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Institutional Biosafety Committee (IBC)

Institutional Biosafety Committee (IBC)

Overview and Purpose of the CWRU IBC

The Case Western Reserve University IBC is charged with the responsibility for the oversight and approval of research activities involving recombinant DNA (rDNA) and synthetic nucleic acid molecules that take place at CWRU, MetroHealth Medical Center, Louis Stokes Veteran's Administration, and University Hospitals Cleveland Medical Center.

Examples of rDNA/synthetic nucleic acid molecule research include, but are not limited to:

  • the production of transgenic species (animals, insects, plants); animals include rodents, fish, frogs, and worms;
  • gene therapy or vaccination studies where the structure of the virus is genetically manipulated in humans or animals;
  • making genetic copies by using animals or human pathogens; or
  • use of rDNA, synthetic techniques, pathogenic or other infectious agents and recombinant viral vectors.

CWRU receives funding from NIH grants, and all recombinant DNA and synthetic nucleic acid molecule research conducted at the aforementioned institutions must comply with the NIH Guidelines (Guidelines) (updated, effective April 27, 2016; revised April 2016) and the CWRU IBC Procedures for Use of Recombinant or Synthetic Nucleic Acid Molecules. To learn more about the NIH Guidelines, please visit the Office of Biotechnology Activities website.

Protocols must be entered into the IRIS system. Users who need to be set up in the system may contact our IBC Coordinator at case-ibc@case.edu or 216.368.0838. If you send an email request for access, make sure to include the person's full name, department/division and preferred email address.

 

IBC Administration and Meeting Schedule

  • The CWRU IBC committee meets once-a-month on the second Thursday of each month at 3 pm. The meeting location varies. Meetings are open to the public.  Click here to see the IBC 2016-2017 Meeting Schedule.
  • All new research, requests for continuing review, and significant protocol modifications are reviewed by the full committee. Updates/amendments are required for key changes to research plan prior to initiation of  changes.
  • The deadline for submissions is one (1) month prior to the meeting date. Click here to see the IBC 2016-2017 Meeting Schedule.
  • Submission and review of projects, including continuing reviews and updates/amendments, is done electronically through the iRIS system.

 

IBC Contacts

Questions or feedback for the IBC? Contact any of the following individuals:

Colleen Karlo  - IBC Assistant Director

jck2@case.edu
216.368.0838

Kim Volarcik  - Executive Director, Research Compliance

kav6@case.edu
216.368.0134

CWRU IBC

case-ibc@case.edu

 

 

Principal Investigator's Responsibilities

Principal Investigators are Responsible for the Following:

  1. Determine whether or not activities under his/her direction involve rDNA, pathogenic or other infectious agents, viral vectors, or vaccine studies where the structure of the virus is genetically manipulated.
  2. Register the experiment(s) with and obtain approval from the CWRU IBC prior to initiation of proposed experiment(s).
  3. Comply with federal, state, local, and institutional guidelines for safe handling of biohazardous materials; appropriate safeguards against environmental release should remain in place during the condition of the proposed experiments.
  4. Educate and inform personnel of the risk potential and provide them with adequate training to minimize their exposure.

Initial Submission:

  • If approval is required before initiation of the research, then research shall not proceed until email notification of approval is received. Allow up to four (4) weeks for approval if your protocol is received by the registration due date for the next committee meeting.
  • After the registration is reviewed you will be notified of the approval status or any changes to the proposed research protocol the committee requests. If you have any questions or concerns about the status of your registration or changes requested by the committee, contact the IBC Assistant Director at case-ibc@case.edu.

Approved Protocol:

Once a protocol is approved, an approval letter is sent to the faculty principal investigator. The letter lists the study's CWRU IBC Protocol number and title, the Biosafety Level and Risk Group set by the IBC, date of approval, and the date by which a continuing review is required for continuation of the study, and any additional requirements.

During the Conduct of Experiment(s) Outlined in the Approved CWRU IBC Protocol:

  • If at any time during the approved research period you propose to change the containment level for the research, you must notify the IBC immediately for the committee's review and approval of the change or modification before it is implemented.
  • Investigators shall report any significant problems, violations of the Guidelines, or any significant research related accidents and illnesses to the Institutional Biosafety Committee, Biological Safety Officer (where applicable), Greenhouse/Animal Facility Director (where applicable) within 14 working days of discovery of the problem, violation or accident, and to NIH/OSP, and other appropriate authorities (if applicable) within 30 days of discovery of the problem, violation, or accident.

Continuing Review Requirements:

  • For all human studies regardless of the Biosafety level or projects conducted at BL-3 committee approvals are valid for only one (1) year.
  • For projects conducted at BL-1 and BL-2, committee approvals are valid for three (3) years from the date of approval.
  • Before the expiration date of each approval period, a continuing review application must be submitted to the CWRU IBC using the continuing review request form in the iRIS system.

 

Research Projects Requiring IBC Registration

  • Cloning of DNA encoding molecules toxic to vertebrates within LD50 < 100ng/kg body weight.
  • Cloning of total DNA from all Class 2, 3, or 4 human or animal pathogens (including HIV and related viruses, and human tumor viruses).
  • Experiments using as vectors more than two-thirds of the genome of infectious animal or plant viruses or defective recombinant viruses grown in the presence of a helper virus.
  • Experiments using as vectors more than two-thirds of the genome of infectious animal or plant viruses or defective recombinant viruses grown in the presence of a helper virus.
  • Cloning using human or animal pathogens as host-vector systems.
  • All experiments that may generate transgenic animals requiring BL-1 containment.
  • This includes rodents constructed, purchased or transferred, or plants which may extend the host-range of human, or animal pathogen that require BL-2 or greater containment.
  • All human gene transfer experiments.
  • Experiments involving whole plants.
  • Experiments using as vectors less than two-thirds of the genome of defective animal or plant viruses, free of helper virus.
  • Cloning of DNA for more than one-half of the genome of Class 1 or Class 2 human or animal pathogens, or cloning of known oncogenes.
  • All experiments that make use of constructed, purchased, or transferred transgenic rodents at BL-1 containment.

 

Creation of Transgenic Mice through the CASE Transgenic and Targeting Facility

Orders for the creation of BL-1 transgenic mice do not require a separate IBC protocol. Please go to http://ko.case.edu to place your order.

Questions about transgenic orders can be submitted to the CWRU IBC mailbox at case-ibc@case.edu

 

Procedures to Obtain a Letter of Exemption

Please refer to the Procedures to Obtain a Letter of Exemption for examples of projects that are exempt from the Guidelines.  The CWRU IBC reviews project to determine exempt status.  If a project is determined to be exempt, the CWRU IBC will issue a notification letter for the determination of exempt status.

Please contact the CWRU IBC to obtain a request for exemption application and further assistance at case-ibc@case.edu

Human Studies

  • All research using recombinant or synthetic DNA, a vaccine (when the structure of the virus has been genetically manipulated), or other materials derived from rDNA must comply with the NIH Guidelines (Guidelines) (updated, effective April 27,2016; revised April 2016).
  • This research also requires review and approval by the CWRU Institutional Biosafety Committee.
  • Additionally, this research requires review and approval by one of the following biomedical Institutional Review Boards (MetroHealth Medical Center IRB, Louis Stokes Veterans Administration IRB, and University Hospitals Cleveland Medical Center IRB), which is dependent upon where this study will take place.
  • All significant adverse events that occur during the course of a human clinical study registered with the IBC must be reported to the IBC. Study-related serious adverse events (SAEs) occurring within clinical research projects involving the introduction of recombinant or synthetic nucleic acid molecules into humans must be reported to NIH/OSP and the IBC within 15 calendar days of sponsor notification and within 7 calendar days if fatal or life threatening. Other SAEs should be reported to NIH/OSP and the IBC as part of the principal investigator’s annual report.
  • Protocols must be entered into the IRIS system. Users who need to be set up in the system may contact our IBC Coordinator at case-ibc@case.edu or 216.368.0838. If you send an email request for access, make sure to include the person's full name, department/division and preferred email address.

 

PI Training

Investigators and laboratory staff must maintain current safety training through their institutional Environmental Health and Safety Departments (EHS).  Investigators in laboratory space at CWRU can access information about training requirements at dates at the CWRU EHS website.

Click here to access the NIH Training brochure on Investigator Responsibilities under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.

 

Quality Improvement and Post-Approval Monitoring

Investigators and research staff conducting research approved by the CWRU IBC are responsible for ensuring compliance with federal regulations, policies and procedures, as well as local institutional policies.  In order to assist researchers and facilitate compliance with CWRU IBC approval and stipulations for the conduct of IBC-regulated research, the CWRU Research Compliance Office has established a process for post approval monitoring and review.  This process will involve research compliance monitoring of CWRU IBC and investigator research records.

The program and process provides monitoring and review of a research study to:

  • Ensure proper conduct, records and reports are performed as stated in the IBC-approved protocol;
  • Review of standard operating procedures, good laboratory practices, and regulatory requirements;
  • Comparison of the implementation of the IBC research protocol by the investigator to the specifics of the CWRU IBC-approved protocol or records; and
  • A review of the CWRU IBC records and processes.

The program has developed a CWRU IBC Post Approval Monitoring Review Form that can be used as a self-assessment tool in preparation for a post approval monitoring review or independently at the Investigator’s discretion.

 

Resources

The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules

CWRU Procedures and Documents:

Other Research Oversight Activities: