To: Principal Investigators, Study Coordinators, Research Administrators and the Temple University Research Community
From: Kenneth Soprano, PhD Vice President for Research and Graduate Studies
Kenneth Geller, PhD
Assistant Vice President for Research/ Health Sciences Center
Richard C. Throm Director, Office for Human Subjects Protection
Date: January 1, 2005
Re: Institutional Review Board Announcement
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ We are pleased to announce the addition of two Institutional Review Boards to assist in the review process for medical intervention protocols performed at Temple University. A central IRB - the Western Institutional Review Board - has been selected to review Phase III and Phase IV industry sponsored clinical trials. Additionally, the Institutional Review Board of the Fox Chase Cancer Center will serve as the IRB of record to review all oncology-related protocols to be performed by Temple Investigators. This includes oncology protocols opened at both the Fox Chase and Temple sites, and oncology protocols opened only at Temple as the site.
The Western Institutional Review Board (WIRB) will review human subjects research that: (i) meets the PHS definition of a clinical trial*; (ii) has a protocol designed and written by the sponsor; (iii) is sponsored by a for-profit entity/company; and (iv) is classified as Phase III or Phase IV clinical research -(and does not involve an oncology component). The WIRB meets daily and functions following their preferred submission process. Details of the WIRB submission process can be found at: http://www.wirb.com/html/download.html
The Fox Chase Cancer Center IRB (FIRB) will review clinical trials that involve an oncology component. It should be noted that the Fox Chase review process is two tiered where the first tier involves review of the study protocol by its Research Review Committee (RRC). The RRC generally meets three times per month to evaluate the scientific merit, general methodology, and statistical analysis of clinical research protocols prior to submission to the Fox Chase Institutional Review Board. Details of the RRC submission process can be found at: www.protonet.fccc.edu/fccc/pims/rrc/
The second tier of review is conducted by the Fox Chase Institutional Review Board. After review by the RRC, each protocol involving human subjects is initially reviewed by the FIRB and, if approved, is reviewed on a continuing basis by the FIRB. A progress report and updated consent form are submitted to and reviewed by the FIRB at least annually and more frequently if needed. Details of the FIRB submission process can be found at: www.fccc.edu/research/institutional_review/
The Temple Institutional Review Board (TIRB) will review all investigator-initiated human subjects research, Phase I and Phase II clinical trials, and any other protocol not fitting the requirements for the WIRB or FIRB. All social and behavioral research will continue to be reviewed by the Temple IRB (B-Committee). Details of the TIRB submission can be found at: www.research.temple.edu/irb/irbforms.html
Please note that all protocols regardless of the reviewing IRB are to be submitted to the Temple University Office for Human Subjects Protection (3425 Carlisle Street, 3 rd Floor), and must include the Temple University face sheet completed as requested. The face sheet may be found at: www.research.temple.edu/irb/irbforms.html
Please visit the Temple IRB website to determine the appropriate submission materials to prepare. And please continue to visit the Temple IRB website for additional information and important updates on the IRB and IRB review processes at: www.research.temple.edu/irb/
*A clinical trial is defined by the Public Health Service as "A controlle d study involving human subjects, designed to evaluate prospectively the safety and effectiveness of new drugs or devices or of behavioral interventions."