This page contains guidance on recruiting subjects and guidelines for consent.
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.
Payment for Recruitment 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.
For additional assistance, please contact: Tracy Ziolek
Community Research Partners
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.
For additional assistance, please contact: Tiffany Finn.
Research results and the Electronic Medical Record (EMR)
The IRB has recently added language to the informed consent form template to inform subjects about the potential for research results to appear in their electronic medical record maintained by the University of Pennsylvania Health System (“UPHS”). This language is required for all research that involves UPHS resources (e.g. a laboratory or imaging services) or involves a research procedure that generates test results that may be placed in a subject’s electronic medical record. The purpose of this document is to provide guidance to the research community to help explain the meaning of this language to research subjects.
An explanation of the required language is outlined below. Responses to frequently asked questions about electronic medical records and research results are also included in this guidance document.
For additional assistance, please contact: Any Senior Administrator listed on the directory
Required Elements of Consent
Template HIPAA Language - For developing Combined Informed Consent/HIPAA Authorization forms
The IRB has routinely provided template language to meet regulatory requirements for HIPAA authorization that is obtained at the time of consent. This template has recently been updated (January 2016) and a clean copy is available in the "Forms" page of our website for use by study teams.
This attached copy highlights the changes from the previous version to the new version.
*Please note that the IRB will not require changes to HIPAA langauge for previously approved studies, however the new template should be utilized for studies currently being developed.
Reportable Diseases: Requirements for Reporting & Informing Subjects
The purpose of this guidance is to inform researchers about the requirements related to reportable diseases and to provide template language for inclusion in the consent form to inform subjects of these reporting requirements.