06. Rehearse consent, withdrawal and incident responses
Lesson
LEARNING OBJECTIVES
Turn participant-protection principles into field actions, explain the limits of withdrawal accurately, and prepare proportionate escalation procedures for unexpected problems.
WRITE ACTIONABLE PROCEDURES
For consent, specify who provides information, how privacy and questions are handled, what comprehension checks are appropriate, how a decision is recorded and where records are stored. Use only the reviewed process and materials. Record version and date so the team knows which information was provided.
A neutral comprehension check might ask a participant to describe what they understand participation to involve. If an explanation is unclear, clarify respectfully; do not coach a preferred answer merely to obtain a signature. Respect a decision to decline or stop.
WORKED FICTIONAL CONSENT OPENING
“We are inviting selected households to consider a research interview about water use. Taking part is your choice. The interview would involve the topics and time explained in the information sheet. You may ask questions, decline or stop according to the process described. Your decision will not change the services to which you are entitled.”
This is an illustrative opening, not a complete approved consent form. Actual wording must accurately describe the real study, burdens, data handling, withdrawal and contacts. Do not state that services are unaffected unless the study arrangements support that promise.
WITHDRAWAL NEEDS A PLAN
Distinguish stopping future participation from removing already collected information. Explain what is possible after data have been de-identified, combined or published, according to the reviewed plan. Do not promise unconditional deletion if the team cannot identify or retrieve an individual's records.
Record withdrawal without collecting unnecessary explanations. Specify which staff may alter study records and how the analytical handling of withdrawn or incomplete observations will be documented.
INCIDENT AND DISTRESS PROCEDURES
List likely problems such as a misplaced form, an unintended disclosure, participant distress, equipment malfunction or a staff safety concern. Define immediate protective actions, whom to contact, what information to record, who decides whether work pauses, and how follow-up is documented. Use locally reviewed escalation and referral arrangements rather than invented emergency contacts.
Keep incident reports access-restricted. A public teaching notebook is not a suitable incident register. Review incidents for process improvement without concealing deviations or pressuring staff to suppress reports.
YOUR TASK
Run three role-plays: a refusal, a request to withdraw after an interview, and a lost paper form. For each write a short action sequence, responsible roles and documentation steps.
Prepare an incident-response card that field staff can use, leaving contact details to be filled with verified project information before deployment. Add a check that every interviewer can explain the limits of their authority.
SELF-CHECK AND FEEDBACK
Is repeated persuasion appropriate after a clear refusal? No; respect the decision. Can every interviewer promise to erase a published aggregate? No; explain actual limits. Does a completed training card replace ethics review? No; operational instructions must implement the reviewed plan.
PORTFOLIO OUTPUT
A consent/withdrawal SOP, three role-play notes and a reviewed-contact incident-response template.
FURTHER READING
WMA Declaration of Helsinki.
https://www.wma.net/policies-post/wma-declaration-of-helsinki/
CDC Field Epidemiology Manual: Collecting Data.
https://www.cdc.gov/field-epi-manual/php/chapters/collecting-data.html
Turn participant-protection principles into field actions, explain the limits of withdrawal accurately, and prepare proportionate escalation procedures for unexpected problems.
WRITE ACTIONABLE PROCEDURES
For consent, specify who provides information, how privacy and questions are handled, what comprehension checks are appropriate, how a decision is recorded and where records are stored. Use only the reviewed process and materials. Record version and date so the team knows which information was provided.
A neutral comprehension check might ask a participant to describe what they understand participation to involve. If an explanation is unclear, clarify respectfully; do not coach a preferred answer merely to obtain a signature. Respect a decision to decline or stop.
WORKED FICTIONAL CONSENT OPENING
“We are inviting selected households to consider a research interview about water use. Taking part is your choice. The interview would involve the topics and time explained in the information sheet. You may ask questions, decline or stop according to the process described. Your decision will not change the services to which you are entitled.”
This is an illustrative opening, not a complete approved consent form. Actual wording must accurately describe the real study, burdens, data handling, withdrawal and contacts. Do not state that services are unaffected unless the study arrangements support that promise.
WITHDRAWAL NEEDS A PLAN
Distinguish stopping future participation from removing already collected information. Explain what is possible after data have been de-identified, combined or published, according to the reviewed plan. Do not promise unconditional deletion if the team cannot identify or retrieve an individual's records.
Record withdrawal without collecting unnecessary explanations. Specify which staff may alter study records and how the analytical handling of withdrawn or incomplete observations will be documented.
INCIDENT AND DISTRESS PROCEDURES
List likely problems such as a misplaced form, an unintended disclosure, participant distress, equipment malfunction or a staff safety concern. Define immediate protective actions, whom to contact, what information to record, who decides whether work pauses, and how follow-up is documented. Use locally reviewed escalation and referral arrangements rather than invented emergency contacts.
Keep incident reports access-restricted. A public teaching notebook is not a suitable incident register. Review incidents for process improvement without concealing deviations or pressuring staff to suppress reports.
YOUR TASK
Run three role-plays: a refusal, a request to withdraw after an interview, and a lost paper form. For each write a short action sequence, responsible roles and documentation steps.
Prepare an incident-response card that field staff can use, leaving contact details to be filled with verified project information before deployment. Add a check that every interviewer can explain the limits of their authority.
SELF-CHECK AND FEEDBACK
Is repeated persuasion appropriate after a clear refusal? No; respect the decision. Can every interviewer promise to erase a published aggregate? No; explain actual limits. Does a completed training card replace ethics review? No; operational instructions must implement the reviewed plan.
PORTFOLIO OUTPUT
A consent/withdrawal SOP, three role-play notes and a reviewed-contact incident-response template.
FURTHER READING
WMA Declaration of Helsinki.
https://www.wma.net/policies-post/wma-declaration-of-helsinki/
CDC Field Epidemiology Manual: Collecting Data.
https://www.cdc.gov/field-epi-manual/php/chapters/collecting-data.html
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