25

25 Personal Privacy Protection in Health Care Information Systems, Australian Standard AS 4400-1995.

26 The December 1991 Guidelines for Good Clinical Research Practice in Australia. Published by the Therapeutic Goods Administration of the Commonwealth Department of Health and Family Services, recommends retention of data for at least 15 years.

2.9 The procedures formulated by institutions must include guidelines on the establishment and ownership of and access to databases containing confidential information, and any limits on this.

2.10 When the data are obtained from limited access databases, or via a contractual arrangement, written indication of the location of the original data, or key information regarding the database from which it was collected, must be retained by the researcher or research unit.

2.11 Researchers must be responsible for ensuring appropriate security for any confidential material, including that held in computing systems. Where computing systems are accessible through networks, particular attention to security of confidential data is required. Security and confidentiality must be assured in a way that copes with multiple researchers and the departure of individual researchers.

APPENDIX 4

Office of the Federal Privacy Commissioner— Guidelines on Privacy in the Private Health Sector Section A.3.5 Health information held before the commencement of the Privacy Act

The new provisions in the Privacy Act are effective from 21 December 2001.

Only some of the National Privacy Principles (NPPs) apply to information collected before 21 December 2001. These include NPP 4 on data security, NPP 5 on openness, NPP 7 on identifiers and NPP 9 on transborder data flows. NPP 6 on access also applies to information already collected, but only where that information is still in use and if compliance would not pose an unreasonable administrative burden or expense.

For further information on when each of the NPPs apply, see the Guidelines on Privacy in the Private Health Sector or the OFPC Information Sheet 10—2001 Application of the Privacy Act to information already held

APPENDIX 5

Office of the Federal Privacy Commissioner—Information Sheet 9 2001— Handling Health Information for Research and Management, Attachments 1 and 2.

The following diagrams are designed to outline the circumstances in which it is lawful under the National Privacy Principles to collect, use or disclose health information.

Requirements when collecting health information without consent:

• for research or the compilation and analysis of statistics relevant to public health or public safety, or

• for the management, funding or monitoring of a health service.

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Requirements for using or disclosing health information for research or the compilation or analysis of statistics relevant to public health or public safety or for health service management activities

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APPENDIX 6

Information about the National Statement on Ethical Conduct in Research Involving Humans

The National Statement on Ethical Conduct in Research Involving Humans (National Statement) is a significant advance for research Australia. It is issued by the National Health and Medical Research Council (NHMRC) under the National Health and Medical Research Council Act 1992. It has been endorsed or supported by the Australian Vice-Chancellors’ Committee, the Australian Research Council, and the Academies of Humanities, Science, Social sciences, and Technological Science and Engineering.

The National Statement applies to all disciplines of research involving or impacting upon humans. All individuals, institutions and organisations conducting research that involves human participants should use it.

The National Statement provides general ethical principles that should be applied to all research involving humans, as well as guidelines on specific research types, participant groups and other issues.

The National Statement can be downloaded free of charge from the NHMRC web site at http://www.nhmrc.gov.au/publications/synopses/e35syn.htm

It can also be purchased from AusInfo Government Bookshops for $14.00 (inc. GST) by phoning their toll free number 132 447 (catalogue no. 9818566).

The National Health and Medical Research Council

The National Health and Medical Research Council (NHMRC) is a statutory body within the portfolio of the Commonwealth Minister for Health and Aged Care, established by the National Health and Medical Research Council Act 1992. The NHMRC advises the Australian community and Commonwealth; State and Territory Governments on standards of individual and public health, and supports research to improve those standards.

The NHMRC advises the Commonwealth Government on the funding of medical and public health research and training in Australia and supports many of the medical advances made by Australians.

The NHMRC also develops guidelines and standards for the ethical conduct of health and medical research.

The Council comprises nominees of Commonwealth, State and Territory health authorities, professional and scientific colleges and associations, unions, universities, business, consumer groups, welfare organisations, conservation groups and the Aboriginal and Torres Strait Islander Commission.

The Council meets up to four times a year to consider and make decisions on reports prepared by committees and working parties following wide consultation on the issue under consideration.

A regular publishing program ensures that Council’s recommendations are widely available to governments, the community, scientific, industrial and educational groups.

The Council publishes extensively in the following areas:

A list of current publications is available from:

The Publications Officer

ONHMRC

MDP 100

GPO Box 9848

Canberra ACT 2601

Phone: (02) 6289 9520 (24-hour answering machine)

Toll free: 1800 020 103

Fax: (02) 6289 9197

E-mail: nhmrc.publications@health.gov.au

Internet: http://www.nhmrc.health.gov.au