Consequential changes to sections of the National Statement

Purpose, Scope and Limits

Institutions are responsible for establishing procedures for the ethical review of human research. That review can be undertaken at various levels, according to the degree of risk involved in the research (see Section 2: Themes in research ethics: risk and benefit, consent, and Chapter 5.2: Responsibilities of HRECs, other ethical review bodies, and researchers). Research with more than a low level of risk (as defined in paragraph 2.1.6,) must be reviewed by an HREC. Research involving no more than low risk may be reviewed under other processes described in paragraphs 5.1.18 to 5.1.21. Institutions may also determine that some human research is exempt from ethical review (see paragraphs 5.1.22 and 5.1.23).

Institutions are responsible for establishing procedures for the ethical review of human research. That review can be undertaken at various levels, according to the degree of risk involved in the research (see Chapter 2.1: Risk and benefit and Chapter 5.1: Governance responsibilities of institutions). Research with a greater than low level of risk (as defined in Chapter 2.1) must be reviewed by an HREC. Research involving no more than low risk may be reviewed under other processes described in 5.1.10 to 5.1.14. Institutions may also determine that some human research is exempt from ethics review (see 5.1.15 to 5.1.18).

Citation changes and change from ‘ethical’ review to ‘ethics’ review. Note that this change has been made throughout the document as has the removal of the word ‘paragraph’ preceding numbered guidelines.

Paragraph 2.3.6(a)

Before approving the use of an opt-out approach for research, an HREC or, where appropriate, another review body must be satisfied that:

• (a) involvement in the research carries no more than low risk (see paragraphs 2.1.6 and 2.1.7, page 18) to participants

Before approving the use of an opt-out approach for research, an HREC or, where appropriate, another review body must be satisfied that:

• (a) involvement in the research carries no more than low risk to participants (see Chapter 2.1)

Citation change and minor wording change.

Paragraph 2.3.10(a)

Before deciding to waive the requirement for consent (other than in the case of research aiming to expose illegal activity), an HREC or other review body must be satisfied that:

• (a) involvement in the research carries no more than low risk (see paragraphs 2.1.6 and 2.1.7, page 18) to participants

Before deciding to waive the requirement for consent {} an HREC or other review body must be satisfied that:

• (a) involvement in the research carries no more than low risk to participants (see Chapter 2.1)

Text removed as inclusion is an error and Chapter 4.6 already excludes the option of the use of a low-risk review process for this type of research.

Paragraph 3.1.62

Shared or banked data or information that is stored in a form that can identify individuals can sometimes be used in research that qualifies as negligible or low risk research; however, it cannot be used in research that is exempt from ethics review (see paragraph 5.1.22).

Shared or banked data or information that is stored in a form that can identify individuals can sometimes be used in research that qualifies as lower risk research; however, it cannot be used in research that is exempt from ethics review (see 5.1.16).

Language alignment and citation correction only.

Paragraph 3.2.3

If the research involves only the use of stored biospecimens and involves no more than low risk, then the provisions of paragraphs 5.1.18 – 5.1.21 for non-HREC levels of review may apply.

If the research involves only the use of stored biospecimens and involves no more than low risk, then the provisions of 5.1.10 to 5.1.14 for non-HREC levels of review may apply.

Citation changes only.

Paragraph 4.2.9(b) and (d)(i)

A review body may also approve research to which only the young person consents if it is satisfied that:

• (a) he or she is mature enough to understand the relevant information and to give consent, although vulnerable because of relative immaturity in other respects;
• (b) the research involves no more than low risk (see paragraph 2.1.6);
• (c) the research aims to benefit the category of children or young people to which this participant belongs; and
• (d) either
  • (i) the young person is estranged or separated from parents or guardian, and provision is made to protect the young person’s safety, security and wellbeing in the conduct of the research (see paragraph 4.2.5).  (In this case, although the child’s circumstances may mean he or she is at some risk, for example because of being homeless, the research itself must still be low risk)

A review body may also approve research to which only the young person consents if it is satisfied that:

• (a) he or she is mature enough to understand the relevant information and to give consent, although vulnerable because of relative immaturity in other respects;
• (b) the research involves no more than low risk (see Chapter 2.1);
• (c) the research aims to benefit the category of children or young people to which this participant belongs; and
• (d) either
  • (i) the young person is estranged or separated from parents or guardian, and provision is made to protect the young person’s safety, security and wellbeing in the conduct of the research (see paragraph 4.2.5).  (In this case, although the child’s circumstances may mean he or she is at some risk, for example because of being homeless, the research itself must still be no more than low risk)

Language alignment and citation correction only.

Introduction to Chapter 3.3

As a general principle, research including genomics will require review by an HREC; however, if no information that can identify an individual is used and no linkage of data is planned, the research may be determined to carry low risk.

As a general principle, research including genomics will require review by an HREC; however, if no information that can identify an individual is used and no linkage of data is planned, the research may be determined to carry lower risk.

Language alignment only.

Introduction to Section 4

Human research may be conducted only with ethical approval. Section 5 describes the processes that institutions may use to provide that approval. Those processes include ethical review by Human Research Ethics Committees (HRECs) or other ethical review bodies, according to the risks of the research (see paragraphs 5.1.6 to 5.1.8).
Ethical review by an HREC is required for any research that involves more than low risk (see paragraph 5.1.6). It is also required for research discussed in several chapters of Section 3, as well as for research discussed in the following
chapters of this section: Chapter 4.1: Women who are pregnant and the human fetus, Chapter 4.4: People highly dependent on medical care who may be unable to give consent, Chapter
4.5: People with a cognitive impairment, an intellectual disability, or a mental illness, Chapter 4.6: People who may be involved in illegal activities, Chapter 4.7: Aboriginal and Torres Strait Islander Peoples and Chapter 4.8: People in other countries

Human research may be conducted only with ethical approval. Section 5 describes the processes that institutions may use to provide that approval. Those processes include ethics review by Human Research Ethics Committees (HRECs) or other ethics review bodies, according to the risks of the research (see Chapter 2.1 and Chapter 5.1).
Ethics review by an HREC is required for any research that involves greater than low risk {}. It is also required for research discussed in {} the following chapters of this section: Chapter 4.1: Women who are pregnant and the human fetus, Chapter 4.4: People highly dependent on medical care who may be unable to give consent, Chapter 4.5: People with a cognitive impairment, an intellectual disability, or a mental illness, Chapter 4.6: People who may be involved in illegal activities, Chapter 4.7: Aboriginal and Torres Strait Islander Peoples and Chapter 4.8: People in other countries.

Language alignment and citation correction.

Introduction to

Chapter 4.1
Chapter 4.4
Chapter 4.5

Research to which this chapter applies must be reviewed and approved by a Human Research Ethics Committee (HREC) … except where that research uses collections of non-identifiable data and involves negligible risk, and may therefore be exempted from ethical review.

Research to which this chapter applies must be reviewed and approved by a Human Research Ethics Committee (HREC) … except where that research satisfies the eligibility requirements for research than can be exempted from ethics review (see 5.1.17).

Revised to align with changes to Section 5.

Introduction to Chapter 4.6

Research that is intended to study or expose illegal activity or that is likely to discover it must be reviewed and approved by a Human Research Ethics Committee (HREC) … except where that research uses collections of non-identifiable data and involves negligible risk, and may therefore be exempted from ethical review.

Research to which this chapter applies must be reviewed and approved by a Human Research Ethics Committee (HREC) … except where that research satisfies the eligibility requirements for research than can be exempted from ethical review (see 5.1.17).

Index

Glossary /
Terms Used in This Document

See Rationale/Comment

See Rationale/Comment

The index has been removed as the National Statement is fully web-based.

The Glossary has been reduced in scope and includes only technical terms or ordinary terms that are used with a meaning specific to the National Statement.