SBREC application submission guide · 2019. 8. 21. · APPLICATION SUBMISSION GUIDE . TABLE OF...

Flinders University SOCIAL AND BEHAVIOURAL RESEARCH ETHICS COMMITTEE

A P P L I C A T I O N S U B M I S S I O N G U I D E

TABLE OF CONTENTS SECTION A - PROJECT TITLE AND TIMEFRAME ...................................................................... 4

A1 Project Title ........................................................................................................................................ 4

A2 Plain language, or lay, title ................................................................................................................. 4

A3 Period for which approval is sought .................................................................................................. 4

SECTION B – RESEARCHER / SUPERVISOR INFORMATION ................................................... 4

SECTION C - PROJECT DETAILS ............................................................................................... 5

C1(a) Project Outline .................................................................................................................................. 5

C1(b) Project Significance ........................................................................................................................... 5

C1(c) Research Objectives .......................................................................................................................... 5

C2 Medical or health research involving the Privacy Act 1988 .............................................................. 5

C2(a) Records sought from a Commonwealth Agency ............................................................................... 5

C2(b) Health information ............................................................................................................................ 6

C3 Health research involving Aboriginal or Torres Strait Islander ......................................................... 6

C4 Project Type and Data ....................................................................................................................... 6

C5 Research Method .............................................................................................................................. 7

C6 Research Objectives .......................................................................................................................... 7

SECTION D – PARTICIPANT INFORMATION .............................................................................. 7

D1(a) Identity and Basis for Recruitment ................................................................................................... 7

D1(b) Participant numbers approached and population pool ................................................................... 7

D1(c) Source of Participants ...................................................................................................................... 8

D1(d) Conflict of Interest ............................................................................................................................ 8

D1(e) Participant Age .................................................................................................................................. 8

D1(f) Informed Consent ............................................................................................................................. 9

D2 Cultural or religious background ...................................................................................................... 9

D3 Language ......................................................................................................................................... 10

D4 - A Participant contact and recruitment .......................................................................................... 10

D4 - B Verbal Scripts .............................................................................................................................. 11

D4 - C Email text .................................................................................................................................... 12

D5 Participant Information .................................................................................................................. 12

D6 Direct Recruitment Approaches ..................................................................................................... 13

Developed by Andrea Fiegert - Last amended 29 June 2015 - 2 -

D7 Confidentiality and anonymity ....................................................................................................... 13

D8 Permissions ..................................................................................................................................... 13

D9 Incidental People ............................................................................................................................ 14

D10 Time Commitment .......................................................................................................................... 14

SECTION E – RESEARCH CONDUCTED OVERSEAS .............................................................. 15

E1 Recruitment of Overseas Participants ............................................................................................ 15

E2 Identity of Overseas Country.......................................................................................................... 15

E3 Overseas ethics approval processes ............................................................................................... 15

E4 Student supervision ........................................................................................................................ 16

E5 Overseas co-researchers ................................................................................................................ 16

SECTION F – SPECIFIC ETHICAL MATTERS ........................................................................... 16

F1 Values and benefits ....................................................................................................................... 16

F2 Burdens and Risks .......................................................................................................................... 16

F3 Management of burdens and/or risks ........................................................................................... 17

F4 Concealment .................................................................................................................................. 18

F5 Feedback and/or debriefing .......................................................................................................... 18

F6 Questionnaires .............................................................................................................................. 18

F7 Participant reimbursement ........................................................................................................... 19

F8 Data transcription .......................................................................................................................... 19

F9 Participant Control of Data ............................................................................................................ 19

F10(a) Data Transmission Protocols ......................................................................................................... 20

F10(b) Data Type....................................................................................................................................... 20

F10(c) Data de-identification .................................................................................................................... 20

F10(d) Data Storage Location ................................................................................................................... 20

F10(e) Data Retention Period ................................................................................................................... 21

SECTION G – OTHER MATTERS ............................................................................................... 21

G1 Other Ethics Committees / Centres ............................................................................................... 21

G2 Funding .......................................................................................................................................... 22

G3 Attachment Checklist ..................................................................................................................... 22

G4 Research involving or impacting on Indigenous Australians ......................................................... 22

SECTION H – CERTIFICATION and SIGNATURES ................................................................... 22

Research Involving Children or Vulnerable Adults ..................................................................................... 22

Translations ................................................................................................................................................ 23

Signatures ................................................................................................................................................... 23

APPENDIX B – LOW RISK CHECKLIST ........................................... Error! Bookmark not defined.

PARTICIPANT DOCUMENTS ..................................................................................................... 23

Letter of Introduction ................................................................................................................................. 23


Information Sheet ...................................................................................................................................... 25

Consent Forms ............................................................................................................................................ 26

Interview / Focus Group Questions ............................................................................................................ 28

Surveys ....................................................................................................................................................... 28

Debriefing / Feedback Information ............................................................................................................ 28


SECTION A - PROJECT TITLE AND TIMEFRAME A1 Project Title Provide the project title of the research project. A2 Plain language, or lay, title Provide a plain language, or lay, project title of the research project that describes the project with the exclusion of complex language or jargon. A3 Period for which approval is sought Date data collection is due to commence

Enter either the date that you would like to be able to commence data collection or check the box that says following approval. Please note that regardless of what date you list, data collection cannot commence until you have received formal notification of final ethics approval. This date needs to be at least 2-weeks after the Committee meeting date as a response will not emailed to you until 1 to 1 ½ weeks after the Committee meeting.

Date data collection is expected to be completed

Enter the date that ‘data collection’ is expected to be completed.

Date project is expected to be completed

Enter the date that the ‘project’ (including data collection and write up (e.g., thesis or project write up) is expected to be completed. The Committee recommends that the ‘write up’ stage of the project is covered under ethics approval to ensure that applicants will be able to make further contact with participants if need be (e.g., if additional research is recommended for a thesis). Please note that this is the date that will become the ethics approval expiry date for your project once final ethics approval is granted. If you ensure that the date listed here allows you enough time to collect data and write up your project this will minimise the need for you to request extensions of time later.

SECTION B – RESEARCHER / SUPERVISOR INFORMATION Principal Researcher List all contact details. If the research will be conducted as a

Flinders University student (even if the researcher is a staff member) then the Flinders University number and degree enrolled in needs to be provided. Note a student number only needs to be provided for the Principal Researcher (not 2nd or subsequent researchers).


All other researchers The contact details for all other researchers (internal and external) to be involved in the project need to be provided, including all supervisors.

Copies of correspondence All principal researchers and student supervisor’s SECTION C - PROJECT DETAILS C1(a) Project Outline Provide an outline of the research / evaluation project including why the project will be conducted. Please do not use acronyms / initials without an explanation of what they stand for. Even if as a researcher they are common knowledge they may not be known by Committee members from another discipline or lay members who are external to the University. National Statement reference See paragraph 5.2.6 under the heading ‘Researcher Responsibilities’ in Chapter 5.2: Responsibilities of HRECs, Other Ethical Review Bodies and Researchers. C1(b) Project Significance Provide an explanation of the significance of the research project. National Statement reference See 5.2.5 under the heading of ‘Researcher Responsibilities’ in Chapter 5.2: Responsibilities of HRECs, Other Review Bodies and Researchers. C1(c) Research Objectives Provide all of the research objectives of the project in a numbered format. Tab across to add more rows for additional research objectives. C2 Medical or health research involving the Privacy Act 1988 Indicate whether the research is related to medical or health matters. If YES, provide responses to items C2(a) and C2(b). If NO go to item C4. C2(a) Records sought from a Commonwealth Agency Answer this question if you answered YES to item C2. Indicate whether personal information will be sought from the records of a Commonwealth Agency. If YES, complete Part A of the Appendix ‘Privacy Legislation Matters’ that relates to compliance with the Guidelines under Section 95 of the Privacy Act 1988 available from the SBREC Guidelines, Forms and Template web page. Definitions from the Guidelines under Section 95 of the Privacy Act 1988

Personal information Personal information by which individuals or collectivities can be identified. This is defined in the Privacy Act 1988 as information or an opinion (including information or an opinion forming part of a database), whether true or not, and whether recorded in a material form or not, about an individual whose identity is apparent, or can be reasonably ascertained, from the information or opinion

http://data.gov.au/dataset/commonwealth-agencies/

http://data.gov.au/dataset/commonwealth-agencies/

http://www.nhmrc.gov.au/guidelines/publications/e26

http://www.flinders.edu.au/research/researcher-support/ebi/human-ethics/resources/forms.cfm


Commonwealth Agency A Commonwealth agency means a Commonwealth Minister, Department, body established under a Commonwealth act, or a person appointed by the Governor General or holding office under a Commonwealth act, a federal Court and the Federal Police.

C2(b) Health information Answer this question if you answered YES to item C2. Indicate whether health information will be sought from a Private Sector Organisation or a health service provider funded by the State Department of Health. If YES, complete Part B of the Appendix ‘Privacy Legislation Matters’ that relates to compliance with the Guidelines under Section 95 of the Privacy Act 1988 available from the SBREC Guidelines, Forms and Template web page. C3 Health Research involving Aboriginal or Torres Strait Islander Peoples Indicate whether the project comprises health research involving Aboriginal and Torres Strait Islander peoples. If YES, please note that YES should also be checked for item G4 regarding review by Yunggorendi First Nations Centre. IMPORTANT Proposals to conduct health-related research involving Aboriginal or Torres Strait Islander peoples or communities in South Australia must also be submitted to the Aboriginal Health Council of South Australia (AHCSA). National Statement reference See the NHMRC Value and Ethics – Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research. C4 Project Type and Data

Intent to Publish Indicate whether the project will be a research and/or evaluation project and whether there is any intent to publish (e.g., book, journal article, conference paper, thesis).

Primary data type Indicate whether the data to be obtained will be quantitative or qualitative.

Information Sought by Indicate whether information will be sought from participants by:

− questionnaire / survey; and/or − interview; and/or − focus group; and/or − experiment; and/or − computer / online; and/or − other (please state). Multiple types can be selected.

Audio/video Recording and Photography

Indicate whether participants will be audio recorded, and/or video recorded and/or photographed.

http://www.health.sa.gov.au/Default.aspx?tabid=70

http://www.nhmrc.gov.au/guidelines/publications/e26


http://www.flinders.edu.au/yunggorendi/

http://www.ahcsa.org.au/



C5 Research Method Provide an outline of the research method which includes the following information:

− who will be recruited to participate; − where participants will be sourced from (e.g., public, organisation, health service); − what participants will be asked to do (e.g., interviews, focus groups, survey). − whether participants will be audio recorded, video recorded or photographed. If YES, indicate

why and how this will assist the researcher in addressing the research objectives listed in item C1(c) below.

− where the research will be conducted. C6 Research Objectives Explain how the information being requested from participants addresses the research objectives listed in item C1(c). SECTION D – PARTICIPANT INFORMATION D1(a) Identity and Basis for Recruitment Outline who the participants will be and what the basis for their recruitment will be (e.g., organisation employee or client, student, member of public, have been diagnosed with Asperger’s Syndrome, health service client). If more than one participant type / group will be recruited to participate in the research, please list them in a numbered list or underneath clear headings. Please note: if you are planning on recruiting participants from any organisation which falls under the banner of the Southern Adelaide Local Health Network (SALHN) then your application does not fall under the remit of the Social and Behavioural Research Ethics Committee. You will need to submit a new ethics application to the Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC) instead. D1(b) Participant numbers approached and population pool

How many people approached? Indicate how many people (potential participants) will be approached to participate in the research. Please either specify the number or provide an approximation if the exact number is unknown. Note a response needs to be provided for each participant type / group.

Size of population pool? Indicate the size of the population pool from which participants will be drawn. Please either specify the number or provide an approximation if the exact number is unknown. Note a response needs to be provided for each participant type / group. The possible risks to participant anonymity and confidentiality cannot be assessed without this information. Please note that where the participant sample size is very

http://www.sahealth.sa.gov.au/wps/wcm/connect/public+content/sa+health+internet/about+us/our+local+health+networks/southern+adelaide+local+health+network

http://www.flinders.sa.gov.au/research/pages/ethics/7017/

http://www.flinders.sa.gov.au/research/pages/ethics/7017/


small it may not be possible to guarantee participant anonymity and/or confidentiality (see item D7).

D1(c) Source of Participants Indicate from what source participants will be recruited from (e.g., organisation staff or clients, members of public, school or university students). Please ensure that a response is provided for each participant type / group to be involved in the research in a numbered list.

1. Participant type / group 1 Source

2. Participant type / group 1 Source

3. Participant type / group 1 etc Source

If participants information will be sourced from a database please also indicate whether permission has or will be sought from the custodians of this data (please also include this information in item D8 regarding permissions). D1(d) Conflict of Interest Indicate whether any of the researchers (or research assistants) have any role, or relation (e.g., personal, professional financial), with the participants or organisation from which participants will be sourced as outlined in item D1(c). If YES, consider and comment on whether there may be a potential for a conflict of interest for any researchers (or research assistants) to be involved with the research. If YES please explain how any identified possible conflict of interest may be managed. References − See paragraph 3.1.3, paragraph 5.2.10 and Chapter 5.4: ‘Conflicts of Interest’ in the National Statement on Ethical

Conduct in Human Research; and − See section 7.2 under the heading of ‘Responsibilities of Researchers’ in the Australian Code for the Responsible

Conduct of Research.

D1(e) Participant Age Indicate whether participants will be under the age of 18 year of age. If YES, indicate what the age range of participants will be and whether participant information has been presented in a manner and format appropriate to the age group of participants. If some participants will be over 18 and some below check both the ‘yes’ and ‘no’ boxes and provide an explanation in the text boxes below. Please note that 17-year old Australian University students may participate in research without parental consent providing the project is deemed to be low risk by the SBREC. Participants recruited outside of an Australian University under the age of 18-years will require parental consent unless a compelling argument can be made to the Committee. Important Information If you are intending to conduct research involving children or vulnerable adults you are required to have undergone a Criminal History Check. A set of procedures has been agreed between the University and the Department for Communities and Social Inclusion (DCSI) Screening and Licensing Branch. For specific information about these procedures please refer to the About Human Ethics Approval SBREC webpage and the Criminal History Check Procedures webpage.

http://www.flinders.edu.au/research/researcher-support/ebi/human-ethics/about.cfm#vulnerable

http://www.flinders.edu.au/research/researcher-support/ebi/human-ethics/about.cfm#vulnerable

http://www.flinders.edu.au/staff/teaching-learning-resources/police.cfm


D1(f) Informed Consent Indicate whether participants will have the ability to give informed consent. If YES, check ‘yes’ in the yes/no response box. If NO, explain why participants may not be able to give informed consent and explain how this will be managed (e.g., parental / guardian / carer consent). Please be reminded that researchers should not deviate from the specific consent that participants have provided unless a submitted modification request has been reviewed and approved by the SBREC Chair. Please see below for an example. If participants have agreed / consented: Researchers should not:

To be involved in an anonymous audio-recorded interview where the audio-recording will only be used for the purposes of interview transcription by the researcher; and

Allow anyone else, other than the researchers, to have access to the audio-recordings.

That participation would be confidential and anonymous and that their identity or identifying information will not be published in any resulting reports and that only the researchers will have access to the original data collected.

Publish the identity of a participant, or any information that could result in a participant being identifiable. This would violate the anonymity and confidentiality assurances given to participants. The researchers should also not allow anyone other than the researchers to have access to the original information collected during the course of the research.

National Statement References − See section 2.2.6 under General Requirements for Consent; − See paragraph 3.1.6 under the heading of ‘Beneficence’; − See paragraphs 4.4.9 to 4.4.14 under the heading ‘Process to be followed’ for information on seeking consent form

people who are highly dependent on medical care; and − See paragraphs 4.5.5 to 4.5.10 under the heading ‘Respect’ for information on seeking consent form people with a

cognitive impairment, an intellectual disability, or a mental illness.

D2 Cultural or Religious Background Indicate whether the participant group is comprised of people from a specific cultural or religious background (e.g., Aboriginal and/or Torres Strait Islander peoples; Greek, Italian, French, Indonesian, etc) and whether any such categories are likely to form a significant proportion of the participants to be involved in the research. If the research will involve or impact on Aboriginal and/or Torres Strait Islander peoples, please note that YES should be checked for item G4 regarding review by Yunggorendi First Nations Centre. References See Chapter 4.7: Aboriginal and Torres Strait Islander Peoples of information about research involving or impacting on Indigenous peoples.




D3 Language Indicate whether there are particular issues with language. If participants first language is not English applicants should select ‘YES’ this question. Indicate whether participant information will need to be presented in a language other than English. If YES applicants are required to submit copies of all information to be given to participants in both English and the other language. Section H of the application form (Certification and Signatures) will request applicants to certify that accurate translations have been provided. If anyone other than the researcher will be involved in translating participants’ responses, please indicate how anonymity / confidentiality matters will be managed. The Committee recommends that translators be asked to complete and sign a confidentiality agreement a template for which can be downloaded from the Guidelines, Forms and Template web page. D4 - A Participant contact and recruitment Provide a detailed explanation of how participants will be contacted (e.g., approached) and recruited to participate in the research project. Please ensure that the following information is included: − how potential participants will be contacted / approached; − whether participant selection criteria will be used. If YES, please indicate what the selection

criteria is and ensure that participants are informed in all documents to be given to potential participants and any recruitment advertisements to be used;

− whether potential participants will be directly approached (e.g., face-to-face, telephoned, classroom, meeting) by either one of the researchers or by an organisation / service on the researcher’s behalf. If a third party (i.e., organisation / service) will recruit on behalf of the researcher the Committee prefers that interested respondents be asked to contact the researcher directly if they are interested in participating, rather than contacting the organisation / service. This ensures that the organisation / service provider will not have any knowledge who has agreed to participate which will serve to minimise possible perceptions of obligation / pressure to participate.

− how participants will indicate willingness to be involved in the project. For questionnaire studies, please note that questionnaire completion is considered to be consent with the exclusion of child participants. This means that although a consent form is not required for participants over the age of 18-years a parental consent form is required for child participants.

Please ensure that this information is provided for each participant type / group to be involved in the research. It is useful for the Committee if information requested above is listed under a clear heading for each participant type. For example;

1. Participant type / group 1 Information about contact and recruitment (as requested above)



National Statement References − See paragraphs 2.2.2 to 2.2.6 under General Requirements for Consent and 5.2.16 under Participants Interests’; − Paragraph 3.1.7 under the heading of ‘Research Merit and Integrity’; and − Paragraph 3.19 under the heading of ‘Justice’.



D4 - B Verbal Scripts If participants will be contacted directly (e.g, face-to-face, in class, by telephone) by either the researcher, or an organisation on the researcher’s behalf, please ensure that a verbal script is provided of what will be said to potential participants during contact and recruitment. The Committee recognises that a verbal script cannot predict all the possible responses or questions from potential participants and does not expect that the researcher will read directly from it during interaction with participants as this would impede open and natural communication. The verbal script should be an explanation of the key points that will be communicated to participants during contact and recruitment so that the Committee can be confident that participants will receive a complete picture of what the research entails to ensure that informed consent can be given. Please ensure that the following information, based on the information contained in the Letter of Introduction is included in verbal recruitment scripts:

− Opening statement Staff – introduce self (e.g., name, position, department / discipline / school). Student – introduce self (e.g., name, degree / course, department / discipline / school). In both cases the project should be identified as a Flinders University research project.

− Introduction of Project This should include the project title, plain language description of the project and what data collection will lead to (e.g., thesis, publication, film, book, poster etc).

− Invitation to participate An invitation to participate should include:

o What each person will be asked to do if they agree to participate in the research (e.g., interview, questionnaire, observations, focus groups, photography etc);

o A clear explanation that participation is entirely voluntary and that non-participation will have no adverse implications on courses of study, results, services provided or employment (whichever is relevant);

o An indication of the expected time commitment (e.g., 30 minutes on 2 occasions); and o Where the research will be conducted (e.g., workplace, classroom during class time,

public place, online, own home etc).

− Snowball sampling Participants recruited via snowball sampling should be given an information pack about the research allowing interested respondents to contact the researcher directly if they would like to participate. This approach serves to (a) protect the anonymity of potential participants and (b) allow self-selection of interested respondents. Requests for individuals to provide the names and contact details of other individuals who may be interested in participating will not be approved by the SBREC.

− Anonymity and Confidentiality Assurances Include a clear statement advising respondents whether or not participation will be anonymous and/or confidential. If anonymity and/or confidentiality cannot be assured please ensure that Information Sheet also includes this information and an explanation as to why these assurances can’t be given.

− Recording (audio / video) Advise potential participants whether audio and/or video recording will be conducted as part of the research. If YES, advise what specifically will be recorded. In addition, advise potential participants that consent will be obtained for recording to occur on the consent form to be provided.

− Consent Advise potential participants how they can indicate their consent to participate (or assent in the case of minors). For example, completion of a Consent Form, completion and return of a questionnaire or a verbal statement (if appropriate).


− Secretarial / Transcription Assistance Advise potential participants whether secretarial assistance or a professional transcription company (or translators) will be used for the research. If YES, please provide advice that they will be bound by the same level of confidentiality as the researchers and will be asked to sign a confidentiality agreement. A template for this is available from the Guidelines, Forms and Template SBREC web page.

− Thank you If a respondent does not wish to participate, thank them for their time.

Important If respondents will be recruited face-to-face offer a copy of the Letter of Introduction and Information Sheet at the time they are approached. If respondents are approached via telephone, ensure that a copy has already been sent to them prior to contact or offer to send them some more information following the telephone call. D4 - C Email text If participants will be directly approached by email (by researcher or organisation / service) please ensure that the text of what will be said in the email is provided so that the Committee can confirm that informed consent can be given. Please note that participant recruitment emails to be distributed for student projects need to be written and come from the student’s supervisor using wording based on the Letter of Introduction pro forma available from the Guidelines, Forms and Template webpage. Please also note that a copy of the Information Sheet should be attached to the email. Please ensure that the following information is included:

− Researcher is introduced;

− Project identified as a Flinders University research project;

− A description of the project is provided;

− A clear explanation of what would be expected of participants (e.g., participation in an interview, questionnaire completion etc);

− An invitation to participate and a clear statement that participation is entirely voluntary and that choosing not to participate will have no negative implications (e.g., on services provided, course of study or results, employment etc);

− An indication of the expected time commitment;

− If approached face-to-face, offer a copy of the Letter of Introduction and Information Sheet. If approached via telephone then ensure that a copy has already been sent to them prior to contact or offer to send them some more information.

− Explanation of how they can indicate their willingness to participate (e.g, complete consent form and hand back to researcher, complete questionnaire at time or later stage, post completed consent form back, verbal consent).

− If a respondent does not wish to participate, thank them for their time.

National Statement Reference See paragraphs 2.2.2 to 2.2.6 under General Requirements for Consent and 5.2.16 under Participants Interests’. D5 Participant Information List what information will be given to participants; and when this information will be provided (e.g, recruitment email, letter of Introduction, information sheet, consent form, questionnaire, debriefing information).






The Committee seeks an assurance that documents such as recruitment emails, Letters of Introduction, Information Sheets and Consent Forms are distributed to potential participants before a decision is made on whether or not to participate so that informed consent can be given. National Statement References See paragraphs 2.2.2 to 2.2.6 under General Requirements for Consent and 5.2.16 under Participants’ Interests in the National Statement on Ethical Conduct in Human Research. D6 Direct Recruitment Approaches

Indicate whether potential participants will be directly approached by either one of the researchers or an organisation / service on the researcher’s behalf. Recruitment conducted face-to-face, via email, via telephone, within a meeting or classroom setting is considered to be a direct personal approach. If recruitment will be conducted via a direct personal approach please consider and explain how the researchers will address any real or perceived coercion or obligation to participate felt by potential participants. D7 Confidentiality and anonymity

Confidentiality and Anonymity Assurances

Explain what confidentiality and anonymity assurances will be given to potential participants (e.g., will participation be anonymous and/or confidential?). Please ensure that this is clearly explained to potential participants in the Letter of Introduction and Information Sheet.

Please note that where the participant sample size is very small it may not be possible to guarantee participant anonymity and/or confidentiality.

Informed Consent Explain how free and informed consent will be obtained from participants.

References − National Statement on Ethical Conduct in Human Research, see section 2.2.6 under General Requirements for

Consent; − National Statement on Ethical Conduct in Human Research, see paragraph 3.1.11 under the heading of

Beneficence; and − Australian Code for the Responsible Conduct of Research paragraphs 2.5.2 and 2.7.

D8 Permissions Indicate (in a numbered list) whether any permission(s) will need to be sought to conduct the research, whether the request for permission and correspondence granting permission is attached. Examples of people / organisations permission may need to be sought from include; − Organisational Head from which employee participants will be recruited; − Health Service Head from which employee and/or client/patient participants will be recruited; − School principal of a Primary or Secondary School from which employee, parent/guardian and

child participants may be recruited. This applies to public, private, independent and catholic schools.

− Department for Education and Child Development (DECD); − Catholic Education Office; − Head of a Child care Organisation from which employee and/or child participants will be

recruited;

http://www.decd.sa.gov.au/research/pages/research/


− Flinders University Head of (relevant) School; − Flinders University (relevant) Course Coordinator; − Dataset / database custodians; − Community leaders (i.e., Indigenous communities, overseas communities); − Permit / permission to enter protected Indigenous lands. Please note − that permission should be sought, in the first instance, from the Chief Officer or Head of the

peak organisation or governing body unless adequate justification can be provided that contextual circumstances require a different approach;

− that permission cannot be provided from any of the researchers listed on the application. If permission needs to be sought from, for example, the Head of a Department (one of researchers) then permission will need to be provided by either another senior member of the Department Management or someone from Faculty management.

− that where a class application is submitted by a course coordinator / lecturer permission letters will need to be provided for every student.

D9 Incidental People Consider and comment on whether any incidental people may be involved in the research. Examples of people that may be incidentally involved in research include: − family members and house mates if research (e.g., interview) is conducted in participants

homes; − children and spouses if they are present when research is conducted (e.g., interview, survey). − colleagues (including management) if research is conducted in the workplace; − members of the public if research is conducted in a public place (e.g., café, park, shopping

mall); If anyone may be incidentally involved in the research please consider and comment on how incidental people may be informed about the research. Examples may include; − An oral statement to the person or group incidental to the research immediately prior to the

commencement of the research may be sufficient; − For situations where large groups of people may be incidentally involved in a public place it

may be appropriate to place a sign with information about the research or distribute some flyers. If a sign or flyers will be used please provide a copy for the Committee to review.

D10 Time Commitment Please indicate how long you think each component of the research will take participants to complete (e.g, survey, interview, focus group, observation) and where the specific component will be conducted. This question does not relate to the time commitment expected for the researchers. If any component of the research will be conducted within participants home please consider and comment on whether any safety precautions may need to put into place to protect the wellbeing of both the researcher(s) and participants. Include this information in the response to items F2 and F3 of the application form. Please ensure this information is clearly conveyed to potential participants in the Letter of Introduction and Information Sheet to ensure that informed consent can be given.


National Statement References

− See paragraphs 2.2.2 to 2.2.6 under General Requirements for Consent and 5.2.16 under Participants’ Interests in the National Statement on Ethical Conduct in Human Research; and

− Section 5.1.2 (b) under Processes of Research Governance and Ethical Review in the National Statement on Ethical Conduct in Human Research.

SECTION E – RESEARCH CONDUCTED OVERSEAS E1 Recruitment of Overseas Participants Indicate whether the research will be conducted overseas. Please note that regardless of the physical location of the researcher, if participants to be recruited are located overseas the NHMRC considers it to be overseas research. As such, the National Statement and local ethical considerations will need to be considered to by the researcher. If your project will recruit overseas research participants please:

− read item 4.8.4 in the chapter ‘People in other Countries’ of the National Statement on Ethical Conduct in Human Research; and

− ensure you are familiar with the University’s Policy on Travel, Accommodation and Subsistence available from http://www.flinders.edu.au/ppmanual/policySecretariat/travel.html which states that all travel is prohibited to Level 5 regions (see section 7). Please be reminded that all travel to level 4 areas requires approval from the person responsible for authorising travel in your area and the Cost Centre Head.

If your project will not recruit overseas research participants go straight to item F of the application form and do not complete anything else in section E. National Statement Reference See Chapter 4.8: ‘People in other countries’ of the National Statement on Ethical Conduct in Human Research. E2 Identity of Overseas Country Indicate which country or countries the research project will be conducted in or research participants will be recruited from. E3 Overseas ethics approval processes Explain whether there any ethics approval processes relevant to the research in the country or countries the research will be conducted in. If YES, please indicate whether the processes are mandatory and given a brief explanation of how the ethics approval process functions. Please also explain the values and principles on which the ethics approval processes rely and whether they require reporting of approval from the SBREC before approval will be granted. If YES, please confirm that you will provide a copy of any relevant overseas ethics approvals to the Committee on receipt. Please also ensure that you include this information in response to item G1. If NO, please provide written evidence of how you know that ethics approval from the relevant country (or countries) is not required if possible. For student projects, if written evidence cannot be provided please attach a letter from your supervisor confirming that ethics approval will not need to be sought.

http://www.flinders.edu.au/ppmanual/policySecretariat/travel.html


E4 Student supervision If the researcher is a student, please explain how their academic supervision will be maintained while you are in the field overseas, with particular reference to the wellbeing of both the researcher(s) and participants. National Statement Reference − See Section 1: Value and Principles of Ethical Conduct; and − See section 5.1.2 (b) under Processes of Research Governance and Ethical Review. E5 Overseas co-researchers Indicate whether any co-researchers will be recruited in the country or countries in which the research will be conducted. If NO, please proceed to section F of the application. If YES, please explain how their expertise and capacity to conduct the component of the research they will be involved in will be determined. SECTION F – SPECIFIC ETHICAL MATTERS F1 Values and benefits Explain the value and benefits of the project to the participants, the discipline and the community. National Statement Reference See Section 1: Values and Principles of Ethical Conduct in the National Statement on Ethical Conduct in Human Research. F2 Burdens and Risks Not discounting the value and benefits of the project, consider and explain to the Committee what possible burdens and/or risks may be associated with the project for both researchers and participants. The Committee requires this information:

− to confirm that any possible burdens and/or risks identified will be managed appropriately (see item F3) by the researchers; and

− to confirm that the benefits of the research outweigh any possible burdens and/or risks in order to comply with the National Statement on Ethical Conduct in Human Research.

Examples of possible burdens and/or risks may include:

− psychological harms, including feelings of worthlessness, distress, guilt, anger or fear (e.g., disclosure of sensitive or embarrassing information or learning about a genetic possibility of developing an treatable or untreatable disease);

− physical harms, including injury, illness or pain; − risks to the safety and wellbeing of researchers and/or participants; − devaluation of personal worth, including being humiliated, manipulated or in other ways treated

disrespectfully or unjustly; − social harms, including:

• damage to social networks or relationships with others; • discrimination in access to benefits, services, employment or insurance; • social stigmatisation; and


• findings of previous unknown paternity status. − economic burdens / harms, including the imposition of direct or indirect costs on participants;

and − legal harms, including discovery and prosecution of criminal conduct. If the researcher(s) are

mandated reporters or it is possible that illegal activities could be uncovered or disclosed during the course of the research, participants should be advised in the Information Sheet that although information will be treated with the strictest confidence by the researcher but that disclosure of information either must be reported to the relevant authorities or cannot be safe from legal search or seizure.

National Statement References − See Section 1: Value and Principles of Ethical Conduct; − Section 2 under Chapter 2.1: Risk and Benefit (specifically paragraphs 2.1.2 – 2.1.8); − Paragraph 3.1.2 under the heading of ‘Research Merit and Integrity’; and

− Chapter 4.6: People who may be involved in illegal activities.

F3 Management of burdens and/or risks Please explain in detail how any possible burdens and/or risks associated with the project identified in item F2 (above) will be responded to and managed. Depending on the possible burdens and/or risks associated with a project, it may be advisable for applicants to provide potential participants with the contact details of free support services, which may be accessed if required, in the Information Sheet. It is important to provide these contact details to potential participants prior to any decision being made about whether or not to participate to ensure that informed consent can be given. The Committee requires this information:

− to confirm that any possible burdens and/or risks identified (item F2) will be managed appropriately by the researchers; and

− to confirm that the benefits of the research outweigh any possible burdens and/or risks in order to comply with the National Statement on Ethical Conduct in Human Research.

Some ways to manage some burdens and/or risks: Possible burden and/or risk Possible ways to manage Economic burdens Economic burdens, including the imposition of direct or indirect costs on

participants can be managed by reimbursing participants an amount proportionate to the costs associated with research participation.

Psychological harms Psychological harms, including feelings of worthlessness, devaluation of person worth, distress, guilt, anger or fear (e.g., disclosure of sensitive, personal and/or embarrassing information) can be managed by ensuring participants are provided with the contact details of relevant counselling services on the Information Sheet which participants may access free of charge if required. It is important that potential participants receive this information prior to making a decision about whether or not to participate to (a) ensure that informed consent can be given and (b) to ensure that the onus is not on the participant to contact the researcher if they are distressed. Please note that counselling should note be provided by the researchers. Even if a researcher has extensive clinical experience the Committee advises that a clear line needs to be drawn between a clinical setting and research. On that basis it is not appropriate for the researcher to provide counselling to participants for the purposes of the research.

Safety Issues for research conducted in the home of a participant

− Take another researcher or research assistant with you if possible. The Committee acknowledges that this is not always possible.

− If conducting research alone, applicants could consider (a) taking a mobile phone with them ensuring it is easily accessible; and/or (b)


arranging to have telephone contact with a colleague or supervisor (who knows the address of where you’ll be) before and after visiting a participant’s home.

Refer to section 5.1.2 under Processes of Research Governance and Ethical Review in the National Statement on Ethical Conduct in Human Research.

Legal Harms including discovery or disclosure of criminal activity

If the researcher(s) are mandated reporters or it is possible that illegal activities could be uncovered or disclosed during the course of the research, participants should be advised in the Information Sheet that although information will be treated with the strictest confidence by the researcher but that disclosure of information either must be reported to the relevant authorities or cannot be safe from legal search or seizure.

National Statement References

− See Section 2.2.6 under General Requirements for Consent in the National Statement on Ethical Conduct in Human Research; and

− Section 2 under Chapter 2.1: Risk and Benefit (specifically paragraphs 2.1.2 – 2.1.8) in the National Statement on Ethical Conduct in Human Research.

F4 Concealment Indicate whether the true purpose of the research will be concealed from participants. If YES, please outline the rationale for, and provide details of, the concealment. The Committee understands that concealing the true purpose of a project is sometimes necessary for the purposes of the research project, however seeks an assurance that any concealment is justified and that participants are provided with appropriate de-briefing information. National Statement reference See paragraphs 2.3.1 to 2.3.4 in the Chapter 2.3: Qualifying or Waiving Conditions for Consent. F5 Feedback and/or debriefing Indicate whether or not any feedback or debriefing will be provided to participants that may be relevant to the research. The Committee recommends that debriefing information be provided of any research involving the concealment of the true purpose of the research (item F4) from participants. If YES, please explain in detail how and when participants will be informed of any deliberate deception and provide any information to be provided to participants. References − See paragraph 1.5 under the heading of ‘Justice’ and paragraph 1.3(d) under the heading of ‘Research Merit and

Integrity’ in Section 1: Value and Principles of Ethical Conduct of the National Statement on Ethical Conduct in Human Research;

− National Statement on Ethical Conduct in Human Research, see paragraph 3.1.15 under the heading of ‘Beneficence’; and

− See section 4.4 to 4.12 under the heading of ‘Responsibilities of Researchers’ in the Australian Code for the Responsible Conduct of Research.

F6 Questionnaires If participants are required to complete a questionnaire, explain what the arrangements are for the secure and confidential return of completed questionnaires to the researcher. Examples of secure and confidential return of questionnaires may include:

− return via a sealable self-addressed envelope; − personal collection by the researcher (if participation is not anonymous);


− secure collection box place in a location accessible by participants following completion. Please also ensure that you explain how participants will be informed of the arrangements for the return of completed questionnaires. It is recommended that the arrangements are included in the Information Sheet even if instructions are also provided to participants verbally or at the end of the questionnaire. Information Sheets The Committee advises that a full Information Sheet will need to be provided to all potential participants (in writing or electronically) that may be involved in a questionnaire study. Half-page condensed versions of the Information Sheet as the questionnaire introduction will not be accepted.

F7 Participant reimbursement Indicate whether it is the intention of the researcher to reimburse participants. If YES, please indicate how participants will be reimbursed (e.g., monetary value, voucher, meal) and provide a justification for the re-imbursement. It is generally appropriate to reimburse the costs to participants associated with taking part in the research including costs such as travel, accommodation and parking. On some occasions it may be appropriate for participants to be paid for time involved in the research; however any payment that is disproportionate to the time involved, or any other inducement that is likely to encourage participants to take risks, is considered to be ethically unacceptable. Please note that the SBREC does not approve the use of raffles and lotteries as incentives for participation without the provision of a compelling case. Decisions about payment or reimbursement in kind, whether to participants or their community, should take into account the customs and practices of the community in which the research is to be conducted. National Statement reference See items 2.2.10 and 2.2.11 under the heading Reimbursing Participants in the National Statement on Ethical Conduct in Human Research. F8 Data transcription Please indicate whether there may be any relevant data transcription issues. For example:

If conducting interviews or focus groups will audio or video-recorded data need to be transcribed?

If YES, will it need to be transcribed by the researcher(s), secretarial assistance or by a professional transcription company? If a transcription company will be involved, the Committee will seek an assurance that they will be asked to sign a transcription confidentiality agreement. A template for this can be found on the SBREC Guidelines, Forms and Template web page.

F9 Participant Control of Data Please explain whether participants will have any control over the immediate reporting and in future use of data collected during the course of the research. For example, will participants have the opportunity to view transcripts of their interview and/or the final report for comment / amendment? Ensure that you clearly explain to participants (preferably in the Information Sheet) what access they may have to data and how they will get this access.



F10(a) Data Transmission Protocols Explain what protocols will be used for the secure transmission of data if data is sent to: • Transcribers (transcription company, secretarial assistance or researchers); • Translators (formal translators, community translators or researchers); or • Other members of the research team (including student supervisors). IF transcription or translation services will be used, explain whether the data received will be deleted on completion of the services. F10(b) Data Type Explain how the data will be stored on completion of the project. For example: • Will any written data be stored in hard-copy? • Will audio recordings be stored? • Will video recordings be stored? • Will data be stored on the Flinders University computer server? Important − USB / flash drives are not considered to be a secure data storage medium following

completion of the research. Data storage using a USB / flash drive will not be approved; − Those holding primary material (e.g., research data), including electronic material, must

understand their responsibilities for security and access; and − The Committee recommends that audio tapes should be retained as they may be required for

the verification of results and/or secondary data analysis unless written transcriptions have been reviewed and agreed to by participants.

Reference See paragraph 2.4.4 and section 2.5 under the heading of ‘Responsibilities of Researchers’ in the Australian Code for the Responsible Conduct of Research. F10(c) Data de-identification Indicate whether data will be stored in a de-identified form. If YES, please indicate whether this means that: a) The data cannot in any way be linked to an individual or organisation (non-identifiable data);

OR b) The data has had all identifying information removed but the means still exists to re-identify

individuals and/or organisations (re-identifiable data). If NO, please explain to the Committee how any relevant anonymity and confidentiality standards will be met for data. National Statement Reference See Chapter 3.2: Databanks under the heading of ‘what are data?’. F10(d) Data Storage Location

Indicate where the data will be stored securely. Wherever possible and appropriate, research data should be held in the researcher’s department or other appropriate institutional repository; however researchers will be permitted to hold copies


of the research data for their own use. If research data will be stored in any locations other than Flinders University applicants must provide full details of storage arrangements. Reference Australian Code for the Responsible Conduct of Research paragraph 2.2.2.

F10(e) Data Retention Period Indicate how long research data will be stored securely at Flinders University for. − Research data for class projects, submitted by a topic coordinator (covering all students in

topic) that is for assessment purposes only, needs to be stored for at least 12-months. − Research data involving a South Australian Government Department needs to be stored for at

least 7-years from the data of publication. − Research data for all other research conducted needs to be stored for at least 5-years from the

date of publication. − Note that research data for work that has community or heritage value should be stored

permanently, preferably within a national collection. Reference Australian Code for the Responsible Conduct of Research paragraphs 2.1, 2.2.2, 2.5, 2.6 and 2.7.

SECTION G – OTHER MATTERS G1 Other Ethics Committees / Centres Consider and indicate whether any other centres or Ethics Committee(s) will be approached for approval of this project. For example: − School of Medicine Research and Evaluation Reference Group – for Graduate Entry Medicine

Program (GEMP) projects; − Other NHMRC Ethics Committees. If YES, please indicate which centre or Ethics Committee approval will be sought from and whether or not approval has been received yet. Also, please ensure that you submit a copy of the approval with your application. IMPORTANT Please note that Flinders University now accepts ethics approvals for social and behavioural research projects from external / non-Flinders Human Research Ethics Committees that are registered with the NHMRC, without further scrutiny. Therefore, in such cases, approval from the Flinders SBREC is not required. However, a copy of the application (with attachments) and final approval notice must be provided to the SBREC Executive Officer via email to [email protected] Full information is provided on the SBREC homepage. Health Research Involving Aboriginal or Torres Strait Islander Peoples Proposals to conduct health-related research involving Aboriginal or Torres Strait Islander peoples or communities in South Australia must be submitted to the Aboriginal Health Council of South Australia (AHCSA). As AHCSA is registered with the NHMRC, ethics approvals will be accepted from them, and there is then no requirement to gain approval from Flinders SBREC, as described immediately above.

http://www.sa.gov.au/government/links

http://www.nhmrc.gov.au/health-ethics/human-research-ethics-committees-hrecs/human-research-ethics-committees-hrecs

mailto:[email protected]

http://www.flinders.edu.au/research/researcher-support/ebi/human-ethics/human-ethics_home.cfm




G2 Funding Indicate whether funding has been applied for or received, and whether the funding source was internal (i.e., Flinders University) or external (e.g., ARC or NHMRC). If funding has been applied for or received, please indicate: − The amount of funding; − The name of the funding body or bodies; − The grant project title; − The grant project number (if known); and − Any affiliation or financial interest.

National Statement reference See paragraph 5.2.7 under the heading ‘Researcher Responsibilities’ in Chapter 5.2: Responsibilities of HRECs, Other Ethical Review Bodies and Researchers.

G3 Attachment Checklist Please ‘select’ all the documents that are attached to your ethics application. IMPORTANT: Please double-check that those attachments are attached to the PDF version of your ethics application before it is submitted. It is the responsibility of the applicant to ensure that all relevant documentation is attached for the Committee to review. If all relevant information is not attached this may impact the ability of the Committee to review your application. G4 Research involving or impacting on Indigenous Australians If your research involves or impacts on Indigenous Australians in any way, check ‘yes’ in response to this question. A copy of your application will be forwarded by the SBREC Executive Officer to the Yunggorendi First Nations Centre for Higher Education and Research, for comments and recommendations, which will be incorporated into the Committee's response. SECTION H – CERTIFICATION and SIGNATURES Research Involving Children or Vulnerable Adults If you are intending to conduct research involving children or vulnerable adults you are required to have undergone a Criminal History Check. A set of procedures has been agreed between the University and the Department for Communities and Social Inclusion (DCSI) Screening and Licensing Branch. For specific information about these procedures please refer to the About Human Ethics webpage and the Criminal History Check Procedures webpage. Please ensure that you provide a response to the two questions listed below regardless of whether or not your project involves children and/or vulnerable adults. − Indicate whether your proposed research involve you, or any member of your research team in

undertaking any activities involving children or vulnerable adults. − If YES, indicate whether you, and/or any member(s) of the research team who will be

conducting these activities, have applied for and been notified that you and/or they have a cleared criminal history check, and whether this clearance is current for the life of the proposed study.

http://www.flinders.edu.au/yunggorendi/index.cfm

http://www.flinders.edu.au/yunggorendi/index.cfm

http://www.flinders.edu.au/research/researcher-support/ebi/human-ethics/about.cfm

http://www.flinders.edu.au/research/researcher-support/ebi/human-ethics/about.cfm

http://www.flinders.edu.au/staff/teaching-learning-resources/police.cfm


Translations Indicate whether your proposed research requires documentation to be translated into another language. Signatures All submitted applications must include the true signature (scanned or electronic signature) of the principal researcher. For student projects please note that it must also be signed by the students supervisor. LOW / NEGLIGIBLE RISK ASSESSMENT FORM If you feel that your project is either low or negligible risk research please also submit a copy of the ‘Low / Negligible Risk Assessment Form’ along with your application form and all relevant attachments. Please refer to the SBREC home page for more information on how low and negligible risk applications are reviewed. National Statement reference − See Section 2: Themes in Research Ethics: Risk and Benefit, Consent; and − Paragraph 3.1.7 under the heading of ‘Beneficence’. PARTICIPANT DOCUMENTS Letter of Introduction The purpose of a Letter of Introduction is to introduce the student researcher(s) to potential participants, provide them with information about the project to assist them to give informed consent and to invite them to participate in there research. Please note that the Letter of Introduction needs to be provided to potential participants prior to a decision being made about whether or not to participate. Please note that a Letter of Introduction is only required for student research projects (i.e., not required for staff research projects). National Statement Reference See Section 2.2.6 under General Requirements for Consent. The guidelines and customisable template for a Letter of Introduction can be found on the SBREC Guidelines, Forms and Template web page, however a summary of what must be included in the Letter of Introduction is listed below. Important. If it is necessary to submit more than one Letter of Introduction, please ensure that you include label header on each one which indicates who it is intended for. Letterhead Flinders University letterhead containing the contact details of the

person who will be signing the letter (i.e., should be supervisor for student projects). If the research is to be conducted overseas ensure that international dialling codes are listed including all phone numbers listed in the SBREC contact information footer.

http://www.flinders.edu.au/research/researcher-support/ebi/human-ethics/human-ethics_home.cfm



If it is necessary for a mobile number to be listed (e.g., for rural or overseas research) the Committee advises that unless unavoidable it is preferable that personal mobile numbers are not listed. Applicants should understand that listing of a personal mobile number carries with it a risk that participants may continue to contact the researcher following completion of the research.

Opening Statement The student’s primary supervisor should introduce the student, including their full name, degree/course and department / discipline / school. Please ensure that the project is identified as a Flinders University project.

Project Introduction State the project title in full, list a plain language description of the project and indicate what data collection will lead to (e.g., thesis, publication, film, book, poster etc).

Invitation Include:

− what the potential participant is being asked to participate in (e.g., interview, focus group, survey, observation, audio and/or video recording, photography);

− that participation is voluntary and that participants can withdraw at any time without negative implications on their course of study / employment / service provided;

− the expected time commitment for participation for each component of the research if there is more than one (e.g. 30 minutes on two occasions); and

− where the research will be conducted (e.g., in workplace, in classroom, in public place, online, participants home etc).

Snowball Sampling Participants recruited via snowball sampling should be given an information pack about the research allowing interested respondents to contact the researcher directly if they would like to participate. This approach serves to (a) protect the anonymity of potential participants and (b) allow self-selection of interested respondents. Requests for individuals to provide the names and contact details of other individuals who may be interested in participating will not be approved by the SBREC.

Consent Advise potential participants how they can indicate consent to participate (or assent in the case of minors). For example, consent form completion, completion of survey, verbal statement). If a consent form will be required please explain how this can be returned to the researchers.

Confidentiality Include EITHER an assurance of confidentiality and anonymity OR a statement that confidentiality and anonymity cannot be guaranteed and the reasons why not. It is ok if the anonymity cannot be assured; you just need to make sure that you clearly inform potential participants about this.

Recording Advise potential participants whether audio and/or video recording will be conducted as part of the research. If YES, advise what specifically will be recorded. In addition, advise potential participants that consent will be obtained via a consent form to be provided.


Secretarial Assistance Advise potential participants whether secretarial assistance, a professional transcription company, or translators will be used for the research. If YES, please advise whether or not they will be bound by the same level of confidentiality as the researchers. The Committee recommends that translators and transcribers should be asked to sign a confidentiality agreement.

Enquiries Direct any enquiries relating to the research to the person signing the letter which will be the student’s supervisor.

Sign-off Yours sincerely, name, position and department / discipline / school.

Ethics Approval Add the following statement at the bottom of the letter to advise potential participants that they can contact the SBREC if they have a complaint about the research or would like further information about the ethics approval of the project.

This research project has been approved by the Flinders University Social and Behavioural Research Ethics Committee (Project Number xxxx)(This number will be provided by SBREC following approval). For more information regarding ethical approval of the project the Executive Officer of the Committee can be contacted by telephone on 8201-3116 or by fax on 8201-2035 or email [email protected].

Information Sheet An Information Sheet provides more detailed information about the project than the Letter of Introduction which must be provided to potential participants to ensure that informed consent can be given. Please note that Information Sheet needs to be provided to potential participants prior to a decision being made about whether or not to participate. Important. If it is necessary to submit more than one Information Sheet, please ensure that you include label header on each one which indicates who it is intended for. National Statement References − See Section 2.2.6 under General Requirements for Consent; and − See items 2.2.10 and 2.2.11 under the heading of ‘Reimbursing participants’.

An Information Sheet example and guidelines are available from the Guidelines, Forms and Template web page, however a summary of what should be included in an Information Sheet to ensure potential participants are able to give informed consent are listed below. a) a description of the project in language appropriate to the audience; b) an explanation of the participant’s role in the project which advises:

− what the potential participant is being asked to participate in (e.g., interview, focus group, survey, observation, audio and/or video recording, photography);

− that participation is voluntary;

− the expected time commitment for participation for each component of the research if there is more than one (e.g. 30 minutes on two occasions); and

− where the research will be conducted (e.g., in workplace, in classroom, in public place, online etc).

mailto:[email protected]




c) an explanation of how a respondent can indicate their willingness to be involved (e.g., sign consent form and send it to researcher at specified address; completion of questionnaire will indicate consent etc);

d) any alternatives to participation (e.g., research conducted in a classroom situation where not all students will choose to participate. What activity will they be involved with in this situation?);

e) how the research will be monitored; f) whether there may be any possible burdens and/or risks associated with participation in the

research project (see guidelines for items F2 and F3); g) if the researcher(s) are mandated reporters or it is possible that illegal activities could be

uncovered or disclosed during the course of the research, participants should be advised in the Information Sheet that although information will be treated with the strictest confidence by the researcher but that disclosure of information either must be reported to the relevant authorities or cannot be safe from legal search or seizure.

h) provision of services to participants adversely affected by the research (e.g., contact details of free counselling services that may be accessed if required). If it is necessary to provide this information please ensure that it is included in the Information Sheet which is provided to potential participants before a decision is made about whether or not to participate;

i) contact details of the researchers (all researchers listed in item B1 of the application, including student supervisors);

j) how anonymity and confidentiality will be protected (e.g, advise whether or not anonymity and confidentiality can be assured. If not, explain why it can’t be assured);

k) the participant’s right to withdraw from further participation at any stage, along with any implications of withdrawal and whether this also means that data can be withdrawn at any stage;

l) the amounts and source(s) of funding for the research; m) financial and other relevant declarations of interests of researchers, sponsors or institutions; n) any re-imbursement of costs to participants (e.g, travel costs, reimbursement for time). Please

note that the SBREC does not approve the use of raffles and lotteries as incentives for participation without the provision of a compelling case.

o) the likelihood and form dissemination of the research results, including publication (e.g., thesis, journal article, poster, book, film).

p) any expected benefits to the wider community; and q) any other relevant information. Consent Forms Potential participants need to be provided with a Consent Form prior to making a decision about whether or not to participate to ensure that informed consent can be given. Important –

1. If it is necessary to submit more than one Consent Form, please ensure that you include label header on each one which indicates who it is intended for.

2. In every respect the Consent Form must accord with the information provided to the Committee in the application form and to potential participants in the Letter of Introduction and Information Sheet.


National Statement Reference − See Chapter 2.2 which specifically deals with consent; − See Section 2.2.6 under General Requirements for Consent; and − See items 4.2.6 and 4.2.7 in Chapter 4.2: Children and Young People.

Consent Form templates are available from the Guidelines, Forms and Template web page which should be amended, as necessary, to make it relevant and appropriate to the proposed research. Please remember to renumber items following amendment. The four types of Consent Forms should be used for the following:

Consent Form (standard) − Interviews (structured; semi-structured; unstructured)

− Focus Groups

− Experiments

Note: Consent Forms are not required for surveys for adult participants (> 18 years). Completion of the survey is considered to be consent.

Consent Form (parent / guardian) Research involving the recruitment of child participants (< 18 years) or those who lack competence to give their consent (e.g., people with a mental disability and/or highly dependent on medical care) involving:

− a survey; − interview; − focus group; − observation; or − recording (e.g., photography, audio or video recording

research participation). Note: where possible the Committee recommend that where child participants are capable, they be afforded the opportunity to countersign the Parental Consent Form to indicate their assent.

Consent Form (observation of professional activity)

Observation of professional activity.

Photographic Release Form Research involving the taking of photographs. A separate Consent Form is required to ensure that potential participants have the option of choosing to participate in the research but not to be photographed.

Additional Notes Regarding Consent

Non-written Consent While in most instances written consent is required, there may be some circumstances and in some communities where this is inappropriate and an alternative means of establishing consent is necessary (see item 2.2.5 in Chapter 2.2 under the heading of ‘General Requirements for Consent in the National Statement). In all such cases, applicants must explain to the Committee the reasons why approval for non-written consent is requested and clearly outline the alternative method proposed.



Child Participants Question: Will the SBREC ever waive parental consent for participants aged under 18 years? Response: YES While 18 years is the usual age of consent, the Committee will consider approving participation of those aged 16 and 17 years without parental / guardian consent in specific circumstances. These may include situations where 16 and 17 year old participants are independent of their parents, provided that the Committee considers that waiving the requirement for parental consent would not pose any additional risks to these participants. In such cases, the applicant would be required to argue their case. In addition, please note that 17-year old Flinders University students may participate in research without parental consent providing that the project is deemed to be low risk by the SBREC. Participants recruited outside of the University under the age of 18-years will require parental consent unless a compelling argument can be made to the Committee. Confidentiality and Anonymity In addition to being the means by which participants indicate their consent, the Consent Form includes information about what will happen to the information they provide; who will be given access to the data; and the level of confidentiality and anonymity that is accorded to participants. The template assumes that confidentiality and anonymity will be assured, however for research projects in which this is neither possible, nor appropriate, the form should be amended accordingly. Research Involving Focus Groups In most instances, assurances offered to participants involved in Focus Groups will need some qualification. For example, the researcher can provide assurance that he/she will respect confidentiality and anonymity, but the researcher will have no control over other participants in the group. For this reason, the researcher should remind group members of this limitation and, where possible, gain verbal agreement between all participants that they will maintain anonymity of other members and the confidentiality of the discussion. Interview / Focus Group Questions If your project involves conducting interviews and/or focus groups please ensure that you provide an attachment containing:

− the list of interview questions or very interview topics to be discussed; and/or − a list of focus group questions or very interview topics to be discussed. Surveys If your research will be conducted with the use of a survey tool please ensure that you submit a final version of the survey tool to be provided to participants. If only a draft version can be provided at the time of submission then please assure the Committee that the final version will be submitted as soon as possible. Please note that the SBREC cannot adequately assess whether your application complies with the guidelines of the National Statement on Ethical Conduct in Human Research if the research instruments are not submitted for review. Debriefing / Feedback Information If in response to item F5 of the application you outlined that debriefing and/or feedback information would be provided to the participants please ensure that:


− you submit a copy of the information to be provided (verbal or written) in debriefing and/or feedback; and

− you provide a clear explanation of how and when the information will be provided to participants and how they will be informed of these arrangements.

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