October 19, 2006
Good afternoon and welcome to UCLA Human Research News.
Below is a message sent today from Vice Chancellor for Research Roberto Peccei to the Clinical Chairs regarding a pilot program for review of Phase III and Phase IV industry-sponsored clinical trials by an outside IRB.
Dr. Peccei's message and the associated terms and conditions are provided here for information only- individual investigators do not need to take any action at this time.
Please direct questions regarding this announcement to me at jbrook@oprs.ucla.edu or to Kip Kantelo, OPRS Assistant Director, at kkantelo@oprs.ucla.edu.
Sincerely,
Judith L. Brookshire
Director, UCLA Office for Protection of Research Subjects
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To All Clinical Chairs:
As announced previously, the UCLA Human Research Policy Board (HRPB) has approved a pilot program to allow specified categories of human subjects research to be submitted to, and reviewed and approved by, an unaffiliated, private IRB. UCLA is the first University of California campus to implement such a program.
I am pleased to announce that Western Institutional Review Board (WIRB) of Olympia, Washington has been selected as the private IRB for this program. We hope to go live with protocol submission to WIRB starting Tuesday, January 2, 2007.
I have attached a document outlining the terms and conditions under which research may be submitted to WIRB. The HRPB must approve each Department, Division or Organized Research Unit that wishes to participate in this program. In order for your Department, Division or Organized Research Unit to participate in this pilot program, you must return this document, completed and signed, to my office by December 1, 2006. You will be notified once the HRPB has approved your participation in this program.
The following steps will also need to be completed prior to submission of protocols to WIRB:
- A contract between UCLA and WIRB must be finalized.
- The Office of Clinical Trials (OCT) will develop processes for management of the relationship with WIRB (including billing).
- As WIRB must review research according to University of California and UCLA policies, WIRB will work with the Office for Protection of Research Subjects (OPRS) to integrate those policies into its systems and processes.
- WIRB personnel will visit UCLA to train investigators and staff regarding WIRB requirements and processes.
- OPRS will modify UCLA's Federal wide Assurance with the U.S. Department of Health and Human Services to list WIRB as an IRB of record for the institution.
With this move, I expect that we will be able to improve UCLA's competitiveness as a site for industry-sponsored research without compromising human subject protections. This program will also ease the burden on OPRS, allowing for more efficient handling of research that is not eligible for WIRB review.
Sincerely,
Roberto Peccei
Vice Chancellor for Research
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Terms and conditions for Departments, Divisions and Organized Research Units (ORUs) to Use Western Institutional Review Board (WIRB) for Phase III and IV studies Initiated by and fully funded by a for-profit entity
The term “department” is used in this document to mean a department, division or Organized Research Unit.
The term “chair” is used in this document to mean a department chair, division chief or director of an Organized Research Unit.
In order to participate in the pilot program to have WIRB review Phase III and Phase IV clinical trials, a department must agree to the following terms and conditions and designate individual(s) responsible for carrying out the terms and conditions. A department may not participate in the pilot project until approved to do so by the Human Research Policy Board (HRPB).
1. WIRB is the only private IRB to which eligible protocols may be sent for review.
2. The chair or a designated faculty member will review each protocol intended for submission to WIRB and will be responsible for verifying that a protocol meets the following criteria and is otherwise acceptable for submission to WIRB:
- The study meets the UCLA definition of a “clinical trial.”
- The study is a Phase III or Phase IV clinical trial.
- The study will be fully sponsored by a for-profit entity, with required indemnification of UCLA.
- The study will be conducted according to a sponsor-initiated protocol
- The study does not involve gene transfer, gene medicine or human embryonic stem cells.
- The sponsor will pay the entire cost associated with use of WIRB.
- The study meets any other criteria set by the department in its discretion, within the limits set by the above criteria.
3. A designated department staff member will serve as the liaison between the department and the Office of Clinical Trials (which will serve as the designated UCLA point of contact for WIRB). The department staff member will be responsible for the following:
- Providing verification to the Office of Clinical Trials that the chair or designated faculty reviewer has approved a protocol for submission to WIRB, that the Principal Investigator is eligible to conduct research submitted to WIRB, and the Principal Investigator and research staff have had required human subjects training prior to submissions to WIRB.
- Facilitating gathering of required information and communication between the PI/research team and WIRB and the Office of Clinical Trials, particularly for the submission of a protocol according to processes established by WIRB and the Office of Clinical Trials.
- Performing such tracking and record-keeping as deemed necessary by the department or by the Office of Clinical Trials.
- Alerting WIRB and the Office of Clinical Trials of all communications to/from the Food and Drug Administration, the federal Office for Human Research Protections, or any other federal or state agency regarding studies referred to WIRB.
- Helping to assure compliance with applicable UCLA policies and procedures, WIRB decisions and requirements, as well as with all applicable federal, State, and local laws regarding the protection of human subjects in research.
- Ensuring prompt payment of WIRB fees billed to Principal Investigators.
4. Any changes in the designated reviewer and designated staff liaison will be reported to the Office of Clinical Trials and to the Human Research Policy Board (via the Office of the Vice Chancellor for Research).
5. Reliance on review by WIRB does not change the obligations of Principal Investigators. Principal Investigators must still retain ultimate responsibility for the conduct of the study, the ethical performance of the project, the protection of the rights and welfare of human subjects, and strict adherence to any stipulations imposed by the reviewing IRB. Principal Investigators must still agree to comply with all UCLA policies and procedures, WIRB decisions and requirements, as well as with all applicable federal, State, and local laws regarding the protection of human subjects in research. Each Principal Investigator is also responsible for ensuring payment of WIRB fees incurred.
