Policy

Informed Consent Policy

Lawful, valid and informed consent for weight management assessment, prescribing and treatment

For Weight Loss ClinicRef BS-WEI-POL-004See a sample (PDF) →
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  • Editable Microsoft Word (.docx)
  • Mapped to the CQC standards
  • Optional 3-monthly updates

What's inside

This policy is fully drafted and structured, ready to brand and complete for your service. It covers:

  • 1. Purpose
  • 2. Scope
  • 3. Policy statement
  • 4. Definitions
  • 5. Core consent procedure for weight loss treatment
  • 6. Withdrawal of consent and declining treatment
  • 7. Roles and responsibilities
  • 8. Training
  • 9. Records, monitoring and audit
  • 10. Related documents
  • 11. Version control and review
  • Appendix A - Informed consent checklist (weight loss treatment)
  • Appendix B - Consent record statement
  • 12. Disclaimer

Legislation & standards it maps to

  • Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 - Regulation 11 (Need for consent), Regulation 9 (Person-centred care) and Regulation 12 (Safe care and treatment)
  • Mental Capacity Act 2005 and the Mental Capacity Act 2005 Code of Practice
  • Montgomery v Lanarkshire Health Board [2015] UKSC 11 (standard of disclosure of material risks)
  • General Medical Council - Decision making and consent (2020) and Good practice in prescribing and managing medicines and devices (2021)
  • Human Medicines Regulations 2012 (prescribing, supply and prescription-only medicine controls)
  • Data Protection Act 2018 and the UK General Data Protection Regulation (lawful basis and special category health data)
  • Care Quality Commission (Registration) Regulations 2009 and the Care Quality Commission single assessment framework
  • Advertising Standards Authority and the UK Code of Non-broadcast Advertising and Direct & Promotional Marketing (the CAP Code) restrictions on prescription-only medicine promotion

Who it applies to

All clinical, prescribing, administrative and bank/locum staff, contractors and independent prescribers engaged by [Organisation Name] in the assessment, prescribing, supply and review of weight loss treatments.

Glossary

Plain-English explanations of the technical terms and legislation used in this document.

Asynchronous consultation
A consultation that does not happen in real time, for example where a patient completes an online questionnaire that a clinician reviews later.
Bariatric
Relating to the treatment of obesity, including weight loss surgery.
Best interests
A decision made for someone who cannot decide for themselves, choosing the option that is best for them.
Body mass index (BMI)
A measure of body weight in relation to height, used to help judge whether a person is underweight, a healthy weight, overweight or obese.
Caldicott Guardian
The senior person responsible for protecting the confidentiality of people's health and care information.
CAP Code
The UK rulebook for non-broadcast advertising and marketing, which limits how prescription-only medicines may be promoted.
Capacity (mental capacity)
Whether a person can understand and make a particular decision for themselves at the time it needs to be made.
Care Quality Commission (CQC)
The independent regulator of health and social care services in England.
Comorbidity
An additional health condition a person has at the same time as the main condition being treated.
Contemporaneous record
A note written at the time of, or very soon after, the event it describes, so it is accurate and reliable.
Contraindication
A specific situation or condition in which a treatment should not be given because it could be harmful.
Data Protection Act 2018
The UK law that governs how personal information must be handled, working alongside the UK General Data Protection Regulation.
Data Protection Officer
The person responsible for overseeing how an organisation protects personal data and follows data protection law.
Data subject rights
The legal rights people have over their own personal information, such as the right to see a copy of it.
Duty of candour
The legal duty to be open and honest with a person and their family when something goes wrong with their care.
General Medical Council (GMC)
The body that regulates doctors in the United Kingdom and sets standards for their practice.
General practitioner (GP)
A doctor based in the community who provides general medical care and coordinates a person's wider healthcare.
GLP-1 receptor agonist
A type of prescription-only medicine used to support weight loss, given as an injection or tablet, which can have side effects affecting the gut, pancreas and gallbladder.
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
The regulations setting out the fundamental standards that providers of regulated health and care must meet, including the need for consent.
Human Medicines Regulations 2012
The main UK law controlling how medicines are licensed, prescribed, supplied and advertised.
Hypoglycaemia
An abnormally low level of sugar in the blood, which can make a person feel unwell and may need urgent treatment.
Independent prescriber
A trained health professional, who may not be a doctor, who is legally allowed to assess patients and prescribe medicines.
Informed consent
Agreement to treatment given freely after the risks, benefits and alternatives have been clearly explained.
Material risk
A risk that a reasonable patient, or this particular patient, would think is important when deciding whether to have a treatment.
Medullary thyroid carcinoma
A rare type of thyroid cancer that is a reason not to use certain weight loss medicines.
Mental Capacity Act 2005
The law that protects and supports people who may be unable to make particular decisions for themselves.
Montgomery v Lanarkshire Health Board
A 2015 court ruling that requires clinicians to tell patients about the risks that matter to them when seeking consent.
Multiple endocrine neoplasia type 2 (MEN 2)
A rare inherited condition that increases the risk of certain tumours and is a reason not to use some weight loss medicines.
National Institute for Health and Care Excellence (NICE)
The body that produces evidence-based guidance on treatments and care for use across health and social care.
Near miss
An event that could have caused harm but did not, by chance or because it was caught in time.
Nominated Individual
The senior person responsible to the regulator for supervising how a service is provided.
Off-label use
Using a licensed medicine in a way that is different from what its licence officially covers, for example a different condition or dose.
Prescription-only medicine (POM)
A medicine that may lawfully be supplied only on the instruction of an appropriate prescriber.
Registered Manager
The person registered with the regulator as responsible for the day-to-day running of a service.
Regulated activity
A type of care or treatment the law requires a provider to register with the regulator to deliver.
Safeguarding
Protecting people's health, wellbeing and rights and keeping them safe from abuse, harm or neglect.
Sharps
Needles, blades and other items that can cut or puncture the skin.
Single assessment framework
The structure the regulator uses to judge a service, built around quality statements and five key questions (safe, effective, caring, responsive, well-led).
Special category data
Sensitive personal information, such as health data, that the law gives extra protection and needs a specific legal condition to use.
Summary of Product Characteristics (SmPC)
The official document for a medicine that sets out how it should be used, including its licensed uses, doses and risks.
Synchronous contact
Communication that happens in real time, such as a phone call or video consultation.
Titration
Gradually adjusting the dose of a medicine, usually building it up slowly, to find the right level for a person.
UK General Data Protection Regulation (UK GDPR)
The UK's main data-protection law governing how personal information is collected and used.
Unlicensed medicine
A medicine that does not have a UK licence for the use intended, which can be supplied only in limited circumstances with extra justification.

How it works

  1. Buy securely with Stripe - instant, no VAT, no account needed.
  2. Download your editable Word file from the link we email you straight away.
  3. Complete the placeholders for your service, then have it approved before use.
  4. Add the optional updates subscription and we keep it current as guidance changes.

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