Committees for the Protection of Human Subjects (IRBs)
The Committees for the Protection of Human Subjects is the official name of the IRB committees that are appointed by and serve under the auspices of the CHOP Executive Committee of the Medical Staff. The CHOP IRB reviews research involving human subjects via full board review procedures, expedited review procedures, or exempt determinations. Any non-exempt human subjects research must be reviewed and approved by the IRB prior to any intervention or interaction with human subjects, including recruitment procedures.
Guidance on Special Topics
The principal investigator is responsible for knowing the research regulations that apply to their study, additional requirements imposed by the funding agency, study sponsor and relevant regulatory authority (e.g. adverse event reporting, progress reports).
This section provides links to various topics focused on consent and HIPAA authorization. It includes guidance on the regulatory requirements, consent templates, and information about written and verbal consent/HIPAA authorization, e-consent, parental permission, assent, and waivers.
The Food and Drug Administration oversees clinical trials to ensure they are designed, conducted, and reported according to federal law and regulations. This section provides information about research with investigational drugs, biologics, and devices.
This section focuses on children, pregnant women and the fetus, adults with diminished capacity, and prisoners in the research context.
Social and behavioral research has led to important scientific findings influencing health care today. Some of the topics unique to social/behavioral research that deserve particular comment are covered on this page.
Certificates of Confidentiality (CoC) are issued by the NIH or the FDA to protect identifiable research information from forced disclosure. This page includes information on procedures for obtaining a COC and COC consent language.
This section provides information about setting up registries and repositories, how to use an honest broker, and sharing data and biospecimens.
Ancillary review assists the IRB with matters related to research feasibility, risk, regulatory requirements and research compliance. This section describes the ancillary committees at CHOP and when their approval may be required.
Study instruments and tools must be provided at the time of protocol submission. This page provides a list of instruments the IRB recognizes as validated, which therefore do not have to be attached to a submission for IRB review.
Investigators must consider the possibility of incidental findings as part of their assessment of the risks and benefits of research participation. This page includes guidance on clinical significance of results, the investigator’s obligations, and the return of results.
This section provides information on providing information to potential subjects (recruitment) and obtaining information about the prospective participant to determine if they are eligible for the research (screening).
Inconvenience and costs to subjects related to research impose impediments to enrollment and research participation. This page incudes guidance on compensation for time, effort and inconvenience versus reimbursement, and their tax implications.
This section provides information on the CHOP Research Institutes Training Requirements for human subjects research and a link to CHOP's Research Institute Human Research Protection Program Training.
The Children's Hospital of Philadelphia's (CHOP) IRB is organized and operates in compliance with the Department of Health and Human Services regulations, as described in 45 CFR 46, for federally funded research and FDA regulations, as described in 21 CFR Parts 50 and 56, for FDA regulated research.
Find CHOP specific information, such as IRB hours, eIRB Help Line, IRB Analyst Office Hours for All Study Staff, IRB Chair Office Hours for Principal Investigators, IRB training information, IRB timelines, IRB newsletters, and much more.