Informed Consent Form Template for England and Wales

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Informed Consent Form Template

I need an Informed Consent Form Template for a multi-center clinical trial starting in March 2025, which will involve collecting sensitive medical data from patients across five hospitals in England, with specific emphasis on data protection and right to withdraw.

Document background

The Informed Consent Form Template is essential for healthcare providers and researchers operating under English and Welsh jurisdiction. It serves as a crucial document for documenting patient understanding and voluntary agreement to medical procedures or research participation. The template ensures compliance with UK healthcare regulations, including the Mental Capacity Act 2005 and Data Protection Act 2018, while incorporating best practices from medical ethics and legal requirements. It should be used whenever informed consent is required for medical procedures, research studies, or clinical trials.

Suggested Sections

1. Introduction: Purpose of the consent form and study/procedure identification

2. Patient Information: Basic details of the person giving consent including name, date of birth, and contact information

3. Description of Procedure/Study: Clear explanation of what is being consented to, including purpose, methods, and duration

4. Risks and Benefits: Detailed outline of potential outcomes, side effects, and expected benefits

5. Declaration of Consent: Formal statement of voluntary agreement and understanding

6. Signatures: Space for patient, healthcare provider, and witness signatures with dates

Optional Sections

1. Alternative Treatments: Description of other available treatment options and their implications

2. Data Processing Information: Details of how personal data will be collected, stored, used, and shared

3. Withdrawal Rights: Information about the right to withdraw consent and its implications

4. Financial Information: Details of any costs, compensation, or insurance arrangements related to the procedure/study

Suggested Schedules

1. Patient Information Sheet: Detailed supplementary information about the procedure/study in plain language

2. Risk Assessment Form: Comprehensive breakdown of potential risks and mitigation measures

3. Privacy Notice: Detailed information about data protection and privacy practices

4. Glossary of Terms: Definitions of medical and technical terms used in the consent form

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

Healthcare
Clinical Research
Pharmaceutical
Academic Research
Biotech

Relevant Teams

Clinical Operations
Research & Development
Legal
Compliance
Medical Affairs

Relevant Roles

Medical Director
Research Coordinator
Clinical Trial Manager
Healthcare Compliance Officer
Principal Investigator

Find the exact document you need

Assent Form

A legal template under English and Welsh law used to obtain formal agreement from individuals who may not have full legal capacity to provide consent.

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Let's create your Informed Consent Form

Authors

Alex Denne

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