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Institutional Review Board (IRB)

The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.

Drexel University has three internal Institutional Review Boards (IRBs). The IRBs are composed of faculty and professional staff members as well as representatives from the local community.

Protocols requiring committee approval may be internally or externally designed and funded. On this website you will find the necessary forms and instructions to assist you in applying to the Drexel IRBs, as well as guidance on conducting human research in a manner that promotes protection of human subjects.

Investigators who plan to use an institutional review board other than the onsite Drexel IRB will submit to the external IRB in conjunction with the Human Research Protection Program (HRPP). After the HRPP confirms regulatory and institutional compliance, the researchers will then submit directly to the designated IRB. Learn more

Clinical Trials

For each clinical trial, one IRB-approved informed consent form used to enroll subjects must be posted on a publicly available Federal Web site that will be established as a repository for such informed consent forms (e.g., ClinicalTrials.gov). The informed consent form must be posted after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.

Clinical trial as defined by 45 CFR part 46.102(b): Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

OHRP Human Subject Regulations Decision Charts

OHRP Human Subject Regulations Decision Charts [PDF]: The OHRP Decision Charts are intended to provide  guidance to investigators interested in non-human subjects research, exempt, expedited determinations and more. The Drexel IRB will need to review all applications and provided final determinations regarding the level of review.