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Time between first receiving study information and deciding about participation is more than an empty calendar interval. Someone may want to organize questions, speak with a trusted person or consider alternatives. The site can make room for those needs in its scheduling.
Define the workflow
Ask which issues could influence the decision. Explain access to information materials and a clear channel for questions. Do not assume one universal waiting period for every trial. The approved process, clinical circumstances and applicable local requirements should be considered while preserving a voluntary decision.
Worked example
For example, a shift worker wants to review the visit schedule at home. Staff arrange another conversation at a convenient time and provide a contact number. They do not use limited study places as a reason for an immediate signature. Changes in available information are also addressed at the next discussion.
Practical checks
- Identify unresolved questions and the person’s preferred time for another conversation.
- Confirm a suitable copy of the information is available to review outside the appointment.
- Review sample discussions for language that turns scheduling pressure into pressure to participate.
Decision and boundaries
The process is stronger when the person can say they are not ready and knows how to obtain answers. Reflection time is not advice to postpone necessary clinical assessment. In time-sensitive circumstances, the investigator determines a suitable approach within the applicable consent framework and the person’s situation.
Frequently asked questions
- Should everyone receive the same interval?
- Needs differ. A single interval should not be applied to every study without examining the relevant study and local framework.
- Should contact end if a decision is postponed?
- A follow-up can be agreed according to the person’s preference, avoiding repeated reminders that create pressure to join.