Epidemiological Studies (Confidentiality) Act 1981

The Act builds on several defined terms that together determine the scope of the secrecy obligations.

Prescribed study is the trigger. It means either the Vietnam Veterans Study or a Commonwealth epidemiological study declared by the regulations to be a study to which the Act applies (section 3(1)). The Vietnam Veterans Study is defined by reference to its start date (1980) and the population it covers: members of the Defence Force who served between 1 January 1962 and 31 December 1972 (whether or not they served in Vietnam) and Australian Public Service members who served in Vietnam in that same period. Once a study is declared, the full regime applies.

Epidemiological study is defined very broadly. It includes the study of the incidence or distribution of a disease, a physical or mental state, or a condition, circumstance, occurrence, activity, behaviour, course of conduct, or state of affairs that is or may be disadvantageous to the person concerned or to the community, as well as the factors responsible for such incidence or distribution. It also includes a series of such studies. This definition captures not only classic disease‑mapping research but also studies of social or behavioural factors, as long as they are potentially disadvantageous.

Commonwealth epidemiological study narrows the field to studies conducted by or on behalf of the Commonwealth. Studies run entirely by state governments or private entities are not covered unless they are conducted on behalf of the Commonwealth.

Document is defined extremely broadly: any record of information, however recorded or stored, in written or printed form, on film, by electronic means or otherwise, and includes x‑rays and photographic images.

Court includes any tribunal, authority, or person having power to require production of documents or answering questions, but expressly excludes the Commonwealth Ombudsman. This means the Ombudsman can still compel disclosure of study documents and information, and the Act does not prevent that.

Person who has assisted, or is assisting, in the conduct of an epidemiological study is defined in section 3(2). It includes a person who has conducted or is conducting the study, or has supervised or is supervising its conduct. It does not include a person who assisted only because they were or are one of the subjects of the study, or because they provided information about a subject (including themselves). So study participants and informants are not caught by the secrecy obligations, but researchers, data entry staff, analysts, and administrative personnel are. The Act expressly extends to state public servants, corporate employees, and contractors under section 9.

Information concerning the affairs of a person is also broadly defined. It includes information as to the existence or non‑existence of a document concerning the person, and information relating to the whereabouts of such a document. Under section 3(4), it extends to deceased persons unless the contrary intention appears. This means the secrecy protection continues after the subject dies.

The Act primarily affects individuals and organisations involved in the conduct of a prescribed epidemiological study. That includes the researchers, epidemiologists, statisticians, data managers, interviewers, laboratory staff, and administrative personnel who handle personal information as part of the study. Because the definition of “assisting” is broad and extends to supervisors and those who have ever assisted, anyone who has ever worked on the study in any capacity that involved access to personal information is bound, even after they leave the study or after the study ends. Section 9 makes clear that state public servants, employees of corporations, and independent contractors are all covered, as are unpaid volunteers. This means a university employee, a private research contractor, or a state health department officer seconded to a Commonwealth study is subject to the same criminal penalties as a Commonwealth public servant.

The subjects of the study are affected differently. They are not bound by the secrecy obligations themselves, but their personal information is protected by the Act. They have a right under section 7(b) to obtain information that concerns only themselves, and they can consent to information about them being given to others (section 7(c)). They cannot, however, compel the release of information about other subjects.

The Minister responsible for the study is given a specific power under section 5: to authorise in writing the giving of access to documents prepared or obtained in one prescribed study to persons assisting in another prescribed study. This creates a limited doorway for data sharing between studies, but it is discretionary and not a right.

Courts and tribunals are directly affected by section 8. They cannot require a person who assisted in a prescribed study to produce a document or divulge information concerning the affairs of another person. This overrides the usual powers of courts to compel evidence, which is a significant limitation on the justice system. However, the Commonwealth Ombudsman is excluded from the definition of “court”, so the Ombudsman can still compel access.

Regulations made under section 13 can expand the class of persons affected by declaring additional studies to be prescribed studies, thereby subjecting new cohorts of researchers and subjects to the regime.

The central duty is in section 4: a person who has assisted in a prescribed study must not, directly or indirectly, make a record of, or divulge or communicate to any person, any information concerning the affairs of another person acquired by virtue of that assistance. This applies except for the purpose of the conduct of that study. The same duty applies under section 6 to documents accessed under a Ministerial authorisation across studies: the information may only be used for the conduct of either the source study or the receiving study.

The duty is not absolute. Section 7 provides exceptions: the information may be given to the person who supplied it (for example, a doctor or hospital that provided data), to the person it concerns if it relates to only one person, to any of several persons with the consent of the others, or to a nominee of any such person. This allows researchers to return information to study subjects or their nominees, but only if the information relates solely to that person or with consent of others concerned.

Section 11 creates a right to publish conclusions based on the study, statistics derived from it, or particulars of procedures used. However, the publication must not enable the identification of any individual, including a deceased person. This right includes communication to a court or production of documents to a court, which is otherwise prohibited under section 8. So aggregated results can be presented in legal proceedings.

Section 5 gives the Minister a discretionary power to authorise access to documents from one prescribed study to another. This creates a defence to a prosecution under section 4 or 6 if the access was given in accordance with that authorisation. The note to section 5 clarifies that the defendant bears an evidential burden in establishing the authorisation defence, meaning they must point to evidence that the access was authorised.

Section 10 imposes a duty on a person who is or is about to become a person to whom section 4 or 6 applies to take an oath, affirmation, or declaration of secrecy if required by the Minister. Failure to do so is an offence with the same penalty: imprisonment for six months or ten penalty units.

Section 8 gives persons who assisted in a prescribed study a right to refuse to comply with a court order for production or disclosure of personal information or documents concerning the affairs of another person. This right is not discretionary: the Act says the person “shall not be required” to produce or divulge. It overrides any other law or court order.

Breach of the primary secrecy duties in sections 4, 6, or the oath requirement in section 10 carries a maximum penalty of imprisonment for six months or ten penalty units. Ten penalty units under the Crimes Act 1914 (Cth) is currently $2,200 (one penalty unit being $220 as of 2024), but the Act itself does not specify the dollar amount; it refers to the penalty unit concept defined in the Crimes Act. The Act does not create any civil penalties, injunctions, or disciplinary measures; enforcement is entirely through the criminal law.

Chapter 2 of the Criminal Code applies to all offences against this Act (section 3A). This imports the default fault elements: for a physical element consisting of conduct, intention is required; for a physical element consisting of a circumstance, recklessness is required; for a physical element consisting of a result, recklessness is required. This means a prosecutor must prove that the accused intended to make a record or communicate, and was reckless as to whether the information concerned the affairs of another person. However, the note to section 5 places an evidential burden on the defendant who seeks to rely on a Ministerial authorisation as a defence. That means the defendant must adduce or point to evidence that suggests a reasonable possibility that the access was authorised; then the prosecution must disprove it beyond reasonable doubt.

Section 10 creates an offence of failing to take an oath or declaration of secrecy when required by the Minister. The requirement can be made at any time, even before the person begins assisting. This provision can be used to ensure that all personnel who might come into contact with study data are explicitly made aware of their obligations and have formally acknowledged them under oath.

The Act does not specify who may prosecute these offences. As Commonwealth offences, they would normally be prosecuted by the Commonwealth Director of Public Prosecutions. The Act does not provide for private prosecutions. The maximum penalty of six months imprisonment means the offences are summary offences under Commonwealth law, with a two‑year limitation period (Crimes Act section 15B).

No specific enforcement powers such as search warrants, surveillance, or monitoring are provided in the Act. Enforcement relies on complaints, investigation, and subsequent prosecution.

The most significant interaction is between section 8 and the ordinary powers of courts to compel evidence. Section 8 provides that a person who has assisted in a prescribed study “shall not be required” to produce documents or divulge information concerning the affairs of another person. This overrides any subpoena, notice to produce, or court order that would otherwise compel such production or disclosure. It prevails over the Evidence Act 1995 (Cth) and any state evidence laws, and over rules of court. The only exception is the Commonwealth Ombudsman, who is excluded from the definition of “court” and therefore can still compel production. This means the Ombudsman can access study documents and information in the course of an investigation, but the study personnel cannot be forced to produce them in other legal proceedings.

The Act does not directly address the Privacy Act 1988 (Cth). The secrecy obligations in this Act are likely to be considered a specific regime that would override the Australian Privacy Principles for the purposes of a prescribed study. For example, APP 6 restricts use and disclosure of personal information but would be inconsistent with the broader disclosure prohibition in section 4 of this Act. Under section 2A of the Privacy Act, the Information Commissioner must have regard to other laws; this Act would be a specific law that allows or requires certain handling of personal information. However, researchers must still comply with the Privacy Act to the extent it is not inconsistent. Given the criminal penalties under this Act, the safer view is that the secrecy obligations in this Act take precedence over any permissive disclosure under the Privacy Act.

The Act also interacts with freedom of information laws. Documents held by a prescribed study that contain personal information concerning another person would likely be exempt from disclosure under the Freedom of Information Act 1982 (Cth) on the basis that their disclosure would contravene a secrecy provision (section 38 of the FOI Act, or the conditional exemption for personal privacy in section 47F). The Act provides no exception for FOI access.

Section 11 allows publication of conclusions, statistics, or procedures provided individuals are not identifiable. This may interact with ethical guidelines for human research, such as the National Statement on Ethical Conduct in Human Research, which also requires de‑identification before publication.

The application of Chapter 2 of the Criminal Code (section 3A) means that general criminal law principles about fault, attempt, and complicity apply. The Act itself does not create secondary offences, but the Code’s provisions on aiding, abetting, or conspiracy would apply to anyone who assists in a breach.

The source text provided does not include any amendment notes or lists of amending Acts. However, internal evidence shows that the Act has been amended at least once. Section 3A refers to “Chapter 2 of the Criminal Code” and includes a note. Chapter 2 of the Criminal Code commenced in 1995 (Criminal Code Act 1995), so section 3A must have been inserted after that date. The original 1981 Act did not contain this section. The note in section 5 about subsection 13.3(3) of the Criminal Code similarly indicates a post‑1995 insertion or amendment. Other than section 3A, the remaining sections appear to be in their original form. The penalty unit reference in sections 4, 6, and 10 replaced earlier fixed dollar amounts (originally likely “$500” or similar) when the Crimes Act was amended to introduce penalty units, but the source text shows “10 penalty units”, confirming that the Act has been updated to use the penalty units system. There are no recorded amendments that have changed the substantive scope of the secrecy provisions, the court exclusion, or the definitions, based on the text provided.

The source text does not reference any cases, and the Act has generated very little reported litigation. This is likely due to its narrow application: it applies only to a small number of studies (the Vietnam Veterans Study and any declared by regulation), and the criminal penalties act as a strong deterrent against breach. Furthermore, the persons most likely to be affected (researchers and government officials) are typically conscientious about confidentiality. Most disputes about access to study data would be resolved administratively, possibly through the Minister’s authorisation power under section 5 or by subjects seeking their own information under section 7. The exclusion of the Ombudsman from the definition of “court” means the Ombudsman can compel information, which may lead to complaints that are resolved without litigation. One possible area of litigation would be if a court attempted to enforce a subpoena against a researcher, and the researcher invoked section 8 as a defence. The court would then have to interpret whether the person was “assisting” and whether the document or information concerned “the affairs of another person”. There may also be interpretive disputes about whether a study is a “Commonwealth epidemiological study” or whether a person is “assisting”. However, no such reported cases are evident in public databases, likely because the Act’s criminal provisions and court immunity are straightforward and rarely challenged.

Several features of the Act can easily trap researchers and administrators.

The definition of “assisting” is deceptively broad. It includes anyone who has ever assisted in the conduct of the study, not just current staff. A data entry clerk who worked on the Vietnam Veterans Study for one week in 1981 is still bound for life. The only exclusion is for persons who assisted solely because they were subjects or provided information. This means that a person who helped clean the study office or performed IT support could potentially be caught if they had access to personal information.

The definition of “information concerning the affairs of a person” includes information about whether a document exists and where it is located (section 3(3)). Merely revealing that a study has a file on a particular person could be a breach. Similarly, information about deceased persons is protected (section 3(4)). Disclosure of the fact that a deceased veteran was included in the Veterans Study could be an offence.

The Act applies retrospectively. For the Vietnam Veterans Study, it covers information and documents obtained before the Act commenced (section 12(1)). For a study declared by regulation, it covers information acquired before the regulation took effect (section 12(2)). So researchers can find themselves bound by secrecy obligations for historical information they held long before any legal restriction existed.

Section 8 prevents any court from compelling production or disclosure. This is powerful but not absolute: the Ombudsman is excluded, so the Ombudsman can still compel. Also, section 8 only applies to “a person who has assisted … in the conduct of a prescribed study”. If the study is not prescribed, the protection does not apply. And if a researcher is no longer assisting, they may still be bound by section 4 (criminal secrecy) but section 8 might not protect them from a court order because they are no longer “assisting”. The wording “has assisted” might continue, but the phrase “has assisted, or is assisting” in section 8(1) suggests it includes past assistants. However, the interplay with current status is untested.

The authorisation mechanism under section 5 is narrow: it only allows access to documents from one prescribed study to another prescribed study. It does not allow sharing with non‑prescribed studies, or for purposes other than the conduct of the receiving study. And the defendant bears the evidential burden of proving access was in accordance with the authorisation. If the authorisation has any technical defect, the defence fails.

Publication under section 11 must not enable identification of an individual person, including a deceased person. This is more restrictive than many privacy laws, which usually exclude deceased persons. If a study involves a small sub‑population, such as Vietnam veterans from a particular unit, aggregated statistics might still be identifiable. Researchers must be extremely cautious.

The oath requirement under section 10 can be imposed at any time, even years after the study commenced. A person who refuses is guilty of an offence, even if they have never previously been required to take an oath.

For any person involved in a prescribed epidemiological study, compliance begins with understanding that all personal information obtained through the study is restricted. The default rule is that no record or communication of such information is permitted except for the purpose of the conduct of that same study. This means internal communications, data analysis, and publication of individual‑level data are prohibited unless they are necessary for the study itself.

The first step is to ensure that all personnel who will have any access to personal information (including contractors, casual staff, and even volunteers) are identified and, if required by the Minister, made to take an oath or declaration of secrecy under section 10. Even if not required by the Minister, it is good practice to have all staff sign a written confidentiality agreement that mirrors the statutory obligations, and to train them on the criminal penalties.

Records of personal information must be stored securely and access logged. Any sharing of data between prescribed studies must be preceded by a written authorisation from the Minister under section 5. Without that authorisation, sharing information between two prescribed studies is a criminal offence. The organisation should apply for such authorisation well in advance, and the authorisation instrument should be kept as evidence. If the information needs to be shared with a non‑prescribed study, the Act provides no mechanism; alternative de‑identification or consent pathways must be explored, but careful legal advice is needed because the Act does not provide a general exception for de‑identified data (only aggregated publication under section 11).

If a study subject requests their own information, section 7(b) allows disclosure where the information concerns only that person. If the information concerns multiple persons, all must consent under section 7(c). The organisation should establish a formal process for handling such requests, including verification of identity and ensuring that only the information relating to that person is released.

When publishing results, researchers must ensure that conclusions, statistics, or procedures are presented in a way that does not enable identification of any individual, living or deceased. This may require using statistical disclosure control techniques, such as cell suppression, for small counts. The Act does not require ethical approval, but compliance with the National Statement on Ethical Conduct in Human Research is also advisable.

If a court issues a subpoena or notice to produce for documents or information about the affairs of a study subject, the recipient should respond by invoking section 8: they are not required to produce or divulge. The organisation should have a legal procedure for responding to such processes, including promptly notifying the relevant government department or the Minister, and seeking legal advice. The documents should not be produced unless the court makes a definitive order that section 8 does not apply (which is unlikely given its plain language).

If the Ombudsman requests information, section 8 does not apply, so the request must be handled under the Ombudsman Act. The secrecy provisions in sections 4 and 6 still apply, but the Ombudsman has powers to compel. The organisation should seek legal advice and, if necessary, apply to the Minister for an authorisation to disclose, or rely on section 7 if the disclosure fits one of the exceptions.

Finally, any person who has ever assisted in a prescribed study should be aware that the obligations are lifelong. Even after leaving the study or retiring, they cannot disclose or record personal information from the study unless an exception applies. They should not keep personal notes or copies of data for personal use. Destruction of records must be done in accordance with any records authority, but even after destruction, the obligation not to divulge from memory continues.