Recruitment and Informed Consent
The Institutional Review Board is responsible for reviewing procedures to be implemented to recruit participants as well as the circumstances under which consent will be obtained to ensure that subject selection is equitable, and enrollment minimizes undue influence to participate. Likewise, all associated participant facing materials must be submitted to the IRB for review and approval.
The Institutional Review Board is responsible for reviewing study recruitment plans as well as any associated participant facing materials. Click below for guidance on recruitment plans and materials such as advertisements, brochures, etc.
Social Media Guidance
Researchers utilize social media for two main purposes: recruitment and as a component of the research interventions or data collection methods. When appropriate and applicable for the study, the Penn IRB supports the use of social media in research. This guidance is meant to serve as a resource to guide research teams considering the use of social media for research.
Compensation & Incentives
Paying or otherwise incentivizing participants for their time contributing to a research study can be a useful tool to both recruit and retain participants. The Penn IRB is responsible for reviewing the rates, forms and schedules of remunerations to subjects participating in research at the university. This guidance provides direction on subject payments and incentives, as well as recruitment finders fees / bonuses
Required Elements of Consent
The Institutional Review Board is responsible for reviewing procedures and circumstances under which consent will be obtained to ensure that subject selection is equitable, and enrollment minimizes undue influence to participate. Click Learn More for guidance on consent form completeness, health literacy, and remote consent.
Inclusion of Participants Not Fluent in English
Limited English Proficiency (LEP) persons should not be systematically excluded from research without a sound scientific or ethical rationale to ensure equitable subject selection. However, federal regulations at 45 CFR 46.116(a)(3) and 21 CFR 50.20 require that informed consent be obtained in language that is understandable to the subject (or the subject’s legally authorized representative). This guidance outlines procedures to ensure the equitable and safe enrollment of such participants.
Waivers of Consent
When participants are prospectively enrolled, it is generally assumed that participants are available and prospective consent is feasible. However, sometimes this is not the case. The Institutional Review Board is responsible for reviewing requests for waivers of informed consent, along with the investigator’s rationale for such requests. Click Learn More for guidance on the regulatory criteria for waivers of informed consent, alterations of informed consent, and waivers of documentation of informed consent.