STANDARD OPERATING PROCEDURE FOR SUBMITTING A PROTOCOL TO THE CLINICAL GENE TRANSFER SUBCOMMITTEE

Purpose: This SOP establishes the standard procedure for submitting a clinical gene transfer protocol to the Institutional Biosafety Committee’s (IBC) Clinical Gene Transfer Subcommittee for review.

Procedure:

  1. The PI must submit a signed cover letter to Environmental Health & Safety (EHS) stating the intent of the protocol.
  2. The PI must submit a copy of the following to EHS:
    • Clinical Protocol
    • Letter of approval from the National Institutes of Health
    • Recombinant DNA Advisory Committee (RAC)
    • Completed Local Standard Operating Procedure for conducting the trial (SOP)
    • Verification of Investigational New Drug status (IND) of the test agent
    • Principle Investigator's informational brochure
  3. EHS will send a copy of the complete set of information to the Chair of the Clinical Gene Therapy Subcommittee for initial review.
  4. If the Chair approves the protocol for review, the Chair will communicate with the members of the subcommittee and the PI to arrange a meeting to review the protocol.
  5. EHS will send a copy of the protocol and associated documents to each of the subcommittee members for review.
  6. The Chair schedules a meeting within a reasonable amount of time. The PI must attend the review committee meeting and be prepared to present the protocol and answer questions posed by the committee.
  7. The committee will then privately discuss and vote on the protocol. The protocol may be "approved", "conditionally approved" or "not approved". The Chair will send a letter to the PI stating the committee’s decision. If further information is necessary for the committee to reach a decision this will be requested. A copy of this letter is sent to EHS for the files.
  8. Once approval is voted by the IBC subcommittee, the protocol will be presented by the subcommittee chair (or chair’s designee) to the full IBC. The IBC will then vote to “approve”, “conditionally approve” or ”not approve” the protocol. The investigator and the IRB will be notified of this decision by letter or e-mail within 1 week.
  9. A copy of each protocol and all information pertaining to that protocol is filed in the EHS office.
  10. After beginning the study investigators must notify the chair of the IBC subcommittee should the protocol be amended or closed so that documents in the protocol file can be kept up to date.
  11. Following approval, PIs will be queried on a regular basis to determine the status of their protocol and level of accruals.
  12. PI will immediately report any adverse events involving subjects, employees or bystanders to EHS, which in turn will notify the chair of the IBC subcommittee.
  13. Prior to the enrollment of the first subject, EHS personnel will perform a review to make sure that all biologic safety procedures as described in the CGTSC-approved protocol SOP are in place. This will include, but not be limited to, documentation of training of all personnel who will have contact with the gene transfer agent.
  14. At the time of the treatment of the first subject, EHS personnel will observe the preparation, handling, administration, storage and disposal procedures of the gene transfer agent to assure compliance with the protocol-specific SOP and standard biosafety procedures.
  15. A full report will be sent to the PI, the chair of the CGTSC, the Director of EHS and the protocol file. Should minor deficiencies be found, the chair of the CGTSC will request that they be corrected before additional subjects are treated. Should deficiencies be found which might affect the safety of patients, employees or community members, the chair of the CGTSC may request whatever actions are necessary to mitigate the risk including immediately suspension the protocol. Should any actions be taken the Dartmouth CPHS and the Dartmouth Institutional Biosafety Committee will be informed.

Information Necessary for Gene Transfer Protocol Submission to the Sub-Committee on Gene Transfer Research of the Dartmouth College Institutional Biosafety Committee

For protocol consideration the following information should be submitted to:

Eric Cook, MPH
Dartmouth College Environmental Health and Safety
Hinman Box 6216
603-646-1762

  1. Copy of the research protocol.
  2. Copy of the Investigator's Brochure.
  3. Copies of correspondence from Food and Drug Administration (FDA) and the National Institutes of Health (NIH) Recombinant DNA Advisory Committee (RAC) indicating their approval of the proposed protocol.
  4. Standard Operating Procedures (SOP) to be used in the conduct of the protocol. This document should include answers to each of the following questions.
  1. How will the agent be shipped to Dartmouth Hitchcock Medical Center (DHMC)?
  2. Who will be responsible for documenting receipt and initial storage of the agent at DHMC?
  3. What will be the procedure for keeping an inventory of the agent?
  4. Who will have the authority to order release of the agent for administration?
  5. Where will the agent be stored prior to use? What security measures will be taken to avoid unauthorized use of the agent?
  6. Where and how, if necessary, will the agent be prepared prior to administration?
  7. How, if necessary, will the agent be transported from the site of preparation to the site of administration?
  8. What precautions will be taken to avoid accidental spills or potential exposure to DHMC personnel and the public during storage and transportation?
  9. Should an accidental spill of the agent occur what will be the clean-up procedure?
  10. What precautions will be taken to protect personnel involved in the protocol from accidental exposure?
  11. Should an exposure (i.e., skin, mucous membranes, inhalation, ingestion) occur how will this be handled?
  12. If applicable, how will unused portions of prepared agent be disposed of?
    13.
  13. Is there a risk of exposure to DHMC employees or the public through contact with the subject or their excretions? If so what potential danger would this pose? How will such exposures be prevented?
    14.
  14. Explain how employees who may come into contact with the agent will, or have been, trained in safety procedures.
    15.
  15. List of "emergency contacts" in case of spills, accidental exposures or other environmental or safety concerns.
    16.
  1. After receipt of the above information a meeting of the sub-committee will be scheduled to review the protocol. The local PI or their representative will be required to attend this meeting.
    2.