Model Consent Form Template for England and Wales

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Key Requirements PROMPT example:

Model Consent Form

"I need a Model Consent Form for a medical research study starting in March 2025, which will involve collecting blood samples from adult participants in London hospitals and sharing the anonymized data with our research partners in the EU."

Document background
The Model Consent Form serves as a crucial legal document in England and Wales for organizations seeking to obtain explicit, informed consent from individuals. This document is essential for compliance with UK data protection laws, including GDPR, and provides a structured approach to capturing consent for various purposes such as medical procedures, research participation, or data processing. The form typically includes clear information about the purpose of consent, rights of the individual, and withdrawal mechanisms. Organizations should customize the Model Consent Form based on their specific requirements while maintaining compliance with relevant legislation and regulatory requirements.
Suggested Sections

1. Personal Details: Full name, contact information, and relevant identifiers of the person giving consent

2. Purpose Statement: Clear explanation of what consent is being sought for and specific activities or data processing being authorized

3. Rights Statement: Details of right to withdraw consent, how to exercise rights, and any time limitations

4. Declaration: Clear statement of consent, date and signature fields, and witness section if required

Optional Sections

1. Parental/Guardian Consent: Additional declarations and signature fields for cases involving minors or those lacking capacity

2. Data Processing Details: Specific processing activities, data retention periods, and third party sharing information when personal data processing is involved

3. Risk Disclosure: Detailed explanation of potential consequences when activity involves specific risks

4. Emergency Contacts: Alternative contact details when involving medical procedures or high-risk activities

Suggested Schedules

1. Information Sheet: Detailed information about the activity/procedure, used when main form needs to remain concise

2. Privacy Notice: Detailed information about data processing, required when significant personal data is involved

3. Supporting Documentation: Any relevant certificates, qualifications, medical history forms, or risk assessments if applicable

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

Relevant Industries
Relevant Teams
Relevant Roles
Industries

UK GDPR: The UK General Data Protection Regulation - Primary legislation governing data protection and privacy rights in the UK post-Brexit

Data Protection Act 2018: UK's implementation of data protection laws, working alongside UK GDPR to regulate how personal information is used

PECR: Privacy and Electronic Communications Regulations - Specific rules for electronic communications, marketing, and cookies

Mental Capacity Act 2005: Legislation protecting and empowering people who may lack the mental capacity to make certain decisions

Health and Social Care Act 2012: Framework legislation for health and social care services in England, including consent requirements

NHS Act 2006: Primary legislation governing the operation of the National Health Service and related consent requirements

Human Tissue Act 2004: Legislation regulating the storage and use of human tissue, including consent requirements for tissue samples

Human Rights Act 1998: Incorporation of the European Convention on Human Rights into UK law, protecting fundamental rights and freedoms

Clinical Trials Regulations 2004: Regulations governing the conduct of clinical trials, including consent requirements for participants

Children Act 1989: Primary legislation concerning the welfare of children, including matters of consent involving minors

Family Law Reform Act 1969: Legislation establishing consent rights for 16-17 year olds, particularly in medical treatment contexts

Common Law Contract Principles: Fundamental principles of contract law including offer, acceptance, consideration, and intention to create legal relations

Misrepresentation Act 1967: Legislation governing false or misleading statements that induce someone to enter into an agreement

Research Governance Framework: Framework setting standards for health and social care research, including consent requirements for research participants

Teams

Employer, Employee, Start Date, Job Title, Department, Location, Probationary Period, Notice Period, Salary, Overtime, Vacation Pay, Statutory Holidays, Benefits, Bonus, Expenses, Working Hours, Rest Breaks,  Leaves of Absence, Confidentiality, Intellectual Property, Non-Solicitation, Non-Competition, Code of Conduct, Termination,  Severance Pay, Governing Law, Entire Agreemen

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