R 1. PROJECT DETAILS Project title: Data Warehousing & Successful Implementation in What type of project is this? (Tick as many as apply) 0 Funded Consultancy 0 Clinical Trial 0 Staff Research Project 0 Practical Class 0 Student Research Project 0 Doctorate 0 PhD 0 Masters by Research 0 Postgraduate Diploma 0 Honours 1 Masters by Coursework 0 Undergraduate 0 Other Through which School/Section is the research to be conducted? Faculty of Science What is your expected completion date? (Approval will be granted up until this date) Your project must not commence until full approval is granted. 2. RESEARCHERS Principal Researcher (must be a STAFF MEMBER) Title & Name: Position: Lecturer School/Section: School of Science Phone number: - Email address: Please list academic qualifications: Describe what this researcher will do in the context of this project: Include a brief summary of relevant experience for this project: Student/Other Researcher/s **copy and paste this table for each person involved in the project Title & Name: Position: Student School/Section: School of Science Phone number: Email address: Student ID number: Please list academic qualifications: Describe what this researcher will do in the context of this project: Include a brief summary of relevant experience for this project:   3. LAY DESCRIPTION Provide a brief outline of the project describing in everyday, jargon-free language the key aspects of the research (e.g., who will be participating, what information will be collected and by what means, what participants will be required to do, etc.) and the key research aims. The lay description must be in everyday, jargon-free language that is comprehensible by the average educated layperson. Define any technical terms or discipline-specific phrases, and use the full form of all acronyms the first time they are used. (300 words max.) 4. RESEARCH AIMS & SIGNIFICANCE State the aims, key research questions, and significance of the project. Where relevant, state the specific hypothesis to be tested. Also provide a brief description of the relevance of your proposed project to current research; (supported by a literature review and references) – refer to National Statement 1.1c, a justification as to why your research should proceed, including an explanation of any expected benefits to the community and its potential to contribute to existing knowledge. (600 words max.) 5. FUNDING & FINANCIAL BENEFITS Researchers should include any source of funding (e.g., departmental, commercial, non-commercial, governmental) The HREC will consider whether there is a conflict of interest. Are any of the researchers affiliated with or in receipt of any financial benefit from any of the external organisations involved in your research? 0 Yes 1 No If yes, explain how, how much and for what purpose: NA Has this protocol received research funding or is this submission being made as part of an application for research funding? 0 Yes 1 No What is the status of the funding application? 0 Approved 0 Refused 0 Pending If yes, what is the source of the funding? NA What is the project grant title and proposed grant duration? NA What is the registration number of the grant/funding application? NA What is the deadline for the granting body? NA Does this project require HREC approval before consideration for funding? 0 Yes 1 No How will participants be informed of the source of the funding? NA 6. MULTI CENTRE RESEARCH Other HREC Approvals The principal researcher is responsible for informing each HREC of all other sites at which the research is being proposed or conducted; disclosing to each HREC any previous decisions regarding the research made by another HREC; and informing each HREC of whether the protocol is presently before another HREC. Is this protocol being submitted or has it been previously submitted to another Human Research Ethics Committee? 0 Yes 1 No If yes, give details of other centres involved; the approval status of the study at each centre; and details of any required amendments. NA 7. EXTERNAL APPROVALS If your research involves participants from other organisations (e.g. educational institutions, companies, agencies, collectives), you may need to obtain authorised approval before approaching participants, eg: Department of Education and Training, School Principals, School Councils (for research involving Government schools); Catholic Education Office (Catholic schools); School Boards (Independent schools); Senior Officers (Commercial or Government entities); Elders (Aboriginal communities); or Representative bodies (Collectives). Copies of approval letters must be attached to this application or, if pending at the time of submission, forwarded to HREC when available. Some authorities may decline to provide permission letters until ethics approval has been granted. In such cases, you should submit your application to the HREC for provisional approval pending receipt of the documentation. Does research involve or impact on participants from external agencies or organisations? 0 Yes 1 No If yes, has required permission been obtained from relevant agencies? 0 Yes 1 No If yes, please specify from whom and attach a copy NA If no, specify from whom, and advise when this will be obtained NA 8. RESEARCH METHODOLOGY Provide an outline of the proposed method, including details of data collection techniques, tasks participants will be asked to do, the estimated time commitment involved, and how data will be analysed. If the project includes any procedure that is already established and uses accepted techniques please include a description of the procedure. (500 words max). 9. RECRUITMENT OF PARTICIPANTS Participant Details Describe your proposed recruitment strategy to source target participants. Provide the number and age range, giving a justification of your proposed sample size. Include details of statistical power of the sample where appropriate. To ensure the requirements for consent are met, refer to the National Statement Chapter 2.2 General requirements for consent: Target participants Who are the target participants? (Tick as many as applicable) 0 Students or staff of this University 1 Adults (over the age of 18 years and competent to give consent) 0 Children/legal minors (under the age of 18 years, with parental consent)* 1 Elderly individuals 0 Individuals from non–English-speaking backgrounds 0 People in other countries 0 Pensioners or welfare recipients 0 Intellectually or mentally impaired individuals unable/with compromised capacity to provide consent 0 Physically disabled individuals 0 Patients or clients of professionals 0 Prisoners, parolees, or wards of the state 0 Individuals highly dependent on medical care with a compromised capacity to give consent 0 Aboriginal and/or Torres Strait Island communities 0 Other collectives where leader/council of elders may need to give consent 0 Women who are pregnant and the human foetus 0 People who may be involved in illegal activities *Parental consent may not be required in some instances - refer National Statement, 4.2.8 & 4.2.9 Proposed Recruitment Method A copy of all recruitment materials used (e.g., printed advertisements, radio and television advertisement transcripts, posters, letters of invitation) must be attached to this application for review by the committee. What is the proposed recruitment method? (Tick all that apply) 0 Mail-out 1 Email Have you attached a copy of the text of the email that will be sent? Yes 0 No 0 If no, please explain: 1 Telephone 0 Contact details obtained from public documents (e.g., phone book) 0 Recruitment by researcher(s) 0 Participants from a previous study 0 Snowball (participants suggest other potential participants) 1 Personal contacts – Provide details: 0 Other – please explain: 0 Advertisement (e.g. for a noticeboard or FedNews) Have you attached a copy of the advertisement? Yes 0 No 1 If no, please explain: 0 Facebook Have you attached a copy of the advertisement that will be posted on Facebook? Yes 0 No 1 If no, please explain: I think no need to publicize the research that we are handling as it can be done face to face meeting. 0 Recruitment by a third party (e.g., employer, doctor) Have you attached a copy of the letter requesting their assistance, and/or the letter confirming their willingness to assist? Yes 0 No 1 If no, please explain: 0 Private sources Have you attached a copy of the relevant approval letter? Yes 0 No 1 If no, please explain: 10. BURDENS OF RESEARCH (RISK & RISK MANAGEMENT) This section raises the issue of your duty of care toward research participants. To what risks are participants subjected? What will you do should an emergency occur, or should a participant become upset or distressed? What is your risk management strategy? Refer National Statement: Section 2.1 Risk and Benefit Likely Benefits Are participants likely to gain direct or indirect benefit from the research? Yes 1 No 0 If yes, provide details How will potential benefits to participants or community outweigh the risks? Research Activities Which of the following activities will the research involve? (Tick as many as apply) 0 Use of a questionnaire (attach copy) 0 Interviews (attach interview questions) 0 Observation of participants without their knowledge 1 Participant observation 0 Audio- or video-taping of interviewees or events 0 Access to personal and/or confidential data (including student, patient or client data) without participants' specific consent 0 Administration of any stimuli, tasks, investigations or procedures which may be experienced by participants as physically or mentally painful, stressful or unpleasant during or after the research process 0 Performance of any acts which may diminish the self-esteem of participants or cause them to experience embarrassment, regret or depression 0 Investigation of participants involved in illegal activities 0 Procedures that involve deception of participants 0 Administration of any substance or agent 0 Use of non-treatment of placebo control conditions 0 Collection of body tissues or fluid samples 0 Collection and/or testing of DNA samples 0 Participation in a clinical trial 0 CTN Trial 0 CTX Trial Please provide Phase number, i.e., either 1, 2, 3 or 4 0 Testing a medical/diagnostic device 11. Risk Management Procedures Identify as far as possible all potential risks to participants (e.g. physical, psychological, social, legal, economic) associated with the proposed research. Explain what risk management procedures will be put in place. Any potential risks should be outlined in the Plain Language Information Statement (PLIS) along with contact details of an appropriately qualified organisation for participant reference in case of distress, eg: Lifeline Where will the research be conducted? (Tick as many as apply) 0 Federation University 0 Other location(s) If other, please give details (including the URL for web-based studies) Are facilities at the research location appropriate for the scientific needs of the research? 0 Yes 0 No If no, please elaborate Are the facilities appropriate to meet any physical, emotional or other needs of participants that result from their participation? 0 Yes 0 No If no, please elaborate Are there any specific risks to researchers? 0 Yes 0 No If yes, please describe the risks identified, and your planned Risk Management protocol for researchers What plans are in place to deal with adverse/unexpected outcomes? Will parts of this project be carried out by independent contractors? Yes 0 No 0 If yes, please confirm that the independent contractor will receive from the first-named Principal Researcher, a copy of the approved ethics protocol and be made aware of their responsibilities arising from it. If necessary, has the Principal Researcher ensured that the other researchers have undergone a police check and a Working With Children check? Yes 0 No 0 N/A 0 How will the conduct of the project be monitored to ensure that it conforms to the procedures set out in this application, the University's human ethics guidelines, the National Statement 5.5, and the Australian Code for the Responsible Conduct of Research 3.4? (In the case of student projects please give details of how the supervisor/s will monitor the conduct of the project; e.g., how often student and supervisor will meet; how meetings will be conducted: email/phone/in person; how efforts will be coordinated if a number of researchers are involved.) Will there be support provided for participants? (You may need to consider having additional support for participants during or after the study, depending on risks to participants. Consider whether your project would require additional support and what support would be available.) What debriefing will participants receive following the study and when? (Attach a copy of any written material or statement to be used in such a debriefing. Participants may need to talk with the researchers about the experience of being involved in the study as well as learn more about the aims of the research.) 12. INCENTIVES FOR PARTICIPATION Note that while participants may, in certain circumstances, be paid or reimbursed for their inconvenience and time, the payment should not be of an amount that risks inducement to participate, thus potentially biasing the project's results. If rewards are to be used, all participants are to receive the reward. Are financial or other rewards proposed to be given to participants? 0 Yes 0 No If yes, describe how much and in what form the payment/incentive will take (e.g., money to reimburse travel costs, vouchers for movie tickets, chocolate frogs). 13. CONSENT Dependent or Unequal Relationships The consent of a person to participate in research must not be subject to any coercion. Research involving those in dependent or unequal relationships (e.g., teacher/student, manager/employee, parent/child, doctor/patient) may compromise a participant's ability to give consent that is free from any form of pressure (real or implied) arising from this unequal power relationship. The HREC therefore recommends that, where possible, researchers should choose participant cohorts where no dependent relationship exists. However, if the researcher believes that research involving people in dependent relationships is purposeful and methodologically defensible, the HREC will require additional information explaining why this is so and how any risks inherent in the dependent and unequal relationship will be managed. The HREC will also need evidence to show that participants have been reassured that refusal to participate will not result in any discrimination or penalty. Applicants should note that reasons of convenience will not normally be considered adequate justification for conducting research in situations where dependent relationships exist. * Please refer to the National Statement on Ethical Conduct in Human Research – Chapter 4.3 for information on unequal relationships before answering the following question. Does a dependent or unequal relationship exist between any participant and researcher, particularly those involved in recruiting? Yes 0 No 0 If yes, please explain the relationship and the steps to be taken by the researchers to ensure that the participant's participation is purely voluntary and not influenced by the relationship in any way. Informing Participants – Plain Language Information Statement (PLIS) The potential participant must be provided with information at their level of comprehension about the purpose, methods, demands, risks, inconveniences, discomforts, and possible outcomes of the research (including the likelihood and form of publication of research results) so their consent is fully informed. Download the current template for the PLIS from the HREC website. Have you attached a copy of the PLIS for participants? 0 Yes 0 No If no, please explain Does the PLIS comply with the following guidelines? YES N/A It is presented on the Fed Uni HREC approved template, downloaded from the website 1 * It has clear identification of the University, the School(s) involved, the project title, the Principal and Other Researchers (including FedUni contact details). 1 * It details what involvement in the project will require (e.g., involvement in interviews, completion of questionnaire, audio/video-taping of events), estimated time commitment, any risks involved. 1 * It advises how participants' contact details were obtained and/or how potential participants were selected 1 0 If staff or students of the Federation University are to be involved as participants, it advises that the project has received clearance by the HREC 1 0 It advises that if the sample size is small this may have implications for privacy/anonymity. 1 0 It states clearly that if participants are in a dependent relationship with any of the researchers involvement in the project will not affect ongoing assessment, grades, employment, management or treatment of health (as relevant). 1 0 It states clearly that involvement in the project is voluntary and that participants are free to withdraw their consent to participate at any time, and to withdraw any unprocessed data previously supplied. 1 * It states that arrangements will be made to protect confidentiality of data, including that confidentiality of information provided is subject to legal limitations (e.g., subpoena, freedom of information claim, or mandatory reporting in some professions). 1 0 It advises whether or not data will be destroyed after a minimum period. 1 0 It provides any other relevant information. 1 * * Required Obtaining and Documenting Consent How will informed consent be obtained/recorded? 0 Signed consent form 0 Recorded verbal consent 0 Implied by return of survey *NB If consent is to be implied by return of survey, all information that would normally be presented on the consent form must be included in the PLIS 0 Other (Please specify): The correct template for the consent form can be found at: http://federation.edu.au/research-and-innovation/research-support/ethics/human-ethics/human-ethics3 Is a copy of the consent form attached to this application form? 0 Yes 0 No If no, please explain how consent will be documented: Does the consent form comply with the following guidelines? 0 It is presented on the Fed Uni HREC approved template, downloaded from the website 0 It states the title of the project and names of the researchers 0 It confirms that the project is for research 0 It confirms that involvement in the project is voluntary and that participants are free to withdraw at any time or withdraw any unprocessed data previously supplied 0 It details specific requirements of participants (e.g., interviews will be audio-/video-taped) 0 It advises of any legal limitations to data confidentiality 0 It advises that if the sample size is small this may have implications for privacy/anonymity 0 It provides any other information relevant to obtaining participant consent 14. DISCONTINUING PARTICIPATION Are participants advised as part of the informed consent process that they have the right to withdraw at any time or withdraw any unprocessed data previously supplied? 0 Yes 0 No If yes, please detail how participants are informed of this right. If no, please explain why this advice has not been given 15. INFORMATION PROTECTION (DATA; STORAGE; SECURITY) Confidentiality Please give attention to implications for compliance with legislative requirements including, for example, Guidelines Approved under Section 95A of the Privacy Act 1988, produced by NHMRC, and Statutory Guidelines on Research Issued for the Purposes of Health Privacy Principles produced by the Office of the Health Services Commissioner. What are Data? (NS Ch3.2 Databanks) Data are pieces of information, eg: • What people say in interviews, focus groups, questionnaires, personal histories and biographies; • Analysis of existing information (clinical, social, observational or other); • Information derived from human tissue such as blood, bone, muscle and urine. (Note: Where the sample size is very small, or information is obtained through a focus group, it may be impossible to guarantee anonymity or confidentiality of participants' identity, and participants involved in such projects need to be advised of this limitation.) Tick which method will be used to guarantee confidentiality/anonymity? 0 Individually identifiable data, where the identity of a specific individual can reasonably be ascertained. Examples of identifiers include the individual's name, image, and date of birth or address. 0 Re-identifiable data, from which identifiers have been removed and replaced by a code, but it remains possible to re-identify a specific individual by, for example, using the code or linking different data sets. 0 Non-identifiable (anonymous) data, which have never been labelled with individual identifiers or from which identifiers have been permanently removed, and by means of which no specific individual can be identified. A subset of non-identifiable data are those that can be linked with other data so it can be known that they are about the same data subject, although the person's identity remains unknown. Tick all that apply from the boxes below: 0 Participants will have the option of being identified in publications arising from the research. 0 Participants will be referred to by pseudonym in publications arising from the research. 0 Personal information will be obtained from a Commonwealth department or agency? (If yes, you may need to comply with the requirements of the Privacy Act 1988). 0 Any other method of protecting the privacy of participants (e.g., use of direct quotes with specific, written permission only; use of real name with specific, written permission only). Please describe: Security and Storage Does the Principal Researcher accept responsibility for the security of the data collected? 0 Yes Who will have access to data? 0 Access by named researchers only 0 Access by other(s) than named researcher(s) If others have access to data, identify who, at which storage site, for what purpose, and their connection to the project. Which of the following methods will be used to ensure data security? 0 Data will be kept in locked filing cabinets 0 Data and identifiers will be kept in separate, locked filing cabinets 0 Access to computer files will be available by password only 0 Other (please describe) Does data storage comply with the NHMRC/ARC Australian Code for the Responsible Conduct of Research? See Section 2: Management of research data and primary materials 0 Yes 0 No If no, please explain Please confirm that at the conclusion of the study, the data will be kept in locked facilities in the School through which the project is being conducted 0 Yes If data is to be kept elsewhere during fieldwork, please explain how and where data will be held, including arrangements for data security Please confirm that any data collected will be kept for a minimum of 5 years from date of research publication. 0 Yes Will the data be destroyed at some point after being kept for the minimum 5 year period? (Data may be kept indefinitely, but must be appropriately secured) 0 Yes 0 No If yes, how and when will data be disposed of? Please confirm that any data collected will be disposed of by the Principal Researcher, who is responsible for the data. 0 Yes 16. Dissemination of Results Explain when, how, where and to whom results will be disseminated, including whether participants will be provided with information on the project's findings or outcomes. How will results be made available to participants? (Tick as many as apply) 0 Written summary of results 0 Copy of final manuscript (thesis, article, etc.) 0 Verbal presentation (info session, debriefing, etc.) 0 Presented to all participants 0 Presented if requested 0 Presented to representative participants (e.g. CEO, school principal) 0 Other - Please explain: 0 None - Please explain: How will results be made available to peers and colleagues: Tick as many as apply 0 Conference papers 0 Journal article(s) 0 Thesis 0 Book 0 Other - Please explain 0 None - Please explain 17. LEGAL ISSUES Does the project involve subject matter or conduct that may give rise to legal vulnerability of participants or researchers? 0 Yes 1 No If yes, please give details Are adequate precautions to be taken? 1 Yes 0 No 0 N/A If yes, please give details Confidentiality of information provided can only be protected within the limitations of the law. Depending on the research proposal, you may need to state these limitations specifically (subpoena, freedom of information claim, mandated reporting by some professions, etc.) Have you included appropriate information on the legal limitations of protecting confidentiality in the PLIS and consent form? 1 Yes 0 No 0 N/A If no, please advise how participants will be advised 18. CHECKLIST OF ATTACHMENTS Please check that the following documents are attached to your application. Applicants should note that where questionnaire or interview questions are submitted in draft form, a copy of the final documentation must be submitted for final approval when available. Are the following documents attached? Yes No N/A Recruitment advertisement (e.g. for noticeboard or FedNews) 0 0 0 Plain Language Information Statement 0 0 * Consent form 0 0 0 Evidence of external approvals related to the research 0 0 Pending 0 0 Questionnaire 0 0 Draft 0 0 Interview Schedule 0 0 Draft 0 0 Debriefing material 0 0 0 Other 0 0 0 * Required   19. DECLARATIONS Researcher Declarations: The information contained herein is, to the best of my knowledge and belief, accurate. I have read the University's current human ethics guidelines, and accept responsibility for the conduct of the procedures set out in the attached application in accordance with the guidelines, the Australian Government's National Statement on Ethical Conduct in Human Research 2007 (Updated May 2015), The Australian Code for the responsible Conduct of Research, and any other condition laid down by the Federation University's Human Research Ethics Committee or its sub-committees. I have attempted to identify all risks related to the research that may arise in conducting this research and acknowledge my obligations and the rights of the participants. I and my co-researchers and supporting staff have the appropriate qualifications, experience and facilities to conduct the research set out in the attached application and to deal with any emergencies and contingencies related to the research that may arise. ……………………………………………….. Principal Researcher ……………………………………………………… (Print name in block letters) Date: …..../…...../…..... …………………………………………… Other Researcher ……………………………………………… (Print name in block letters) Date: …..../…...../…..... …………………………………………………… Other Researcher ………………………………………………… (Print name in block letters) Date: …..../…...../…..... …………………………………………… Other Researcher ……………………………………………… (Print name in block letters) Date: …..../…...../…..... …………………………………………………… Other Researcher ………………………………………………… (Print name in block letters) Date: …..../…...../…..... …………………………………………… Other Researcher ……………………………………………… (Print name in block letters) Date: …..../…...../…..... …………………………………………………… Other Researcher ………………………………………………… (Print name in block letters) Date: …..../…...../…..... *NB: If the following section is not completed, the application will not be accepted for review. Declaration by authorised signatory: Head of School, Deputy Head of School, Associate Dean Research, or Ethics Coordinator (Mt Helen campus only) I have reviewed this project and consider the methodological/technical aspects of the proposal to be appropriate to the tasks proposed and recommend its approval. I consider the Researcher(s) to have the necessary qualifications, experience and facilities to conduct the research proposed and to deal with any emergencies and contingencies that may arise. Comments/Provisos Signature: …………………………………………………………………….. Signatory Name:…………………………………………………………………….. 0 Head of School or 0 Deputy Head of School or 0 Associate Dean of Research or 0 Faculty Ethics Coordinator Date ............/……....../...........