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In the fields of biobanking and clinical research, the active role of the patient as more than a donor or study subject is becoming more prevalent as biobanks and researchers increasingly recognize the added value of patient engagement in a variety of ways. Simultaneously, medical disciplines and new legislation have sharpened the focus on patient rights and the ethical obligations of parties using their data. These developments have introduced new approaches to patient data ownership, acquiring consents, returning results to patients, and introducing greater overall transparency. While the importance of patient-centered medical research is widely recognized today, the ethical obligations in this area and the practical benefits that patient engagement pose for biobanks and clinical research have only more recently begun gaining traction.
The timing couldn’t be better. New developments in healthcare IT help link patients to medical research in new and remarkable ways, helping transparency, engagement, and patient empowerment become a reality.
The Informed Patient
The importance of informing and educating patients who are participating as donors or study subjects in biobanks and in clinical research has become more widely recognized in recent years. Recent studies exploring the use of patient data in biobanks and clinical trials, such as one conducted by Kondylakis et al. in 2017, have argued for greater transparency and updating practices of informed consent to provide more information and to require renewed consent for the reuse of patient data (1). Another study, by Elger and Clercq published in the same year, discusses the practical as well as ethical reasons for biobanks to return results to patients, expressing the need for a return-of-results policy (2). Both studies outline clear ways to provide patients with more information and explain how doing so is not only the moral thing to do but is also advantageous for the biobank or research institution.
The first study reviews current practices for obtaining consent in biobanking and examine the legal requirements in the EU for reusing the biomaterials and data acquired through previous consents. While the discussion of patient rights and the importance of informed consent is not new, this study concentrates specifically on the reuse of available data, a practice that does not always require renewed informed consent from patients. This article contributes a practical argument to the common ethical viewpoint that patients should be informed on the use of their data and that reuse should require renewed consent. According to the study, it is in a biobank’s own interest to accommodate donors with greater transparency and make the information about the uses of donations more accessible. By providing donors with more information on the use and reuse of their biospecimen data, biobanks can maintain and even build trust with patients, which has been found to promote willingness to donate (1). This offers biobanks a valuable incentive to inform patients on how their data is being used, regardless of the legal requirements concerning the reuse of available data.
The value of transparency and detailed consents also holds true for patients involved as study subjects in clinical research (3). Here too, patients can be provided more information on the progress of the study they are involved in and on the role that their participation plays in the study. In combination with improved, detailed consent-obtaining practices, this transparency and greater two-way communication between researchers and patients incentivizes greater patient participation in clinical trials (3).
Another important aspect of transparency, both in biobanking and in clinical trials, is the return of results to patients. In addition to the role that human biological material and data plays in understanding the human body and advancing medical treatments, it also has the potential to inform biobank sample donors of their individual results, which could greatly benefit them and even save lives. If, for example, a donor tests positive for a certain condition with a high risk of developing cancer, the disclosure of these results would give the patient the opportunity to receive early treatment to avoid cancer. While there is rather broad ethical consensus regarding the ethical obligation to return results, the legal duty to do so remains controversial. The problem, the 2017 study by Elger and Clercq explains, “is that nondisclosure might expose researchers to legal liability for negligence and in the long run impede research” (2). Additionally, there is a disagreement regarding the cost-effectiveness and feasibility of returning results (2). However, studies have identified practical reasons for biobanks to return results that may provide new incentives for doing so. One such study, “showed that parents of children included in hypothetical biobanks considered biobanks more beneficial if they returned results” (2). In another study, 90% of those surveyed believed that “the return of results is important when considering participation in biobanks” (2). In general, it has been found that people are more satisfied with biobanks that disclose their findings, which is why returning results has been used to incentivize individuals to participate in a biobank (2).
The practice of making the results of clinical research available to patients and to the public is also gaining more traction. Greater data transparency in clinical trials has been shown to help build trust and confidence in patients involved in trials (3). Using online platforms like www.clinicaltrials.gov and www.clinicaltrialsregister.eu, for example, pharma companies can make the results of clinical trials available regardless of their outcomes, creating greater data transparency (3). In this way, informing patients is not only an ethical obligation or in some cases a legal requirement but also an effective practice for building trust and incentivizing participation in a biobank or clinical trial.
The Engaged Patient
In addition to acting as an incentive for patients to donate to biobanks and participate in clinical trials, greater transparency also offers new opportunities for patient engagement. In recent years, the role of patients in clinical research has shifted from being mere “subjects” to participating as “informed collaborators” (3). While building informed consent forms (ICFs), some researchers now seek patient inputs to improve the design and content of ICFs for better transparency. Researchers also propose seeking clarification from patients of their understanding of ICF protocol and using this information to build ICFs that are found more widely acceptable in patient populations (3).
Likewise, the role patients play in biobanking has evolved from simply being donors to becoming partners in the design and development of biobanks (4). Many biobanks have begun recognizing the value of patient perspectives and have found ways to engage them as collaborators. For example, patients are increasingly playing a role in helping identify and prioritize research topics and are joining research advisory groups and steering groups (4). Biobanks and researchers who appreciate the value of patients in these areas stress the importance of “active, early, and sustained engagement and involvement” of patients (4). A primary obstacle to patient engagement on this level, however, is the limited knowledge patients have of the fields of biobanking and research and of their role in these fields. By supplying patients with relevant information, biobanks and researchers lay the groundwork for a new level of patient engagement that can provide valuable insight and direction to their work.
The Empowered Patient
After reviewing the benefits of improved patient information, there remains the issue of how to do this. The biggest roadblocks to supply patients with information in the past have been the questions of cost-effectiveness and general feasibility. New technology, however, is making the flow of information between medical research institutions and patients easier than ever before. A new class of IT tools has been developed, for example, that implements electronic consents to connect researchers with patients. These tools help uphold sustained communication with patients regarding their samples and data, enabling among other things the collection of informed consent for the secondary use of data and biomaterial (1). In an effort to supplement and bolster existing systems, these IT tools are generally provided as attachments to infrastructures such as EHRs and Biobanks to enable patients and donors to receive relevant information and to actively update their consents. Users of these IT solutions can also calibrate consent processes according to the various national laws and regulations, making ICFs much easier to navigate through streamlined, IT-driven processes (1). By acting as the missing link between researchers and patients, these kinds of IT tools empower patients with information so that they can take ownership of their data, discover their results, and contribute their valuable perspectives to biobanking and medical research.
The CentraXX Patient
A prime example of how IT can link patients to research is the CentraXX Patient App. As an attachment to CentraXX modules used for biobanking, clinical trials, and hospital data aggregation, the CentraXX Patient App (www.kairos.de/en/products/centraxx-patient-app) makes transparent all data that is held on the patient, including all research data (i.e. biospecimen data, lab findings, etc.). In terms of transparency, the Patient App offers patients access to a duplicated, “read only” view of their entire record.
The app also facilitates quick bi-directional communication. Using the app, patients can submit self-assessments and transmit biometric data, collected for example by the Apple HealthKit™. This expedited, two-way communication also allows those on the research side to schedule follow-up visits and to request reconsenting for the secondary use of data and specimens. The app is extremely flexible concerning consent regulations. Consents supported by the app can take a variety of forms including a simple checkbox, a phone call, or a finger print, among others and can be determined in accordance to local regulations.
A further gain of using the CentraXX Patient App is the recruiting tool, which greatly expedites and streamlines patient recruiting for studies. The collected patient data can be used to alert CentraXX users conducting a study of potentially eligible recruits. Linked to the CentraXX automated recruiting tool, the app also alerts patients of studies they are eligible for, informs them about the study, and asks for agreement to participate. Expediting the two-way communication between researchers and patients with the capability of reaching patients via mobile app is an enormous upgrade from the traditional means of searching through patient contact information and placing telephone calls. Patients identified for studies can be linked to study sites more immediately using the CentraXX Patient App.
Together, the greater transparency, bi-directional communication, and streamlined recruiting tool provided by the CentraXX Patient App leave CentraXX patients informed, engaged, and empowered.
By PD Dr. rer. nat. Christian Stephan/Amir Sohn Firestone, Kairos GmbH
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