This page contains guidance on recruiting subjects and guidelines for consent.
Required Elements of Consent (Revised 1.21.19 for New Common Rule)
Please click here to download our guidance document which outlines the required elements of consent according to the Common Rule regulations.
To assist researchers at Penn and other institutions which rely on Penn IRB review, the Penn IRB routinely provides templates for developing appropriate consent forms for both Biomedical and Social/Behavioral research. Please visit the forms and templates page of this website to download the most recent versions of these templates. The forms and templates page also includes templates to assist with:
- Developing a Concise Summary of research for prospective subjects- The template for concise summary is built into the Biomedical ICF template and the Social Behavioral ICF template.Click Here to download additional guidance for developing a concise summary using our template.
- Adding appropriate HIPAA language to your consent form
- Adding conflict of interest disclosure language
- Adding Risks of Social Media
- Adding Genetic Information Non-Discrimination Act (GINA) language
- Developing appropriate assent forms for children/minors
- Obtaining Short Form consent - please note that short form consent templates are available on the forms page in select languages. If you need a short form in a language that is not available please utilize the English short form to obtain a translation.
Health Literacy Guidance for Drafting Consent Forms
About 30 million Americans have below-basic literacy, which can hamper the understanding of research. Please download the attached guidance to review best practices for drafting consent forms that facilitate participant comprehension.
Please note that the IRB may stipulate that this guidance be applied to new or updated consent forms submitted for review.
Subject Recruitment Materials, Subject Compensation, Recruitment Finders Fees / Bonuses
Regarding Direct Recruitment of Penn Medicine Patients
Contacting patients for recruitment purposes is permissible under the federal HIPAA regulations and is described in the Notice of Privacy Practices (NPP) that Penn Medicine patients acknowledge before clinical care is delivered.It is standard practice for clinical and research teams within Penn Medicine to communicate with patients in various ways. Regarding contact for research recruitment, IRBs are required to review and approve the appropriateness of the recruitment methods proposed in a research study. The IRB provides detailed guidance for investigators contacting patients for participation in research.
Regarding 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 the document provided below.
For additional assistance with developing recruitment materials, please contact: Tiffany Finn.
Regarding Subject Compensation
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.
Regarding Payment for Recruitment of Subjects (Finders Fees / Bonuses)
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.
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
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.
Community Research Partners
IRB Consent Short Form Translations
Currently the IRB provides translated Short forms in the following languages:
- Chinese (Traditional)
- Haitian Creole
- Portuguese (Brazil)
- Spanish (US)
Please see the Forms and Templates page to download the templates.
These versions comply with the 2018 Common Rule criteria for consent. They are based on the Penn IRB provided English Short Form template and were translated by Language Line Solutions