Macquarie University Human Research Ethics Committees

Prior Review Form (PREF)

Guideline for submission of applications

Complete this form if your research lists Macquarie University (Macquarie University) and/or Macquarie University Hospital (Macquarie University Hospital) as a site, and you have received approval from one of the following:

  • NSW Health HRECs (or state-equivalent) or Lead HRECs
  • Cancer Institute NSW Clinical Research Ethics Committee
  • An Australian University registered with the NHMRC
  • The Australian Institute of Health and Welfare

Researchers projects may not commence at Macquarie University or Macquarie UniversityHospital without ethics approval from a Macquarie University HREC.

  • PREFs must be signed by the Principal Investigator (Macquarie Universitystaff member, or student supervisor).Unsigned applications will not be accepted.
  • PREFs must be submitted as a PDF document, in addition to:
  • ApprovedHuman Research Ethics Application Form (HREA),plus all approval correspondence.
  • Participant Information and Consent Form (PICF) relevant to this site (i.e. describing the activities that will occur at Macquarie Universityand/or Macquarie University Hospital).
  • Other documentation relevant to Macquarie University / Macquarie University Hospital

Please submit your applicationto.

SECTION 1:TITLE

*1.1Full project title

SECTION 2:INVESTIGATORS AND RESEARCH PERSONNEL

List the details of the Principal Investigator, and any Co-Investigators, Associate Investigators, Supervisors, Research Assistants or Research Co-ordinators who will be conducting research at Macquarie University and/or Macquarie University Hospital.

*2.1Principal Investigator/Supervisor at this site

The Principal Investigator is:

  • Responsible for the research being conducted at the Macquarie University/ Macquarie University Hospital.
  • A Macquarie University staff member.
  • The first point of contact for the Macquarie UniversityHREC regarding this protocol.

Note:If the project is to be undertaken by an Honours/Masters/PhD student, the supervisor will be considered the Principal Investigator. The student may be named as a co-investigator.

Title / Prof / Dr / Mr / Mrs / Ms / Other:
First name:
Surname:
Macquarie UniversityStaff no.
Full mailing address:
Faculty / Human Sciences
Medicine and Health Sciences / Science and Engineering / Business and Economics
Arts
Department/Unit:
Position:
Tel No. (W):
Tel No: (H):
Mobile No:
Fax number:
E-mail address:
Relevant qualifications and expertise:

*2.2How many known other investigators/personnelwill play a specified role in the conduct of the research project at this site?

0  Proceed to Section 3. / 1 or more Complete 2.3.

2.3Other Investigator(s)/Personnel at this site

Role / Co-Investigator / Associate Investigator
Research Assistant / Research Coordinator
Title / Prof / Dr / Mr / Mrs / Ms / Other:
First name:
Surname:
Investigator type / Staff / Student
Staff/Student no.
Full mailing address:
Faculty / Human Sciences
Medicine and Health Sciences / Science and Engineering / Business and Economics
Arts
Department/Unit:
Position:
(students to specify degree/course)
Tel No. (W):
Tel No: (H):
Mobile No:
Fax number:
E-mail address:
Relevant qualifications and expertise:

Note:To list additional “Other Investigators/Personnel”, please copy and paste the above table into the space below and complete the details for all personnel at this site.

SECTION 3:FUNDING AND SUPPORT

*3.1Is this a funded project or do you intend to apply for funding?

No  / Skip to 3.7
Yes  / Please complete 3.2 to 3.6
First, please list the funding bodies that support this project or to which submission is planned. 

3.2Please indicate the status of this funding.

Approved /  / Skip to 3.4.
Pending
Submitted
Not yet submitted

3.3Will this study still be undertaken if funding is not successful?

No
Yes

3.4Please state the title of the project as it appears on your grant application.


Please attach grant application.

3.5Will this research be undertaken on behalf of (or at the request of) a commercial entity or any other sponsor?

No
Yes / Attach research contract and refer to Macquarie University HREC fee structure on our website.

3.6Where the project is a collaborative enterprise with any organisations or individuals, including contracted research activities undertaken through one of the University’s corporate entities (e.g. Access Macquarie, MGSM Pty Ltd), please identify which organisation and individual will have the primary responsibility for the project.

Organisation(s):
Individual(s):

*3.7In undertaking this research at Macquarie University/Macquarie University Hospital, do any “conflict of interest” issues arise that have not already been detailed in your HREA?

Please refer to National Statement chapter 5.4.

For instance, are any of the researchers in a dual role such as researcher/clinician, researcher/carer, researcher/employer, etc.? Or do any of the researchers have access to personal files/databases as a condition of employment rather than as a researcher?

No
Yes / Any “conflicts of interests” must be declared on all Participant Information and Consent Forms (PICFs).
Please provide details of the “conflict of interest” and considerations or mechanisms in place to address these issues. 

*3.8Do the researchers at Macquarie University/Macquarie University Hospitalhave any affiliation with or financial involvement in any organisation or entity with direct or indirect interests in the subject matter or materials of this research?

No
Yes / Please provide details. 

*3.9Do the researchers at Macquarie University/Macquarie University Hospitalexpect to obtain any direct or indirect financial or other benefits from conducting this project?

No
Yes / Ensure that such benefits are included in the Participant Information and Consent Forms (PICFs).
Please provide details. 

3.10Have conditions been imposed upon the use, publication or ownership of the results including the review of data, manuscript draft or scientific presentation by any party other than the listed researchersthat have not already been detailed in your HREA or ethics application?

No
Yes / Please provide details. 

SECTION 4:PRIOR ETHICAL REVIEWS

*4.1Indicate the proposed start date of the project at this site.

Date: / / / /

*4.2Indicate the proposed finish date of the project at this site.

Date: / / / /

Note:Approval is given for a five-year period, conditional on completion of a yearly Progress Report and a Final Report.

*4.3To how many other HRECs have you submitted a proposal relating to this research project?

None
One or more / Please give the name(s) of the HREC(s) and indicate the status of the application(s). 
HREC(s): / 
Status: / Submitted / Deferred / Rejected / Approved 

Please attach ethics application form and all approval correspondence.

*4.4Has this project been previously submitted to/approved by one of Macquarie University’s HRECs?

No
Yes  / Please state the reference number and original date of approval. 
Reference no.:
Date: / / / /

*4.5Are you applying for a new period of ethics approval because the previous approval period has expired (i.e. It has been at least five years since the original approval was granted)?

No
Yes  / Please append your final report to this application and indicate below any differences between this application and the previously approved project. 

SECTION 5:NATURE OF RESEARCH

*5.1Dotheresearch methods and processes that will occur at Macquarie University/Macquarie University Hospitaldiffer from those detailed in your HREA or ethics application form?

No
Yes / Please describe these differences below. 

*5.2Does the research involve limited disclosure to participants?

No
Yes / Please articulate your reasoning below. 

*5.3Are youasking the Macquarie UniversityHREC to waive the requirement of consent?

No
Yes / Please articulate your reasoning below. 

*5.4Do the basis, background evidence, hypotheses and/or aims of the research proposed to occur at Macquarie University/Macquarie University Hospitaldiffer from those detailed in your HREA or ethics application form?

No
Yes / Please describe these differences below. 

*5.5Does the research involve a practice or intervention which is an alternative to a standard practice or intervention?

No
Yes / Please explain how the practice/intervention differs. 

*5.6Are there any additional risks to participants as a result of participation in this research project at Macquarie University/Macquarie University Hospitalthat have not already been detailed in your HREA or ethics application form?

No / Skip to 5.11.
Yes / Please complete 5.7 to 5.10.
First, please list the risks (e.g. physical or psychological distress). 

5.7Explain how these risks will be negated/minimised/managed.

5.8Indicate who will be primarily responsible for dealing with any problems and their expertise in handling these.

5.9Explain how these risks will be monitored.

5.10Explain how these risks—if they result in harm to participants—will be reported.

*5.11Are there any further ethical considerations that you wish to raise?

No
Yes / Please detail these considerations below. 

SECTION 6:PARTICIPANT information and consent

*6.1How many participantsare expected to be recruited from Macquarie University/ Macquarie University Hospital?

Comment on how this number will allow the aims of the study to be achieved.

No.:
Comment:

*6.2What is the age range of participants involved in the study at this site?

Age range: / from / to

*6.3Are the participants at this site Macquarie Universitystudents,Macquarie University Hospitalstaff and/or Macquarie University Hospitalpatients?

No
Yes

*6.4Describe the research data that will be collected directly from participants at Macquarie University/Macquarie University Hospitalonly.

*6.5Using the relevant checkboxes below (more than one may apply), are the participants who are the focus of this project at Macquarie University/Macquarie University Hospital:

  1. in a teacher–student relationship with the researchers?—see National Statementchapter 4.3
/ 
  1. a teaching unit co-ordinator in which the research takes place? —see National Statementchapter 4.3
/ 
  1. in an employer–employee relationship with the researchers? —see National Statementchapter 4.3
/ 
  1. in any other dependent relationship with the researchers? —see National Statementchapter 4.3
/ 
  1. Macquarie University staff members?
/ 
  1. Aboriginal or Torres Strait Islander?—see National Statementchapter 4.7
/ 
  1. residing in countries outside Australia—see National Statementchapter 4.8
/ 
  1. wards of state? —see National Statementchapter 4.2
/ 
  1. prisoners or detainees? —see National Statementchapter 4.3
/ 
  1. refugees or asylum seekers?
/ 
  1. members of the armed services? —see National Statementchapter 4.3
/ 
  1. mentally ill? —see National Statementchapter 4.5
/ 
  1. intellectually impaired? —see National Statementchapter 4.5
/ 
  1. physically disabled?
/ 
  1. unconscious or critically ill patients? —see National Statementchapter 4.4
/ 
  1. in a carer-client relationship with the researcher (e.g. medical practitioner, social worker, psychologist, legal practitioner, etc.)? —see National Statementchapter 4.3
/ 
  1. in a carer-client relationship with other professional workers (e.g. medical practitioner, social worker, psychologist, legal practitioner, etc.)? —see National Statementchapter 4.3
/ 

If you checked any of the above, please give details and explain how you will mitigate any real or perceived pressure to participate—see National Statement 2.2.9.

*6.6Who will be involved in the recruitment of participants at Macquarie University/Macquarie University Hospital?

*6.7Will participants at Macquarie University/Macquarie University Hospitalbe involved in any related studies?

No
Yes  / Please provide further details. 

*6.8What processes will be used to identify and select potential participants at Macquarie University/Macquarie University Hospital?

*6.9Describe how and where the initial contact will be made with potential participants at Macquarie University/Macquarie University Hospital.

*6.10Indicate where the research will be undertaken at Macquarie University/Macquarie University Hospital(e.g. clinics). Please specify all location(s) and venues (including the URL for web-based studies).

*6.11Does recruitment for Macquarie University/Macquarie University Hospital involve a direct personal approach from the researchers to the potential participants?

No
Yes / Please list the precautions that will be taken to minimise any pressure (real or perceived) on individuals to enrol—see National Statement 2.2.9.

*6.12Does recruitment for Macquarie University/Macquarie University Hospitalinvolve the circulation/publication of an advertisement?

No
Yes / First, please provide one (1) copy of each different advertisement.
Second, please indicate where and how often it will be published. 

*6.13Will written consent be obtained for all participants at Macquarie University/Macquarie University Hospital?

Yes / For participants at Macquarie University/Macquarie University Hospital, please utilise the Macquarie University PICF templates, which include the Macquarie Universitylogo and Macquarie UniversityHREC details.
No / Please give your reasons in the textbox below.

*6.14 Does your research at this site involve working with minors?

A Working with Children Check is required for unsupervised contact with minors. Contact your Faculty for further information.

See National Statement 4.2.7 – Children and young people.

No / Skip to 6.16.
Yes / Please complete item 6.15

6.15Will consent be obtained for minors participating in the research at Macquarie University/Macquarie University Hospital?

Note:Researchers may wish to consult Understanding Consent in Research Involving Children(Spriggs 2010) for guidance on this matter.

Yes
No / Please use the textbox below to give your reasons. 

*6.16Please describe how participants (or those deciding for them) will be informed about the project and choose whether to participate.

*6.17If a participant (or person on behalf of a participant) chooses not to participate or to withdraw from the research, are there specific consequences they should be aware of prior to making these decisions?

No
Yes  / Please detail these consequences below. 

*6.18Is there a possibility that individual participants may be identifiable by others and thereby be exposed to risks?

No
Yes / Please detail these circumstances below. 

*6.19Will participantsat Macquarie University/Macquarie University Hospital receive any financial or other benefits as a result of participation?

See National Statement sections 2.2.9 (Coercion and pressure), and 2.2.10-2.2.11(Reimbursing participants).

If the proposed research activity involves Aboriginal and Torres Strait Islander people, refer to Principle 11 of the Australian Institute of Aboriginal and Torres Strait Islander Studies (AIATSIS) Guidelines for Ethical Research in Australian Indigenous Studies(

No
Yes / Please indicate the amount/benefit and the justification. 

*6.20Are you recruiting any participants who will be attending for the purposes of therapeutic care?

No
Yes / Please provide the details of this care. 

*6.21Do you intend to access stored samples/stored medical information of individual participants for this research project and/or future research projects?

No
Yes / Please describe how consent will be obtained from these individuals (or those acting on their behalf). 

*6.22Will the results of the research have significance for the welfare of the participants?

No
Yes / Please describe your plan for making this information available to the participants. 

*6.23Is there a possibility that the research will involve the disclosure of unlawful conduct or concealment of a crime by individuals or groups?

No / Skip to Section 7.
Yes / Please continue to complete the remainder of Section 6.

6.24Will investigators/researchers have a legal duty to disclose any of that information?

No / Skip to Section 7.
Yes / Please describe how this legal duty will be managed.

6.25What steps, if any, will be taken to protect participants?

SECTION 7:OTHER ETHICAL CONSIDERATIONS

7.1In the case of participants at Macquarie UniversityMacquarie University Hospitalfor whom competence in English is not adequate for informed consent, what arrangements have been made to ensure comprehension of the Participant Information & Consent Form?(See National Statement5.2.16 – Participants’ interests)

SECTION 8:PRIVACY AND CONFIDENTIALITY

*8.1Please describe the information that will be collected directly from participants at Macquarie University/Macquarie University Hospital.

*8.2Please indicate all research personnel (i.e. listed in Section 2 of this form) and others (e.g. student supervisors) who—for the purposes of this research—will have authority to use or have access to the information. In addition, please describe the nature of the use or access for each person.

NATURE OF USE/ACCESS
Principal Investigator/Supervisor
Other Investigator (1) 
Other Investigator (2) 
Others (specify): / 

*8.3Please indicate the information that will be stored at the completion of this project and the conditions under which they will be stored.

*8.4Please specify the form in which results will be reported and communicated to participants.

*8.5Who will be responsible for communicating the project results to participants?

Principal Investigator/Supervisor
Other Investigator (1)
Other Investigator (2)
Others (specify):

SECTION 9:PROJECT-SPECIFIC DETAILS

*9.1Please indicate whether or not the participants in your research at Macquarie Universitywill be involved in any physically invasive or potentially harmful proceduresthat have not already been detailed in your HREA or the ethics application form?

More than one category may be applicable.

Yes / No
  1. clinical trial (different from whatis detailed in your HREA)

b.drug administration
c.needle insertion
d.electromagnetic stimulation
e.chiropractic manipulation
f.other (explain) / 

9.2If you answered ‘Yes’ to any of the items in 9.1.1, please state the nature of the procedures, all the risks involved and, where appropriate, quantify these risks (e.g. probability of any adverse events).

All this information must be included in the Participant Information and Consent Forms (PICFs).

*9.3Is the research at Macquarie University/Macquarie University Hospitaltargeting any particular ethnic or community group?

No / Skip to Declaration by Principal Investigator.
Yes / Please complete all of items beginning with 9.7.
First, please indicate which group is/groups are being targeted. 

9.4Will recruitmentfor Macquarie University/Macquarie University Hospital be conducted in consultation with a representative of this group?

No / Please answer9.5thenskip to Declaration by Principal Investigator.
Yes / Skip to 9.6.

9.5Please provide your reasons for not undertaking any consultation.

9.6With whom have you consulted, and how do they represent this group?

SECTION 10:DECLARATION BY PRINCIPAL INVESTIGATOR

*10.1To the best of my belief the proposed project at Macquarie University/Macquarie University Hospital conforms in all respects with the National Statement on Ethical Conduct in Human Research.

Information about and links to legislation, guidelines and codes governing research with humans is available at:

Signature of Principal Investigator:
Name of Principal Investigator:
(BLOCK LETTERS)
Date: / / / /

Human Research Ethics Committee – Prior Review Form (PREF) Version – 18.08.2017 Page 1 of 15