Does the standard medical procedure consent process meet the criteria required for informed consent? - A concept analysis

Published:January 20, 2023DOI:


      • Dimensional analysis identifies three perspectives of the informed consent process.
      • Legal perspective addresses requirement of formal informed consent discussion.
      • Health care perspective incorporates goals of individual performing the procedure.
      • Patient perspective reveals unique goals not identified by previous perspectives.
      • Informed consent is complex and compromised of separate but related perspectives.



      Informed consent is a complex process that is legally required before any surgical procedure.


      The purpose of this manuscript was to perform a concept analysis of the informed consent process.


      The use of dimensional analysis identified three separate yet related perspectives of the informed consent process: legal, health care, and patients. A database search using the Cumulative Index to Nursing and Allied Health Literature and PubMed were performed.


      A total of 27 publications were reviewed. The legal perspective addresses the requirement of informed consent, which starts with the discussion between the health care provider and the patient undergoing the surgical procedure and ends with a signature on a piece of paper. The health care perspective also addresses the legal requirement but incorporates the goals and objectives of the individual initiating the informed consent discussion. The patients' perspectives also incorporate goals and objectives; however, they differ from that of the health care provider in that they go beyond what happens in the operating room or during hospitalization.


      Viewing informed consent through these different yet related perspectives provides insight into this complex process and may enhance the researcher's ability to understand and improve the informed consent process.
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        • Akyüz E.
        • Erdem Y.
        Patients' experiences of informed consent and preoperative education.
        Clinical Nursing Research. 2021; 30: 529-538
        • American Academy of Pediatrics
        Pediatrics. 1976; 57: 414-416
        • American Academy of Pediatrics, Committee in Bioethics
        Informed consent, parental permission, and assent in pediatric practice.
        Pediatrics. 1995; 95: 314-317
        • Ares G.J.
        • Buonpane C.
        • Helenowski I.
        • Reynolds M.
        • Hunter C.J.
        Outcomes and associated ethical considerations of long-run pediatric ECMO at a single center institution.
        Pediatric Surgery International. 2019; 35: 321-328
        • Bielby P.
        The conflation of competence and capacity in english medical law: a philosophical critique.
        Medicine, Health Care, and Philosophy. 2005; 8: 357-369
        • Burkle C.M.
        • Pasternak J.J.
        • Armstrong M.H.
        • Keegan M.T.
        Patient perspectives on informed consent for anaesthesia and surgery: American attitudes.
        Acta Anaesthesiologica Scandinavica. 2013; 57: 342-349
        • Cabrales-Vega R.A.
        • Calvachi-Jiménez J.V.
        • Foronda-Castro J.E.
        • Giraldo-Pinto D.L.
        • Jojoa-Saa J.A.
        • Mendoza-Ortiz V.P.
        • Ugarte-Julio L.A.
        • Martínez J.W.
        [Informed consent is for whom?].
        Revista de salud publica (Bogota). 2012; 14: 502-511
      1. Caron, C.D., & Bowers, B.J. (2000). Methods and application of dimensional analysis: A contribution to concept and knowledge development in nursing. In B. L. K. Rodgers, K. A. (Ed.), Concept development in nursing: Foundations, techniques, and applications In B. L. K. Rodgers, K.A. (Ed.) (2nd ed.). Philadelphia, PA (pp. 285-319). Saunders.

        • Cawich S.O.
        • Barnett A.T.
        • Crandon I.W.
        • Drew S.D.
        • Gordon-Strachan G.
        From the patient's perspective: Is there a need to improve the quality of informed consent for surgery in training hospitals?.
        The Permanente Journal. 2013; 17: 22-26
        • Childers R.
        • Lipsett P.A.
        • Pawlik T.M.
        Informed consent and the surgeon.
        Journal of the American College of Surgeons. 2009; 208: 627-634
        • Chotai P.N.
        • Nollan R.
        • Huang E.Y.
        • Gosain A.
        Surgical informed consent in children: A systematic review.
        Journal of Surgical Research. 2017; 213: 191-198
        • Cocanour C.S.
        Informed consent-It's more than a signature on a piece of paper.
        The American Journal of Surgery. 2017; 214: 993-997
        • Crepeau A.E.
        • McKinney B.I.
        • Fox-Ryvicker M.
        • Castelli J.
        • Penna J.
        • Wang E.D.
        Prospective evaluation of patient comprehension of informed consent.
        The Journal of Bone Joint Surgery American Volume. 2011; 93 (111-117): e114
        • Dhar H.
        • Dhar D.
        Informed consent in clinical practice and literature overview.
        Archives of Gynecology and Obstetrics. 2012; 286: 649-651
        • Faghanipour S.
        • Joolaee S.
        • Sobhani M.
        Surgical informed consent in Iran–how much is it informed?.
        Nursing Ethics. 2014; 21: 314-322
        • Falagas M.E.
        • Korbila I.P.
        • Giannopoulou K.P.
        • Kondilis B.K.
        • Peppas G.
        Informed consent: How much and what do patients understand?.
        American Journal of Surgery. 2009; 198: 420-435
        • Gentry K.R.
        • Lepere K.
        • Opel D.J.
        Informed consent in pediatric anesthesiology.
        Paediatric Anaesthesia. 2017; 27: 1253-1260
        • Guinand J.
        • Gapany C.
        • Simon J.-P.
        • Wasserfallen J.-B.
        • Joseph J.-M.
        A survey on surgeons' perceived quality of the informed consent process in a Swiss paediatric surgery unit.
        Patient Safety in Surgery. 2015; 9 (PMID: 26322127; PMCID: PMC4552157): 30
        • Hall M.J.
        • Schwartzman A.
        • Zhang J.
        • Liu X.
        Ambulatory surgery data from hospitals and ambulatory surgery centers: United States, 2010.
        National Health Statistics Report. 2017; : 1-15
        • Jones J.W.
        • McCullough L.B.
        • Richman B.W.
        A comprehensive primer of surgical informed consent.
        Surgical Clinics of North America. 2007; 87: 903-918
        • Jubbal K.
        • Chun S.
        • Chang J.
        • Zhang S.
        • Terrones L.
        • Huang J.S.
        Parental and youth understanding of the informed consent process for pediatric endoscopy.
        Journal of Pediatric Gastroenterol Nutrition. 2015; 60: 769-775
        • Lashley M.
        • Talley W.
        • Lands L.C.
        • Keyserlingk E.W.
        Informed proxy consent: Communication between pediatric surgeons and surrogates about surgery.
        Pediatrics. 2000; 105: 591-597
        • Lemaire R.
        Informed consent–a contemporary myth?.
        The Journal of Bone & Joint Surgery. 2006; 88: 2-7
        • Loeff D.S.
        • Shakhsheer B.A.
        The ethics of informed consent and shared decision-making in pediatric surgery.
        Seminars in Pediatric Surgery. 2021; 30 (N.PAG-N.PAG)
        • Long K.L.
        • Ingraham A.M.
        • Wendt E.M.
        • Saucke M.C.
        • Balentine C.
        • Orne J.
        • Pitt S.C.
        Informed consent and informed decision-making in high-risk surgery: A quantitative analysis.
        Journal of the American College of Surgeons. 2021; 233: 337-345
        • Mattingly A.S.
        • Rose L.
        • Eddington H.S.
        • Trickey A.W.
        • Cullen M.R.
        • Morris A.M.
        • Wren S.M.
        Trends in US surgical procedures and health care system response to policies curtailing elective surgical operations during the COVID-19 pandemic.
        Journal of American Medical Association Network Open. 2021; 4e2138038
      2. Merriam-Webster. (2022). Definition of Informed Consent. (2022, January 22)

        • Moeini S.
        • Shahriari M.
        • Shamali M.
        Ethical challenges of obtaining informed consent from surgical patients.
        Nursing Ethics. 2020; 27: 527-536
        • Mohamed Tahir M.A.
        • Mason C.
        • Hind V
        Informed consent: Optimism versus reality.
        British Dental Journal. 2002; 193: 221-224
        • Nadeau D.P.
        • Rich J.N.
        • Brietzke S.E.
        Informed consent in pediatric surgery: Do parents understand the risks?.
        Archives of Otolaryngology - Head & Neck Surgery. 2010; 136: 265-269
        • Pfeil M.
        Parents’ experience of giving consent for their child to undergo surgery.
        Journal of Child Health Care. 2011; 15: 380-388
        • Pianosi K.
        • Gorodzinsky A.Y.
        • Chorney J.M.
        • Corsten G.
        • Johnson L.B.
        • Paul H.
        • Hong P.
        Informed consent in pediatric otolaryngology: What risks and benefits do parents recall?.
        Otolaryngology-Head & Neck Surgery. 2016; 155: 332-339
        • Pietrzykowski T.
        • Smilowska K.
        The reality of informed consent: Empirical studies on patient comprehension-systematic review.
        Trials Journal. 2021; 22: 57-64
        • Ruske J.
        • Sharma G.
        • Makie K.
        • He K.
        • Ozaki C.K.
        • Menard M.T.
        • Belkin M.
        • Shah S.K.
        Patient comprehension necessary for informed consent for vascular procedures is poor and related to frailty.
        Journal of Vascular Surgery. 2021; 73: 1422-1428
        • Shlobin N.A.
        • Sheldon M.
        • Lam S.
        Informed consent in neurosurgery: A systematic review.
        Neurosurgery Focus. 2020; 49: E6
        • Silva A.H.D.
        • Wijesinghe H.
        • Mundil N.
        • Lo W.
        • Walsh A.R.
        • Solanki G.A.
        • Rodrigues D.
        Consent in paediatric neurosurgery: Adequacy of documentation and parental perspectives.
        Childs Nervous System. 2019; 35: 2363-2369
        • Thornton R.G.
        Informed consent.
        Baylor University Medical Proceedings. 2000; 13: 187-190
        • Vikas H.
        • Kini A.
        • Sharma N.
        • Gowda N.R.
        • Gupta A.
        How informed is the informed consent?.
        Journal of Family Medicine and Primary Care. 2021; 10: 2299-2303