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Patient Informed Consent Form for the United Kingdom

Patient Informed Consent Form Template for England and Wales

A Patient Informed Consent Form is a legally binding document used in England and Wales that documents a patient's authorization for medical treatment after being informed of the risks, benefits, and alternatives. The document complies with the Mental Capacity Act 2005 and current NHS guidelines, ensuring that patients make informed decisions about their healthcare. It serves as evidence that the healthcare provider has fulfilled their duty to inform and obtain proper consent before proceeding with treatment.

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What is a Patient Informed Consent Form?

The Patient Informed Consent Form is a critical document required by law in England and Wales before conducting any significant medical procedure or treatment. It serves multiple purposes: documenting the patient's understanding and agreement to treatment, protecting healthcare providers from liability, and ensuring compliance with legal and regulatory requirements. The form must include detailed information about the proposed treatment, potential risks, expected benefits, and alternatives. It should be used whenever a medical procedure requires explicit consent, particularly for invasive procedures, surgical operations, or treatments with significant risks.

What sections should be included in a Patient Informed Consent Form?

1. Patient Information: Full name, date of birth, NHS number, contact details, and relevant medical history of the patient

2. Healthcare Provider Information: Details of the healthcare facility, primary healthcare provider, and other relevant medical professionals

3. Procedure Description: Detailed explanation of the proposed treatment or procedure, including its purpose and method

4. Risks and Benefits: Comprehensive list of potential risks, complications, side effects, and expected benefits of the procedure

5. Alternative Treatments: Information about alternative treatment options and consequences of not proceeding with treatment

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

7. Declaration of Consent: Patient's formal declaration of understanding and voluntary agreement to proceed with treatment

8. Signatures: Signature sections for patient, healthcare provider, and witnesses with dates

What sections are optional to include in a Patient Informed Consent Form?

1. Interpreter Declaration: Section for interpreter details and confirmation of accurate translation when patient's primary language isn't English

2. Legal Representative Authorization: Section for consent from authorized representative when patient lacks capacity to consent

3. Photography Consent: Additional consent for medical photography or video recording when procedure requires documentation

4. Clinical Trial Information: Additional information and consent requirements for procedures that are part of clinical trials

5. Student Involvement: Consent for student observation or participation in teaching hospitals

What schedules should be included in a Patient Informed Consent Form?

1. Patient Information Leaflet: Detailed information about the procedure in plain language, including preparation instructions

2. Risk Statistics: Statistical data and visual representations about procedure outcomes and risks

3. Aftercare Instructions: Detailed post-procedure care guidelines, recovery information, and follow-up requirements

4. Emergency Contact Form: List of emergency contacts, relevant medical information, and action plan in case of complications

5. Medication Schedule: Details of required medications, dosages, and timing before and after the procedure

Authors

Alex Denne

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

Jurisdiction

England and Wales

Publisher

Ƶ

Document Type

Consent Form

Sector

IP

Cost

Free to use
Relevant legal definitions


























Clauses
























Industries

Mental Capacity Act 2005: Primary legislation governing how capacity is assessed and decisions are made for those who lack capacity to consent

Data Protection Act 2018: UK implementation of GDPR, governing how patient data must be handled and processed

Human Rights Act 1998: Ensures respect for human rights in healthcare decisions and treatment

Health and Social Care Act 2012: Framework for healthcare provision and standards in England

Care Act 2014: Legislation governing the provision of care and support services

Access to Health Records Act 1990: Governs patient access to their medical records and information

Medical Act 1983: Regulates medical practice and professional standards

Healthcare Quality Commission Regulations 2009: Sets standards for healthcare providers and services

GMC Guidance on Consent: Professional guidelines from the General Medical Council on obtaining and documenting consent

NHS England Consent Guidance: Specific NHS guidelines on informed consent procedures and documentation

NICE Guidelines: National Institute for Health and Care Excellence standards for clinical practice

Montgomery Precedent: Key legal case (Montgomery v Lanarkshire Health Board [2015]) establishing patient's right to be informed of material risks

CQC Standards: Care Quality Commission requirements for healthcare providers regarding consent and documentation

NHS Standard Contract: Contractual requirements for NHS service providers including consent procedures

Professional Indemnity Requirements: Insurance and liability requirements for medical professionals regarding consent

Teams

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