Flinders University
SOCIAL AND BEHAVIOURAL RESEARCH ETHICS COMMITTEE
APPLICATION SUBMISSION GUIDE
1
TABLE OF CONTENTS
SECTION A - PROJECT TITLE AND TIMEFRAME
A1 Project Title
A2 Plain language, or lay, title
A3 Period for which approval is sought
SECTION B – RESEARCHER / SUPERVISOR INFORMATION
SECTION C - PROJECT DETAILS
C1(a) Project Outline
C1(b) Project Significance
C1(c) Research Objectives
C2 Medical or health research involving the Privacy Act 1988
C2(a) Records sought from a Commonwealth Agency
C2(b) Health information
C3 Health research involving Aboriginal or Torres Strait Islander
C4 Project Type and Data
C5 Research Method
C6 Research Objectives
SECTION D – PARTICIPANT INFORMATION
D1(a) Identity and Basis for Recruitment
D1(b) Participant numbers approached and population pool
D1(c) Source of Participants
D1(d) Conflict of Interest
D1(e) Participant Age
D1(f) Informed Consent
D2 Cultural or religious background
D3 Language
D4 - A Participant contact and recruitment
D4 - B Verbal Scripts
D4 - C Email text
D5 Participant Information
D6 Direct Recruitment Approaches
D7 Confidentiality and anonymity
D8 Permissions
D9 Incidental People
D10 Time Commitment
SECTION E – RESEARCH CONDUCTED OVERSEAS
E1 Recruitment of Overseas Participants
E2 Identity of Overseas Country
E3 Overseas ethics approval processes
E4 Student supervision
E5 Overseas co-researchers
SECTION F – SPECIFIC ETHICAL MATTERS
F1 Values and benefits
F2 Burdens and Risks
F3 Management of burdens and/or risks
F4 Concealment
F5 Feedback and/or debriefing
F6 Questionnaires
F7 Participant reimbursement
F8 Data transcription
F9 Participant Control of Data
F10(a) Data Transmission Protocols
F10(b) Data Type
F10(c) Data de-identification
F10(d) Data Storage Location
F10(e) Data Retention Period
SECTION G – OTHER MATTERS
G1 Other Ethics Committees / Centres
G2 Funding
G3 Attachment Checklist
G4 Research involving or impacting on Indigenous Australians
SECTION H – CERTIFICATION and SIGNATURES
Research Involving Children or Vulnerable Adults
Translations
Signatures
APPENDIX B – LOW RISK CHECKLIST
PARTICIPANT DOCUMENTS
Letter of Introduction
Information Sheet
Consent Forms
Interview / Focus Group Questions
Surveys
Debriefing / Feedback Information
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 Templateweb 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 opinionCommonwealth 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 Templateweb 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.
C5 Research Method
Provide an outline of the research method which includes the following information:
who will be recruited to participate;
whereparticipants 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 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.
- Participant type / group 1
Source - Participant type / group 1
Source - 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.
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 researchersto 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 Templateweb 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:
howpotential participants will be contacted / approached;
whetherparticipant 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;
- Participant type / group 1
Information about contact and recruitment (as requested above) - Participant type / group 2
Information about contact and recruitment (as requested above) - Participant type / group 3
Information about contact and recruitment (as requested above)
National Statement References