Clinical Trials: Instructions for Submission to the IBC

Last Updated: September 9, 2026 10:15:25 AM PDT

Follow these instructions for submission to the Human Gene Transfer-Institutional Biosafety Committee (HGT-IBC).

Principal investigators overseeing clinical trials may require approval from the UC San Diego Human Gene Transfer Institutional Biosafety Committee (HGT-IBC) or Campus Institutional Biosafety Committee. This is done by registering the Principal Investigator (PI), completing a Biohazard Use Authorization (BUA) and the PI submitting the BUA. After approval, the PI must follow the approval conditions stipulated by the HGT-IBC.

When would a clinical trial require IBC review?

A Clinical Biohazard Use Authorization (BUA) is required for:

Investigational drugs comprised of materials that fall under the NIH Guidelines section III-C shown below.
Human gene transfer is defined by the National Institutes of Health in section III-C 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.
Investigational drugs comprised of materials that are not subject to NIH Guideline III-C but are considered recombinant and/or synthetic materials and are administered in UCSD buildings
Investigational drugs comprised of materials that are not subject to the NIH Guideline III-C but are human or human-derived materials or infectious agents (e.g. certain allogeneic or autologous cells, RSV, BCG)
Collection and/or processing of patient specimens outside of the hospital/Medical Center and within UC San Diego locations.

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

UC San Diego has two Institutional Biosafety Committees (IBCs): The campus IBC and the Human Gene Transfer IBC (HGT-IBC).

UC San Diego’s third-party contracted IBC, Sabai Global, administers the HGT-IBC reviews of clinical trials that are sponsor (industry) funded AND are covered by section III-C-1 of the NIH Guidelines.UC San Diego has an exclusive contract with Sabai and does not accept IBC reviews from other external IBCs.

The campus IBC reviews clinical trials that employ investigational products which are not comprised of recombinant materials (e.g., phages) and clinical trials that involve recombinant investigational products but are federally funded or PI-funded/initiated. Review by the campus IBC follows campus IBC submission procedures and timelines.

Determine which IBC oversees your trial. (Click image for larger view.)

Step 1: Activity

Collecting → Research
Administrating → Clinical (proceed to Step 2)

Step 2: Regulatory Check

Does not fall under NIH Guideline III-C1 → Campus handles BUA
Falls under NIH Guideline III-C1 → (proceed to Step 3)

Step 3: Funding Source

Industry Funding → Sabai handles BUA
Federal, PI or EAP Funding → Campus handles BUA

How do you determine if your clinical trial requires IBC review?

Sponsor documents (clinical protocol and/or investigator’s brochure) will reveal whether the administration of the investigational product requires IBC review. The Human Gene Transfer Biosafety Officer ehsbio@ucsd.edu in conjunction with our third party IBC administrator Sabai Global can help to determine if IBC review is required.

2. Expanded Access requires IBC review.

IBC review is required for the Expanded Access Program, Emergency Use Authorizations and single patient INDs.

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 Investigational New Drug (spIND) protocol, expanded access program or emergency authorization, is not research subject to the NIH Guidelines. However, the use of an investigational product may pose a hazard to healthcare workers and community members. To ensure occupational health support, these protocols will need to be submitted to the campus IBC for review and approval. The campus IBC is set-up to accommodate expedited reviews for compassionate use protocols. Contact ehsbio@ucsd.edu for questions regarding IBC oversight of expanded access or to request an expedited review.

3. Policies

The HGT IBC approved a policy “Requirements for the Safe Handling of Investigational New Drugs for Administration into Human Subjects” which establishes safety standards for Investigational Drug Services (IDS) Pharmacies and Gene Therapy administration areas to prevent occupational exposure and unintentional environmental release of Investigational New Drugs (INDs) during compounding and administration. The policy applies to IDS Pharmacies and clinical sites employing UC San Diego personnel that handle Investigational New Drugs (INDs) under the oversight of the Human Gene Therapy Institutional Biosafety Committee (HGT-IBC), and that are identified as authorized locations and personnel on an approved Biohazard Use Authorization (BUA) application.

4. 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. PIs 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.

5. Complete the Biohazardous Use Authorization for human gene transfer.

Once registered, the PI can initiate a new BUA. There are two types of BUA’s: Research and Clinical. Choose “Clinical” for the transfer of investigational products into human research participants.

Sabai Global administered HGT-IBC review of clinical trials

The HGT IBC partners with Sabai Global to help clinical coordinators complete and submit the BUA and navigate the committee process. This service by Sabai Global is provided to the PI for a fee and is required for submission of the BUA. As part of the service, Sabai Global will initiate, submit, and maintain the BUA on behalf of the PI. Study teams who plan on carrying out industry-funded clinical trials that require IBC review should contact Sabai Global at clientservices@sabaiglobal.com to initiate the submission and review process. If you have questions about the Sabai Global process or need assistance contacting Sabai, please email EHSBio@ucsd.edu.

Campus IBC review of clinical trials

Clinical trial BUAs that are reviewed by the campus IBC are initiated, populated, submitted, and maintained by the PI and their study team. See instructions for the BUA renewal process.

6. Submit the Biohazardous Use Authorization.

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

Fully comply with the NIH Guidelines in the conduct of recombinant or synthetic nucleic acid molecule research.
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).
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, require a BUA amendment and IBC approval prior to commencing work.
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.
Be adequately trained in good microbiological techniques and use-appropriate microbiological practices and laboratory techniques for the research being performed.
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.
Make available to all clinical staff the protocols that describe the potential biohazards and the precautions to be taken.
Ensure that 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 clinical 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, then hit the “Submit” button.

7. How to transfer a BUA to a new PI

The receiving Principal Investigator (PI) should start a new BUA application in the My Research Safety portal (see How to Apply for a BUA).
In the Project Summary field, note that this is a BUA transfer and list:
- The previous BUA number and PI’s name
- A description of the biological material(s) and procedure(s) that will be transferred
Then add the new PI (or PI Contact) as authorized personnel on the original BUA (the one to be transferred). They will then be able to copy over the relevant information from the previous BUA protocol to the new BUA protocol.

8. Complete Biosafety Training online.

Principal Investigators are required to complete the EH&S online training course Clinical Use of Recombinant DNA in the UC Learning Center 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. Sabai Global requires the provision of an IATA training certificate for at least one person who will be handling the investigational product.

Additionally, the PI and all personnel who handle the investigational product (e.g., pharmacists, nurses, surgeons, etc.) must have current Bloodborne Pathogens (BBP) training. Two forms of BBP training are acceptable: the UC Learning Center Researcher BBP training or the annual UC San Diego Health Workplace Safety: Environment of Care training.

9. Site Visits

The HGT Biosafety Officer (BSO) will conduct annual visits of all areas where investigational products that are covered by a BUA are stored, prepared, and administered. The HGT-BSO may contact the study team with the request to facilitate the site visit by connecting the HGT-BSO to the supervisor of a respective area.

10. IBC Review Process

The HGT-IBC meets monthly to review new, renewed 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 with conditions, or grant approval of the BUA. If there are questions or requests for information, the IBC may defer until the next scheduled meeting or approve conditionally. Approve conditionally 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, agents may require administration in a single patient examination room with the door closed and a biohazard sign posted while following standard precautions.

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

List of Calendar Dates for UCSD HGT IBC Meetings
Scheduled for the second Tuesday of each month, from 9-11 a.m PT and the fourth Wednesday of each month, from 9-11 a.m. PT, unless noted otherwise*

January 13, 2026
January 28, 2026
February 10, 2026
March 10, 2026
April 14, 2026
April 29, 2026
May 27, 2026
June 9, 2026
June 24, 2026
August 11, 2026
August 26, 2026
September 8, 2026
September 23, 2026
October 13, 2026
October 28, 2026
November 10, 2026
December 8, 2026

11. Biohazardous Use Authorization Amendments

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/trial.

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.

12. Biohazardous Use Authorization Renewals

Biohazard Use Authorizations (BUA) for Clinical Trials must be renewed every year. Sabai Global will initiate the renewal process for applicable trials (by contacting the clinical coordinator or the PI for trials) that are reviewed by the HGT-IBC. BUA Renewals require another vendor review fee. For all clinical trials that are reviewed by the campus IBC, the study team is responsible for the initiation of the BUA renewal.

13. Biohazardous Use Authorization Deactivation

The BUA may be deactivated when the following criteria have been met and confirmation has been submitted to EH&S Biostaff or, as applicable, to Sabai Global by the study team:

The clinical trial is closed to enrollment.
There is no investigational drug remaining on-site.
It has been at least a month since the last dose was administered to the last participant.

14. Post-administration sample collection (follow up visits) is considered research.

Patients may be shedding investigational products (IP) after administration. As such, the collection of patient samples during follow up visits may pose an exposure risk to healthcare personnel if the collection occurs during the shedding period, which varies, depending on the type of IP (e.g. replication-selective viral vectors). HGT-IBC oversight of clinical trials ends with the administration of the IP. Therefore, a research BUA must be in place to cover the collection of patient samples outside of the Medical Center. The research BUA is reviewed by and maintained under the campus IBC and follows campus IBC review, approval processes, and approval duration for research protocols. The PI is responsible for providing nursing and laboratory staff with agent specific training and information on handling precautions, PPE and communicating occupational health requirements.

15. IBC Meeting Minutes

All official minutes from IBC meetings are available on the IBC Meeting Minutes page.

16. Resources

Questions? Contact EH&S Biosafety.

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