Decision questions to determine appropriate IRB Panel review:
Temple University utilizes three (3) review boards:
Temple University Institutional Review Board (TIRB)
Fox Chase Cancer Center Institutional Review Board (FIRB)
Western Institutional Review Board (WIRB)
To determine which review board will review your protocol, answer the following questions:
1. Does this research meet the PHS definition of a clinical trial?*
2. Is the protocol designed and written by the sponsor?
3. Is the sponsor of the research a for-profit entity/company?
4. Is the protocol a phase III or phase IV clinical study?
5. Is this an oncology protocol?
Each submission packet is specific per the review board and must be followed and completed as directed. All protocols regardless of which panel will review are to be submitted to the Temple University Office for Human Subjects Protections (OHSP)
*The code of Federal Regulations defines research as “a systematic investigation, including research development, testing and evaluation, designed to develop or to contribute to generalizable knowledge”. As examples, the following are human research; case reports, retrospective evaluation, case-controlled evaluation of disease incidence, prospective randomized trials and data collection to support an application to the FDA. OR
A clinical trial is defined by the Public Health Service as “ A controlled study involving human subjects, designed to evaluate prospectively the safety and effectiveness of new drugs or devices or of behavioral interventions.”
