GMC: Good Practice in Research: Summary

SJT Textbook: Good Practice in Research

Good Practice in Research GMC

This good practice in research GMC guide explains the ethical, legal and governance standards for medical research as tested in MSRA SJT.

🎥 Video Lesson (YouTube)

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DIFFICULTY: ★★★☆☆ Moderate FREQUENCY: Medium PRIORITY: Must-Know
📍 EXAM MINDSET

Patient safety, valid consent, ethical approval, and transparency always outweigh academic ambition or personal gain.

🎯 THE CORE PRINCIPLE

Good Practice in Research applies the principles of Good Medical Practice to all research involving human participants, human tissue, or medical records. This includes clinical and non-clinical studies, as well as clinical trials of medicinal products.

Doctors must ensure that all research is:

* Lawful and ethically approved
* Scientifically sound
* Proportionate in risk
* Conducted with integrity
* Based on valid, informed consent
* Focused on participant safety and dignity

In MSRA SJT, high-scoring answers prioritise ethical approval, governance, consent, risk minimisation, conflict-of-interest management, and immediate action if safety concerns arise.

The good practice in research GMC guidance requires valid ethical approval before any study begins.

⚡ HIGH-YIELD ACTIONS (What Scores Points)

1. Confirm legal and governance approval before starting research.
2. Ensure a Research Ethics Committee (REC) has approved the protocol where required.
3. Use a clearly defined, approved research protocol.
4. Obtain valid, informed, voluntary consent before participation.
5. Minimise foreseeable risks and ensure benefits outweigh harms.
6. Protect confidentiality and comply with data protection law.
7. Declare and manage conflicts of interest transparently.
8. Keep accurate research records and registrations.
9. Report adverse events and safety concerns immediately.
10. Act with honesty and integrity in data collection and reporting.

MSRA SJT frequently tests breaches of good practice in research GMC consent rules.

🚨 RED FLAGS (Act Immediately)
• Starting research without ethical approval
• Involving participants without valid consent
• Concealing adverse events
• Falsifying or selectively reporting data
• Undeclared financial conflicts of interest
• Exposing participants to disproportionate risk
• Misleading participants about aims or risks
TRAP ANSWERS (Decoy Detectors)
Trap Answer Why It Tanks Your Score
“Consent is implied once ethics approval is granted” Consent must be obtained from each participant.
“Adverse events only need reporting at study end” Safety concerns require immediate reporting.
“Small audit-style projects don’t need governance checks” Governance applies to all human research.
“Conflicts only matter if money is involved” Non-financial conflicts also matter.

These traps prioritise convenience, academic gain, or speed over participant safety.

💬 MODEL PHRASES (Use These in SJT Logic)

Model Phrase
“I must ensure appropriate ethical approval is in place.”

* “I will obtain valid, informed consent before participation.”
* “Participant safety overrides research goals.”
* “I need to declare and manage any conflicts of interest.”
* “Any adverse events must be reported immediately.”

🧠 MEMORY AID
RESEARCH

R – REC approval
E – Explicit informed consent
S – Safety first
E – Ethics and law compliance
A – Adverse event reporting
R – Record keeping
C – Conflicts declared
H – Honesty and integrity

Adverse event reporting is mandatory under good practice in research GMC standards.

🏃 EXAM SPEEDRUN
1 Check ethical and legal approval.
2 Verify protocol compliance.
3 Obtain informed consent.
4 Minimise risk and monitor safety.
5 Report adverse events.
6 Declare conflicts.
7 Maintain accurate records.

📋 QUICK FAQ

Does all research need ethical approval?
Most studies involving people, tissue, or identifiable data require governance and often REC approval. Is consent always required?
Yes, unless specific legal exemptions apply (e.g. certain emergency research), with strict safeguards. Who is responsible for patient safety in research?
Every doctor involved in the research team. Must conflicts of interest always be declared?
Yes — financial and non-financial conflicts. Can doctors support research without being investigators?
Yes, by informing patients about eligible studies and supporting participation appropriately.

Conflicts of interest must always be declared under good practice in research GMC guidance.

📚 GMC ANCHOR POINTS

• Good Medical Practice – Integrity and governance
• Consent to Research
• Confidentiality and Data Protection
• Raising and Acting on Concerns
• Conflicts of Interest
• Clinical Trials Regulations

💡 MINI PRACTICE SCENARIO

You are recruited to collect data for a study that has not yet received REC approval. Best action: Decline involvement until ethical approval is confirmed. Why: All research involving participants must be ethically approved before commencing.

Participant safety is the overriding priority in good practice in research GMC policy.

🎯 KEY TAKEAWAYS

✓ Research must be lawful and ethically approved
✓ Participant safety always comes first
✓ Valid consent is mandatory
✓ Risks must be proportionate to benefit
✓ Conflicts must be declared
✓ Adverse events must be reported immediately
✓ Accurate records are essential
✓ Honesty and transparency are fundamental

🔗 RELATED TOPICS

* → Consent to Research
* → Confidentiality
* → Raising and Acting on Concerns
* → Data Protection
* → Conflicts of Interest

📖 FULL PRACTICE QUESTIONS

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

You are participating in a research study when a participant develops an unexpected complication.

Options:
A. Report the adverse event immediately
B. Continue the study without disclosure
C. Inform the principal investigator
D. Update the participant and provide treatment
E. Wait until publication to report it
F. Record the event accurately
G. Conceal the incident to protect funding
H. Amend data to minimise impact

👆 Click to reveal correct three

Correct three: A, C, D
• A: Protects participant safety.
• C: Governance responsibility.
• D: Duty of care continues in research.

Why others are weaker/wrong:
• B/E/G/H: Dishonest and unsafe.
• F: Important but secondary to immediate safety action.


Example SJT — Rank 5 (best → worst)

A doctor discovers undeclared financial ties to a trial sponsor.

Options:
A. Declare the conflict immediately
B. Seek advice from the research sponsor
C. Continue silently to avoid disruption
D. Withdraw from the project temporarily
E. Edit records to remove evidence

👆 Click to reveal ideal order

Ideal order: A (1) > D (2) > B (3) > C (4) > E (5)
• A/D: Honesty and participant protection.
• B: Acceptable but secondary.
• C: Unsafe.
• E: Serious misconduct.

📦 QUICK-REFERENCE CARD (Screenshot/Print)
GOOD PRACTICE IN RESEARCH
Ethics approval
Informed consent
Safety monitoring
Data protection
Conflict declaration
Honest reporting
RED FLAGS
No ethical approval
No consent
Hidden adverse events
Data falsification
Undeclared conflicts
MEMORY AID
RESEARCH