IRB Guides

IRB Guidance: 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

Is your study exempt from IRB Review?
If you think your study is exempt, refer to the Instructions for the Claim of Exemption Form

Guidance on Device Accountability in Clinical Research:
This document will help define device accountability in clinical research and the two main categories of research devices. In addition, this document will describe the Penn Medicine requirements for proper device accountability in clinical research studies and the support services available for research device accountability. Download

IRB Guidance on Standard Screening Instruments:
The screening instruments included in this document do not need to be included in submissions for IRB review. Download

IRB Guidance on the UPenn/CHOP IRB Agreement:
The Upenn/CHOP Cooperative agreement has been in effect for a year and has recently been revised to include additional scenarios.  Please review the revised agreement to determine if a protocol meets the criteria for a single IRB review by either an IRB at Penn or CHOP. Download

Penn/CHOP Agreement determination instructions:

Please complete form checking appropriate box (make sure the form is signed)
Send to Institution you feel will be the IRB of record along with IRB specific submission requirements (contact respective IRB office for specific requirements).  If PI determination is confirmed by IRB chair or designee, a copy of determination form with IRB chair or designee signature will be forwarded to PI by the IRB of record. The reciprocal IRB will receive a copy as well.

Penn/CHOP Agreement Determination Form

IRB Guidance on Payment of 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

IRB Guidance on 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

IRB Guidance on Humanitarian Use Devices
The Institutional Review Board is responsible for reviewing the use of Humanitarian Use Devices to ensure protection of the rights and welfare of human subjects. Download guidance on submission requirements.

IRB Guidance on Emergency Use of Test Articles

Emergency Use of a test article is exempt from prior IRB review and approval, provided that such emergency use is reported to the IRB within 5 working days. Any subsequent use of the test article at the institution is subject to IRB review.

Under FDA regulations, patients given emergency use test articles are considered research subjects and data from the emergency use may be used in research through reporting to the sponsor and the FDA. Under HHS regulations, whenever emergency care is initiated without prior IRB review and approval, the patient may not be considered to be a research subject and the data derived from use of the test article may not be used in a prospective systematic investigation designed to develop or contribute to generalizable knowledge. Download guidance on submission requirements.

IRB Guidance on Pennsylvania Laws that May be Relevant to Human Research
This guidance document describes Pennsylvania laws on surrogate consent and mandatory reporting requirements that may be applicable to human research. Download

IRB Guidance on Payment for Recruitment of Human 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