Chapter 12. Research
Learning objectives
• understanding the importance of maintaining a standard of research practice which is consistent with the standards as provided by the National Health and Medical Research Council, the Australian Research Council, relevant legislation, policies and guidelines of Institutional Ethics Committees
• understanding the significance of accepted standards of research practice to decisions by courts as to liability in civil actions
• identifying the importance of obtaining a legally valid consent from individuals prior to their participation in research
• identifying the legal obligations in relation to privacy and confidentiality of information obtained or required for the purpose of research.
Introduction
The law is relevant to clinical research in the same way that it is relevant to clinical practice. Where medical students or medical practitioners are involved in clinical research it is important that they have an understanding of what the law requires, what the law prohibits and what the law provides by way of redress, and/or compensation. In the same way that the law applies to allegations of medical negligence, the failure of the medical practitioner to obtain a legally valid consent or to protect the privacy and confidentiality of a patient’s information, so the law also applies to the researcher and the research participants. Though there is very little case law or legislation in Australia that specifically addresses researchers, institutions supporting research, research projects or research participants, the general civil and criminal principles, obligations and requirements imposed under Australian law apply. In addition, institutions, organisations and individuals engaged in research are regulated by national guidelines, policies and codes developed to protect the quality and safety of research practices in Australia. While these guidelines, policies and codes do not have the legal impact of legislation or case law they are very significant pieces of evidence to place before the courts as benchmarks of appropriate and competent research practices. While the majority of clinical experimentation aimed at improving the quality of healthcare services is conducted on both animals and humans, it is research involving human participants that will be the focus of this chapter.
What is Research?
The National Health and Medical Research Council (NHMRC), Australian Research Council and Universities Australia have defined research as ‘original investigation undertaken to gain knowledge, understanding and insight’. 1 A broader definition is provided by the United Kingdom Research Assessment Exercise, which describes research as:
That which … includes work of direct relevance to the needs of commerce, industry and to the public and voluntary sectors; scholarship; the invention and generation of ideas, images performances, artefacts including design, where these lead to new or substantially improved insights; and the use of existing knowledge in experimental development to produce new or substantially improved materials, devices, products and processes, including design and construction. 2
While these definitions include the elements of gaining new knowledge, gaining and improving insight and improving on existing knowledge, the history of medical research in many countries has been found wanting in terms of compliance with ethical and legal standards. The Nuremberg Tribunal hearings, conducted at the end of World War II, resulted in the formulation of the Nuremberg Code consisting of ten principles that set the standards for ethical medical experimentation. 3 The Declaration of Helsinki, published by the World Medical Association in 1964 (and subsequent versions) was based on this Nuremberg Code and provided the ethical principles and values upon which national4 and international5 guidelines and statements for research involving humans were developed and applied. It is of note that despite the recognition by medical researchers of the need for compliance with the legal and ethical obligations and standards there continued to be research studies and clinical trials conducted that resulted in the injury and death of research participants.
Examples of such research include: the National Women’s Hospital (Auckland), where women unaware of their diagnosis of cervical cancer were left untreated for the purpose of observation; monitoring of the effects of non-treatment of hepatitis in groups of institutionalised children and the vaccine trials on children in the Melbourne orphanages between the 1940s and 1970s. 6 These experiments demonstrate the potential harm where researchers do not observe and abide by accepted legal and ethical standards. As noted by Rothman and Michels: 7
Exactly why codes such as the Nuremberg Code and the Declaration of Helsinki have not prevented unethical research from occurring is unclear. The answer to this question is likely to be multifactorial and may derive from the perceived inevitability of scientific progress, the aura of science, the entrenched power of medical professionals, self interest and a perceived utilitarian belief in the benefits of research.
In Australia, research conducted on humans is regulated by legislation and case law, the National Statement on Ethical Conduct in Human Research (National Statement) and the Australian Code for the Responsible Conduct of Research (the Code). It is important for medical students to understand that the National Statement and the Code in relation to research involving humans are based on, and directly referable to, ethical principles and values. Though many of the principles and elements addressed within the National Statement and the Code will be shared with the legal requirements, compliance with the legal obligations is not within the ambit of either the National Statement or the Code. This chapter therefore focuses on the legal obligations relevant to research involving humans and the legal parameters in which such research must take place.
Legislation
Legislation prohibiting cruelty to animals exists in all states and territories. In addition, New South Wales has legislation specifically directed to the use of animals for experimentation purposes. 8 The NHMRC’s Code of Practice for the Care and Use of Animals for Scientific Purposes is incorporated within the regulations under the legislation in each of the states and territories and is directed to protecting animals involved in experimentation. 9 In relation to experimentation involving human participants, however, there is no legislative equivalent to that which applies to animals.
The legislation regulating human experimentation is a combination of general and specific Acts made at Commonwealth, state and territory levels. The following is an overview of the legislation that applies to research involving humans.
National Health and Medical Research Act
The National Health and Medical Research Council Act 1992 (Cth) establishes the NHMRC in Australia and contains the council’s powers, functions and obligations. The NHMRC is an independent statutory entity that, in addition to other activities, provides national guidelines for individual and institutional researchers, research participants, human research ethics committees and those involved in conducting or reviewing research. Under s 3 (1) the object of the Act is:
to make provision for a national body to pursue activities designed:
a. to raise the standard of individual and public health throughout Australia; and
b. to foster the development of consistent health standards between various States and Territories; and
c. to foster medical research and training and public health research training throughout Australia; and
d. to foster consideration of ethical issues relating to health …’
To facilitate these objectives, the functions of the NHMRC include inquiring into, issuing guidelines on, and advising the community about:
• matters relating to the improvement of health
• the prevention, diagnosis and treatment of disease
• the provision of healthcare, public health research, medical research
• ethical issues related to health. 10
In addition to inquiring into these issues and developing and distributing guidelines, it is also part of the function of the NHMRC to advise the community, the Commonwealth, states and territories about these matters and make recommendations to the Minister11 about expenditure on public health, research and training and medical research and training.
Under s 35 (1) of the National Health and Medical Research Council Act 1992 (Cth) the NHMRC must establish the Australian Research Committee and the Australian Health Ethics Committee. The later entity advises the NHMRC on ethical issues relating to health and works to develop and provide the NHMRC with guidelines for the conduct of medical research involving humans. In 2007 the NHMRC released the National Statement on Ethical Conduct in Human Research (National Statement) and the Australian Code for the Responsible Conduct of Research (the Code). The National Statement provides guidelines and sets national standards for researchers conducting research on humans, human research ethics committees and other bodies or entities involved in the ethical review of research involving humans. The National Statement emphasises the responsibility of the institution, through which the research is being conducted, to ensure ‘quality, safety and ethical acceptability of research that they sponsor or permit to be carried out’. 12 The Code13
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