Introduction

Importance of informed consent

Remember the time when the healthcare provider or surgeon handed over a form and asked you to read and sign it? We all have experienced it, for ourselves or for our loved ones. Why do you think reading and signing that piece of paper is so important? That form is called the ‘consent form’. The consent form is a written agreement between the healthcare provider and the patient confirming voluntariness and complete understanding of the potential risks and/ or benefits of the treatment or procedure, and the consent provided is referred to as informed consent. Informed consent is based on the principles of clinical ethics, which state that every individual has the right to be informed of all the benefits and risks associated with any treatment or procedure, evaluate the risks and benefits and has the right to accept or reject the treatment or procedure if they desire to proceed.^1,2

Overview of medical cannabis use

The use of medical cannabis dates back centuries, when it was used for a variety of health problems. Literature shows it was widely used in Asia and Africa and later got introduced in Europe (current day Romania) and lastly in America.³ We all know that cannabis or marijuana is considered a recreational drug and banned in most countries worldwide due to its addictive properties and its effects on the mental state of individuals when consumed excessively. The debate on the use of medical cannabis is ongoing due to a lack of data to identify the potential benefits and risks. The two main ingredients in Cannabis are Cannabidiol (CBD) and Tetrahydrocannabinol (THC). Current evidence suggests it may be used effectively to treat pain, control extreme nausea and vomiting, severe weight loss due to eating disorders and muscle rigidity.⁴ 

In this article, let us understand in detail about informed consent, medical cannabis and the importance of informed consent in medical cannabis use.

Legal and ethical foundations of informed consent

The laws and regulations regarding the use of medical cannabis vary across the world. Informed consent becomes important for individuals to avoid any legal pitfalls and know the challenges in advance. 

Legal requirements

Informed consent in healthcare ensures that patients make voluntary, informed choices or decisions about their health. As a part of clinical ethics, it protects patients’ autonomy and builds trust in the doctor-patient relationship.⁵

Principles of informed consent

Informed consent in healthcare follows principles such as:

• Disclosure: All information about the benefits, potential risks, complications that may arise, potential outcomes of the treatment or procedure and alternatives must be disclosed by the healthcare provider
• Voluntariness: the patient must consent voluntarily without any coercion (forceful or under threat) from the healthcare provider, family members, etc.
• Competence: The patient must have the mental capacity to give consent. In cases where a patient is unable to make such decisions, legally authorised representatives like a parent, guardian or proxy may sign the consent on their behalf
• Comprehension: the healthcare provider must communicate in a language understood by the patient
• Consent: consent must be in written format, though there might be a few exceptions where verbal consent is accepted

There are a few exceptions where consent may not be required, such as:

• Emergency situations: in situations where immediate medical treatment is necessary to save the patient’s life, and in infectious disease outbreaks that require vaccination

Ethical considerations 

Ethical considerations are much more important than obtaining consent. Informed consent keeps the patient’s well-being at the center and is based on a foundation of ethics such as respect, autonomy, and dignity. Let us understand them further:

• Disclosure of all the information and complete transparency: Information such as the nature of the treatment or procedure, risks and benefits, alternative options, outcomes, etc., has to be shared transparently with the patient to make an informed choice. Information shall not be misleading or false
• Autonomy and respect: Every patient has the right to decide about their health and wellbeing and the treatments they want to undergo or refrain from. Similarly, every healthcare provider has to respect the patients’ choice, which can include refusing a life-saving procedure
• Privacy and Confidentiality: It is necessary to keep all the personal and medical information of a patient private and confidential. It cannot be shared with anyone without prior consent unless otherwise required by law

Regulations around medical cannabis use

There are federal and state-level regulations governing the use of medical cannabis. The regulations differ based on the country or province. These regulations focus on patient eligibility, patient rights, prescribing practices and safety protocols.

• Patient eligibility: conditions such as chronic pain, chemotherapy-induced nausea and vomiting, muscle rigidity or spasticity in multiple sclerosis, some rare forms of epilepsy and anxiety disorders qualify for medical cannabis use only after receiving a prescription from a registered healthcare provider
• Protection of patient rights: This ensures protection against workplace discrimination, patients’ right to safe and effective treatment, etc
• Prescribing practices: Only licensed providers are allowed to prescribe medical cannabis to a patient after a thorough evaluation. The prescription must specify the active ingredient (CBD or THC or both in combination), dosage, and its route of administration( oral, inhalational, topical, etc.)
• Safety protocols: Only licensed dispensaries are authorised to dispense the prescribed amount of medical cannabis to the patient

Risks and benefits of medical cannabis

The U.S. FDA (Food and Drug Administration) has not yet approved any product containing whole cannabis plant material for any medical purposes, but it has approved synthetic THC-based medications (e.g. Dronabinol).

Potential benefits of medical cannabis

Some of the modest uses of medical cannabis are:⁴

• Chronic pain management: Studies show some evidence in reducing chronic pain associated with conditions such as multiple sclerosis, arthritis, fibromyalgia, etc
• Reduces inflammation: It reduces inflammation due to its anti-inflammatory properties
• Reduces anxiety 
• Improves muscle flexibility in conditions such as multiple sclerosis
• Improves hunger in severe anorexic patients
• Anticonvulsant properties promise its use as an alternative to conventional epilepsy medication.

All of these benefits show promising results but need further research to ensure their safety in different conditions.

Risks and side effects associated with the use of medical cannabis

While the benefits of treatment for multiple disorders seem promising, there are potential risks or side effects that need to be further evaluated. These include:⁶

• Memory and cognitive issues: Short-term memory impairment is seen with Tetrahydrocannabinol (THC). These effects are temporary and go away as the effect of the drug wears off
• Anxiety and paranoia: While Cannabidiol (CBD) is used for the treatment of anxiety, if taken in higher doses, it may aggravate anxiety in patients
• Confusion, hallucinations and delusions: In high doses, it may cause hallucinations
• Addiction and dependency: For those consuming medical cannabis regularly for a longer period and in higher doses, the chances of dependency on the drug increase
• Risk of misuse: There is concern regarding the use of medical cannabis outside its intended use as a medicine, and more like a recreational drug
• Drug interactions with other medicines and an increased risk during pregnancy and in the elderly
• Common side effects such as increased heart rate, dizziness, dryness of the mouth, and red eyes may be seen in some patients

Weighing risks vs. benefits

Some key points for the healthcare providers to consider before prescribing medical cannabis:

• Patient’s medical condition: The severity of the condition is an important factor taken into consideration
• Availability and outcomes of alternative treatments
• Monitoring and close supervision to assess the effectiveness of medical cannabis for the patient
• Determine the dose and route of administration to maximise benefits and minimise the side effects.

Key elements of informed consent in medical cannabis use

Informed consent for medical cannabis use is important to ensure that patients make informed decisions about their health. 

• Clear, transparent, continuous communication about how cannabis works as a treatment as well as discussing alternative approaches or treatments 
• Informing patients about the side effects, potential drug interactions and risks involved
• Ensuring the patient is well informed, has understood the information and has voluntarily agreed to continue with the treatment
• Documenting the process is a good practice and a legal requirement.

Challenges in ensuring informed consent for medical cannabis

Informed consent for the use of medical cannabis poses major challenges that stem from a variety of factors, such as:

• Limited clinical evidence: research on the use of medical cannabis for various conditions is still evolving and needs to gather enough data on its safety and efficacy
• Lack of standardised guidelines: due to a lack of standardised regulatory guidelines, there could be confusion about its use
• Knowledge and competence: As it is evolving, all healthcare providers might not be aware of the latest trial findings, and this could potentially cause a communication gap between the doctor and patient 
• Varying legal status: the laws differ from state to state in the US and country to country, making it difficult to standardise the process
• Level of patient understanding and their expectations: due to cultural, ethical or societal aspects, awareness and understanding about the use of medical cannabis is limited, and it may be difficult for the patient to weigh the risk-benefit ratio of the treatment
• Handling vulnerable populations: treating conditions in vulnerable populations such as children, pregnant women, and individuals with cognitive impairments becomes a larger challenge.

Role of healthcare providers in ensuring informed consent

It is ethically and legally required to obtain informed consent from individuals who are considered for treatment using medical cannabis. 

It is the responsibility of the healthcare provider to:

• Provide comprehensive information about its uses, side effects, potential benefits, outcomes, complications and alternative treatments
• Create awareness and build trust
• Assess patient understanding and decision-making capacity
• Safeguard the confidentiality and privacy of the patient 
• Address any social or ethical concerns that the patient may have
• Document the informed consent process accurately
• Conduct regular follow-ups and provide support

Summary

The use of medical cannabis to treat chronic pain, chemotherapy-induced nausea, and anorexia is modestly established, and more research needs to be conducted to conclude on the efficacy and safety of medical cannabis in epilepsy, anxiety, multiple sclerosis, etc. There is still much ambiguity over the risks and benefits associated with cannabis for medical use. The lack of uniformity across the healthcare field further complicates its use. Given these circumstances, it is essential that informed consent be obtained from the patient before treatment. Informed consent, based on the principle of clinical ethics (autonomy), ensures that the patients are informed in a language that they understand about the benefits, risks, side effects, and alternatives related to the use of medical cannabis for their condition. Despite some challenges in obtaining informed consent, healthcare providers play a crucial role in empowering patients to choose what is right for their health and well-being. With certain exceptions, the principle remains that the healthcare providers must obtain a written informed consent before providing any treatment.