Introduction
Patients in the hospital setting often face situations that require their decision-making to enable the delivery of treatment services that are customized to their specific needs. For effective decision-making, they receive critical information concerning the potential benefits and risks of the relevant testing and care services that resonate with their health needs to solicit their permission for caregivers to deliver the required care services. After deciding whether to approve the caregivers’ intention to conduct some procedures, the patients offer informed consent to indicate their willingness to partake in testing, treatment, or clinical trials. Informed consent refers to a legal and ethical principle that requires a person to give their voluntary and knowledgeable agreement to undergo a medical treatment, participate in research, or receive healthcare services. As a process, it involves providing the individual with sufficient information about the procedure, including potential risks and benefits, alternative treatments, and the possible consequences of not receiving treatment. A deeper insight into this process requires an analysis of its historical aspects, current research knowledge, application in nursing care, and current or future management.
For a concept to portray a rational meaning, it is imperative to decipher its purpose and significance in an appropriate professional field where it is applicable. The purpose of informed consent is to ensure that patients or research participants have a deep understanding of what they agree to and are fully aware of the potential risks and benefits of their decision. The concept is a crucial aspect of ethical medical practice, as it protects patients’ autonomy and rights to make decisions about their health care. Further, Cusack et al. (2018, p. 827) acknowledge that informed consent builds trust between patients and healthcare providers by demonstrating transparency and respect for patients’ rights and preferences. Obtaining informed consent assists healthcare providers in reducing the risk of legal liability, as patients are less likely to file a lawsuit if they feel they have been adequately informed and have consented (U.S. Department of Health and Human Services, 2018). Ultimately, informed consent ensures that medical treatments, procedures, and research are conducted in a manner that is respectful, ethical, and in the best interests of patients within the healthcare profession.
The validity of informed consent depends on several key factors, including the individual’s capacity to give consent, the quality and comprehensiveness of the information provided, and the absence of coercion or undue influence. Foremost, the individual must be legally and mentally capable of providing informed consent, which implies they must have the cognitive ability to understand the information provided and the legal capacity to make decisions about their health care. Another principal factor is that information provided must be accurate, complete, and presented in a language and format that the individual can understand (Taylor & Brogan, 2020). For instance, a patient needs accurate information about the nature and purpose of the treatment or procedure, potential risks and benefits, alternative treatments, and potential consequences of not receiving treatment (Millum & Bromwich, 2021, p. 57). Finally, the individual must consent voluntarily, without coercion or undue influence from healthcare providers, family members, or others. Coercion can take many forms, such as offering incentives or making threats, and can compromise the individual’s ability to make a free and informed decision. Consent that meets these criteria or depicts all the above chief considerations is valid.
Background, Current Knowledge, and Implications for the Future
Historical Background
The idea of informed consent has its roots in the ancient Greek Hippocratic Oath, which required physicians to obtain the consent of their patients before treating them. Informed consent was not explicitly mentioned in the ancient Greek Hippocratic Oath, but the oath emphasized respecting patients and maintaining confidentiality. Physicians were expected to act in their patient’s best interest and avoid causing harm, an ethical framework that laid the foundation for the modern concept of informed consent. Moreover, the Hippocratic oath emphasizes the importance of teaching and learning in medicine (Wiesing, 2020, p.84). Physicians were expected to share their knowledge and skills while continuing to learn and improve their practice. This commitment to education and professional development is still fundamental to modern medical practice. While the concept of informed consent may not have been explicitly mentioned in the Hippocratic oath, the ethical principles outlined in the oath, especially the emphasis on respect for patients, avoidance of harm, and commitment to education and learning, continue to guide medical professionals today, have had a lasting impact on the practice of medicine.
The notion of informed consent has evolved since the early 20th century to become a prerequisite in the current medical practice. In the modern era, informed consent was first codified in the Nuremberg Code of 1947, which was developed in response to the atrocities committed by Nazi doctors during World War II. The Nuremberg Code required that research subjects be fully informed about the risks and benefits of a study and that they voluntarily consent to participate. This code was later incorporated into the Declaration of Helsinki, now the international standard for ethical research involving human subjects (Annas, 2018). With this attainment, informed consent has become a cornerstone of medical ethics as presently required by law in most countries. It is an essential part of the doctor-patient relationship and ensures that patients are fully informed about their medical treatment (Rai et al., 2019, p. 519). The evolution process may alter the concept’s initial meaning, but its importance in protecting the rights and autonomy of patients remains unchanged.
Nursing Management of Informed Consent Issues
Current research shows that informed consent issues can be complex and difficult to navigate. Researchers must balance the need for informed consent with the desire to recruit participants and conduct the research efficiently. The area of concern is the participants’ understanding of the study. Studies have shown that many participants need to fully understand the risks and benefits of the study, even after signing the consent form (Utz et al., 2019); Fain, 2020). Researchers must take steps to ensure that participants are fully informed and understand the implications of their participation. The power dynamic between the researcher and the participant is another significant concern. Participants may feel pressured to participate in the study due to their relationship with the researcher or the participant’s perceived benefits (Manti & Licari, 2018, p. 148). Researchers must be aware of this dynamic and take steps to mitigate any potential coercion or undue influence. Consequently, informed consent dynamics is an important area of research that requires ongoing attention and consideration.
Informed consent plays a significant role in nursing care as it ensures that patients have the necessary information to make informed decisions about their health care. Nursing care employs the concept of informed consent in several ways, including providing information, verifying patient understanding and documentation, and respecting autonomy. Nurses provide patients with information about their health conditions, proposed treatments, risks, benefits, and alternative options, which constitutes the knowledge patients utilize in making informed decisions about their health care (Hoskins, Grady & Ulrich, 2018). They then verify that patients have understood the information provided by asking them to repeat it or ask questions to confirm their understanding. Accordingly, they document informed consent in the patient’s medical record, including the patient’s understanding of the information provided, the patient’s agreement to the proposed treatment, and the date and time of consent (Liebe & Hunter, 2021). Nurses respect patients’ autonomy by ensuring they can accept or refuse any proposed treatment, even if it contravenes medical advice.
Proper management of current and future consent issues in nursing entails using a strategic approach. Several strategies are applicable in managing issues related to informed consent to ensure that patients understand the treatment options and can make informed decisions about their healthcare. The strategies nurses use range from providing information and confirming patient understanding to documentation, advocacy, assistance, and support provision. For instance, nurses endeavour to provide patients with clear and concise information about their medical condition, proposed treatments, risks, benefits, and alternative options in a language the patients can understand (Nittari et al., 2020, p. 1435). Currently, patients’ comprehension of the information provided is confirmed by asking them to repeat the information or asking questions to confirm their understanding (Schantz et al., 2021). With the advent of sophisticated technologies in the nursing and medical profession, future informed consent issues will be managed using innovative approaches and technologies that enhance communication and patient engagement. Viable mechanisms, including digital consent forms, telehealth technologies, and cultural competence, may be used.
Conclusion and Recommendation
Informed consent is a critical aspect of nursing practice, ensuring patients have the necessary information to make informed decisions about their healthcare. However, issues related to informed consent can arise due to various factors, including patient education levels, cultural differences, and language barriers. To manage these issues, nurses use various strategies, such as providing information, confirming understanding, documenting consent, advocating for patients, seeking assistance, providing support, and re-evaluating consent. In the future, innovative approaches and technologies, such as digital consent forms, telehealth, patient education materials, shared decision-making, cultural competence, and ethical decision-making, will continue to enhance communication and patient engagement, improving patient outcomes and satisfaction. Therefore, healthcare providers should prioritize informed consent and patient engagement to ensure that patients are active participants in their healthcare decisions, whether by using traditional or postmodern strategies.
References
Annas, G. J. (2018). Beyond Nazi war crimes experiments: the voluntary consent requirement of the Nuremberg Code at 70. American Journal of public health, 108(1), 42-46. Retrieved from https://library.oapen.org/bitstream/handle/20.500.12657/57383/978-3-031-01987-6.pdf?sequence=1#page=226
Cusack, C. M., Knudson, A., Kronenfeld, J. P., & Singer, R. F. (2018). Ethical considerations for patient consent and recruitment in pediatric anesthesia research. Anesthesia & Analgesia, 126(3), 822-829.
Fain, J. A. (2020). Reading, understanding, and applying nursing research. FA Davis. Retrieved from https://books.google.co.ke/books?hl=en&lr=&id=-Y__DwAAQBAJ&oi=fnd&pg=PT10&dq=Reading,+understanding,+and+applying+nursing+research&ots=JHkD_h447T&sig=hauPBB9-6b5aOCfvsEjMZ-qNeEA&redir_esc=y#v=onepage&q=Reading%2C%20understanding%2C%20and%20applying%20nursing%20research&f=false
Hoskins, K., Grady, C., Ulrich, C.M., (2018). Ethics education in nursing: Instruction for future generations of nurses. Online Journal of Issues in Nursing, 23(1), 1-11. https://doi.org//10.3912/OJIN.Vol23No01Man03
Liebe, H., & Hunter, C. J. (2021). Ethical considerations of academic surgical research. In Seminars in Pediatric Surgery (Vol. 30, No. 5, p. 151097). WB Saunders.
Manti, S., & Licari, A. (2018). How to obtain informed consent for research. Breathe, 14(2), 145–152. https://doi.org/10.1183/20734735.001918
Millum, J., & Bromwich, D. (2021). Informed consent: What must be disclosed and what must be understood?. The American Journal of Bioethics, 21(5), 46-58. https://doi.org/10.1080/15265161.2020.1863511
Nittari, G., Khuman, R., Baldoni, S., Pallotta, G., Battineni, G., Sirignano, A., Amenta, F., & Ricci, G. (2020). Telemedicine practice: Review of the current ethical and legal challenges. Telemedicine and e-Health, 26(12), 1427–1437. https://doi.org/10.1089/tmj.2019.0158
Rai, E., Chen, R. Y. Y., Noi, C. S., & Hee, H. I. (2019). Evaluation of anesthesia informed consent in pediatric practice – An observation cohort study. Journal of Anaesthesiology, Clinical Pharmacology, 35(4), 515–521. https://doi.org/10.4103/joacp.JOACP_74_18
Schantz, K., Gordon, E. J., Lee, U., Rocha, M., Friedewald, J., Ladner, D. P., Becker, Y., Formica, R., Reese, P. P., Kaufman, D., Barah, M., Walker, M., Mehrotra, O., Viveros, D., & Mehrotra, S. (2021). Patient and clinician perceptions of informed consent and decision making about accepting KDPI > 85 kidneys. Transplantation direct, 8(1), e1254. https://doi.org/10.1097/TXD.0000000000001254
Taylor, H., & Brogan, J. (2020). Exploring the concept of ‘informed consent’ within the context of paramedic practice. Journal of Paramedic Practice, 12(7), 1-6. https://doi.org/10.12968/jpar.2020.12.7.CPD1
U.S. Department of Health and Human Services. (2018). Guidance on informed consent for in vitro diagnostic device studies using leftover human specimens that are not individually identifiable. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-informed-consent-in-vitro-diagnostic-device-studies-using-leftover-human-specimens-not-individually-identifiable/index.html
Utz, C., Degeling, M., Fahl, S., Schaub, F., & Holz, T. (2019). (Un)informed consent. Proceedings of the 2019 ACM SIGSAC Conference on Computer and Communications Security, 4E, 973–990. https://doi.org/10.1145/3319535.3354212
Wiesing, U. (2020). The Hippocratic oath and the declaration of Geneva: legitimization attempts of professional conduct. Medicine, Health Care and Philosophy, 23(1), 81-86. https://doi.org/10.1007/s11019-019-09910-w
write