With the progression of technology, it has become evident that there is a place for electronic documentation in clinical research.
One area of particular benefit includes the informed consent process. Electronic informed consent (eIC) has the potential to offer great advantages over the traditional paper consent process. If used correctly, eIC can serve as an effective tool for educating study subjects, managing informed consent records, and ensuring research participants are made aware of new information or study amendments.
What is Electronic Informed Consent?
Electronic informed consent involves using an electronic method, such as a computer system, website, text, audio or video program to provide a potential clinical subject information about a study and document the subject’s consenting signature.
The signature generally can be documented in one of two types:
1. Full signature
A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature, per 21 CFR 11.3(b)(7).
2. Indication of consent
Indication of consent can be used instead of a full signature only if an IRB waives documentation of informed consent. An example includes a clicked checkbox on a form to indicate consent.
Informed consent is frequently misjudged as simply obtaining a signature from a clinical research subject. It is the informed portion that is sometimes forgotten.
Informed consent includes conveying information about a clinical study through a presentation mode that is appropriate for the prospective subject.
Per 21 CFR 50.20, informed consent must include a process that facilitates the subjects’ comprehension of the study information and allows adequate opportunity for the subject to ask questions to consider whether or not to participate.
Implementing an electronic informed consent program can allow an investigator to effectively present study information to clinical subjects, while still complying with the multiple regulations involved in the informed consent process.
Regulatory Requirement for Electronic Informed Consent
The FDA is aware of the industry’s desire to use electronic informed consent and has responded by issuing a draft guidance document in March 2015 titled, Use of Electronic Informed Consent in Clinical Investigations.
This guidance provides a Q&A session to help industry better understand FDA’s thinking on this widely used tool. In the guidance, FDA cites three additional guidance documents that are applicable to electronic informed consent:
Computerized Systems Used in Clinical Investigations – Guidance for Industry – Provides recommendations regarding the use of computerized systems in clinical investigations
- Part 11, Electronic Records; Electronic Signatures – Scope and Application – Guidance for Industry – Provides guidance on methods of electronic record and electronic signature management that comply with 21 CFR 11
- General Principles of Software Validation - Guidance for Industry and FDA Staff – Provides guidance on appropriate methods of software validation in terms of compliance with the quality management system
In addition to the guidance documents, certain FDA regulations can be used as reference for how to compliantly deploy electronic informed consent. Details on the regulatory requirements applicable to eIC can be found collectively in 21 CFR 50 (protection of human subjects), 21 CFR 11 (electronic records, electronic signatures), and 21 CFR 56 (institutional review boards).
These regulations lay out the specific requirements for informed consent, and more broad requirements if a company is to use electronic records. When combined, the guidances referenced above, 21 CFR 50, and 21 CFR 11 create the foundation for the regulatory requirements for eIC.
To learn more about clinical research and electronic informed consent, grab our free whitepaper: Informed Electronic Consent for Clinical Investigations.