Content

Home » Publications »Human Research Ethics Handbook »Commentary on the National Statement »Preamble to the National Statmement

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Research Ethics Handbook – Commentary on the National Statement on Ethical Conduct in Research Involving Humans has been revoked.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.

PREAMBLE TO THE NATIONAL STATEMENT

The full text of the Preamble is an important component of the National Statement. It describes the purpose of the Statement and the historical context, both international and national, in which the Statement has emerged.

In the section headed 'Statutory considerations' on page 3 of the Statement, there is an explanation of how the Statement is designed to fulfil the statutory responsibility of the National Health and Medical Research Council as well as meeting wider goals.

The section headed 'The meaning of ethics and research' on page 3 is essential reading. It first outlines the scope of research ethics then explains how the term 'research' is to be understood in the Statement, thus indicating the scope of the responsibility of Human Research Ethics Committees (HRECs).

The Preamble comments on the dynamic context of research in Australia on page 8 and introduces categories of security for personal information on page 9.

Guidance or prescription?

The section headed 'Structure and interpretation' on page 10 explains, how the first part of the National Statement (NS 1.1­1.21) relates to the parts that follow.

In this part of the Preamble, it is stated that all research involving humans 'must conform' to the principles and values in that first part of the Statement. Earlier in the Preamble, the National Statement is described as providing 'guidance for rather than prescription of ethically sound research design and practice'.

What is intended is that paragraphs 1.1­1.21 of the National Statement contain essential matters that HRECs are to consider in determining whether any research proposal is or is not ethically acceptable. It is this sense that the expression 'must conform' is intended to convey. The conclusion reached by any HREC will be the result of giving such consideration to these principles as well as other parts of the National Statement and other relevant guidance. It is in this sense that the National Statement is described as providing guidance and not prescription.

[top]

 

| Handbook TOC | Abbreviations | Commentary on the National Statement |
| A Research Ethics Collection | A Research Law Collection |
| Bibliography | Appendices | Downloads |

 

Related topics

footer links