Company blog exploring technology and transformation in clinical trials

Electronic Informed Consent: Types and Technologies

by on January 20, 2012 updated April 2, 2012

in General Tech & Innovation,Regulatory & IRB

Wondering if electronic informed consent is right for your clinical research study? My 2-part series will help you answer that question.

Mitchell Parrish of Quorum IRB recently led a webinar about electronic informed consent, which included discussion of regulatory and other considerations. In this series, I summarize the information presented by Parrish, as well as provide some additional commentary.

During part 1, I explored the basics of electronic informed consent, including the possibilities, benefits, and challenges. With that foundation in place, it’s time to explore the regulatory side of electronic informed consent, along with the technology used to facilitate that consent. To tie everything together and illustrate the theory in practice, I’ll describe an electronic consent platform currently being used in clinical trials.

As you assess various electronic informed consent platforms, you will need to determine the type of electronic consent used by that platform. As Parrish noted in his presentation, the type of consent will determine your regulatory requirements.

Types of Electronic Consent: A Key Regulatory Consideration

From a regulatory perspective, Parish distinguished between two types of consent, a full signature and an indication of consent other than a full signature.

Full Signature

A full signature is an electronic signature treated as though the signature were handwritten on paper. For example, a signature provided on a credit card scanning machine would be considered a full signature. Full signatures are typically not an option unless consent is conducted in-person at a facility with the required technological hardware and software.

OHRP allows full signatures as long as they are legally valid within the jurisdiction where the research is conducted, provided that the IRB considers the following:

  • How the signature is created
  • If the signature can be shown to be legitimate
  • If the consent document can be produced in hard copy for review by the potential participant

Should you choose to use a full signature, make sure to provide the IRB with adequate information to assess these considerations. If a full signature is not feasible, you need to understand regulations related to consent other than a full signature.

Square, a credit card processing startup, allows you to sign directly on an Apple device. In the clinical research arena, this indication of consent would be considered a "full signature."

Indication of Consent Other Than a Full Signature

Indication of consent other than a full signature can take several forms. For example, a participant could check a check box to indicate consent. Alternatively, the informed consent software could contain text telling participants that submission of the form or survey indicates consent to participate.

Though subject to fewer technological constraints, indication of consent other than a full signature has important regulatory considerations. DHHS and FDA regulations state that an IRB must require documentation of informed consent, as required by 45 CFR 46.109(c) and 21 CFR 56.109(c).

However, both regulations also permit IRBs to waive documentation of informed consent. This IRB waiver is required in instances when consent is indicated with less than a full signature.

Waiver of Documentation of Informed Consent

So when can you obtain an IRB waiver for indication of consent other than a full signature? Parish discussed applicable DHHS and FDA regulations.

Applicable DHHS Regulations

According to DHHS regulations, a study can qualify for a waiver of documentation of consent according to two criteria.

  1. 45 CFR 46.117(c)(1)1) the only record linking the subject and the research is the consent document and 2) the principal risk of the research is the potential harm from a
    breach of confidentiality
  2. 45 CFR 46.117(c)(2)1) the research presents no more than minimal risk of harm to subjects and 2) involves no procedures for which written consent is normally required outside of the research context

The applicable FDA regulations are slightly different than those of DHHS.

Applicable FDA Regulations

Though the FDA also uses the second criteria used by DHHS, it does not use the first. Therefore, FDA permits a waiver of documentation of consent according to the following regulation:

  • 45 CFR 46.117(c)(2)1) the research presents no more than minimal risk of harm to subjects and 2) involves no procedures for which written consent is normally required outside of the research context
fda electronic consent

The FDA regulations regarding IRB waiver of consent documentation varies slightly from that of DHHS.

To illustrate this regulation, Parrish provided the example of an online weight loss survey study containing questions about overall health and weight loss progress. Such an example would likely qualify for a waiver of documentation because it presents no more than minimal risk and involves no procedures for which written consent is normally required outside of research.

IRB Review of Consent Document

If a waiver of documentation of consent is granted, you still need to provide documentation that subjects will receive the appropriate study information. Therefore, the IRB must review and approve the “consent form” or “information sheet” provided to participants in electronic format.

Now that we’ve discussed the types of electronic consent, it’s helpful to understand the technologies used to facilitate that consent.

Technologies to Facilitate Consent

Parish provided several examples of informed consent technologies, as well as instances in which those technologies might be used.

  • Podcasts
    A Principal Investigator records herself explaining the study on a digital player for playback to potential participants
  • Embedded comments in consent forms
    Various sections of an online consent form have a link to a voice recording adding explanatory information
  • Videos
    In addition to a written form, there is a video explaining the study that includes diagrams, charts, and demonstrates various procedures
  • Interactive website
    Potential participants are provided access to a website containing multi-media that they can navigate to help further explain information about the study

IRB Review of Consent Technology

In addition to reviewing the consent document, the IRB typically needs to review electronic consent technology as well. Parrish encouraged those interested in using electronic consent technologies to communicate with their IRB. With good communication, your IRB can help you determine what requires review and guide you in the appropriate submission of technologies for review.

That’s the extent of Parrish’s very informative webinar, but to illustrate electronic consent technology in practice, I’d like to highlight an electronic consent platform currently being used in clinical trials.

Systemedicus: Electronic Informed Consent in Action

As noted in both parts of this series, a variety of technologies can be used to facilitate consent. Systemedicus, a company specializing in technology for clinical trials, offers a product that serves as an excellent example of the possibilities.

econsent systemedicus

This screenshot from the Systemedicus website shows various screens visible to participants during the consent process.

Their eConsent product is a patent-pending electronic informed consent platform on an Apple-based hardware/software system. The Systemedicus platform uses several interesting technologies to improve the consenting process and overcome some of the challenges of electronic consent.

Sophisticated Electronic Consent Features

According to the Systemedicus website, their eConsent platform has the following features:

  • …video records the entire consent process and records the page turns as the subject reviews the consent document
  • The subject is shown multi-media content regarding the study to enhance comprehension and retention
  • The subject will answer and interactive quiz to confirm their understanding and awareness of the materials
  • Using facial recognition technology along with a magstripe identity card and signature capture, the subject will authenticate their consent

If you read part 1 of this series, you know that electronic informed consent has great potential but is not without challenges. After surveying the technology used by Systemedicus, it’s clear that the developers were mindful of these challenges and constructed their platform to overcome them. For example, the use of facial recognition technology, a magstripe identity card, and signature capture addresses potential verification issues discussed in part 1.

The Advantage of an Apple-Based Platform

Aside from the technology features listed above, I really like that Systemedicus chose Apple’s iOS as the foundation for their eConsent platform. For one, Apple’s iOS is ubiquitous and many people already have experience with it.

But more importantly, Apple is unmatched in providing an extremely intuitive user experience. This experience is so intuitive, in fact, that even babies can operate Apple mobile devices. Think that’s hyperbole?

Check out this video:

So why does an intuitive user experience matter?

A recent study assessed the readability of informed consent documents. This study found the average reading level of consent forms to be consistent with the reading ability of an 11th grader. Meanwhile, IRBs and federal agencies often recommend that consent forms be written for a 6th-8th grade reading level. The growing consensus in the industry is that informed consent documents have become too complex.

Given this reality, we certainly don’t want technology that will further complicate the informed consent process. For this reason, an intuitive user experience is ideal for electronic consent. I think Systemedicus’ choice of an Apple-based product was a wise one given its accessibility to a variety of ages, educational levels, and technological skill sets.

Integration with eCompliance and eSource

Another nice feature of the Systemedicus eConsent system is that it integrates with their eCompliance and eSource system. Nick Taylor of Outsourcing Pharma did a great interview with Dr. Jay Udani, CEO of Systemedicus, who demonstrated the features of these eCompliance and eSource systems. The technology looks quite slick, as you can see by checking out the video at Outsourcing Pharma.

Will You Use Electronic Informed Consent?

Now that I’ve gone over electronic informed consent basics, regulatory considerations, and emerging technology, it’s your turn to share your thoughts. Have you used electronic informed consent? Do you think you will use electronic informed consent? What do you like about it? Do you have concerns? Please chime in below.

(DISCLOSURE: Medicus Research, a natural health CRO that is affiliated with Systemedicus, is a client of Rebar Interactive. But I would still think their technology was very cool even if that were not the case. On a general note, I do not accept payment for blog posts.)

Image Credits: Engadget and FDA

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  • Gfokoth

    This is a brilliant idea, moving with technology helps keep abreast and conviniently reach people. Especially when conducting surveys where a written signature is not always a must but a check box is sufficient. Making provision for electronic signature is great and authentication issues can be dealt with.This will be helpful if the investigator/designee will be available to answer any questions arising from the consent as you cannot perdict all the questions. 

     

  • Visions_2334

    Looks like people are researching on this subject.

    http://pro.sagepub.com/content/55/1/813.abstract 

    • http://rebarinteractive.com/ Rahlyn Gossen

      You wouldn’t happen to be one of the authors of this paper? :) Looks great. I’ll give it a read.

  • Pingback: The 6 Best Rebar Interactive Blog Posts of 2012 • Clinical Trial Patient Recruitment & Digital Marketing

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