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 provides a guide for researchers and institutions in ‘responsible research practice’. While the Code is written specifically for universities and other public sector research institutions it is also considered a valuable resource document for any organisation engaged in research. The first part of the Code is directed to providing guidance on best practice in research and the second part contains a framework for managing any breaches of the Code or misconduct in research. There are no mandatory provisions in relation to compliance with the National Statement or the Code, however, compliance is a prerequisite for access to research funding.
The NHMRC also has obligations and responsibilities imposed under the Prohibition of Human Cloning for Reproduction and Regulation of Human Embryo Research Amendment Act 2006, the Prohibition of Human Cloning for Reproduction Act 2002 and the Research Involving Human Embryo Act 2002. 14
The Privacy Act
The Privacy Act 1988 (Cth) protects the privacy of ‘personal information’15 (particularly ‘sensitive information’ which includes ‘health information’), 16 collected or held by the Commonwealth or the private sector. Privacy legislation attempts to balance the interests of the public in having the privacy of their information protected against the interests of the public in having information available. In this context the issue is whether, and how, personal/sensitive information can be legally acquired and made available for the purpose of research. The privacy legislation existing at Commonwealth, state and territory levels establishes privacy principles17 for the collection, storage, disclosure, access, accuracy, security and use of personal information (refer to Chapter 4, Privacy and confidentiality of patient information). These legislative provisions are applicable to personal/sensitive information collected as part of the research process and are reinforced by the National Statement, the Code and the guidelines which also specifically address the requirements in relation to privacy of participant information. The Federal Privacy Commissioner has given approval to two sets of guidelines (issued by the NHMRC) that must be adhered to in circumstances where researchers are handling health information for research purposes without the consent of the individual to whom the information belongs. The guidelines, which aim to protect the privacy of participant information elicited during medical research are included under ss 95 and 95A of the Privacy Act 1988 (Cth). The privacy and medical research guideline under s 95 sets out the procedure for human research ethics committees and researchers when personal information is disclosed for research purposes from Commonwealth agencies. Section 95A deals with access to health information for medical research where consent cannot be obtained. The guidelines require that the public interest in the research outweighs the public interest in the protection of the privacy. 18
In addition, legislation in a number of states and territories authorises statutory guidelines similar to those provided by the NHMRC in relation to the disclosure of personal information for the purpose of medical research. 19 It is also common practice for individual researchers, research institutions and those involved in the collection of data to be bound by contractual terms protecting privacy of information as part of their employment contract, funding agreement or research access agreement.
Guardianship legislation
Guardianship legislation in a number of the jurisdictions provides the process by which consent, in relation to participation in medical research of individuals without legal capacity, may be obtained (refer to Chapter 6, Consent). As the legislation differs between the states and territories medical researchers must familiarise themselves with the legal requirements in the jurisdiction in which they are practising.
Clinical Trials
A clinical trial is that part of a research study which aims to discover whether a particular intervention, based on preliminary data, is actually beneficial. Clinical trials are conducted under two schemes for the purpose of researching therapeutic goods. These schemes are the Clinical Trial Exemption (CTX) Scheme and the Clinical Trial Notification (CTN) Scheme. The schemes are utilised when there is a proposal to introduce a drug or drug product, which is not entered in the Australian Register of Therapeutic Goods. This may include where there is a new drug, or a new formulation for, or new use of, an existing drug, or a new route for an existing drug. All CTX and CTN schemes are legally required to have an Australian sponsor that will be the person, body, or institution which takes overall responsibility for the conduct of a trial. The sponsor therefore is responsible not only for ensuring that the trial complies with any legal obligations but also in assuming liability in the event of injury or damage.
The CTX scheme, which is the process for approval or rejection, requires the Therapeutic Goods Administration to evaluate the data and assess safety issues in relation to the proposed guidelines for usage of the new drug and/or drug product. The Human Research Ethics Committee is then required to consider the proposed clinical trial protocols in light of any information supplied by the Therapeutic Goods Administration and the Australian sponsor. In the CTN trial the Human Research Ethics Committee reviews the data on the new drug/drug product and, after giving approval for the trial, the Australian sponsor notifies the Therapeutic Goods Administration.
Legal issues
The researcher conducting medical/clinical research involving human subjects has an obligation to protect the research participants from harm. The type of harm may include an injury due to the negligent conduct of the researcher, the failure of the researcher to obtain a legally valid consent from the participants, and/or a failure of the researcher to protect the privacy and confidentiality of the participant’s information. In addition, in relation to professionals such as medical practitioners, there are professional disciplinary consequences for engaging in research in a way that is indicative of professional misconduct and/or unsatisfactory professional conduct. The following provides some examples of the legal actions that may arise for a medical practitioner engaged in research.
Negligence
A research participant may initiate an action in negligence against the researcher on the grounds that the researcher, researching institution, or ethical review body did something or failed to do something that amounted to a breach of the duty of care owed to the research participant and, as a result, the participant sustained a damage. In the same way that a medical practitioner owes a duty of care to their patients (as persons they can reasonably foresee) so the research participant is owed a duty of care by those carrying out, supervising or supporting the research. As previously stated, the determination as to whether there was a breach of that duty would be considered in light of whether the research was conducted in a manner consistent with peer professional opinion as to what was competent, reasonable and accepted research practice. This standard is set in the civil liability legislation in each of the states and territories. The significance of the National Standard, the Code and any relevant guidelines and policies to determinations as to the standard can not be overemphasised (refer to Chapter 5, Negligence).
Trespass to the person
The law requires that before undertaking any medical treatment a legally valid consent is obtained by the medical practitioner from the patient or from their substitute decision-maker. The same expectation applies prior to the inclusion of a participant in a research project or clinical trial. To be legally valid the consent must be voluntary, cover the specific project or trial, and be informed. In addition, the participant must have the capacity to give a legally valid consent (refer to Chapter 6, consent).
In relation to the requirement of voluntariness it is important that any medical practitioner, or medical student who is in a therapeutic relationship with a patient ensures the patient understands that their participation, or non-participation, in the research will have no impact on their medical treatment. That is, the role of the medical practitioner, as the patient’s treating physician, is separate and distinct from their role as researcher. A practical way of dealing with this issue is for the medical practitioner to remain at ‘arms length’ from the activity of obtaining consent when there is any potential for confusion of roles by the patient. The patient must be clear that there will be neither a benefit nor disadvantage to their voluntary decision as to whether or not they participate in the research project or clinical trial.
The law requires that the consent covers the specifics of the research project or clinical trial. Though the research participant has consented to one part of a project or trial that does not mean they have consented to other parts or activities that were not included in the original consent. For example, has the participant consented to the use of their information after the data is collected, have they consented to the use of their human tissue at a later date or for a different study? In relation to biobanks, it has been suggested that there may be, in future, the use of levels of consent such as: 20
LEVEL 1: limited or specific consent for use in a specific and defined research project
LEVEL 2: qualified consent where the participant gives consent to the initial intervention and wishes to be contacted in the future if there is any extension or substantial variation from the initial project
LEVEL 3: full or unspecified consent which would operate as consent to multiple research purposes into the future.
The law also requires that the researcher fully and frankly discloses information to potential research participants prior to obtaining their consent. In the case of Halushka v University of Saskatchewan21 the patient was assured that the experimental drug had been used previously and found to be safe. This information was not correct and, after consenting to participate in the research and taking the drug the patient suffered a cardiac arrest. The court found that as there had not been ‘full and frank’ disclosure of the facts the researchers were liable for the damage. This decision is consistent with the findings in Weiss v Solomon. 22 In this case the court held the researcher and the hospital liable where the participant had not been informed of the risks associated and known about the experimental treatment.
The researcher must obtain consent from the participant with the capacity to give a legally valid consent or some person or body that has the legal authority to consent on their behalf. It is clear that all adults (over the age of 18 years) of sound mind have the legal capacity to give consent to participate in a research project or clinical trial.
The situation in relation to children is similar to that which applies in obtaining a consent prior to medical treatment. That is, does the child have a level of maturity so as to understand the nature of the research and are they able to voluntarily communicate a preferred choice. 23 This is referred to as ‘Gillick competent’. While there is legislation in the Australian Capital Territory, 24 New South Wales, 25 South Australia26 and Victoria27 that pertains to a child’s capacity to consent to medical treatment the provisions are not applicable to research. It is preferable if the child is of an age to understand the nature of a research project or trial that they are included in any discussion prior to obtaining their consent and any refusal should be considered very seriously. It would appear that where a child lacks capacity their refusal to consent might be overridden by the parent or the legal guardian where their opinion is considered to be in the ‘best interest’ of the child.
Impaired capacity
When an adult has impaired capacity due to an intellectual disability, mental disorder, acquired brain injury, physical disability or dementia it is imperative that they are assessed in light of whether they, as an individual, are competent in relation to this particular project or trial at this particular time to consent. If they are assessed as being incompetent to give a legally valid consent to participate in the research then consent must be sought from a person or body that has a legal authority to give consent on their behalf. The legislation in each of the jurisdictions identifies the person or entity that may give consent to experimental healthcare or medical research and the process by which this consent may be obtained. As an example, the Victorian Guardianship and Administration Act 1986 sets out the legal process when medical research can be performed on an adult who has no capacity to give consent on their own behalf. The 2006 amendments to this legislation require that the research project, for which purpose the procedure is being performed, must have been approved by the Victorian Human Research Ethics Committee. After this approval has been obtained only a registered medical practitioner or dental practitioner can perform or supervise the medical research procedure on the particular patient under the Act, and only if satisfied that the statutory criteria are met in the case of this particular patient. In New South Wales the Guardianship Tribunal, and in Queensland the Civil and Administrative Tribunal, must approve the clinical research or clinical trial before a person who is incapable of giving consent can participate. Approval of the relevant ethics committee is required prior to the application. The approval of the respective tribunals of the clinical research or trial does not operate as consent to the participation of the particular person. In Western Australia the Guardianship and Administration Act 1990 does not permit a legal guardian or next-of-kin to consent on behalf of an adult who is not competent to consent on their own behalf to participation in research. Participation of such an adult is only permitted if the medical professional considers that participation of the adult is in their ‘best interest’. Once again, it can be seen that there are significant differences between the individual states and territories. Medical practitioners and medical students must therefore familiarise themselves with the legal requirements in the jurisdiction in which they are studying or practising.
Professional misconduct
Allegations of professional misconduct may arise in circumstances in which a researcher, regulated with a professional authority, does something or fails to do something which amounts to ‘notifiable conduct’, ‘unsatisfactory professional conduct’ or ‘professional misconduct’. 28 For example, the allegations of research fraud bought against Dr William McBride before the New South Wales Medical Tribunal in 1989 resulted in an order to have his name removed from the Medical Register. 29
SCENARIO AND ACTIVITY
This is a literature search and reflective exercise therefore there is no answer provided.
Students are invited to locate information on a study conducted by a medical practitioner in the National Women’s Hospital in Auckland New Zealand. This study commenced in 1966 and ran for almost 2 decades. The project was designed to show that carcinoma in situ in the cervix was not a precursor to invasive carcinoma. A judicial inquiry was ordered by the Ministry of Health ‘Committee of Inquiry into Allegations Concerning the Treatment of Cervical Cancer at the National Women’s Hospital and into Other Related Matters’ (the Cartwright Inquiry). This study will be very easy to locate on any research or research ethics database. The following articles may be of assistance in getting started: Heslop, B, ‘All about research — looking back at the 1987 Cervical Cancer Inquiry’, NZ Med J (2004) August (6); Paul, C, ‘Internal and external morality of medicine: lessons from New Zealand’ BMJ (2000) February 320 (7233) 499–503.
Consider the legal issues and actions that potentially and actually arise from the conduct of the researcher and the institution.
To ensure that you have identified and understood the key points of this chapter please answer the following questions.
1 Where on the web would you locate the National Health and Medical Council Act 1992 (Cth)?
2 In the National Statement on Ethical Conduct in Human Research (2007) what are the guidelines in relation to protecting the privacy of participant information, protecting vulnerable groups, obtaining consent from persons with impaired capacity, and obtaining consent from children?
3 Once you have read the Australian Code for the Responsible Conduct of Research identify the process for managing breaches of the Code and research misconduct.
4 Identify the elements in a negligence action and describe how they may be relevant to a research participant who is injured as a result of their participation in a clinical trial.
5 Identify the legislation in your state or territory which empowers a person or body to consent for an adult with no capacity to give a legally valid consent to participate in a clinical trial or research project. What are the requirements under that legislation?
Further reading
Bennett, B.; Deakin, C., ‘Registration of clinical trials: challenges for global regulation’, JLM 82 (2009) 17.
Chalmers, D.; Nicol, D., ‘Human genetic research databases and biobanks: towards uniform terminology and Australia Best Practice’, JLM 15 (2008) 538.
Parker, M., ‘Naked regulators: Moral pluralism, deliberative democracy and authoritative regulation of human embryonic stem cell (hESC) research’, JLM 16 (2009) 580.
Endnotes
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6. Kerridge, I.; Lowe, M.; McPhee, J., Ethics and Law for the Health Professions. 2nd edn (2005) The Federation Press, Sydney; at 528. 12 Research 291.
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29 As discussed in; Kerridge, I.; Lowe, M.; McPhee, J., Ethics and Law for the Health Professionals. 2nd ed (2007) The Federation Press, Sydney; p 537.
