Patient Consent Statement Template for England and Wales

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Key Requirements PROMPT example:

Patient Consent Statement

"I need a Patient Consent Statement for a Phase III diabetes drug trial starting in March 2025, including specific clauses about data usage for research purposes and the right to withdraw from the study at any time."

Document background

The Patient Consent Statement is a crucial document in medical practice within England and Wales, designed to protect both healthcare providers and patients. It ensures compliance with legal requirements for informed consent, as established by the Mental Capacity Act 2005 and reinforced by the Montgomery v Lanarkshire Health Board [2015] ruling. The document must detail the proposed treatment, associated risks, benefits, alternatives, and potential complications. It serves as evidence that the patient has received and understood all necessary information before agreeing to treatment, thereby protecting their autonomy and right to make informed decisions about their healthcare.

Suggested Sections

1. Patient Information: Full name, date of birth, NHS number, contact details of the patient and healthcare provider

2. Procedure Description: Clear, non-technical explanation of the proposed treatment or procedure

3. Risks and Benefits: Comprehensive outline of potential risks, complications, and expected benefits of the procedure

4. Alternative Options: Information about alternative treatments available, including the option of no treatment

5. Data Protection Statement: Information about how patient data will be collected, stored, and used in accordance with GDPR and Data Protection Act 2018

6. Confirmation of Understanding: Patient acknowledgment of information provided and opportunity to ask questions

7. Consent Declaration: Express consent statement and signature blocks for patient/guardian and healthcare professional

Optional Sections

1. Specific Procedure Risks: Additional detailed risks specific to complex or high-risk procedures

2. Research Participation: Additional consent for use of data or participation in research studies

3. Photography Consent: Specific consent for medical photography or recording during procedure

4. Translator Declaration: Section for translator details and confirmation of accurate translation where required

5. Mental Capacity Assessment: Documentation of capacity assessment when patient's decision-making capacity is in question

Suggested Schedules

1. Procedure Information Sheet: Detailed technical information about the procedure including preparation instructions

2. Patient Information Leaflet: Supplementary information in plain language about the procedure and aftercare

3. Anatomical Diagrams: Visual aids explaining the procedure and affected body parts

4. Post-Procedure Care Instructions: Detailed guidelines for aftercare, recovery, and follow-up appointments

5. Emergency Contact Information: List of emergency contacts and when to seek urgent medical attention

Authors

Alex Denne

Head of Growth (Open Source Law) @ Genie AI | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

alex.den.21@genieai.co

Relevant legal definitions

Clauses

Relevant Industries

Relevant Teams

Relevant Roles

Industries

Mental Capacity Act 2005: Primary legislation governing how capacity is assessed and decisions are made for those who lack capacity to consent. Essential for ensuring valid consent and determining when alternative decision-making frameworks must be used.

Data Protection Act 2018: UK's implementation of GDPR, governing how patient data must be processed, stored, and protected. Critical for consent relating to data handling and information sharing.

Human Rights Act 1998: Ensures respect for privacy, dignity, and self-determination in medical treatment. Article 8 particularly relevant for consent to medical treatment.

Health and Social Care Act 2012: Framework legislation for healthcare delivery in England, including requirements for patient involvement in care decisions.

Medical Act 1983: Establishes professional standards for medical practitioners, including requirements for obtaining proper consent from patients.

Montgomery v Lanarkshire Health Board [2015]: Landmark case establishing modern standard for informed consent, requiring disclosure of material risks that a reasonable patient would want to know about.

GMC Guidance on Consent: Professional guidelines from the General Medical Council on consent procedures and requirements for medical practitioners.

NHS England Consent Guidelines: Specific operational guidance for obtaining and documenting consent within NHS settings.

NICE Guidelines: National Institute for Health and Care Excellence guidelines providing evidence-based recommendations for specific treatments and procedures.

Control of Patient Information Regulations 2002: Specific regulations governing how patient information can be used and shared, requiring appropriate consent mechanisms.

Regulated Activities Regulations 2014: Sets standards for health and social care services, including requirements for consent and patient involvement.

Caldicott Principles: Guidelines for handling patient information, including principles for information sharing and confidentiality.

NHS Constitution: Establishes rights and responsibilities within the NHS, including patient rights to be involved in treatment decisions.

Equality Act 2010: Ensures consent procedures are accessible and non-discriminatory, protecting patients with protected characteristics.

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Authors

Alex Denne

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