National Statement on Ethical
Conduct in Research Involving Humans
Part 14 - Epidemiological Research
Epidemiological research is concerned with the description of health and welfare in populations through the collection of data related to health and the frequency, distribution and determinants of disease in populations, with the goal of improving health. Some epidemiological research may require whole of population studies and be beyond an individual institution or organisation.
Epidemiological research is part of wider public health and health services research concerned with improvements of health and welfare in human populations and with improving the efficiency and performance of human health services. Public health and health services research are usually or often carried out with human participants, or data or biological samples from them, and provide important new knowledge that is not readily obtainable in other ways.
Public health surveillance should be distinguished from public health and epidemiological research. Its role is to monitor the health status of the community, known risk factors and emerging threats to community health. Its purpose is to facilitate a prompt, effective and corrective response. It may be carried out for reasons of disease surveillance, provision of information to government health services or to inform the development of health policy. Public health agencies generally are required or authorised by law to conduct health surveillance.
In epidemiological research, medically relevant information about individuals and groups is accumulated so those features of groups of persons may be investigated whether the information was or was not originally obtained for research purposes.
Categories of personal information
Epidemiological research includes the use of the following types of data:
Identified
Data that allow the identification of a specific individual are referred to as "identified data". Examples of identifiers may include the individual's name, date of birth or address. In particularly small sets of data even information such as a postcode may be an identifier.
Potentially identifiable (coded, re-identifiable)
Data may have identifiers removed and replaced by a code. In such cases it is possible to use the code to re-identify the person to whom the data relate so that the process of de-identification is reversible. In these cases the data are referred to as "potentially identifiable".
De-identified, (not re-identifiable, anonymous)
The process of de-identification can be irreversible if the identifiers have been removed permanently or if the data have never been identified. These data are referred to as "de-identified". It should be recognised that the term "de-identified" is used frequently, in documents other than this Statement, to refer to sets of data from which only names have been removed. Such data may remain "potentially identifiable".
14.1 All epidemiological research must be approved by a Human Research Ethics Committee (HREC) and should be conducted according to written protocols that state the aims of the study, the data needed and the way in which the data will be collected, used and protected.
14.2 When an HREC considers a protocol for epidemiological research it must be satisfied that:
(a) the research complies with any relevant Commonwealth and State/Territory legislation or policies dealing with the privacy and confidentiality of data held by Government authorities;(b) researchers have the necessary skills in epidemiology and facilities for the research;
(c) access to medical or other records for research should be restricted to properly qualified researchers and research associates responsible to them; and
(d) there is a scientifically acceptable process for the disclosure of information and communication of research results and, where there is to be selective disclosure of information, that there are scientifically justifiable reasons for so doing.
14.3 Consent of participants should generally be obtained for the use of identified or potentially identifiable data for epidemiological research.
14.4 An HREC may approve access to identified or potentially identifiable data without consent of those the data identifies where the HREC is satisfied that:
(a) either
the procedures required to obtain consent are likely either to cause unnecessary anxiety for those whose consent would be sought or to prejudice the scientific value of the research and there will be no disadvantage to the participants or their relatives or to any collectivity involvedor
it is impossible in practice, due to the quantity, age or accessibility of the records to be studied, to obtain consent;AND
(b) the public interest in the research outweighs to a substantial degree the public interest in privacy.
14.5 Where an HREC approves the use of potentially identifiable data that has been coded, the HREC should decide whether an independent person should hold the code.
14.6 Where the research involves a collectivity, the HREC should be satisfied that the requirements of 8. Research Involving Collectivities have been fulfilled.
14.7 Where identified or potentially identifiable data are used in the research, an HREC must be satisfied that the information:
(a) will be collected, dealt with and stored in accordance with the Information Privacy Principles of the Privacy Act,1988 (Cth) (see Appendix 2) and the Standards Australia Personal Privacy Protection in Health Care Information Systems (AS4400-1995); and(b) will not be used so as to cause material, emotional or other disadvantage to any participant; and
(c) will not be used for any purposes other than those specified in the approved protocol.
14.8 Where research involves linkage of data sets, an HREC may approve the use of identifiers to ensure that the linkage is accurate, but once linkage has been completed the HREC should require that the resulting data be coded or de-identified.
14.9 If identified or potentially identifiable data are to be used for any research purposes or by any persons other than those specified in the approved protocol, a new protocol must be presented to an HREC for approval.
14.10 Information arising from both long and short term epidemiological research must be securely stored.
14.11 When consolidating data for statistical analysis and the preparation of results, researchers must preserve the confidentiality of information about participants.
14.12 Results of research must not be published in a form that permits identification of individual participants and must be published in a form which gives due regard to cultural or other sensitivities.
14.13 If in the course of epidemiological research new knowledge of clinical relevance is obtained, or existing treatment is thought to need alteration, that knowledge should be disclosed to the appropriate health authorities and, wherever possible, participants and their usual medical attendants should be informed.
[Preamble] [Part 1] [Part 2] [Part 3] [Part 4] [Part 5] [Part 6]
[Part 7] [Part 8] [Part 9] [Part 10] [Part 11] [Part 12] [Part 13]
[Part 14] [Part 15] [Part 16] [Part 17] [Part 18] [Part 19]
[Appendix 1] [Appendix 2] [Appendix 3]