Institutional Biosafety Committee Charter

INTRODUCTION

The University of Charleston, South Carolina, a component of the College of Charleston (Institution) recognizes the Institution’s responsibility to protect the health and safety of the Institution community, the community at large, and the environment from risks inherent in the conduct of research and teaching. This policy establishes the Institutional Biosafety Committee (IBC) to ensure that all such research, teaching activities, and research facilities comply with applicable federal, state and local regulations, institutional policies, and the highest standards of ethics and practice.  (See Biosafety Policy, Official Divisional Policy, Academic Affairs Division and Division of Business Affairs; Approved February, 2017)

The Institutional Biosafety Committee is a College-wide committee charged with formulating policy and procedures and reviewing and approving projects related to the use of biohazardous agents including human pathogens, oncogenic viruses, other infectious agents, and recombinant and synthetic nucleic acid (r/sNA) molecules. The IBC is responsible for review and approval of projects involving r/sNA molecules and biohazardous materials. The committee sets containment levels in accordance with National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC) guidelines, and adopts emergency plans covering accidental spills and personnel contamination.

CHARGE TO THE IBC

The IBC shall work with the Institution’s research community to ensure that work conducted at, or under the auspices of, the institution involving biohazardous agents and r/sNA molecules, including transgenic plant and animal work and human gene transfer research, is carried out in accordance with the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines, latest edition).

The IBC shall also meet any oversight obligations that arise from research that is reviewed by other established Institution committees and offices including but not limited to, Human Participants and Animal Care and Use.

ROLES AND RESPONSIBILITIES

Institutional Biosafety Committee

  1. Meet at least two (2) times per year to conduct the business of the Committee.
  2. Establish and regularly review IBC policies and procedures.
  3. Assure review for r/sNA research conducted at or sponsored by the institution to determine compliance with the NIH Guidelines, and approve those research projects that are found to conform to the NIH Guidelines. Periodically review r/s NA research conducted at the institution to ensure continued compliance with the NIH Guidelines.
  4. Review, make requests for modifications if required, and approve, when appropriate, research involving infectious agents to humans, animals or plants, as well as research using human-derived biological materials, select agents, and toxins.
  5. Ensure Principal Investigator, students, and support staff have appropriate training for handling biohazardous agents detailed in the project
  6. Investigate potential violations of the NIH Guidelines.
  7. Take appropriate action, including suspending research, in situations that present a risk of harm to life or health and in cases of serious, repeated or continued non-compliance with federal, state and local laws and regulations, and Institution policies and guidelines, regardless of the source of funding for the project.
  8. Open IBC meetings to the public when possible and consistent with protection of privacy and proprietary interests, and make meeting minutes available to the public upon request.
  9. Perform annual review of the IBC’s compliance with the NIH Guidelines and submit review findings to the Institutional Official.

IBC Chair

  1. Ensure that Principal Investigators are aware of the responsibility to register research involving biohazardous agents and r/sNA molecules with the IBC.
  2. Ensure that faculty teaching laboratory courses are aware of the responsibility to register laboratory exercises involving biohazardous agents and r/sNA molecules with the IBC.
  3. Review or designate an IBC member to review exempt study registration forms.
  4. Direct and prioritize IBC activities and serve as the chair for all meetings.
  5. Ensure appropriate training for the Institutional Biosafety Committee members, in consultation with EH&S and Research Protections & Compliance Manager (RCPM)
  6. Report any significant problems with or violations of the NIH Guidelines to the IO, the PI’s Department Chair/Dean and EH&S immediately. Report must be made to NIH/Office of Biotechnology Activities (OBA) within 30 days (or immediately in the case of accidents resulting in overt exposure which occurred in Biosafety Level (BL) 2 laboratories).
  7. Assess the resources necessary for the IBC to fulfill all of its responsibilities as articulated in the NIH Guidelines, taking into account not only the protocol submission and review process, but also training and surveillance responsibilities. Make recommendations to the IO when additional resources are required to fulfill IBC responsibilities and to ensure safe research, laboratory teaching, and compliance.
  8. If public comments are made on IBC actions, forward both the public comments and the IBC’s response to the NIH Office of Biotechnology Activities.

IBC Vice Chair

  1. Serve as the chair for meetings in the absence of the chair.
  2. Perform all duties of the Chair in event that the Chair is unable to continue to serve for the current academic year.
  3. Consult with the Chair on questions and conflicts as needed.
  4. Perform such duties as assigned by the Chair.

Institutional Official (IO)

  1. The Provost or designee shall serve as the IO.
  2. Ensure the IBC has established and implemented policies that provide for the safe conduct of all activities involving biohazardous agents and r/sNA molecules in compliance with federal, state and local regulations, guidelines and applicable institutional policies.
  3. Ensure that the reporting of significant problems, violations of the NIH Guidelines, or significant research-related accidents and illnesses is accomplished in accordance with NIH/OBA requirements.
  4. Conduct an annual assessment of the resources necessary for the IBC to fulfill all of its responsibilities; plan and adjust budget appropriately.

The Principal Investigator (PI) is responsible for full compliance with approved research protocols, the institution's biosafety policies and procedures, NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid, the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogen Standard (human-derived materials) and other local, state and federal regulations that apply to research. Specific activities include but are not limited to:

  1. Make an initial determination of the risk and required levels of physical and biological containment in consultation with EH&S, and submit appropriate form(s) for IBC review.
  2. Update IBC approved projects with the IBC and/or EHS as required, and provide current listings of personnel involved in IBC-approved projects.
  3. Ensure that laboratory staff and students are appropriately trained including precautionary measures and practices.
  4. Supervise the safety performance of the laboratory staff and students to ensure that the required safety practices and techniques are employed.
  5. Immediately report any significant problems with or violations of the NIH Guidelines and any research-related accidents or illnesses to the IBC Chair, the PI’s Department Chair/Dean and EH&S. The IBC Chair will report to the NIH/Office of Biotechnology Activities (OBA) within 30 days (or immediately in the case of accidents resulting in overt exposure which occurred in Biosafety Level (BL) 2 laboratories).

Office of Environmental Health and Safety (EHS) is the operational arm of the IBC. It oversees the daily implementation of the Biosafety Program. Specific activities include, but are not limited to:

  1. Pre-review applications submitted for IBC review to ensure compliance with applicable environmental health and safety standards, biosafety regulations and guidelines, and institutional policies.
  2. Provide to the IBC regulatory expertise and technical advice on laboratory security/biosecurity, research safety practices and procedures, biosafety administrative controls and compliance requirements.
  3. Develop and review the biological safety manual and other related documents.
  4. Develop and administer infectious waste disposal policies and procedures to comply with state regulations.
  5. Develop and administer emergency response to accidental biohazard spills and personnel contamination.
  6. Ensure, as applicable, enrollment in the Occupational Health Program in place at the Institution.
  7. Provide and document instruction and training on safe work practices to researchers, staff and students, as applicable.
  8. Conduct routine inspections of work areas and maintain records of laboratory inspection results
  9. Review construction design for safety features.
  10. Review animal research and human research protocols involving biohazardous materials.
  11. Investigate r/sNA laboratory accidents and report to the IBC Chairperson any significant problems or violations, and any significant research-related injuries or illnesses associated with r/sNA research.

Office of Research and Grants Administration, Research Protection and Compliance (ORGA RP&C) is responsible for administering the Institution’s compliance programs in the areas of human subjects (Institutional Review Board), the care and use of animals in research (Institutional Animal Care and Use Committee) and the Institutional Biosafety Committee.  Specific IBC activities include, but are not limited to:

  1. Provide regulatory expertise and administrative support for the IBC
  2. Assist the IBC Chair with general oversight of IBC operations to promote compliance, including ensuring adequate training of IBC members.
  3. Serve as a permanent ex-officio non-voting member of the IBC.
  4. Coordinate posting of policies, guidance documents, public notification of convened IBC meetings, and other resources on the IBC.
  5. Schedule IBC meetings, post protocols for review, and prepare meeting agendas and minutes.
  6. Facilitate protocol review and approval process, including protocol modifications.
  7. Notify Principal Investigators of the results of IBC review.
  8. Submit annual report to NIH/OBA (e.g. updated roster and biographical sketches)
  9. Maintain records of approved protocols, meeting minutes, and membership rosters in accordance with Federal standards.
  10. Upon request, make the following information available to the public:  a) IBC meeting minutes after review by Legal Affairs to protect privacy and intellectual property,
    b) documents submitted to or received from funding agencies which are required to be available to the public, c) rosters and biographical sketches of IBC members that have been submitted to NIH.
  11. Facilitate communication between the IBC and the Institutional Animal Care and Use Committee (IACUC) and the Institutional Review Board for the Protection of Human Research Participants (IRB) as needed.
IBC MEMBERSHIP

IBC voting members shall be appointed by the President upon recommendation of the Assistant Vice President for Research (following consultation with the IBC Chair, IO, RP&C, EH&S and others such as academic department chairpersons, when appropriate) to serve renewable three year terms. Alternate members may also be appointed.

Voting membership (including the Chair) shall consist of no fewer than five (5) members (roster faculty and other members) with collective experience and expertise in biohazardous agents, r/sNA technology, biological safety and containment principles, with ability to identify any potential risk to public health or the environment, and must include at least:

  • two members not affiliated with the institution to represent the interest of the surrounding community with respect to health and protection of the environment,
  • one full-time roster faculty member with expertise in r/sNA,
  • one faculty member with expertise in plant, plant pathogen or plant pest containment principles,
  • one faculty member with expertise in animal containment principles,
  • one member representing laboratory technical staff.

Ex officio non-voting members shall include a representative from ORGA RP&C and a representative from EHS Office.

Non-member consultants may be utilized for advice and information in specialized areas as needed. These consultants may be Institution faculty or staff, or may be unaffiliated with the Institution. Consultants may present their assessments in writing or in person, during Committee meetings.

The Chair of the IBC shall be a full time roster faculty member and shall be elected at the first IBC meeting of the academic year by a simple majority of a quorum of the voting members of the IBC.

IBC MEETINGS

The IBC shall meet at least two (2) times per year. Meetings dates shall be posted on the IBC website. Meetings may be held face-to-face or via teleconferencing or videoconferencing, and shall be open to the public, except when proprietary or privacy issues will be discussed. E-mail may only be used to circulate materials.

A simple majority shall constitute a quorum. A quorum is required for the conduct of IBC business. To constitute a quorum, at least one community member must be present. 

No IBC member may be involved (except to provide information requested by the Institutional Biosafety Committee) in the review or approval of a project in which he/she has been or expects to be engaged or has a direct financial interest.

The IBC shall elect a Chair and Vice Chair at the first meeting of the Academic Year.  The officers shall serve for one year renewable terms.

Meetings shall be conducted in accordance with modified Robert’s Rules of Order.         

IBC MINUTES AND RECORDS

Minutes of every convened meeting should contain the date and place of the meeting, whether minutes of the prior meeting were approved, a list of those members present, whether and why the meeting was open or closed, all major motions, major points of order, and whether motions were approved, and the time of meeting adjournment. The minutes should reflect the committee’s rationale for its decisions, documenting that the IBC has fulfilled its review and oversight responsibilities.

Meetings of the previous meeting of the IBC shall be reviewed at the convened meeting and either approved as presented, approved as corrected, or approved as amended. Minutes of the meetings shall be made available to the public upon request following review by Legal Affairs to assure that no proprietary or private information is disclosed.

All minutes and other IBC records and correspondence shall be maintained in the RP&C Offic

RP&C and a representative from the Institution’s Office of Legal Affairs will respond to requests for copies of meeting minutes received from persons not associated with the University. Legal Affairs will respond to requests after redacting minutes as necessary.

Comments received from the public regarding the IBC’s actions will be referred to the IO and the IBC Chair. The IO, in consultation with the Office of Legal Affairs is responsible for review and approval of the IBC’s response to public comments.

APPEALS

A Principal Investigator may appeal the decision of the IBC by submitting a request to the IO with a copy to the IBC Chair and RP&C. The IO in consultation with the IBC Chair shall consider re-review of the protocol by the IBC or deem that the original decision of the IBC shall stand. If the IBC finds upon re-review that approval of the protocol is not warranted, the decision shall be final.

Approved by the IBC:  October 18, 2017