Digital Informed Consent

Clinops toolkit econsent for clinical trials

eConsent Webinar by Quorum

I attended a webinar last month about including eConsents (for example on tablets, iphones, or other electronic devices) in the operations of your trial for consenting subjects.  It was a case study presented by Quorum Central Institutional Review Board (IRB) and an eConsent provider.there are benefits and risks with eConsent forms for clinical research

Obviously, everything we are sharing with our patients has to be reviewed and approved first by an IRB.  We’re all so used to dealing with paper that electronic submissions or submissions of digital materials bring with them additional administrative burden at this point.  The case study gave helpful background on the relevant regulations and guidances alongside a presentation of some potential benefits and obstacles to implementation.

Potential Benefits of eConsent

  • As we embrace centralized monitoring, tools like eConsent will be critical to permit access, auditing, and remote monitoring.
  • We can inform more and assist our patients with a better understanding of the protocol through video-modules or other educational components.
  • Since the signatures will be electronic, there is the promise that consent forms will no longer become lost or missing.
  • We’ll benefit from improved version tracking and standardization.

Some Perceived Issues with eConsent

In no particular order, here are some of my current concerns about deploying an eConsent strategy at some or all of my study sites.

  • will econsent be confusing to my study sites or potential study participantsPrivacy and confidentiality are a huge concern. This was addressed in the webinar and one of the speakers acknowledged that devices and laptops are often stolen.  If you are using eConsent in your trial you will need to ask questions about the storage and encryption of the data.
  • Limit to the “Exchange” – the consent process is meant to be a conversation and should not be time-constrained or private.  The potential study participant needs to be able to ask questions and understand the consent process.  How will they have this exchange if they are just left alone in a room holding a tablet or another electronic device with an eConsent to advance through?  Once they return the completed eConsent, how will they know and remember that they can withdrawal consent at any time.  Where will they get contact information for the investigator and the IRB in case they experience issues during or after the trial? Will they still have to have a paper copy or an emailed version on the consent?
  • Set up and approval – using eConsent will take some lead time 1) to educate the IRB and 2) to program and develop.  Extra time at the start of a clinical trial is a luxury most study sponsors typically do not have.
  • Training – will my study staff find it confusing or difficult?  Will potential study participants be suspicious or nervous?
  • Logistics There are other operational concerns including implementation costs, security, and system constraints (will it work if there is no wifi or a secured network? Where will I store and charge the devices?
  • Consents change – if there is an amendment or any new information to add to the consent, then the eConsent will require additional programming and approvals.  This issue was covered in the webinar and they actually suggested a hybrid approach of eConsent at the beginning of a trial and paper for any amendments.

Your Thoughts?

Don’t get me wrong, I really enjoyed the webinar and I found the idea of eConsent interesting but I’m not signing up just yet.  Would you agree that there is seemingly a lot of extra complexity being introduced when choosing eConsent as a service offering in your trial?

Have you participated in a trial that used eConsent?  What were your impressions and how was the experience overall?  I’d love for you to leave me a comment below, discuss your experience in the LinkedIn ClinOps Toolkit group or on Facebook, or just email me.

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About The Author

Nadia

Nadia Bracken, lead contributor to the Lead CRA blog and the ClinOps Toolkit blog, is a Clinical Program Manager in the San Francisco Bay Area.

4 Comments

  • Dr. EKPauli

    September 13, 2013

    I attended the webinar organized through Quorum IRB and have done some investigation on this topic (eConsent). I am hoping you will address my questions:

    (1) What is the FDA ruling on eConsent (there is NO signed, original, informed consent for their review if audited)? I have asked for ruling documentation from CROs and Sponsors interested in using this technology for clinical trial participation but nothing has been provided.

    (2) Do you have data on consent rate relative to a face-to-face consent?

    (3) What are the disease types that have utilized an eConsent format?

    (4) Do you have stratification information regarding age segments vs rate of consent?

    • Nadia

      Nadia

      September 15, 2013

      Hi Dr. EKPauli, you raise some interesting questions but I have not worked on any trials utilizing eConsent in order to answer. I hope that others will chime in to give us more information on whether the consent rate is inconsistent with face-to-face. I am also curious whether eConsent is more appropriate for various age segments. Having worked with elderly subjects and cognitively challenged subjects, I wonder if eConsent would be the best approach.

      I’m not aware of any NDAs that have been submitted yet with eConsent components. I am interested to hear if anyone is aware of eConsent being used successfully in an inspected study and regulatory applicaiton.

  • Alaina Dixon

    Alaina Dixon

    August 9, 2013

    Great article! MD Anderson and University of Texas Hospitals (maybe not all yey) use eConsents for both clinical research and non-clinical research (eg consent to treat). The reduction in ICF completion and other consent errors is significant and a major TOS saver for CRAs. (IMO)

  • Shawn

    July 26, 2013

    Amazing work on this site, Nadia! I absolutely concur with respect to taking the initiative to inquire into storage and encryption of data for eConsent users. This is a very pressing and vital topic in the industry. Very insightful read!

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