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Clinical Trials with rDNA: Instructions for Submission to the IBC

Last Updated: October 31, 2024 10:27:19 AM PDT
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Instructions for Submission to the Human Gene Transfer-Human Gene Editing- Institutional Biosafety Committee (HGT-HGE-IBC)

The National Institutes of Health Office of Science Policy requires

Review by the UCSD HGT-HGE-IBC is done by registering the Principal Investigator (PI), completing a BUA, and PI submitting the BUA. After approval, the PI must follow the approval conditions stipulated by the HGT-HGE-IBC.

Human gene transfer is defined by the National Institutes of Health as the deliberate transfer into human research participants of either:

  1. Recombinant nucleic acid molecules, or DNA or RNA derived from recombinant nucleic acid molecules, or
  2. Synthetic nucleic acid molecules, or DNA or RNA derived from synthetic nucleic acid molecules, that meet any one of the following criteria:
    1. Contain more than 100 nucleotides; or
    2. Possess biological properties that enable integration into the genome (e.g., cis elements involved in integration); or
    3. Have the potential to replicate in a cell; or
    4. Can be translated or transcribed.

1. Determine if your clinical trial involves human gene transfer.

Sponsor documents (clinical protocol and investigator’s brochure) will reveal whether the Investigational New Drug involves human gene transfer. The Human Gene Transfer Biosafety Officer ehsbio@ucsd.edu in conjunction with our IBC administrator will determine if IBC review is required.

2. Expanded Access Requires IBC Review

The deliberate transfer of recombinant or synthetic nucleic acids into one human research participant, conducted under a Food and Drug Administration (FDA) regulated individual patient expanded access Investigational New Drug (eIND) or protocol, including for emergency use, is not research subject to the NIH Guidelines. However, expanded use may pose a hazard to health care workers and community members. These trials will need to be submitted to the IBC for review and approval. The HGT IBC and Campus IBC are set-up to accommodate expedited reviews for expanded access. Contact ehsbio@ucsd.edu for questions regarding IBC oversight of expanded access or to request an expedited review.

3. Register the Principal Investigator (PI) for Access to Biological Use Authorization (BUA) Application.

The PI must be entered in the Environment, Health & Safety (EH&S) database to enable certain research safety authorizations and access EH&S online applications. Complete the PI Information form for access or to update information. PI’s can access the Biological Use Authorization (BUA) through My Research Safety. The BUA Application will require a UCSD Business Systems (sometimes referred to as a Single Sign-On) username and password. See How to Get Access to UC San Diego Business Systems for simple instructions. Contact your departmental security administrator (DSA) if you need assistance.

4. Complete the Biohazardous Use Authorization for human gene transfer

Once registered, the PI can log into the BUA application, through My Research Safety and can initiate a new BUA. There are two types of BUA’s: Research and Clinical. Choose “Clinical” for gene transfer into human research participants. The HGT IBC partners with Clinical Biosafety Services (CBS) to help clinical coordinators complete and submit the BUA and navigate the committee process. This service is provided to the PI for a fee and is required for submission of the BUA. In most cases the pharmaceutical sponsor covers this cost. If clinical research without gene transfer is done using human specimens in laboratory space outside of the medical center, a research BUA is required.

5. Submit the Biohazardous Use Authorization

Once the BUA is completed, PI’s must accept the responsibilities associated with their role:

  1. Fully comply with the NIH Guidelines in the conduct of recombinant or synthetic nucleic acid molecule research.
  2. Obtain Institutional Biosafety Committee (IBC) approval of an initial research protocol prior to initiating any research with recombinant or synthetic nucleic acid molecules or infectious agents, by way of a Biohazard Use Authorization (BUA).
  3. Remain in communication with the IBC and Biosafety Officer throughout the conduct of the research. Any changes resulting in an increased level of hazard, addition of new biological materials, new procedures or change in locations, requires a BUA amendment and IBC approval prior to commencing work.
  4. Adhere to approved containment and emergency plans for handling accidental spills and personnel exposure. Report any significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses to the Biological Safety Officer.
  5. Be adequately trained in good microbiological techniques and use appropriate microbiological practices and laboratory techniques for the research being performed.
  6. Ensure the integrity of the physical containment (e.g., biological safety cabinets) and the biological containment (e.g., purity and genotypic and phenotypic characteristics). Investigate and report any significant problems pertaining to the operation and implementation of containment practices and procedures in writing to the Biological Safety Officer.
  7. Make available to all laboratory staff the protocols that describe the potential biohazards and the precautions to be taken.
  8. Ensure that laboratory personnel receive appropriate training regarding their duties, the practices and techniques required to ensure safety, and the necessary precautions to prevent exposures and deal with accidents. Supervise the safety performance of the laboratory staff to ensure that the required safety practices and techniques are employed. Correct work errors and conditions that may result in the release of recombinant or synthetic nucleic acid molecule materials or infectious agents.

The responsibility statements can be found in the BUA authorization, step 14 BUA submittal. Check the I agree” radio button and the “Submit” button.

6. Complete Biosafety Training Online

Principal Investigators are required to complete the EH&S online training course Clinical Use of Recombinant DNA if their clinical trials involve the transfer of recombinant or synthetic nucleic acids into human subjects. This training must be completed prior to initial approval. It is recommended that all authorized personnel in the trial also take this training.

7. IBC Review Process

The HGT-IBC meets monthly to review new, renewal and amended Biohazardous Use Authorizations. In preparation for the HGT-IBC meeting, all personnel should complete the necessary training, submit all current documents, inform committee of any changes to the trial, and prepare for a site visit to all locations where the IND will be handled and administered into subjects. The IBC may deny, defer, approve pending, approve with conditions, or grant approval. If there are questions or request for information, the IBC may defer until the next scheduled meeting or approve pending. Approve pending would allow the HGT Biosafety Officer to approve the BUA once the sponsor or PI provides satisfactory responses. Most BUA’s are approved with some conditions which are spelled out in the approval letter. For example, some agents may require administration of Investigational New Drug (IND) be done in a single patient examination room with the door closed and a biohazard sign posted.

Please note the following UC San Diego Human Gene Transfer HGT-IBC meeting dates. Public participation at the HGT-HGE-IBC meeting is not mandatory but welcome. Contact ehsbio@ucsd.edu for more information.

List of Calendar Dates for UCSD HGT & HGE IBC Meetings
Scheduled for the second Tuesday of each month, from 9:00-11:00 AM PT, unless noted otherwise* 

  • January 9, 2024
  • February 13, 2024
  • March 12, 2024
  • March 15, 2024* (11 am - 1 pm)
  • April 9, 2024
  • May 14, 2024
  • June 4, 2024* (9 am - 10 am)
  • June 11, 2024
  • July 9, 2024
  • August 13, 2024
  • August 27, 2024
  • September 10, 2024
  • October 8, 2024
  • October 22, 2024* (1 pm - 2 pm)
  • November 12, 2024
  • December 5, 2024
  • December 10, 2024

8. Biohazardous Use Authorization Amendment

A BUA amendment and IBC approval are required prior to work for any of the following changes:

  • Any increased level of hazard
  • Addition of new biological materials and new procedures; or
  • Change in location(s)

Remain in communication with the IBC and Biosafety Officer throughout the conduct of the research.

Any updates to Sponsor documents need to be provided to the IBC and Biosafety Officer before being implemented. You will be notified if an amendment is required.

9. Biohazardous Use Authorization Renewal

Biohazard Use Authorization (BUA) for Clinical Trials Using Human Gene Transfer (HGT) must be renewed every year. EH&S or our vendor will initiate the renewal process by contacting the clinical coordinator or the PI. BUA Renewal requires another vendor review fee.

10. Biohazardous Use Authorization Deactivation

The BUA may be deactivated when the following criteria have been met and confirmation has been submitted to EH&S Bio staff by the PI:

  1. The clinical trial is closed to enrollment.
  2. There is no investigational drug remaining on-site.
  3. It has been at least a month year since the last dose was administered to the last participant.
Questions? Contact EH&S Biosafety.

Note: This page has a friendly link that's easy to remember: http://blink.ucsd.edu/go/clinicaltrials