What is Informed Consent?

By Matthew AdamsReviewed by Lily Ramsey, LLM

Introduction to the concept of informed consent
The key elements of informed consent in healthcare
Legal and ethical implications of informed consent
Challenges and considerations in obtaining informed consent
The role of informed consent in patient autonomy and trust
References 
Further reading

Informed consent represents one of the most important ethical aspects of clinical treatments and scientific research involving humans.

This article will discuss the key elements of informed consent alongside its application in research and the clinic. Alongside these core features, how researchers should approach seeking informed consent and the role it plays in patient autonomy will be considered.

Image Credit: Pressmaster/Shutterstock.com

Introduction to the concept of informed consent

The attitudes that underlie informed consent have been an inherent aspect of the legal system for centuries around the globe. Observed as far back as ancient Greece and in Indian traditional systems of medicine. However, the first recognizable pieces of what would come to be the modern system of informed consent occurred in the 20^th century.

Seen in landmark legal battles in 1914 and 1957 (in the United States of America and the United Kingdom, respectively). ^1,2 These legal cases sought to protect bodily autonomy and uphold a patient's right to know the side effects of treatment.

At its core, informed consent upholds the idea that each person has the intractable right to decide what is and is not done to their body in clinical treatments and scientific research.

This protects the individual, requiring physicians and researchers to consider the patient as the primary decision maker.

The key elements of informed consent in healthcare

Multiple elements make up informed consent. The first aspect of obtaining informed consent is the prerequisite that the individual making the decision is competent. This means the patient is sound of mind and an adult. ³ If this is not the case, other avenues may be explored (discussed later in this article).

After assessing that the individual is competent enough to consent, informed consent requires disclosing information about the treatment/research. This disclosure of information will include details of the proposed actions.

Such information will include the patient has condition, treatment options, and outcomes of non-treatment. Information surrounding the specific treatment options advised, such as the potential side effects, aimed benefits/outcomes, and the duration of treatment will also be disclosed. ⁴

This information will also include the purpose of the research, the process in which it will occur, and potential alternatives. ⁵ Overall, provided in the disclosure will be all pertinent information, preferably in an easily understandable format.

Documentation of informed consent is hugely important.

Whilst verbal consent may be given when patients cannot sign or in routine investigations, written confirmation of informed consent is massively important for administrative purposes. ⁶

Documenting the content of discussions surrounding the potential treatments and specifics is important for proof of good faith efforts on the clinician's behalf. ⁷ Patients/research participants should expect a copy of this document. ³

Finally, obtaining informed consent should be entirely voluntary, with the patient given suitable time to make such a decision. This consent cannot be coerced from the patient.

Legal and ethical implications of informed consent

Informed consent is hugely important for researchers and physicians to obtain. The two main approaches considered when discussing informed consent are ethical and legal.

Ethically, the practice of informed consent is derived from the core tenant previously highlighted: a patient is the final decision maker when it comes to having or not having a treatment/being involved in research.

The ability to make this decision is derived from having access to all information surrounding the treatment, including the positives and negatives.

These ethical aspects are philosophical and derived from the universal belief that all individuals deserve bodily autonomy. ⁸ Additional to the ethical implications of informed consent, obtaining informed consent is also enshrined legally.

Battery is the act of touching someone without consent. This extends even to medical treatment, meaning consent must be obtained before intervention. ³

Challenges and considerations in obtaining informed consent

With the importance of informed consent, it is no surprise that there are numerous challenges in both obtaining it and its application. Barriers to fully understanding the aspects of the treatment/research pose a challenge, such as where there is a language barrier. ⁹

Individuals who are unconscious or incapacitated cannot give informed consent, in such cases, the family may be consulted for consent, or in the case of life-saving treatment, informed consent is waived. ^3,10

Other aspects that may fully prevent obtaining informed consent include the individual being a child, which requires parental consent, and assent if the child is older than seven.

Potential challenges in insight in vulnerable groups mean that research and treatment with these groups require further tailored approaches for communication. ⁹

Finally, religious and cultural beliefs may dictate a participant's treatment/research involvement decision. ⁹

This may be due to a patient's belief that what can and cannot be done to their body is derived from religious or cultural principles. The liberty in decision offered by the informed consent process protects these beliefs.

The role of informed consent in patient autonomy and trust

Outside of the mentioned ethical and legal aspects of informed consent for performing treatments or enrolment within research, informed consent also informs how patients feel about clinical interventions.

As mentioned, patient autonomy is a primary philosophical justification for informed consent in the clinic and research.

Informed consent protects a patient's right to choose to refuse treatment, even if a physician deems the treatment beneficial. This decision is entirely for the patient and serves to protect their interests.

Breaches of this right may impact a patient's trust in the healthcare system, influencing a patient’s future decision not to seek treatment.

This process of obtaining informed consent not only potentially positively impacts a patient's trust in the healthcare system but also prevents potential overreaching of physicians, even if they have positive intentions.

References

1. Katz J. The Silent World of Doctor and Patient. Johns Hopkins University Press; 2002. https://books.google.co.uk/books?id=x1DNCNNX8AIC.

2. Kumar N. Informed consent: Past and present. Perspect Clin Res. 2013;4(1):21. doi:10.4103/2229-3485.106372

3. Satyanarayana Rao K. Informed consent: An ethical obligation or legal compulsion? J Cutan Aesthet Surg. 2008;1(1):33. doi:10.4103/0974-2077.41159

4. Pallocci M, Treglia M, Passalacqua P, et al. Informed Consent: Legal Obligation or Cornerstone of the Care Relationship? Int J Environ Res Public Health. 2023;20(3):2118. doi:10.3390/ijerph20032118

5. Jefford M, Moore R. Improvement of informed consent and the quality of consent documents. Lancet Oncol. 2008;9(5):485-493. doi:10.1016/S1470-2045(08)70128-1

6. Kakar H, Gambhir R, Singh S, Kaur A, Nanda T. Informed consent: Corner stone in ethical medical and dental practice. J Fam Med Prim Care. 2014;3(1):68. doi:10.4103/2249-4863.130284

7. Hall DE, Prochazka A V., Fink AS. Informed consent for clinical treatment. Can Med Assoc J. 2012;184(5):533-540. doi:10.1503/cmaj.112120

8. Beauchamp TL, Childress JF. Principles of Biomedical Ethics. Oxford University Press; 2001. https://books.google.co.uk/books?id=_14H7MOw1o4C.

9. Musmade P, Nijhawan L, Udupa N, et al. Informed consent: Issues and challenges. J Adv Pharm Technol Res. 2013;4(3):134. doi:10.4103/2231-4040.116779

10. NHS. Consent to treatment. https://www.nhs.uk/conditions/consent-to-treatment/. Published 2022. Accessed February 11, 2023.

Further reading

• Ethical Considerations in AI-Driven Healthcare
• Ethics in Pharmacy
• The Pros and Cons of Artificial Wombs