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. Likewise, all associated participant facing materials must be submitted to the IRB for review and approval.
Informed Consent Completeness
The Common Rule states broad points about the consent process and documentation, along with basic required and additional elements of consent. Additionally, consent forms must contain required institutional language. Click for an in-depth guidance on this information and when HIPAA authorization should be included. Biomedical Consent Completion Guidance Social Behavioral Consent Completeness Guidance
Health Literacy Guidance
The Common Rule states that “the information that is given to the participant or LAR must be in language that is understandable to the participant or LAR.” About 30 million Americans have below-basic literacy, which can hamper the understanding of research. The Health Literacy Guidance outlines best practices for drafting consent forms to better facilitate participant comprehension. The NIA Glossary contains definitions of commonly used terms within clinical research.
Health Literacy Guidance
Clinical Research Glossary
Remote Consent & Procedures
The Penn IRB supports the use of remote consent and remote study procedures, when appropriate. However, the use of remote methods must be outlined for IRB review to ensure that risks to subjects continue to be minimized and the data integrity of the study can be maintained. This guidance is meant to serve as a resource to guide research teams considering the use of remote procedures for research. Penn Medicine and Penn Dental Remote Consent Guide Penn Medicine Guidance on the Use of Electronic Signatures in Research and 21 CFR Part 11 Compliance. Guidance for Other Schools
Inclusion of Participants Not Fluent in English
Non-English-speaking subjects 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.