Medical Law and Ethics - Case Study Example

Informed Consent Approximate word count: 1840 (excluding list of abbreviations used and cited references list); Word count limit: 2000. List of abbreviations used: IC: Informed Consent; NHS: National Health Service; NICE: National Institute of Clinical Excellence; NSF: National Service Framework; PRHO: Pre-registration house officers; SHO: Senior House officers; STD: Sexually Transmitted Disease; UK: United Kingdom; Other abbreviations carry their usual significance. Informed Consent Since time immemorial, man’s quest has been to protect himself from forces of nature and other elements primarily against disease. Being a social animal, and to ensure congenial living along with fellow human beings, (s)he evolved a ‘law’. As technological advancements took place and as human civilizations marched to the 21st century, disease associated pharmaceutical, medical interventions and the like came into picture. Consequently, to ensure safety of fellow human beings ‘Medical law and ethics’ came into existence around 1950s. As years passed on, stricter control and laws were enforced, essentially to differentiate between what was a genuine effort in research and murder under the guise of medical trials. Presently, we have various laws and guidelines adopted by different countries and unions, including the European Union (1, 2). One among such guidelines is the Informed Consent (IC). Coming to the issues at hand, three cases have been opened for advice. For the purpose of clarity, we name the cases as follows: Case 1. Patient dies owing to an artery being inadvertently severed during surgery. Surgery performed by a junior doctor in the absence of a supervising senior doctor and without the informed consent of the dead patient. A novel surgery technique involving laser equipment was adopted. The supervising senior doctor was also called to give advice on another case and since s/he cannot be present at two places at the same time, chooses not to be present at the operation theatre. As the patient dies ‘Blame game’ and ‘wriggling out of the situation with excuses’ starts - Hospital authorities clearly at the receiving end. Case 2. Patient’s brother, aged 16, male, taking medical consultation for an STD presumably contracted through a one night stand with his girlfriend, exhibits malicious behaviour. Clinicians deserve a better deal or patients are required to show better behaviour. Case 3. Patient (the adolescent with STD) administered substandard drug. Consequently, develops (presumably life threatening) severe respiratory infection. Hospital authorities definitely caught on the wrong foot again, as a better, albeit costly, drug is available for the same STD condition and is recommended by the National Institute of Clinical Excellence (NICE). An evergreen debate in Medical Law and Ethics concerns ‘Informed consent’ (IC). Although of recent origin, IC is generally obtained for two reasons: firstly in the field of Medical practice and secondly in Biomedical research. Case 1 presents a tricky situation owing to the adoption of a ‘novel surgical technique (medical practice) involving laser equipment (biomedical research)’. Now, given the information that IC from the patient who died was not obtained, whips up the debate on IC afresh. A number of studies were conducted on ‘Informed consent in clinical practice’ (6 – 13). Aim of almost all of these studies is to find answers to the following questions: Should an IC be obtained? Who should obtain the IC from the patient? From whom should the IC be obtained if the patient is incapable of issuing the same? What should be the position in emergency wherein an IC cannot be obtained from the near and dear ones of the patient? Does issuance of an IC mean lack of trust in the medical personnel and mistrust in the health care service provider? Will, not obtaining an IC, by the hospital authorities, represent a breach of medical law and ethics? What should be the stance of hospital authorities in the event of a death in cases wherein an inexperienced staff adopted novel techniques, and wherein an IC was not obtained? What should be the attitude of clinicians in case of neonates, children and young persons? Above all, what should be done in the event of the clinician’s ignorance or lack of knowledge of IC guidelines? In this report, we shall try to answer some of these questions with specific reference to the cases mentioned. Given the information that a novel technique involving a medical device (Laser equipment) was utilized in the present situation, and taking into account that the hospital is a member of the local NHS trust, an IC becomes mandatory, as per the guidelines of the 2000 NHS plan, (14). Such an IC, without exceptions, becomes mandatory in Austria (15) and in rest of the Europe as well (1, 14, 16). With the implementation of human rights acts, 1998 in 2000 in UK (16), IC in all likelihood would have bailed out the hospital authorities in the present situation. Oral consent from the patient perhaps is not a viable option in the present situation, as the patient died and the proof for the same was obliterated. Now, let’s consider the practical aspects of obtaining an IC. In UK, many-a-time, ICs are obtained by junior doctors, pre-registration house officers (PRHO) (17), or senior house officers (SHO) (8). Then, were the junior doctor and/or the senior doctor, involved in the surgery in case 1, aware of the IC guidelines (7, 8, 17)? In addition, was the patient in a position to give consent? Was the situation an emergency? Assume for the moments that Case 1 is an emergency, the patient being in an incapable position for giving consent, and no time to contact the near and dear one’s of the patient for an IC. Also, and above all, assume that the doctors involved have no knowledge of IC guidelines; the inadvertent act of an artery being severed can be either a case of inexperience or human error. The question that needs to be answered in such a situation is “should inexperienced personnel be allowed to perform ‘novel surgical technique using medical equipment’ wherein an IC could not be obtained?” What if in such situations an experienced senior doctor is not available, as in the present case… The list of questions that arise out of this situation is endless… On the other hand, if the act of the artery being severed is human error, then probably one should investigate whether junior doctor(s) involved in the present case was under stress. Junior personnel being stressed to their maximum limits owing to lack of proper supervision, resulting in errors, at emergencies is not new and can be inferred from the present case as well. Obviously, the senior doctor, presumably more experienced, cannot be present at two places at the same time. He has to choose between two things and generally, in such situations, many of the doctors prefer important cases, or as animal instinct would suggest, ‘opt for the case wherein there’s less risk involved’. Whatever might be the case, this act of the senior doctor not being present at the surgery wherein a novel technique was utilized and which proved costly, deserves a better explanation. Perhaps, the junior doctor can excuse her/himself out of the situation by saying that unless one fails in his/her attempts, one cannot learn and be a better surgeon. Needless-to-say, in the practical reality of life, Success, in comparison to failure, has never been a good teacher. In case 2, the patient’s younger brother who has contracted a Sexually transmitted disease (STD), exhibits malicious behaviour. Such behaviour in all likelihood can be considered normal of an adolescent who’s suffering the consequences of his behaviour. Generally, rather than taking responsibility for carelessness, young people of that age tend to blame others. Probably, restraint from the hospital authorities is advised in such cases. Still better, inform the parents of the misbehaving adolescent either on the spot or later. (One might argue why should we treat such cases or put up with such a behaviour; well taking into consideration the young person’s age and experience in life, restraint from the hospital authorities would be prudent). In case three, the adolescent was administered a substandard drug which led to the development of a (presumably life threatening) severe respiratory infection. This hospital, being a member of the local NHS trust, National Service Framework (NSF) guidelines published on 15 Sept 2004, slated to be the first ever in the world (14), apply in the present context. Digging deeper into the guidelines, Standard 4 – Growing up into adulthood, which deals with STDs in young people, should be applied here. As per this document, young people are eligible to consult on their own with access to the best medical care and confidential information, despite them (the young people) being under majority [a person is considered a ‘major’ upon crossing his/her 18th year in life, as per UK laws]. Furthermore, the guidelines also mention that if the health service provider is convinced that the young person is competent enough to understand the implications of his treatment options, s/he can consent to treatment (NSF Guidelines Standard 4: Growing up into adulthood; Confidentiality & Rights – 3.4). In the present case 3, if the clinicians were aware of all the NSF guidelines, although the adolescent might’ve consented to the usage of cheaper option owing to his financial situation, clinicians’ wise judgment should’ve prevailed. Additionally, this entire episode suggests that the adolescent’s parents probably were not aware of their ward’s medical consultations. Informed consent for neonates, children and young people has been a subject of intense research in recent times (3, 4, 18, 19). While the NSF guidelines state that parents of children and young people be informed about medical interventions and consent for the same obtained; IC might not be necessary in young people if, as already stated, the clinicians are convinced that the young person is competent enough to understand the implications of treatment options available. Thus, in part, the NSF guidelines are self-contradictory. For the simple reason, how can people below 18 years of age be competent enough to fully understand the implications of medical interventions, when highly qualified clinicians themselves failed to recognize the practical implications of administering a substandard alternative (in the present example) on a young person? Given this self-contradictory situation, clinicians involved should’ve informed the adolescent’s parent (it is inferred from cases 2 and 3, that the adolescent’s parents/guardians were not informed). Continuing the discussion in similar lines, what would be the case if the adolescent were an orphan? Maybe the orphanage should be intimated or perhaps whoever is in charge of the young person’s well being. In the worst case scenario, wherein an IC could not be obtained for adolescents, the clinicians should use their wise judgment to see that the medical intervention should in no-way be an impediment for the young person to progress to his/her adulthood. This is where clinicians breached the NSF guidelines… In all of the instances presented here, there’s a definite breach of NHS guidelines with regard to IC. Nevertheless, it should be borne in the mind’s of the readers that obtaining an IC may not be possible in all cases and in certain cases obtaining an IC may be an impediment for start of medical intervention, which when not given at the appropriate time might prove to be costly. Put simply, IC should be a part of the process and not the end (6) and with existing guidelines being not clear on how to seek an IC (12), the debate continues… References: 1. Declaration of Helsinki on Ethical principles for medical research involving human subjects, adopted by the general assembly of the world medical association (1996) – As mentioned in the official journal of the European Union: Commission directive 2005/28/EC of 8 April 2005: L91/15 (9.4.2005) 2. European parliament and of the council of the European Union. Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the Laws, regulations and administrative provisions of the member states relating to implementation of good clinical practice in the conduct of Clinical trials on Medical products for human use – as cited in reference 13. 3. Maharaj NR, et al. Intersex conditions in children, and adolescents: surgical, ethical and legal considerations. Journal of Pediatric & Adolescent Gynaecology, Dec 2005; vol. 18 Issue 6, p399 – 402. 4. Gill, Denis. Guidelines for informed consent in biomedical research involving pediatric populations as research participants. European Journal of Pediatrics, 2003; Vol. 162 Issue 7/8, p455. 5. Jacquelyn Ann K. Kegley. Challenges to informed consent – viewpoint. EMBO reports, 2004; vol. 5 no.: 9: 832. 6. Jaynes, Tammi. Informed consent: imparting knowledge or signing a form? Applied Clinical Trials, Jun 2005; vol. 14 issue 6, p104 – 106. 7. Chadha, NK. How much do healthcare professionals know about informed consent? A Bristol Experience. Surgeon Dec 2004; vol. 2 issue 6, p328 – 333. 8. Lloyd, Tom et al. Informed consent: are basic surgical trainees meeting the standards? Quality in primary care, Jun 2004; vol. 12 issue 2, p97-101. 9. Stiffler, Helen L. Guidelines for obtaining informed consent for clinical research. Applied clinical trials, Nov 2003 supplement, vol. 12, p6. 10. Hogue, Elizabeth. What you should know about informed consent. Nursing, Jun 86; vol. 16 issue 6. 11. Parker, Michael J. Getting ethics into practice. British Medical Journal, 7/12/2004; vol. 329 Issue 7458, p126. 12. Cassell J, Young A. Why we should not seek individual informed consent for participation in health services research. Journal of Medical Ethics; Oct 2002; Vol. 28 Issue 3, p313. 13. Corrigan, Oonagh P. Consent is not enough – putting incompetent patients first in clinical trials. Lancet, 6/21/2003; Vol. 361 Issue 9375, p2096. 14. Department of Health. Reference guide to consent for examination or treatment, London: Department of Health, 2001. Available online: http://www.doh.gov.uk/consent - accessed 28-Dec-2005. 15. Druml, Christiane. The European Directive: a further blow to science in intensive care medicine in Austria. Intensive care medicine, Feb 2004; vol. 30 Issue 2, p335-335. 16. Worthington R. Clinical issues on consent: some philosophical concerns. J Med Ethics 2002; 28: 377-380. 17. Schildeman, Jan. Informed consent in clinical practice: pre-registration house officer’s knowledge difficulties and the need for post graduate training. Medical Teacher, Nov 2005; vol. 27 Issue 7, p 649-651. 18. Dalla-vorgia P et al. Overview of European Legislation on informed consent for neonatal research. Archives of Disease in Childhood – Fetal & Neonatal Edition, Jan 2001, vol. 84; Issue 1, p70-73. 19. Larcher, Vic. Consent, competence and confidentiality. British Medical Journal, 2/12/2005; vol. 330, Issue 7487; p353-356. Read More