Why is ethical approval necessary?

In general, all research projects and teaching practicals involving human participants as subjects require ethical approval. Post-graduate research projects are included in this requirement.
Ethical approval is required for the following reasons:

1. to protect the rights and welfare of human subjects of research from any physical and mental discomfort, harm and danger from research procedures;
2. to protect your rights as a researcher to carry out legitimate investigation, as well as the University's reputation for research conducted and sponsored by it;
3. to minimise the potential for claims of negligence made against you and the University.

The Human Research Ethics Committee (HREC) has been established by the University to assist you in obtaining ethical clearance for your research and to protect the rights of all concerned.

It should also be noted that many journals now require the letter of approval from an appropriate Ethics Committee as a precondition for publication.

Who should apply for ethical approval?

All research undertaken by Staff, Honours, Masters, Doctorate and other Higher Degree and Diploma students, involving humans which include...

* the use of questionnaires/surveys or interviews;
* access to medical or other personal records;
* investigations of human behaviour;
* routine testing of human subjects;
* the administration of drugs, ionising radiation, chemical agents or vaccines;
* any other experimentation on human beings:

must be submitted for the approval of the Human Research Ethics Committee.

As a rule, undergraduate pre-honours or course work projects may be approved by the Head of Department but, if there is any doubt, reference should be made to the Senior Ethics Officer.

What type of research needs ethical approval?

(a) The following are examples of categories of research involving human participants that require ethics approval; the list is not exhaustive:

1. questionnaires;
2. surveys or interviews;
3. telephone interviewing;
4. recording by audio- or video-tape;
5. the collection of body tissues or fluid samples;
6. the administration of painful stimuli;
7. the administration of any substance or agent;
8. the trial of treatments or therapeutic techniques;
9. CTN or CTX trials of drugs or devices;
10. contracted research.

(b) There is usually a legal requirement for approval by the Human Research Ethics Committee of a protocol which involves requests for access to or collection from banks of existing data of records of personal information of subject(s) held by a third party (either a public or private organisation, agency or individual) where:

• the information is not publicly available;
• the data have been recorded in such a way that the subject(s) can be identified directly or through identifiers linked to the subject(s);
• the disclosure of which should require the obtaining of consent from the subject(s).

(c) This category includes access to human pathology or diagnostic specimens eg. blood sera, which have been provided originally to authorities (pathology laboratories, clinicians etc.) by subjects for purposes other than those sought in the project and which would not be provided as a rule to the researcher for the proposed research without the consent of the subject(s) or clearance by the authority or agency in possession of the specimens.

(d) All research funded by a granting body and administered by the University must have clearance from the University's Ethics Committee. The Research Office has determined that no funds will be released until certification has been provided. This also applies to conjoint academic appointments, for example in hospital situations.

(e) Research involving children, prisoners or adults not competent to consent.

(f) Research involving Aboriginal and Torres Strait Islander communities within the context of the NHMRC Statement on Human Experimentation.

(g) Research that requires access to personal information held by the Commonwealth that does not satisfy the Information Privacy Principles of the Privacy Act.

(h) Research involving the use of genetic registers where personal identifiers are to be extracted.

(i) Research involving hospital patients or their medical records.

(j) Research that may impose an undue disadvantage upon participants.

Where can I get information on the ethical principles which are considered in the approval process?

National Statement on Ethical Conduct in Research Involving Humans

University of Sydney Guidelines for Using the Ethics Application Form for Research Involving Humans (link)

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