EXPLANATORY STATEMENT
STATUTORY RULES 1988 NO. 204
Issued by Authority of the Minister for Community Services and Health
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.
The Regulations prescribe four studies to be epidemiological studies to which the Act applies. The four studies, which are being conducted on behalf of the Commonwealth by the National Campaign Against Drug Abuse, are -
• a survey of illicit drug users on patterns and predictors
• an evaluation of cocaine usage in high income groups
• the determination of the extent and nature of cocaine use by illicit drug users and upper economic strata individuals
• the illicit drug charge database project.
The study on patterns and predictors involves interviewing users of illicit drugs to identify the social learning framework for current drug use and possible future use.
The study of cocaine usage in high income groups will estimate the demographics of cocaine users in university and tertiary education institute staff and stock market industry groups to assist in the understanding of the characteristics of cocaine users in Australia.
The study of cocaine usage by illicit drugs users and upper economic strata individuals will determine the extent and nature of cocaine usage by these two groups and will assess recruitment and supply factors and the attitudes of identified users.
The illicit drug charge database project will establish a database, using court records in Western Australia, to determine changes over time with respect to the number of charges and offences, the type and the quantity of drugs and the result of court cases. The study will aim to determine how those changes over time are affected by changes in government policies, treatment practices and penalties.
The Regulations came into operation on the date of their notification in the Gazette.
Overview
The Epidemiological Studies (Confidentiality) Act 1981 was enacted by the Parliament of Australia to address the need for confidentiality in information collected during epidemiological studies conducted by or on behalf of the Commonwealth. This legislation ensures that sensitive data gathered in such studies, particularly those relating to drug use and health, remains protected and is not disclosed without proper authority. The Act was introduced to safeguard the privacy of individuals participating in these studies and to maintain the integrity of the research. The policy objective is to enable comprehensive and honest responses from participants by assuring them that their information will be handled confidentially, thereby facilitating more accurate and reliable epidemiological data.
Scope and Application
The Epidemiological Studies (Confidentiality) Regulations (Amendment) govern the confidentiality of information obtained in specific epidemiological studies conducted by, or on behalf of, the Commonwealth. The Act applies to four particular studies, each being overseen by the National Campaign Against Drug Abuse. These studies include a survey of illicit drug users on patterns and predictors, an evaluation of cocaine usage in high income groups, the determination of the extent and nature of cocaine use by illicit drug users and upper economic strata individuals, and the illicit drug charge database project. These studies aim to gather comprehensive data on drug use patterns, demographics, and the effects of government policies and penalties on drug-related charges and offences. The confidentiality provisions of the Act are designed to protect the sensitive information collected from these studies, ensuring that it is not disclosed without proper authorisation. The Act’s scope is confined to these specific studies as defined by the regulations, and it applies to any person or entity involved in the collection, handling, or dissemination of the study data.
Key Provisions
The Epidemiological Studies (Confidentiality) Regulations (Amendment) Statutory Rules 1988 No. 204 provide amendments to the existing regulations under the Epidemiological Studies (Confidentiality) Act 1981 (the Act). Section 13 of the Act allows the Governor-General to make regulations, consistent with the Act, to prescribe necessary matters for carrying out or giving effect to the Act. These regulations specifically address four epidemiological studies being conducted on behalf of the Commonwealth by the National Campaign Against Drug Abuse. These studies include a survey of illicit drug users on patterns and predictors, an evaluation of cocaine usage in high-income groups, the determination of the extent and nature of cocaine use by illicit drug users and upper economic strata individuals, and the illicit drug charge database project. The regulations prescribe these studies as prescribed studies under the Act, ensuring the confidentiality of information collected in these studies.
The Act imposes several obligations and requirements on the parties and entities involved in the epidemiological studies. Firstly, the studies must be conducted in accordance with the regulations and the Act, ensuring the confidentiality of the collected information. The studies must comply with the prescribed protocols to maintain the integrity and security of the data. Secondly, researchers and personnel involved in the studies are required to handle the collected information with utmost care and to use it solely for the purposes of the study. They must not disclose any personal information without proper authorisation. Thirdly, the regulations require the establishment of appropriate measures to safeguard the data, including secure storage, access controls, and data encryption. Furthermore, researchers must obtain informed consent from participants and ensure that the studies adhere to ethical standards.
Failure to comply with the provisions of the Act and the regulations may result in offences, penalties, or civil and criminal consequences. Breaches of confidentiality may lead to civil actions for damages, where affected individuals can seek compensation for any harm caused by the unauthorised disclosure of personal information. Additionally, the Act may provide for criminal penalties, including fines and imprisonment, for those who intentionally or recklessly breach the confidentiality provisions. The maximum penalties for such offences can vary depending on the severity of the breach and the specific provisions of the Act. It is important for parties and entities governed by the Act to adhere to the confidentiality requirements to avoid legal repercussions and to maintain public trust in epidemiological research.