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Institutional Biosafety Committee (IBC) - Policies and Procedures for Research Involving Recombinant DNA or Infectious Agents

University of Maine
Office of the Vice President for Research
443 Corbett Hall
Orono, ME 04469-5717
581-1498

Approved: 03/04/1994
Amended:  01/04/2007

Contents

I. Preamble

II. Responsibilities of the University of Maine

III.   The Institutional Biosafety Committee (IBC)

A. Responsibilities and Authority of the IBC

B. Membership of the IBC

IV. Responsibilities of the Principal Investigator (PI)

A. General Responsibilities of the PI

B. Responsibilities of the PI to the IBC

C. Responsibilities of the PI Prior to Initiating Research

D. Responsibilities of the PI During the Conduct of the Research

V. Responsibilities of the Department Chair or Unit Director

VI. Responsibilities of the Biosafety Officer

VII. Responsibilities of the Authorized Institutional Official

VIII. Appendix: Department of Health and Human Services, National Institutes of Health, Guidelines for Research Involving Recombinant DNA Molecules (PDF) April 2002 and amendments thereafter.

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 (PDF), 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 (PDF), April 2002.

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The University of Maine
Orono, Maine 04469
207.581.1110
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