FDA Issues Final Guidance on the Use of Electronic Informed Consent
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FDA Issues Final Guidance on the Use of Electronic Informed Consent
The informed consent process has been an area of debate over the past few years. Regulations and guidelines controlling the conduct of clinical trials require informed consent to be obtained from each study subject prior to initiation of clinical investigation. In December 2016, FDA published its final guidance on the use of electronic informed consent. This guidance document finalizes the draft guidance entitled “Use of Electronic Informed Consent in Clinical Investigations--Questions and Answers” published in March 2015.
The final guidance applies to stakeholders in clinical research community including institutional review boards (IRBs), investigators, sponsors and potential trail human subjects. The document provides guidelines on the use of electronic systems that may possibly involve multiple electronic media to obtain informed consent for both HHS and FDA regulated clinical investigations.
Key Focus Areas
The guidance document provide summary of requirements in question and answer format. Some of the key questions addressed in the guidance include:
- How should information in the electronic informed consent (eIC) be presented to the subject?
- How and where may the eIC process be conducted?
- How and when should questions from subjects be answered?
- What steps may be taken to facilitate the subject’s understanding of the information being presented?
- How can electronic signatures be used to document eIC?
- What special considerations should be given to the use of eIC for pediatric studies?
- What steps can be taken to help ensure privacy, security, and confidentiality of the eIC information?
- What are the IRB’s responsibilities in the eIC process?
This guidance has addressed these questions and many more to ensure clarity in adhering to the electronic informed consent requirements.
Click here to download the file
