Content
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Research Ethics Handbook – Commentary on the National Statement on Ethical Conduct in Research Involving Humans has been revoked.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.
Introduction
The primary purpose of the Human Research Ethics Handbook is to help Australian Human Research Ethics Committees (HRECs) assess and facilitate the ethical conduct of research involving human participants and resolve the challenges encountered during this process. The Handbook's starting point is a widespread commitment to both the integrity of the ethics committee process and its importance in relation to research practice, and to making this process more effective.
The Handbook contains guidance for HRECs in their interpretation and application of the National Statement on Ethical Conduct in Research Involving Humans, thereby helping them maintain and improve the quality of their work. It provides information for researchers on substantive and procedural issues, and is a resource for potential research participants. It is open to the addition of new material and the development of new perspectives and viewpoints.
It should be understood that the Handbook is intended to provide information, and explanation. The National Statement remains as the primary and definitive source of ethical principles governing the conduct and review of research involving humans.
The Commentary on the National Statement , is designed to explain why a paragraph in the National Statement has been included, identify the ethical premises on which a paragraph is based, suggest how it might be implemented by an HREC or researcher, clarify a questioned interpretation or relate it to another paragraph(s).
The Research Ethics Collection , presents the issues confronting ethics committees and researchers within the context of discussions about specific topics and areas of research practice.
The Research Law Collection , presents concise and accessible accounts of legal issues in human research.
The Australian Health Ethics Committee (AHEC) believes that this approach is the one most likely to provide a text that is accessible, sensitive to the various contexts within which ethical issues arise in research practice, and flexible enough to allow continuous updating and revision as new developments occur in particular areas. AHEC believes that the topic-based approach also permits the experiences of researchers and ethics committee members to be drawn upon and provides a framework for ongoing feedback from the users of the Handbook.
The Handbook is designed to be used by individuals with widely differing personal, philosophical and ethical perspectives. To achieve this, AHEC has adopted the view that the diversity of opinions and outlooks in the community should be acknowledged and reflected. Accordingly, it has attempted to identify contentious and unresolved issues as well as those about which there is a significant degree of consensus. Consequently, contributions from a wide range of people have been brought together, including ethics committee members, community representatives, clinical researchers, social scientists, lawyers, ethicists and those active in other areas where specific issues might arise. As a result, the volume as a whole provides some concise accounts of relevant ethical issues, as well as practical guidance where difficult decisions need to be made.
The Handbook seeks to promote uniformity in ethics committee practices throughout Australia, while still allowing for variation in relation to local contexts. Although AHEC has been careful to avoid endorsing any particular ethical theory, some generalisations have been made where the Committee believes that these will be helpful in a practical setting.
Although is it is intended for use on a day-to-day basis, the Handbook should also provide a stimulus for continuing discussion and debate about the ethics of research practice in Australia. It should be seen as part of an ongoing process of development and change in research practice in Australia. It performs a number of functions, including summarising current practices, reflecting critically on current standards and providing practical guidance. Above all, however, it should be useful to ethics committee members, researchers, research participants, regulatory bodies and policy makers.
A note on structure and relationships between parts of the Handbook
The Commentary on the National Statement is arranged by reference to the National Statement, using its paragraphs as headings (and page numbers in relation to the Preamble of the National Statement) preceded by the initials 'NS'. No commentary has been added to those paragraphs whose origins, ethical premises, implementation and interpretation are, at present, clear.
The Research Ethics Collection contains extended discussion of topics in research ethics, arranged alphabetically. Material in the Research Ethics Collection that is relevant to passages in the Commentary is identified and cross-referenced.
The Research Law Collection contains accounts of legal issues and is arranged in alphabetical order of topics. Material in this collection that is relevant to passages in the Commentary is identified and cross-referenced.
The Human Research Ethics Handbook is available on the NHMRC Website at: http://www.nhmrc.gov.au/publications/hrecbook/misc/contents.htm
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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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