EXPLANATORY STATEMENT
STATUTORY RULES No 315 of 1988
EPIDEMIOLOGICAL STUDIES (CONFIDENTIALITY) ACT 1981
EPIDEMIOLOGICAL STUDIES (CONFIDENTIALITY) REGULATIONS (AMENDMENT)
Section 13 of the Epidemiological Studies (Confidentiality) Act 1981 (the Act) provides that the Governor-General may make regulations, not inconsistent with the Act, prescribing all matters required or permitted by the Act to be prescribed or necessary or convenient to be prescribed for carrying out or giving effect to the Act.
The purpose of the Act is to provide for the confidentiality of information collected in certain epidemiological studies conducted by, or on behalf of, the Commonwealth.
Subsection 3(1) of the Act defines “prescribed study” to mean the Vietnam Veterans Study or a Commonwealth epidemiological study which is declared by the regulations to be a study to which the Act applies. “Commonwealth epidemiological study” is defined to be an epidemiological study conducted by, or on behalf of, the Commonwealth.
Nine studies have already been declared to be epidemiological studies to which the Act applies. The Regulation amends Regulation 3 of the Epidemiological Studies (Confidentiality) Regulations to declare a further study to be an epidemiological study to which the Act applies. The purpose of the study is to determine the extent of the Human Immunodeficiency Virus in intravenous drug users. The study is being conducted on behalf of the Commonwealth by the Commonwealth AIDS Research Grants Committee Working Party on AIDS in Intravenous Drug Users.
The study involves the interviewing of intravenous drug users. In order to obtain the co-operation of participants, it is imperative that they are able to be assured of complete confidentiality. Prescribing of the study will mean that it is an offence under the Act for a person involved in the conduct of a study to divulge or publish information that would enable the identification of individual participants.
The Regulation came into operation on the date of its notification in the Gazette.
Overview
The Epidemiological Studies (Confidentiality) Act 1981 was enacted to address the need for protecting the confidentiality of information gathered in specific epidemiological studies conducted by or on behalf of the Commonwealth. The Act was introduced to ensure that the privacy and identity of participants in these studies are safeguarded, thereby encouraging individuals to provide honest and complete information without fear of disclosure. The policy objective of the Act is to facilitate the conduct of epidemiological research by guaranteeing the confidentiality of participant data. The regulations, including those amended in 1997, play a crucial role in identifying which studies are covered under the Act, thereby extending its protective provisions to new studies as they are declared. The Epidemiological Studies (Confidentiality) Regulations (Amendment) further extends the confidentiality provisions to a study focused on determining the extent of Human Immunodeficiency Virus among intravenous drug users, conducted by the Commonwealth AIDS Research Grants Committee Working Party on AIDS in Intravenous Drug Users. This amendment ensures that participants in this study are assured of confidentiality, enabling the collection of accurate and reliable data.
Scope and Application
The Epidemiological Studies (Confidentiality) Act 1981 applies to specific epidemiological studies conducted by or on behalf of the Commonwealth. The Act ensures the confidentiality of information collected in these studies, with a particular focus on protecting the identity of individual participants. The Act's application extends to any study defined as a "prescribed study," which includes the Vietnam Veterans Study and any study declared by regulations to fall under the Act's purview. The Act’s regulations can extend its application to new studies, such as the study on the extent of Human Immunodeficiency Virus in intravenous drug users, conducted by the Commonwealth AIDS Research Grants Committee Working Party on AIDS in Intravenous Drug Users. Once a study is prescribed under the Act, it becomes an offence to divulge or publish information that would identify individual participants. This legislative framework is designed to facilitate the ethical and effective conduct of epidemiological research by ensuring participant confidentiality. The Act applies nationally across Australia, given its Commonwealth nature, and its scope can be expanded through the regulations to include additional studies as necessary.
Key Provisions
The Epidemiological Studies (Confidentiality) Act 1981 (the Act) is designed to ensure that information collected in specific epidemiological studies conducted by or on behalf of the Commonwealth is kept confidential. Under Section 13 of the Act, the Governor-General has the authority to create regulations that are necessary or convenient for the implementation of the Act. These regulations must not contradict the provisions of the Act itself.
The Act specifies that a “prescribed study” (Section 3(1)) refers to either the Vietnam Veterans Study or any Commonwealth epidemiological study declared by regulation to be subject to the Act. The term “Commonwealth epidemiological study” is defined as an epidemiological study conducted by or on behalf of the Commonwealth. Currently, nine studies have already been declared as studies to which the Act applies. The Epidemiological Studies (Confidentiality) Regulations (Amendment) amends Regulation 3 to include an additional study that aims to determine the prevalence of the Human Immunodeficiency Virus (HIV) among intravenous drug users. This study is being conducted on behalf of the Commonwealth by the Commonwealth AIDS Research Grants Committee Working Party on AIDS in Intravenous Drug Users.
Participation in this study involves interviewing intravenous drug users. To encourage genuine and honest responses, it is crucial that participants are assured of their complete confidentiality. By declaring this study as a prescribed study, it becomes an offence under the Act for any person involved in the study to disclose or publish any information that could potentially identify individual participants. This regulation came into effect on the date it was notified in the Gazette.
The obligations imposed by the Act on the parties involved in the study are stringent. Those conducting the study must ensure that all information gathered remains confidential and is not shared or published in a way that could identify participants. This requirement is critical to maintain the integrity of the study and to protect the privacy of the individuals involved. Failure to comply with these obligations can result in severe consequences, including both civil and criminal penalties. Under the Act, the penalties for breaching the confidentiality provisions can be substantial, reflecting the importance of protecting the personal information of study participants.