Written by:
Lauri Carlile, Chief Research Services Officer, Advarra
During Health Literacy Month, we are reminded that giving people access to health information is not enough. That information must also be presented in a way they can find, understand, and use to make decisions. In few places is that obligation more important—or more challenging—than in clinical research.
Informed consent is meant to support a person’s autonomy. Before joining a clinical trial, a potential participant should understand that research is voluntary, what the study involves, the potential risks and benefits, and the alternatives to participation. The individual should also have time to consider the information, ask questions, and decide whether participation is right for them.
Informed consent has evolved over decades in response to ethical failures in human research. The Belmont Report articulated respect for persons and voluntary, informed choice as foundational principles. Those principles are reflected in federal requirements under the Common Rule and FDA regulations, as well as ICH Good Clinical Practice guidelines. More recently, the revised Common Rule emphasized that consent should begin with a concise, focused presentation of the information most likely to help someone understand why they might or might not want to participate.
These protections are essential. Yet as regulatory requirements have been layered with institutional policies, legal language, and study-specific operational details, the document at the center of the consent process has become increasingly difficult to navigate. Informed consent forms can stretch to dozens of pages, particularly in complex studies such as oncology trials. They may include detailed visit schedules, descriptions of every procedure and blood draw, privacy language, state-specific requirements, and other information that extends well beyond the basic elements of consent.
The result is a paradox: In trying to disclose everything, we risk obscuring what participants most need to know.
When More Information Produces Less Understanding
The problem is not disclosure itself. Participants deserve complete and accurate information. The challenge is that multiple functions and stakeholders often shape a single document, and the information is not always organized around what a participant needs to make an informed decision. What began as a tool to help people make an informed choice can start to look like a contract or a restatement of the study protocol.
But informed consent is not a contract, and it should not be treated as one. It is an ethical process grounded in respect for people. A participant facing a serious diagnosis should not have to search through 40 or 50 pages to find the information most relevant to a deeply personal decision. Critical facts—including meaningful risks—can become buried among operational details.
For example, in a recent one-week snapshot of 53 submissions reviewed by Advarra’s IRB, each submission included an average of two informed consent forms. The primary informed consent form—the central document outlining the study and what participation involves—averaged 26 pages. For cancers and other neoplasms, the largest therapeutic area represented with 33 submissions, the primary forms averaged 28 pages. Among the other therapeutic areas represented, averages ranged from 17 pages for heart and blood diseases to 26 pages for nervous system diseases.
Document length is only part of the challenge. The setting matters, too.
People may be considering research while coping with a new diagnosis, weighing treatment options, or navigating an unfamiliar and stressful healthcare environment. Handing someone a dense document in that moment, without adequate time or support, does not create understanding simply because the required information is present.
Health literacy asks us to consider not only what we disclose, but whether people can meaningfully use it. That shifts the central question from “Did we include everything?” to “Can this person understand the choice in front of them?”
eConsent Should Be More Than Paper on a Screen
Electronic informed consent offers an important opportunity to improve the clinical trial participant experience, but the value of eConsent does not come from converting a long paper document into a long digital document. A 50-page form is still a 50-page form, even when viewed on a tablet.
Used thoughtfully, eConsent can make information easier to absorb. Digital tools can present content in smaller sections, incorporate visuals and video, define unfamiliar terms, and allow participants to revisit information at their own pace. Brief knowledge checks can help identify concepts that need further discussion—not as tests participants must pass, but as prompts for meaningful conversation with the research team.
eConsent can also support a tiered approach. The initial experience would give potential participants a concise, understandable explanation of the study: its purpose, the voluntary nature of participation, what participation will require, the most important risks and potential benefits, and available alternatives. Participants who want or need more detail could then explore additional layers, such as a specific visit schedule, procedure information, or logistical expectations.
This does not mean withholding information. It means organizing information around how people actually learn and make decisions. A visit-by-visit schedule, for example, may be more useful as an accessible study resource or timely reminder than as several pages embedded in the initial consent form. Where applicable, sponsors and study teams could also consider presenting the HIPAA authorization separately from the informed consent form (ICF), helping participants distinguish between consent to participate in research and authorization to use and disclose their protected health information.
Consent Continues Throughout the Study
Technology can also reinforce a principle that is too often lost: Consent is not a signature collected at the beginning of a trial. It is an ongoing process.
Studies change. New risks may emerge, procedures may be added, and follow-up expectations may evolve. Participants need to understand what has changed and what the new information means for them. They must then have a genuine opportunity to decide whether they wish to continue being part of the study.
A well-designed digital experience can make updates more visible and understandable. Rather than asking participants to work through an entirely revised document to locate a critical change, an eConsent platform can highlight new information, explain its significance, capture questions, and connect the participant with the study team. It can also preserve easy access to study information throughout participation, when questions naturally arise.
None of this replaces the human interaction at the heart of informed consent. Technology should support conversation, not substitute for it. Participants still need access to knowledgeable study staff who can answer questions, assess comprehension, and give them appropriate time and space to decide. Digital approaches must also account for accessibility, language needs, varying levels of digital comfort, and alternatives for people who cannot or prefer not to use electronic tools.
A Shared Responsibility to Simplify
Improving informed consent will require more than a new platform. Sponsors, CROs, investigators, sites, IRBs, legal teams, technology providers, and regulators must all challenge practices that add length without improving understanding.
Every piece of information should pass a simple test: Does a person need this to decide whether to participate, and is it presented clearly? Details that are important but not essential to that initial decision may be more useful in a separate resource or an additional digital layer.
Simplifying consent would benefit the broader research ecosystem, reducing administrative burden for sites and allowing IRBs and study teams to focus more attention on participant protection, comprehension, and conversation. Most importantly, it would help participants make decisions consistent with their own values and circumstances.
The future of informed consent should not be measured by how much information we can fit into a document or display on a screen. It should be measured by whether people understand the choice before them and feel able to say “yes” or “no.” eConsent can help us get there, but only if we use it to redesign consent around the person making the decision.