The Office of Research and Graduate Studies (ORGS) and the Institutional Official (IO), designated and charged by the Provost, have established the IBC. ORGS and the IO have charged the IBC with the responsibility and authority to regulate Covered Work. The IBC will base its decisions and actions related to Covered Work on applicable regulations and guidance documents, the Southern Methodist University Biological Safety Manual, and other documents describing best laboratory practices. The IBC will report to the IO regarding regulatory matters related to the Covered Work.

Covered Work

1. Work involving biological agents, including but not limited to, those agents in all risk groups defined in Biosafety in Microbiological and Biomedical Laboratories (BMBL).
2. Recombinant or Synthetic DNA (r/sDNA) as defined by the NIH Guidelines for Research Involving Recombinant or Synthetic DNA Molecules (NIH Guidelines).
3. Dual use research of concern as defined by the National Science Advisory Board for Biosecurity [NSABB, Department of Health and Human Services (DHHS)].
4. Select agents and select agent toxins (SAT), regulated either by DHHS or by the United States Department of Agriculture (USDA).
5. Human blood, human blood components, products made from human blood, and Other Potentially Infectious Materials, as defined by the OSHA Bloodborne Pathogens Standard (29 CFR 1910.1030).

IBC Members

The IBC Chair recruits and nominates IBC members. IBC members are formally appointed by the Chair in writing for a renewable term of three years. Terms of appointment are staggered in a manner such that one third of the committee is appointed each year.

The IBC membership shall be consistent with the NIH Guidelines:

• The committee shall consist of no fewer than five full members.
• Two members shall be representatives from the community and shall not be associated with the University, except in their roles as IBC members.
• Specialists in plants, animals, human gene transfer, and infectious diseases may be represented on the committee, either as full members or as ad hoc (i.e., advisory) members. Ad hoc members will serve only in an advisory role and will not be allowed to vote.
• The Director of Environmental Health and Safety is designated as a voting member.
• The Director of Research Compliance is designated as an ex officio (i.e., non-voting) member at committee meetings and in an advisory role.

IBC Chair

The IO appoints the IBC Chair for a renewable term of three years.

Principal Investigator (PI) / Project Director (PD)

PIs / PDs are responsible for full compliance with the NIH Guidelines, the BMBL, and IBC directives when using biohazardous materials. They will:

• Instruct, train, and supervise research Personnel in laboratory practices and techniques required to ensure safety, procedures for dealing with spills or potential exposures to the agents described in the research, aseptic technique, characteristics of the material(s) used, and signs and symptoms of laboratory acquired infections in Personnel.
• Develop specific biosafety standard operating procedures for biohazards used in the laboratory and maintain a copy in the laboratory. All research Personnel shall review these documents and their review shall be documented in writing.
• Inform the research Personnel of the Occupational Health Program and provisions for any precautionary medical practices advised or required (e.g., vaccinations or serum collection).
• Ensure compliance by laboratory Personnel with relevant regulations, guidelines, and policies.
• Obtain IBC approval prior to initiating or modifying any research involving use of biohazards and maintain that approval through timely submission of annual reviews.
• Immediately report any significant problems or any research-related accidents and/or illnesses to EHS and the IBC.
• Comply with federal and international permitting and shipping requirements for recombinant or synthetic nucleic acid molecules and transgenic or biohazardous materials.
• Maintain documentation of all safety-related training for research Personnel and records of vaccinations or declinations (if required).

Research Personnel

Research Personnel that work in a laboratory have a responsibility to:

• Participate in appropriate training and instruction to ensure that they are adequately trained and fully understand instructions. This includes taking the Biological Safety Training offered by Environmental Health and Safety (EHS) on a yearly basis.
• Fully comprehend all biological agents and select agents and toxins being used in the laboratory and the potential risks associated with exposure, as well as fully understand the associated emergency response procedures.
• Follow all laboratory practices and Protocols and comply with all applicable policies, procedures, and guidelines.
• Complete any necessary medical surveillance.
• Report all thefts, security incidents, accidents, spills, or contamination incidents to supervisor.

Researchers initiate the application process by filling out and submitting the IBC Registration Application to Research Compliance. This application is located on the Research Compliance website. Upon receipt, Research Compliance will assign a Protocol Number and forward to the Director of Research Compliance. The Director of Research Compliance will perform a preliminary review for completeness, request any needed information, and make a recommendation to the Chair regarding an appropriate type of review.

Application Form

Depending on the severity of hazards involved in the proposed research, the IBC Chair will determine which of the following two types of review will be necessary.

Expedited Review

This type of review will be used for low-hazard research. Examples of this research include, but are not limited to:

• Work involving only Risk Group 1 biological agents
• Recombinant DNA work that would be considered exempt from registration according to the NIH Guidelines
• Recombinant DNA work that would be considered “Experiments that Require IBC Notice Simultaneous with Initiation” according to NIH Guidelines

These Protocols will can be reviewed via “Designated Member Review,” meaning the IBC Chair can designate a single member to review the Protocol. Alternatively, these Protocols can be distributed to the full committee for review via email. The reviewing member(s) will read the application, request more information as needed, make any comments, and vote for one of the possible outcomes. If any member feels that more thorough discussion is necessary, the application will be subject to Full Committee review.

Full Committee Review

This type of review will be used for higher-hazard research. Examples of this research include, but are not limited to:

• Work involving Risk Group 2 and above biological agents
• Recombinant DNA work that would be considered “Experiments that Require IBC Approval Before Initiation” according to NIH Guidelines
• Work with human blood or other potentially infectious materials according to the OSHA Bloodborne Pathogen standard.

These Protocols will be distributed to the full committee via email. An IBC meeting may be convened and all members will discuss the proposed research. Members may request more information if needed. Upon conclusion of the discussion, members will vote for one of the possible outcomes.

Upon completion of review of proposed research, IBC members will vote for one of the following outcomes:

Approved

The proposed research is approved as submitted for a term of three years from approval date. A letter will be generated, notifying the Researcher of the outcome. Research may begin upon notification of approval.

Approved Pending Modification / Training Completion

IBC members may request modifications to the proposed research plan. A letter will be generated, notifying the Researcher of the requested modifications. The Researcher must make the requested changes and resubmit the application to Research Compliance. The modified application will proceed through the review process as described above.

Denied

The proposed research cannot be conducted due to the level of risk involved. A letter will be generated, notifying the Researcher of the outcome. If this happens, the IBC will work with the Researcher to find a way to conduct research if possible.

All changes to the approved Protocol must be reported to the IBC. The method of reporting depends on the nature of the change. The following changes require the submission of a NEW APPLICATION FORM:

• New PI / PD
• New biohazardous material
• New technique or procedure
• New work location

The following changes require the submission of a YEARLY UPDATE FORM:

• Minor Personnel changes
• Recent training completions

Closing Out a Research Protocol

It is the responsibility of the PI / PD to inform the IBC once all research activities related to an approved Protocol are completed. To do this, the PI / PD will complete and submit a Yearly Update Form, indicating that all research activity has ended.

Yearly Updates

An IBC Protocol is approved for a period of three years. For the first two years of the research, on the anniversary of the original approval, the PI / PD must complete and submit a Yearly Update Form. This form documents any study and Personnel changes over the past year. A full roster of study Personnel must be listed on the form. The update form will be reviewed by the process detailed above.

Yearly Update Form

Renewal

Upon the third anniversary of the original approval of an IBC Protocol (after two Yearly Progress Reports), an entirely new application must be submitted for review. Researchers will follow the procedures used for initial application submission. The application will be reviewed by the process detailed above.

The post approval monitoring (PAM) program is designed to monitor ongoing research activities approved by the IBC, with the goals of improving research methodology through direct observation of approved procedures and providing timely feedback to the research team. Post-Approval Monitoring will coincide with annual Laboratory Safety Surveys. During the survey, the Protocol will be reviewed and research activities will be observed. Any potential issues will be openly shared with the PI / PD or laboratory representative and the IBC, and a corrective action plan for addressing any deficiencies will be developed.

Non-compliance occurs when biohazardous research is conducted in a manner that disregards or violates federal, state, or local regulations or SMU policies. Once the IBC becomes aware of potential Research Misconduct, they are required to investigate the matter. Once the investigation is complete, one of three outcomes will be determined: No Non-Compliance Found, Non-Compliance Issues Found, or Serious Non-Compliance Issues Found. Depending on the severity of the issues, the IBC may take the following actions:

• Corrective plan with timeframe
• Oversight and monitoring activities
• Suspension or termination of research
• Notification of NIH and Funding agency

Appeals to decisions made by the IBC on project applications may be made in writing and submitted to the committee Chair within 30 days of the decision notification. The appeal should include the investigator’s position and any new, relevant information. If the IBC Chair believes that the new information warrants an appeal, the full IBC will hear the appeal at the next meeting. The IBC’s determination of the appeal is final. However, if the appeal is denied, the Researcher may submit a revised Protocol for consideration.

All research Personnel listed on an IBC Protocol must complete the EHS-provided Biological Safety Training on a yearly basis, as well as Laboratory-Specific Training when they begin work in the lab. In addition, some Personnel will be required to complete Laboratory Safety Training. More details about the required training can be found here.

If a research project involves work with human materials, all research Personnel listed on the Protocol must participate in the Bloodborne Pathogens Program. Human materials can include human blood, human blood products, human cell lines, non-humamn primate materials, and other potentially infectious materials. More details about the Bloodborne Pathogens Program can be found here.

All records associated with the IBC, including applications, meeting minutes, and letters, will be kept for a period of 3 years after the Protocol has been officially closed.

It is the responsibility of the PI / PD to inform the IBC of his or her intention to leave SMU and close out a research Protocol. To do this, the PI / PD will complete and submit a Yearly Update Form, indicating that all research activity has ended.

• National Institutes of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
• Centers for Disease Control and Prevention’s (CDC) Biosafety in Microbiological and Biomedical Laboratories (BMBL)
• SMU Biological Safety Program
• Biosafety in the Laboratory: Prudent Practices for Handling and Disposal of Infectious Materials
• Texas Commission on Environmental Quality (TCEQ) and Texas Department of State Health Services (TXDSHS) Regulations
• Occupational Safety and Health Administration’s (OSHA) Bloodborne Pathogens Standard (29 CFR 1910.1030)
• National Science Advisory Board for Biosecurity’s (NSABB) Reports and Recommendations
• Department of Health and Human Services (DHHS) and United States Department of Agriculture (USDA) Select Agent Regulations