5 Informed Consent Fixes For Sponsors And Investigators

By Tasha Mohseni, President and Founder, RD Research Services, LLC

Recently, I sat down to review a 30-page consent form. Section by section, the content was technically compliant.

By the last page, I found myself asking a different question: If someone with a regulatory background like me had to concentrate and reread some parts, what on Earth would it look like to a participant with no clinical (or regulatory) background at all?

That question reveals a real problem. The ICF explains study procedures, potential risks, alternatives, privacy protections, compensation, and legal disclosures. Sponsors add each section to satisfy regulatory requirements, reduce ambiguity, and ensure transparency. Yet, after I read page after page, an important question remained: Would the participant truly understand what they're agreeing to?

Informed consent functions as a communication process that helps individuals make an informed, voluntary decision about their participation in research. Sponsors and investigators that recognize this can strengthen participant understanding while improving study quality.

Consent Forms Keep Getting Longer, And That’s Not Helping Matters

Rarely do consent forms become lengthy because sponsors intentionally want to overwhelm participants. Instead, document expansion is often the cumulative result of years of revisions. Teams incorporate new regulatory expectations. Safety information and new risks emerge as trials evolve. Legal language grows. Institutional preferences accumulate. Sponsors attempt to anticipate every possible question or liability concern.

The result is consent forms that are increasingly difficult for participants to navigate. An analysis of consent forms from federally funded U.S. clinical trials found that their average readability exceeds the reading comprehension skills of most adults, even though most U.S. adults read below a sixth-grade level.¹ Ironically, providing more information doesn’t necessarily produce better-informed participants. Information overload can obscure details that matter most when someone is deciding whether to enroll in a clinical trial. The challenge is no longer providing information; it's communicating the information effectively.

The Three Pillars Of Informed Consent

Ethical guidance spanning decades consistently emphasizes that informed consent involves much more than obtaining a signature. Although terminology differs slightly across international guidance, three interconnected principles remain central to an effective consent process.

Information

Participants should receive the information necessary to make an informed decision. Current GCP guidance calls on sponsors to present information in plain language rather than relying on technical or scientific terminology.² The main objective is to disclose the information in a meaningful way.

Comprehension

Providing information is only the beginning. Sponsors must provide the information in a way that participants can understand. Participant comprehension becomes especially important when studies involve complex procedures, innovative technologies, adaptive designs, or situations involving limited disclosure. In those circumstances, investigators should take additional steps to confirm understanding rather than rely on the consent form alone.

Voluntariness

Participation must be voluntary. This principle is foundational to ethical clinical research: Participants should feel free to decline participation or withdraw from a study without coercion, undue influence, or pressure.

These three pillars operate together. A participant can’t make a voluntary decision without understanding the information presented.

Where The Consent Process Commonly Breaks Down

Communication failures with consent often appear in:

• documents written at a technical reading level,
• conversations that focus on obtaining signatures instead of supporting decision-making,
• limited opportunities for participants to ask questions,
• assumptions that silence indicates understanding, and
• information presented in a way that overwhelms participants.

While informed consent may satisfy documentation requirements, the existence of these issues indicate it falls short of the broader ethical objective of informed consent. Fortunately, sponsors and investigators can strengthen participant understanding without fundamentally redesigning their studies.

Mitigation Strategy #1: Write For Participants, Not Regulators

Sponsors should start by asking this question: Could someone without scientific training explain this study after reading the consent form?

Sponsors think of plain language as oversimplifying science. Instead, plain language translates complex concepts into language participants can realistically understand. Shorter sentences, familiar terminology, logical organization, descriptive headings, and active voice improve readability without sacrificing accuracy. If reviewers struggle to understand what study participation involves, prospective participants will likely struggle as well. One review of consent forms found that although most met recommended page-length targets, the majority still yielded a difficult reading level because of long, complex sentences.³

Mitigation Strategy #2: Treat Consent Like A Conversation

The consent form should support the interaction between participants and the research team. Investigators should encourage questions throughout the discussion, pause after complex sections, and invite participants to express concerns without feeling rushed. FDA draft guidance recommends opening the conversation with a concise, focused presentation of the key information most likely to help a prospective participant decide whether to enroll.⁴ These conversations establish trust while allowing investigators to identify misunderstandings before enrollment occurs.

Mitigation Strategy #3: Verify Understanding Instead Of Assuming It

One of the most effective communication techniques is to ask participants to explain key aspects of the study in their own words.

Rather than asking “Do you understand?” investigators might instead ask:

• Can you describe what will happen if you participate?
• What do you see as the biggest risks?
• What alternatives do you have?
• What would happen if you decided to leave the study?

These open-ended questions help investigators identify misunderstandings that yes or no questions often miss. In another study, participants that received a teach-back explanation (wherein physicians ask patient-specific questions and identify and resolve any misunderstandings in real-time) of the consent form scored higher on a comprehension quiz and reported greater trust in the investigator, without meaningfully lengthening the consent visit.⁵

Mitigation Strategy #4: Use Participant-Centered Communication Tools

Depending on the study population and protocol, sponsors should supplement written consent with participant-centered communication tools such as:

• visual timelines of study visits,
• diagrams illustrating study procedures,
• short educational videos,
• audio explanations, and
• frequently asked questions.

These tools should complement, not replace, the consent discussion while providing various modes for participants to understand the information presented. Because decentralized clinical trials are now mainstays in trial design, sponsors must incorporate educational tools in mediums that support them.

Mitigation Strategy #5: Evaluate The Consent Process Not Just The Consent Form

Many organizations devote considerable effort to reviewing the consent document before study activation. Far fewer routinely evaluate how effectively the consent process functions after enrollment begins.

Sponsors should collect feedback from participants and study teams on questions such as:

• Which sections were most confusing?
• Which explanations were most helpful?
• Where did participants require additional clarification?
• What information surprised participants after enrollment?

These insights can guide continuous improvement across future studies while helping organizations identify recurring communication challenges. Sponsors should treat improving participant understanding as an ongoing quality improvement initiative.

Beyond Compliance

The consent form remains one of the most important documents in clinical research. It communicates study procedures, risks, benefits, alternatives, privacy protections, and participants' rights. However, informed consent has never been solely about documentation. It’s about helping individuals make informed, voluntary decisions based on information they genuinely comprehend. Sponsors and investigators who focus exclusively on document risk are overlooking the broader communication process that determines whether informed consent has truly occurred. As clinical trials become increasingly complex, participant understanding will become even more important. The consent form is where informed consent begins. It should never be where the consent process ends.

References:

1. Mirza, F. N., Wu, E., Abdulrazeq, H. F., Connolly, I. D., Tang, O. Y., Zogg, C. K., Williamson, T., Galamaga, P. F., Roye, G. D., Sampath, P., Telfeian, A. E., Qureshi, A. A., Groff, M. W., Shin, J. H., Asaad, W. F., Libby, T. J., Gokaslan, Z. L., Kohane, I. S., Zou, J., & Ali, R. (2024). The literacy barrier in clinical trial consents: A retrospective analysis. eClinicalMedicine, 75, Article 102814. https://doi.org/10.1016/j.eclinm.2024.102814
2. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). (2025, January 6). Guideline for good clinical practice E6(R3). https://database.ich.org/sites/default/files/ICH_E6(R3)_Step4_FinalGuideline_2025_0106.pdf
3. Kato, R., Joseph, R., Haule, L., & Kafuye, M. (2025). Readability of health research informed consent forms: Case of the National Health Research Ethics Committee in Tanzania. BMC Medical Ethics, 26, Article 64. https://doi.org/10.1186/s12910-025-01200-w
4. U.S. Food and Drug Administration. (2024, March). Key information and facilitating understanding in informed consent: Draft guidance for sponsors, investigators, and institutional review boards. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/key-information-and-facilitating-understanding-informed-consent-guidance-sponsors-investigators-and
5. Seely, K. D., Higgs, J. A., Butts, L., Roe, J. M., Merrill, C. B., Zapata, I., & Nigh, A. (2022). The “teach-back” method improves surgical informed consent and shared decision-making: A proof of concept study. Patient Safety in Surgery, 16, Article 33. https://doi.org/10.1186/s13037-022-00342-9

About The Author:

Tasha Mohseni is a research ethics and compliance professional dedicated to advancing ethical, high-quality research. With more than six years of experience supporting IRB, COI, and Reponsible Conduct of Research (RCR) programs, she helps organizations navigate complex regulatory requirements while strengthening research integrity. Tasha specializes in regulatory content development, compliance training and education, IRB application and post-approval support, and research process improvement. She is passionate about creating practical resources that empower researchers and research professionals to build compliant, efficient, and ethically responsible research programs.