flinders university and€¦ · web viewbelow are the definitions of exempt, negligible risk, low...

Social and Behavioural Research Ethics Committee (SBREC) APPLICATION FORM – Version 10

Section 1 Screening Tool ALL Applicants need to complete BOTH sections

Section 2 Application Form

Need Advice / Assistance?It is the responsibility of researchers to submit applications to the correct committee. Refer to the ‘About Human Ethics Approval’ web page for online guidance. Please also feel free to contact one of the SBREC administrators if you need advice / assistance.

Ms Andrea MatherJoint Executive Officer

+61 8 [email protected]

Ms Rae TylerJoint Executive Officer


Professor Amanda Kearney(SBREC Chairperson)


Mr Hendryk FlaegelManager, Research Ethics and Compliance


Important TipApplicants are encouraged to read the National Statement on Ethical Conduct in Human Research (National Statement) as they prepare their application for guidance about ethical issues in research.

While the committee needs to ask certain questions, to be compliant with the National Statement, applicants are encouraged to ask questions of the Committee within the application form; and to inform the committee of research processes that may not be known by all members of the committee. In addition, don’t feel hesitant about discussing possible burdens and/or risks within the application, as research can only be approved once the committee is satisfied that all possible burdens and/or risks have been considered and will be managed in way that is protective of participants.

Cover Page

Select one category in each of the three tables below; and provide the project title and some brief information about the principal researcher:

Application Type? Project Type? Original or Follow-up Study?

New application Flinders University – Student project Original Study

Response to Deferral:Project number =

Flinders University – Staff project Follow-up Study

Flinders University - Associate / Other

Project Title:

Principal Researcher:

Flinders College:

Discipline

Version 10 P a g e | 1

https://nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018

mailto:[email protected]




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

Section 1 Screening Tool

A1 – Topics of Research Will any of the following topics be covered, in part, or in whole?

A2 – Conduct of ResearchWill any of the following methods be employed?

Research investigating sensitive personal or cultural issues such as (but not limited to): Deception of participants or active concealment

Explorations of grief, death or serious / traumatic loss; gambling; substance abuse; gender identity; sexuality; fertility; parenting; race or ethnic identity; termination of pregnancy etc

Opt-out approach to consent

Waiver of consent for research

Withholding standard beneficial practices from a participant group

Research investigating physical health such as(but not limited to): Any psychological interventions or treatments or tests

Physical health status; disease progression; end of life etc Any physical interventions or treatments or tests

Collection of body fluids / tissues (e.g. blood, saliva, bone, tissue)

Research investigating potential criminal behaviour such as (but not limited to):

Researcher going into home of participants or other activities which may place the researcher at risk

Illicit drug taking, abuse, potential mandatory reporting, possible self-report of criminal behaviour etc Clinical research

Human Genetic research

Other topics researcher deems to be of more than low risk

Research involving the derivation of embryonic stem cell lines or other products from a human embryo

Specify - Research involving human foetus or foetal tissue

Recruitment from any organisation under the banner of the Southern Adelaide Local Health Network (SALHN) (including Flinders Medical Centre, Noarlunga Hospital and GP Plus Clinics)None applicable

None applicable

A3 – Participant Vulnerability AssessmentWill any of the participants fall within the following categories?

A4 – Location of Research

Will any participants to be recruited be from an overseas country?

Suffering a psychological disorder Yes

Suffering a physical vulnerability NoMembers of a socially identifiable group with special cultural or religious needs or political vulnerabilities

People who are unable to give free and informed consent If YES, are any of the countries part of the European Union?

Minors (<18) excluding Australian University students Yes

People highly dependent on medical care No

People with a cognitive impairment, an intellectual disability, or a mental illness Does the research involve any of the following?

Pregnant women Research will be undertaken in a politically unstable area

* Australian Indigenous peoples and/or communities Research will involve sensitive cultural issues

None applicable Research in countries where criticism of government and institutions might put participants and/or researchers at risk

Research in countries at Department of Foreign Affairs and Trade Travel Advisory level 2 or above

* Note – All projects involving and/or impacting Indigenous peoples and/or communities must be reviewed by the full Committee.


https://europa.eu/european-union/about-eu/countries_en

Section 1 Screening Tool Continued….

Below are the definitions of exempt, negligible risk, low risk and greater than low risk research as outlined in the National Statement on Ethical Conduct in Human Research 2007 (Updated 2018). Please read and consider which category your project your project may fall under.

1.Exempt Research Research is deemed to be exempt from any ethics review only if (a) it is negligible risk and involves the use of existing collections of data or records that contain only non-identifiable data about human beings. If you think your project may fall under this category email [email protected] for confirmation.

2.Negligible Risk ResearchResearch is ‘negligible risk’ where there is no foreseeable risk of harm or discomfort; and any foreseeable risk is not more than inconvenience. Where the risk, even if unlikely, is more than inconvenience, the research is not negligible risk’. An application needs to be submitted.

3.Low Risk Research 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. An application needs to be submitted.

4.Greater than Low Risk Research Research involving risk that is more serious than emotional discomfort needs to be reviewed by the full Committee.

Based on the definitions provided above, please indicate below whether you would like to submit your application as negligible risk; low risk; or greater than low risk. Please select one option from each table below.

Submitting application as… Research Area…

Negligible Risk Psychology researcher

Low Risk Non-Psychology researcher

Greater than low risk / concern

Note – selecting ‘greater than low risk’ does not mean that your project will not be approved; it just means that the full Committee needs to review it.

ALL applicants

Need to complete the full application form attached. Items C3 and G4 only need to be completed if Aboriginal and/or Torres Strait Islander peoples and/or communities will be involved and/or impacted by the project.



Section 2APPLICATION FORM

Social and Behavioural Research involving Humans

Research Involving Children or Vulnerable Adults

In addition to requiring ethics approval, researchers who intend to conduct research involving children or vulnerable adults must undergo a Criminal History / Screening Check whether conducting research in Australia or overseas. This should be obtained in parallel with ethics approval (and can take many weeks to obtain). Screening checks for the University are conducted via the State Government's Department for Communities and Social Inclusion (DCSI) Screening Unit.

Staff members should follow the advice for staff on this webpage. Students should enquire within their College or discipline regarding procedures that may already be established for this purpose. If there are no such procedures in place, please contact your Head of College Services. Accordingly, Section H (Certification and Signatures) asks whether the research will involve children and vulnerable adults, and if yes, asks for confirmation that a current Criminal History / Screening Check is in place.

A. PROJECT TITLE and TIMEFRAMEThis section seeks information that will assist the SBREC with determining research merit and integrity based on the guidelines of the National Statement (see section 1).

A1. Project Title

Overtype response here

A2. Plain language, or lay, title


A3. Period for which approval is sought

Projects may not commence until formal written notification of final ethics approval has been provided.

Date data collection is planned to commence: / /Important Note – data collection cannot commence until final ethics approval has been granted by the SBREC. Or following approval:

Date data collection is expected to be completed:

Date project is expected to be completed:

B. RESEARCHER / SUPERVISOR INFORMATION

Please note it is a requirement that all supervisors receive a copy of all correspondence relating to student projects

Principal Researcher (Flinders University staff / associate or student researcher)

Title: First Name: Family Name:

Status: Staff: Flinders Uni Student: Associate:



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

https://screening.dcsi.sa.gov.au/

https://screening.dcsi.sa.gov.au/

Flinders Uni Student No.(Principal researcher only)

Degree enrolled in:(no acronyms)

Supervisor(s)Provide full details in tables below

Flinders University College and Discipline (no acronyms)

Residential Address if a student:

Phone: Principal Researcher Email:

Researcher 2 / Supervisor


Status: Staff: Flinders Uni Student: Associate / Other:

Copies of correspondence required? Yes No

Flinders University Collegeor External Organisation


Phone: Email:







Phone: Email:







Phone: Email:







Phone: Email:








Phone: Email:

Note: To add more tables for additional researchers / supervisor, simply ‘copy’ and ‘paste/ one of the tables above.

CONTACT Person for the Project



Flinders University College orExternal Organisation Postal Address


Phone: Email:

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

C. PROJECT DETAILSThis section also refers to research merit and integrity, and enables reviewers to understand the planned research, its objectives and how that matches with the methods and data types (see National Statement section 1).

C1. Brief outline of:

A The project:


B Significance:


C Research objective(s):

No. Research objective1.

2.

3.

*Note: tab across to add new rows for additional research objectives.



C2 / C3 Health and Medical Research

C2-A Will the project involve any of the following? Select the boxes that apply in the table below.

Health, health related matters and/or medical matters

Prospective assignment of human participants, or groups of humans, to one or more health, or health related, interventions, treatments or tests to evaluate the effects on health outcomes. Some examples include:

Psychotherapeutic and/or behavioural therapies

Health Service changes

Preventive care strategies

Educational interventions that are health related

Educational interventions relating to healthNone apply

Note – projects involving health or medical matters can still be reviewed by this Committee; on the condition that the project

is not clinical in nature and will not involve recruitment of staff or patients from any organisations under the banner of the Southern Adelaide Local Health Network (SALHN).

If any boxes were selected above (other than ‘none apply)’, answer ‘B’ below. If a ‘none apply’ response was provided, select the ‘none apply’ option in the table below and proceed to item C4.

C2-B Will personal information be sought from the records of a Commonwealth agency?

YesNo

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.

If NO, go to question B below.

C2-C Will health information be sought from a private sector organisation or a health service provider funded by a State Department of Health?

YesNo

If YES, complete Part B of the Appendix ‘Privacy Legislation Matters’ that relates to compliance with the Guidelines under Section 95A of the Privacy Act 1988.

If you answered ‘NO’ to both A and B above, proceed to item C4.

C3 Does the project comprise of health research which will involve, and/or impact, Aboriginal and Torres Strait Islander peoples?

YesNo

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). However, please note that ethics approval from AHCSA will remove the requirement to gain approval from Flinders SBREC, as described in section G1, below.

C4. Project Information and Data Type


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

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

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

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

Data Type Publication and 3rd Party Commissioned / Funded Projects What type of data will be obtained? Select all boxes that apply

Qualitative data - only Intend to publish; or may publish in the future

Quantitative data - only Project has been commissioned by a 3rd party

Qualitative and Quantitative Project has been / will be funded by a 3rd party

Information to be sought by:Select all boxes that apply

Survey - Online Interview If OTHER, please state:

Survey – Flinders SONA System Focus Group

Survey - Hard-copy Workshop

Survey - Telephone Oral History

Intervention Secondary data analysisIf yes, provide info in table below

Evaluation OtherIf yes, provide info in box to right

Additional Data Types X If YES, provide brief description in relevant line below

Will any of the following occur as part of the research project?

Place a ‘X’ in all the boxes that apply

Video Recording

Audio Recording

Photography of People

Photography - Objects / Locations

Overt Observations

Covert Observations

Movement Tracking - eg. Bluetooth

Other…

Secondary Data AnalysisIF your project involves secondary data analysis, select all boxes that apply below:

Data will be accessed via a third party

I was involved in collecting the original data set

Identifiable – Data set contains identifiable information about people

Re-Identifiable - Data set is de-identified, but information can be re-identified

Non-identifiable - Data set is de-identified but no means exists to re-identify data

Not Applicable

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

WHO will be recruited? (e.g., students, staff, CEOs, children, members of public, doctors, nurses etc)

Source of Participants (e.g., organisation, members of public, University, school)

Research Method – (what will participation involve for each participant group?)


Additional Data Types (Audio / video recording / photographs / observations / movement tracking etc)

Secondary Data Analysis / Document Review (e.g. Type of data / information? Source? De-identified data?)

WHERE will each component of the research be conducted? (e.g., University, organisation, workplace, library etc)

C6. Addressing Research ObjectivesBriefly describe how the information which will be requested from participants addresses the research objectives outlined in item C1(c)


D. PARTICIPANT INFORMATIONThis section is important as it links to the Respect value as well as to Research Merit. It enables reviewers to determine whether all issues arising from an expectation that the research be conducted with respect are addressed. This involves an examination of consent and whether it is both free and informed, as well as whether or not it is necessary to guarantee anonymity and confidentiality (i.e., not all research requires these guarantees; but either way, it is important to inform potential participants). (see National Statement section 1)

D1. Brief outline of:

A Identity and Basis for RecruitmentWho will the participants be? What is the basis for their recruitment to the study? What component of the research will each participant group be involved in?

Overtype response here (use table below if useful)

Participant Type Basis for Recruitment Component of Research Involved In(e.g, survey, interview, focus group, observations)

B Participant Numbers Approached and Population PoolPlease specify the number of people that will be approached (or an approximation if the exact number is unknown) AND the size of the population pool from which participants will be drawn. This is important for reviewers to know, especially if anonymity is being offered.

Overtype response here (use table below if useful)

Participant Type / Group Population Pool Numbers to be approached Expected / Required No.

C Source of ParticipantsFrom what source will participants be recruited (e.g., members of public, specific departments / organisations, schools, aged care facilities?). Please provide specifics.



Participant Type Source of Participants (e.g, NGOs, public) Specific Organisations / websites / social media sites etc

D Participant AgeWill any participants be less than 18 years of age? IF YES, please indicate the age range or potential participants and confirm whether information has been presented in a manner and format appropriate to the age group of participants.

YesNo

Please note: that 17 year old University students may participate in research without parental consent (e.g., from any Australian University). Participants recruited outside of a University under the age of 18-years will require parental consent unless a compelling argument can be made to the Committee.

Age range of each participant type / group Information presented in a manner / format appropriate to age group and participants? Yes/No

E Informed Consent and AssentDo participants have the ability to give informed consent or assent? Provide your responses for (a) all participant groups to be recruited (e.g. adult participants; children and/young people); and (b) all parents / guardians / proxies that consent may need to be obtained from.

Adult Participants

Participant Group Able to provide informed consent?

HOW will consent be sought? (eg, verbal / telephone / in writing) IF via SIGNED consent form; how will it be returned?

Note: To add more ‘component’ rows press ‘tab’ at the end of the last row.

Children and Young People

Participant Group Able to ASSENTto participate?

HOW will ASSENT be sought? (eg, verbally / in writing) IF via SIGNED assent form; how will it be returned?


If children / young people will be recruited, but will not be given the opportunity to assent, please explain below why this decision was made:


Parents / Guardians / Proxies


Will CONSENT be sought from parents / guardians or a proxy? Y / N

HOW will CONSENT be sought? (eg, verbally / in writing) IF via SIGNED consent form; how will it be returned?


If you would like to provide additional information about how informed consent and/or assent will be obtained, please provide the information below.


D2. Cultural and/or Religious BackgroundIn the table below, indicate whether people of a particular cultural or religious background will be deliberately recruited for the purposes of this project? (for example, Aboriginal and/or Torres Strait Islander peoples, Greek people, etc) OR if any such categories are likely to form a significant proportion of the population to be sampled.

Cultural or Religious Background of participants to be recruited?

Incidental Recruitment of this cultural or religious group? Yes / No

Deliberate Recruitment of this cultural or religious group? Yes / No

D3. Language

Will there be any issues with language?

YesNo

Please note that translated versions of participant information / documents should not be provided to the committee until after the application has been reviewed by the full Committee or Low Risk Sub-Committee; as the committee may request changes to the documents that require translation.

If YES, (a) what are the issues; and (b) will information / participant documents need to be presented in a language other than English?


WHO will translate information and how will anonymity and confidentiality matters be managed if translation will be conducted by someone other than a researcher?


D4. Recruitment and Conflicts of Interest

A Management of Conflicts of InterestAre there any conflicts of interest that may exist for; (a) any of the researchers and supervisors; and (b) any third party recruiting organisations and/or non-researcher. To provide your response please complete the tables below. Please delete any tables that are not required.

Examples of Conflicts of Interest; personal and/or professional networks used to recruit (i.e, recruitment of friends/family; collegiate relationship); dependent relationships / perceptions of power asymmetry (i.e, doctor/patient, employer/employee, staff/student, coach/players) financial affiliation or commercial interest of researchers and/or funding body, employed by source of participants.

Are there any potential conflicts of interest for any of the researchers / supervisors listed in item B of the


application? Please consider and provide responses in the tables below.

Researcher 1 – Name:Questions Applicant ResponsePotential conflict of interest? If NO, explain why not.

Current / past relationship with potential participants? Yes / NoIF yes, what is the researcher’s relationship / affiliation?

Will this researcher be involved in recruitment? If yes, provide detailsIF 3rd party organisation will recruit on researcher’s behalf, does the researcher have a current or past relationship / affiliation with the organisation? Yes / NoIF yes to any questions above, a conflict of interest may exist. What strategies will be put in place to minimise possible perceptions of obligation / pressure to participate?

Note: To add additional rows place cursor in bottom row of right hand column and press ‘tab’.


Current / past relationship with potential participants? Yes / NoIF yes, what is the researcher’s relationship / affiliation?

Will this researcher be involved in recruitment? If yes, provide detailsIF 3rd party organisation will recruit on researcher’s behalf, does the researcher have a current or past relationship / affiliation with the organisation?Yes / NoIF yes to any questions above, a conflict of interest may exist. What strategies will be put in place to minimise possible perceptions of obligation / pressure to participate?


Current / past relationship with potential participants?Yes / NoIF yes, what is the researcher’s relationship / affiliation?

Will this researcher be involved in recruitment? If yes, provide detailsIF 3rd party organisation will recruit on researcher’s behalf, does the researcher have a current or past relationship / affiliation with the organisation? Yes / NoIF yes to any questions above, a conflict of interest may exist. What strategies will be put in place to minimise possible perceptions of obligation / pressure to participate?

Note: If there are more than 3 researchers, copy and paste the table below to provide information about the other researchers.

Third Party Organisations and/or Non-ResearchersIf your project will involve a third party organisation and/or non-researcher recruiting participants on behalf of the researcher, could there be a conflict of interest? (E.g. service provider / client) Please consider and complete the table below.

RECRUITING Organisations and/or Non-Researchers


Questions Applicant ResponseWill any non-researchers and/or 3rd party organisations be involved in the recruitment of participants? Yes / No

If yes, is the 3rd party organisation also funding this project? Yes / No

What is the individuals and/or organisations affiliation / relationship with potential participants (e.g. servicer provider / client)?

Does the organisation have a commercial interest in this project? If yes, provide details. Yes / No

IF yes to any questions above, a possible conflict of interest may exist. Explain how the conflict will be managed in a way that will minimise possible participant perceptions of obligation / pressure to participate?

B Contact and RecruitmentPlease provide a detailed explanation of how each participant type / group will be initially contacted and recruited. Please use a heading for each type / group.

If participants will be contacted via telephone, email or postal address, please clarify how the contact details will be obtained.

C Verbal ScriptIf potential participants will be approached directly (e.g., face-to-face, in a group setting, on telephone) please provide a verbal script of what will be said by researchers or a third party who will recruit on the researcher’s behalf.

Note - 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.

Overtype response here. Type ‘not applicable’ if this is the case. DO NOT leave blank.

Verbal Script to recruit / contact -

D Email TextIF potential participants will be approached via email (by the researchers or by a 3rd party organisation); provide the text that will be used in the email sent to potential participants. See below for committee advice regarding recruitment emails.

Student ProjectsEmail text must be written and sent by the student’s supervisor - referring potential participants to the Letter of Introduction and Information Sheet (attached).

Assistance from Third Party OrganisationsOrganisations should only forward on the researcher’s recruitment email to potential participants (ie. not write own email).

Overtype response here. Type ‘not applicable’ if this is the case. DO NOT leave blank.

Email Text to recruit / contact -

D5. Information given to participantsOutline what information will be given to potential participants before a decision is made about participation; and when the information will be given (e.g letter of introduction, information sheet, and


consent form).

WHAT documentation / information will be given to potential participants ?

WHAT information will be given to recruiting organisations?(if applicable)

WHEN will information be given?

HOW will information be provided?E.g, email, hard-copy, verbally

Email Recruitment

WHAT information will be attached to email?

Additional Information

If participants will be recruited via email, please confirm that a copy of all relevant participant documentation (i.e, Letter of Introduction, Information Sheet and Consent Form) will be given to potential participants prior to a decision being made about participation.

Yes, I confirm all relevant documentation will be given to potential participants prior a decision being made about participation.

Not applicable

D6. Direct Personal Recruitment ApproachesDoes recruitment involve a direct personal approach to potential participants (e.g., face-to-face, classroom, telephone) by the researchers or by other parties/organisations to be involved in contact and recruitment?

YesNo

If yes, please justify why a direct recruitment approach is required below.

Overtype response here.

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


D7. Confidentiality and AnonymityFor each component of the project (e.g, survey, interview, focus group etc), please provide information about whether or not participation will be anonymous and/or confidential by completing the table below.

Please note participation cannot be anonymous for focus groups / workshops / classroom participation; where participants may be recruited from a small population pool; or where only a small sample will be recruited. Participants involved in such projects should be clearly advised of this limitation in the Information Sheet and Consent Form.

Answer YES or NO to the questions in the box below


Anonymity Confidentiality

Research Component? (e.g., survey, interview etc)

ResearcherWill the researcher know who has participated? Y/N

Other PeopleWill participation occur in the workplace or group situation? Y/N

Population PoolWill participants be recruited from a small population pool? Y/N

PublicationsWill participants be identifiable in resulting publications? Y/N

Will information provided by participants be kept confidential? Y/N


Additional Information

D8. PermissionsIndicate whether any permissions may need to be obtained to conduct the research, recruit specific people, access existing data sets etc; and submit correspondence requesting and granting permission.

Please note that 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.

Please note for class projects where permission letters are required to conduct the research, permission letters will need to be provided for every student.

Permission will be sought from: Permission request attached?

Correspondence granting permission attached?

1.

2.

3.

D9. Incidental People

Are there any incidental people who may affect; or be affected by; the project being undertaken? (e.g, in the near vicinity when research is taking place)

YesNo

If yes, how will these people be informed that the research is taking place?

Place letter ‘X’ next to all methods to be used.

Brief verbal explanationFlyer SignOther

Note– incidental people should not be recruited as participants.

D10. Time CommitmentIndicate the expected time commitment(s) by participants AND the proposed location(s) for every


component of the research (e.g., survey, interview, focus group, observation). This information should be clearly conveyed to potential participants in the Letter of Introduction and/or Information Sheet.

Component of Research (e.g., questionnaire, interview)

Expected Time Commitment

Proposed Location (be specific, e.g, café, work place, private residence, library etc)

1.

2.

3.

4.

E. RESEARCH CONDUCTED OVERSEASThe following section relates to chapter 4.8 of the National Statement and provides information to enable reviewers to assess the necessity for other ethics review as well as how a student researcher will be supervised in the field.

E1. Recruitment of Overseas Participants

A Will any participants be recruited from an overseas country?

Yes NHMRC categorises ‘overseas’ research on the location of participants, not the researcher.

No If ‘NO’ go to section F

If YES, please ensure that you are familiar with the University’s Travel, Accommodation and Subsistence Policy, which states that all travel is prohibited to Level 4 regions (see section 7). Please be reminded that all travel to Level 3 areas requires approval from the person responsible for authorising travel in your area and the Cost Centre Head.

B If YES to ‘A’ above, will any of the researchers be travelling overseas to conduct this research?

YesNo

E2. Identity of Overseas CountryIf research participants will be recruited from overseas indicate from which country or countries they will be recruited from.

Please list the country (or countries) participants will be recruited from in the table below and indicate whether the country (or countries) are part of the European Union?

No. Country (countries) Participants to be Recruited from? Part of the European Union? Y/N1.

2.

3.

Note: To add more ‘country’ rows press ‘tab’ at the end of the last row.

E3. Overseas Ethics Approval ProcessesIndicate whether there any ethics approval processes, relevant to the research, in the country (or countries) where research will be conducted.

YesNo

If ‘NO’, indicate how this is known to the applicant and provide either (a) written correspondence confirming that no ethics approval is required or (b) in the case of student projects, written confirmation from the student’s supervisor that this is the case.





https://www.flinders.edu.au/ppmanual/finance/travel-accommodation-and-subsistence.cfm


If ‘YES’, indicate whether the ethics approval processes are mandatory.

YesNo

Give a brief explanation of how the ethics approval process functions and the values and principles on which they rely.


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


E5. Overseas Co-researchersWill co-researchers be recruited in the country, or countries in which the research will be conducted?

YesNo

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

If YES, how will their expertise and capacity to conduct the component of the research they will be involved in be determined?


No. Co-researcher full name and title Role in research1.2.3.

F. SPECIFIC ETHICAL MATTERSThis section relates to the value of Beneficence (closely related to Merit) and Justice (closely related to Respect). This section requires the researcher to think about benefits and risks so that reviewers can weigh these factors. When risks are identified the researcher must demonstrate plans to manage and mitigate risks. The Justice value requires that there is no unfair burden of participation for certain groups of participants, especially if the benefits are felt by another group. Justice can also be considered in assessing benefits, especially for groups of people who may often be excluded from research participation (see National Statement see section 1).

F1. Project Value and BenefitsOutline the value and benefits of the project to the participants, the discipline, the community etc.




F2 / F3 Management of Burdens and/or RisksNotwithstanding the value and benefits of the project (listed above), please outline potential burdens and/or risks that may be associated with the project for participants, researchers and incidental people that may be involved (e.g, lack of anonymity, disclosure of illegal activity, transport of participants, conducting research in participants homes, participant emotional distress etc). Please also provide a management strategy for every potential burden / risk identified.

Potential Burden / Risks Management Strategy?1.

2.

3.

4.

Note: To add additional rows place cursor in bottom row of right hand column and press ‘tab’.

Is the researcher(s) to be involved in participant recruitment a mandated reporter?

YesNo

If illegal activities may be disclosed by participants during the course of the research, explain in the table above how this will be managed. Please note that even if a researcher is not a mandated reporter that researchers could be held criminally liable if they fail to disclose information to authorities relating to serious indictable offences (e.g., murder, rape child abuse) under S241 of the Criminal Law Consolidation Act of South Australia).

F4. Concealment and Debriefing

Will the true purpose of the research be concealed from participants?

YesNo

If YES, answer the questions below. If NO, go to item F5

Outline the rationale for, and provide details of, the concealment

Will participants be debriefed following research participation?

YesNo

How will debriefing be provided to participants? (Eg. verbal, via email, via post)

If a debriefing sheet will be provided to participants, is a copy attached to this application?

YesNo

F5. Project Outcome FeedbackWill any feedback be provided to participants on project completion about the outcomes of the project? If YES, please (a) clarify how participants will be informed of this process; and (b) please provide copies of any written feedback information to be provided to participants.

Yes


No

If NO, please explain why not

If YES… answer the questions in the table below.Please note that the committee recommends either providing all participants with feedback, or none at all (i.e, feedback only provided to those who request it is not the preferred option).

No. How will feedback be provided to EACH participant type? (e.g, email, poster, website etc)

How will participants be advised of the feedback process?(e.g, Information Sheet; email, verbally etc)

1.

F6. QuestionnairesIf participants will be required to complete a questionnaire indicate what the arrangements will be for the secure and confidential return of questionnaires to the researcher (e.g., sealable self-addressed envelope, collection by researcher or someone other than researcher, secure collection box etc).

Please also indicate how participants will be informed of the arrangement (e.g., verbal instruction, information sheet, information listed at end of questionnaire etc).

HOW will the questionnaire be completed?

Online (eg. Survey Monkey, Qualtrics, SONA etc) If OTHER, please state:

Email

Hard-copy - in participant’s own time

Hard-copy - in a group situation (eg. class, workshop)

Hard-copy – at end of a training session or Workshop

Verbally – in person

Verbally – via telephone or Skype

Other

HOW will completed questionnaire be returned?

Online (eg. Survey Monkey, Qualtrics, SONA etc) If OTHER, please state:

Email – to the researcher

Hard-copy – in sealed envelope to researcher

Hard-copy – into a secure collection box

Hard-copy – posted

Verbal answers provided. Nothing to be returned.

Other

IF survey / questionnaire will be undertaken in-person, answer the questions below:

WHO will distribute the questionnaires to participants?

WHO will collect the completed questionnaires?


HOW will participants be informed of the arrangements of questionnaire completion AND return?

F7. Participant ReimbursementIs it the intention of the researcher to reimburse participants for their time, travel or participation? Refer to the Application Submission Guide available from the SBREC Guidelines, Forms and Templates web page for guidelines on participant reimbursement.

YesNo

If YES, how much or what will participants be given as a reimbursement?


If YES, please also provide a justification for the amount or item to be provided as reimbursement.


F8. Data TranscriptionIndicate whether data may need to be transcribed. If YES, please indicate who will transcribe the data (e.g, researcher(s), secretarial assistance, professional transcription company). If anyone other than the researcher(s) will transcribe data, confirm whether they will be required to sign a confidentiality agreement, a template for which is available from the SBREC Guidelines, Forms and Templates web page.

Will any data need to be transcribed? (e.g, interview or focus group recordings etc)

YesNo

If NO, and the research will involve interviews and/or focus groups, please clarify why data will not need to be transcribed?

If YES… who will transcribe the data? Select which ones apply in the table below.

Type of Data (e.g., interview recordings) Researcher Secretarial Assistance Professional

Transcription CompanyOther?……………………..

If YES, and data will be transcribed by someone outside of the research team (excluding Professional Transcription Companies), will they be asked to sign a confidentiality agreement?

YesNo

F9. Participant Control of Data

Interviews


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




Will interview participants be given the opportunity to review and edit their individual transcripts?

Yes If YES, ensure participants are informed about this in the Information Sheet.

No

If NO, please explain why not; and confirm that the interview audio recordings will be retained on project completion.

Surveys / QuestionnairesWill survey participants be able to edit information provided after completion of the survey?

Yes If YES, ensure participants are informed about this in the Information Sheet.

No

Focus Groups Please confirm that a) focus group participants will not be given the opportunity to review and edit transcripts of the focus

group; andb) focus group audio recordings will be retained on project completion.

Confirm

F10. DATA STORAGE AND RETENTION This section relates to Research Integrity, with some types of research data and data storage being subject

to audit. It also relates to Respect and any undertakings made by the researcher regarding anonymity and confidentiality (see National Statement see section 1).

Note that the data should be retained in accordance with the Australian Code for the Responsible Conduct of Research (section 2) and Flinders University policy.

F10(a) Data Transmission ProtocolsDuring the research project:

Research TeamWhat protocols will be used for the secure transmission of data (if required) to other members of the research team and/or from student to supervisor?

Note – a response MUST be given to this question. The only exception to this is if the project has a single staff researcher.

Transcribers / InterpretersWhat protocols will be used for the secure transmission of data (if required) to transcribers and/or interpreters?

Deletion following Service CompletionIf transcription or interpreter services will be used, will the data received be deleted by transcribers / interpreters on completion of services?

F10(b) Data TypeHOW and WHAT data will be stored on project completion?


https://www.flinders.edu.au/ppmanual/research/research-practice.cfm

https://www.nhmrc.gov.au/guidelines-publications/r39



Data Storage – Hard-copy and Soft-Copy

HARD-COPY DataWHAT information will be stored in HARD-COPY format?

Committee prefers hard-copies to be scanned and stored electronically where possible

LIST below ALL Data to be stored in Hard-Copy

…

‘X’ - Select all that apply below

SOFT-COPY (Electronic) DataWHAT information will be stored in SOFT-COPY format?

Audio recordings – interviewsMUST be retained if participants will not get to review / edit transcripts.

Audio recordings – focus groups MUST be retained.

Audio recordings – verbal consent

Video recordings

Photographs

Observation Notes

Survey data

Transcripts (e.g. interviews, focus groups etc)

Artefacts provided by participants (e.g. artwork, assignments etc.)

Other – Please specify below:

...

F10(c) Data De-identification

Will data be stored in a de-identified form?

YesNo

If YES, please confirm whether data will be stored in a non-identifiable or re-identifiable format. Place a cross in the box that applies.

Non-IdentifiableIt will not be possible to link the data to an individual or organisation (i.e, non-identifiable).

Re-IdentifiableWhile all identifying information will be removed, the means will still exist to re-identify individuals and/or organisations (i.e. re-identifiable data)

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


F10(d) Data Storage Location on Project CompletionClarify where the data will be stored securely. Wherever possible, research data should be held in the researcher’s department or other appropriate institutional repository, however researchers are permitted to hold copies of research data for their own use, and for copies of the data to be stored in locations other than Flinders University.


If data will not be stored at Flinders University, explain why and indicate where and how long it will be stored for in accordance with the retention periods listed below (see the Australian Code for the Responsible Conduct of Research, paragraphs 2.1, 2.2.2 and 2.2.3).

On project completion, WHERE will data be stored?

Select all that apply below with an ‘x’

Flinders University Location External to University

- USB / Flash-drive / External Hard-driveNot deemed to be secure for long-term storage

- USB / Flash-drive / External Hard-driveNot deemed to be secure for long-term storage

Computer Server Other. If yes, specify below:

…Flinders University Cloud Storage

Library

Locked filing cabinet

Other. If yes, specify below:

…

F10(e) Data Retention PeriodData will be stored securely at location listed above for:

At least 12-months after the completion of the project if the research project is for assessment purposes only, such as class research projects completed by all students.Note: Applies to research projects which include a whole topic list of students on one application, not for projects that include one or a few student researchers.

At least five years from the date of publication

At least seven years from the date of publication if the research involves a South Australian Government Department (e.g., DECD)

Permanently if data relates to work that has a community or heritage value, preferably within a national collection

G. OTHER MATTERSG1. Other Ethics Committees

Indicate any other centres involved in this research AND/OR any other Ethics Committee(s) being approached for approval of this project including the approval status of each. If copies of approvals cannot be provided at the time of application submission please confirm that copies of all approvals will be submitted to the Committee on receipt.

IMPORTANTPlease 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 Applying for Human Ethics Approval SBREC web page.


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




Other Centres and Ethics Committees to be approached for approval? Ethics Approval Attached?

1.

2.

3.

Please note that if other Ethics Committees request amendments to your project once SBREC has also approved your project, you will need to submit a request to modify your project using the Modification Request Form available for download from the SBREC Managing Your Ethics Approval web page.

G2. FundingThis information helps committee reviewers assess any possible conflicts of interest (see National Statement chapter 5.4).

G2(a) Has this project been commissioned by a funding body?

YesNo

G2(b) Has funding been received / applied for? If YES answer all the questions below.

YesNo

G2(c) Is the funding that has been received / applied for from an internal (i.e., Flinders University) or

external (non-Flinders) funding source (e.g., ARC, NHMRC, etc)?

Internal

External

G2(d) List how much funding has been received / applied for and the name

of the relevant funding body (e.g., ARC, NHMRC, etc).

$ Funding received / applied for Funding Body

1.

2.

G2(e) List the grant application or award number (if known) and the grant project title (as provided in

the funding application).



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

GRANT Project Number (e.g. for ARC / NHMRC, etc) GRANT Project Title

1.

2.

G2(f) If funding has been applied for (or received), please declare any affiliation or financial interest that any researchers listed in the application may have.


G2(g) Please indicate whether the funder / funding bodies have any requirements as a condition of funding to be provided (e.g., access to raw or aggregated data, data storage location, data ownership, intellectual property etc). Please also indicate if the research will go ahead if funding is not obtained.


G3. Attachment ChecklistIndicate below what documentation is attached to this application.

Recruitment Materials Attached

Recruitment advertisement Flyer

Poster

Social Media Advertisement

Newspaper Advertisement

Other (please specify)…;

Letter of Introduction Student projects only. Must be written by supervisor.

Information SheetsFor each participation group.

Consent Forms Interview

Focus Group

Experiment

Observations

Parent / guardian

Photographic Release Form

Talent Release Form

Other (please specify)……

Assent FormFor child participants and young people (if hard-copy form used)

Research Tools Survey / Questionnaire(s)

Interview questions / topics

Focus group questions / topics

Observation Grid


Recruitment Materials Attached

Other (please specify)…

Feedback material

Debriefing material Only required if true aims of project will be concealed

Privacy Legislation Matters

DVD to be viewed by participants

Translated copies of all participant documentation (if relevant)

G4. Research Involving or Impacting on Indigenous AustraliansDoes this research involve; and/or impact; on Indigenous Australian peoples and/or communities?If yes, a copy of your application will be forwarded by the SBREC Executive Officer to the Associate Dean: Research, Office of Indigenous Strategy and Engagement (OISE) at Flinders University, for comments and recommendations, which will be incorporated into the Committee's response to applicants.

YesNo

H. CERTIFICATION and SIGNATURES

The Researcher and/or Supervisor whose signature appears below certifies that they accept responsibility for the conduct of this research with regard to all conditions specified by the Social and Behavioural Research Ethics Committee, and that they will not commence the relevant research until final ethics approval is granted.

By submitting this application, the applicant(s) agree to comply with the National Statement on Ethical Conduct in Human Research and the Australian Code for the Responsible Conduct of Research, and are expected to be familiar with their responsibilities under each document.

Research Involving Children or Vulnerable AdultsPlease note that if your research involves contact with children and/or vulnerable adults, you must have a current Criminal History / Screening Check in place prior to commencing the relevant research, which must be valid for the duration of the proposed study.

Please submit a copy of your Criminal History / Screening clearance to [email protected], when available.






http://www.flinders.edu.au/oise/oise_home.cfm

Yes No N/A

Will any of the researchers listed on this project be involved in data collection with children and/or vulnerable adults? If YES, complete section below.

List below all researchers who will be involved in data collection with children and/or vulnerable adults and confirm each have applied for or have received a cleared criminal history check in South Australia.

Researcher Name(s) Applied for Criminal History Check? Received Cleared Criminal History Check?

1.

2.

3.

*Note: tab across to add new rows for additional researchers

Translations

Does your proposed research require documentation to be translated into another language?

Yes Place the letter ‘X’ in the relevant boxNo

n/a

If YES, please indicate below who; or which; professional translation organisation, will translate information and documents to be provided to prospective participants.

Name of Translator (if one of researchers) or Name of Translation Organisation

Please note that translated versions of participant information / documents should not be provided to the committee until after the application has been reviewed by the full Committee or Low Risk Sub-Committee; as the committee may request changes to the documents requiring translation.

Conditions Subsequent to Approval

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 ethics approval of the protocol including: serious or unexpected adverse effects on participants; proposed changes in the protocol (method, changes in recruitment processes etc); any changes in the research team; 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; compliance with any conditions of approval; and will request an extension of time if required prior to the ethics approval expiry date.

A pro forma is available from the Managing Your Ethics Approval section of the SBREC web site.

Principal Researcher’s Signature:

............................................................

Date:

............................................

Supervisor’s Signature: (for all student projects)

............................................................

Date:

...........................................

PLEASE NOTE: notification of the Committee decision cannot be emailed to applicants until a signed electronic copy of the ethics application has been submitted to the SBREC.

SUBMISSION InstructionsPlease email one (collated) PDF copy of the following to the Ethics Team at [email protected]

Signed application form; Privacy Matters Form A and/or B (if required); Letter(s) of Introduction (student projects only); Information Sheet(s); Consent Form(s); Photographic Release Form (if required); Research Tools (e.g., Questionnaire, Interview and/or Focus Group Questions; Any correspondence granting permission to undertake the research (if required); Evidence of any other ethics approvals that may need to be sought (if required);

LATE APPLICATIONSPlease note that applications received after the closing dates listed in the Meeting Schedule on the SBREC Applying for Human Ethics Approval web page will be held over to the following meeting. Applications submitted and reviewed as low/negligible risk are not subject to these closing dates.





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

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

flinders university and€¦ · web viewbelow are the definitions of exempt, negligible risk, low...

Documents