Research Participation and Therapeutic Misconception

What the term means

Therapeutic misconception is when people in a research study mix up research with ordinary treatment. A 2016 systematic review defines it as research subjects conflating research purpose, protocols and procedures with clinical treatment. [1] A 2015 paper describes it as participants failing to adequately grasp the difference between taking part in a clinical trial and receiving ordinary clinical care. [2]

This matters for emerging treatments because many are first offered in studies. A study is designed to answer a question. A treatment plan is designed to help one person. This page is information only. It does not advise anyone to join or avoid a study.

Evidence labels used here

All evidence below is from human studies about people's understanding, not about any treatment. We label systematic reviews of surveys and interviews as mixed, because rates vary a lot between studies and settings.

How common is it?

A systematic review of psychiatry research found 31 eligible papers out of 88 extracted reports. Rates of therapeutic misconception varied widely, from 12.5% to 86% in some research populations. [1] Contributing factors included the perceived medical roles of researchers, media, research setting and subject factors. [1] Higher misconception was linked to lower education, older age, poor insight, cognitive deficits, more symptoms and decreased independence. [1] These findings are from psychiatric research and may not carry over to other fields.

Why it happens

The 2015 paper by Lidz and colleagues argues that therapeutic misconception does not mainly come from poor disclosure or from participants being incompetent. Instead, researchers and participants use different primary frames. Researchers see a scientific design for testing efficacy. Most participants have a personal frame centered on their own medical problem. [2] The authors argue that reducing it means helping people adjust their frame, not only adding information. [2] That is an argument based on interview material, not a trial result.

Can it be reduced?

One randomized trial tested a "scientific reframing" consent approach against a traditional consent procedure. It enrolled 154 patients considering hypothetical trials. [3] Scores on a 10-item Therapeutic Misconception Scale were lower with reframing (26.4, 95% CI 23.7 to 29.1) than with the usual approach (30.9, 95% CI 28.4 to 33.5; p = 0.004). [3] Willingness to take part did not differ significantly (52.1% vs 56.3%). [3] The authors note more study is needed in real-world trials. [3] The trial used hypothetical studies, and about 92% of participants were white, so results may not apply broadly. The systematic review also suggested a neutral educator at consent and education modules may help, though it called for more research. [1]

Hope is not the same as a misunderstanding

A 2022 systematic review of qualitative studies of patients in phase 1 oncology trials (13 studies) found patients mainly joined hoping for therapeutic benefit. [4] The authors concluded that patient views more commonly reflected hope, differences between hope and expectation, and cultural narratives such as staying positive and trusting experts, rather than poor understanding. [4] Hoping a study might help is understandable. The safeguard is to keep hope while knowing the study's purpose and uncertainties.

Things the official consent rules require

Under 21 CFR 50.25, FDA-regulated research consent must state that the study involves research, explain its purposes, and identify any procedures that are experimental. It must also disclose appropriate alternatives. [5] In the United States, a Phase 1 study's job is described by the FDA as testing safety and dosage, not showing benefit. [6]

Questions that help separate research from treatment

• What question is this study trying to answer?
• Might I receive a placebo or a different dose than others?
• What happens if it does not help me, or if I leave?
• What are my alternatives outside the study?

Related guides

Clinical trials explained for participants, informed consent in emerging treatments, expanded access and clinical-trial phases explained.