Special Topics in Human Subjects Research
At Yale University, we are dedicated to advancing the ethical and responsible conduct of research involving human subjects. Our “Special Topics in Human Subjects Research” page serves as a valuable resource for researchers, students, and the broader academic community who are passionate about understanding and navigating the complexities of human subjects research.
Contact Us
Have questions or need further guidance? Connect with our team of experts by writing to hrpp@yale.edu and access additional support and resources tailored to your specific needs. Together, we can uphold the highest standards of integrity and respect in human subjects research.
eConsent in the Conduct of Human Subjects Research
Electronic informed consent (also referred to as eConsent or eIC) refers to the use of electronic systems and processes to: (1) convey information related to the study; and/or (2) to obtain and document informed consent. The electronic systems and processes may include text, graphics, audio, video, and/or other media. eConsent does not apply to situations where research participants sign a hard copy of a consent form, which is then scanned to create an electronic version and transmitted electronically.
Contact Information
For questions related to e-consent and Part 11 compliance, please contact HRPP@yale.edu.
Part 11 Compliance & Applicability to Human Subjects Research
The Food and Drug Administration (FDA) regulation on Electronic Records and Electronic Signatures (21 CFR 11, or Part 11) provides the criteria under which the FDA will accept electronic records and electronic signatures as equivalent to paper records and handwritten signatures executed on paper. These regulations are specifically relevant to studies that are regulated by the FDA. The purpose of Part 11 is to ensure that electronic records, electronic signatures, and handwritten signatures executed to electronic records (e.g., signature using a stylus on a tablet) to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.
The Yale HRPP has created a guidance document for our research community, which provides an overview of Part 11, outlines Part 11 applicability to FDA-regulated human subjects research, and details requirements for Part 11 technology. Applicable regulations, references and citations are also provided, along with eConsent and data system decision trees.
Use this decision tree to help determine whether you must comply with Part 11 for data capture systems and e-consent.