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 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.
Social and Behavioral:
Claim of Exemption
Is your study exempt for further IRB review? If you think your study is exempt, refer to the Instructions for the Claim of Exemption Form
Social and Behavioral:
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.
Requests for emergency uses of investigational drugs or devices: Call 215.746.6272 or 215.868.3114.
NIH Genome Wide Association Study (GWAS) Registry
Any request to submit data into the NIH Genome-Wide Association Studies repository must include certification that the submission has been approved by the responsible Institutional Official. At Penn the IRB serves that function and this guidance document details (i) how to submit requests for GWAS certification to the IRB, (ii) how the IRB will consider these requests and (iii) how studies can be drafted to ensure that IRB Certification can be granted.
Sponsor-Investigator held Investigational New Drug Applications
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
The University of Pennsylvania IRB believes that finder’s fees and bonus payments 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 or bonus payments 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.
Community Research Partners
Guidance to foster community engagement in the research process, patients and other community stakeholders are involved in various levels of research design and conduct. Download guidance.
This guidance document describes Pennsylvania laws on surrogate consent and mandatory reporting requirements that may be applicable to human research. Download guidance.
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.
Research results and the electronic Medical record