procedures.
3. Correct work errors and conditions that
may result in the release of recombinant DNA or infectious agents.
4. Ensure the integrity of the physical
containment (e.g., biological safety cabinets) and the biological containment (e.g.,
purity and genotypic and phenotypic characteristics).
V. Responsibilities of the Department Chair
or Unit Director
The chair of any department or
director of any unit in which research using recombinant DNA or infectious
agents is conducted shall be familiar with this policy and shall exercise the
following responsibilities:
A. Assures compliance with the University's
policies and procedures for the use of recombinant DNA or infectious agents.
B. Assures proper management of the
laboratory facilities and allows only those research projects to be conducted
for which the facilities are adequate and safe.
C. Assures
proper supervision of research personnel.
D. Nominates, at the request of the AIO
(from among members of the department or unit), representatives to serve on the
IBC.
VI. Responsibilities of the Biosafety Officer
(BSO)
A. Ensures
through periodic inspections that laboratory standards are rigorously followed.
B. Suspends any research activity if
he/she determines that the activity is not being conducted in a safe and
responsible manner.
C. Reports to the IBC Chair and the AIO all
significant problems with and violations of this Policy and all significant
research-related accidents and illnesses of which the BSO becomes aware.
D. Develops emergency plans for dealing
with accidental spills and personnel contamination and investigating research
laboratory accidents involving recombinant DNA or infectious agents.
E. Provides technical advice on laboratory
security and safety.
VII. Responsibilities of the Authorized
Institutional Official (AIO)
A. Provides
administrative oversight and serves as the institutional representative
responsible for reporting to the National Institutes of Health and other cognizant
federal agencies.
B. Reports within 30 days to the National
Institutes of Health Office of Recombinant DNA any significant problems with
and violations of the Federal Regulations and significant research-related
accidents and illnesses.
C. Takes appropriate, corrective action to
remedy reported safety problems or Policy violations and reports that action to
the IBC.
D. Forwards the names of individuals to be
appointed to the IBC by the President.
In addition, the AIO forwards the name of one member to be appointed by
the President to serve as Chair for a term of two years. At the beginning of the Chair's second year
of service, the AIO forwards the name of one member to be appointed by the
President as Chair-Elect to succeed the current chair.
E. Maintains
files of the IBC.
F. Makes available to the public, upon
request, all minutes of IBC meetings and any documents submitted to or received
from funding agencies which the latter are required to make available to the
public. If comments are made by members
of the public on IBC actions, the University shall forward to NIH both the
comments and the IBC's response.
VIII. Appendix:
Department of Health and Human Services, National Institutes of Health, Guidelines
for Research Involving Recombinant DNA Molecules, April 2002.
