conduct-research-with-human-participants

name	conduct-research-with-human-participants
category	school
description	Conduct approved human-participant research with valid consent, role controls, privacy, safety monitoring, deviations, withdrawal, and accountable closeout. Use when operating a study that interacts with people or uses identifiable private information.

conduct-research-with-human-participants

Protect participant autonomy and welfare throughout the study, not only when a form is signed.

When to use

• Use after the authorized ethics body has approved or formally determined the status of the actual study.
• Use a nonparticipant research workflow when no living person is interacted with and no identifiable private information is obtained or analyzed.

Preconditions

• Confirm current protocol, approvals, sites, investigators, training, delegation, insurance, agreements, recruitment materials, consent versions, and reporting contacts.
• Verify participant population, capacity, languages, accessibility, safeguarding, compensation, clinical or educational relationships, and emergency resources.
• Activate secure systems for screening, identifiers, contact, study data, recordings, specimens, safety events, withdrawals, and access logs.

Procedure

1. Establish the approval and role boundary for recruitment, screening, consent, intervention, data access, safety review, payment, clinical response, and reporting.
2. Recruit only through approved routes and keep supervisors, teachers, clinicians, carers, and gatekeepers from exerting inappropriate influence.
3. Conduct consent and ongoing choice using accessible information, comprehension checks, capacity or assent procedures, guardian authority where approved, adequate decision time, and a clear no-penalty refusal route.
4. Reconfirm willingness before material procedures, recordings, sensitive questions, specimen use, optional sharing, and new activities.
5. Verify eligibility and assign study identifiers without copying unnecessary personal data into operational files.
6. Follow the approved protocol and document source observations, timing, intervention fidelity, equipment, operator, and contextual conditions.
7. Maintain participant safety through risk checks, distress and adverse-event response, safeguarding, clinical escalation, unblinding rules, stop criteria, and independent monitoring where required.
8. For urgent disclosures, use the site-specific school, remote, clinic, or field route and keep authorized continuous contact until a qualified responder confirms handoff.
9. Apply privacy, minimum access, secure transfer, recording controls, re-identification separation, disclosure review, and approved sharing restrictions.
10. Record deviation and withdrawal handling promptly, including cause, immediate protection, data or specimen disposition choices, reporting duty, corrective action, and effect on validity.
11. Report adverse events, unanticipated problems, breaches, complaints, protocol deviations, and conflicts through the required channels and timelines.
12. Reconcile participant flow, consent versions, procedures, data, specimens, compensation, withdrawals, events, and missing records.
13. Close participation with debriefing, referrals, result-return commitments, contact limits, and verified retention or disposal.

Failure plan

• If immediate harm or credible self-harm, abuse, medical, or safety risk appears, prioritize the approved emergency and safeguarding route over research continuity.
• If consent is uncertain, outdated, coerced, or not understood, pause the affected activity and seek authorized review.
• If an unapproved procedure or data use occurs, stop it, preserve evidence, protect affected people, and report rather than silently repairing the record.
• If a participant withdraws, honor the approved choices and explain any data that cannot lawfully or scientifically be removed.
• Never backdate consent, invent signatures, conceal deviations, retaliate against complaints, or promise confidentiality beyond the actual legal and technical limits.

Worked example

A multi-site adolescent mental-health study recruits through schools, records video, collects optional specimens, and encounters a disclosure of immediate self-harm risk. The researcher stops the interview, follows the approved emergency and safeguarding plan, limits disclosure to authorized responders, and documents the event without continuing data collection. The team verifies assent and guardian materials by site, handles the participant's withdrawal choice, reports the event and a related protocol deviation, and pauses that site until the ethics body accepts corrective training and controls.

Done

• A participant protection register records approval and role boundary, population safeguards, privacy, emergency routes, monitoring, complaints, and reporting duties
• A consent and study conduct log verifies consent and ongoing choice, approved versions, eligibility, procedures, identifiers, compensation, data, specimens, and withdrawal choices
• A safety and deviation report proves participant safety actions, events, deviation and withdrawal handling, notifications, corrective action, reconciliation, and closeout