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Guidelines and Policies

Challenging Ethical Issues in Contemporary Research on Human Beings Cth
NHMRC
An analysis of 10 different research projects and the ethical issues that arise therein, regarding such topics as consent, privacy and confidentiality, patient safety and welfare etc.

Declaration of Helsinki – Ethical Principles for Medical Research Involving Humans International
World Medical Association
Provides physicians with recommendations to guide them in biomedical research involving humans.

Embryo Research Licencing Committee Information Kit Cth
NHMRC
Provides information for licence holders and ethics committees on embryo research licensing.

Guidelines for Ethical Review of Research Proposals for Human Somatic Cell Gene Therapy and Related Therapies (1999) Cth
NHMRC
Provides guidance to both ethical committees and those preparing ethics submissions on somatic cell gene therapy.

Information Sheet (Private Sector) 9 – 2001: Handling Health Information for Research and Management Cth Private
NHMRC
Guidelines on when information collected can be used for research without the patient’s consent.

National Statement on Ethical Conduct in Human Research Cth
NHMRC
A series of guidelines re research: eg research involving tissue samples, genetics or stem cells. Participation by children, pregnant women, people with an intellectual disability or mental illness.

Research ethics oversight of biomedical clinical trials Canada
Canadian General Standards Board
CAN/CGSB 191.1-2013

Research Governance in NSW Public Health Organisations NSW
NSW Health
This guideline summarises the principles, standards and requirements for the responsible conduct of quality research. It also clarifies the responsibilities and accountabilities of key parties involved in research taking place in NSW Public Health Organisations.

Values and Ethics – Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research Cth
NHMRC
Guidelines for ethical research on Aboriginal and Torres Strait Islander People, in line with guidance from Aboriginal people around a framework of Aboriginal and Torres Strait Islander Principles.

Moral science: Protecting participants in human science research [PDF]
Presidential Commission for the Study of Bioethical Issues (2011)

International ethical guidelines for biomedical research involving human subjects
World Health Organization and Council for International Organizations of Medical Sciences (1993)

Cases

Rogers v Whitaker (1992) 175 CLR 479 Cth
It would be expected that a reasonable person, when considering whether to participate in a research project, would want far more information than if only therapeutic treatment was involved.

Halushka v University of Saskatchewan (1965) 53 DLR 436 CAN
The patient had been wrongly reassured that the experimental drug was safe and had been used many times before, when this was not true. Halushka went into a complete cardiac arrest following administration of the drug. The court found that for consent for research to be valid there had to be a ‘full and frank’ disclosure of the facts; that had not occurred in this case. Halushka was awarded $22,500 in damages.

Weiss v Solomon [1989] RJQ 731 CAN
The heirs of a research subject (Weiss), who had died in the course of participating in a non-therapeutic trial, successfully sued the principal investigator and the hospital. The court held that both the researcher and the hospital, through its research ethics committee, were liable because they did not adequately warn Weiss of the risks associated with the treatment.

Hassan v Minister for Health (No 2) [2008] WASCA 149 WA
The woman was admitted to hospital for an induced labour to remove her foetus, which had died in utero. The patient was invited to participate in a clinical trial of prostaglandin, in the form of the drug misoprostol. The patient had a massive haemorrhage and a total hysterectomy was performed to stop the bleeding but the patient was left sterile. The plaintiff alleged that the doctor had failed to warn her of the risk that she might have to have a hysterectomy by choosing to induce labour, and failed to inform her of alternative procedures such as dilatation and evacuation (D&E). Both the trial judge and the Court of Appeal agreed there was a duty of care but they did not find that there had been a breach of that duty which had caused the hysterectomy. The hysterectomy was found to have been an unavoidable complication, given the patient’s obstetric history.

South Eastern Sydney Area Health Service v King [2006] NSWCA 2 NSW
Case concerned a 13-year-old patient who had become a quadriplegic as a result of a radical and experimental treat- ment involving radiotherapy, systemic chemotherapy and intrathecal chemotherapy. The area health service was found to be negligent as the treating doctor was unaware that the protocol for the treatment had been amended.

Re MP [2006] QGAAT 86 QLD
A 38-year-old man with a rare genetic condition accepted treatment for this genetic condition was replacement therapy with large doses of oral u. The patient’s general practitioner sought approval for the treatment as ‘experimental’ treatment because it had not been approved for such use by the Therapeutic Goods Administration. The Guardianship and Administration Tribunal (now part of QCAT) found that the treatment was not experimental merely because it had not been approved by the Therapeutic Goods Administration. The drug was the only treatment available and it had been used for many years to treat the patient’s condition.

Re application by Hope [2012] QCAT 191 QLD
A doctor wished to get approval for a study for patients with head injuries, testing the effectiveness of an ultrasound scan rather than computerised tomography (CT) scans, to identify dangerous increases in cranial pressure after a head injury. The Tribunal found that the research was ‘clinical research’ rather than ‘special medical research or experimental health care’.

Re Baby A [2008] FamCA 417 Cth
Baby A had been born with a rare and fatal metabolic disorder that had no known treatment. Her parents and treatment team wished for her to be treated with an experimental drug known as drug X. The drug had not been tested on humans but had given promising results in mice. The judge doubted whether approval was neces- sary as a special treatment. The treatment was clearly the only option for the child, even though no one could say what its effects would be with certainty. Nevertheless, Dessau J proceeded on the basis that the treatment did require approval as the judge wished for there to be no doubt that the parents had the power to consent to the treatment. The treatment was approved and a declaration was made that the parents were empowered to consent to it.

Simms v Simms [2002] EWHC 2734 (Fam) UK
This case concerned both an 18-year-old and a 16-year-old sufferer of vCJD. The parents of the patients sought a declaration that it would be in the patients’ best interests for them to be treated with Pentosan Polysulphate, a drug that was licensed for other conditions, but not for vCJD. Dame Butler-Sloss P began by examining whether the treatment was supported under the Bolam test in medical negligence and found that it was, as there was ‘a responsible body of relevant professional opinion which supports this innovative treatment’.

Traill v Medical Practitioners Board (Occupational and Business Regulation) [2006] VCAT 1920 VIC
A doctor was found guilty of unprofessional conduct for recommending and administering a number of unproven and ineffective treatments to three vulnerable patients.

Legislation

Australian Code for the Responsible Conduct of Research [PDF]    Cth
NHMRC
Guides Australian Institutions and Researchers in responsible research practices.

Privacy Act 1988 Cth
Aims to protect the privacy of personal information held by Commonwealth agencies or by the private sector. Sections 95 and 95A of the Act provide a process to resolve the conflict that may arise between the public interest in privacy and the public interest in research.

Health Records and Information Privacy Act 2002 NSW
Exceptions for medical research without consent.

Statutory guidelines for controlling the disclosure for research under the Health Records and Information Privacy Act 2002 NSW [PDF]

Papers, Reports and Books

Changing perspectives in biobank research: from individual rights to concerns about public health regarding the return of results
Forsberg, JS, MG Hansson, et al (2009) 17 (12) European Journal of Human Genetics 1544-9

Enrolling pregnant women in research – lessons from the H1N1 influenza pandemic
Goldkind, SF, L Sahin, et al (2010) 362(24) New England Journal of Medicine 2241-43

The ethics of obtaining consent in labour for research
Rachel Reid et al (2011) 51 (6) Australian and New Zealand Journal of Obstetrics and Gynaecology 485–492

The rights of patients in research
Goodare, H and R Smith (1995) 310 British Medical Journal 1277-8

Protection of patient’s rights to privacy
International Committee of Medical Journal Editors (1995) 311 British Medical Journal 1272

Medical data: does patient privacy trump access for research?
Adrian O’Dowd (2013) British Medical Journal Published online 11 September 2013

Uniform requirements for manuscripts submitted to biomedical journals: Writing and editing for biomedical publication [PDF]
International Committee of Medical Journal Editors (2007)

From single biobanks to international networks: developing e-governance
Kaye, J (2011) 130 (3) Human Genetics 377-82

The rise of litigation in human subjects research
Mello, MM, dM Studdert, et al (2003) 139 (1) Annals Internal Medicine 40-5

Privacy and the use of health data for research
O’Keefe, CM and CJ Connolly (2010)  193 (9) Medical Journal of Australia 537-41

Protecting vulnerable research subjects in critical care trials: enhancing the informed consent process and recommendations for safeguards
Silverman, H (2011) 1 (1) Annals of Intensive Care 8

Law and medical practice: Rights, duties, claims and defences.
Skene, L (2004) Sydney, LexisNexis Butterworths

Legal rights in human bodies, body parts and tissue
Skene, L (2007) 4 (2) Journal of Bioethical Inquiry 129-33

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