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Please note:
The Human Research Ethics Handbook – Commentary on the National Statement on Ethical Conduct in Research Involving Humans has been revoked. This information is kept here for archival purposes only. For the current guidelines, Human Research Ethics Committees should refer to the National Statement on Ethical Conduct in Human Research 2007.
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'.
Epidemiological studies may require participants to fill in questionnaires or undergo a medical examination or laboratory tests, or they may simply require the examination of medical records.
Reference could be made to the Research Ethics Collection, ' Epidemiology research ' page E39 for a discussion of the issues.
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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.
HRECs need to establish precisely what data are to be collected and used, whether they will be identifiable, potentially identifiable or de-identified and how they will be collected, used and stored. [Footnote 24]
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When an HREC considers a protocol for epidemiological research it must be satisfied that:
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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;
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researchers have the necessary skills in epidemiology and facilities for the research;
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access to medical or other records for research should be restricted to properly qualified researchers and research associates responsible to them; and
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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.
14.2(a)
The relevant Commonwealth legislation is the Privacy Act 1988 (Cth). Guidelines for the use and disclosure of Commonwealth information are 'Guidelines under Section 95 of the Privacy Act 1988 (Cth).
See also NS 18.118.5.
14.2(b)
HRECs should assess the qualifications of the researcher in relation to the type of study to be conducted, the research population involved, the methodology to be used and the supervisory or support resources to be made available to the researcher.
14.2(c)
This is a major area of ethical concern in epidemiological research. Such research may involve collecting and storing data relating to individuals and groups. Such data, if disclosed to third parties, may result in harm or distress for the participant/s. Consequently, researchers should make arrangements for protecting the confidentiality of such data by omitting information that might lead to the identification of individual participants, or limiting access to data by other means.
One means of minimising the risks to privacy and confidentiality is to confine access to personal information only to those whose access is essential to the research. HRECs need to be satisfied that such restrictions exist and will be effective.
Identifiable data should not be used when a study can be carried out without personal identification of participants. When personal identifiers remain on records used for a particular study, researchers should explain to the HREC why this is necessary and how confidentiality will be protected. [Footnote 25] Further discussion can be found in the Research Law Collection on ' Privacy ', page L43 and ' Confidentiality ', page L7.
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Consent of participants should generally be obtained for the use of identified or potentially identifiable data for epidemiological research.
HRECs need to be alert to the correct classification of the data in each research proposal so they can be satisfied that consent will be sought for use of identified or potentially identifiable data.
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An HREC may approve access to identified or potentially identifiable data without consent of those the data identifies where the HREC is satisfied that:
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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 involved
or
it is impossible in practice, due to the quantity, age or accessibility of the records to be studied, to obtain consent;
AND
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the public interest in the research outweighs to a substantial degree the public interest in privacy.
A researcher who proposes not to seek informed consent has an obligation to provide the HREC with adequate justification for this decision, as well as an explanation of how the study could still be considered ethical in the absence of such informed consent.
An example of a situation involving 'unnecessary anxiety' might be the effect on a person of consent being sought for access to information in order to conduct research on risk factors for a serious illness. The person may be a member of a population relevant to the research because of age, geography, demography, gender or a range of socioeconomic factors. The effect of disclosing the disease that is the focus of the research may be to cause the kind of anxiety referred to. Even if the research does disclose information of clinical relevance, paragraph 14.13 is designed to address the protection of such persons.
The expression 'disadvantage' should be given a broad meaning.
An example of a situation where seeking consent could prejudice the scientific validity of the research might be where disclosing relevant information may result in changes to participant behaviour that the study proposes to examine.
An example of a situation of impossibility in practice might be where there has been a significant increase in medical practitioner reports of a side-effect from a particular drug. The Government organisation responsible may decide to release this information to researchers so that the cause of the increase can be identified. However, in order to do this the researchers would need to compare the above-mentioned reports with the medical records of individuals who had taken the drug but had not developed the side effect. This would necessarily involve the examination of thousands of medical records. Therefore, it would be impossible to obtain consent from each individual before accessing their record.
See also 'Guidelines under Section 95 of the Privacy Act 1988 (Cth).
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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.
HRECs will need to assess what constitutes an 'independent person' in order to protect the privacy of participants.
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Where the research involves a collectivity, the HREC should be satisfied that the requirements of 8. 'Research involving collectivities' have been fulfilled.
This paragraph is regarded as sufficiently clear, and so no commentary has been added.
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Where identified or potentially identifiable data are used in the research, an HREC must be satisfied that the information:
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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
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will not be used so as to cause material, emotional or other disadvantage to any participant; and
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will not be used for any purposes other than those specified in the approved protocol.
HRECs need to:
- clearly understand how the personal information is to be used in the research, and that its use will not harm participants; and
- be satisfied that controls are in place to confine its use to the research.
The Privacy Act 1988 (Cth) is available at http://scaleplus.law.gov.au
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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.
Some epidemiological research involves linking sets of data about individuals. Once the sets are linked so that individual data are matched, the research can often proceed without the need for identifying data. Accordingly, the conversion to coded or de-identified forms at that time will not obstruct the research and will better protect participants.
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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.
Epidemiological research projects frequently accumulate data that can be used for different purposes or be subjected to analysis for correlation of different factors, either by the same researchers or by others. Every such new use or analysis is a research proposal to be reviewed by an HREC before proceeding.
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Information arising from both long and short-term epidemiological research must be securely stored.
Epidemiological research will often accumulate quantities of personal information in electronic, sound, print or other forms. HRECs need to be satisfied that appropriate and secure storage arrangements will be provided. The duration for which the data need to be stored may affect the form that is used.
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When consolidating data for statistical analysis and the preparation of results, researchers must preserve the confidentiality of information about participants.
HRECs need to understand the processes to be used when individual data are aggregated either for statistical analysis or the presentation of results of the research. They need to be satisfied that confidentiality of personal information is protected.
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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.
HRECs need to understand clearly how the results of the research will be published.
Both researchers and ethics committees should be aware that some studies can involve a risk of harm for participants in indirect ways. For example, when scarce health care personnel are taken from routine duties in order to meet the needs of a study, or when, unknown to a community, health care priorities are changed. Other instances of harm include the effects of damaging publicity, disruption of social mores, and insensitivity to specific cultural values when researchers are investigating cultures other than their own.
HREC review should also include assessment of the risks for participants or groups already suffering from stigmatisation, prejudice, loss of prestige or self-esteem, or economic disadvantage. Researchers should inform the ethics committee and potential participants of any such risks, as well as the strategies devised to prevent or minimise these. Researchers should be able to demonstrate that the benefits of the study outweigh the risks for both individuals and groups.
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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.
Part of the benefit that communities, groups and individuals may reasonably expect from epidemiological studies is that they will be told about findings relevant to their health and welfare. Where findings could be applied to public health measures, communication to the relevant health authorities would be appropriate. Research proposals should include provision for communicating findings to communities and individuals.
HRECs should be aware that it may not always be possible to inform individual participants about research findings. Where this is so, potential participants should be advised. For example, it may not always be possible to extract information about individuals and their families from pooled findings. In this situation, when findings indicate a need for health care, all participants should be advised to obtain an individual diagnosis and individual advice.
When data are unlinked, and participants therefore cannot be advised as above, researchers should provide the communities involved with the relevant health care advice, with appropriate protections for individual privacy.
Points to consider NS 14.114.13
- Does the research proposal comply with relevant Federal and State or Territory legislation and policies dealing with confidentiality of data held by government authorities?
- Is access to medical or other records restricted to appropriately qualified researchers and their research associates?
- Are data securely stored?
- If access to identified, or potentially identifiable, data without the consent of the people concerned is to be approved, is this decision justifiable in terms of the exceptions allowed by the National Statement?
- Are there adequate plans in the research proposal to protect participants from risks of breach of confidentiality and invasion of privacy?
- If there are burdens of privacy invasion involved in the research, are these ethically acceptable?
- Are there alternative, less intrusive, methods of carrying out this research project?
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Handbook TOC
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Abbreviations
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Commentary on the National Statement
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A Research Ethics Collection
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A Research Law Collection
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Bibliography
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Appendices
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