UNC Asheville Institutional Biosafety Committee

Charter

Purpose:

The Institutional Biosafety Committee (IBC) is charged with assessing the safety of recombinant DNA research and to identify any potential risk to public health or the environment. Further, the committee will assure the safe acquisition, use and disposal of all biohazardous materials at the University. The IBC, in conjunction with the Biological Safety Program Manager, regulates biological materials used in research, teaching and service operations at the University.

UNC Asheville acknowledges its responsibility to provide a program for the handling, storage and disposal of biohazardous materials, to provide emergency response for incidents involving biohazardous materials, and to educate the UNC Asheville community about the safe use of biohazardous materials in research, teaching, and service activities.

Duties:

1. Ensuring UNC Asheville compliance with:
a. All federal, state and local regulations;
b. Procedures and principles relating to the prevention and/or control of infectious diseases, including strict adherence to the most recent version of the CDC/NIH publication Biosafety in Microbiological and Biomedical Laboratories (BMBL); and,
c. The procurement, storage, use and disposal of biohazardous materials used in UNCA research teaching, and service facilities.

2. Certifying investigators and instructors, their laboratories and/or their practices for work are conducted at appropriate biological safety levels.

3. Overseeing the development and maintenance of written biohazard safety/infectious disease control plans that minimize exposures for all affected personnel using proper engineering controls and work practices; to make the plan available to the institutional community; and to recommend updates to the plan, as necessary. Additionally, overseeing the development and implementation of educational programs related to infectious diseases and biohazard safety.

4. Following the National Institutes of Health (NIH) protocol notification, procedure for individuals exposed to recombinant DNA, synthetic nucleic acids, or regulated pathogens.

5. Identifying tasks that carry the risk for transmission and the occupational groups involved.

6. Reviewing instances of potentially infectious disease outbreaks related to research, teaching and service activities that the committee oversees.

7. Recommending to the UNC Asheville Environmental Health and Safety Committee (EHSC) policies and procedures to protect the health and safety of all faculty, staff, students, and visitors at UNC Asheville.

Membership:

Five (5) voting members, approved by the Provost in consultation with FWDC. Faculty members serve staggered three-year terms which may be renewed, while the community representatives serve one-year terms which may be renewed.

Voting Members
1. At least two faculty members who have expertise in proper handling of biohazardous materials;
2. One faculty member at large (appointed by FWDC); and
3. Two members unaffiliated with the university and the research facility to provide representation for the general community (Community Representatives).

Associate Members
Two faculty members who have the expertise in proper handling of biohazardous materials who can participate as voting members in the event of a conflict of interest declared by Voting Members.

Non-voting Members
1. Representative from the Environmental Health and Safety Office, ex officio.
2. Liaison from Academic Affairs, ex officio and non-voting, as needed, to facilitate the work of the IBC, ex officio.

Procedures:

The administrative functions of the IBC will be handled by the EH&S Professional at UNCA. The following research conducted at or sponsored by UNCA will be registered with the EH&S Professional:

  • All recombinant or synthetic nucleic acid molecular work.
  • Work involving the use of microorganisms pathogenic to humans, plants, or animals.
  • Any work with Biological Select Agents and Toxins (BSAT), including research with botulinum toxins at any quantity.
  • Work involving human materials, such as tissue, blood, or cell cultures.

Recombinant or synthetic nucleic acid molecule research will be reviewed as follows:

  • Experiments that require NIH and IBC approval prior to initiation (Sections III-A and III-B).
    • The EH&S Professional in conjunction with the IBC Chair will review the registration and determine if it requires NIH and IBC approval before initiation. A registration packet will be submitted to the NIH OSP and the IBC. The IBC will review and approve or disapprove all registrations in this category at a convened meeting.
  • Experiments that require IBC and IRB approval prior to research participant enrollment (Section III-C).
    • The EH&S Professional in conjunction with the IBC Chair and the IRB will coordinate to review the registration and determine if it requires IBC approval prior to initiation. The IBC will approve or disapprove the registration at a convened meeting.
  • Experiments that require IBC approval before initiation (Section III-D).
    • The EH&S Professional in conjunction with the IBC Chair will review the registration and determine if it requires IBC approval before initiation. The IBC will review and approve or disapprove all registrations in this category at a convened meeting.
  • Experiments that require IBC notice simultaneous with initiation (Section III-E).
    • The EH&S Professional in conjunction with the IBC Chair will review the registration and determine if it requires notification of the IBC and will inform the PI that the registration has been reviewed and the containment level that is required. The EH&S Professional will submit the registration at the next IBC meeting for review and comment. The IBC may change the conditions of the approval at any time it deems necessary to ensure UNCA compliance. 
  • Experiments that are exempt from the NIH Guidelines (Section III-F).
    • The EH&S Professional in conjunction with the IBC Chair will review the registration and determine if it is exempt and will inform the PI that the registration has been reviewed and the containment level that should be used. The IBC will not vote on exempt experiments.

Work involving the use of microorganisms pathogenic to humans, plants, or animals as well as BSAT will be reviewed as follows: 

  • Risk Group 2
    • The EH&S Professional will review registrations involving non-recombinant Risk Group (RG) 2 pathogens and notify the PI of the containment level required.
  • Risk Group 3 & Risk Group 4
    • Research with RG 3 and RG 4 pathogens are currently not permitted at UNCA. 
  • Biological select agents and toxins (BSAT)
    • The IBC will review and approve or disapprove all registrations of BSAT (as defined by 42 CFR Part 73, 7 CFR Part 331, and 9 CFR Part 121) at a convened meeting. Research involving botulinum toxins at quantities considered exempt from BSAT regulation must still be registered with the IBC.

Work involving human materials, such as tissue, blood, or cell cultures, will be reviewed by the EH&S Professional who will notify the PI of the containment level required.

Meetings:

Meetings will be held at the call of the IBC Chair. When possible and consistent with the protection of privacy and proprietary interests, IBC meetings will be open to the public (NIH Guidelines, Section IV-B-2-a-6). 

Quorum and Voting:

A minimum of three voting members must be present at IBC meetings in order to conduct business.  If the quorum does not include at least one member who is not affiliated with UNCA, the chairperson may defer action on items in order to permit their consideration with community input.  Only protocols receiving approval from the majority of votes of members in attendance will be approved by the IBC. 

IBC Minutes:

Minutes will be reviewed by the chairperson and then released to all committee members for review. The minutes will be voted on by the IBC at the next convened meeting before being considered final.

At a minimum, NIH-advised minutes should reflect the date and place of the meeting, whether minutes of the prior meeting were approved, individuals in attendance, whether and why the meeting was open or closed, all major motions, major points of order, and whether motions were approved. In general, the minutes should offer sufficient detail to serve as a record of major points of discussion and the committee’s rationale for particular decisions, documenting that the IBC has fulfilled its review and oversight responsibilities as outlined under Section IV-B-2-b of the NIH Guidelines. Minutes do not need to be transcripts or kept at a level of detail that attributes each remark to a specific individual. 

Confidentiality:

Upon request, UNCA shall make IBC meeting minutes available to the public (NIH Guidelines, Section IV-B-2-a-7). If public comments are made on IBC actions, the BSO will forward both the public comments and the IBC’s response to OSP. 

It is expected that IBC members will not disclose the details of meetings or associated submissions with individuals not affiliated with the IBC. Such disclosures could compromise Principal Investigators’ research goals and proprietary interests as well as the willingness of members to conduct open discussions. Members contacted for information should forward requests to the EH&S Professional, who will consult with the Office of University Counsel and the Office of Media Relations as appropriate.

Conflict of Interest:

IBC members must disclose to the Committee any potential, actual, or perceived conflict of interest of a financial, professional, or personal nature that may affect any aspect of the research, and compliance with applicable UNCA, state and federal requirements regarding conflict of interest. The individual who has disclosed a conflict will be recused from voting on the specific matter but may provide information requested by the IBC. A notation will be made in the meeting minutes indicating that a recusal occurred. An IBC member’s declaration of a conflict of interest will be initiated through the EH&S Professional at the time of project submission to enable the activation of Associate Member(s) on the day of IBC project review in order to ensure a Committee quorum.  A PI that is not an IBC member is permitted to attend the IBC meeting at which his or her submission will be discussed in order to provide information to the committee.

Annual Review and Changes to Charter:

This charter will be reviewed annually by the IBC. It may be modified or amended by approval of a majority of voting members of the IBC.

Committee Member

Committee Role

Position, Department

Ryan Steed

Chair. Scientific and Lab Specialist

UNCA Glaxo Wellcome Dist. Professor, Chemistry

Amanda Wolfe

Scientific and Lab Specialist

UNCA Professor, Chemistry

Robert Berls

Faculty Member at Large

UNCA Professor, Drama

Ricky L. Hesson

Community Representative

Asheville Fire Department

John Finn

Community Representative

Resolute Therapeutics

Kevin Gibson

EH&S (Non-Voting)

UNCA EH&S Professional, Office of the Deans

Marietta Cameron

Liaison from Academic Affairs (Non-Voting)

Dean of Natural Sciences, Office of the Deans

PUBLIC NOTIFICATION
INSTITUTIONAL BIOSAFETY COMMITTEE

The University of North Carolina Asheville receives research funding from the National Institutes of Health (NIH). As a condition for NIH funding of recombinant DNA research, institutions shall ensure that such research conducted at or sponsored by the institution, irrespective of the source of funding, shall comply with the NIH Guidelines (Section I-D., Compliance with the NIH Guidelines). The NIH system of oversight for recombinant DNA research described in the NIH Guidelines is based on expectations of transparency and public access to information about recombinant DNA research activities.

Meetings will be held at the call of the IBC Chair. When possible and consistent with the protection of privacy and proprietary interests, IBC meetings will be open to the public (NIH Guidelines, Section IV-B-2-a-6).

UNC Asheville IBC Meeting 

Date: TBD

Time: TDB

Zoom Link: TBD

Contact Us: psteed@unca.edu