What should an institutional biosafety committee (ibc) include in the annual report to the nih osp?

Institutional Biosafety/recombinant DNA Committee (IBC) Charter

I. Introduction

• • The University of Texas at El Paso (UTEP) follows the National Institutes of Health (NIH) system for enhancing science through safety and ethics of recombinant or synthetic nucleic acid (rDNA) research. The responsibility of NIH oversight of rDNA research lies with the NIH Office of Science Policy (OSP). UTEP uses the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, the Institutional Biosafety Committee (IBC), and the NIH Recombinant DNA Advisory Committee (RAC) as key tools for biosafety and rDNA research oversight. The NIH Guidelines are intended to assist UTEP, the IBC, the Biological Safety Officer (BSO), and the Principal Investigators (PI) in determining the safeguards that must be implemented to conduct rDNA research. This document outlines the responsibilities and procedures that the UTEP IBC uses to implement, promote and manage safe, and ethical rDNA research at UTEP.

II. Roles and Responsibilities

• • University of Texas at El Paso  
    The University must ensure that all recombinant or synthetic nucleic acid research conducted at or sponsored by UTEP is conducted in compliance with the NIH Guidelines regardless of funding source. The University places institutional authority with the UTEP IBC to review research involving rDNA and to ensure that all research is conducted in full conformity with the provisions of the NIH Guidelines.

• • Institutional Official (IO)
    The IRO is appointed by the President of the University and is responsible for appointing members to the IBC and ensuring that the IBC conducts business as required in compliance with NIH Guidelines.

• • Institutional rDNA/Biosafety Committee (IBC)  
    The IBC is responsible for reviewing rDNA research activities and for approving those which are in conformity with the intent and specifics of the NIH Guidelines. Furthermore, the IBC is authorized by the IRO to enforce the NIH Guidelines and to ensure that investigators/staff adhere to approved protocol conditions. The IBC also reviews research protocols involving Risk Group 2 or higher microorganisms. As per the NIH Guidelines, the IBC through the IRO is responsible for reporting significant incidents, violations and research-related accidents and illnesses involving recombinant or synthetic nucleic acids to the OSP.

• • Principal Investigator/Project Director (PI/PD)  
    The Principal Investigator or Project Director (PI/PD), defined as a current UTEP faculty, is responsible for full compliance with the NIH Guidelines in the conduct of rDNA research. The PI shall submit a research protocol proposal to the IBC for review. The PI shall ensure that rDNA research activities subject to the NIH Guidelines are initiated or modified only after that research or proposed modification thereof has been reviewed and approved by the IBC. Furthermore, the PI must report to the IBC any incidents involving contamination of personnel, research-related illnesses, accidental spills, loss of containment, and violations of the NIH Guidelines.

III. Research

Research covered by this policy will fall into one of the following four categories.

1. rDNA (Recombinant or synthetic nucleic acids):
   • Molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell;
   • Molecules that replicate as a result of the above.
2. RG2 (Risk Group 2): Agents that are associated with diseases that are rarely serious and for which preventive/therapeutic interventions are often available
3. RG3 (Risk Group 3): Agents that are associated with serious/lethal human diseases for which preventive/therapeutic interventions may be available (high individual risk, but low community risk)
4. RG4 (Risk Group 4): Agents that are likely to cause serious/lethal human diseases for which preventive/therapeutic interventions are not usually available (high individual risk and high community risk)

IV. IBC Membership

• • The UTEP IBC shall be comprised of a minimum of five members so that collectively they have the experience and expertise in rDNA technology, the capability to assess the safety of rDNA research, and identify any potential risk to public health or the environment.

• • Each member of the UTEP IBC is appointed by the IRO for a term of three (3) years. Members may be reappointed by the IRO for additional terms. The IBC shall include: at least two members who are not affiliated with UTEP and who are not part of the immediate family of a person affiliated with UTEP; the University Veterinarian; a person with expertise in plant pathogens or plant pest containment principles if research with plant rDNA molecules is being reviewed; and, the University BSO.

• • Recombinant DNA Research or sponsored rDNA research involving humans will be reviewed by an ad hoc committee of consultants prior to review by the IBC.

• • To ensure continuity, the appointment of committee members shall be for staggered terms so that no more than one-half of the appointments expire each academic year. The IBC Vice-Chair shall be appointed by majority vote of the IBC for a term of three (3) years.
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  • Each year, an IBC member will be considered to receive a letter of recognition for exemplary service to the IBC by the IBC chair through the IRO.

V. IBC Policies and Procedures

• • The UTEP IBC will meet to review rDNA and biosafety protocols at least twice a year, and more frequently, if deemed necessary. The UTEP IBC meetings are open to the public and advance notice is posted on the UTEP IBC website. The rDNA and biosafety protocols must be prepared by the PI/PD on standardized IBC Protocol Submittal Form that is made available by the IBC coordinator. All protocol information must be typed and only one research project per submittal form will be accepted. Protocols are approved for a three year term.
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  • Initial Submissions, Triennial submissions, Mid-Reviews, and Procedural Modifications will be reviewed by the convened IBC committee.
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  • Closing reports will be administratively reviewed by the IBC Chair and/or BSO.
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  • Personnel Modification(s), with the exception of the PI, will be administratively reviewed and approved upon training verification by the IBC Coordinator.
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  • Submitted protocols received and deemed exempt from NIH Guidelines will be administratively reviewed and acknowledged by the IBC Chair and BSO, or their Designees, unless the research involves agents that fall into RG2 (Risk Group 2) and higher. The convened IBC committee will review these submissions, as well as the annual reports. In the event the IBC reviews the submission and requests modifications from the PI, the revised exempt protocol will be reviewed by an assigned reviewer(s) and approved if all requested modifications have been satisfactorily addressed. The assigned reviewer(s) has/have the right to bring back the revised protocol for Full Committee review at the following convened meeting.

• • Submissions (to include New Protocols, Procedural Amendments and Mid-Reviews) should be received at least 2 weeks prior to the scheduled convened meeting and Triennial submissions should be received at least 30 days prior to the expiration date.
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  • Personnel Modifications and Closing Reports can be submitted at any time during the three-year approval period.
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  • If a Closing Report is not submitted within 60 days after the approved project’s expiration date, the project will be administratively closed and the PI will be notified by the IBC office alerting them that the protocol has been closed.

• • All submissions must be through IRBNet.org and electronically signed by the PI in order to be considered for review.
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  • The BSO will inform the IBC at each meeting, as applicable, on laboratory safety inspections, laboratory construction/modification, and spills/incidents.

• • The IBC Chair-person will provide the IRO a report on the IBC's activities at least annually. The IBC will also provide an annual report to NIH which will include the IBC members and biographical sketches for each member. The points of contact regarding questions and information about the IBC, other than Texas Public Information Act (TPIA) requests, are the IBC Chair and/or IBC Coordinator. In the case of a TPIA request, the IBC Chair through the IRO will notify OSP of any public comments made on IBC activities. All information requested via TPIA request will be provided by the Vice President for Business Affairs Office and in compliance with the Texas State Attorney General Office. 
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  • The IBC requires that all individuals covered under a new research protocol attend training courses, including General Laboratory Safety and online NIH Guidelines training, triennially; as well as Biosafety/Bloodborne Pathogens, annually; and be enrolled in the UTEP Occupational Health Medicine Program, if applicable.

VI. Protocol Review Process

• • After the Principal Investigator (PI) submits a protocol, the protocol form will be administratively checked by the IBC coordinator and forwarded to the IBC Chair and the BSO for an administrative screening.

• • Protocols will be reviewed and voted on at scheduled meetings of the IBC, if a quorum is present. A quorum for IBC meetings is defined as a majority of the voting members including at least one non-affiliated member of the committee. The IBC can, by majority vote, approve a protocol as is; approve a protocol conditionally; or table a protocol for modifications and further review. If a PI fails to address any concern by the IBC or fails to provide additional information requested by the IBC after 60 days from the request, then the IBC can take administrative action.

• • The IBC promotes compliance with the University policy regarding Conflicts of Interest ( http://admin.utep.edu/Default.aspx?tabid=50599 ). IBC member(s) that serve as a Principal Investigator of a protocol that is being reviewed or has a personal or financial interest, must recuse themselves from the vote. This action will be recorded in the meeting minutes. Any protocols involving animals or human subjects will be shared between the IACUC and the IRB, and concurrent approvals will be required. All approved protocols will be active for three year terms and subject to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (see http://osp.od.nih.gov/sites/default/files/NIH_Guidelines.html). The Principal Investigator will be notified of the IBC's decision via email with a formal memo for all protocols.  

• The PI must immediately report any incidents involving contamination of personnel, research- related illnesses, accidental spills, loss of containment, and violations of the NIH Guidelines to the UTEP IBC Chair (915-747-6607) and BSO (915-747-7179) immediately and must reference the incident in the annual update. The IBC Chair and/or Vice-Chair in consultation with the BSO is responsible for reporting significant incidents, violations and research - related accidents and illnesses involving recombinant DNA to the IRO and the OSP within thirty (30) days or immediately depending on the nature of the incident.

VII. Failure to Comply

PI's are expected to comply with the IBC standards outlined in this Charter. Noncompliance includes, but is not limited to:

1. Failure to register biohazardous agents, including non-exempt recombinant DNA molecules;
2. Failure to provide the required mid-report and/or other required documentation within 60 days of the specified due date; 
3. Poor biological safety/biological containment practices as documented through routine lab inspections; or 
4. Failure to correct a documented (confirmed) biological safety complaint or concern.

Noncompliance will be reported to the IBC which may result in suspension or termination of all approved registrations. The PI's Department Head, Dean, EH&S, and ORSP grant administrators/VPR will be notified of the noncompliance.

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