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An invitation to hear about a study does not mean that someone has agreed to participate. First contact should provide access to a suitable discussion, while informed consent supports an informed and voluntary decision about the research itself.
Define the workflow
An invitation should identify the activity as research and avoid promising access to treatment. The site can decide which information is needed only to arrange an appointment. Eligibility assessment and study-specific procedures require separate consideration; a reply to an advertisement should not be treated as permission for those activities.
Worked example
For example, a person leaves a telephone number after seeing an advertisement. The coordinator explains the purpose of the call and that a discussion is optional. Attending an appointment does not guarantee eligibility or receipt of the investigational product. Qualified staff conduct the detailed consent process at the appropriate stage.
Practical checks
- Show invitation, eligibility assessment and consent as separate steps in the contact script.
- Separate contact details needed for scheduling from unnecessary health information at first contact.
- Check that the advertisement and telephone explanation create consistent expectations about participation.
Decision and boundaries
The workflow is understandable when the person can explain why they were contacted and what happens next. This is an operational example. Study approvals and applicable local requirements still determine which advertisements, records and preliminary assessment activities may be used.
Frequently asked questions
- Does accepting an invitation constitute consent?
- No. Requesting information or booking a discussion does not automatically authorize research procedures; the appropriate consent process remains necessary.
- Must the first call explain the entire protocol?
- Provide clear information for deciding about the discussion, then plan the detailed process with appropriate time and qualified staff.