This article is written by Angela Gill Nelms and was originally published on medcitynews.com here.
Many of you have also consented for an approved medical procedure. You were running, fell, and hurt your leg. Your doctor needed an X-ray or CT scan to assess the damage. First stop – “sign here.” That is consent.
Consent, and specifically eConsent, can help empower participant engagement in clinical trials and should be an integral part of a research strategy. This begs the question: how can your research team effectively utilize eConsent and what are the risks of maintaining paper-based consent processes?
What is consent? What is informed consent?
Let’s start with the basics. Consent is a legal contract. At its core, it is intended to protect the rights of the consentee to have control over her body and medical decisions that impact it. Medical consent contracts in the US stem from four battery cases in the early 1900s: Mohr v. Williams, Pratt v. Davis, Rolater v. Strain, and Schloendorff v. Society of New Your Hospitals.
As a result of the 1914 case Schloendorff v. Society of New York Hospitals “informed consent” established legal precedence. Herein lies an important detail.
There is a difference between consent and informed consent. Consent is when you move to the last page of a document and sign where it says, “Sign Here.” Informed consent is a process where you read and collaborate with a consenter to fully understand the implications of the consent you are providing.
Informed consent takes commitment. Both parties must comprehend complicated or confusing information that may lead to unknown results.
Negative Impacts of Consent Errors
Some consents are easy. Yes, you may use my photograph in your advertisement. Yes, I will engage in an established procedure where the risk-benefit profile has been thoroughly tested.
Consents for complicated clinical research trials, however, can be 10 to 25+ pages describing information like the nature of the medical condition, potential therapies, how the therapy is used in the clinical trial, and potential risks and benefits.
Institutional Review Boards, sponsors, and researchers collaborate to put all of these details into simple language so that anyone can make an informed decision.
In an ideal world, the consenter will collaborate closely with the consentee so that all questions are answered, and the process occurs in a non-persuasive manner. But this is harder than it sounds.
Informed consent gone wrong can significantly impact the trial. For instance:
- Lack of participant comprehension.
- If the participant consents to something she didn’t understand, she may not participate as expected. For example, she did not realize that she has to return to the clinic every few months for blood draws, so she doesn’t show up.
- Participant dropout.
- Once the participant gets clarity on their original misunderstanding, they decide they no longer want to participate. For example, now that the participant understands she must go back for blood she decides to discontinue participation.
- Reduced enrollment.
- The potential participant is confused or feels pressured in front of the consenter and so she decides to forgo participation.
- Language barriers impede equal opportunity.
- A translator is not available to assist in the consent and so the potential participant is unable to participate.
Add this list to the many document pages and limited time available to consent the patient. The combination often leads to errors in the document(s). Sections that require initials and dates are missed.
The paper copy of the document is misplaced. A participant signs an older outdated version of the document.
It is clear that by 2021 there must be a winning solution for everyone. Arguably, this winning solution is called eConsent. Electronic Consent (eConsent) opens up a variety of possibilities to protect the potential participant, research team and ultimately drive the advancement of cures. A few key benefits include:
Access from any computer. Anywhere.
The potential participant may review the document from the comfort of their home, the doctor’s office, or a family member’s living room.
They have time in their preferred environment to focus on becoming informed. The researcher equally benefits. She doesn’t have to schedule an appointment for the participant to come into the office or wait for someone who qualifies to show up in the clinic. And she can expand her outreach so that more individuals have the opportunity to participate.
Structured consent formatting improves comprehension.
An electronic document opens the doors for a variety of media options to inform the potential participant. For instance, consent could include built in comprehension breaks, glossaries and even videos to improve the ability of the informed process to occur.
Increased inclusion of diverse participant populations.
The consent document can be easily translated in an electronic form so that an additional translator is not required during the consent process. It may also be read out loud by the computer with a screen reader to include participants with sight or reading impairments.
Data validation and version control.
Electronic systems ensure that those often-missed initials and dates are completed. Every time. Additionally, version control, audit trails and automatic filing reduce common FDA findings that negatively impact the clinical trial, site and investigator. Monitoring teams have access to the documents from anywhere and so if errors do occur, they may be identified earlier in the process to allow for correction reducing the negative impact.
Informed consent processes are complicated, confusing, and overwhelming for many participants in clinical trials.
Pair that with paper processes and time-limited researchers, and you have a recipe for risk. The risk that the trial doesn’t go as planned, participants drop out, and regulatory bodies site audit findings.
Creating the simplest process for informed consent benefits the potential participant by allowing them the time and resources to understand fully what they are consenting to. Through eConsent processes, research also opens the door to a more diverse population to engage in trials.
About the Author:
Angela Gill Nelms brings more than 15 years of research and trial experience to Florence Healthcare, marrying her sponsor and site clinical research with FDA inspection experience where she partnered with more than 60 US and European hospitals in over 50 trials. As the Chief Operating Officer at Florence Healthcare, Angela is charged with strategically guiding the direction of the company, creating a “Best Place to Work” culture, driving innovative products, delivering white glove customer service and making sure clinical teams around the world are successful. In 2016, Florence had one customer and now serves more than 8,500 research sites, sponsors and CROs in 30 countries across its innovative network.