The Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) and the US Food and Drug Administration (FDA) on Wednesday finalized a question and answer (Q&A) guidance on using electronic systems to obtain informed consent for both HHS-regulated human research and FDA-regulated clinical investigations of medical products.
The guidance focuses on procedures to be followed when using electronic informed consent (eIC) to help: Ensure protection of the rights, safety and welfare of human subjects; facilitate the subject’s comprehension of the information presented; ensure appropriate documentation is obtained when multiple electronic media are used; and ensure the quality and integrity of eIC data included in FDA applications and made available to the agency during inspections.
In terms of changes to the draft, first issued in March 2015, FDA notes that there’s further clarification in all 16 questions and answers, including those on how to present information in the eIC to the subject, steps to improve the subject’s understanding of the research, how to verify a subject’s identity who electronically signs the informed consent, how to use eIC for pediatric studies, what eIC documentation is required for FDA submissions, steps to ensure that eIC materials are archived appropriately and what eIC documents FDA will require during an inspection.
The sponsor of FDA-regulated research is expected to submit to the agency “the same eIC materials that will be presented to subjects to obtain eIC for their participation in the clinical investigation.”
And although investigational new drug application (IND) regulations do not specifically require submission of informed consent documents to FDA as part of an IND, the Q&A notes that the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) may request submission of the informed consent form for review under certain circumstances, for example, “when unusual known clinical toxicity is associated with the study drug or class of drugs; when the study population is particularly vulnerable; when the clinical investigation has significant potential for serious risks to human subjects; or for a postmarket safety clinical trial.”
However, on the medical device side, the guidance notes that investigational device exemption (IDE) regulations do require such applications to include copies of all forms and informational materials provided to subjects for obtaining informed consent.
As far as site inspections, the guidance notes: “FDA regulations require that FDA be granted access to records and reports made by the investigator, including site-specific versions of the eIC, the materials submitted to IRBs for review and approval, all amendments to the site-specific eICs, and all subject-specific signed eICs,” the final guidance says.
Use of Electronic Informed Consent Questions and Answers Guidance for Institutional Review Boards, Investigators, and Sponsors