- Biological and Biochemical Research and Teaching Laboratory Practice
- IBC Composition and Function
- Roles and Responsibilities
- Review Procedures
- IBC Coordination with Other Committees
- Incident Reporting
Carleton College is responsible for ensuring that all research involving recombinant or synthetic nucleic acid molecules conducted at or sponsored by Carleton is in compliance with federal regulations. The National Science Foundation (NSF) requires (as stated in Article Subject 38 of the NSF’s “Grant General Conditions” effective January 25, 2016) that NSF grantees who are conducting research that falls within the scope of the National Institute of Health’s “Guidelines for Research Involving Recombinant DNA or Synthetic Nucleic Acid Molecules” [as amended in April 2019 and hereafter referred to as the “Guidelines”] shall comply with those Guidelines. The Guidelines specify practices for constructing and handling recombinant DNA molecules and organisms and viruses containing recombinant DNA molecules. (See Addendum I: Definitions.)
1. Biological and Biochemical Research and Teaching Laboratory Practice at Carleton
As a primarily undergraduate educational institution, students are active participants in biological and biochemical research at Carleton. In addition, biological teaching laboratories often involve students in authentic research projects. Because our students arrive with little or no prior experience in handling recombinant DNA (rDNA) and biological agents and organisms, no research or laboratory experiments will be performed at Carleton with biological agents in biosafety risk groups (BRG) 3 or 4. Furthermore, the facilities at Carleton do not support research (or laboratory projects) at biosafety levels 3 or 4. Only work at biosafety level 1 will be allowed in teaching laboratories at Carleton. Faculty mentored research at biosafety level 2 is acceptable, upon approval by the IBC. There will be no research performed at Carleton that involves human gene transfer or gene transfer into animals other than rodents. Finally, no work at Carleton will involve large-scale (greater than 10 liters of culture media) research. Therefore, Carleton is not required to, nor does it appoint, a Biosafety Officer (BSO).
2. IBC Composition and Function
The Carleton Institutional Biosafety Committee (IBC) shall oversee research and teaching laboratory projects involving recombinant and synthetic nucleic acid molecules – as defined below and in the NIH Guidelines – performed at Carleton, in order to protect the health and safety of students, employees, and the public. The IBC will review each proposed project to ensure that the procedures, project, personnel, and facilities are adequate and comply with the NIH Guidelines. Members who serve on the IBC play a vital role in ensuring that research and laboratory work at the college are in compliance with federal regulations. Thus, service on this committee counts towards service requirements for promotion and tenure. Community members receive a modest annual stipend for their participation on the IBC.
- Consist of no fewer than five members, with terms of three years, selected because they collectively have experience and expertise in recombinant DNA technology and the capability to assess the safety of recombinant DNA activities (see also Addendum II: Recommended IBC Membership);
- Include (among the five or more members) at least two members who are not affiliated with the College (apart from their membership on the committee), and who shall represent community interests with respect to health and protection of the environment;
- Be appointed by the Associate Provost;
- Serve three-year terms, which can be renewed;
- Consult with the Provost to gather recommendations for replacements when a committee member completes a term or resigns from the committee;
- Meet at least twice per year and additionally as needed;
- Review and approve all recombinant DNA research experiments as specified in Guidelines Section III, or determine whether experiments are exempt (Guidelines Section III-F) and notify the Principal Investigator of the results of review;
- Keep minutes of activities and make them available to the public upon request;
- Receive administrative support from the Administrative Assistant to the Associate Dean and the Sponsored Research Grants and Compliance Specialist; and
- Report any significant problems with or violations of the Guidelines and any significant research-related accidents or illnesses to the Provost and to the NIH Office of Science Policy (OSP) [by email NIHGuidelines@od.nih.gov] within 30 days of identification of non-compliance, unless the IBC determines that a report has already been filed by the Principal Investigator. (Guidelines Section IV-B-2-b-(7))
3. Roles and Responsibilities
NIH Guidelines Section IV specifies the roles and responsibilities of principal investigators (PIs), biological safety officers (BSOs) as applicable, and recipient institutions with respect to the safe conduct and oversight of recombinant or synthetic nucleic acid research. Investigators, laboratory staff, BSOs, and institutional officials must read and be aware of their duties and expected biosafety practices, as described by the NIH Guidelines.
- Establish and implement policies that provide for the safe conduct of research with recombinant or synthetic nucleic acid molecules, compliant with the Guidelines;
- Establish and maintain an Institutional Biosafety Committee (IBC)
- Ensure adequate expertise and training for the IBC Chair and members, Principal Investigator/s involved in approved DNA research activities, and laboratory staff (see Guidelines Section IV-B-1-h);
- Inform Principal Investigators of their responsibilities outlined in the Guidelines Section IV-B-7;
- File an annual report with the Office of Biotechnology Activities (OBA) that names Carleton’s IBC Chair and contact person; and includes a roster of members that offers, for each member, a biographical statement that Includes at least his/her professional occupation and qualifications or other background relevant to his/her capabilities to review recombinant DNA research;
- Establish procedures that the IBC will follow with regard to review and approval of applications and compliance with federal regulations, such as setting and modifying containment levels as warranted, and implementing contingency plans for handling accidental spills and personnel contamination resulting research involving recombinant or synthetic nucleic acid molecules;
- Report any significant problems, violations of the Guidelines, or any significant research-related accidents or illnesses to NIH Office of Science Policy (OSP) within 30 days (or immediately as required), unless Carleton determines that a report has already been filed by the PI or the IBC (Guidelines Section IV-B-1-j).
Principal Investigator (PI) responsibilities
- A PI at Carleton working with rDNA – that, is, conducting research involving recombinant or synthetic nucleic acid molecules, infectious agents, and/or transfer vectors – must complete a registration form even if s/he believes that the project might be exempt. Completing the registration form will help ensure that any PI will be prepared to answer questions that may arise in an audit by the NIH, NSF, or other parties.
- Note: Participation in research at other institutions by Carleton faculty or research staff is expected to be approved by that institution’s IBC.
- For experiments that are determined to be exempt (Guidelines Section III-F), the Chair of IBC will require the PI to notify the committee of any changes on an annual basis.
- For work that is determined to be non-exempt (such as experiments as specified in Guidelines Section III), the PI will
- Comply with the NIH Guidelines in the conduct of rDNA research, as outlined in Guidelines Section IV-B-7 and with conditions approved by the IBC;
- Complete and document training;
- Report any subsequent changes (e.g., changes in the source of DNA or host-vector system) to the IBC for review;
- Renew their previous IBC registrations every three years;
- Obtain approval of the IBC before initiation of the new activities or modifications when required;
- Report immediately to Carleton’s IBC any significant problems pertaining to the operation and implementation of containment practices and procedures, violations of NIH Guidelines, or any significant research-related accidents or illnesses: report serious adverse events (SAEs) [the PI or Carleton must notify Office of Biotechnology Activities (OBA) within 30 days] according to Guidelines Section IV-B-7-a-(3).
4. Review Procedures
Principal Investigators (PIs) will use a google form to administer an exemption self-assessment. The chair of the IBC will inform the IBC at its next regularly scheduled meeting of the projects that are deemed exempt by this self-assessment. PIs who self-declare exemptions that seem questionable to the IBC will be required to submit a regular IBC application. PIs must audit exempt procedures using the self-assessment every three years and when procedures are modified.
IBC Application Process
PIs will submit applications before the beginning of each term, for IBC consideration. The IBC will meet to review applications at the beginning of each term, if needed. The IBC requests that PIs attend IBC meetings at which their applications are being discussed, in order for the committee to ask questions and learn more specifics about the project, as needed. After this exchange, the PI will be excused from the meeting and the IBC will deliberate and make a decision. The IBC Chair will notify the PI when approval by the IBC has been granted, informing the PI of registration number and protocol expiration date.
Approved applications will be available to all IBC members in the IBC Dropbox folder. In addition, the general public may submit a request to the IBC chair to view them, with confidential information redacted. A spreadsheet of approved IBC research experiments will be maintained indefinitely. This approval will be valid for up to three years. After three years, a new application must be submitted to the IBC. In addition, PIs must submit modifications to existing approved procedures on an annual basis (see below).
Conflict of Interest
PI applicants who are also IBC members will be excused from the IBC meeting before the deliberations and decision by the remaining IBC members.
The IBC can issue conditional approval, which requires the PI to provide additional information to complete an application. The chair of the IBC will verify that the conditions have been met before issuing an approval on behalf of the IBC.
Minor Modification of Existing Approved Procedures
PIs must submit annual modifications to existing approved procedures using the registration amendment form. These modifications may include: changes to personnel or changes to vectors used within the same family.
5. IBC Coordination with Other Committees
The IBC shall function independently of, but in coordination with other institutional committees such as (but not limited to) the Human Subjects Research Committee (also known as the Institutional Review Board, or “IRB”) or Institutional Animal Care and Use Committee (IACUC). The IBC may approve, approve with conditions/modifications, or disapprove all research activities that fall within its jurisdiction as specified by both governmental and institutional policies. Approval by the IBC in and of itself shall not constitute approval for full project implementation, since a protocol may be subject to review and disapproval by other Carleton research review bodies. In turn, no institutional officials or committees may approve the conduct of research that has been disapproved by the Carleton IBC.
i. Any research involving human subjects and recombinant or synthetic nucleic acid molecules shall be reviewed and approved by both the IBC and the Human Subjects Research Committee (also known as Carleton’s Institutional Review Board, or “IRB”). This includes any research in which a Carleton investigator is a collaborator, including work conducted outside of Carleton.
ii. Any research involving live vertebrate animals and recombinant or synthetic nucleic acid molecules shall be reviewed and approved by both the IBC and the Institutional Animal Care and Use Committee (IACUC). This includes any research in which a Carleton investigator is a collaborator, including work conducted outside of Carleton.
6. Incident Reporting
Reporting any lab incidents in a timely manner is a critical part of the research process, and it’s required by both the National Institutes of Health guidelines and Carleton College policies. Incident reports help to protect the health and safety of researchers, lab staff, university employees and the general public, and are key to assessing the biggest essential training and resource needs of the university.
What to report
According to the NIH, you must report “any significant problems pertaining to the operation and implementation of containment practices and procedures, violations of the NIH Guidelines or any significant research related accidents and illnesses to the IBC, NIH OBA, and, as applicable, the Biological Safety Officer, Greenhouse or Animal Facility Director or other appropriate authorities.”
Types of incidents include, but are not limited to:
- Spill or accident involving rDNA or potentially hazardous material
- Personal injury such as a needle stick or eye splash
- Overt personnel exposure such as inhalation
- Illness such as a lab-acquired salmonella infection
- Breach of containment or failure to follow approved containment conditions
- Escape or improper disposition of a transgenic animal
Addendum I: Definitions
(from Guidelines Section I-B)
In the context of this policy and the NIH Guidelines, recombinant and synthetic nucleic acid molecules are defined as:
- Molecules that a) are constructed by joining nucleic acid molecules and b) that can replicate in a living cell, i.e., recombinant nucleic acids; or
- 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 (1) or (2) above.
Addendum II: Recommended IBC Membership
As stated in “In order to ensure the competence necessary to review and approve recombinant or synthetic nucleic acid molecule activities, it is recommended that the Institutional Biosafety Committee:
- Include persons with expertise in recombinant or synthetic nucleic acid molecule technology, biological safety, and physical containment;
- Include or have available as consultants persons knowledgeable in institutional commitments and policies, applicable law, standards of professional conduct and practice, community attitudes, and the environment; and
- Include at least one member representing the laboratory technical staff.”
Addendum III: Links
- Carleton’s IBC Registration Form
- Carleton’s rDNA Registration Amendment Form
- Carleton’s form for self-assessment of exempt experiments
- Carleton’s training through CITI
- NIH Policy on Research Involving Recombinant or Synthetic Nucleic Acid Molecules
- NIH Biosafety page/Institutional Biosafety Committees [with link to Institutional Biosafety Committee Registration Management System (IBC-RMS)]
- Useful links and regulations page