Consent Policy

1. Introduction

Marylebone Diagnostic Centre (MDC) is committed to ensuring that all patients are able to make informed, voluntary and clearly understood decisions about their care.

This Consent Policy describes how consent is obtained, recorded and respected across all MDC clinical and diagnostic services.

Consent at MDC follows:

• CQC Fundamental Standards
• GMC Decision Making and Consent guidance
• UK GDPR and Data Protection Act 2018
• Mental Capacity Act 2005
• Health Research Authority (HRA) ethical standards

2. Principles of Consent

Consent must always be:

• Voluntary – given freely and without pressure
• Informed – based on clear, understandable information
• Specific – for each procedure, purpose or use
• Documented – recorded appropriately
• Reversible – patients can withdraw consent at any time

No test or procedure is carried out without appropriate consent unless legally permitted in an emergency.

3. Types of Consent at MDC

3.1 Implied Consent

Applies to simple, low-risk procedures such as:

• Checking vital signs
• Entering a consultation room
• Providing general information

Implied consent must never be assumed for intimate, invasive or high-risk procedures.

3.2 Verbal Consent

Used for straightforward tests such as:

• Blood sampling
• Urine collection
• Semen analysis for diagnostic purposes
• Non-intimate examinations
• None-invasive therapy

Clinic staff must ensure the patient understands what is being done and why.

3.3 Written Consent

Required for:

• Intimate or sensitive examinations
• Procedures with potential risks
• Research participation
• Use of identifiable data for secondary purposes
• Photography, videography or audio recording (clinical or promotional)
• Any procedure where the patient may require detailed documentation

Documentation is stored securely in the patient’s medical record.

4. Information Provided Before Consent

Patients will receive clear explanations regarding:

• Purpose of the test or procedure
• What will happen
• Risks and potential side effects
• Alternatives, including doing nothing
• Likely outcomes
• Costs and financial responsibility
• How results will be delivered

Patients are encouraged to ask questions and take time before agreeing.

5. Consent for Data Use

MDC collects clinical and operational data to improve patient care, service quality, and research.

We uphold absolute transparency and respect for patient rights.

5.1 Clinical Care and Operations (Lawful Basis: Legitimate Interest / Contract / Legal Obligation)

Consent is not required for essential uses that enable us to provide clinical care, such as:

• Recording medical history
• Processing laboratory results
• Sharing data with clinicians involved in the patient’s care
• Maintaining safety and compliance

These are lawful under GDPR.

6. Consent for Research Data Use

MDC may use anonymised or pseudonymised patient data for:

• Clinical research
• Service improvement
• Epidemiological insights
• Laboratory method development

Key protections:

• No identifiable information is used unless the patient gives explicit written consent
• Data is anonymised in line with ICO guidance
• Ethical principles of the Health Research Authority are followed
• Patients may opt out at any time without impacting their care

When consent is required:

• Participation in clinical studies
• Providing identifiable data or biological samples for research
• Use of identifiable photographs or video
• Publication involving identifiable patient anonymous details

7. Consent for Marketing Communications

MDC operates a strict opt-in marketing policy, compliant with PECR and GDPR.

We require explicit consent for:

• Email newsletters
• Promotional SMS
• Marketing-based phone calls
• Use of testimonials or patient stories
• Use of patient likeness (photos/video)

Patients may withdraw marketing consent at any time via:

• Email
• SMS opt-out
• Request through reception or clinical staff

Marketing consent is never a condition for receiving care.

8. Capacity to Consent

MDC follows the Mental Capacity Act 2005.

A patient has capacity if they can:

• Understand information
• Retain information
• Weigh information
• Communicate their decision

If a patient lacks capacity, decisions are made in their best interests, with appropriate documentation.

9. Withdrawal of Consent

Patients may withdraw consent at any time by informing a member of staff.

Once withdrawn:

• Further use of data ceases unless legally required
• Procedures will not be carried out
• The patient will be supported to understand any clinical implications

Withdrawal does not affect the legality of prior processing.

10. Documentation & Storage

All consent decisions are recorded in the patient record, including:

• Type of consent
• Information provided
• Confirmation that questions were answered
• Any patient-specific considerations

Records are stored securely according to the Data Retention & Health Record Management Policy.

11. Policy Review

This policy is reviewed annually or sooner if required by law, regulation or service changes.

Approved by:
Clinical Governance Committee – Marylebone Diagnostic Centre