Comparative Analysis of Informed Consent in Healthcare - Term Paper Example

Comparative Analysis of Informed Consent Student’s Name Institutional Affiliation Comparative Analysis of Informed Consent The provision of healthcare is guided by ethical principles and regulations that have been put in place in various jurisdictions. These principles and regulations are meant to protect the patient while ensuring that healthcare workers handling the patient do what is within their scope of practice to offer efficient services to patients. In the ED, patients often present with varying medical conditions requiring various forms of interventions to be implemented. Before the implementations of appropriate interventions, permission from the patient is supposed to be sought (Townsend & Luck, 2010). This is what is defined as allowing patients their autonomy before implementing therapeutic interventions be it in a treatment setup or during a clinical research (Lindberg, Fagerstrom, Sivberg & Willman, 2014). Allowing a patient to make a choice of whether to accept or not accept a given intervention requires that patients fully understand why they need the intervention and the possible consequences of receiving or refuting the intervention (Steer, 2012). Patients are said to have an informed consent to accept an intervention after making an autonomous decision regarding the treatment. In this paper, the principles of informed consent shall be examined from an Australian context in addition to a comparison and contrast to the practice in the United States. Principles/Elements of Informed Consent Information disclosure is the first element of Informed Consent. This entails informing the patient or the recipient of an intervention about the proposed intervention including the possible negative and positive outcomes as a result of the intervention (Morgans, 2010; Dhar H & Dhar D, 2012). However, this may not be easily done in an emergency situation where there is no sufficient time to explain all the details of why the patient needs the intervention, the details of the intervention, and the possible consequences of the intervention (Morgans, 2010). The time limitedness of information disclosure in emergency context is identified as a limited ‘window of opportunity’. Nevertheless, during disclosure, explanatory statements may be required to ensure that what is been disclosed is succinctly conveyed to the recipient without been misconstrued or perceived ambiguous. Patients shall need to be told about their health status including the diagnosis that has been made regarding their health status (Cockcroft, Sandhu & Norris, 2009). The purpose and nature of the treatment to be given need to explained too together with risk and benefits of the suggested intervention. Furthermore, if there are any other alternative interventions to the primary suggested ones, they shall be made known to the patient in addition to the risks and benefits linked with the alternative interventions (Cockcroft, Sandhu & Norris, 2009). The patients also need to understand the short-term and long-term effects, if any, of the interventions or treatment upon their lifestyle. A second opinion is allowed to be sought by the patient from other persons if they feel like doing so regarding the interventions to be given to them. The consequences of refusing the proposed intervention shall also be explained to the patient. During disclosure, if the patients have any questions they are allowed to ask (Cockcroft, Sandhu & Norris, 2009). The disclosure can be done orally, through written documents or via the use of both methods. Patients who prefer their families or significant persons in their lives around them during the disclosure shall be allowed to have the same (Morgans, 2010). The same requirements highlighted above are applicable in disclosure before consent from study participants is sought in clinical research. The second element in obtaining informed consent is to ensure that patients comprehend what has been disclosed to them (Morgan, 2010; Hall, Prochazka & Fink, 2012). After the disclosure, patients are supposed to be asked to ascertain their understanding of the information by explaining it back to the healthcare provider or researcher. The patients' comprehension accuracy is partly dependent on the person disclosing the information. The discloser is expected to be succinct and unbiased for the patient's optimum comprehension outcome (Hall, Prochazka & Fink, 2012). The major deterrent to sufficient patient comprehension is usually the language used. The medical language or even research language may be complex for the patient’s understanding. This has to be simplified such that the patient can understand what it all entails. However, the patient must have been ascertained to be in a state of mind capable of understanding the disclosed information before the element of disclosure and comprehension are passed (Steer, 2012). The third element of informed consent is voluntariness in that the information conveyed should be expressed such that it's not coercive, under undue pressure or threatful to the patient (Steer, 2012). This is meant to allow patients to make a decision to refuse or accept an intervention based on their understanding of the interventions including all the possible consequences associated with an acceptance or refusal of the interventions suggested (Morgan, 2010). However, the risk of coercive solicitation of consent is high in an emergency situation as encountered by paramedics due to the emotional response and stress associated with a medical emergency and limited time for options considerations. The patient may end up voluntarily giving consent out of hope of positive outcome or ‘false hope' and their belief that the outcome relies on their compliance with the healthcare worker's request (Morgans, 2010). Nevertheless, it is required that patients accept requests out of their will. The fourth element pertaining informed consent is an ascertainment of patients’ competence in making a choice or decision. This includes ascertaining a patient’s state of mind to make a decision (Steer, 2012). Patients who may not be deemed legally competent to make decisions include ill patients psychologically or physiologically compromised or young children and infants (Steer, 2012; Pick et al., 2013). Generally, unconscious patients cannot give consent on their own and can only be included in emergency research if the research is for the therapeutic benefit for the patient or if it’s a minimally invasive observational research (Morgans, 2010). After all the above elements have been certified the last element of informed consent entails making sure that the patient records and signs the relevant form indicating that consent has been granted. Comparison and Contrast of Informed Consent The Australian’s common law allows every competent adult the choice to accept or refuse a given medical intervention (Pick, Berry, Gilbert & McCaul, 2013). Failure to obtain consent before initiating any clinical intervention may have clinical consequences for the health care worker attending to the patient. In fact, the trespass law grants patients the right to refuse subjection to an invasive procedure unless they consent to it be it a necessity or an emergency situation (Pick et al., 2013). Similarly, the US’s has its Federal law that provides for the same basic patient rights and requirements for informed consent (Mazur, 2013). The US and Australia share many similarities regarding the informed consent concepts. The various elements of informed consent are shared by the two countries although there are slight differences or alterations in an attempt to clarify the elements to suit the respective jurisdiction. The various shared concepts of disclosure include the requirement to disclose information regarding the intervention to be implemented including the possible risks and expected benefits whether it is a conventional intervention or experimental, the consequences of refusing the proposed intervention, and the time and cost involved (Mazur, 2013; Morgans, 2010). In both countries, it is a requirement that patients be informed about a given proposed intervention regardless of whether they wish not to be informed about it. Information can only be withheld if its felt that revealing that information may cause serious mental health or physical health harm (Mazur, 2013; Steer, 2012). The patients required to give consent must also exhibit comprehension of the disclosed information and should give their consent voluntarily, and be deemed competent to do so (Heywood, Macaskill & Williams, 2010). In both countries, it is recommended that the consent should be confirmed in written form because of the ambiguity associated with unwritten consent such as through body language. Although the two countries have a system of waiving of informed consent in emergency interventions or research, the US has a more detailed requirement for waiver in emergency situations after a modification of the previously standard requirements (Morgans, 2010). Another contrast is seen in community-based informed consent and results transparency. In the US, a panel of patients, carers or survivors representing the community are required to give consent, especially when obtaining informed consent before a clinical research on a given population. Besides, the results obtained from the research have to be made available to the community. This has given a voice to the communities subject to research in the US. However, in Australia, there are no ethical guidelines that insist on community consultation nor require that the results obtained after a given research be made publicly available (Morgans, 2010). Conclusion Informed consent gives patients who ought to receive an intervention the right to be explained the form of intervention, understand the intervention and make a decision whether to accept or refuse the intervention voluntarily. The various elements that constitute an informed consent have substantial similarities across most jurisdictions but may differ in fine elements. The outstanding difference between informed consent in Australia and US is the extension to allow communities or a sample group of people affiliated to a given research as study participants to give informed consent to allow the research to proceed with the condition that research findings are made available to the public too. References Cockcroft, S., Sandhu, N., Norris, A. (2009). How does national culture affect citizens rights of access to personal health information and informed consent? Health Informatics Journal, 15(3), 229-243. Dhar, H. & Dhar, D. (2012). Informed consent in clinical practice and literature overview. Archives of Gynecology and Obstetrics, 286(3), 649-651. Hall, D., Prochazka, A. & Fink, A.S. (2012). Informed consent for clinical treatment. Canadian Medical Association or its Licensors, 184(5), 533-540. Heywood, R., Macaskill, A. & Williams, K. (2010). Informed consent in hospital practice: Health professionals' perspectives and legal reflections. Medical Law Review, 18(2), 152-184. Lindberg, C., Fagerstrom, C., Sivberg, B. & Willman, A. (2014). Concept analysis: Patient autonomy in a caring context. Journal of Advanced Nursing, 70(10), 2208-221. Mazur, D.J. (2013). Informed consent in the twenty-first century: What it is, what it isn't, and future challenges in informed consent and shared decision making. Sociology Compass, 7(9), 762-774. Morgans, A. (2010). Waiver of informed consent in prehospital emergency health research in Australia. Monash Bioethics Review, 29(1), 1-16. Steer, B. (2012). Paramedics, consent and refusal- are we competent. Australasian Journal of Paramedicine, 5(1), 1-10. Townsend, R. & Luck, M. (2012). Protective jurisdiction, patient autonomy and paramedics: the challenges of applying the NSW Mental Health Act. Australian Journal of Paramedicine, 7(4), 1-11. Read More