In March 2015, the FDA published a guide, written in question/answer form, intended to outline the use of electronic media, and the processes used to obtain electronic informed consent from participants (or their representatives) in a clinical investigation.
This guide explains that informed consent is not just obtaining a signature on a document, it also involves :
- Providing adequate information;
- Facilitating the participant’s understanding of the clinical investigation;
- Giving the participant the opportunity to ask questions and to decide whether or not to participate.
These requirements continue after obtaining the participant’s initial consent and involve providing information as the clinical study progresses.
Several types of electronic media can be used to transmit information on the study and to obtain informed consent from the participant :
- text, graphics, audio, video, podcasts and interactive sites,
- biological recognition devices,
- card readers.
- The information given to the participant must be understandable.
- Consent must be obtained in accordance with Articles 21 CFR part 50 (Protection of Human Subjects) and 21 CFR part 312.60 (Research on new drugs : General Liability of Researchers).
- According to the 21 CFR Part 11 (Electronic Records – Electronic Signatures) , the electronic signature has the same value as a signature on a paper document. A copy of the document (electronic or paper) is given to the participant (or his or her representative).
This guide aims to provide recommendations to:
- Protect the participant’s rights, safety and well being
- Ensure the quality and integrity of data obtained electronically from the subject and used by the FDA during inspections.
The computer systems used to store data should be secure with restricted access, to avoid the risk of confidential patient information being accessed by the public