Understanding informed consent

Informed consent allows patients and providers to make decisions about their medical health and treatment, building trust between practitioners and their patients.  It ensures individuals are fully aware of any treatments, procedures, or testing they agree to, and their agreement is made from clear, comprehensive information.

Components of informed consent

Informed consent involves giving detailed information before a procedure, testing, treatment, or study, allowing potential patients to ask questions and make an informed decision. 

• Purpose: The individual must understand the purpose of the procedure, treatment, or research, including why it is conducted and the expected outcomes. 
• Risks and benefits: A clear explanation of the risks or side effects alongside potential benefits associated with the procedure or research is crucial, helping individuals weigh potential harms and benefits. Benefits should be realistic and balanced. 
• Alternatives: Individuals should be informed about alternative options that may be available, including other treatments or procedures.
• Procedure: A detailed description of how the procedure or research will be conducted, including the steps involved, the duration, and what the individual can expect during and after the process.
• Confidentiality: Potential patients or participants should be briefed on confidentiality practices, including data storage, who will have access and privacy maintenance.
• Voluntariness: The consent must be given voluntarily, without influence. Individuals should be aware that they may withdraw their consent at any time, which will not affect their relationship with the practitioner or researcher.

Related: 9 elements of informed consent

Challenges and considerations

While informed consent is a crucial process, it can come with some challenges:

• Complex information: Practitioners should consider how they can best present complex information to make it clear yet thorough.
• Cultural differences: Practitioners should be aware of cultural differences.
• Capacity to consent: Some individuals may have limited capacity to consent, such as minors or individuals with cognitive impairments, requiring special care and consideration. 
• Ongoing process: Informed consent should be an ongoing process, keeping patients informed throughout the process and able to withdraw consent if needed.

See also: HIPAA Compliant Email: The Definitive Guide

Best practices

Best practices for informed consent ensure that the process is ethical and respectful of individuals' autonomy. Here are the best practices for obtaining and managing informed consent:

• Provide clear and comprehensive information: Purpose, risks, benefits, alternatives, and procedure details must be provided. 
• Ensure comprehension: To ensure comprehension, use simple language, avoid jargon, make information accessible, use visual aids, and confirm understanding through questions or teach-back methods.
• Document the consent process: Where applicable, obtain written consent, sign and date forms, and maintain detailed records of the consent process, including information provided, the date of consent, and any concerns.
• Adapt to special circumstances: Obtain consent from legal guardians for minors and vulnerable populations, adapting the process to their needs. Provide documents in the individual's preferred language, using professional translators if necessary.
• Ongoing communication: Periodically revisit the consent process, especially if there are significant changes to the procedure or study.
• Ensure ethical practice: Transparency and respect for autonomy are crucial in research procedures.
• Training and education: Ensure all staff involved in obtaining consent are trained in ethical practices and the importance of informed consent. Regularly update training to reflect current best practices and legal requirements.
• Legal and ethical compliance: Adhere to local laws and guidelines for informed consent, and align with ethical standards and professional codes of conduct related to informed consent.

Related: What is explicit consent?

FAQs

Why is informed consent important?

Informed consent respects individual autonomy, promotes transparency, ensures ethical and legal compliance, and helps individuals make informed decisions about their health, and participation in treatment, research, or other significant actions.

Read more: Patient consent: What you need to know

How can practitioners ensure that individuals understand the information provided?

Practitioners can ensure understanding by using simple, clear language, avoiding jargon, using visual aids, and employing techniques like teach-back, where individuals repeat the information in their own words to confirm comprehension.

Can an individual withdraw their consent after initially agreeing?

Yes, individuals can withdraw their consent at any time without facing any penalties or negative consequences. This right should be communicated during the consent process.

What should be done if an individual does not fully understand the consent information?

If an individual does not fully understand the information, practitioners should take extra time to explain the details, use simpler language, provide additional resources, and answer any questions until they are confident.