Post contributed by guest blogger Miguel Kitamura of Kitamura Law. Not affiliated with Covington & Burling LLP.

Earlier this year, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) published guidance on the use of electronic informed consent in clinical investigations, entitled “Points to Consider for Informed Consent Using Electromagnetic Means in Clinical Trials and Post-marketing Clinical Trials” (“e-Consent Guidance”).  PMDA released an English version of the e-Consent Guidance in August.  Although electronic consent has been used in a face-to-face setting in Japan for several years, the e-Consent guidance formally introduces use of the practice in a remote setting.

The e-Consent Guidance provides that investigators can use electronic means to obtain informed consent if information related to the trial is provided at the same level as “conventional face-to-face setting[s].”  Electronic means, as referred to in the e-Consent Guidance, include one or more of the following elements: explaining the study remotely using video conferencing, displaying digital documents, and obtaining electronic signatures.  Conventional methods may be combined with electronic methods during the consent process.

According to the e-Consent Guidance, before using electronic methods in the consent process, investigators should consider the appropriateness of such methods, and specify the electronic consent procedure for review by the institutional review board (IRB).  Recognizing that an electronic consent process may not be preferred by all subjects, the e-Consent Guidance also provides that subjects should have the option to use paper-based or face-to-face processes instead.  Similarly, the e-Consent Guidance explains that investigators should take into account potential subjects’ familiarity with electronic systems or difficulty using electronic systems because of, for example, impaired vision or motor skills, when determining whether electronic consent is appropriate and the procedures necessary to support electronic consent. 

In addition to the principles above, the e-Consent Guidance provides:

  • Investigators should establish procedures to verify that the person from whom the consent is obtained is the subject who will be participating in the study, or the subject’s legally authorized representative.  This could include, for example, presentation of an identification document (e.g., My Number Card, driver’s license, passport, health insurance card).  For digital signatures (i.e., handwritten signatures on a screen via electronic means), an authentication procedure in the electronic system is recommended.  If the subject is providing an electronic signature, multi-factor authentication is preferred. 
  • When the consent process takes place remotely, both the investigator and the subject (and the subject’s legally authorized representative and impartial witness, if applicable) should participate from a place and by a method that protect the subject’s privacy.  The investigator should show the subject that there is no one present who is not connected to the clinical trial.
  • While it is acceptable to provide information through videos or slides as part of the explanation to potential subjects, such materials should be accompanied by live explanation, in person or through video conferencing.  This is because subjects may not fully understand the content from self-learning/e-learning materials alone.  Subjects should have opportunities to ask questions at the time of the explanation and after the explanation.  When the entire consent process takes place remotely, more may be necessary to establish a relationship with the subject so that the subject feels enabled to ask questions.
  • Electronic signature procedures should adhere to Japan’s regulatory requirements.  If it is difficult for a subject to provide an electronic signature, the investigator should mail a paper-based informed consent form to the subject, and make it possible for the subject to return the form after signing and confirm the signer’s identity. 
  • The investigator should clarify to the IRB whether electronic informational materials are considered part of the written information required by Japan’s GCP regulations, or whether they are only presented to subjects to facilitate understanding and are thus only reference materials.  If the required written information is presented via electronic materials, prior IRB approval should be obtained.  The investigator should also specify to the IRB how dynamic content, such as videos, is handled.  The electronic materials presented to subjects should be available to the IRB and the regulatory authorities upon request. 
  • During a Good Clinical Practice inspection of a clinical investigation site, signed informed consent forms and all written information presented to subjects, even if in electronic form, should be available at the site.  If the site uses a Cloud system to access or store the written information and consent forms, these records still need to be accessible at all times.  Any transfer of data from one Cloud system to another should not cause de-linkage of the written information/consent from the subject’s signature and date.
  • When selecting and using an information and communication system, investigators and sponsors should take appropriate measures, including security measures, based on the risks associated with the system.  Investigators should explain to subjects how to use the information and communication system correctly and safely.  When a sponsor provides an information and communication system for obtaining electronic consent, it should take into account the principles and recommendations above and assist medical institutions’ preparation to use the system to obtain electronic informed consent.  If the medical institution uses its own system, the medical institution is responsible for taking appropriate measures, including security measures, and ensuring there is appropriate training.

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Contributors for the China & APAC Food, Drug, Device, and Cosmetics blog:

John BalzanoJulia PostMuyun Hu, Annie Wang, Kaixin Fan, and Kexin Yang.

Photo of Kaixin Fan Kaixin Fan

Kaixin Fan is a member of the Litigation and Investigation and the Food, Drug, and Device Practice Groups. She has advised clients in various high-stakes disputes, including clients in the food, beverage, and consumer packaged goods industries in matters implicating consumer protection statutes.

Kaixin Fan is a member of the Litigation and Investigation and the Food, Drug, and Device Practice Groups. She has advised clients in various high-stakes disputes, including clients in the food, beverage, and consumer packaged goods industries in matters implicating consumer protection statutes. Kaixin also has experience in advising clients in complex investigations and counseling life sciences clients on FDA regulatory matters.

Kaixin maintains an active pro bono practice, with experience in the areas of housing, reproductive rights, and gender-based violence.

Photo of Julia Post Julia Post

Julia Post advises biotechnology, pharmaceutical, medical device, and trade association clients on a variety of federal and state regulatory and compliance matters. In particular, Julia has experience in areas including biosimilars and interpretation and implementation of the Biologics Price Competition and Innovation Act…

Julia Post advises biotechnology, pharmaceutical, medical device, and trade association clients on a variety of federal and state regulatory and compliance matters. In particular, Julia has experience in areas including biosimilars and interpretation and implementation of the Biologics Price Competition and Innovation Act of 2009; human cells, tissues, and cellular and tissue-based products (HCT/Ps); market exclusivity; informed consent requirements; and pharmacy substitution practices.

Prior to joining the Food and Drug practice group, Julia was a member of the Litigation practice group where she focused on representing clients in Hatch-Waxman patent litigation.