GMC: Consent to research: Summary

SJT Textbook: Consent to Research

GMC Consent to Research

This GMC consent to research guidance explains how doctors must obtain informed, voluntary and capacity-based consent before enrolling any participant in medical research.

🎥 Video Lesson (YouTube)

🎧 Podcast Lesson (Spotify / Apple / Amazon)

GMC consent to research requires explicit, informed and voluntary participation.

🎯 THE CORE PRINCIPLE

Consent to research is about protecting participants’ autonomy, dignity, and safety while enabling ethical medical research. Doctors must ensure that consent is informed, voluntary, and given by someone with capacity, and that participants understand their right to withdraw at any time without detriment to their care.

Special safeguards apply to children, vulnerable adults, and adults who lack capacity. In these groups, the law requires additional layers of protection, consultation with those close to the participant, and clear justification that the research cannot be carried out in less vulnerable populations.

In MSRA SJT scenarios, high-scoring answers demonstrate careful explanation of risks and benefits, respect for autonomy, legal awareness, early involvement of ethics committees, and meticulous documentation.

⚡ HIGH-YIELD ACTIONS (What Scores Points)

1. Provide clear, tailored information about the purpose, risks, and benefits of the research.
2. Confirm that consent is voluntary and free from pressure.
3. Assess and document the participant’s capacity to consent.
4. Explain the right to withdraw at any time without impact on care.
5. Obtain parental consent and involve the child appropriately when researching with children.
6. Apply additional safeguards for vulnerable adults.
7. For adults lacking capacity, ensure research is directly related to their condition and seek views of those close to them.
8. Use ethics committee approval before starting research.
9. In emergencies, obtain delayed consent as soon as practicable.
10. Comply with legal frameworks for human tissue and clinical trials.

MSRA SJT frequently tests breaches of GMC consent to research safeguards.

These traps minimise legal requirements or bypass capacity and autonomy.

Capacity assessment is central to GMC consent to research standards.

💬 MODEL PHRASES (Use These in SJT Logic)

* “Participation is voluntary and they may withdraw at any time.”
* “I will assess and document capacity to consent.”
* “For this vulnerable participant, additional safeguards are required.”
* “Ethics committee approval must be in place before recruitment.”

V – Voluntary
A – Adequately informed
L – Lawful
I – Individual capacity
D – Documented
C – Children need parental input
O – Ongoing right to withdraw
N – No pressure
S – Safeguards for vulnerable
E – Ethics approval
N – Notifiable approvals if required
T – Tissue governed by law

📋 QUICK FAQ

Can a participant withdraw from research at any time?
Yes. They must be told they can withdraw at any time without affecting their care. Can children consent to research?
Parental responsibility consent is required, but the child’s views and capacity must be considered. Is research on adults lacking capacity allowed?
Only if directly related to their condition and with strict legal safeguards. Can emergency research start without consent?
Yes, if approved by an ethics committee, but consent must be sought as soon as possible. Does consent for treatment equal consent for research?
No. Research always requires separate, specific consent.

📚 GMC ANCHOR POINTS

• Valid consent – Consent to Research Guidance
• Protection of vulnerable groups – GMC Research Guidance
• Adults lacking capacity – Mental Capacity Act 2005
• Children and consent – 0–18 Years Guidance
• Human tissue use – Human Tissue Act

💡 MINI PRACTICE SCENARIO

A patient with mild learning disability is invited to take part in a drug trial. Best action: Assess capacity carefully and provide tailored information before seeking voluntary consent. Why: Capacity and informed consent are essential before research participation.

🎯 KEY TAKEAWAYS

✓ Consent must be informed and voluntary
✓ Capacity must always be assessed
✓ Participants can withdraw at any time
✓ Extra safeguards protect vulnerable groups
✓ Ethics approval is mandatory
✓ Emergency research still requires later consent
✓ Documentation is essential

🔗 RELATED TOPICS

* → Decision Making and Consent
* → 0–18 Years Guidance
* → Capacity and Best Interests
* → Confidentiality
* → Human Tissue and Post-Mortem Practice

📖 FULL PRACTICE QUESTIONS

Example SJT — Best of 3 (8 options; choose three)

A researcher wishes to recruit adults with dementia into a study.

Options:
A. Assume consent if no objection is raised
B. Assess capacity to consent
C. Seek views of family or legal proxy
D. Proceed without safeguards due to benefit
E. Ensure ethics committee approval
F. Ignore the Mental Capacity Act
G. Document the consent process
H. Withhold information to avoid distress

Example SJT — Rank 5 (best → worst)

A patient in an emergency trial cannot give immediate consent.

Options:
A. Begin research under ethics approval and seek delayed consent later
B. Wait until consent is obtained before any intervention
C. Enrol without approval and never seek consent
D. Enrol and never inform the patient later
E. Ignore the consent process entirely