Is IRB Review Required? The first question one should consider when assessing the requirement for IRB review is whether the activity meets the regulatory definition of human research. Anyone unsure of about IRB review requirements and whether their proposed activity constitutes “human research” requiring IRB review should contact the Office of Regulatory Affairs. The IRB staff will determine if the activity is human research. If an activity does not meet the regulatory definition of human research, the IRB will, upon request, issue a letter stating that the project does not require IRB review or approval.Download guidance.
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Claim of Exemption
Is your study exempt from IRB Review? If you think your study is exempt, refer to the Instructions for the Claim of Exemption Form
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Certificates of Confidentiality allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding. See the NIH Certificate Kiosk for additional information.
Office of the Vice Provost for Research, COI Policies
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Cooperative Agreement: CHOP/Penn
Investigators are encourages are encouraged to review the CHOP/Penn IRB Cooperative Agreement to determine if their study is eligible for consideration under the agreement. Download guidance.
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Payment to Research Subjects
The Penn IRB is responsible for reviewing the rates, forms and schedules of remunerations to subjects participating in research at the university. It is the IRB’s charge to ensure that the amount of remuneration and the proposed method and timing of disbursement do not present undue influence to subjects. Download guidance.
Payment for Recuitment of Subjects (finders fees)
The University of Pennsylvania IRB believes that finder’s fees to investigators and study staff create a potential conflict of interest. The Institutional Review Boards do not approve of finder’s fees being paid to University of Pennsylvania or UPHS investigators, physicians, nurses, and others who have a treating and/or counseling relationship to a subject being referred for enrollment in a clinical trial.
The Institutional Review Boards do not approve of finder’s fees being paid to any, house staff or University of Pennsylvania Health System (UPHS), or University of Pennsylvania employee for referring or recruiting prospective subjects. The IRB may review and approve small, nominal value gifts to staff organizations as long as such gifts are not based on any indicator of trial enrollment. Download guidance.
Pennsylvania Law
This guidance document describes Pennsylvania laws on surrogate consent and mandatory reporting requirements that may be applicable to human research. Download guidance.
Recruitment Materials
The Institutional Review Board is responsible for reviewing study recruitment procedures and materials to ensure protection of the rights and welfare of human subjects and equitable subject selection into research [21 CFR 56.107(a), 56.111(a)(3)]. Any method of advertisement must be approved by the IRB before it is implemented. All advertisements must comply with informed consent and subject selection regulations pursuant to 21 CFR 50.20, 50.25, and 56.11(a)(3) as well as the institutional policy described in this document. Download guidance.
