For a long time, participating in a clinical trial usually meant going to a hospital, university, clinic, or other research site. Participants met research staff face-to-face, signed consent forms in person, received study interventions at the site, and returned for scheduled assessments. The research site was not only where the study happened. It was also where researchers could closely oversee consent, safety, privacy, and study procedures.
Decentralized clinical trials (DCTs) are changing that model. Instead of requiring every activity to happen at a traditional research site, DCTs bring some or even most parts of a study closer to participants. A person might provide electronic consent from home, meet the study team through telehealth, use a smartwatch to record health information, complete assessments through an app, or have a healthcare professional visit the home. Some trials are fully decentralized, while others use a hybrid approach that combines remote activities with occasional visits to a research site. Apostolaros et al. (2020) note that these approaches can reduce travel demands and allow research participation to fit more naturally into participants’ daily lives.
There are clear advantages to this shift. Removing geographic barriers may make clinical research available to people who live far from major research centers or who find frequent site visits difficult. DCTs can also support more frequent data collection and potentially improve recruitment and retention (Apostolaros et al., 2020). But moving a trial outside the research site does not move ethical responsibility with it.
In fact, decentralization can make some familiar research ethics questions more complicated. According to Vayena et al. (2023), decentralized trials can create distinct concerns involving participant safety and rights, scientific validity, privacy, informed consent, and ethics oversight. A consent conversation may now happen through a screen. Sensitive information may travel from a wearable device through an app and into cloud-based systems. An adverse event may occur hundreds of miles from the investigator. Third-party technology companies, mobile healthcare professionals, and other vendors may also become part of the research process.
These changes matter to Institutional Review Boards (IRBs). The basic ethical principles behind IRB review have not disappeared simply because research has become digital. What has changed is the environment in which those protections must work. Van Rijssel et al. (2024) argue that the ethical effects of DCT technologies extend beyond obvious concerns such as data protection and safety because technology can also affect participant experiences, responsibilities, relationships, trust, and privacy.
For researchers, this means a decentralized protocol cannot simply be a traditional protocol with telehealth and an app added to it. Researchers and IRBs need to think carefully about where the research is happening, who is responsible at each point, what new risks are being introduced, and whether participants remain adequately protected when the research site is no longer the center of the trial. That is where the IRB conversation around decentralized clinical trials truly begins.
I. Redefining the IRB’s Oversight Boundaries in a Decentralized Trial
In a traditional clinical trial, the research site provides a clear center of responsibility.
In a traditional clinical trial, the research site provides a clear center of responsibility. Participants visit the site, trained staff carry out study procedures, and investigators can directly oversee much of what happens. A decentralized clinical trial changes this picture. Research activities may be spread across participants’ homes, local clinics, laboratories, telehealth platforms, and other settings. This creates an important question for an IRB: Where does oversight begin and end when the study no longer happens in one place?
The answer is not to reduce oversight. Instead, researchers need to make the structure of the trial more visible. According to Han et al. (2026), ethical and regulatory oversight remains one of the major ethical challenges identified across the DCT literature. Their scoping review also highlights that existing ethical and regulatory frameworks do not always fit neatly with the distributed nature of decentralized research.
From One Research Site to a Distributed Research Environment
A DCT can involve many different research settings. A participant might have a video appointment at home, visit a nearby laboratory for blood work, meet a mobile healthcare professional for another procedure, and complete other study activities remotely.
According to Apostolaros et al. (2020), decentralized approaches can use telemedicine, mobile healthcare providers, and other methods to move trial activities away from the traditional research site. Their work highlights an important point for IRB review: decentralization changes not only the location of research but also how trial activities must be coordinated and supervised.
Researchers should therefore make each remote activity clear in the protocol. The IRB should be able to see which procedures happen at the main site, which happen elsewhere, and which can be completed from the participant’s home. This gives reviewers a better understanding of how the trial will actually operate.
Clarifying Who Is Responsible
DCTs may also bring more people into the research process. Local healthcare professionals, mobile nurses, laboratories, couriers, technology providers, and other third parties may perform tasks that would normally be handled at the main research site. That convenience can create a less obvious problem: responsibility may become scattered.
De Jong et al. (2022) found that European regulators identified investigator oversight as an important challenge in decentralized trials. Their study notes that concerns become particularly important when researchers have less face-to-face contact with participants and delegated activities are carried out away from the central site. Apostolaros et al. (2020) similarly highlight investigator delegation and oversight as major practical considerations in DCT design. Researchers should be able to explain who is performing each study task, whether that person is appropriately qualified, and how the investigator will maintain oversight.
For the IRB, this means that using outside providers should not create gaps in participant protection. A task can be delegated, but the responsibilities surrounding that task still need to be clearly defined.
Accounting for Geographic and Regulatory Differences
Decentralized trials can also reach participants who live far beyond the main research institution. That wider reach is valuable, but it may bring several jurisdictions into the same study. For example, local requirements may affect whether certain healthcare professionals can perform study procedures in a participant’s location. Apostolaros et al. (2020) note that researchers conducting decentralized activities across jurisdictions need to consider issues such as professional licensing and other legal and regulatory requirements.
Petrini et al. (2022) also highlight that the growth of DCTs creates a need for ethics committees to have suitable approaches for evaluating studies that rely heavily on digital technologies and activities conducted outside conventional research sites. These questions are much easier to address before recruitment begins than after a participant has already enrolled.
Give the IRB a Clear Map of the Trial
One useful approach is to give the IRB an oversight map of the study. Researchers can identify each major activity, where it happens, who performs it, and who supervises it. For example, the map might show that the central research team handles recruitment, local laboratories collect specimens, mobile healthcare professionals conduct home visits, and a contracted platform supports remote assessments. This simple structure can help IRB reviewers see how all the pieces of the trial connect.
According to van Rijssel et al. (2022), ethics reviewers assessing a decentralized trial paid particular attention to the possible risks and burdens created by decentralized procedures. The authors recommend that researchers address these concerns explicitly when submitting DCT protocols for ethics review. Vayena et al. (2023) similarly identify ethics oversight as one of three broad areas that require greater ethical attention as decentralized trials expand.
The goal is not to make a DCT look like a conventional site-based study. It is to make sure the IRB can clearly see how responsibility follows the participant wherever the research takes place. Once those oversight boundaries are clear, the next question becomes more personal: How can researchers make sure that someone enrolling from a phone, tablet, or computer truly understands the study and is freely choosing to participate? That brings us to remote informed consent.
II. Making Remote Informed Consent More Than an Electronic Signature
In a decentralized clinical trial, informed consent may happen without the participant and researcher ever sitting in the same room. A participant might receive study information through an online portal, watch a short video, speak with the research team through telehealth, and sign the consent form electronically.
That can make enrollment much more convenient. But convenience should not be confused with informed consent. Clicking “I agree” or adding an electronic signature only documents a decision. It does not tell the IRB whether the participant actually understood what participation involves.
According to Bierer and White (2024), remote consent is one of several important ethical concerns that emerge when clinical trials move away from traditional research sites. For IRBs, the focus should therefore remain on the quality of the consent process, not simply the technology used to capture a signature.
Verify Who Is Giving Consent
When consent happens face-to-face, study staff can usually confirm who they are speaking with. Remote enrollment can make this less straightforward. Researchers need a reasonable process for confirming that the person completing the consent is the intended participant. The issue becomes even more important when a legally authorized representative is involved or when a participant may have limited decision-making capacity.
Petrini et al. (2022) note that fully digital consent requires researchers to consider whether an electronic signature is legally valid and whether the participant can be appropriately identified. They also point out that complicated electronic identification procedures may themselves become barriers for some participants. The goal is to find the right balance. Identity verification should be reliable without turning enrollment into a difficult technical process.
Make Understanding Part of the Process
A strong e-consent process should help people understand the study rather than simply move them through a form. Researchers can use short videos, diagrams, audio explanations, expandable definitions, and simple knowledge questions to explain difficult information. Participants should also have an easy way to contact a real person when something is unclear.
There is evidence that these tools can help. According to Skelton et al. (2023), a systematic review of electronic informed consent studies found that e-consent may improve participants’ comprehension and recall of study information, although the available evidence varied considerably across studies. Similarly, Cohen et al. (2023) reviewed 35 studies involving more than 13,000 participants and found that e-consent generally performed as well as or better than paper consent for comprehension, acceptability, and usability. Still, technology alone does not guarantee understanding. A long consent form remains difficult to understand even when it appears on a tablet instead of paper.
Keep the Choice Voluntary
Remote consent also changes the setting in which people make their decision. A digital system can quietly shape behavior. Bright buttons, default selections, repeated reminders, or a design that makes “accept” much easier to find than “decline” may push participants toward a particular choice.
Van Rijssel et al. (2024) highlight that digital technologies can influence behavior, relationships, trust, responsibilities, and participants’ sense of freedom. Their analysis suggests that researchers should look beyond whether an e-consent system technically provides the required information and consider how participants actually experience the process. Participants should have enough time to consider enrollment, ask questions, and say no without feeling that the system is pushing them forward.
Plan for Consent After Enrollment
Consent does not end when someone enters a trial. New information may emerge, procedures may change, or an amendment may require participants to reconsider aspects of their participation. This makes reconsent an important part of DCT planning.
Vayena et al. (2023) note that decentralized trials create both opportunities and challenges for maintaining ethically meaningful relationships with research participants. Researchers should therefore explain how important updates will reach remote participants, how questions will be answered, and how new consent will be documented when necessary.
A good remote consent process should ultimately leave the participant with the same thing we expect from consent in any clinical trial: a clear understanding of what they are agreeing to and a genuine choice about whether they want to take part.
Once a participant gives that consent, however, another issue quickly comes into view. Apps, wearables, smartphones, and remote monitoring systems can begin generating information throughout the study. The next IRB question is therefore not just what participants agreed to share, but where that information goes after they share it.
III. Protecting Participants When Research Data Travels Through Apps, Wearables, and the Cloud
One of the biggest advantages of a decentralized clinical trial is that researchers do not have to wait for participants to return to a study site to collect information. A smartwatch can record heart rate throughout the day. An app can collect daily symptoms. A glucose monitor can provide readings while a participant goes about normal life. But every new source of information creates another place where participant data must be protected.
In a traditional study, researchers may have greater control over where information is collected and stored. In a DCT, data can move through several devices, companies, and computer systems before researchers ever see it. Vayena et al. (2023) highlight that the use of wearables, apps, and web-based systems can increase cybersecurity concerns because DCTs rely on distributed digital networks. For IRBs, it is therefore important to look beyond the device itself and ask what happens to participant information throughout its journey.
Follow the Data From the Participant to the Research Team
Consider something as ordinary as a smartwatch used to monitor physical activity. The device records the information, but that may only be the beginning. Data might first move to the participant’s smartphone, then to the manufacturer’s platform, then to a cloud server, and eventually into the research database. Each step creates another point where information is handled.
According to Petrini et al. (2022), data integrity and confidentiality must be protected not only when information is stored but also while it is being transmitted and managed. The authors also note that information stored on personal devices can potentially be connected with other information on those devices, including location, contacts, cameras, microphones, and purchasing activity.
For this reason, an IRB submission should make the data pathway easy to understand. Researchers should know what information leaves the participant’s device, where it goes, where it is stored, and who can access it along the way.
Collect What the Study Actually Needs
Wearables and smartphones can collect enormous amounts of information. That does not mean a study needs all of it. A device selected to measure physical activity, for example, may also have the ability to collect location information, sleep patterns, or other behavioral data. Continuous monitoring can make this problem even less obvious because information may be gathered in the background while participants are working, sleeping, traveling, or spending time with other people.
Van Rijssel et al. (2024) note that apps and digital devices can increase the possibility of passive collection of information such as location, audio, or video. They also highlight concerns about information being shared with commercial parties. Vayena et al. (2023) recommend data minimization as one way to address this concern. In simple terms, researchers should collect what they need to answer the research question and be able to explain why they need it. For an IRB, “the device collects it” is not a good enough reason to keep additional information.
Know Who Else Can See the Data
The research team may not be the only organization involved in handling participant information. A DCT might rely on a wearable manufacturer, app developer, cloud service, analytics company, or technology vendor. This creates questions that researchers should answer before enrollment begins. Does the vendor retain a copy of the information? Can it use the data for another purpose? How long will it keep the information? Can other organizations gain access?
These questions matter because participants may assume that information collected for research remains entirely within the research institution. The actual data pathway may be much more complicated. According to Vayena et al. (2023), privacy-by-design and privacy-by-default approaches can help reduce unnecessary collection and unauthorized uses of participant information. The protection plan should therefore cover every organization and system involved in handling research data, rather than stopping at the research team’s own database.
Prepare for Security Problems Before They Happen
No digital system is completely free from risk. A participant can lose a phone. A password can be compromised. Software can fail. Information can be sent to the wrong place. A vendor can also experience a security breach. That is why cybersecurity should be part of the study plan from the beginning.
Vayena et al. (2023) highlight privacy impact assessments as a useful way to identify vulnerabilities and match safeguards to the sensitivity of the information being collected. They also recommend protections such as encryption, pseudonymization, anonymization where appropriate, and other privacy-preserving measures.
Researchers should also know what they will do if those protections fail. A strong DCT protocol should explain how a suspected breach will be identified, who will respond, what systems or data collection activities may need to be stopped, and how affected participants will be protected.
Ultimately, an IRB does not need to understand every line of code behind an app or wearable. It does need enough information to determine whether participant data are being collected responsibly, moved securely, accessed appropriately, and protected throughout the study.
Protecting information, however, is only one part of protecting the participant. When blood collection, medication use, device setup, or other study procedures move into the home, the IRB must also consider what happens when something goes wrong and trained research staff are not physically nearby. That brings us to participant safety in home-based research.
IV. Managing Participant Safety When Study Procedures Happen at Home
A participant’s home can make a clinical trial more convenient, but it is not a clinical research unit. There may be no investigator down the hall, no research nurse watching a procedure, and no study team immediately available if something unexpected happens. That difference matters when decentralized trials move activities such as specimen collection, medication administration, physiological measurements, or device use into the home. According to de Jong et al. (2022), regulators view participant safety as an important concern in decentralized trials, particularly when investigators have less direct contact with participants. The goal should not be to recreate a hospital inside someone’s home. Instead, researchers need to decide which activities can safely move outside the research site and build a clear plan for problems that may arise.
Decide What Can Safely Be Done at Home
Not every study procedure is a good candidate for decentralization. A questionnaire completed on a phone presents a very different level of physical risk from administering an investigational treatment. Even familiar procedures can become harder when participants are expected to perform them without direct supervision.
Apostolaros et al. (2020) highlight the importance of considering which trial activities can appropriately be conducted remotely and when qualified healthcare professionals are needed. Researchers should think about the complexity of the procedure, the participant’s ability to perform it correctly, and what could happen if it is performed incorrectly. For the IRB, the important question is not simply, “Can this procedure be done at home?” It is, “Can it be done at home with an acceptable level of risk?”
That may mean providing training, written instructions, demonstrations, or access to study staff. Higher-risk activities may require a home visit from a trained healthcare professional or an in-person appointment instead.
Make Adverse Event Reporting Easy
When participants visit a research site regularly, staff may notice symptoms or changes that participants themselves do not recognize as important. In a DCT, that safety net may be weaker. According to Vayena et al. (2023), decentralization can create challenges for detecting adverse events because researchers may have fewer opportunities for direct observation. A participant at home needs to know what symptoms require attention, whom to contact, and what to do if the situation is urgent.
Safety instructions should therefore be practical. A participant should not have to search through a long study document to find an emergency number. Researchers also need an escalation plan. Who reviews an adverse event report? How quickly should someone respond? When should the participant contact emergency services or seek local medical care?
Bierer and White (2024) note that DCTs can create safety concerns when clinical assessment occurs remotely, and investigators have limited ability to examine participants directly. A protocol should therefore explain how the research team will recognize when remote management is no longer appropriate.
Have a Backup Plan When Technology Fails
Technology can support participant safety, but relying on it too heavily can create another risk. A wearable may stop recording. An app may crash. A home monitoring device may give an unusual reading. Internet service may disappear during an important telehealth appointment.
Petrini et al. (2022) highlight that technological reliability is an important ethical consideration in decentralized trials. If a digital tool is being used to support clinical monitoring, researchers need to consider what happens when that tool does not work as expected. A backup might be as simple as a telephone call, a replacement device, or an in-person assessment. What matters is that the plan exists before the failure occurs.
Remember That the Home Is a Personal Space
Conducting research at home also introduces concerns that rarely arise inside a clinic. Family members may be present during telehealth appointments. A caregiver may help with study procedures. Research materials or medications may be accessible to children or other household members. A visiting research professional is also entering a participant’s private living space.
Van Rijssel et al. (2024) note that decentralized technologies and procedures can change participants’ experiences of privacy and their relationships with people around them. Researchers should therefore consider how home-based activities affect not only the procedure itself but also the participant’s everyday environment. A well-designed DCT should give participants clear instructions about storing study materials, involving caregivers, preparing for home visits, and maintaining privacy where possible.
The central safety question is simple: If something goes wrong at home, does the participant know what to do, and does the research team know how to respond? A strong protocol should make the answer clear before the first participant enrolls.
But safety is not the only issue created by bringing research into the home. Remote participation may remove travel barriers for one person while creating technology, cost, language, or accessibility barriers for another. The next section looks at why decentralized does not automatically mean accessible, and what IRBs should consider to prevent a new digital participation gap.
V. Preventing Decentralization From Creating a New Digital Participation Gap
One of the strongest arguments for decentralized clinical trials is that they can make research easier to join. A participant who lives several hours from a major medical center may no longer need to make repeated trips to the study site. Someone with work or caregiving responsibilities may be able to complete study activities from home. That sounds like greater access, and often it is. But there is another side to the story.
Moving a trial online can remove one barrier while quietly creating another. A study that depends on smartphones, reliable internet, wearable devices, video calls, and digital platforms may be easy for some people to navigate and difficult for others. According to Vayena et al. (2023), decentralized trials have the potential to improve access to research, but digital and socioeconomic inequalities may also leave some populations behind.
For IRBs and researchers, the question should therefore go beyond whether a DCT makes participation easier. They should also ask: Easier for whom?
Remote Does Not Automatically Mean Accessible
Digital access is not evenly distributed. Some potential participants may not own a suitable smartphone or computer. Others may have limited internet service, especially in rural or underserved communities. Even when the technology is available, participants may differ greatly in their confidence using apps, wearable devices, online portals, or video platforms.
According to Petrini et al. (2022), decentralized approaches may create disparities for people who lack access to digital technologies or have difficulty using them. The authors highlight older adults, people with limited digital literacy, and socioeconomically disadvantaged groups among those who may face additional barriers.
Accessibility also includes disability and language. A study app that works well for one participant may be difficult to use for someone with impaired vision, limited dexterity, or another accessibility need. Likewise, offering a digital platform only in English can limit meaningful participation even when translated study documents are available.
Look for Costs That Have Shifted to Participants
A DCT may save participants the cost of traveling to a research center, but it can also transfer new expenses and responsibilities into their homes. Participants may need internet data for video visits, electricity to keep devices charged, space to store study materials, or time to troubleshoot technical problems. They may also be asked to package specimens, arrange courier collections, or learn how to operate unfamiliar equipment.
Van Rijssel et al. (2022) found that ethics reviewers raised concerns about the burdens decentralized procedures may place on participants. Their findings highlight why convenience should not be judged only from the research team’s perspective. Researchers should identify these less visible demands during protocol development. Otherwise, a study described as “low burden” may feel very different to the person actually completing it.
Build Alternatives Into the Study
Digital barriers do not always require abandoning decentralization. Often, they require better planning. Researchers can provide study devices rather than requiring participants to own them. Technical support can be available by telephone. Interfaces can be designed with accessibility in mind. Materials can be offered in appropriate languages. Where the protocol allows, participants who struggle with video visits might have telephone or in-person alternatives.
De Jong et al. (2022) note that decentralized methods should be selected with the characteristics and needs of the study population in mind. This is important because accommodation works best when it is part of the study design, not something researchers try to invent after an excluded participant encounters a problem.
Ask Who Digital Recruitment Is Missing
The same concern applies before participants even enroll. Online advertising, patient portals, social media, and electronic health systems can help researchers reach large numbers of people quickly. But a digital-first recruitment strategy may repeatedly reach people who are already comfortable online while overlooking those who are not.
Bierer and White (2024) highlight the possibility that decentralized approaches can improve diversity by reducing geographic barriers, while also warning that technology requirements may worsen existing disparities. For IRBs, equitable recruitment therefore requires looking at both sides of the equation. Researchers should explain not only who their recruitment strategy is likely to reach, but also who it might systematically miss.
Decentralization should widen the door to clinical research, not simply replace a geographic barrier with a digital one. When researchers plan for differences in technology access, ability, language, cost, and digital literacy from the beginning, remote participation has a much better chance of delivering on its promise of broader access.
These issues bring the discussion back to the larger purpose of IRB review. Whether a trial happens in a research center, through a smartphone, or inside a participant’s home, innovation should never come at the expense of meaningful participant protection. The final section brings these considerations together and looks at how researchers can build ethical safeguards into decentralized trials from the start.
Conclusion
Decentralized clinical trials are changing where research happens, but they do not change what researchers owe the people who take part. That distinction matters. Moving a study visit from a clinic to a video call may be convenient. Collecting health information through a wearable may provide researchers with valuable real-world data. Allowing participants to complete procedures from home may open a study to people who otherwise could not participate. Yet each of these changes also shifts part of the research environment beyond the walls of the traditional study site.
For researchers navigating these requirements, Beyond Bound IRB provides comprehensive support backed by expertise and care in handling the process. Our goal is simple: no roadblocks, just support. We take a comprehensive, bespoke approach to the needs of each study, helping researchers identify potential IRB concerns, eliminate obstacles, and establish a clear path from protocol preparation through review. Through direct engagement with researchers, we work to foster collaboration and provide an efficient, stress-free service designed to move studies forward with greater confidence.
Every study is different, and IRB support should reflect that. Beyond Bound IRB offers transparent pricing and customized pricing based on the actual needs and scope of your project. Researchers can also benefit from our affiliated network and the experience of professionals who understand that decentralized research may require careful attention to remote procedures, participant protections, technology use, and changing research environments. Rather than leaving you to work through those questions alone, we help you prepare for review and work toward fast, confident approval.
Strong IRB preparation also starts with knowing how to recognize ethical and regulatory concerns before they become problems. That is where IRB Heart, our researcher training program, can help. IRB Heart gives researchers practical training to better understand IRB expectations, strengthen ethical research practices, and approach protocol development with greater confidence.
If you are preparing a decentralized, digital, hybrid, or traditional research study, you do not have to navigate the IRB process alone. Contact Beyond Bound IRB for hands-on IRB support, or explore IRB Heart to strengthen your knowledge through practical IRB training. Let us help you move from uncertainty to a clear, well-prepared path toward ethical research and approval.
References
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