Informed consent addresses core principles of medical ethics—beneficence, nonmaleficence and autonomy. In this era of ever-increasing legal and social scrutiny of complex surgical procedures, informed consent is not just an ethical debate but a legal requirement. Unfortunately, many surgeons, to their own peril, still see it as a mere formality. This article deliberates upon informed consent process in surgical practice with emphasis on Indian perspectives and discusses common scenarios and special situations through legal citations in order to sensitize surgeons regarding their obligations pertaining to informed consent.
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NHS (2017) Consent to treatment. https://www.nhs.uk/conditions/consent-to-treatment/. Accessed 14 Sep 2020
Bruce L (2020) A pot ignored boils on: sustained calls for explicit consent of intimate medical exams. Hec Forum:1–21. https://doi.org/10.1007/s10730-020-09399-4
Tribble C, Julliard W (2019) First, we do harm: obtaining informed consent for surgical procedures. Heart Surg Forum 22:E423–E428. https://doi.org/10.1532/hsf.2743
Schloendorff v. Society of New York Hospital | Project Gutenberg Self-Publishing - eBooks | Read eBooks online. http://self.gutenberg.org/articles/eng/schloendorff_v._society_of_new_york_hospital. Accessed 6 Oct 2020
Samira Kohli vs Dr. Prabha Manchanda & Anr on 16 January, 2008. https://indiankanoon.org/doc/438423/. Accessed 4 Oct 2020
MCI (2002) Ethics Regulations-2002. https://www.mciindia.org/documents/rulesAndRegulations/Ethics%20Regulations-2002.pdf. Accessed 14 Sep 2020
Dr. Janaki S. Kumar and Another v Sarafunnisa on 21 June 1999 - Judgement - LawyerServices. https://www.lawyerservices.in/Dr-Janaki-S-Kumar-and-Another-Versus-Sarafunnisa-1999-06-21. Accessed 6 Oct 2020
Doyal L (2001) Closing the gap between professional teaching and practice. BMJ 322:685–686
Director General Indian Council of Medical Research (2006) Ethical Guidelines for Biomedical Research on Human Participants. http://www.icmr.nic.in/ethical_guidelines.pdf. Accessed 6 Oct 2020
Dr. T.T. Thomas vs Smt. Elisa And Ors. on 11 August, 1986. https://indiankanoon.org/doc/600254/. Accessed 6 Oct 2020
Jones JW, McCullough LB, Richman BW (2007) A comprehensive primer of surgical informed consent. Surg Clin N Am 87:903–918, viii. https://doi.org/10.1016/j.suc.2007.07.012
Ashraf B, Saaiq M, Zaman K-U (2014) Qualitative study of Nocebo Phenomenon (NP) involved in doctor-patient communication. Int J Health Policy Manag 3:23–27. https://doi.org/10.15171/ijhpm.2014.54
Bolam v Friern Hospital Management Committee. https://www.lawteacher.net/cases/bolam-v-friern-hospital-management.php. Accessed 6 Oct 2020
Sidaway v Board of Governors of the Bethlem Royal Hospital | (1985) 1 All ER 643 | United Kingdom House of Lords | Judgment | Law | CaseMine. https://www.casemine.com/judgement/uk/5a8ff8db60d03e7f57ece8a3. Accessed 6 Oct 2020
Canterbury v. Spence, 464 F.2d 772 | Casetext Search + Citator. https://casetext.com/case/canterbury-v-spence. Accessed 6 Oct 2020
Pearce & Anor v United Bristol Healthcare NHS Trust | (1998) EWCA Civ 877 | England and Wales Court of Appeal (Civil Division) | Judgment | Law | CaseMine. https://www.casemine.com/judgement/uk/5a8ff71560d03e7f57ea7414. Accessed 6 Oct 2020
Langerman A, Siegler M, Angelos P (2016) Intraoperative decision making: the decision to perform additional, unplanned procedures on anesthetized patients. J Am Coll Surg 222:956–960. https://doi.org/10.1016/j.jamcollsurg.2016.02.011
Shalowitz DI, Garrett-Mayer E, Wendler D (2006) The accuracy of surrogate decision makers: a systematic review. Arch Intern Med 166:493–497. https://doi.org/10.1001/archinte.166.5.493
Spatz ES, Suter LG, George E, Perez M, Curry L, Desai V, Bao H, Geary LL, Herrin J, Lin Z, Bernheim SM, Krumholz HM (2020) An instrument for assessing the quality of informed consent documents for elective procedures: development and testing. BMJ Open 10:e033297. https://doi.org/10.1136/bmjopen-2019-033297
Rector TS (2008) How should we communicate the likelihood of risks to inform decisions about consent? IRB Ethics Hum Res 30:15–18
OR Manager Inc (2009) Frequent questions on informed consent. https://www.ormanager.com/wp-content/uploads/pdfx/ORMVol25No4InformedConsentFAQ.pdf. Accessed 6 Oct 2020
Kumar A, Mullick P, Prakash S, Bharadwaj A (2015) Consent and the Indian medical practitioner. Indian J Anaesth 59:695–700. https://doi.org/10.4103/0019-5049.169989
Rao N (2010) Ethics of medical practice. In: textbook of forensic medicine and toxicology, 2nd edn. Jaypee Brothers Medical Publishers (P) Ltd., New Delhi, pp 23–44
Herring J (2012) Consent to treatment. In: Medical law & ethics, 4th edn. Oxford University Press, UK, pp 149–220
Vinod Khanna vs R.G. Stone urology and laparoscopy ... on 6 July, 2020. https://indiankanoon.org/doc/179114819/. Accessed 3 Dec 2020
Singh TSS (2017) Is it time to separate consent for anesthesia from consent for surgery? J Anaesthesiol Clin Pharmacol 33:112–113. https://doi.org/10.4103/0970-9185.202206
Waisel D (2010) Legal aspects of anesthesia care. In: Miller R (ed) Miller’s anesthesia, 7th edn. Churchill Livingstone, Philadelphia
Tewari A, Garg S (2003) Informed consent and anaesthesia. Indian J Anaesth 47:311–312
Charan Lal Sahu v. Union Of India . | Supreme Court Of India | Judgment | Law | CaseMine. https://www.casemine.com/judgement/in/5609ac42e4b014971140e6ba. Accessed 6 Oct 2020
Pecanac KE, Kehler JM, Brasel KJ, Cooper Z, Steffens NM, McKneally MF, Schwarze ML (2014) It’s big surgery: preoperative expressions of risk, responsibility, and commitment to treatment after high-risk operations. Ann Surg 259:458–463. https://doi.org/10.1097/SLA.0000000000000314
Jones JW, McCullough LB (2015) What is meant by high-risk informed consent? J Vasc Surg 62:510–511. https://doi.org/10.1016/j.jvs.2015.06.002
Mani RK, Amin P, Chawla R et al (2012) Guidelines for end-of-life and palliative care in Indian intensive care units: ISCCM consensus Ethical Position Statement. Indian J Crit Care Med Peer-Rev 16:166–181. https://doi.org/10.4103/0972-5229.102112
Law Commission of India (2006) Medical treatment of terminally ill patients (for the protection of patients and medical practitioners). Accessed 5 Oct 2020
Common Cause (A Regd. Society) vs Union Of India on 9 March, 2018. https://indiankanoon.org/doc/184449972/. Accessed 5 Oct 2020
OHCHR | Principles for the protection of persons with mental illness. https://www.ohchr.org/EN/ProfessionalInterest/Pages/PersonsWithMentalIllness.aspx. Accessed 28 Nov 2020
Murty OP (2013) Uniform guidelines for postmortem work in India. J Forensic Med Toxicol 30(1 & 2):1–137
Government of India (1994) Transplant of human organs act, 1994. http://www.medindianet/tho/thobill1.asp. Accessed 14 Sep 2020
(1974) Code of Criminal Procedure, 1973. An act to consolidate and amend the law relating to criminal procedure. https://www.indiacode.nic.in/handle/123456789/1611?sam_handle=123456789/1362. Accessed 6 Oct 2020
Board of Governors (2020) Telemedicine practice guidelines https://www.mohfw.gov.in/pdf/Telemedicine.pdf. Accessed 6 Oct 2020
(2015) The Gazette of India https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadGazette_NotificationsFiles/Gazette_Notification_31_July_2015.pdf. Accessed 6 Oct 2020
Chauhan RC, Purty AJ, Singh N (2015) Consent for audio-video recording of informed consent process in rural South India. Perspect Clin Res 6:159–162. https://doi.org/10.4103/2229-3485.159941
Burkle CM, Anderson KA, Xiong Y, Guerra AE, Tschida-Reuter DA (2017) Assessment of the efficiency of language interpreter services in a busy surgical and procedural practice. BMC Health Serv Res 17:456. https://doi.org/10.1186/s12913-017-2425-7
American Health Lawyers Association (2016) Understanding informed consent: a guide for active-duty military and military medical beneficiaries. https://download.militaryonesource.mil/12038/MOS/AHLA/Understanding_Informed_Consent_Military_and_Beneficiaries.pdf. Accessed 24 Nov 2020
Section 3 in The Medical Termination of Pregnancy Act (1971) https://indiankanoon.org/doc/1836566/. Accessed 28 Nov 2020
Research studies and standards division ministry of health and family welfare (2006) Standards for female and male sterilization services. https://nhm.gov.in/images/pdf/guidelines/nrhm-guidelines/family-planning/std-for-sterilization-services.pdf. Accessed 6 Oct 202046
Samar Ghosh vs Jaya Ghosh on 26 March, 2007. https://indiankanoon.org/doc/766894/. Accessed 6 Oct 2020
Parihar M (2004) ICOG FOGSI recommendations for good clinical practice on female sterilization. https://www.fogsi.org/wp-content/uploads/fogsi-focus/Female_Sterilization.pdf. Accessed 6 Oct 202048
Jones JW, McCullough LB (2002) Consent for residents to perform surgery. J Vasc Surg 36:655–656. https://doi.org/10.1067/mva.2002.127430
Bagnall NM, Pucher PH, Johnston MJ, Arora S, Athanasiou T, Faiz O, Darzi LA (2017) Informing the process of consent for surgery: identification of key constructs and quality factors. J Surg Res 209:86–92. https://doi.org/10.1016/j.jss.2016.09.051
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Kumar, B., Ali, M., Kumar, M. et al. Consent in Surgical Practice. Indian J Surg (2021). https://doi.org/10.1007/s12262-020-02698-7
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