Human Research Ethics Committee

Office Use Only

Date Received:

Office Use Only

HRECProject Number

Purpose of this form

The purpose of this form is to enable applicants to provide sufficient detail about their research project to allow Austin Health HREC to make an informed decision about the ethical and scientific acceptability of the proposal.

Use of this form

This form is to be used only for projects suitable for Low & Negligible Risk Research (LNRR). Before proceeding, please read carefully the “Information for Applicants” document that explains which ethics review application format should be used. If in doubt, please contact the Research Ethics Unit office

Attachments

Before submitting your application, please check that you have electronically attached copies of all required supplementary documentation e.g.

  • Project Protocol
  • Participant Informationand Consent Form
  • Budget
  • Pamphlets, questionnaires
  • all required authorisation signatures

Submitting the Application

Please submit:

  1. onecomplete, signed original applicationto:

Research Ethics Unit

Henry Buck Building

Austin Heath

145 Studley Road, Heidelberg, 3084

  1. onecomplete, electronic copy to

Human Research Ethics Committee

ABN: 96 237 388 063

P.O Box 5555 Heidelberg 3084

Telephone: 03 9496 4090 Fax: 03 94964103

Trials or studies submitted to the Austin Health Research Ethics Unit directly or via SERP attract submission fees. Trials or studies to be run at Austin Health where Austin Health is a ‘participating site’ and the HREC review has been performed at another SERP reviewing HREC attract Research Governance fees (for both new protocols and protocol amendments).

Upon payment this document becomes a Tax Receipt.

Please retain a copy, as no further receipts will be issued.

1. Principal Investigator
<Principal Investigator>
2. Project Title/Protocol Number
<Project Title/Protocol Number>
3. Sponsor Name
<Sponsor Name>
4. Sponsor ABN
<Sponsor ABN>

Please tick the appropriate box to indicate level of ethics fee payable

In house study (Austin Health only) internal transfer via SPF$100 (excluding GST)

In house study (Austin Health only) via credit card or cheque$110 (including GST)

Non-Commercially sponsored study internal transfer via SPF$200 (excluding GST)

Non-Commercially sponsored study via credit card or cheque$220 (including GST)

Commercially sponsored study via credit card or cheque$1,100 (including GST)

Option 1 - For Internal Projects only (to be eligible, you must have an Austin Health SPF number beginning with Y3000 or above)
Austin Health SPF No / Name of Dept/SPF / Expense Classification / Charge (see fee schedule)
$ (GST n/a)
Authorised by / Title & Printed Name / Signature
Option 2 - Payment by Cheque or Credit Card (including GST)

Credit Card (complete details below)

Cheque (made out to “Austin Health”)

Type (please tick)

Visa MasterCard BankCard

Credit card number / Exp date / Name on Card
Signature
Amount / $(including GST)
Section 1 – Administration

1.1 Project Full Title

1.2List the Version date and number of the Application, Protocol & any other attachments.

List of documents & version dates and numbers:
  1. Application Version Number: Version date (Day Month Year):
  2. Protocol Version Number: Version date (Day Month Year):

1.3Please name the sites at which this research project will be undertaken
Section 2 – Investigators
2.1Principal Investigator*
Title
First Name
Surname
Organisation
Department
Mailing Address
Suburb /City
Postcode
Country
Email
Phone (BH)
Mobile
Qualifications
* NBthe Principal Investigator is NOT permitted to be a student ThePrincipal Investigator unless they have significant research and/or clinical experience. This will be assessed on a case by case basis. The Principal Investigator should preferably be a senior member of the department who preferably has significant research experience and can take full legal, ethical, financial and administrative responsibility for the study and is an Austin Health employee.
2.2Associate Investigator(s)
Title
First Name
Surname
Organisation
Department
Mailing Address
Suburb /City
Postcode
Country
Email
Phone (BH)
Mobile
Qualifications
Is the Associate Investigator a student? / Yes / No
Associate Investigator(s)
For multi-site studies, add additional Associate Investigator details by copying this table.
Title
First Name
Surname
Organisation
Department
Mailing Address
Suburb /City
Postcode
Country
Email
Phone (BH)
Mobile
Qualifications
Is the Associate Investigator a student? / Yes / No
Associate Investigator(s)
Title
First Name
Surname
Organisation
Department
Mailing Address
Suburb /City
Postcode
Country
Email
Phone (BH)
Mobile
Qualifications
Is the Principal Investigator a student? / Yes / No
Repeat as required for each associate investigator
Please attach a ½ page curriculum vitae for each Investigator who is NOT an Austin Health employee describing his/her position and research experience.
Low & Negligible Risk Research (LNRR)- Austin HealthPage 1 of 23
Author: Research Ethics UnitMay 2012
2.3Contact person for the project (if not the Principal Investigator)
Title
First Name
Surname
Organisation
Department
Mailing Address
Suburb /City
Postcode
Country
Email
Phone (BH)
Mobile
Qualifications
2.4Student Supervisor(if applicable)
Title
First Name
Surname
Organisation
Department
Mailing Address
Suburb /City
Postcode
Country
Email
Phone (BH)
Mobile
Qualifications
Section 3 – Project Details
3.1Lay Description
Briefly outline in simple terms, using plain English, the project’s aim(s), justification, participant group(s), method and possible outcomes. (150 words max.)
3.2Study protocol
Please attach a copy of the completestudy protocol.For guidance, there is an Annotate Protocol Template available from the Research Ethics Unit with annotated sections. Please contact the Research Ethics Unit for a copy. The protocol at a minimum must include details of:
  • Literature review
  • Rationale for the study

Explain why this research is necessary given existing knowledge in this field. Note that replication of previous studies in the field is acceptable if, for example, the aim is to confirm or extend existing results, using more rigorous experimental criteria.

  • Research questions and hypotheses
  • Aims
  • Methodology

This should include a scientific description of experimental procedures, surveys and questionnaires, recruitment strategies and other relevant information. Please provide sufficient detail to enable the HREC to determine the project’s methodological rigour. Indicate any limitations of the project design and any potential sources of bias and how these will be dealt with. For questionnaires, for instruments that are no well-known, details of validation or other publications should be provided.

  • Inclusion/exclusion criteria

Please include details of criteria for inclusion and/or exclusion of participants or data. Note that exclusion criteria should not be given as “anyone who does not meet the inclusion criteria”; only independent criteria for exclusion should be given. For example, the inclusion criteria may be “adults with late-onset diabetes: and the exclusion criteria might be “persons taking ‘x’ medication”.

  • Sample size calculation and statistical analysis
  • Data storage, retention and final fate.

3.3Provide the anticipated project start and finish dates (allow time for ethics review)

Start date / * /
Finish date / # /

* Start date refers to the time the first participantis recruited.

# Finish date refers to when no further contact with participants/data source is foreseen including the data analysis and reporting period.

Section 4 – Other Approvals

The Principal Investigator is responsible for informing each ethical review body of all other Australian sites at which the research is being proposed or conducted, at the time of submission of the research project; of any previous decisions regarding the research made by another ethical review body; and informing each ethical review body of whether the project is presently before another ethical review body.

4.1Hasthis applicationbeen, or will it be, submitted to other ethical review bodies in Australia?

Yes No

If yes, provide the namesof other HRECs whohave reviewed, or will review, the project:

4.2If this application has been submitted to other ethical review bodies in Australia, has HREC approval been granted?

Yes NoPending □ Awaiting result of this submission □

If yes, please attach a copy of the approval(s).

4.3 Other External Approvals/Reviews

If your research has undergone peer review, review from a funding body or involves participants from other organisations, copies of letters of approval or reviews must be attached to this application (if pending at the time the application is submitted, forward to the HREC or non-HREC review body, when available).

Has the research undergone peer review and/orsubmission to a funding body for review?

Yes No

If Yes, please specify and attach a copy of the communication(s)

Section 5 – Recruitment of Participants

5.1 Participant Details

Provide number, age range andtypeof participants:

5.2What is the proposed method of recruitment of participants?

This explanation should include how potential participants will be identified and how initial contact will be made.

5.3Will participants from other organisations be involved, apart from the organisations listed for the investigators? e.g., participants recruited from the community.

Yes No

If yes, please specify:

Section 6 – Consent

Informing Participants: Participant Information and Consent Form

The potential participant must be provided with information at their level of comprehension about the purpose, methods, demands, risks, inconveniences, discomforts, and possible outcomes of the research (including the likelihood and form of publication of the research results).For specific guidelines for writing the Participant Information and Consent Form please visit the Research Ethics Unit website

6.1 Will the research involve informed consent of participants? Yes No

If yes, provide details of how informed consent will be obtained/recorded

If no, please justify why consent will not be obtained

Section 7 – Information Protection (confidentiality, data storage and security)

7.1 Will the project involve collection, use or dissemination of records?

Yes - complete Appendix 1No

7.2 Tissue Banks -Does the project involve access to tissue from an established tissue bank?

Yes No

If yes, please provide the name of the tissue bank

7.3 Has consent been given for access to tissue bank samples?

Yes No

Please attach a copy of the PICF from the tissue bank or, if unavailable, provide details of the consent obtained when samples were collected.

Section 8 – Dissemination of Results

8.1Explain when, how, where and to whom results will be disseminated

8.2Will results be provided to participants? If not, provide details or justification why results will not be provided.

Section 9 – Study Agreement

Please refer to the Australian Code for the Responsible Conduct of Research and VMIA Standard Research Agreements.

9.1 Is a written research agreement, signed by all relevant parties, attached?

Yes No N/A (single site) (If you have ticked N/A, proceed to Q10)

Collaborative research involving two or more institutions/parties requires a written agreement to be in place before the research commences.

If No, please give an explanation

If Yes, name the organisation entering into this agreement with your organisation (Health Service, University, Collaborative group etc.)

9.2Has the research agreement been reviewed and approved by an approved legal delegate/team?
Yes No

If No, the agreement mayrequire legal review.Contact your research governance office for advice.

9.3 Is there a possibility of new Intellectual Property being developed from this project?
Yes No
9.4Does the research agreement state arrangements for the use of existing intellectual property and the parties’ rights in relation to ownership?
Yes No N/A
9.5 Does the research agreement describe arrangements for the use of all new intellectual property developed through the research project?
Yes No N/A
If the answer is Yes to 9.3 and No to 9.4 and/or 9.5 then you should:
Discuss the issue of incorporating Intellectual Property terms into the agreement with your associates and any legal or business manager assisting with development of the agreement. Please refer to the Office of Research for advice via .
Section 10 – Resources and Budget Information

Organisations may incur costs in providing support for your research over and above those costs associated with standard care. Any costs over and above routine care which are to be met by the organisation are to be clearly identified and detailed. This includes both the ‘Actual’ costs and ‘In kind’ support.

10.1Has this protocol received research funding (including the researcher receiving any remuneration and/or in kind funding to perform this research) or is this submission being made as part of an application for research funding?

Yes No

If Yes, please complete the budget details below as applicable for this site.

10.2Study Budget

Include relevant salaries and other costs and attach a copy of the budget to this application.

An explanation of how the research project will be funded at the site must be provided to ensure adequate financial arrangements are planned. Details of the impact of the research and any costs that may be incurred by the organisation should be provided.

Please select the way the amount of funding will be expressed in the table below:

Amount per year

Amount per participant

Both as Amount/year and Amount/participant

Type of funding / Source of funding / Amount ($)
Commercially sponsored
Sponsored, other
(e.g. collaborative groups)
External funding
(e.g.NHMRC, Foundations, etc)
Internal/Departmental funding
Other (specify)
TOTAL FUNDING
for the study

10.3Will participants receive any reimbursement for expenses or inconvenience incurred during participation in the research?

Yes No

If Yes, please give details

10.4Departments and services involved in research*

* Note: A signed Declaration from the Head of Department must be attached for all departments involved

Please list the departments/locations involved in the research at this site

Department/location
(e.g. Pathology, Allied Health) / Name of responsible person

Provide details about the account number(s)/cost centre details into which funds are to be deposited.

Insert the account number(s)/cost centre details into which funds are to be deposited:

Section 11 – Declarations

Declaration by the Principal Investigator and Associate Investigator(s)

Project Title (in full):
HREC Reference Number:(Office use only)
Principal Investigator:
Associate investigator(s):

I/we certify that:

  • All information is correct and complete as possible;
  • I/we have had access to and read the NHMRC “National Statement on Ethical Conduct in Human Research” (2007)
  • The research will be conducted in accordance with the National Statement;
  • I/we have consulted any relevant legislation and regulations, and the research will be conducted in accordance with these;
  • I/we will immediately report to the HREC(via the Research Ethics Unit) anything which might warrant review of the research, including:
  • Serious or unexpected adverse effects on participants;
  • Complaints;
  • Proposed changes in the protocol; and
  • Unforseen events that might affect continued ethical acceptability of the project;
  • I/we have attempted to identify all the risks related to the research that may arise in conducting this research and acknowledge my obligations and the rights of participants;
  • I/we will not continue the research if ethical approval or site authorisation is withdrawn and will comply with any special conditions required by the HREC, including;
  • Conditions of approval stipulated by the HREC;
  • Cooperate with monitoring requirements. At a minimum annual progress reports and a final report will be provided to the HREC.
  • I/we have the appropriate qualifications, training, experience and facilities to conduct the research set out in the attached application and to deal with any emergencies and contingencies related to the research that may arise;

Investigator name / Designation / Signature / Date

(repeat as required)

Designation means designated title related to the project e.g.principal investigator, associate investigator, student, study coordinator or other.

Declaration by Austin Health Department Head/s where the Principal Investigator will conduct the research for the purpose of resourcing the research project.

Project Title (in full):
HREC Reference Number:(Office use only)
Principal Investigator:
Associate Investigator(s):

I certify that I have read the project details for the research project application named above.

I certify that I have discussed this research project and the resource implications for this Department, with the Principal Investigator.

I certify that there are suitable and adequate facilities and resources for the research project to be conducted at Austin Health. This is for ‘Actual costs’ and ‘In kind’ contribution.

My signature indicates that I support this research project being carried out using such resources.

Department…………………..……………………………………………………………………………..

Name of Head of Department ……………………………………………………………………………..…….

Signature …………………………………………………………………………Date……………………………

*Where an investigator is also Head of Department, certification must be sought from the Chief Medical Officer. Investigators must not approve their own research on behalf of their Department.

Declaration by Head of Supporting Departmentsat Austin Health(repeat as required)

This form is to be completed by the Head of any Department that is providing support or services to the research project, but which does not have any member(s) on the research team. Please note if you are using Health Information Services, you must fill out their specific forms. Please contact the Research Ethics Unit for this form.

Project Title (in full):
HREC Reference Number:(Office use only)
Principal Investigator:
Associate Investigator(s):

I have discussed this project with the Principal Investigator and have read the research project. I am: (tick whichever applies)

Able to perform the investigations/services indicated, within the present resources of the Department;