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Research Ethics Handbook – Commentary on the National Statement on Ethical Conduct in Research Involving Humans has been revoked.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

A Research Law Collection

EXPLANATORY NOTE

This is a collection of opinions on recurrent legal issues relevant to research involving humans. It is not an exhaustive collection and suggestions for additional topics are welcome. The opinions have been written by some of the contributors, who are listed at the front of this Handbook, and the views they express are not all necessarily shared by NHMRC. Nonetheless, they provide an informative range of opinion on important legal matters relevant to research involving humans.

Contents

Children and Young People, Research Involving

Consent to a child's participation in research
Consent by children under the age of majority but with sufficient competence to decide
Younger children
Consent of any organisation or person required by law
Research cannot be carried out that is not in a child's best interests
Child's refusal to participate

Clinical Trials

Complaints

Health complaints legislation

Confidentiality

Meaning of confidential information
Situations where a duty of confidentiality arises
Circumstances where confidential information may be lawfully disclosed
Obtaining confidential information from third parties
Information obtained from public authorities

Consent

Legal requirements concerning consent
Information required for consent to be effective
Competence to give consent
Free and voluntary choice
Information

If there is a legally protected intellectual property interest, who owns it or has authority to use it?
Agreement between any relevant parties about the use that may be made of intellectual property

Deception, Research Involving

Discrimination