Drug Side Effects, Technology-Related Risks Often Are Conveyed Inadequately

By Stacey Kusterbeck

To make an informed choice on whether to participate in a research study, participants need to know about possible side effects of the drugs being studied. However, informed consent forms convey study drug side effects inconsistently and inadequately, a recent study found.¹ Of 547 informed consent forms, 19% gave no indication of side effect frequency, and 16.1% used a verbal descriptor (very common, common, uncommon, rare, or very rare) with a frequency band (for example, “may affect more than one in five people”), absolute frequency (for example, 10 out of 100 participants), or percentage, as recommended by the European Commission. Just 3.6% of informed consent forms used verbal risk descriptions with the correct probability of occurrence. None of the informed consent forms used risk visualizations to display frequency of side effects.

Of course, it is impossible to include everything about a study in consent forms. “It’s important for study teams to convey the most important information to potential participants,” says Edward Kuczynski, director of the Human Research Protection Program at University of California, San Francisco. Kuczynski recommends these practices:

• Serious side effects (even if uncommon) and common side effects should be enumerated.
• Uncommon side effects and side effects that are not serious do not need to be listed. However, the person obtaining consent should be prepared to list them should the potential participant ask.
• Institutional review boards (IRBs) should create a template for listing the side effects of an investigational drug with categories such as “Severe and Common,” Severe and Uncommon/Rare,” and “Not Severe but Common.”

There are concerning gaps with informed consent in digital health technologies, which include wearable devices and mobile applications and pose unique ethical risks, another study found.² “We began with a simple observation: Digital health is reshaping clinical research faster than consent practices are evolving,” says Rahma Risky Alifia, a research success data assistant at Arizona State University’s College of Health Solutions.

Alifia and colleagues conducted a study to answer this question: Do consent forms meet today’s ethical standards, especially those involving technology? “As the NIH (National Institutes of Health) issued guidance in 2024 for digital health consent, we wanted to assess whether real-world consent forms actually aligned with these ethical standards,” says Alifia. The researchers reviewed 25 informed consent forms from digital health studies. None of the forms fully adhered to the required ethical elements. “What was particularly striking was that technology-specific risks and participant rights were systematically underrepresented,” says Alifia.

The researchers identified these informed consent elements for digital health research that are not included in current guidance: Data removal requests, commercial profit sharing, study information disclosure, and result sharing during the study. “More than 25 of 43 key items related to technology were missing in over 90% of the forms,” says Alifia. This included important information about who controls the data, how vendors are involved, and what rights participants keep after a study ends. The gaps appeared across different types of technologies (devices, apps, and sensors), indicating that this issue is related to institutional rather than technology-specific barriers. The researchers identified these critical ethical gaps with informed consent practices for digital health research:

• Transparency failures: Many forms do not say who controls the participants’ data, how long they are kept, or whether participants can access or delete data later. Many forms also failed to disclose third-party vendor involvement and associated terms of service.
• Risk disclosure: The studies do not communicate technology-specific risks clearly. For example, information about data breaches, reidentification risks, and how the technology might affect daily routines often was missing.
• Justice concerns: There was inadequate disclosure about who bears financial burdens (such as who pays for connectivity, device loss, or damage). “This can shift costs onto participants, especially those with limited resources or digital literacy,” warns Alifia.
• Vendor accountability: “A significant blind spot exists around third-party technology partnerships. Consent documents often obscured who the actual data controller is,” says Alifia. When roles are vague, responsibility effectively drifts from researchers to tech partners without participants realizing it.

Informed consent forms should address these specific concerns regarding technology-specific risks, recommends Alifia:

• Data governance: Participants should understand who controls the data, where they are stored (physical location or cloud), how long they are retained, and whether participants can access, modify, or delete their data during and after the study.
• Third-party involvement: There should be clear disclosure of vendor partners, and participants should be informed about relevant terms of service and end-user agreements, data-sharing arrangements, and who the legal data controller is.
• Practical impacts: Participants should understand how using the technology affects daily routines (including device charging, app notifications, and any workflow changes).
• Financial obligations: Participants must know who pays for data plans, accessories, or replacements; what happens if a device is lost or damaged; and whether participants can keep using the service after the study.
• Digital-specific risks: Participants should know the potential for data breaches, linkage, and reidentification risks; challenges with technology integration; and how software or firmware updates could change what data are collected or how the data are used.
• Participant rights: Consent should cover the ability and procedure to request data removal, how data might be linked across technologies, and any commercial uses or benefit-sharing.

If study participants are not fully informed of these specific risks, “the ethical concerns are substantial, and violate core biomedical principles,” emphasizes Alifia. Patients cannot give real consent without a clear picture of digital risks and responsibilities, so autonomy is undermined. There also is unfair distribution of burden, since people with fewer resources or limited technology expertise may end up paying more for data plans, device replacements, and extra time to manage apps. “If the consent form doesn’t clearly explain these costs and offer help (like subsidies, training, or non-digital options), the study can unintentionally make existing inequalities worse,” says Alifia.

Participants who later discover undisclosed risks may disengage from the study and from research more broadly, because of erosion of trust. There also is the risk of exploitation. Without transparency about vendor relationships and data commercialization, participants may unknowingly contribute to commercial profit without their informed consent. “When ethical responsibility is not clear through third-party partnerships, participants have no obvious path for questions, complaints, or redress,” adds Alifia.

When reviewing study protocols for digital health research, IRBs should get answers to these questions, recommends Alifia:

• On data governance: Who is the data controller? Where will data be stored? How long will it be retained? How can participants access, modify, or delete their data during and after the study?
• On third-party relationships: Are all vendor partnerships disclosed? Do materials include a link to terms of service and end-user agreements? How are vendor responsibilities defined?
• On technology-specific risks: Do materials explain breach response, re-identification risk, accuracy and integration limits, and the effect of mid-study updates?
• On equity considerations: How might technology requirements create barriers? Who bears financial costs such as connectivity, accessories, loss, or damage? How will the study support participants with limited digital literacy or language needs?
• On participant rights: Can participants withdraw and have their data deleted? Will the study team notify participants if technology updates change risks or data flows? Can participants request data removal after the study?
• On post-study access: What happens when the study ends? Can participants keep accessing beneficial services (such as tools and data) after the study ends? Are participants informed about continued access (or lack thereof)?
• On completeness: Does the consent form address all NIH-recommended elements for digital health research?

“IRBs should also consider requiring updated institutional templates that incorporate digital health-specific elements, rather than relying on traditional consent frameworks that weren’t designed for these technologies,” says Alifia.

Stacey Kusterbeck is an award-winning contributing author for Relias. She has more than 20 years of medical journalism experience and greatly enjoys keeping on top of constant changes in the healthcare field.

References

1. Coleman C, Jokinen O, Duhig J, et al. Risk communication of study drug side effects: An evaluation of informed consent forms from ClinicalTrials.gov. Patient Educ Couns. 2025;140:109261.

2. Alifia RR, Sadeghi M, Eluru M, et al. Bridging ethical gaps in digital health research: A framework for informed consent aligned with NIH guidance. BMC Med Ethics. 2025;26(1):132.