Ethical Principles of Gaining Informed Consent

Ethical principles of gaining informed consent “Respect for human beings involves giving due scope to peoples capacity to make their own decisions. In the research context, this normally requires that participation be the result of a choice made by the participants” (NHMR, 2007, p. 3). Freegard 2012 (p. 60), states that “respecting the rights of others,” includes a responsibility for Health professionals “to let others know about their rights” and that this forms the basis of an informed consent.Discuss the values and principles of ethical conduct in relation to gaining an informed consent from potential research participants in relation to your project. In your discussion • Briefly highlight the features of an informed consent • Discuss why gaining informed consent from participants is important in research and how this contributes to the four principles of ethical conduct in research 1. respect for human beings, 2. research merit and integrity, 3. ustice, and 4. beneficence • Draw on other ethical theories to support your discussion (at least one) • For your essay you should refer to the NHMRC National Statement on Ethical Conduct in Human Research: (http://www. nhmrc. gov. au/guidelines/publications/e72) Study Abstract Coronary artery bypass grafting may leave one-third patients with persistent pain, as well as hypersensory symptoms at and away from the primary site of pathology (central sensitisation).Subjects who have undergone this surgery, are under 81 years of age and have no co-morbidities will be recruited. Through the use of quantitative sensory testing (such as heat pain threshold and pressure pain threshold), participants will be assessed for the prevalence of central sensitisation. Positive findings may lead to the re-assessment of patient analgesic management for better outcomes. This essay will define the features involved in gaining ‘informed consent’ from research participants for the proposed physiotherapy research study.It will discuss ethical principles that are embedded in the National Statement; a document released to “promote ethically good human research” (National Healthy and Medical Research Council [NHMRC], 2007, p. 7). It will also discuss the principles and values within principle-based ethics (bioethics), deontology, and utilitarianism as they apply to gaining this consent. Finally, it will highlight utilitarianism and its’ contribution to the safeguarding of research participants.To achieve consent classified as ‘informed’ the therapist must disclose all information relevant to a forthcoming intervention, in a time of decision-making. Beauchamp and Faden (2004) define informed consent as “autonomous authorisation of a medical intervention…by individual patients”, whilst Kerridge, Lowe & McPhee explain that “informed consent allows mentally competent patients to make autonomous choices, and protects [the] mentally incompetent patients from harm” (2005. p215-216).Ethically sound informed consent includes four elements: competence, voluntariness, disclosure of information, and understanding and acceptance of information (Kerridge, et al. , 2005). Briefly summarised this means that the patient (or in this case, the participant) is able to express free choice (autonomy) through a cognitive reasoning process, from adequately disclosed information. Furthermore it means the documentation and terminology is suitably matched to the participant’s level of understanding (e. g. ay terms) and that adequate time is given for decision-making (Brody & Engelhardt 1987; Oliver, 2010). Finally, harm must be minimized to any participant (non-maleficence), the research should be scientifically valid (research merit and integrity), and any cognitively impaired or incapable participant should have a suitable third party to give consent (Kerridge, et al. , 2005). Although it may appear this process is lengthy or arduous in nature, without these philosophical deliberations informed consent would continue to remain simply an ethical ideal.Bioethics is a principle-based theory that is strongly linked with the ethical practice of health care facilitators today, and was foundational in establishing The Universal Declaration of Human Rights (United Nations, 2012). Insofar as informed consent has been expounded, two main principles of bioethics have emerged as paramount; autonomy and non-maleficence. Although seemingly clear, the boundary of both respecting a person’s autonomy and doing no harm becomes blurred when the patients have disabilities that remove their ability to reason and justify soundly (e. g. total brain injuries or severe stroke patients).Although the participants in the proposed study will be fully-abled as per the exclusion criteria, understanding why cognitively impaired participants cannot give ‘informed’ consent further elaborates on higher-order-thinking required in the informed consent process. Without such a process, patients whom elect to become participants may not understand that this research is a separate entity to their regular treatment regime, and essentially will have become coerced into consenting due to a lack of clarification (Kerridge, Lowe, & Stewart, 2009; Rigg, 2012a; Rigg, 2012b).Usually health care practice is guided by codes from the profession’s governing board (such as the Australian Physiotherapy Association), in order to respect patient rights. However, research ethics are different in construct compared with general health care practitioner ethics, as the primary purpose of research is the collection and expansion of knowledge, rather than benefitting the participant (British Medical Association, 2004). With this in mind, the NHMRC has also instated a committee to oversee the thical application of research to ensure that participants are protected from any harm and their rights respected; known as Australian Health Ethics Committee (AHEC). Committees such as AHEC utilise the National Statement when making decisions over the ethical nature of proposed research studies involving humans (NHMRC, 2009). The statement was founded on four principles: respect for human beings, research merit and integrity, justice, and beneficence (Kerridge et al. , 2009).Informed consent is deeply intertwined with respecting human beings and beneficence, as the autonomous decision to involve oneself voluntarily in a study is based on the premises that all information disclosed is accurate and understandable, and that the study itself will cause no harm. Not surprisingly, research merit and integrity and beneficence are also interpolated, as if a study was conducted with no purpose (which merit is derived from) it would be in essence harming the patient as an abuse of their time, misconception of their autonomous consent, and unnecessary expose to risk (Peiper, I. 2011). In this study, participants will be given an information sheet prior to consenting that will extensively outline the study, its’ risks and benefits, and emphasise the voluntary nature of their involvement. Should any harm arise (such as pain sensitisation/irritation or minor burns) the researchers will attempt to alleviate discomfort through various means (such as analgesics) and herein beneficence is actioned.This is also an example of deontological philosophy, as the health care practitioner is bound by their code to respect the participant’s rights, and do no harm (Australian Physiotherapy Association [APA], 2008; Rigg, 2012c; United Nations, 2012). Furthermore, to ensure they can comprehend the information sheet, Kerridge (2009) recommends testing participant cognition to ensure that they are capable of such reasoning. When reviewing studies the AHEC will ensure that the research question, the hypothesis and the proposed benefits of the study are validated, and moreover that the benefits outweigh the risks (NHMRC, 2009; Peiper, 2011).Although this process safeguards participants it is also useful to ensure, pending the study’s success, that these benefits can then equally be distributed to those who are in need of them (a virtue of egalitarian philosophy). This is exampled as per the suggested research project, as if patients are successfully identified as centrally sensitised, then alterations to pain management post-surgery, and promotion for non-invasive techniques can be pursued. In this right, delivery of these benefits upholds justice in the field of research and the participant consent has also been justified.Granted, justice is more complicated to exemplify in research, as mentioned previously, the purpose of research is not of direct benefit to the participant rather society as a whole (Kerridge, 2005). This concept is deeply rooted in utilitarianism. Although ethical standards do not allow more than “minor risk to harm” (NHMRC, 2009) the truest form of utilitarianism philosophy would suggest that any risk, should the benefit outweigh it, is worthwhile to greater the good of many (Shannon, 1981).It is likely that this kind of research is what brought about the National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research (The Commission) (Shannon, 1981). The Commission clarified the different reasons for which informed consent was so vital, and made several key delineations on the practice of researchers. It therefore played a large role in the evolution of informed consent ethics and helped promote a new moral standard of professional research conduct.The Australian Physiotherapy Association furthermore encourages high standards of ethical research as outlined in its’ guideline: “APA members shall strive for standards of excellence in all aspects of physiotherapy practice, education, research & promotion” (APA, 2012). Altogether by understanding the principles of bioethics and the various philosophies that apply to research, it is possible to conduct ethical research as a health care practitioner, and consent that is classified as ‘informed’ is obtainable.It has been clearly outlined the importance in gaining true ‘informed’ consent from participants when conducting research. Ethical principles found in bioethics, deontology, egalitarianism, and the four core principalities of the National Statement were expounded to investigate the justification of ethical research. The counter-argument of true utilitarianism philosophy was explored to further strengthen the need for ethical committees that safeguard the wellbeing of research participants.

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