Table of Contents:
- e-Consent: A Key Advancement in Clinical Research and Digital Health
1.1. Electronic Informed Consent: Definition
1.2. Informed Consent in Medical Research and Ethics
1.3. Moving from Paper-based Informed Consent to Digital Consent
1.4. Benefits of Electronic Informed Consent
- Digital Consent Design and Bioethics
- Types of Digital Consent Forms and e-Consent Systems
- Electronic Informed Consent and Multimedia Tools
- Teleconsent, Electronic Signatures, and Clinical Trials
- Digital Consent, Electronic Health Records, and Patient Preferences
- Self-administered Electronic Informed Consent and Patient-centered Research
- Digital Consent and Interoperability between Legacy Systems
- Electronic Informed Consent in Prospective Cohort Studies and Follow-ups
- Digital Consent: Conclusion
1. e-Consent: A Key Advancement in Clinical Research and Digital Health
1.1. Electronic Informed Consent: Definition
With the increasing use of digital health tools, electronic informed consent is becoming a key component in medical research and routine clinical care. The digital consent process refers to sophisticated software programs and standards, which provide interactive tools for obtaining informed consent. Note that according to the US Food and Drug Administration (FDA), “electronic informed consent refers to using electronic systems and processes that may employ multiple electronic media, including text, graphics, audio, video, podcasts, passive and interactive Web sites, biological recognition devices, and card readers, to convey information related to the study and to obtain and document informed consent.” Since a vast majority of patients worldwide have access to mobile devices and a data plan, e-Consent provides numerous forms of interactions and customized options, which can boost self-paced learning and retention of information. Smartphone-based features, such as GPS options and telephone tapping, can improve knowledge acquisition and voluntary enrollment; all in accordance with international legal and ethical requirements.
1.2. Informed Consent in Medical Research and Ethics
e-Consent supports information disclosure, voluntary participation, and informed decision-making – three core elements in research ever since the adoption of the Declaration of Helsinki in 1964. Informed consent is fundamental in research ethics. The consent process involves giving information and obtaining consent prior to research. Clinical research that involves human participants must be accepted and understood by the participants themselves. In fact, informed consent is defined by the International Conference on Harmonization – Good Clinical Practice (ICH-GCP) guidelines as a process in which “a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate.” Note that Good Clinical Practice (GCP) is an international ethical standard guidance for designing, conducting, and monitoring clinical trials. The digital consent process, in particular, empowers patients and becomes a key component in patient-centered care.
1.3. Moving from Paper-based Informed Consent to Digital Consent
Clearly, e-Consent can revolutionize medical research and routine clinical care. As explained above, digital informed consent is much more than obtaining a patient’s signature on a paper form or a click on a mobile device. Acknowledging the complexity of today’s clinical trials, the consent process is a legal and ethical requirement. The digital consent process requires experts to provide sufficient medical information about a clinical study, which can facilitate comprehension and retention of knowledge. During this process, participants should be given an opportunity to discuss and ask questions about potential risks, alternatives, and further treatments. With the adoption of numerous technological advancements in clinical trials and medical settings, it’s logical to assume that all paper-based health care procedures are shifting to digital innovations. From electronic data capture to electronic patient reported assessments, the consent process is no exception. Study sites can adopt innovative tools, and BYOD approaches to obtain patient consent and guarantee scientific success. Electronic consent tools can improve patient understanding of the protocol and protocol compliance. Also, digital tools can help sponsors and researchers monitor the consent status at a study site, in real time and at low costs. By providing medical information and ensuring patient safety, researchers can increase enrollment rates, improve recruitment and retention, and ensure medical success.
1.4. Benefits of Electronic Informed Consent
Technologies are reshaping standard medical practices worldwide. Research shows that digital tools surpass paper-based consent forms and improve doctor-patient communication. With a wide range of digital capabilities, electronic informed consent reveals numerous benefits for patients, researchers, and sponsors:
- Knowledge acquisition and engagement: e-Consent forms can provide detailed and standardized information, which can be customized in accordance with a patient’s needs (e.g., hyperlinks, videos, spoken text). For instance, online tools eliminate the need for long paper forms, which often contain pages of complicated terminology. Additional links, visuals, and games can help patients obtain detailed information and a clear understanding of the study protocol. With a wide range of capabilities, digital consent leads to better understanding and high engagement. We should note that social media platforms and online support groups also lead to an increase in patient motivation and engagement.
- Convenient and accessible: Digital consent is effective and convenient at the same time. Electronic informed consent forms are widely accessible. Users can read the consent form at home, without feeling pressured to sign the document. In fact, self-paced learning can help patients form questions and gain a clear understanding of the study protocol. E-consent can also increase the involvement of underrepresented populations in research, such as people in remote locations and patients with disabilities. Here we should mention that e-Consent can benefit the involvement of pregnant women, previously categorized as vulnerable subjects.
- Patient-centered care and digital health: Informed consent is fundamental in bioethics. Electronic consent, in particular, can empower patients. It becomes one of the leading tools designed to optimize health research and patient-centered care. Interestingly, patient-centered care is one of the main aims in today’s digital health practices. Since patients are perceived as equal partners in health care decision-making, they are given control over their health data.
- Scientific findings and interoperability: Sponsors, research sites, and contract research organizations can also benefit from digital consent. Electronic informed consent can lead to high enrollment, retention, and comprehension. At the same time, standardized procedures can decrease the need for staff training across multiple sites. Digital consent can reduce costs and optimize health outcomes in the long-term. User-friendly e-Consent, for instance, can facilitate collaboration and interoperability around the world.
- Safety and regulations: By improving recruitment methods and reducing on-site monitoring, digital consent can lead to a significant decrease in regulatory compliance risks, delays, and costs. Interestingly, a recent survey across 418 sites across the globe revealed that researchers believe that e-Consent can reduce site burden and improve doctor-patient communication. Patients also agree that e-Consent is beneficial and satisfactory in research and practice.
- Advanced technologies beyond borders: What’s more, e-Consent software programs provide a wide range of sophisticated features, such as electronic signatures, remote monitoring, and interactive tasks, which can improve medical research worldwide. Health technologies are reshaping the future of medical research and e-Consent is one of the key advancements in today’s tech-based world.
2. Digital Consent Design and Bioethics
In today’s digital world, health apps and wearable devices collect vast amounts of information. Thus, electronic informed consent with all its advantages over standard methods becomes an essential ethical requirement. Note that electronic consent is defined as consent designed for a mobile device without direct interactions with a health professional. Electronic consent, as stated earlier, can lead to voluntary engagement and higher comprehension.
Despite the need for informed consent in research and bioethics, studies show that the consent process needs to be modified to meet patient needs. Due to the length and complexity of digital terms and policies, users are used to accepting legal provisions without reading or understanding them (Wilbanks, 2018). Digital consent, on the other hand, supports knowledge acquisition and transfer of information. The design of e-Consent forms tackles vital factors, such as readability and retention of knowledge. Large-font titles, visuals, and interactive steps can support the whole e-Consent process. Users must be encouraged to express their thoughts in a relaxed environment and discuss any relevant questions with their health provider. In digital settings, this goal can be achieved via the successful integration of “Move forward” and “Elect to learn more” buttons, for example.
Interestingly, Wilbanks (2018) described an innovative digital consent form, designed as a software product and released as an open source tool. We should note that a promising approach in digital consent is the design of fictional participant archetypes. Each subject can select a persona and a fictional story concerning their enrollment in a particular clinical trial. By visualizing the topic and testing various scenarios, users can understand the whole process and its ethical implications. Games and interactive tools can also benefit the digital consent process. For instance, quiz-based games can help users gain deep knowledge about medical procedures, potential risks, and legal requirements. A/B testing, on the other hand, can help developers test different versions and design an effective digital consent tool. Simply because in health care research, electronic informed consent and bioethics go hand in hand.
3. Types of Digital Consent Forms and e-Consent Systems
From security technology to consent forms, bioethics and patient safety always come first. Patients’ medical data is highly sensitive, and consent forms become an essential ethical requirement in health care settings. Informed consent is mandatory prior to accessing and employing patients’ data (e.g., electronic health records). To improve the entire process of digital consent development, experts must review different types of e-Consent systems (Coiera & Clarke, 2004). Recognizing the complexity of today’s medical studies, a wide range of electronic consent forms can be designed and customized in accordance with study protocols and patient preferences. Note that as the relationships between health care organizations and patients are complex, full (blanket) consent is not always recommended. Common e-Consent types involve general consent (opt-in), general denial (opt-out), general consent with specific denials, and general denial with specific consents.
Additionally, Coiera and Clarke (2004) revealed that in order to be effective, e-Consent systems must perform some essential operations. For instance, e-Consent systems must be able to verify a person’s identity, check their role in an organization, recognize a set of defined purposes and consent instructions, retrieve consent, and record the delegation of consent. Most of all, e-Consent systems must integrate security services and standards to guarantee patient safety. In e-settings, this goal can be achieved via standardized sets of rules. However, standard legal frameworks, such as the Health Insurance Portability and Accountability Act (HIPAA) often codify electronic consents in automatic behaviors. Such automatic behaviors can become burdensome in emergency practice and routine clinical care. To set an example, unauthorized clinical staff may be refused access to a patient’s data in emergency situations. Hence, digital consent developers must find the middle ground and create a flexible and standardized e-Consent system.
To find such a balance between real-world settings and regulatory demands, experts should agree on the actual purpose of the e-Consent process. Usually, digital consent can fulfill three vital functions. It can be used as a gatekeeper; as a matter of legal record; or as an audit trail. When used as a matter of legal record, the consent form is more or less passive and required only in legal disputes. When captured as an audit trail, digital consent can be more disruptive to medical care as clinicians must verify they understand the specifics of the given consent. Finally, when the e-Consent document is used as a gatekeeper, only individuals who match the conditions specified in the record can gain authorized access. Thus, before the actual implementation of an e-Consent platform, different types of digital consent and functions must be examined. Electronic consent systems must be developed in accordance with standardized rules, study specifics, and patients’ requests all at the same time.
4. Electronic Informed Consent and Multimedia Tools
In medical research, decision-making is a challenging process. As stated above, e-Consent systems vary between studies and protocols. One thing is certain, though: electronic informed consent is mandatory. The consent process is not only a legal requirement but an ethical principle, which can help patients make an informed and voluntary medical decision. Nevertheless, the effective transfer of information regarding treatments and risks is a complicated task. Complex terminology, limited time, and lack of transparency often affect patient consent (Bethune et al., 2018). In fact, experts agree that consent forms are difficult to read and comprehend, especially for non-native speakers. An analysis of more than 500 consent forms revealed that participants need over 15 years of formal education to understand study protocols. The levels of comprehension and retention of knowledge among patients are also low. To set an example, studies show that a large number of cancer patients are unable to name the medications they take on a daily basis (nor potential side effects).
With the leveraging use of health technologies, as explained above, complicated paper-based forms are slowly replaced by e-Consent forms. Digital consent can facilitate the acquisition and retention of knowledge. Electronic forms are easy to access and read. In addition, multimedia tools and booklets can enhance knowledge transfer and understanding. Bethune and colleagues (2018) revealed that an electronic booklet could enhance patients’ knowledge and improve surgeon-patient communication. Note that their research team recruited 38 patients eligible for lumbar spine decompression for degenerative disease, cervical spine decompression, craniotomy for the brain tumor, and trigeminal neuralgia treatment. Consequently, the recruited subjects were assigned to two groups: 18 to the control group (standard consent discussion), and 20 to the intervention group (e-book in combination with standard consent discussion). The subjects in the intervention group manifested higher levels of knowledge acquisition and retention, enhanced by the e-book they were presented with.
In fact, interactive educational tools can help patients gain a better understanding prior to surgery in a relaxed environment. Patients can choose between texts, animations or illustrations, which can prepare them prior to the actual discussion with their health provider. This is essential because usually, anxiety and perceived risk of negative outcomes affect the standard consent process (especially in rare and complicated cases). Multimedia consent will lead to consistent information and better user experience, for both patients and doctors. For instance, multimedia consent tools can optimize medical resources, reduce the need for staff training, and minimize waiting times. Effective consent procedures can also lead to a decrease in legal cases. Note that in Canada alone, 21% of all legal cases revolve around informed consent, with 65% of those disputes involving a surgical procedure. As a result, multimedia consent is becoming one of the most beneficial aspects of medical research and surgical practice.
5. Teleconsent, Electronic Signatures, and Clinical Trials
Teleconsent is another growing area of research, which can improve clinical trials and routine medical care. Telemedicine technology, which helps patients obtain medical care remotely, can be particularly beneficial in clinical trials (Welch et al., 2016). Paper-based consent forms, as explained above, have been slowly replaced by digital health tools. Note that some of the popular methods to obtain consent remotely include phone calls, email correspondence, and e-Consent. Teleconsent, in particular, can benefit clinical trials which often face low enrollment and poor retention rates. In fact, data shows that 90% of clinical trials fail to recruit the targeted number of participants in a timely manner. This burden on research can lead to poor results, additional costs, and early termination. Telemedicine can reach subjects beyond borders, especially those living in remote locations. In fact, teleconsent can complement the traditional consent process, and help experts recruit subjects worldwide, eliminating travel times and additional costs. This particular aspect of e-Consent will empower underrepresented populations and benefit the study of rare diseases. In addition, a centralized teleconsent model can benefit study sites and researchers. To set an example, a centralized consent system can allow a single person at a central location to obtain consent forms for a multisite study. In the long-term, the teleconsent approach can reduce training costs, errors, and bias.
In a recent study, Welch and colleagues (2016) examined an interesting approach to teleconsent. They designed an environment in which researchers and patients went through the given consent process together (e.g., during an online call). Note that the consent form was coded in HTML5, which allows text, audio, and interactive functions (e,g. select text or checkboxes in real time). To guarantee patient safety, consent forms were saved in a PDF format, and further changes were disabled. Another promising approach to a patient’s confidentiality is the use of browser-based data only. The study showed that teleconsent in real time could help subjects obtain a complete understanding of the study protocol. At the same time, teleconsent can help researchers deal with additional issues, such as missing data.
Despite the impressive benefits teleconsent reveals, one of the major challenges in research is the need for an electronic signature. An electronic signature is an effective tool in digital health, which indicates that a person agrees with a given protocol. Typing a name is not enough to guarantee patient safety, though. Interestingly, Welch and colleagues (2016) used a photo signature approach: a snapshot of the user at the time of signing the file. A capture of a person’s face can reveal vital non-verbal signals in real time, such as anxiety, confusion, and willingness to enroll. Note that users could either use a mouse or a finger to draw their signature. By obtaining a teleconsent form with an e-signature, researchers can reduce travel burden, scheduling difficulties, and further complications. To facilitate interoperability, researchers can integrate consent directly into an electronic data capture system. After all, good documentation is essential in clinical trial management.
6. Digital Consent, Electronic Health Records, and Patient Preferences
Whether it’s a novel clinical trial or a patient’s health record, personal information is highly sensitive. It’s no surprise electronic health records have become a valuable source of information. Electronic health records often contain vital data, such as specimen and social factors. Electronic health records can be exchanged between organizations and research bodies to facilitate research and medical care. Interestingly, although patients are willing to share their medical information for research purposes, studies show that many participants agree that prior consent is mandatory. Informed consent for secondary uses must also be obtained in advance. Trust in health care providers is an essential factor in medical research and clinical care. Note that patients trust hospitals and educational institutions more than pharmaceutical and insurances companies (Harle et al., 2017).
Multimedia tools, as explained above, can facilitate communication, information delivery, and recruitment. Interactive methods can help patients customize the information they receive in accordance with their preferences. Note that patient preferences are an influential factor which can determine the entire consent process. Patient preferences may be different for broad, study-specific, and disease-specific consent forms. They can also vary between high-information-seeking and low-information-seeking subjects. Low-information-seeking subjects, for instance, report high levels of satisfaction with the amount of information they receive. To explore the role of personal predispositions in e-Consent, Harle and colleagues (2017) recruited 32 participants and conducted in-depth interviews regarding patient needs. The research team revealed that both patients and researchers could benefit from the wide range of capabilities digital consent platforms offer.
Since e-Consent can benefit data exchange and medical research, e-Consent applications must be designed to meet patients’ needs and safety regulations. Factors, such as the type of information, circumstances under which data can be shared, risks of participation, and purpose of research, should be considered by developers and health professionals. Most of all, patients and researchers must build a relationship based on trust and transparency to improve research and health outcomes.
7. Self-administered Electronic Informed Consent and Patient-centered Research
While doctor-patient communication and transparency of information matter, mobile technologies are reshaping medical research. Mobile technologies can enable participant-centered research, with self-administered consent forms becoming fundamental tools in practice. Note that an effective electronic informed consent process must cover informedness, comprehension, and voluntariness (Doerr et al., 2017). Interestingly, in a recent Parkinson mPower study, Doerr and colleagues (2017) revealed that e-Consent could lead to an increase in comprehension regarding study protocol and compliance. The research team recruited 9,846 people who were given detailed information and a quiz to evaluate knowledge retention. Note that, as explained above, quiz-based games and interactive tools can benefit information acquisition and enrollment. Interestingly, in the study conducted by Doerr and colleagues (2017), there was no limit to the number of attempts participants had. If users scored well on the quiz-based test, they were allowed to proceed, sign the actual consent form, and enroll in Parkinson mPower study.
When it comes to self-administered digital consent, some of the major aspects researchers must consider involving data storage, transfer, and confidentiality. Interestingly, therapeutic misconception is one of the most commonly discussed challenges in electronic informed consent. Note that therapeutic misconception refers to the belief, or the misleading tendency, to perceive research as a beneficial treatment. Other common issues which can interfere with e-Consent are false expectations due to historical evidence, religious beliefs, patient fear, and the involvement of vulnerable patients. To set an example, some patients may refuse a life-saving procedure due to religious beliefs or social pressure. The involvement of vulnerable patients, such as people with learning disabilities, also requires special considerations.
After all, researchers must embrace the benefits of today’s patient-centered care. Scientific findings show that participants desire to be seen as equal partners in decision-making. Patients are willing to share their thoughts and ideas to become influential partners in medical research. Note that experts believe that even young kids have the right to express their feelings and needs. Thus, assent (or the involvement of children in health care decision-making) is also becoming a crucial aspect in digital informed consent (Nijhawan et al., 2013).
8. Digital Consent and Interoperability between Legacy Systems
Electronic informed consent is essential in patient-centered care and modern cross-institutional cooperation. Digital solutions can improve interoperability and software programs that connect health care platforms become essential. Note that regulatory bodies play a major role in medical research and software development. Usually, digital information exchange is supported by HL7 standards.
When it comes to personal data, patients are the ones who can permit or deny access. Therefore, one of the main requirements for modern information system architectures is to obtain informed consent prior. Digital consent can facilitate the contract between patients and health providers. To set an example, a patient-centered integrated health record will help authorized users access data from all over the world (Bergmann et al., 2005). Bergmann and colleagues (2005) proposed a promising approach to support both research aims and patient safety. The research team integrated an e-Consent form directly into their health care information system. The e-Consent system was able to determine aspects, such as access rights, people involved, and validity times. Note that the study team examined the complex scenario of a thyroid disease care, so multidisciplinary approach was considered. In the case of referral, the authorized health provider was given only a non-transferable privilege to share data.
Virtual records which empower patients and provide integrated medical information are vital in today’s complex environments. The e-Consent process of the future will enhance interoperability and improve health outcomes across the globe. Since digital consent is a specific form of agreement, e-signatures also become mandatory in order to support interoperability, bioethics, and legal requirements.
9. Electronic Informed Consent in Prospective Cohort Studies and Follow-ups
From electronic health records to surgery, digital consent is a key advancement in digital health. As explained above, electronic informed consent can be employed across different settings. For instance, large-scale prospective cohort studies can also benefit from e-Consent systems. Note that although prospective cohort studies are highly beneficial in medical research, follow-ups are hard to conduct (Toledano et al., 2015). In a UK COSMOS cohort study, conducted between 2009 and 2012, Toledano and colleagues (2015) assessed a new approach to digital consent and cohort studies. The team recruited over 100,000 subjects and provided questionnaires which covered topics, such as mobile devices, health, and social factors. Additionally, the collection of subjective data was complemented by objective factors, such as traffic data, records on health events, and biomarkers. Results showed that the web-based e-Consent employed in this UK COSMOS cohort study improved data collection and reduced study costs.
Since a vast majority of people have access to a smart device and a data plan, the use of online platforms can facilitate cohort studies and recruitment across the globe. In the UK alone, 84% of all households report having access to mobile devices and the Internet. Technologies benefit streamlined data collection, data integrity, and online monitoring. Note that push notifications – highly beneficial in mHealth apps – can support the completion of web-based questionnaires and patient engagement. Interestingly, in some cases, electronic signatures are not required. Just like with today’s secure financial transactions, personal details can be enough to facilitate access and follow-up of health-related data. Yet, patient data must be secured; information must be encrypted, with sufficient back-up options to minimize risks.
Mobile devices have transformed the way people live and interact with each other. Interestingly, mobile devices and social networks are often interconnected. Social networks can support the implementation of e-Consent in medical research. Facebook, for instance, can benefit both marketing and research initiatives. Via artificial intelligence and analytics tools, social media channels can help researchers identify populations, target study invitations, and increase recruitment rates. In fact, social channels become effective tools in cohort recruitment and follow-up, especially among younger participants. Users can benefit from online support groups and health-related programs. As online platforms lead to high knowledge acquisition and better study compliance, social media becomes an effective tool in electronic informed consent.
10. Digital Consent: Conclusion
- With the increasing complexity of today’s clinical trials, patient consent is an essential component in research. Health technologies facilitate electronic informed consent, surpassing traditional paper-based forms. Smartphone devices and mHealth apps, for instance, provide impressive possibilities for identifying users and obtaining digital consent. Telemedicine and multimedia tools enhance knowledge acquisition and retention. Studies show that interactive tools and quiz-based games can boost enrollment rates and health outcomes.
- Digital consent can help patients formulate questions prior to medical interventions. Since paper-based consent forms are full of complex terminology, e-Consent can only improve the user experience. Digital consent will also help participants access information in a relaxed environment, without feeling pressured to sign a document straight away. This will eliminate numerous obstacles, associated with religious beliefs, patient fear, and therapeutic misconception.
- Since the vast majority of people worldwide have access to mobile gadgets and the Internet, electronic informed consent will facilitate research across the world. It will support the study of rare diseases and the involvement of underrepresented populations, such as vulnerable patients, people in remote locations, and children.
- Whether a participant decides to provide or deny consent, ethical principles and standards are integrated into today’s digital consent process. For instance, HIPAA and General Data Protection Regulation (GDPR) standards must be considered in the successful development and implementation of electronic informed consent. In fact, since the adoption of the Declaration of Helsinki in 1964, ethical principles and informed consent have become fundamental in research.
- While the full implementation of e-Consent in research is yet to happen, studies reveal its numerous benefits across medical settings. With a wide range of advantages over standard consent methods, electronic informed consent results in high-quality information, knowledge retention, and patient safety. Different e-Consent systems can facilitate different aspects of research, such as prospective cohort studies, surgical interventions, electronic health records, electronic signatures, and legal disputes.
- Investigators, study sites, sponsors, and pharmaceutical companies can also benefit from e-Consent. Digital consent can help experts recruit participants, reduce training costs, deal with missing data, and eliminate errors. A centralized system, for example, can benefit consent monitoring across multiple sites. Harmonized platforms and international standards can lead to high-quality data, boost drug development, and improve health outcomes.
- In the end, e-Consent can improve patient-centered care. Patients are equal partners in health decision-making, and personal preferences can affect the whole study protocol. Multimedia tools can provide a wide range of options to meet patient needs and boost self-paced learning. Subjects must be informed about the entire clinical protocol and voluntarily confirm their desire to participate in a given medical study. Electronic informed consent represents the shifts in digital health, with patients being the center of health care because informed consent is more than signing a document or pressing a “Click to agree”
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