20 Sep The Electronic Informed Consent Has Arrived….
FDA and Office for Human Research Protections (OHRP) have relapsed final guidance that answers commonly asked questions on using electronic systems and processes to obtain informed consent.
The guidance provides recommendations on the use of electronic system and processes to obtain informed consents such as graphics, audio, video, podcasts.
Electronic informed consent (eIC) may be used to complete key steps with the consent process such as:
- Provide information as in the written informed consent form.
- Facilitate the subjects’s ability to retain and comprehend the information.
- Evaluate the subject’s comprehension of the information presented.
- Document the consent.
eIC may also allow for quick notification to the subjects of any changes relating the informed consent, that may affect their willingness to continue to participate.
Since the eIC is a source document, it should be under the control of the trial site as would be a paper copy. To accomplish this, the eIC should be stored in an electronic repository with user management and access controlled by the trial site.
Link to the FDA eIC guidance:
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