EXPEDITED REVIEW APPLICATION FORM LOW and NEGLIGIBLE RISK RESEARCH

Transcription

1 EXPEDITED REVIEW APPLICATION FORM LOW and NEGLIGIBLE RISK RESEARCH approves human research conducted at Southern Cross University (SCU) in accordance with the National Statement on Ethical conduct in Human Research. Make sure you have downloaded this document, have read and understood it, and have applied its principles when completing this application. This form relates to low and negligible risk research review. Low and negligible risk is defined in the National Statement. The application can be submitted at any time in electronic form to the Office of Research Ethics, together with all necessary attachments. Specific information about a research project should normally be provided to participants so that a person s consent to participate in research is voluntary, and based on sufficient information and adequate understanding of the proposed research and the implications of participation, including the purpose, methods, demands, risks and potential benefits of the research. A sample information and consent sheet can be found on the Office of Research website. If you seek to conduct research without obtaining informed consent from participants, please first contact the Chair of HREC via ethics.lismore@scu.edu.au to discuss the options. You must not commence data collection until you receive an ethics approval number. You may contact participants during the planning of your research, but must not collect data from them at this stage. ATTENTION MAC USERS: This form will be corrupted if opened in Preview SECTION 1: ADMINISTRATIVE DETAILS PART 1: Project Basics Project Title: Estimated commencement date: Expected duration of the project (months) and/or completion date: Date of Submission: PART 2: Applicant Details Principal Researcher/Investigator: (Main Researcher/Student/Staff Member and applicant) Staff/Student Number: Position Title: Qualification status (eg staff member - state position, lecturer, postgraduate student, undergraduate student, Honours student): School/Special Research Centre: Phone Number: SCU

2 Is Additional applicant Researcher/Investigator: a student? Staff/Student Number: Position Title: Student I Role in the Research: Supervisor s Name: Qualification Degree being status undertaken: (eg staff member (state position), lecturer, postgraduate student, undergraduate student, honours student): School/Special Research Centre: Additional Researcher/Investigator 1: Name: Phone Number: SCU Position Title: Role in the Research: Additional Researcher/Investigator: Staff/Student Number: Qualification status (eg staff member (state position), lecturer, postgraduate student, undergraduate student, Position honours Title: student): School/Special Research Centre: Role in the Research: Phone Number: Qualification status (eg staff member (state position), lecturer, postgraduate student, undergraduate student, SCU honours student): School/Special Research Centre: Additional Researcher/Investigator 2: Phone Number: Supervisor/Person Responsible*: (NS 5.1.2) (t required where the Principal Researcher/ Investigator is a staff member of the University). * This should be a full time member of the University - they should be adequately experienced and qualified. Staff/Student Number: Position Title: Qualification status: School/Special Research Centre: Phone Number:

3 SECTION 2: ETHICAL CONSIDERATIONS PART 1: Risk Assessment All clinical trial research requires full application to the HREC and cannot be submitted on this form. The World Health Organisation definition of a clinical trial is: any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Does your proposed research involve any of the following? If you answer to any of the statements, your proposal must be submitted to HREC on a National Ethics Application form (NEAF). For further clarification, contact Office of Research Ethics. 1. The ingestion of any substance that would not be considered a part of a participant s regular diet or nutritional requirements 2. The ingestion of a therapeutic good as defined by the Therapeutic Goods Administration (TGA) 3. The administration of a medically prescribed treatment that is not part of participant s normal medical treatment 4. The withholding of an existing medical treatment e.g. prescribed medication 5. An exercise intervention that may cause muscle soreness, injury or discomfort and that is not an activity normally undertaken by participants or for a duration not normally undertaken by participants 6. Research involving the taking of blood samples 7. Research involving the collection of body fluids other than blood e.g. saliva and urine 8. Research directed at participants with an existing physical or mental health condition 9. Research that may cause psychological distress or anxiety to participants Reason for Expedited Approval: Select the reason/s why you consider this application can be given expedited review for approval. (Mark all the relevant boxes more than one may apply): Data obtained is anonymous or will be held confidentially. The research plan is safe and poses low/negligible risk to participants. The research does not involve the participation of vulnerable groups. Other (specify)

4 Do you consider this research Low/Negligible Risk to participants? (NS Section 2) If NO: then your research is not suitable for expedited approval. You must submit the National Ethics Application Form [NEAF]. PART 2: Assessing Application Type Is this a new project? If NO: advise details of the previous project: Name of the Ethics Committee: Ethics Approval Number: ECN Month/year of review: Is this a project which has received external ethics approval and now requires Southern Cross University ratification? If YES: please use the Minimising Duplication of Ethical Review form, available at the Office of Research Ethics website. Is this project currently before another ethics committee? If YES: which committee? Does the research involve any other institution (such as a hospital or school)? If YES: what is the name of the institution? Does the institution require ethical approval from its own ethics committee? If YES: has that approval been obtained? If YES: use the Minimising Duplication of Ethical Review form, available at the Office of Research Ethics website.

5 PART 3: Funding (NS 5.2.7) Have you (or your supervisor if applicable) received or applied for external funding or sponsorship for this research? If YES: Name of the funding organisation: Details of the funding or sponsorship (including details of any in-kind contribution): Amount of external funding/sponsorship: Value of in-kind contribution: Other details: Are there any conditions or restraints on the research as a result of the funding arrangements? (NS ) If YES: State the nature of the conditions and/or restrictions: SECTION 3: PROJECT DETAILS PART 1: Research Details Aim or Purpose of the Research: (NS ) Include a plain language, concise and simple description of the aims and/or purpose of this project.

6 The nature of this project is most appropriately described as involving: Qualitative research Quantitative research Observation Questionnaire/s, Survey/s (attach a copy) Interviews QA/Evaluation surveys On-line data collection Focus groups Experiments Other (specify) Research Background: Background and Rationale Summary Refer to National Statement (NS 1.1), Research Merit and Integrity. Include literature reviews. Do not just copy and paste a complete research plan. (If you need more space please submit this section as a separate file)

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8 PART 2: Participant Details Recruitment/Source of participants - Give details of how the participants are to be recruited/ selected: For example, include details of how you propose to: Initially select and contact your participants. How you will obtain their contact details. Attach copies of documentation you intend to use (letter, advertisement/flyer, script for telephone, , internet, personal or organisation contact as part of your collated supporting document). Provide details of any permission you are required to obtain, or have obtained, from organisations (e.g. university, company, government department) where you are seeking to access staff or other members of that organisation. Intended number of participants - Explain how and why you have chosen this number: Age range of participants: Rationale: How will research participants be affected? What procedures will participation in this research involve for your participants?

9 What time commitment will the research involve for your participants? What travel (if any) will the research involve for your participants? Where will the research/data collection take place? Additional Information E.g. will any refreshments be provided to the participants? Will participants be reimbursed for travel costs? PART 3: Data Analysis (NS 3) and Management How will the data be analysed? How long will the data be stored for in accordance with the Australian Code for the responsible conduct of research, Section 2.1? Where will the data be stored? (Please call Technology Services for options of data storage facilities (ext )?

10 Dissemination of the research results, including publication - If the results of this research are to be published, the participant should be aware of this, e.g. The results of this study may be published in a peer-reviewed journal and presented at conferences, but only group data will be reported. Will the results be published: Provide details about the security and storage of the research material. te that a retention period of 5 years applies to University research material: PART 4: Expected Outcomes (NS ) What are the expected outcomes?

11 PART 5: Benefits (NS and 2.1) What are the expected benefits of this research? To participants: To the broader community: To increasing knowledge: PART 6: Risks (NS 2) Describe the level and nature of the risk to the participants in this research: Describe the mediation techniques you will employ to manage the risks identified:

12 PART 7: Export Controls Once in the website click on Sanctions Regimes for locations and Consolidated List for organisations SANCTIONS: Does the project involve any location/organisation on the current UN or Autonomous Sanctions list? If YES: state the location/organisation involved: DECO: Does the research or teaching activity involve an item and/or technology that may require a permit under Defence Export Controls? If YES, contact Stephen Williams - Director, Office of Research or export.controls@scu.edu.au. PART 8: Review and Feedback Review Process (NS 1.2): Briefly describe the process of review and quality assessment for your research proposal. (E.g. has your supervisor or an external reviewer assessed the research plan?) All participants are entitled to receive the results of research in which they participated. Usually, participants are advised, in the Information Sheet, as to how they can obtain results of research. If there is a consent form, participants can also indicate on the consent form that they would like to receive research results. How will you advise participants that they can obtain feedback on the results of the research once it has been completed? Informed Consent (NS 2.2): Is Informed Consent necessary? How will you obtain the consent of the participants?

13 SECTION 4: RESEARCH CONDUCTED OVERSEAS (NS 4.8) Are you conducting research in an overseas country? If NO: go to Section 5. If YES: Are you familiar with the NS 4.8: People in Other Countries? In what country will the research take place? Does this country have ethical approval processes that would be relevant to this research? If there are such processes, are they mandatory or voluntary in relation to this research? Mandatory Voluntary If no processes are in place, then the researchers need to ensure the HREC that research participants are accorded no less respect and protection than is mentioned in the National Statement. Do you guarantee that this will occur? Is the language of the country being used in all information provided to participants? What is the language? Do the researchers have expertise in this language? Are translators being used in this research? If you are subject to academic supervision, explain how you will keep your Supervisor fully informed about the progress of your research: Are you recruiting co-researchers in the overseas country? If YES: what expertise and capacity do they have to bring to this research? (NS Section ) Please refer to this section and make a statement relevant to your research: Will there be a local, readily accessible contact, should the participants have complaints about the research?

14 Researchers should be able to ensure that there is a process independent to the researcher for dealing with complaints. Describe how this will occur: Is there any risk to the researcher or the participants? (NS ) Address this section with a concise answer in relation to your research. You are advised that overseas travel may require approvals other than ethics approval. For example: Is your research to be conducted in a country which is subject to Australian Department of Foreign Affairs and Travel (DFAT) warnings? If YES: the Supervisor and you should ensure that the Head of School/Special Research Centre is aware of your travel and has given approval for the research to be conducted in a country which may be subject to DFAT warnings. Has this been necessary? Are you aware of appropriate requisite visa/entry permits for the country in which you will be conducting your research? If YES: what is required?

15 SECTION SECTION 5: 5 CERTIFICATIONS SIGNATURES I certify that by approving this application I confirm that the information contained in this form is accurate and complete. I confirm that I have read the National Statement on Ethical Conduct in Human Research and that the project is designed in accordance with the principles outlined therein, as well as the ethical and research requirements of the institutions involved. I have consulted relevant legislation and regulation (such as the Privacy Act 1988) and the research will be conducted accordingly. Applicant s Name: Signature: Date: Supervisor s Name (if applicant is a student): Signature: Date: SECTION 6 CHECKLIST Complete the following checklist to ensure you have correctly completed the Expedited Ethics application form. Have you read the National Statement on Ethical Conduct in Human Research? Have you answered all the questions? Have you attached the Information Sheet? Have you attached a Consent Form? Have you attached a copy of any proposed Questionnaire? Alternatively, have you included sample questions that may be asked of participants? Other (please specify) Do you have all the required signatures? Signatures can be electronic (scanned originals), or the signature pages can be faxed, scanned and ed. If you are a student, have you liaised with your supervisor and has your supervisor approved of all information stated in this application prior to signing? One electronic copy to be ed to Office of Research Ethics NOTED: Have you proof-read your application? Have you checked your spelling and grammar? Have you used the appropriate SCU identification such as current SCU logo on correspondence, or your school s letterhead to identify participant documents? Are additional documents attached?