Do you need ethical approval for a systematic review?

What needs ethics approval?

Overview of the Ethics Approval Process

The information below details the process of applying for Human Ethics Approval for research to be undertaken at the University of Newcastle. If you require further assistance with your application, please contact a Human Research Ethics Officer.

What human research requires ethics approval?
What research is exempt from ethics approval?
Who needs to apply for ethics approval?
How are applications reviewed?
How to access application forms
Closing date for applications
Notification of decisions
Further information and help
Research conducted in another institution/organisation
1. Hunter New England Health
2. NSW Department of Education and Communities
Conjoint Staff and honorary associates

1. What human research requires ethics approval?

Ethics approval must be sought for research involving human participants.

A 'participant' is someone who:

Actively provides research data. For example:
1. completes surveys
2. participates in interviews, discussions or observations
3. undergoes psychological, physiological or medical treatment or testing
4. tests software
5. grants access to personal collections of records, photographs etc.
Is the person from whom tissue or derivaties of tissue has been collected [including blood, urine, saliva, hair, cell lines]
Is identified in a record, e.g. employment record, medical record, education record, membership list, electoral roll or
Is identified or de-identified in data banks or unpublished human research data, e.g. an analysis of existing unpublished datacollected by another researcher or collected for a different research project.

2. What research is exempt from ethics approval?

Use of data, documents or records that are all publicly available, e.g. publicly accessible archives or publications.

3. Who needs to apply for ethics approval?

All human research projects conducted at the University, or by staff and students of the University, require ethical approval before the research can commence.

Applications to the HRECforstudent research projects are to be submitted under the supervisor's name with the student identified as the student researcher.

4. How are applications reviewed?

The University of Newcastle HREC has 3 levels of review to streamline the review of applications for human ethics approval. Two of these levels are expedited review. Modelled on the human research ethics processes at Griffith University,the level of review is determined by the level of risk to participants that is posed by the research described in the application.

Risk is the potential for harm, whether it is physical, psychological, social, economic, or legal, or the potential to cause people to think they have been treated disrespectfully.

LEVELSEXAMPLES OF RISKREVIEWED BY

Negligible Risk Research	Research in which there is no foreseeable risk of harm or discomfort, and any foreseeable risk is no more than inconvenience. E.g. minor survey or interview on a benign topic, giving up time.	Chair, Deputy Chair or Human Ethics Officer
Low Risk Research	Research in which the only foreseeable risk is one of discomfort.E.g. minor side effects, discomfort associated with blood tests, emotional discomfort induced by an interview or survey, management of relationships involving a power imbalance, embarrassment, management of incidental findings or observations, risks to confidentiality and privacy.	HREC Panel
More than Low Risk Research	Research in which there is potential for harm. E.g. physical, psychological, social, economic or legal harms. The risk can be associated with the activities of participation [e.g. novel interventions or trials, exposure to ionising radiation] or potential vulnerability of the research population [e.g. Aboriginal & Torres Strait Islander peoples, people with a cognitive impairment, intellectual disability or mental illness, women who are pregnant] as defined by the National Statement on Ethical Conduct in Human Research.	Full HREC

Please note: response timesvary depending on the level of review. Please see the submission dates and response times page for further information.

5. How to access Application Forms

Application eForms can be accessed by logging into the Research Information Management System [RIMS].

These cover:

Application for approval of new projects,
Renewal of approval for existing projects and
Variations to existing projects.

These eForms provide guidance to completing the questions.

User guides and help material for RIMS can be found at the Research Information Management System [RIMS] support pages of the University's website.

6. Closing date for applications

Refer to the submission dates and response times page.

7. Notification of decisions

Applicants receiveemailed notification of the decision on their application.

8. Further information and help

The principle point of reference for researchers and the HREC is the NHMRC's National Statement on Ethical Conduct in Human Research. The primary purpose of the National Statement is the protection of the welfare and rights of participants in research. It is binding on all institutions and organisations that receive research funding from the Australian government, including the University of Newcastle.

Support - Students should consult their supervisors for advice and assistance in the first instance.

Research Ethics Advisors [REAs] - at the School/Faculty level REAs provide local support to researchers, both staff and students, to design ethically acceptable human research and assist them through the ethics approval process.

Any enquiries you have should be directed to a Research Ethics Advisor in the first instance. If you still have questions, further assistance can be obtained from the Human Research Ethics staff.

9. Research conducted in another institution/organisation

a. Hunter New England Health

If research involves patients, facilities or records of Hunter New England Health, an application for ethics approval must be made to the Hunter New England Health Research Ethics Committee [HNEHREC].

In most cases if the research is to be conducted by staff or students of the University of Newcastle, provided approval is granted by the HNEHREC,it will not be necessary to make a full application to the University HREC. However the HNEHREC approval must be registered with the University HREC within 14 days.

Please note: Researchers will not be covered by the University insurance provisions if the project is not registered.Refer to the Human Research involving the University of Newcastle and Hunter New England Health procedures for further details.

Contact
Dr Nicole Gerrand
Manager, Research Ethics and Governance Unit
E:
T: [02] 4921 4950

b. NSW Department of Education

In most cases, for research involving NSW government pre-schools or schools, an application must be made to the NSW Department of Education via its State Education Research Applications Process [SERAP].

Contact information

If you have any inquiries in relation to SERAP, please contact:

Robert Stevens
Manager, Quality Assurance/Research
Policy, Planning and Reporting
Telephone: [02] 9244 5060

Please Note: The study information/invitation for research participants that is submitted to the NSW Department of Education as part of an application for approval to conduct the research in government schools must be the same version as that submitted to and/or approved by the University's HREC.

It will be necessary to draft a document that takes into account the guidelines of both the SERAP Guidelines and the University's Information Statement and Consent Forms Guidelines and Template document.

10. Conjoint Staff and Honorary Associates

Conjoint staff and honorary associates of the University of Newcastle who are chief investigators on human research projects are required to submit an application to the University'sHREC if any of the following apply:

The research is to be conducted at the University of Newcastle involving staff or students as participants in the research, or records of the University;
A research grant or contract for the project is to be administered by the University of Newcastle and an application is not being submitted to the Hunter New England Health Human Research Ethics Committee;
Itis intended to conduct the research in the name of the University of Newcastle or to use the logo or letterhead of the University of Newcastle in any documentation provided to study participants and an application is not being submitted to the Hunter New England Health human Research Ethics Committee; or
An investigator is a student of the University of Newcastle and the research is to be used towards meeting the requirements for their course of study and an application is not being submitted to the Hunter New England Health Human Research Ethics Committee. This would normally only be the case where the conjoint member of staff is the supervisor for the student's candidature.

Please Note: The University of Newcastle and Hunter New England Health have entered into an agreement regarding human ethics review of proposals that would normally require submission to the human research ethics committees of both institutions. If your proposal involves both institutions, whether by virtue of where the research will be conducted or the affiliations of the researchers involved, please refer to the agreed procedures listed on the Human Research Involving the University of Newcastle and Hunter New England Health Procedures page.