01 · The Question
What If the Participant Has Not Said “I Withdraw,” but Clearly Seems Uneasy?
A participant starts hesitating before procedures. Their answers become reluctant. They repeatedly ask whether they really have to continue. Perhaps they pull away, become visibly distressed, stop responding enthusiastically, or say something ambiguous such as, “I don't know if I want to keep doing this.”
They have not formally withdrawn. Does that mean researchers can continue until the participant explicitly says the right words?
No formal phrase should be treated as the only way a participant can communicate reluctance. At the same time, researchers should not automatically declare someone withdrawn whenever they appear nervous or uncomfortable. The appropriate response is to clarify what the participant wants while protecting voluntariness.
02 · The Short Answer
Do Not Treat Silence or Passive Compliance as Clear Continued Willingness
In Brief
If a participant appears reluctant, distressed, resistant, or uncertain about continuing, pause when appropriate and ask about their wishes in a neutral, non-pressuring way rather than assuming that the original consent still settles the matter.
Discomfort does not automatically equal withdrawal, but neither should researchers require participants to make a formal declaration before taking signs of unwillingness seriously. Clarify whether the person wants to continue, pause, decline a particular activity, or withdraw, and follow the approved protocol for the choice they make.
03 · What You Need to Know
Continued Participation Must Remain Voluntary
The Original “Yes” Is Not Irrevocable
Research consent is not a contract requiring participants to finish whatever they started. Under the U.S. Common Rule, participants must be told that participation is voluntary and that they may discontinue participation at any time without penalty or loss of benefits to which they are otherwise entitled. OHRP describes informed consent as a communication process that continues until completion of the study.
That continuing voluntariness matters when a participant's present behavior appears inconsistent with the willingness expressed at enrollment.
A researcher should not think, “They signed, so I can continue until they formally withdraw.” The better question is whether the participant still appears to be voluntarily agreeing to what is happening now.
Discomfort, Reluctance, and Withdrawal Are Not Identical
Participants can be uncomfortable and still want to continue. A blood draw may make someone anxious. A sensitive interview question may be unpleasant. A lengthy assessment may be tiring. None of these reactions necessarily means the person wishes to leave the study.
But visible reluctance can be information about voluntariness. The researcher should not interpret it automatically in either direction.
Discomfort or hesitation
A sign that the participant may need a pause, clarification, reassurance about their choices, or an opportunity to express what they want.
Withdrawal
A decision to discontinue participation, whether from the entire study or, where the approved study permits it, from particular activities or aspects of participation.
The distinction matters because researchers should neither force continued participation nor prematurely remove someone who actually wishes to remain enrolled.
Look for Signals That Warrant Clarification, Not a Diagnosis
Researchers are not mind readers, and body language is culturally and individually variable. A participant crossing their arms, becoming quiet, or looking away cannot reliably be translated into “withdrawal.”
More direct behaviors may nevertheless create a clear reason to check. Examples include repeatedly refusing to begin a procedure, physically pulling away, expressing uncertainty about continuing, asking whether participation is mandatory, becoming distressed when the next activity is explained, or repeatedly attempting to stop an interaction.
What you observe or hear
What it might mean
What not to assume
“Do I really have to do this?”
The participant may misunderstand voluntariness or may be considering refusal
Do not assume either agreement or withdrawal
Pulling away from a procedure
The participant may be afraid, uncomfortable, or unwilling
Do not continue merely because consent was previously signed
“Can we stop for a while?”
The participant may want a temporary pause rather than permanent withdrawal
Do not automatically terminate all participation
Repeatedly declining one activity
The participant may object to that component while remaining willing to do others
Do not promise partial participation unless the protocol permits it
Visible distress without verbal explanation
The participant may need a pause and an opportunity to communicate
Do not infer the person's decision solely from appearance
Ask Neutral Questions Instead of Questions That Push Toward Continuation
How researchers respond can itself affect voluntariness. A question such as “You're okay to keep going, aren't you?” subtly invites agreement. So can reminders about how much work the team has already done, how important the data are, or how inconvenient withdrawal would be.
A more neutral approach is to make the choices explicit: the participant can take a break, ask questions, decline where the protocol permits, or stop participating. Researchers can then ask what the participant would like to do.
The purpose is not to persuade the person to stay. It is to understand their current decision.
Do Not Require the Participant to Know Research Vocabulary
A participant does not need to say, “I hereby withdraw my informed consent.” Ordinary language can communicate the same decision.
Statements such as “I want to stop,” “I don't want to do this anymore,” or another sufficiently clear refusal should be taken seriously. Where the participant's meaning is ambiguous, clarify it rather than insisting on formal terminology.
If the participant does decide to leave, the broader question of whether someone can change their mind after giving consent is straightforward in principle: research participation must remain voluntary. The consequences and procedures associated with withdrawal should have been addressed through the consent process where appropriate.
A Participant May Be Objecting to One Activity Rather Than the Entire Study
Sometimes discomfort is highly specific. A participant may be happy to complete questionnaires but no longer want blood collected. Another may wish to continue follow-up but decline an optional interview.
Researchers should determine what the participant actually wants rather than translating refusal of one procedure into either “everything is fine” or “the participant has left the whole study.” Whether a participant can withdraw from only part of a study depends on the protocol, scientific feasibility, and applicable requirements.
Temporary Distress May Call for a Pause Rather Than an Immediate Final Decision
Not every moment of discomfort requires the participant to choose immediately between continuing and permanent withdrawal. If appropriate and permitted, a short break may allow the person to recover, ask questions, and decide without pressure.
The researcher should be particularly cautious when continuing immediately could expose the participant to harm or when distress itself makes meaningful communication difficult. Participant welfare takes priority over completing a data collection session on schedule.
Do Not Confuse Reluctance With Loss of Capacity
A participant can understand the study perfectly well and simply dislike it, become tired of it, or decide that participation is no longer worthwhile. Disagreement with the researcher is not evidence of incapacity.
Conversely, if the person's behavior is accompanied by genuine concern about whether they can understand or make the relevant decision, the issue may require assessment under the study's procedures concerning decision-making capacity. Researchers should not use capacity as a convenient explanation for a participant who appears unwilling to cooperate.
If Withdrawal Is Confirmed, Clarify What Happens Next
Once a participant clearly decides to discontinue, researchers should follow the approved withdrawal procedures. OHRP recommends that protocols and consent documents anticipate withdrawal and explain what it means, including relevant consequences and procedures for orderly termination.
Withdrawal from active participation also does not automatically answer every question about information already collected. What happens to participant data after withdrawal depends on the applicable regulatory framework, consent terms, study design, and data status.
Watch Out
Never use the absence of the words “I withdraw” as justification for proceeding through clear resistance to a research procedure. When present behavior creates reasonable uncertainty about willingness, clarify the participant's wishes before treating continued participation as voluntary.
04 · A Practical Example
When a Participant Hesitates During a Research Procedure
Hypothetical Example
“Do We Really Have to Keep Doing This?”
Imagine a participant completing a series of research assessments. Before the next procedure, they become quiet and say, “I'm getting tired of all this. Do we really have to keep doing it?” They have not said that they are withdrawing from the study.
Pause
The researcher does not interpret the absence of a formal withdrawal statement as automatic permission to proceed.
Clarify voluntariness
The researcher reminds the participant that research participation is voluntary and that they are not required to continue simply because they previously agreed.
Ask neutrally
The researcher asks whether the participant would prefer a break, wants more information, wishes to stop the current procedure, or wants to discontinue participation.
Listen to the actual choice
The participant explains that they want a break but still wish to complete the study after resting.
Proceed only after willingness is clear
After the break, the researcher confirms that the participant still wishes to continue and follows any documentation requirements in the approved protocol.
In this example, taking discomfort seriously did not require declaring the participant withdrawn. It created the space needed to determine what the participant actually wanted.
07 · A Quick Checklist
When a Participant Seems Uncomfortable Continuing
Before assuming continued participation, check:
Notice verbal or behavioral signs that make the participant's willingness genuinely uncertain.
Pause the relevant activity when continuing before clarification would be inappropriate or potentially harmful.
Remind the participant neutrally that research participation remains voluntary.
Ask what the participant wants without phrasing the question to favor continuation.
Distinguish a request for a break, refusal of one activity, uncertainty, and withdrawal from the entire study.
Do not infer loss of decision-making capacity merely from reluctance or refusal.
Follow the approved protocol for partial refusal, temporary interruption, withdrawal, and documentation.
If withdrawal is confirmed, explain any necessary orderly termination procedures and what happens to previously collected data as required.
09 · The Bottom Line
You Do Not Need Formal Withdrawal Language to Take Reluctance Seriously
The Bottom Line
When a participant's words or behavior create genuine uncertainty about whether they still want to participate, do not rely automatically on their original consent or wait for a formal declaration of withdrawal. Clarify what they want before continuing the relevant research activity.
Discomfort does not automatically mean withdrawal, so avoid making the decision for the participant as well. Give them room to communicate whether they want to continue, pause, decline a particular activity, or leave the study, and follow the approved procedures for the choice they make.
11 · Cite this Guide
How to Cite This Guide
This guide is intended to be read, shared, and used in research, teaching, and academic work. If you draw on its ideas, explanations, or other content, please acknowledge the source by citing the guide. Doing so gives appropriate credit and helps your readers locate the original resource.
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