FLINDERS UNIVERSITY and by ILvxNEEK

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Flinders University and                                                    Office Use Only
Southern Adelaide Health Service                                           Code:         Project
SOCIAL AND BEHAVIOURAL RESEARCH ETHICS COMMITTEE                                         Number:
                                                                           Yunggorendi        Y              N



            APPLICATION FOR ETHICAL APPROVAL OF SOCIAL OR
           BEHAVIOURAL RESEARCH INVOLVING HUMAN SUBJECTS
Please Note: The questions on this form have instructions and links to relevant documents and guidelines on
how to answer that particular question. To view the instructions and links click the symbol “¶” (Show/Hide) on
the toolbar.


                      New Ethics Application        x

                      Response to Deferral Notice         Project Number




A. PROJECT TITLE and TIMEFRAME

A1.   Project Title

      Qualitative Research Methods topic for the Master in XXXX

A2.   Plain language, or lay, title

      This is a topic for the Master in XXXX (XXX) which involves students undertaking a small
      qualitative topic, with either individual interviews or focus groups (max 8 participants). All
      students will use prescribed methods of contact/recruitment, will use the same templates for
      Letters, Information Sheets and Consent Forms and will, under no circumstances, engage in
      any of the High Risk areas outlines within the SBREC application form. In essence, this is one
      research project which involves a number of students who will either use individual interviews
      or focus groups. We are asking for SBREC approval for the topic for 3 years – all students
      will adhere strictly to this SBREC application form. A similar SBREC application was
      approved in 2009 for a topic on the Doctorate in XXXX.

A3.   Period for which approval is sought.
      Projects may not commence without the prior written approval of the Committee.

              Date data collection is due to commence:                     25 May 2010
              Date data collection is expected to be completed:             1 July 2013
              Date project is expected to be completed:                     1 July 2013
B. RESEARCHER/SUPERVISOR INFORMATION
      Correspondence regarding ethics approval will be emailed to the Principal Researcher with copies to all
      other researchers/supervisors listed on the application unless otherwise indicated.
B1.     Principal Researcher
         Title:             First Name:                                Family Name:

         Prof               Joe                                        Bloggs
         Status:            Staff:                X    Student:                     Associate:

         School/Department/Organisation:    Discipline of XXXX
         Postal Address:     Discipline of XXXX
         Phone:    8xxx xxxx           Fax:    8xxx xxxx           Email:       Joe.bloggs@flinders.edu.au

         Researcher 2/Supervisor
         Title:             First Name:                                Family Name:



         Status:            Staff:                     Student:                     Associate:

         Copies of correspondence required                                          Yes            No

         School/Department/Organisation:
         Postal Address:
         Phone:                        Fax:                        Email:

         Researcher 3/Supervisor
         Title:             First Name:                                Family Name:



         Status:            Staff:                     Student:                     Associate:

         Copies of correspondence required                                          Yes            No

         School/Department/Organisation:
         Postal Address:
         Phone:                        Fax:                        Email:

         Researcher 4/Supervisor
         Title:             First Name:                                Family Name:



         Status:            Staff:                     Student:                     Associate:

         Copies of correspondence required                                          Yes            No

         School/Department/Organisation:
         Postal Address:
         Phone:                        Fax:                        Email:
         Researcher 5/Supervisor
         Title:              First Name:                                Family Name:



         Status:             Staff:                     Student:                      Associate:

         Copies of correspondence required                                            Yes            No

         School/Department/Organisation:
         Postal Address:
         Phone:                         Fax:                         Email:


         Researcher 6/Supervisor
         Title:              First Name:                                Family Name:



         Status:             Staff:                     Student:                      Associate:

         Copies of correspondence required                                            Yes            No

         School/Department/Organisation:
         Postal Address:
         Phone:                         Fax:                         Email:

                        If there are more than six researchers/supervisors involved in the project
                                   please use Appendix B for adding more researchers.

B2.     Student Projects Only (staff members who are conducting research as part of their course of study
        leading to a degree must also complete this section)

       Student Record No.:      See Attached      Degree enrolled in:      XXX
                                list of student
                                IDs

       Supervisor/s:            Prof Joe Bloggs



                   ALL QUESTIONS SHOULD BE ANSWERED IN THE SPACES PROVIDED.
      ATTACHMENTS IN LIEU OF RESPONSE (WITH NOTATIONS TO ‘SEE ATTACHED’) ARE NOT ACCEPTABLE.


C.      PROJECT DETAILS

C1.     Brief outline of:

        (a)   the project;

              This application is for a Qualitative Research Methods topic on the XXX – all students
              will be collecting data using either interviews or focus groups. They will only use the
              prescribed methods of contact and recruitment outline in D4. No students will undertake
              research with individuals from any of the vulnerable groups in the Low Risk Checklist or
              about any of the high risk content areas. The sole purpose is about students gaining
              experience in data collection and therefore they will be mandated to keep their research
              ‘low risk’ (as identified by SBREC).
      (b)     significance;

              The will be no major public health significance for any of the projects – they are all low
              Risk projects with the outcomes of Research Training for students.

      (c)     research objectives.

              The objective of this project is to provide research training for students – we will
              minimise any risks by prescribing the types of method, the contact and recruitment
              process and the types of people/content areas that are allowed.


C2.   Medical or health research involving the Privacy Act 1988

      Is the research related to medical or health matters?

            Yes         Place letter ‘X’ in
            No     X    the relevant box



      If YES, go to question (a) below. If NO, go to item C4.

      (a)     Will personal information be sought from the records of a Commonwealth Agency?

                  Yes
                  No       X


              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
              http://www.flinders.edu.au/research/info-for-researchers/ethics/committees/social-
              behavioural.cfm.

              If NO, go to question (b) below.


      (b)     Will health information be sought from a Private Sector Organisation or a health service
              provider funded by the State Department of Health?

                  Yes
                   No      X

              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
              http://www.flinders.edu.au/research/info-for-researchers/ethics/committees/social-behavioural
              .cfm.

              If you answered ‘NO’ to both (a) and (b) above go to item C4.


C3.   Does your project comprise health research involving Aboriginal or Torres Strait Islander
      peoples?

            Yes
            No     X
C4.   Data

       Are data to be obtained primarily          Quantitative                   Qualitative         X

       Is information to be sought by             Questionnaire                  Interview           X

                                                  Experiment                     Computer

                                                  Focus Group             X      Other

                                                                                 Please state:


       Will participants be video or audio recorded or photographed?       Yes       X
                                                                           No
       If YES, please place a letter ‘x’ in the relevant          Video
       response box or boxes                                      Audio              X
                                                                  Photographed


C5.   Outline of the research method, including what participants will be asked to do.

      Students will either undertake Individual Interviews or a Focus Group. Participants will be
      asked to respond to a series of pre-determined questions. Students will focus on one of the
      following areas of inquiry:

      1. The experiences/perceptions of participants in terms of undertaking their employment (e.g.
      interviewing University lecturers, nurses etc about their job)

      2. The experiences of participants in terms of lifestyle (e.g. recreational activities, shopping,
      transport, eating/food habits, smoking).

      Both of these areas fit within the MPH since they are either about policy/work life or linked to
      areas of public health interest (e.g. smoking, food, transport). All questions will simply focus
      on understanding the perspectives of the participants. A general list will be as follows:

      1. Can you tell me about your experiences of X? (where X either the job, policy or lifestyle)

      2. Can you tell me about your background? (focussing specifically on demographics such as
      time worked in the position, length of time smoked, how often used public transport etc)

      3. Can you tell me why you engage in X? (this area of questioning will try to understand some
      of the background/context around their experiences – from Question 1. This will involve some
      probing in response to Question 1).

      4. Can you provide more information on X that has not already been covered in the
      interview/focus group?

C6.   Briefly describe how the information which is being requested from participants addresses research
      objectives.

      This is a qualitative topic (in the XXX) which is focussed on students learning how to
      undertake research – this is the major objective.
D.    PARTICIPANT INFORMATION

D1.   (a)   Who will be the participants? What is the basis for their recruitment to the study?

            This will differ for each student – however, they will generally be members of the public
            who have no association (professional) with the students – they will NOT include
            children, patients or people who require permission to be interviewed. The basis will be
            pragmatic – students will generally aim to get participants who are easiest to contact and
            recruit.
            In the case of students focussing on Question 1 (experiences of employment), the
            participants will be currently employed within an organisation (e.g. University, NGO,
            Government). Permission will be gained from the Head of the Organisation before
            contact/recruitment will begin.
            In the case of students focussing on Question 2 - interviewing people about their
            experiences of a particular lifestyle (smoking, eating, recreation etc), participants will be
            general members of the public who respond to invitations to take part in the research.

      (b)   How many people will be approached? Please specify the number (or an approximation if the
            exact number is unknown) and the size of the population pool from which participants will be
            drawn.

            Each student will interview around 6 participants OR undertake 1 focus group (with 6-8
            participants). Since they will come from general populations, there will be no major
            potential for identification or lack of anonymity

      (c)   From what source?

            Participants in Question 1 (employees) will come from organisations (no specific types of
            employees – just those who respond to information packs).

            Participants in Question 2 (lifestyle) will come from the general public.

      (d)   What, if any, is the researcher’s role with, or in relation to, the source organisation?
            Comment on any potential for conflict of interest.

            None

      (e)   Are participants under 18 years of age?

                Yes
                No      x


            If yes, what is the age range?




            Has the participant information been presented in a manner and format appropriate to the age
            group of participants?

            N/A
      (f)     Do participants have the ability to give informed consent?

                  Yes    x
                  No


              If not, please explain why not?



D2.   Indicate whether the participant group is comprised of people from a specific cultural or religious
      background or if any such categories are likely to form a significant proportion of the population to be
      sampled.

      No

D3.   Are there particular issues with language?

            Yes
            No     X


      If yes, please provide more information.




      Do the forms or participant information need to be presented in a language other than English?
            Yes
            No     X


      Note: If YES, the translated documents should be submitted to the SBREC with a footnote, signed by
      the researcher/supervisor stating that it is an accurate translation.

      If anyone other than the researcher will be involved in translating participants’ responses, how will
      anonymity/confidentiality matters be managed?

      No other people will be involved in translating participant’s responses other than the
      researcher.

D4.   Please provide a detailed explanation of how participants are to be contacted and recruited? For
      example, if making direct contact how will contact details be obtained, how will participants indicate
      willingness to be involved in the project?

      For ALL students – there will only be two methods of contact and recruitment. These will
      apply whether they are undertaking interviews or focus groups.

      The first method will be snowball sampling (this will mainly be for those students interviewing
      people in the general population) – students using this approach will find the first participant
      (usually from informal networks that they currently have – but NOT in any power relationship
      with the student) – they will be asked to pass on Information Packs (including Information
      Sheet, Letter of Intro and Consent Form) to people they know who may fit the particular
      criteria. These people will then contact the student directly (not via Participant 1) if they wish
      to be interviewed. Once interviewed, these people may then be asked to pass on the
      Information Packs to other people. This process will continue until 6 participants’ have been
      interviewed. If the student wants to undertake focus groups, the same process will occur until
      enough people have been identified for the focus group.
      The second method will involve research within organisations (for Question 1 – employees) –
      the unit manager will firstly be asked to provide Permission (the letter will be forwarded to
      SBREC before data collection). Following organisational permission, Information Packs will
      be distributed to relevant people who will then be asked to contact the student directly (their
      manager etc will not be aware who took part or did not take part). On contact with the student,
      arrangements will be made to undertake interview/focus group at a mutual place of
      convenience, but not on the premises within which they work (to maintain confidentiality).

      Students will be mandated to use ONLY these methods of contact and recruitment. These
      methods have been widely used in a number of SBREC approved applications.


D5.   What information will be given to participants?

      All participants will be provided with the Letter of Introduction, Information Sheet and
      Consent Form. The Template for these has been attached to this application – students will
      insert their particular details (e.g. name, title etc).


D6.   Does recruitment involve a direct personal approach to potential participants by the researchers?

         Yes
         No      x


      If yes, how will the researchers address any real, or perceived, coercion felt by potential participants?




D7.   Indicate confidentiality and anonymity assurances to be given and procedures for obtaining free and
      informed consent of participants.

      All data from interviews will be confidential and anonymous. During focus groups, the
      students will make participants aware of the confidentiality of the data and they will be asked
      not to talk about this outside of the group – however, pure anonymity cannot be maintained and
      participants in focus groups will be made aware of this.


D8.   Indicate any permissions required from, or involvement of, other people (employers, school principals,
      teachers, parents, guardians, carers, etc) and attach letters requesting permission as well as copies of
      permission letters. Permissions 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.

      Some students will be accessing participants through organisations – they will seek permission
      before undertaking any research and will lodge the letters of permission with SBREC.

D9.   Indicate any involvement of incidental people. (For example, in certain professional studies
      consideration may need to be given to how such people will be informed about the research and how
      consent may be obtained for their incidental involvement. An oral statement to the group incidental to
      the observation immediately prior to the commencement of the observation may be sufficient.)

      None
D10. Indicate the expected time commitment by participants, and proposed location, if being interviewed or
     required to complete a survey (This information should be included in the Letter of Introduction to
     participants.)

      Participants will be interviewed for no more than 30 minutes and Focus Groups will be held for
      no longer than 50 minutes.



E.    RESEARCH CONDUCTED OVERSEAS

E1.   Is the research being conducted outside Australia?

         Yes
         No       x

      If ‘YES’, go to item E2. If ‘NO’ go to section F.

E2.   In which country?




E3.   In that country are there ethics approval processes that are relevant to the research?

         Yes
         No

      If ‘NO’ go to item E4.


      Are the processes mandatory?
         Yes
         No


      Give a brief explanation of how the ethics approval process functions, the values and principles on
      which they rely and whether they require reporting of approval of SBREC:




E4.   If the researcher is a student please explain how their academic supervision will be maintained while
      they are in the field, with particular reference to the wellbeing of research participants.



E5.   Will co-researchers be recruited in the country in which the research is being conducted?
         Yes
         No


      If ‘YES’ continue with item E5. If ‘NO’ go to section F.

      How will their expertise and capacity to conduct the part research in which they are involved be
      determined?
F.    SPECIFIC ETHICAL MATTERS

F1.   Outline the value and benefits of the project to the participants, the discipline, the community, etc.

      The benefits will mainly be for the students – the purpose is to develop research skills.
      However, participants’ will be made acutely aware of this.

F2.   Notwithstanding the value and benefits of the project, outline any burdens and/or risks of the project
      to the participants and/or other people.

      Students will not undertake research with any high risk groups or on high risk topics –
      however, some topics may raise the potential for anxieties’, in these cases, relevant, free
      counselling services will be notified within the Information Sheets

F3.   If any issues are raised in item F2, detail how the researcher will respond to such risks. If deemed
      necessary, researchers should be prepared to offer advice and information about appropriate
      professional counselling that is available and/or to encourage participants to report negative
      experiences to the appropriate authorities.

      Counselling services will be provided, where appropriate


F4.   Will the true purpose of the research be concealed from participants?
         Yes
         No      x


      If YES, outline the rationale for, and provide details of, the concealment.




F5.   Describe any feedback or debriefing to be provided to participants that may be relevant to the
      research, including how participants will be informed of any deliberate deception.

      None will be provided due to time constraints, although they will be made aware of this within
      the Information Sheets,

F6.   If participants are required to complete a questionnaire, what are the arrangements for ensuring
      secure and confidential return of the questionnaire to the researcher (sealable, addressed envelope;
      personal collection by the researcher; other)? How will participants be informed of the arrangement (eg
      verbal instruction; written instruction in the participant documentation; or at the end of the questionnaire;
      other)?

      N/A

F7.   Is it the intention of the researcher to reimburse participants?
         Yes
         No      x


      If YES, how much? Please provide justification for the amount of the re-imbursement.




F8.   Indicate any relevant data transcription issues.

      Any audio data will be transcribed by the student only.
F9.   Indicate any issues of participant control of data use in the immediate reporting and in future use of
      the data, eg will participants have the opportunity to view transcripts of their interview and/or the final
      report for comment/amendment? Explain the method to be used in the documentation for participants.

      None – due to time constraints, although this will be made clear in the Information Sheet


F10. DATA STORAGE AND RETENTION
     Note that the data should be retained in accordance with the Australian Code for the Responsible
     Conduct of Research and Flinders University policy.

      Please check all boxes which apply to this research project.

      (a) On completion of the project, data will be stored

           In writing                     X    On computer disk

           On audio tape/CD                    On video tape/DVD

           Other (please indicate):


      (b) Data will be stored in a de-identified form
               Yes       x
               No

          If no, explain how any relevant anonymity and confidentiality standards will be met for data storage.




      (c) Data will be stored securely at Flinders University/Southern Adelaide Health Service for:

             X           At least five years from the date of publication

                         At least seven years if the research involves a South Australian Government Department


      If NO, explain what the data storage arrangements will be and why the data will not be stored at
      Flinders University or Southern Adelaide Health Service.




G.    OTHER MATTERS

G1.   Indicate any other centres involved in the research and any other Ethics Committee(s) being
      approached for approval of this project (if applicable), including the approval status of each. The
      SBREC must receive details of any amendments requested by other Ethics Committees along with
      copies of final approval notices.

      None

G2.   Has funding been received/applied for?
         Yes
         No          X


      If so, how much?
       $
       Name of funding body



       Please declare any affiliation or financial interest.




 G3.   Attachment Checklist
       Copies of the following supporting materials applicable to this research project must be attached to this
       application. Some sample templates of some documents are available from http://www.flinders.edu.au/
       research/info-for-researchers/ethics/committees/social-behavioural.cfm.
                                                                                         Attached       Not Applicable
Letter of Introduction (from the principal researcher or, in the                             X
case of student projects, the supervisor, on University letterhead)
Information Sheets for participants                                                          X
Consent Form(s) for Participation in Research by:      - Interview                           X
                                                       - Focus Group                         X
                                                       - Experiment                                           X
                                                       - Other (please specify)……                             X
Consent Form for Children                                                                                     X
Consent Form for Observation of Professional Activity                                                         X
Questionnaire or survey instruments                                                                           X
Interview questions, or list of topics to be discussed, as appropriate                       X
Advertisement for recruitment of participants                                                                 X
Debriefing material                                                                                           X
Appendix: Privacy Legislation Matters                                                                         X
Video/DVD to be viewed by participants                                                                        X


 PLEASE NOTE: Students will forward to the Principal Researcher a copy of the Letter of Introduction/Participant
 Information with proposed questions to be covered in the interview or focus group/Letter of Consent/ Participant
 Consent form for their individual research assignment.


 G4.   Research Involving or Impacting on Indigenous Australians
       Has a copy of this application been forwarded to the Director, Yunggorendi First Nations Centre for
       Higher Education and Research?

           Yes
           No      X
H.      CERTIFICATION and SIGNATURES

The Researcher and/or Supervisor whose signature appears below certifies that they have read the Ethical
Guidelines for Social and Behavioural Research available from the SBREC website, and the guidelines of any
other relevant authority referred to therein, and accept responsibility for the conduct of this research in respect
of those guidelines and any other conditions specified by the Social and Behavioural Research Ethics
Committee.


As a condition of subsequent approval of this protocol, I/we, whose signature(s) appear(s) below, undertake
to:

(i)     inform the Social and Behavioural Research Ethics Committee, giving reasons, if the research project is
        discontinued before the expected date of completion.
(ii)    report anything which might warrant review of ethical approval of the protocol including:
            serious or unexpected adverse effects on participants;
            proposed changes in the protocol; and
            unforeseen events that might affect continued ethical acceptability of the project.
(iii)   provide progress reports annually, and/or a final report on completion of the study, outlining:
            progress to date, or outcome in the case of completed research;
            maintenance and security of data;
            compliance with the approved protocol; and
            compliance with any conditions of approval.
        A pro forma is available from the SBREC website.



Principal Researcher’s                                                                         Date:
Signature:
                                ............................................................           ....................................


Supervisor’s Signature:                                                                        Date:
(for all student projects)
                                ............................................................           ...................................




            Please forward an electronic copy to human.researchethics@flinders.edu.au and one
            copy of the completed, signed application and attachments, printed on one side of the
            page only and fastened with clips, not staples to the Executive Officer, Mrs Andrea
            Jacobs, Research Services Office, Union Building (entry at South Eastern Corner), (GPO
            Box 2100, Adelaide SA 5001) to arrive by the close date indicated on the current
            Meeting Schedule available from the SBREC website. PLEASE NOTE that applications
            received after the deadline will be held over to the following meeting unless prior
            arrangement has been made with the Executive Officer.
                                                                                                  APPENDIX A

                                          LOW RISK CHECKLIST
Please complete the checklist below to determine whether your research project is low risk research.
Whether the research is determined to be low risk, or not, will have no effect on the length of time
taken to review the application.

Student researchers must review the completed checklist with their supervisors.

This checklist is to assist in processing applications. Identifying a project as “low risk” will not make any
difference to the time taken to process the application.

Definition – “Research is ‘low risk’ where the only foreseeable risk is one of discomfort. Where the risk, even
if unlikely, is more serious than discomfort the research is not low risk” (item 2.1.6 under Section 2: Themes
in Research Ethics: Risk and Benefit, Consent in the National Statement on Ethical Conduct in Human
Research).

(a)     External Requirements
        Is the research being funded by an agency outside the University which requires Human Research
        Ethics Committee approval?

            Yes
            No      X

(b)     Risk Assessment
1.      This section covers information about the focus of your research, ie whether it involves issues which
        are sensitive, personal, have potential to cause embarrassment or distress, or potential to reveal illegal
        activity. Please indicate whether any of the following topics will be covered in part or in whole?
                                                                                          Yes           No
           research about parenting                                                                     X
           research investigating sensitive personal issues                                             X
           research investigating sensitive cultural issues                                             x
           explorations of grief, death or serious/traumatic loss                                       X
           depression, mood states, anxiety                                                             X
           gambling                                                                                     X
           eating disorders                                                                             X
           illicit drug taking                                                                          X
           substance abuse                                                                              X
           self report of criminal behaviour                                                            X
           any other psychological disorder                                                             X
           suicide                                                                                      X
           gender identity                                                                              X
           sexuality                                                                                    X
           race or ethnic identity                                                                      X
           any disease or health problem                                                                X
           fertility                                                                                    X
           termination of pregnancy                                                                     X
           other, please specify…………………….                                                               X

      2. This section deals with research methods involving deception, potential for risk or harm. Are any of the
          following procedures to be employed?
                                                                                          Yes          No
           use of data, obtained from Commonwealth or State Government
              Department/Agency, from which individuals can be identified                                X
           use of data, obtained from any other source,
              from which individuals can be identified                                                   X
           deception of participants                                                                    X
           concealing the purposes of the research                                                      X
           covert observation                                                                           X
           audio or visual recording without consent                                                    X
           recruitment via a third party or agency                                                      X
                                                                                                  APPENDIX A

         withholding from one group specific treatments or methods of learning,                         x
             from which they may “benefit” (e.g. in medicine or teaching)                                X
         any psychological interventions or treatments                                                  X
         administration of physical stimulation                                                         X
         infliction of pain                                                                             X
         administration of ionising radiation                                                           X
         collecting body fluid                                                                          X
         use of medical records from which participants can be identified                               X

3.    Other Risks
      Are there any risks to the researcher, (e.g. research undertaken in unsafe environments or trouble
      spots)? If so, please explain.
      N/A

(c)   Participant Vulnerability Assessment
      Do any of the participants fall within the following targeted categories?
                                                                                         Yes            No
         suffering a psychological disorder                                                             X
         suffering a physical vulnerability                                                             X
         people highly dependent on medical care                                                        X
         minors                                                                                         X
         people whose ability to give consent is impaired                                               X
         resident of a custodial institution                                                            X
         unable to give free informed consent because of difficulties in
            understanding information statement (eg language difficulties)                               X
         members of a socially identifiable group with special cultural or religious
            needs or political vulnerabilities                                                           X
         those in dependent relationship with the researchers (eg lecturer/ student,
            doctor/patient, teacher/pupil, professional/client, employer/employee,
            manager/subordinate)                                                                         x
         participants able to be identified in any final report when specific
            consent for this has not been given                                                          X
         Indigenous Australians                                                                         X

(d)   Research in Overseas Settings Assessment
      Does the research involve any of the following:
                                                                                         Yes            No
         research being undertaken in a politically unstable area                                       X
         research involving sensitive cultural issues                                                   X
         research in countries where criticism of government and
            institutions might put participants and/or researchers at risk                               X

(e)   Opportunity to Comment on ‘Yes’ Response
      If you have answered ‘YES’ to an item in the checklist but you believe that because of the particular
      nature of the project and the participants your project may still be considered ‘low risk’ please provide
      details below.

                      The above checklist is based on that developed by the University of
                             Melbourne, amended for use by Flinders University.
                                                                        APPENDIX B


RESEARCHERS ADDITIONAL TO THOSE LISTED AT ITEM B.

Researcher 7/Supervisor
Title:            First Name:                    Family Name:



Status:           Staff:            Student:               Associate:

Copies of correspondence required                          Yes           No

School/Department/Organisation:
Postal Address:
Phone:                      Fax:               Email:

Researcher 8/Supervisor
Title:            First Name:                    Family Name:



Status:           Staff:            Student:               Associate:

Copies of correspondence required                          Yes           No

School/Department/Organisation:
Postal Address:
Phone:                      Fax:               Email:

Researcher 9/Supervisor
Title:            First Name:                    Family Name:



Status:           Staff:            Student:               Associate:

Copies of correspondence required                          Yes           No

School/Department/Organisation:
Postal Address:
Phone:                      Fax:               Email:

Researcher 10/Supervisor
Title:            First Name:                    Family Name:



Status:           Staff:            Student:               Associate:

Copies of correspondence required                          Yes           No

School/Department/Organisation:
Postal Address:
Phone:                      Fax:               Email:
                  Flinders University, South Australia

               TOPIC ‘XXXX’ <Insert Name of Topic>


         Appendix A - Ethics Application Listings for Students


                     Sampling Method – Interviews

Student Name                 ID              Subject Area to be Covered
  Full Name            Student Number               Employment
  Full Name            Student Number               Employment
  Full Name            Student Number                 Lifestyle
  Full Name            Student Number               Employment
  Full Name            Student Number                 Lifestyle
  Full Name            Student Number                 Lifestyle
  Full Name            Student Number               Employment
  Full Name            Student Number               Employment
  Full Name            Student Number                 Lifestyle
  Full Name            Student Number                 Lifestyle
  Full Name            Student Number               Employment
  Full Name            Student Number               Employment


                   Sampling Method – Focus Groups

Student Name             Student ID          Subject Area to be Covered
  Full Name            Student Number               Employment
  Full Name            Student Number                 Lifestyle
  Full Name            Student Number                 Lifestyle
  Full Name            Student Number                 Lifestyle
  Full Name            Student Number                 Lifestyle

Principal Researcher: Joe Bloggs, Flinders University, Discipline of XXXX.
                                                                              Discipline of XXXX
                                                                              Room XX, XXX Building
                                                                              GPO Box 2100
                                                                              Adelaide SA 5001
                                                                              Tel: 08 xxxx xxx
                                                                              Fax: 08 xxxx xxx
                                                                              joe.bloggs@flinders.edu.au
                                                                              CRICOS Provider No. 00114A




                                   LETTER OF INTRODUCTION


Dear Sir/Madam

This letter is to introduce >>>>>>>>>>>>>>>>>>>>>>>>>>
who is a >>>>>>>>>>>>>>> student in the Discipline of XXXX at Flinders University. The
student will produce their student card, which carries a photograph, as proof of identity.
The student is undertaking research leading to the production of a Master in XXXX degree on the
subject of >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>
The student would be most grateful if you would volunteer to assist in this project, by granting an
interview/focus group which covers certain aspects of this topic. No more than one hour on one
occasion would be required for a focus group and no more than 30 minutes on one occasion
would be required for an individual interview.
Be assured that any information provided will be treated in the strictest confidence and none of
the participants will be individually identifiable in the resulting assignment, report or other
publications. You are, of course, entirely free to discontinue your participation at any time or to
decline to answer particular questions.
The student intends to document the interview/focus group, and will seek your consent, on the
attached form, to document the interview, and use the recording or a transcription in preparing the
thesis, report or other publications, on condition that your name or identity is not revealed.
Any enquiries you may have concerning this project should be directed to me at the address
given above or by telephone on 08 xxxx xxx, by fax on 08 xxxx xxx or by email
(joe.bloggs@flinders.edu.au).
Thank you for your attention and assistance.
Yours sincerely



Joe Bloggs
Topic Coordinator/ Lecturer
Enter name of topic here
Discipline of XXXX




          This research project has been approved by the Flinders University Social and Behavioural
         Research Ethics Committee (Project Number INSERT PROJECT No. here 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, by fax on 8201 2035 or by email
                                    human.researchethics@flinders.edu.au
     .




                                                      18
                                                                      Discipline of XXXX
                                                                      Room XX, XXX Building
                                                                      GPO Box 2100
                                                                      Adelaide SA 5001
                                                                      Tel: 08 xxxx xxx
                                                                      Fax: 08 xxxx xxx
                                                                      joe.bloggs@flinders.edu.au
                                                                      CRICOS Provider No. 00114A




This notice has gone to all students in topic ‘XXXX’ – all
students will use this template to write their Information Sheets which will be given to the
Principal Researcher.

Flinders University and Southern Adelaide Health Service
Social and Behavioural Research Ethics Committee
Guidelines for Preparation of a Participant Information Sheet
An Information Sheet should include all of the points listed below in order for
participants to give informed consent (see section 2.2.6 under the heading ‘General
Requirements for Consent in the National Statement on Ethical Conduct in Human
Research’):
(a) a description of the project in language appropriate to the audience;
(b) an explanation of the participant’s role in the project;
(c) any alternatives to participation;
(d) how the research will be monitored;
(e) provision of services to participants adversely affected by the research, ie a list
of free counselling services;
(f) contact details of the researcher;
(g) how privacy and confidentiality will be protected;
(h) the participant’s right to withdraw from further participation at any stage, along
with any implications of withdrawal, and whether it will be possible to withdraw
data;
(i) the amounts and sources of funding for the research; This is not relevant for this Assignment.
(j) financial or other relevant declarations of interests of researchers, sponsors or
institutions; This will not be relevant for this Assignment
(k) any re-imbursement of costs to participants; This is not applicable
(l) the likelihood and form of dissemination of the research results, including
publication; this is not applicable – small scale data gathering for the assignment only
(m) any expected benefits to the wider community;
(n) any other relevant information. Questions will simply focus on understanding the perspectives
of the participants. Examples are as follows:
       Can you tell me about your background? (focussng specifically on demographics such as
          time worked in the position, length of time smoked, how often used public transport etc)
       Can you tell me why you engage in X? (this area of questioning will try to understand
          some of the background/context around their experiences – from Question 1. This will
          involve some probing in response to Question 1).
       Can you provide more information on X that has not already been covered in the
          interview/focus group?




                                                19
               CONSENT FORM FOR PARTICIPATION IN RESEARCH
    Instructions for Researchers on preparing the Consent Form for approval by the Flinders
                        University and Southern Adelaide Health Service
                       Social and Behavioural Research Ethics Committee


The following pro forma will be amended, as necessary, to make it relevant and appropriate to the
proposed research in order to ensure that participants are able to give free and informed consent. In
every respect the Consent Form must accord with the information provided to the Committee in the
application and to potential participants in the Letter of Introduction and Information Sheet.

Line 2 – Delete non-relevant items from the bracketed information or replace with appropriate description
of the method of data collection.
Line 5 – Replace first series of dots with the words ‘Letter of Introduction’ and/or ‘Information Sheet’ and
the second with the project title, as appropriate.
Item 3 – Delete either ‘audio’ or ‘video’, as relevant, or the entire statement if the interview will not be
taped.
Item 4 – Omit if written information is not being provided, or delete ‘Consent Form’ if non-written consent
is to be sought (see below).
Item 5, dot point 3 – Delete if participants will not be offered confidentiality and anonymity.
Item 5, dot points 4, 5 and 6 – Retain or delete as appropriate.
Item 6 – If audio or video recordings are to be made and it is intended to make them or the transcripts
available to other researchers it is important that participants are made aware that this is an option, in
addition to their more general consent to participation. Accordingly, the provision for the participant to
choose between ‘agree’ or ‘do not agree’ and ‘tape’ or ‘transcript’ is to be retained.
If it is not intended to allow researchers who are not members of the research team to have access to the
tapes or transcripts, then this item should be deleted.
Item 7 – this should be retained only where appropriate, for example, in cases where a participant is
especially vulnerable on account of their age or dependence on a ‘significant other’ for guidance.
Item 8 – retain only if participants will be invited to review and request changes to the transcript of their
interview/participation in focus group sessions.
Item 9 – retain only if participants are invited to review and request changes to their contribution included
in the report or thesis prior to its publication.

NB:      Please remember to re-number items, if necessary.




                                                    20
The following notes relate to particular categories of participants or types of research. Chapter 2.2 of
the National Statement on Ethical Conduct in Human Research (March 2007) deals specifically with
Consent.
Non-written Consent
While in most instances written consent is required, there may be some circumstances and in some
communities where this inappropriate and an alternative means of establishing consent is necessary (see
item 2.2.5 in Chapter 2.2: General Requirements for Consent of the National Statement on Ethical
Conduct in Human Research (March 2007) and the Social and Behavioural Research Ethics Committee
document Information for Researchers/Supervisors).
In all such cases, applicants must explain the reasons why approval for non-written consent is requested
and clearly outline the alternative method proposed.
Child Participants
For research involving children under 18 years* of age or those who lack competence to give their
consent the Consent Form use the pro forma for Parental Consent (see items 4.2.6 and 4.2.7 in Chapter
4.2: Children and Young People of the National Statement on Ethical Conduct in Human Research
(March 2007)).
In addition, the Committee recommends that where child participants are capable, they be afforded the
opportunity to countersign the Parental Consent Form to indicate their consent.
* While 18 years is the usual age of consent, the Committee will consider approving participation by those
aged 16 and 17 years without parental 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 risk to these
participants. In such cases, the applicant would be required to argue their case.
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 to be accorded to participants. The pro forma
assumes that confidentiality and anonymity will be assured. For research projects in which this is neither
possible nor appropriate, the form should be amended accordingly.
Refer item 2.2.7 in Chapter 2.2: General Requirements for Consent of the National Statement on Ethical
Conduct in Human Research (March 2007) and the Social and Behavioural Research Ethics Committee
document Information for Researchers/
Supervisors.
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 the anonymity of other members and the
confidentiality of the discussion. See Chapter 2.2: General Requirements for Consent of the National
Statement on Ethical Conduct in Human Research (March 2007).
                                                                   The Consent Form pro forma follows…




                                                   21
                             CONSENT FORM FOR PARTICIPATION IN RESEARCH
                                 (by interview, focus group, experiment…)

I …............................................................................................................................
being over the age of 18 years hereby consent to participate as requested in the
………………………………… for the research project on ……………………….
1.         I have read the information provided.
2.         Details of procedures and any risks have been explained to my satisfaction.
3.         I agree to audio/video recording of my information and participation.
4.         I am aware that I should retain a copy of the Information Sheet and Consent Form for future
           reference.
5.         I understand that:
                 I may not directly benefit from taking part in this research.
                 I am free to withdraw from the project at any time and am free to decline to answer
                  particular questions.
                 While the information gained in this study will be published as explained, I will not be
                  identified, and individual information will remain confidential.
                 Whether I participate or not, or withdraw after participating, will have no effect on any
                  treatment or service that is being provided to me.
                 Whether I participate or not, or withdraw after participating, will have no effect on my
                  progress in my course of study, or results gained.
                 I may ask that the recording/observation be stopped at any time, and that I may
                  withdraw at any time from the session or the research without disadvantage.
7.         I have had the opportunity to discuss taking part in this research with a family member or
           friend.



Participant’s signature……………………………………Date…………………...


I certify that I have explained the study to the volunteer and consider that she/he understands what
is involved and freely consents to participation.

Researcher’s name………………………………….…………………….................

Researcher’s signature…………………………………..Date…………………….


NB:      Two signed copies should be obtained. The copy retained by the researcher may then be used for
         authorisation of Items 8 and 9, as appropriate.




                                                                            22

								
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