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FDA Issues Draft Guidance Concerning the Use of Electronic Informed Consent in Clinical Investigations

On March 9, FDA announced the availability of a draft guidance document focusing on the use of electronic informed consent (eIC) in clinical investigations. The document provides recommendations for investigators, sponsors, and institutional review boards (IRBs) concerning eIC, which refers to “using electronic systems and processes that may employ multiple electronic media (e.g., text, graphics, audio, video, podcasts and interactive Web sites, biological recognition devices, and card readers) to convey information related to the study and to obtain and document informed consent.” FDA issues this guidance at a time when the clinical research community is “showing greater interest” in using electronic media.

The draft guidance echoes other FDA documents that “informed consent” is not synonymous with obtaining a signature from a subject on an informed consent form.  Instead, FDA believes that this is only one aspect of informed consent, which also includes providing a potential subject with adequate information about the research to permit an informed and voluntary decision about participation in the investigation. Additionally, while FDA believes that informed consent begins with the subject recruitment process, recommendations for using electronic media and processes during subject recruitment are not included in the scope of the guidance.

FDA underscores that participating sponsors, investigators, and IRBs must also meet the Agency’s regulations for electronic records/signatures, informed consent, and IRBs at 21 CFR parts 11, 50, and 56. FDA has provided guidance in the past concerning part 11 and electronic records/signatures.

In particular, the draft guidance makes the following recommendations:

  • Because certain subjects may have a hard time navigating or using electronic systems because of the lack of familiarity, poor eye sight, or impaired motor skills, measures should be taken to make sure that the eIC process is appropriate for these subjects.

  • Interactive computer-based technology may be used to aid the subject in understanding the informed consent material; however, these programs should be appropriate for the intended audience based on the subject’s age, language, and comprehension level.

  • If any or all of the informed consent process takes place at a remote location, all interactive responses by subjects, witnesses, or other involved parties should be documented electronically using software systems to guarantee the responses cannot be changed.

  • The eIC interview process should allow subjects the opportunity to ask questions about the study in some form, such as electronic messaging, telephone calls, videoconferencing, or live chat.

  • The eIC process must guarantee that significant new findings developed during the course of research that may relate to a subject’s willingness to continue to participate in the study will be transmitted to the subject and that the subject signs such an amended eIC.

  • Electronic signatures are permitted if such signatures comply with part 11. The procedure for eIC can include an electronic method to capture the signature of the subject, including an encrypted digital signature, electronic signature pad, voice print, or digital fingerprint. FDA does not mandate a specific method of electronic signature. Additionally, HIPAA authorizations can also be obtained electronically, if the signature of the subject is a valid electronic signature under applicable laws and regulations, such as the E-Sign Act.

  • FDA requires that the person signing the informed consent be given a copy of the written consent form, and the Agency recommends this copy include the subject’s signature and the date when the eIC was signed. This copy should also include a transcript of any audiovisual presentations provided during the eIC process.

  • Computerized systems that support eIC must be secure with restricted access and include methods to confirm confidentiality regarding the subject’s identity, study participation, and personal information after informed consent has been obtained.

  • Investigational device exemptions (IDE) regulations require IDE applications to include copies of all forms and informational materials provided to subjects to obtain informed consent.  As such, the sponsor should submit all eIC materials that will be presented to subjects, including any videos and Web-based presentations.

  • The eIC process should include procedures to make sure that electronic documents can be archived appropriately, and the archival system should have certain audit trail capability.  FDA does not have a preferred method for archiving documents.  Furthermore, if eIC data is stored on a remote computer, in a data storage center, or in “the cloud,” data privacy laws and regulations that apply to the remote storage sites may also apply and should be considered.

  • During inspections of clinical study sites, FDA should have access to all eIC materials (including signed eICs) either in electronic or paper form.

FDA is accepting public comments on the draft guidance document under a formal docket through May 8, 2015.

© 2022 Covington & Burling LLPNational Law Review, Volume V, Number 111

About this Author

Chris Hanson, Food and Drug Attorney, Covington Law Firm

Christopher Hanson advises international and domestic clients on regulatory strategies and compliance for medical devices, pharmaceuticals, biological products, cosmetics, animal products, and radiation-emitting electronic products. His broad range of clients include large multinational companies, venture capital firms, industry associations, clinical laboratories, and development-stage companies.

Mr. Hanson has extensive experience counseling clients on interactions with state, federal, and foreign regulatory agencies, including the Food and Drug Administration (...