Clinical research is crucial for the promotion of health practices because it provides the solutions to the various challenges that face the health care sector, for example determining the effectiveness of new medical intervention when compared to the current methods (Hulley et al. 2013; Portney & Watkins 2015). However, to produce practical outcomes, clinical research has to use people as research specimen. The use of people as research specimen subjects the research participants to serious risks, including poisoning and physical disability. Consequently, human tests raise fundamental ethical issues amongst the various relevant stakeholders. In Australia, clinical research involving human tests must comply with high ethical standards (Lederman 2006; Kotecha et al. 2011; National Health and Medical Research Council 2016a). According to the National Health and Medical Research Council (2016a), Australia has a practical regulatory pathway for the various clinical trials. In the Clinical Trials Notification (CTN) scheme that is under the supervision of the Therapeutic Goods Administration (TGA), it is mandatory for the clinical researchers to directly submit research proposals to Australian Human Research Ethics Committees (HRECs) for purposes of ethical review and subsequent approval. Furthermore, the TGA also manages the Clinical Trials Exemption (CTX) scheme. In this case study report, the Australian clinical research ethics are explored with the objective of making the appropriate recommendations. To achieve the report’s goal, it has been divided into two main sections. The First part is the Discussion Section, where the report provides insights on Australia’s clinical research ethical framework. In the Second and final Section, the report provides a conclusion that summarises the key insights concerning Australia’s clinical research ethical framework.
The relationship between research participants and researchers forms the basis upon which human research is often conducted (Glickman et al. 2009). Moreover, the values such as justice, integrity, beneficence, and the respect for human beings contribute towards shaping that relationship as one of ethical quality, and mutual responsibility. Thus, it is against this background that Australia’s National Statement on Ethical Conduct in Human Research (2007) (Updated May 2015) regards the people who participate in clinical research as ‘participants’ and not ‘subjects’ (National Health and Medical Research Council 2016b). Nonetheless, although the values of justice, integrity, beneficence, and the respect for human beings have a long history in regulating the ethical conduct of clinical researchers around the world, including Australia, they are not the only values for researchers. Other values include respect for the societal cultural diversity, contributing to community goals, and altruism (World Medical Association 2013). Nevertheless, the values of research integrity and merit, respect, beneficence, and justice have occupied a prominent position in Australia’s ethics of human research in the last 60 years, and these provide a flexible and substantial framework for the principles to guide the design, review, as well as the adoption of such research. Accordingly, the country’s ethical framework for clinical research in the National Statement is founded on these values, thereby developing the relevant practical expression.
Moreover, among the values mentioned in the preceding discourse, respect is considered to be central (Portaluppi, Smolensky & Touitou 2010). The value of respect entails recognizing that each person has value in them, and that this value dictates all the interactions between people. The value of respect includes the recognition of the value of human autonomy, which incidentally is the capacity to establish a person’s own life and the ability to make own decisions (Petryna 2009). However, the value of respect transcends beyond the recognition of human autonomy. The value involves the provision for the protection of those people that have diminished or no autonomy, and empowering them in appropriate situations, as well as helping and protecting people in all circumstances it would be wrong not to provide people with help and protection. Subsequently, the reference to the values of justice, integrity, beneficence, and the respect for human beings in Australia’s National Statement serves as an endless reminder that, at all the phases, human research demands ethical reflection that is informed by sound values. The sequence in which these values are considered in practice reflects the order in which the majority of ethical considerations come up in human research.
Furthermore, integrity and research merit are often the initial values explored in Australia’s National Statement. It is argued that unless a proposed clinical research demonstrates merit, and the researchers who are to conduct the research are found to be of high integrity, the participation of people in such a clinical research cannot be said or be considered as ethical (Mason, Laurie, & Smith 2013). At a reflective level, justice entails a regard for human equality that every individual shares with others. People have a deep desire to be treated in accordance with similar justice, including procedural justice and distributive justice. In the context of clinical research, procedural justice is expressed through ‘fair treatment’ during the selection and recruitment of the participants as well as the review of research whereas distributive justice manifests in the fair distribution of the challenges and benefits of research.
Although benefit to people is recognized as an important output of clinical research, it is also crucial that research benefits are realized through just mechanisms, entail no unjust burdens, and are distributed fairly (Mason et al. 2013). Nonetheless, researchers in clinical studies enjoy discretion in the manner in which they can exercise beneficence under ethical research. The researchers can exercise beneficence through: evaluating and taking into consideration the risks of harm and the possible benefits of research to the participants and to the entire community; being sensitive to the interests and welfare of the people that are involved in their clinical research; and reflecting on the cultural and social implications of their work.
Overall, the respect for people is the common threat throughout all the discussions on ethical values under the ethics of clinical research. Therefore, turning to the value of respect as the final value is a strong reminder that it brings together all of the ethical discussions that has preceded the value. In Australia, the government, through Parliament, has adopted a comprehensive regulatory policy that focuses on ensuring that each and every proposed human test satisfies both the ethical and scientific requirements before it is approved for implementation. In this context, the TGA is tasked with the mandate and duty of reviewing the ethical standards of the proposed clinical research, whereas the HRECs are responsible for ensuring that the clinical research proposals that have passed the scientific review also pass the ethical review. In other words, research ethics forms the final hurdle for the execution of a sanctioned scientific clinical research in Australia. Therefore, ethics is significantly crucial to clinical researchers. The design, review, as well as the conduct of clinical research must reflect the values of justice, integrity, and beneficence, the respect for human beings, respect for the societal cultural diversity, contributing to community goals, and altruism.
Glickman, S.W., McHutchison, J.G., Peterson, E.D., Cairns, C.B., Harrington, R.A., Califf, R.M. and Schulman, K.A., 2009. Ethical and scientific implications of the globalization of clinical research. New England Journal of Medicine, 360(8), pp.816-823.
Hulley, S.B., Cummings, S.R., Browner, W.S., Grady, D.G. and Newman, T.B., 2013. Designing clinical research. Philadelphia, PA: Lippincott Williams & Wilkins.
Kotecha, J.A., Manca, D., Lambert-Lanning, A., Keshavjee, K., Drummond, N., Godwin, M., Greiver, M., Putnam, W., Lussier, M.T. and Birtwhistle, R., 2011. Ethics and privacy issues of a practice-based surveillance system Need for a national-level institutional research ethics board and consent standards. Canadian Family Physician, 57(10), pp.1165-1173.
Lederman, R., 2006. Introduction: Anxious borders between work and life in a time of bureaucratic ethics regulation. American ethnologist, 33(4), pp.477-481.
Mason, K., Laurie, G. and Smith, A.M., 2013. Mason and McCall Smith's law and medical ethics. Oxford, UK: Oxford University Press.
National Health and Medical Research Council (2016a). Why conduct a clinical trial in Australia | Australian Clinical Trials. [online] Australianclinicaltrials.gov.au. Available at: https://www.australianclinicaltrials.gov.au/industry-and-sponsors/why-conduct-clinical-trial-australia [Accessed 28 Oct. 2016].
National Health and Medical Research Council (2016b). Human Research Ethics Committees (HRECs). [online] Australianclinicaltrials.gov.au. Available at: https://www.nhmrc.gov.au/health-ethics/human-research-ethics-committees-hrecs [Accessed 28 Oct. 2016].
Petryna, A., 2009. When experiments travel: clinical trials and the global search for human subjects. Princton, NJ: Princeton University Press.
Portaluppi, F., Smolensky, M.H. and Touitou, Y., 2010. Ethics and methods for biological rhythm research on animals and human beings. Chronobiology international, 27(9-10), pp.1911-1929.
Portney, L.G. and Watkins, M.P., 2015. Foundations of clinical research: applications to practice. Philadelphia, PA: FA Davis.
World Medical Association, 2013. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. Jama, 310(20), p.2191.
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