Role of informed consent based on bioethical principles

Authors

Keywords:

bioethics, health care, principled ethics

Abstract

Introduction: Informed consent is an essential component of ethical practice in health care; it is based on the basic principles of bioethics. It aims to uphold the human rights and dignity of patients; it enables them actively participate in making decisions about the care they receive.

Objective: To examine the role of informed consent based on bioethical principles in health care.

Methods: A bibliographic review was performed in electronic databases, where terms related to informed consent, bioethics and health care were used. Fifty-five articles published between 2019 and 2024 were reviewed.

Development: Informed consent is essential to guarantee the autonomy of individuals in the health care setting. It contributes to strengthening professional ethics, promoting transparency and building relationships based on trust. It protects individual rights, facilitates joint decisions and defines legal and ethical responsibilities. However, its application faces challenges such as lack of awareness of its relevance and cultural differences that may hinder its practice.

Conclusions: Informed consent is an essential component of health care that must be prioritized to provide care that is respectful, ethical and aligned with the best interests of patients.

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Author Biographies

Jhon Frank Alfredo Jimenez Villalta, Universidad Nacional de Tumbes

Cirujano Dentista con grado de maestro en estomatología, doctorando en Ciencias de la Salud.

Balgelica Antazara Cervantes Rujel, Universidad Nacional de Tumbes

Licenciada en Enfermería, Maestra en Ciencias de la Salud con mención en Salud Familiar y Comunitaria.

Leslie Bequed Lloclla Sorroza, Universidad Nacional de Tumbes

Licenciada en Enfermería con Grado de Maestro en Ciencias de la Salud, con Mención en Salud Familiar y Comunitaria.

Marilú Elena Barreto Espinoza, Universidad Nacional de Tumbes

Licenciada en Psicología por la Universidad Inca Garcilaso de la Vega en Lima, Magister en educación superior universitaria, Doctora en Psicología por la Universidad nacional Mayor de san Marcos, Doctora en Ciencias de la Salud por la Universidad Nacional de Tumbes.

References

1. Sarkar S, Anand RK, Ray BR, Baidya DK, Maitra S. Role of electronic devices in obtaining informed consent: current trends and future directions [Internet]. J Anaesthesiol Clin Pharmacol. 2022; 38(1):137-8. DOI: 10.4103/joacp.JOACP_598_20

2. Ahmed Ilyas S. Role of informed consent in clinical decision making [Internet]. Global Journal for Research Analysis. 2022 [acceso: 24/06/2024]; 11(03):72-4. Disponible en: https://www.worldwidejournals.com/global-journal-for-research-analysis-GJRA/file.php?val=role-of-informed-consent-in-clinical-decision-making_March_2022_5518374306_2505907.pdf

3. Woodman A, Waheed KB, Rasheed M, Ahmad S. Current state of ethical challenges reported in Saudi Arabia: a systematic review & bibliometric analysis from 2010 to 2021 [Internet]. BMC Med Ethics. 2022; 23(1):82. DOI: 10.1186/s12910-022-00816-6

4. Puig Hernández M. Algunas reflexiones sobre el Convenio de Oviedo y los productos sanitarios. Responsabilidad y certificación en el caso de los ciborgs [Internet]. RBD. 2021; (51):299-320. DOI: 10.1344/rbd2021.51.32660

5. Marín Castán ML. Sobre el significado y alcance de los hitos más decisivos en el desarrollo de la Bioética universal: el Convenio de Oviedo y la Declaración Universal sobre Bioética y Derechos Humanos de la UNESCO [Internet]. RBD. 2021; (52):155-72. DOI: 10.1344/rbd2021.52.34845

6. Ehni H, Wiesing U. The Declaration of Helsinki in bioethics literature since the last revision in 2013 [Internet]. Bioethics. 2024; 38(4):335-43. DOI: 10.1111/bioe.13270

7. Orzechowski M, Woniak K, Timmermann C, Steger F. Normative framework of informed consent in clinical research in Germany, Poland, and Russia [Internet]. BMC Med Ethics. 2021; 22(1):53. DOI: 10.1186/s12910-021-00622-6

8. Buedo P, Sanchez L, Ojeda MP, Della Vedova MN, Labra B, Sipitria R, et al. Consentimiento informado y directivas anticipadas: análisis comparado de la legislación en América Latina [Internet]. RBD. 2023; 58(1):25-44. DOI: 10.1344/rbd2023.58.41678

9. Pietrzykowski T, Smilowska K. The reality of informed consent: empirical studies on patient comprehension-systematic review [Internet]. Trials. 2021; 22(1):57. DOI: 10.1186/s13063-020-04969-w

10. Glaser J, Nouri S, Fernandez A, Sudore RL, Schillinger D, Klein-Fedyshin M, et al. Interventions to improve patient comprehension in informed consent for medical and surgical procedures: an updated systematic review [Internet]. Med Decis Making. 2020; 40(2):119-43. DOI: 10.1177/0272989X19896348

11. Shafique MU, Saleem MS, Saghir M, Javaid MS, Saad M, Sadiq A, et al. An audit of preoperative informed consent in surgical patients at a tertiary care hospital in Lahore, Pakistan [Internet]. Cureus. 2023; 15(12): E50122. DOI: 10.7759/cureus.50122

12. Mavroudis C, Mavroudis CD, Cook T, Mavroudis CL, Siegel A, Golden A. Bioethics in Congenital Heart Surgery [Internet]. En: Mavroudis C, Backer CL. Pediatric cardiac surgery. Hoboken: Wiley; 2023. p. 1055-1085 [acceso: 24/06/2024]. DOI: 10.1002/9781119282327.ch48

13. Mulla H, Mulla H. Informed consent an illusion or legal litigation? Perceptions of today's doctors [Internet]. Research Square. 2023; PREPRINT (Versión 1). DOI: 10.21203/rs.3.rs-2465943/v1

14. Adnan C, Saraswati R, Retnaningsih C. Application of aspects of consent in medical procedures (informed consent) as a form of consensualism principle [Internet]. Soepra J Huk Kesehat. 2022; 8(2):234-50. DOI: 10.24167/shk.v8i2.5164

15. Marrone M, Macorano E, Lippolis G, Caricato P, Cazzato G, Oliva A, et al. Consent and complications in health care: the Italian context [Internet]. Healthcare. 2023; 11(3):360. DOI: 10.3390/healthcare11030360

16. Szalados JE. The Ethics and Laws Governing Informed Decision-Making in Healthcare: Informed Consent, Refusal, and Discussions Regarding Resuscitation and Life-Sustaining Treatment [Internet]. En: Szalados JE. The Medical-Legal Aspects of Acute Care Medicine: A Resource for Clinicians, Administrators, and Risk Managers. Cham: Springer International Publishing; 2021. p. 43-73 [acceso: 24/06/2024]. DOI: 10.1007/978-3-030-68570-6_3

17. Schmidt U. From Nuremberg to Helsinki: Historicizing the codification of post-war research ethics [Internet]. En: Schmidt U. Ethical Innovation for Global Health: Pandemic, Democracy and Ethics in Research. 2023; p. 149-74 [acceso: 24/06/2024]. DOI: 10.1007/978-981-99-6163-4_9

18. Rasheed K, Qayyum A, Ghaly M, Al-Fuqaha A, Razi A, Qadir J. Explainable, trustworthy, and ethical machine learning for healthcare: A survey [Internet]. Comput Biol Med. 2022; 149:106043. DOI: 10.1016/j.compbiomed.2022.106043

19. Dugdale LS, Lerner BH, Callahan D. Pros and Cons of Physician Aid in Dying [Internet]. Yale J Biol Med. 2019 [acceso: 06/07/2024]; 92(4):747-50. Disponible en: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6913818/

20. Nagai H, Nakazawa E, Akabayashi A. The creation of the Belmont Report and its effect on ethical principles: a historical study [Internet]. Monash Bioeth Rev. 2022; 40(2):157-70. DOI: 10.1007/s40592-022-00165-5

21. Budowle B, Sajantila A. Revisiting informed consent in forensic genomics in light of current technologies and the times [Internet]. Int J Legal Med. 2023; 137(2):551-65. DOI: 10.1007/s00414-023-02947-w

22. Pico A, Vega N. La comunicación en el consentimiento informado [Internet]. Revista Colombiana de Cirugía. 2022; 34(1):45-56. DOI: 10.30944/20117582.2147

23. Al-Jardani R, Al-Hadrami W, Al-Balushi M, Al-Adawi M, Al-Nasseri S. Factors Influencing the Quality and Extent of the Informed Consent Process in Patients Undergoing Surgical Procedures [Internet]. Cureus. 2024; 16(8): e68149. DOI: 10.7759/cureus.68149

24. Xavier A, Roma F. Ethical considerations on placebo-controlled vaccine trials in pregnant women [Internet]. Revista Bioética. 2023; 31:e3205ES. DOI: 10.1590/1983-803420233205PT

25. Ibelli F, Scublinsky D, Acuña E, Higuera F, Vidal E, Iannantuono R. Grado de satisfacción con el proceso de consentimiento informado y la participación en ensayos clínicos. Un estudio en 3400 pacientes [Internet]. Medicina (B Aires). 2022 [acceso: 22/01/2025]; 82(4): 534-43. Disponible en: https://pubmed.ncbi.nlm.nih.gov/35904908/

26. Twimukye A, Nabukenya S, Kawuma A, Bayigga J, Nakijoba R, Asiimwe S, et al. Some parts of the consent form are written using complex scientific language: community perspectives on informed consent for research with pregnant and lactating mothers in Uganda [Internet]. BMC Medical Ethics. 2024; 25(1):149. DOI: 10.1186/s12910-024-01147-4

27. Predeina I, Bobrovskaya O, Kaletskiy E, Sergeyev Y. Chapitre E. On some issues of ensuring the rights of minor patients in Russian medical law: ethical and legal aspects of autonomy [Internet]. J Int Bioethique Ethique Sci. 2023; 34(1):45-56. DOI: 10.3917/jibes.341.0045

28. Torgersen LNS, Schulz SM, Lugo RG, Sütterlin S. Patient informed consent, ethical and legal considerations in the context of digital vulnerability with smart, cardiac implantable electronic devices [Internet]. PLOS Digit Health. 2024; 3(5):e0000507. DOI: 10.1371/journal.pdig.0000507

29. Resnik DB, Pugh J. Green bioethics, patient autonomy and informed consent in healthcare [Internet]. J Med Ethics. 2024; 50(7):489-93. DOI: 10.1136/jme-2023-109404

30. Varkey B. Principles of Clinical Ethics and Their Application to Practice [Internet]. Med Princ Pract. 2021; 30(1):17-28. DOI: 10.1159/000509119

31. Romanò M. The Italian law 219/2017: informed consent and advance directives. When the patient-doctor communication time is law, but it is forgotten [Internet]. G Ital Cardiol. 2024;25(6):383-9. DOI: 10.1714/4269.42461

32. Avci E. Protecting Incapacitated Patients' Rights and Best Interests [Internet]. Indian J Palliat Care. 2023; 29(4):343-7. DOI: 10.25259/IJPC_173_2022

33. Mannan S, Alam J, Bari KMA, Mamun SMAA, Orin RM. Ethical obligation and legal requirements: On informed consent practices in Bangladesh [Internet]. Dev World Bioeth. 2023; 23(3):252-9. DOI: 10.1111/dewb.12356

34. Cantú Quintanilla G, Gómez-Guerrero IE, Aguiñaga-Chiñas N, López Cervantes M, Jaramillo Flores ID, Slon Rodríguez PA, et al. Perceptions of COVID-19 patients in the use of bioethical principles and the physician-patient relationship: a qualitative approach [Internet]. BMC Med Ethics. 2024; 25(1):16. DOI: 10.1186/s12910-024-01009-z

35. Lytvynenko AA, Jurkevica TI. Freedom of Contract and Informed Consent as Part of Contract for Healthcare Services [Internet]. Socrates. 2022; 1(22):33-42. DOI: 10.25143/socr.22.2022.1.033-042

36. Lanphier E, Lomotey-Nakon L. Birth, trust and consent: reasonable mistrust and trauma-informed remedies [Internet]. J Med Ethics. 2023; 49(9):624-5. DOI: 10.1136/jme-2023-109210

37. McClelland R, Harper CM. Information Privacy in Healthcare - The Vital Role of Informed Consent [Internet]. Eur J Health Law. 2022 [acceso: 23/06/2024]; 30(4):469-80. Disponible en: https://brill.com/view/journals/ejhl/30/4/article-p469_5.xml

38. Lauck S, Lewis K. Shared decision-making in cardiac care: can we close the gap between good intentions and improved outcomes? [Internet]. Heart. 2023; 109(1):4-5. DOI: 10.1136/heartjnl-2022-321482

39. Krvavac A, Patel PH, Kamel G, Hu Z, Patel N. Improving Consent Documentation in the Medical Intensive Care Unit [Internet]. Cureus. 2019; 11(11): e6174. DOI: 10.7759/cureus.6174

40. Ayudiah F, Putri Y, Sulastri M. Informed Consent in Midwifery: Bridging Legal Requirements and Patient Communication [Internet]. J Curr Health Sci. 2024; 4(1):25-30. DOI: 10.47679/jchs.202465

41. Bengo EMM, Muula A, Bengo JM. Sufficient informed consent to medical treatment of adults: legal and ethical perspectives from Malawi [Internet]. Malawi Med J. 2022; 34(2):143-50. DOI: 10.4314/mmj.v34i2.11

42. Mihiretu MM, Bekele E, Ayele K, Asmare L, Bayou FD, Arefaynie M, et al. Patient knowledge of surgical informed consent and shared decision-making process among surgical patients in Ethiopia: a systematic review and meta-analysis [Internet]. Patient Saf Surg. 2024; 18(1):2. DOI: 10.1186/s13037-023-00386-5

43. Keshtgar A, Hania M, Sharif MO. Consent and parental responsibility - the past, the present and the future [Internet]. Br Dent J. 2022;232(2):115-9. DOI: 10.1038/s41415-022-3877-7

44. Pallocci M, Treglia M, Passalacqua P, Tittarelli R, Zanovello C, De Luca L, et al. Informed Consent: Legal Obligation or Cornerstone of the Care Relationship? [Internet]. Int J Environ Res Public Health. 2023; 20(3):2118. DOI: 10.3390/ijerph20032118

45. Parmar D. Ethical Aspects of Informed Consent in Dementia [Internet]. Glob Bioeth Enq J. 2021 [acceso: 24/06/2024]; 9(1):42-5. Disponible en: https://indianmentalhealth.com/pdf/2021/vol9-issue1/8-Ethical-Viewpoint-Paper_Ethical-Aspects.pdf

46. Lee SSJ. The Ethics of Consent in a Shifting Genomic Ecosystem [Internet]. Annu Rev Biomed Data Sci. 2021; 4(4):145-64. DOI: 10.1146/annurev-biodatasci-030221-125715

47. Welie JVM. Agenciamiento del paciente, autonomía y consentimiento. Perspectivas católicas [Internet]. Med Ética. 2020; 31(4):803-78. DOI: 10.36105/mye.2020v31n4.03

48. Muhtadi A, Santiago F. The Legal Position of Informed Consent in the Doctor-Patient Relationship [Internet]. En: Muhtadi A, Santiago F. Proceedings of the First Multidiscipline International Conference, MIC 2021, October 30 2021, Jakarta, Indonesia. Jakarta, Indonesia: EAI; 2022 [acceso: 07/07/2024]. Disponible en: http://eudl.eu/doi/10.4108/eai.30-10-2021.2315744

49. Prabhu PK. Is presumed consent an ethically acceptable way of obtaining organs for transplant? [Internet]. J Intensive Care Soc. 2019; 20(2):92-7. DOI: 10.1177/1751143718777171

50. Spriggs M. Children and bioethics: clarifying consent and assent in medical and research settings [Internet]. Br Med Bull. 2023; 145(1):110-9. DOI: 10.1093/bmb/ldac038

51. Wijohn Tyson R, Newcomb Ruth M, Reynolds Julia, El-Jack Seif, Armstrong Guy P. Informed consent-patients' understanding of risk [Internet]. N Z Med J. 2024; 137(1590):14-21. DOI: 10.26635/6965.6303

52. Vikas H, Kini A, Sharma N, Gowda NR, Gupta A. How informed is the informed consent? [Internet]. J Fam Med Prim Care. 2021; 10(6):2299. DOI: 10.4103/jfmpc.jfmpc_2393_20

53. Akpa-Inyang F, Chima SC. South African traditional values and beliefs regarding informed consent and limitations of the principle of respect for autonomy in African communities: a cross-cultural qualitative study [Internet]. BMC Med Ethics. 2021; 22(1):111. DOI: 10.1186/s12910-021-00678-4

54. Basukala S, Shrestha O, Thapa N, Karki S, Pandit A, Thapa A. How informed is informed consent? Evaluating the quality of informed consent among surgical patients in a tertiary care hospital in Nepal [Internet]. PLOS One. 2023 [acceso: 24/01/2025]; 18(7):e0288074. Disponible en: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0-288074

55. Wu C, Wang N, Wang Q, Wang C, Wei Z, Wu Z. Participants' understanding of informed consent in clinical trials: A systematic review and updated meta-analysis [Internet]. PLOS One. 2024 [acceso: 24/01/2025];19(1): e0295784. Disponible en: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0-295784

Published

2025-05-27

How to Cite

1.
Jimenez Villalta JFA, Cervantes Rujel BA, Lloclla Sorroza LB, Barreto Espinoza ME. Role of informed consent based on bioethical principles. Rev Cubana Med Milit [Internet]. 2025 May 27 [cited 2025 Jun. 3];54(2):e025066729. Available from: https://revmedmilitar.sld.cu/index.php/mil/article/view/66729