In order to present related information to a clinical study and acquire and document informed consent, electronic systems and processes such as text, audio, and graphics are increasingly being employed. According to FDA per their new draft guidance, this is referred to as electronic informed consent (eIC). To provide recommendations when using an eIC to help ensure and enhance human subject protection, comprehension of the information presented, appropriate documentation of obtained consent, and the quality and integrity of eIC data, FDA has released a new draft guidance entitled Use of Electronic Information Consent in Clinical Investigations.
FDA believes that simply obtaining a written signature is not conclusive of what is meant by informed consent. According to FDA, “informed consent must include a process that facilitates the subject’s comprehension of the information and allows adequate opportunity for the subject to ask questions and consider where or not to participate.” The use of electronic processes allow for an interactive exchange allowing the subject to have more involvement which can lead to additional comprehension regarding the study before obtaining the electronic informed consent.
This draft guidance, released in March 2015, provides recommendations for sponsors, site personnel, and IRB’s regarding several key topics/issues regarding the use of electronic informed consent. The following include a few categories included in the draft guidance:
- Presentation of information to the subject
- Delivery of eIC processes
- Desired steps to ensure subject’s understanding and confidentiality of all information
- Special considerations for pediatric studies
- IRB’s responsibilities in the eIC process
- Required eIC documentation for FDA applications and inspections
For additional information, read FDA’s complete draft guidance. Need help with your approach or content for an informed consent document? Contact us for more information.