Application for HREC Approval Standard Human Research

Application for HREC Approval Standard Human Research



Application for HREC Approval (Standard)

Human Research Ethics Committee



Prior to completing this form, applicants should review theNational Statement on Ethical Conduct in Human Research, and apply its principles in preparing the application.


About this Form

This application form should be used by researchers seeking ethical approval for human research projects that present more than minimal ethical risk to participants. If your project presents minimal ethical risk or less to participants, you may be eligible to apply for ethics approval via the HREC Expedited review process. To assess ethical risk, complete theHREC Risk Assessment Checklist.


Ethics Website

Information to assist in preparing a successful application is available on theEthics website: Student researchers must discuss their application with their supervisor. The Ethics Officer, Mt Helen also welcomes enquiries in the preparation of an application.


Completing the Form

This form can be completed on your computer using the tab key to move through the template. The response area will expand to fit the content. Click inside a checkbox to record a Yes/No response. Electronic signatures can be applied in Section 19: Declarations.


Deadlines

Refer to theHREC meeting datesand note the due date for agenda items. Late applications will be held over until the next available meeting


Attachments

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


Authorisations

Applications without appropriate authorisation will not be accepted:

  • Principal Researcher,andOther Researchers,then

  • Head of School,or

  • Deputy Head of School,or

  • ADR,or

  • Faculty Ethics Coordinator


Submitting the Application:UPDATED PROCESS

Step 1:Complete the application and any attachments, obtain the required signatures, and submit electronically to the Ethics Officer at Mt Helen. (Hard Copy no longer required)


Step 2:Researchers are responsible for follow-up with an email or phone call - prior to the Agenda Due Date to obtain theProject Number & Meeting Number -if you have not been advised by the Ethics office that your application has been accepted



Research Ethics Office:Room 218 Ground Floor, Building F, Mt Helen Campus

Email:research.ethics@federation.edu.au

Phone: +613 53279765


Notification of Outcome

The nominated Principal Researcher will receive notification of outcome from the Ethics Officer within 3 working days after the meeting at which the application is considered.

Do not commence research until written approval has been received from the HREC.

REMOVE PAGES 1 & 2 PRIOR TO SUBMITTING





Group 198

  1. PROJECT DETAILS


Project title:



What type of project is this? (Tick as many as apply)


Funded Consultancy

Class Research Project

Postgraduate Diploma

Clinical Trial

Undergraduate Research

Masters by Research

Staff Research Project

Honours Research

PhD

Other

Masters by Coursework

Higher Doctorate

Through which School/Section is the research to be conducted?



What is your expectedcompletiondate? (Approval will be granted up until this date)

/ /

Your project must not commence untilfullapproval is granted.


  1. RESEARCHERS

Principal Researcher (must be a STAFF MEMBER)


Title & Name:


Position:


School/Section:


Phone number:


Email address:


Academic qualifications:


Describe what this researcher will do in the context of this project:


Include a brief summary of relevant experience for this project:



Student/Other Researcher/s

**copy and paste this table for each person involved in the project


Title & Name:


Position:


School/Section:


Phone number:


Email address:


Student ID number:


Academic qualifications:


Describe what this researcher will do in the context of this project:


Include a brief summary of relevant experience for this project:




  1. LAY DESCRIPTION


Provide a brief outline of the project describing in everyday,jargon-free languagethe key aspects of the research (e.g., who will be participating, what information will be collected and by what means, what participants will be required to do, etc.) and the key research aims. The lay description must be ineveryday, jargon-free language that is comprehensible by the average educated layperson. Define any technical terms or discipline-specific phrases, and use the full form of all acronyms the first time they are used. (300 words max.)



  1. RESEARCH AIMS & SIGNIFICANCE


State the aims, key research questions, and significance of the project. Where relevant, state the specific hypothesis to be tested. Also provide a brief description of the relevance of your proposed project to current research; (supported by a literature review and references) – refer toNational Statement 1.1c, a justification as to why your research should proceed, including an explanation of any expected benefits to the community and its potential to contribute to existing knowledge.

(600 words max.)



  1. FUNDING & FINANCIAL BENEFITS


Researchers should include any source of funding (e.g., departmental, commercial, non-commercial, governmental) The HREC will consider whether there is a conflict of interest.


Are any of the researchers affiliated with or in receipt of any financial benefit from any of the external organisations involved in your research?

Yes

No


Ifyes, explain how, how much and for what purpose:



Has this protocol received research funding or is this submission being made as part of an application for research funding?

Yes

No

What is the status of the funding application?

Approved

Refused

Pending



Ifyes, what is the source of the funding?



What is the project grant title and proposed grant duration?



What is the registration number of the grant/funding application?



What is the deadline for the granting body?



Does this project require HREC approval before consideration for funding?

Yes

No


How will participants be informed of the source of the funding?


  1. MULTI CENTRE RESEARCH

Other HREC Approvals

The principal researcher is responsible for informing each HREC of all other sites at which the research is being proposed or conducted; disclosing to each HREC any previous decisions regarding the research made by another HREC; and informing each HREC of whether the protocol is presently before another HREC.


Is this protocol being submitted or has it been previously submitted to another Human Research Ethics Committee?

Yes

No

Ifyes,give details of other centres involved; the approval status of the study at each centre; and details of any required amendments.


  1. EXTERNAL APPROVALS


If your research involves participants from other organisations (e.g. educational institutions, companies, agencies, collectives), you may need to obtain authorised approval before approaching participants, eg:Department of Education and Training,School Principals,School Councils(for research involving Government schools);Catholic Education Office(Catholic schools);School Boards(Independent schools);Senior Officers(Commercial or Government entities);Elders(Aboriginal communities); orRepresentative bodies(Collectives). Copies of approval letters must be attached to this application or, if pending at the time of submission, forwarded to HREC when available. Some authorities may decline to provide permission letters until ethics approval has been granted. In such cases, you should submit your application to the HREC for provisional approval pending receipt of the documentation.


Does research involve or impact on participants from external agencies or organisations?

Yes

No

Ifyes, has required permission been obtained from relevant agencies?

Yes

No


Ifyes,please specify from whom and attach a copy



Ifno, specify from whom, and advise when this will beobtained




  1. RESEARCH METHODOLOGY


Provide an outline of the proposed method, including details of data collection techniques, tasks participants will be asked to complete, the estimated time commitment involved, and how data will be analysed. If the project includes any procedure that is already established and uses accepted techniques please include a description of the procedure. (500 words max).



Is it likely / possible that any of the data collected may be used by you, or others, for any research other than that outlined in this application? See NS Chapter 2.2 and Chapter 3.2 when preparing your response.


Yes

No


If YES, describe below and ensure this is outlined in all Plain Language Information Sheets and Consent forms.

  • Participants should be fully informed of the possibility of any future use of data collected and their ‘extended’ or ‘unspecified’ consent gained. Failure to do this may restrict the future use of the data.

  • Any restrictions on the use of participants’ data should be recorded and the record kept with the collected data. Restrictions must be accessible to researcherswho want to access those data for research.




  1. RECRUITMENT OF PARTICIPANTS

Participant Details

Describe your proposed recruitment strategy to source target participants. Provide the number and age range, giving a justification of your proposed sample size. Include details of statistical power of the sample where appropriate. To ensure the requirements for consent are met, refer to theNational Statement Chapter 2.2 General requirements for consent:


Target participants

Who are the target participants?(Tick as many as applicable)


Students or staff of this University


Adults (over the age of 18 years and competent to give consent)


Children/legal minors (under the age of 18 years, with parental consent)*


Children in out of home care (under the age of 18 years – Note: Contact DHS for guidance in this area)


Care Leavers – An adult who spent time in care as a child (under the age of 18) this could have been foster care, residential care, or other arrangements outside the immediate or extended family


Women who are pregnant, Human Fetuses and Neonates


Aboriginal and/or Torres Strait Island communities


Other collectives where leader/council of elders may need to give consent


Elderly individuals


Individuals from non–English-speaking backgrounds


People in other countries


Pensioners or welfare recipients


Intellectually or mentally impaired individuals unable/with compromised capacity to provide consent


Individuals highly dependent on medical care with a compromised capacity to give consent


Physically disabled individuals


Patients or clients of professionals


Prisoners, parolees


People who may be involved in illegal activities


*Parental/Guardian consent may not be required in some instances -refer National Statement,4.2.8 & 4.2.9


Proposed Recruitment Method

A copy of all recruitment materials used (e.g., printed advertisements, radio and television advertisement transcripts, posters, letters of invitation) must be attached to this application for review by the committee.


What is the proposed recruitment method? (Tick all that apply)

Mail-out


Email


Have you attached a copy of the text of the email that will be sent?YesNo

Ifno, please explain:


Telephone


Contact details obtained from public documents (e.g., phone book)


Recruitment by researcher(s)


Participants from a previous study


Snowball(participants suggest other potential participants)


Personal contacts – Provide details:


Other – please explain:


Advertisement (e.g. for a noticeboard or FedNews)

Have you attached a copy of the advertisement? YesNo

If no, please explain:


Facebook

Have you attached a copy of the advertisement that will be posted on Facebook?

YesNo

Ifno,please explain:


Recruitment by a third party (e.g., employer, doctor)

Have you attached a copy of the letter requesting their assistance, and/or the letter confirming their willingness to assist?YesNo

Ifno,please explain:


Private sources

Have you attached a copy of the relevant approval letter?YesNo

Ifno, please explain:


  1. BURDENS OF RESEARCH (RISK & RISK MANAGEMENT)


This section raises the issue of your duty of care toward research participants. To what risks are participants subjected? What will you do should an emergency occur, or should a participant become upset or distressed? What is your risk management strategy?

Refer National Statement: Section 2.1 Risk and Benefit


Likely Benefits

Are participants likely to gain direct or indirect benefit from the research?

Yes

No

Ifyes, provide details



How will potential benefits to participants or community outweigh the risks?


Research Activities

Which of the following activities will the research involve? (Tick as many as apply)


Use of a questionnaire (attach copy)

Interviews (attach interview questions)

Observation of participants without their knowledge

Participant observation

Audio- or video-taping of interviewees or events

Access to personal and/or confidential data (including student, patient or client data) without participants’ specific consent

Administration of any stimuli, tasks, investigations or procedures which may be experienced by participants as physically or mentally painful, stressful or unpleasant during or after the research process

Performance of any acts which may diminish the self-esteem of participants or cause them to experience embarrassment, regret or depression

Investigation of participants involved in illegal activities

Procedures that involve deception of participants

Administration of any substance or agent

Use of non-treatment of placebo control conditions

Collection of body tissues or fluid samples

Collection and/or testing of DNA samples

Participation in a clinical trial

CTN TrialCTX TrialPlease provide Phase number, i.e., either 1, 2, 3 or 4

Testing a medical/diagnostic device

  1. RISK MANAGEMENT PROCEDURES


Identify as far as possible all potential risks to participants (e.g. physical, psychological, social, legal, economic) associated with the proposed research. Explain what risk management procedures will be put in place. Any potential risks should be outlined in the Plain Language Information Statement (PLIS) along with contact details of an appropriately qualified organisation for participant reference in case of distress, eg: Lifeline




Where will the research be conducted? (Tick as many as apply)

Federation University

Other location(s)

Ifother, pleasegive details (including the URL for web-based studies)


Are facilities at the research location appropriate for the scientific needs of the research?

Yes

No


Ifno,please elaborate



Are the facilities appropriate to meet any physical, emotional or other needs of participants that result from their participation?

Yes

No


Ifno,please elaborate



Are there any specific risks to researchers?

Yes

No


If yes, please describe the risks identified, and your planned Risk Management protocol for researchers



What plans are in place to deal with adverse/unexpected outcomes?



Will parts of this project be carried out by independent contractors?

Yes

No

Ifyes,please confirm that the independent contractor will receive from the first-named Principal Researcher, a copy of the approved ethics protocol and be made aware of their responsibilities arising from it.



If necessary, has the Principal Researcher ensured that the other researchers have undergone a police check and a Working With Children check?

Yes

No

N/A


How will the conduct of the project be monitored to ensure that it conforms to the procedures set out in this application, theUniversity’s human ethics guidelines, theNational Statement 5.5,and theAustralian Code for the Responsible Conduct of Research 3.4? (In the case of student projects please give details of how the supervisor/s will monitor the conduct of the project; e.g., how often student and supervisor will meet; how meetings will be conducted: email/phone/in person; how efforts will be coordinated if a number of researchers are involved.)




Will there be support provided for participants? (You may need to consider having additional support for participants during or after the study, depending on risks to participants. Consider whether your project would require additional support and what support would be available.)




What debriefing will participants receive following the study and when? (Attach a copy of any written material or statement to be used in such a debriefing. Participants may need to talk with the researchers about the experience of being involved in the study as well as learn more about the aims of the research.)




  1. INCENTIVES FOR PARTICIPATION


Note that while participants may, in certain circumstances, be paid or reimbursed for their inconvenience and time, the payment should not be of an amount that risks inducement to participate, thus potentially biasing the project‘s results. If rewards are to be used, all participants are to receive the reward.


Are financial or other rewards proposed to be given to participants?

Yes

No


Ifyes, describe how much and in what form the payment/incentive will take (e.g., money to reimburse travel costs, vouchers for movie tickets, chocolate frogs).


  1. CONSENT

Dependent or Unequal Relationships

The consent of a person to participate in research must not be subject to any coercion. Research involving those in dependent or unequal relationships (e.g., teacher/student, manager/employee, parent/child, doctor/patient) may compromise a participant’s ability to give consent that is free from any form of pressure (real or implied) arising from this unequal power relationship. The HREC therefore recommends that, where possible, researchers should choose participant cohorts where no dependent relationship exists. However, if the researcher believes that research involving people in dependent relationships is purposeful and methodologically defensible, the HREC will require additional information explaining why this is so and how any risks inherent in the dependent and unequal relationship will be managed. The HREC will also need evidence to show that participants have been reassured that refusal to participate will not result in any discrimination or penalty. Applicants should note that reasons of convenience will not normally be considered adequate justification for conducting research in situations where dependent relationships exist.


* Please refer to the National Statement on Ethical Conduct in Human Research – Chapter 4.3for information on unequal relationships before answering the following question.


Does a dependent or unequal relationship exist between any participant and researcher, particularly those involved in recruiting?


Yes

No

Ifyes, please explain the relationship and the steps to be taken by the researchers to ensure that the participant’s participation is purely voluntary and not influenced by the relationship in any way.




Informing Participants – Plain Language Information Statement (PLIS)


The potential participant must be provided with informationat their level of comprehensionabout the purpose, methods, demands, risks, inconveniences, discomforts, and possible outcomes of the research (including the likelihood and form of publication of research results, and whether their data may be made available for future research projects) so their consent is fully informed. Download the current template for thePLISfrom the HREC website.


Have you attached a copy of the PLIS for participants?

Yes

No


Ifno, please explain



Does the PLIS comply with the following guidelines?


YES

N/A

It is presented on the Fed Uni HREC approved template, downloaded from the website

*

It has clear identification of the University, the School(s) involved, the project title, the Principal and Other Researchers (including FedUni contact details).

*

It details what involvement in the project will require (e.g., involvement in interviews, completion of questionnaire, audio/video-taping of events), estimated time commitment, any risks involved.

*

It advises how participants’ contact details were obtained and/or how potential participants were selected

If staff or students of the Federation University are to be involved as participants, it advises that the project has received clearance by the HREC

It advises that if the sample size is small this may have implications for privacy/anonymity.

It states clearly that if participants are in a dependent relationship with any of the researchers involvement in the project will not affect ongoing assessment, grades, employment, management or treatment of health (as relevant).

It states clearly that involvement in the project is voluntary and that participants are free to withdraw their consent to participate at any time, and to withdraw any unprocessed data previously supplied.

*

It states that arrangements will be made to protect confidentiality of data, including that confidentiality of information provided is subject to legal limitations (e.g., subpoena, freedom of information claim, or mandatory reporting in some professions).

It advises whether or not data will be destroyed after a minimum period.

It advises the de-identified data collected may be used in future research projects

It provides any other relevant information.

*

*Required

Obtaining and Documenting Consent

How will informed consent be obtained/recorded?

Signed consent form

Recorded verbal consent

Implied by return of survey*NB If consent is to be implied by return of survey, all information that would normally be presented on the consent form must be included in the PLIS

Other (Please specify):


The correct template for the consent form can be found at:

http://federation.edu.au/research-and-innovation/research-support/ethics/human-ethics/human-ethics3


Is a copy of the consent form attached to this application form?

Yes

No


Ifno,please explain how consent will be documented:



Does the consent form comply with the following guidelines?

It is presented on the Fed Uni HREC approved template, downloaded from the website

It states the title of the project and names of the researchers

It confirms that the project is for research

It confirms that involvement in the project is voluntary and that participants are free to withdraw at any time or withdraw any unprocessed data previously supplied

It details specific requirements of participants (e.g., interviews will be audio-/video-taped)

It advises of any legal limitations to data confidentiality

It advises that if the sample size is small this may have implications for privacy/anonymity

It provides any other information relevant to obtaining participant consent

  1. DISCONTINUING PARTICIPATION


Are participants advised as part of the informed consent process that they have the right to withdraw at any time or withdraw any unprocessed data previously supplied?

Yes

No


Ifyes, please detail how participants are informed of this right.



Ifno, please explain why this advice has not been given


  1. INFORMATION PROTECTION (DATA; STORAGE; SECURITY)

Confidentiality

Please give attention to implications for compliance with legislative requirements including, for example,Guidelines Approved under Section 95A of the Privacy Act 1988,produced by NHMRC, andStatutory Guidelines on Research Issued for the Purposes of Health Privacy Principlesproduced by the Office of the Health Services Commissioner.


What are Data?(NS Ch3.2 Databanks)

Data are pieces of information, eg:

  • What people say in interviews, focus groups, questionnaires, personal histories and biographies;

  • Analysis of existing information (clinical, social, observational or other);

  • Information derived from human tissue such as blood, bone, muscle and urine.

(Note:Where the sample size is very small, or information is obtained through a focus group, it may be impossible to guarantee anonymity or confidentiality of participants’ identity, and participants involved in such projects need to be advised of this limitation.)

Tick which method will be used to guarantee confidentiality/anonymity?


Individually identifiable data, where the identity of a specific individual can reasonably be ascertained. Examples of identifiers include the individual’s name, image, and date of birth or address.


Re-identifiable data, from which identifiers have been removed and replaced by a code, but it remains possible to re-identify a specific individual by, for example, using the code or linking different data sets.


Non-identifiable (anonymous) data, which have never been labelled with individual identifiers or from which identifiers have been permanently removed, and by means of which no specific individual can be identified. A subset of non-identifiable data are those that can be linked with other data so it can be known that they are about the same data subject, although the person’s identity remains unknown.


Tick all that apply from the boxes below:

Participants will have the option of being identified in publications arising from the research.

Participants will be referred to by pseudonym in publications arising from the research.

Personal information will be obtained from a Commonwealth department or agency? (Ifyes, you may need to comply with the requirements of thePrivacy Act 1988).

Any other method of protecting the privacy of participants (e.g., use of direct quotes with specific, written permission only; use of real name with specific, written permission only).Please describe:

Security and Storage


Does the Principal Researcher accept responsibility for the security of the data collected?

Yes


Who will have access to data?

Access by named researchers only

Access by other(s) than named researcher(s)


If others have access to data, identify who, at which storage site, for what purpose, and their connection to the project.



Which of the following methods will be used to ensure data security?

Data will be kept in locked filing cabinets

Data and identifiers will be kept in separate, locked filing cabinets

Access to computer files will be available by password only

Other (please describe)


Does data storage comply with theNHMRC/ARCAustralian Code for the Responsible Conduct of Research?See Section 2: Management of research data and primary materials

Yes

No


Ifno,please explain



Please confirm that at the conclusion of the study, the data will be kept in locked facilities in the School through which the project is being conducted

Yes


If data is to be kept elsewhere during fieldwork, please explain how and where data will be held, including arrangements for data security



Please confirm that any data collected will be kept for aminimumof 5 years from date of research publication.

Yes


Will the data be destroyed at some pointafterbeing kept for the minimum 5 year period? (Data may be kept indefinitely, but must be appropriately secured)

Yes

No


Ifyes, how and whenwill data be disposed of?



Please confirm that any data collected will be disposed of by the Principal Researcher, who is responsible for the data.

Yes

  1. DISSEMINATION OF RESULTS

Explain when, how, where and to whom results will be disseminated, including whether participants will be provided with information on the project’s findings or outcomes.




How will results be made available toparticipants? (Tick as many as apply)

Written summary of results

Copy of final manuscript (thesis, article, etc.)

Verbal presentation (info session, debriefing, etc.)

Presented to all participants

Presented if requested

Presented to representative participants (e.g. CEO, school principal)

Other -Please explain:

None -Please explain:


How will results be made available topeers and colleagues: Tick as many as apply

Conference papers

Journal article(s)

Thesis

Book

Other -Please explain

None -Please explain






  1. LEGAL ISSUES

Does the project involve subject matter or conduct that may give rise to legal vulnerability of participants or researchers?

Yes

No


Ifyes, please give details



Are adequate precautions to be taken?

Yes

No

N/A


Ifyes,please give details


Confidentiality of information provided can only be protected within the limitations of the law. Depending on the research proposal, you may need to state these limitations specifically(subpoena, freedom of information claim, mandated reporting by some professions, etc.)Have you included appropriate information on the legal limitations of protecting confidentiality in the PLIS and consent form?



Yes



No



N/A


Ifno, please advise how participants will be advised



  1. CHECKLIST OF ATTACHMENTS


Please check that the following documents are attached to your application. Applicants should note that where questionnaire or interview questions are submitted in draft form, a copy of the final documentation must be submitted for final approval when available.


Are the following documents attached?

Yes

No

N/A

Recruitment advertisement (e.g. for noticeboard or FedNews)

Plain Language Information Statement

*

Consent form

Evidence of external approvals related to the research

Pending

Questionnaire

Draft

Interview Schedule

Draft

Debriefing material

Other

* Required













  1. DECLARATIONS

Researcher Declarations:


The information contained herein is, to the best of my knowledge and belief, accurate. I have read theUniversity’s current human ethics guidelines,and accept responsibility for the conduct of theprocedures set out in the attached application in accordance with the guidelines, the Australian Government’sNational Statement on Ethical Conduct in Human Research 2007 (Updated May 2015),The Australian Code for the responsible Conduct of Research,and any other condition laiddown by the Federation University’s Human Research Ethics Committee or its sub-committees. I have attempted to identify all risks related to the research that may arise in conducting this research and acknowledge my obligations and the rights of the participants. I and my co-researchers and supporting staff have the appropriate qualifications, 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.


………………………………………………..

Principal Researcher



………………………………………………………

(Print name in block letters)


Date: …..../…...../….....



……………………………………………

Other Researcher


………………………………………………

(Print name in block letters)


Date: …..../…...../….....



……………………………………………………

Other Researcher


…………………………………………………

(Print name in block letters)


Date: …..../…...../….....


……………………………………………

Other Researcher


………………………………………………

(Print name in block letters)


Date: …..../…...../….....



……………………………………………………

Other Researcher


…………………………………………………

(Print name in block letters)


Date: …..../…...../….....


……………………………………………

Other Researcher


………………………………………………

(Print name in block letters)


Date: …..../…...../….....


……………………………………………………

Other Researcher


…………………………………………………

(Print name in block letters)


Date: …..../…...../….....

*NB: If the following section is not completed, the application will not be accepted for review.

Declaration by authorised signatory:

Head of School, Deputy Head of School, Associate Dean Research, or Ethics Coordinator (Mt Helen campus only)

I have reviewed this project and consider the methodological/technical aspects of the proposal to be appropriate to the tasks proposed and recommend its approval.

I consider the Researcher(s) to have the necessary qualifications, experience and facilities to conduct the research proposed and to deal with any emergencies and contingencies that may arise.

Comments/Provisos





Signature:……………………………………………………………………..




Signatory Name:……………………………………………………………………..





Head of School or

Deputy Head of School or


Associate Dean of Research or


Faculty Ethics Coordinator




Date............/……....../...........



CRICOS Provider No. 00103D

V1 2018

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