Participant Pause, Stop, and Modification Procedure

About this procedure

This standard operating procedure gives research teams a reusable process for supporting participant control and accessibility during VR, digital-health, behavioral, rehabilitation, wearable-technology, and other technology-assisted clinical research. It covers what to do before a session, when a participant asks to pause, how to work through a modification, what to do when a participant stops or withdraws, and how to document and learn from each event.

Core principle: a request to pause, modify, receive assistance, or stop is treated as participant communication and an accessibility consideration — not automatically as noncompliance, treatment failure, or a reason for exclusion.

Scope: cross-disability, and intended to be adapted to the approved protocol, institutional policy, study population, technology, safety requirements, and applicable ethics or legal requirements.

Suggested participant-facing statement

“You can ask to pause, change something about the setup or procedure, get assistance, or stop at any time. If something is uncomfortable, inaccessible, confusing, or difficult to use, please tell us. We will discuss what can be adjusted safely and within the study requirements. You may also choose to stop or withdraw.”

Modification pathway

• 01Identify

  Clarify the barrier or access need relevant to the procedure.

• 02Discuss

  Ask the participant what change would help and consider available alternatives.

• 03Evaluate

  Confirm that the proposed modification is safe, feasible, and compatible with essential study requirements.

• 04Implement

  Apply the agreed modification and explain any change to the procedure.

• 05Confirm

  Ask whether the modification adequately addressed the barrier.

• 06Document

  Record the barrier, accommodation, participant response, and any effect on data collection or interpretation.

Documentation and continuous improvement

Each pause, modification, or withdrawal is documented using the Barrier → Accommodation → Participant Response → Design Modification process, recording only what is necessary for research operations, safety, interpretation, and approved study records. Where relevant, teams note whether an accommodation affected measurement conditions, so accommodation-related differences are not automatically interpreted as psychological or behavioral outcomes. Post-session review looks for recurring barriers, and changes that affect approved procedures go through the institution’s required review before implementation.

The procedure is a public dissemination component of the Accessible Adaptive VR framework and pairs with the Disability-Inclusive Clinical Research Accommodation Planning Form and the Accessible VR Clinical Research Toolkit. Skyward Sojourn provides the initial implementation context for the broader framework; the earlier eight-participant study was not designed to demonstrate disability inclusion.