Three Focus Areas That Build Trust With Participants in Informed Consent Programs
The cornerstone of access to any clinical research project is the informed consent process–the decision of a participant to join a study based upon full and complete sharing of information about what the study will require, the risks of participation, and the voluntary nature of that participation.
This isn’t simply the participant’s signature on a paper or electronic form. According to governmental organizations like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), that signature is only part of the process. Of perhaps even greater importance is the provision of information to the patient accompanied by a discussion of the study and a chance to have questions answered, so that the decision can truly be considered “informed.”
What Is Informed Consent?
Clinical trial sponsors require participants willing to involve themselves in short or long-term evaluations. Thus, they must provide details on several study elements. This is included in a paper or digital-based informed consent document called an ICF (informed consent form).
The numerous items contained in one of these documents are outlined in the ICH GCP E6 R2 guidelines by which clinical research studies must abide. Some of these requirements are highlighted below, the full list can be found in section 4.8.10 of the E6 R2 document:
- Sponsor-provided information on the trial’s potential benefits and risks
- Trial protocols and procedures
- Statements that let subjects know they can refuse treatment or leave the study without losing entitled benefits
Once this material is reviewed, a participant must acknowledge their voluntary participation by signing the informed consent form. The form is countersigned by the PI (principal investigator) or another qualified person from the site, attesting that the participant has received all the information, has had the opportunity to ask any questions, and is making an informed decision.
Challenges to Informed Consent
The informed consent process includes many challenges, beginning with the requirement to communicate complex scientific protocols in language accessible to the layperson. And, the information that must be communicated to a potential participant becomes more complex with the ever increasing demands of modern day protocols. Researchers are also faced with explaining the risks of participating in clinical research and the protection of a subject’s personal data. Other challenges include addressing participant anxiety about new procedures and navigating the involvement of caregivers or legal representatives when, due to age or capacity, subjects cannot provide consent for themselves.
Then there are issues related to the informed consent document itself. These documents are often very technical, up to 25-30 pages in length, and written in advanced language at a high reading level. Among the challenges here are the intimidating appearance of the paperwork and the potential for the subject to have difficulty grasping complex medical terms.
Improving Processes, Building Trust
As shifting populations and advanced technology continue to transform clinical trials, sponsors must consider three core informed consent areas to help improve the consent process:
Simplify and personalize the content
Content requirements in the FDA, EMA, and the ICH GCP regulations describe what is expected to be included in an informed consent form. ICFs are required to convey all of the protocol required procedures, as well as the potential risks associated with each of these. However, this can often result in overly technical and complex language that can be intimidating to the reader. This not only increases the length of the form, but also causes frustration and anxiety for potential participants.
Instead, it’s best to utilize plain language in informed consent paperwork. Sentences and paragraphs should be short. If technical terms must be listed, they should be further explained in the document’s body, and listed in a glossary for further reading. As a guidepost, documents should be written at an 8th-grade reading level, approximately that of a 13-year-old.
Every clinical trial is different, and so each informed consent document must reflect the needs of the potential participants and the condition the therapy intends to treat. Consideration should be given to alternative ways of presenting this information, such as video, audio, or interactive graphics to take advantage of the digital capabilities of electronic consent.
During construction of the informed consent one should also consider the cultural aspects of its targeted group. If needed, test the language with representatives of a Patient Advisory Council (PAC). These are networks of advocates who advise sponsors on ways to improve patient access, experience, and outcomes, and can provide helpful insight into how an ICF will be received.
Use a variety of digital delivery channels
There’s no longer any reason to hand-deliver a multi-page consent document to potential subjects. On top of being environmentally unfriendly, it’s often not a feasible solution in a decentralized clinical trial (DCT), where patients are often remote. Thus, delivery through electronic consent should be a prime consideration alongside how to facilitate the remote consent discussion through the means of a connected ‘telemedicine’ interaction.
Also, take into consideration the type of device that trial participants will use for these digital deliveries. More than half the global population uses their smartphones to receive emails and text messages and the average US adult spends 4 hours per day on a mobile device, highlighting the rise in the consumption of digital information through smart devices.
And even where consent will be on-site, there are significant benefits to the digital presentation of information. Digital delivery makes it easier to personalize communications, and digital creation of source content makes it easier to repurpose content to other channels. The update to ICH GCP E6 makes specific reference to considering the use of technology to improve the consenting process.
Use technology to reduce the consent processing burden for participants and researchers
Interviews with Medable PAC representatives reveal the biggest issue with informed consent forms is the lack of clinical trial information. Applying digital technology can reduce the burdens of the consent process for both participants and researchers, whether remotely or in a clinic.
eConsent is one method for reducing this burden on sponsors and subjects.
- Digital delivery of informed consent information
- Provides enhanced multimedia information that participants can review in-depth with family members and caregivers
- Improves participant’s trial comprehension and information retention
TeleConsent is another tool that improves patient comprehension while facilitating a remote consenting process.
- Enables remote consent, accelerating patient screening and enrollment
- Enables visual engagement with trial representatives to build trusted relationships, even over a remote connection
- Gives participants the power to digitally consumer and sign ICFs from the comfort of their own home or local clinic
With the normalization of DCTs and wearable technology by medical and pharmaceutical organizations, a trusted informed consent platform ensures integrity is maintained and expectations are understood by participants. This is why Medable relies on its PAC to enhance the performance of our eConsent and TeleConsent platforms.