The limitations of paperwork are one of the major bottlenecks in clinical research studies. Recruitment is one of the most laborious and resource-consuming elements of running a study, and yet it is the most critical when it comes to patient retention.
This means there’s no room to cut corners at the initial stages of a clinical study. However, there are ways to streamline the process. Consent forms are cumbersome, slow, and prone to getting lost or outdated. Further, they’re viewable by anyone who shares a space with them.
eConsent forms, on the other hand, offer improvements in speed, accuracy, and security of patient data, as well as boosting the range of patient education materials needed for an applicant to give informed consent.
It’s always better to have in-person conversations with patients in a clinical research context, but this isn’t always a practical reality. eConsent also allows remote access to patients who otherwise would be out of reach.
So, what is eConsent (or e-Consent) for research? And how might it boost the efficiency of your studies? Let’s find out.
The Importance of Informed Consent and e-Consent for Research
Consent comes in many forms, but as a component of ethical practice, in research terms, it necessarily must be informed. Informed consent is a critical component of recruitment in human research, and implies that the person consenting knows and fully understands what they’re consenting to.
The importance of informed consent is particularly emphasized in contexts such as human research because of the common divide in scientific literacy between the researchers and the average participant.
Essentially, what this means, is that participants in research are not commonly educated on the topic that the research is covering, and may have little to know scientific education at all. Hence, in order to consent to the degree required by ethical considerations, they must be updated on some of the principles and practicalities of what they’re being asked to do.
This process of informed consent safeguards patients against exploitation ensures closer compatibility of patients with the study and improves engagement and sense of value from the patient’s perspective throughout the research period. Each of these results in a more statistically powerful trial that is compliant with modern ethics.
One part of informed consent that is particularly important is the knowledge that the participant can withdraw consent at any time. Commonly, this piece of information must be understood along with the following:
- The length and purpose of the trial – Trial length is a direct contributor to patient dropout rates, so it’s a critical piece of information for participators to understand for the benefit of both parties.
- The possible risks and benefits of the trial – As an ethical necessity, patients must be educated on the potential outcomes of any intervention, both good and bad.
- What to expect during the trial – setting expectations is also an important part of retaining participants for the long haul.
- How a patient’s personal data will be used – Patients may consent to different levels of data usage, and it’s important that they’re aware of how it will be handled and used.
It is the responsibility of the researchers to ensure the information around these topics is accurate, and that the informed consent procedures are understandable and fair. A participant then needs to be given as much time as they need to understand and make an informed decision.
So, it should be clear that consent is a painstaking yet critical process, especially in research with high levels of participation. This is doubly true for complex study protocols, which take longer to explain and are harder to understand, and may change throughout the study, requiring more than one round of participant consent.
With an eConsent platform, this process is simplified by presenting patients with two-way communication channels that can allow participants to ask questions and gather information in a manner that is more convenient and digestible to them.
eConsent, therefore, has a lot of potential to benefit the ethical, financial, and time constraints of human research, especially in clinical trials.
What is eConsent in Clinical Trials?
eConsent is not a complicated concept; it’s a simple method of expressing consent to participate in a clinical trial using electronic means. An eConsent platform uses eSignatures, which replace the need for ink signatures in confirming the desire to participate.
This is a system that’s being widely accepted and saw a huge boost in usage during the pandemic restrictions, and is being more commonly accepted by ethics committees and institutional review boards (IRBs) as a viable method of obtaining informed consent from participants.
The most important factor that clinical trials must consider when using eConsent platforms is that by no means must the new approach jeopardize informed consent. That is, there can be no drop in the level to which patients are informed about the trial, and they must voluntarily confirm their willingness to participate after having been informed on all aspects of the trial relevant to that decision.
So, eConsent in clinical trials is a more convenient and secure way of gathering consent, for distributing information to inform participants. It is not a shortcut or a replacement for one-on-one meetings.
If this still feels relatively abstract, we can draw upon an example platform. Here’s an example of what this might include:
A generalizable Research Electronic Data Capture (REDCap) web application is set up to meet the criteria of a clinical trial.
From the study side, the application should include the following:
- The framework addresses all the regulatory requirements of informed consent, referencing the FDA’s part 11 of Title 21 of the Code of Federal Regulations and ensuring compliance, as well as elements such as version control, and facilitation of other elements of consent.
- It’s set up for ease of monitoring and adjustments by IRBs, study teams, and review by other stakeholders such as sponsors and monitors. Each stakeholder has their own limited access to the platform, based on their needs.
- The framework can accommodate multiple versions of the same consent and multiple consent types within the same study, such as consent on behalf of another. This makes changes in protocol easy to describe and fast to acquire consent for.
- It can collect and track user interaction metrics for review purposes, allowing investigators and platform designers to improve protocols or interfaces as necessary from the data this provides.
For patient considerations, it should:
- Contain all of the relevant information to inform a patient, in easily-digestible formats, relative to their needs. This may be in audio or visual form, and include selectable modules of information for the patient to cover at their convenience.
- Meet the patient where they are, whether this is in terms of location or technological literacy, health, and experience. This means, that not only the format, but the accessibility needs to match patient contexts. Whether this is a PC application or a mobile device.
- Provide ease of data entry with an appropriate user interface. The style of the interface, the language options, and the navigation should be tailored to its audience, and customizable for segmentation.
- Be accessible on patients’ personal devices where appropriate. This maximized the strength of the remote capabilities and user-friendliness of the platform.
What all this amounts to at its most basic level is a user-friendly consent form that is accessible on a platform that can also host the relevant information to make that decision to consent. Clearly, this is a much more advanced form of consent process than the traditional pen and paper approach.
Whether a patient is considering initial consent or wants to consider dropping out of the trial and requires more information, this platform allows them to gather the appropriate educational material, ask the right questions and make an informed decision, all with an online application.
This system is a step up from paper consent forms in several ways, not least in the speed with which this information can be disseminated. Let’s take a look at some of the ways it differs from the more traditional approaches.
Paper Vs. eConsent in Clinical Trials
Traditionally, consent forms are pen and paper methods of acquiring and storing information. Many of the advantages of eConsent over the paper alternative relate to the speed, security, and efficacy of managing these data.
While a paper consent form can be uploaded to a digital medium, the eConsent form begins as digital and can be stored and backed up at the moment of creation. This skips the need for data copying, which is a weak point for data integrity and expedites the process as a whole.
It’s also possible to make eConsent forms more secure to access with security devices such as 2-factor authentication for both recording and accessing, something which is impossible with a hard copy.
Another advantage over paper consent is that the platforms used for eConsent forms can be updated remotely with current or specific information on things like data privacy rights, as well as allowing consent version control across all sites with immediate effect. This eliminates the risk of out-of-date forms being used and the need to recall old documents.
Paper consent, then, is inherently less organized and less secure, but one of the major roadblocks that recruitment faces is in the time it takes to access each individual and secure their participation and informed consent.
Manually assigning each patient consent forms, or relevant educational literature, then receiving them back for collection, recording each, and storing them safely takes a lot of time and human resources that with eConsent platforms is immediately relived.
Further, paper consent forms cannot be updated remotely or en masse, and contain limited information and accessibility relating to customer feedback and enquiries.
This is mitigated tremendously with electronic consent procedures and allows for more complex studies, larger recruitment drives, and much faster distribution of relevant information to patients along the way.
eConsent in Clinical Trials Can Improve Your Study
From a patient perspective, the benefits of eConsent to the overall experience are clear. However, there are also many benefits from the side of the researcher, relating to the convenience and quality of the data you can get from a good eConsent platform.
eConsent for research has some serious strengths that are worth exploiting in certain studies, more than others. Here are some examples of where such a platform can boost your study:
- Decentralized studies – Decentralized studies can throw up some roadblocks when it comes to on-site visits. Implantable devices are a good example of this. While class I and class II devices may not always require an on-site visit, there are many cases where a participant will still be called in. For class III, however, in-patient settings are a necessity and with a push towards more decentralized studies, eConsent can play a powerful role in keeping investigators connected with their patients.
- International studies – For the same reason, international collaborations can greatly benefit from the remote capacity of eConsent for research systems.
- Mid-study protocol change – The ease of adjusting consent forms on a server and updating the relevant information for patients affected by a protocol change is one of the most significant benefits of the system. Patients can be consulted, updated, and reconsented immediately and remotely with eConsent systems if needed.
- Past Participants – It’s a simple extension of the application to reach out to past participants of previous studies and get their consent for new uses of their data. This is a tremendous time-saver and doesn’t involve any physical risk, since the procedure is already finished. Thus, in-person meetings are not as critical.
With all these advantages, it’s tempting to jump right in, but before anyone employs eConsent for clinical trials, they should know the challenges around it and its limitations.
Challenges That Arise When implementing eConsent
When implementing any new system, there are always going to be considerations for its efficacy, its range of applications and simply how to make the best use of it to solve the problems it’s designed to address. Of course, this is true for eConsent systems, so before jumping in, take a look at some of the challenges investigators face with such a solution:
- True intent – consider the disclaimer forms and licensing agreements attached to every piece of software you install. By clicking ‘accept’ without reading it, you are consenting, but you’re not informed. The same danger is present when using eConsent with patients. It’s important that researchers have true intent to inform their participants, not simply to go through the motions and get the form checked. eConsent is not a shortcut!
- The location – eConsent is still a new concept, and in many locations, there often aren’t any set guidelines on getting it approved. This means it’s important to be mindful of where you’re planning to run it, and perhaps, where possible, tailor the site preference of the study design with this in mind to maximize its application.
- In-person consent is still preferable – The best way to guarantee that an applicant is informed is still to be there in person. eConsent is not a way of replacing in-person consent under all circumstances. It should be used to make the impossible possible, i.e., reach more participants in a shorter amount of time, and increase the accuracy of their responses, but it should not ultimately replace personal interventions by investigators. In fact, eConsent itself can be used in person, on the patient’s own device. This combines the benefits of both approaches by providing a streamlined and accessible means of acquiring, recording, and storing informed consent while allowing a personal connection between investigators and their patients.
- Which devices? – The technology you plan to use will matter. Whether you want participants to consent on-site or remotely, can they use their own devices?
- Testing – Any eConsent system you’ll be using needs to be tested in advance, with real users. The closer these users resemble an actual study, the better. This means handling signature flow and checking out the user experience of new content you’re adding before it goes out to life participants.
- Older cohorts – For elderly participants, or participants who are otherwise less familiar with the technology involved, eConsent might be a tricky thing to navigate.
Before using eConsent in clinical trials, mull over the limitations of the system and be sure to understand what it can and can’t do. This will ensure you’re getting the most out of the platform and not making any sacrifices to the quality of your study.
Conclusion
Implementing eConsent for research applications to your study could be a game-changer. Reach applicants where they are, disseminate critical information for informed consent, and store and process data in a secure yet accessible manner, all with one platform.
The cascade of benefits that come from a platform like this culminates in faster recruitment, bigger cohorts, better data, and more attainable deadlines. Further if used correctly, such an application can boost patient retention and thus improve the statistical power of the study itself.
