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Important Information and Instructions for Applicants This application form is to be used by researchers seeking a Low Risk review for a research project which involves analysing data collected from patient records, where data is de-identified • To find out if your research project is eligible for a Low Risk Review, you should complete a Low Risk Review Checklist and refer to Section of the National Statement regarding risk and benefit • Read the UNDA human research policy and procedures found at Human Research Ethics - Policies and Procedures All UNDA researchers are expected to read and adhere to these documents • Familiarise yourself with the National Statement on Ethical Conduct in Human Research (2007, updated May 2015) (NS) This document provides the primary guidelines for this application and for ethics review Hyperlinks to relevant chapters are included throughout this application • Download a new form from ethics application forms to ensure that you are using the most current version of this form • Handwritten applications will not be accepted • Type an X in checkboxes that apply • Provide descriptive responses to questions beginning with How, Describe, Outline, Explain, Why and Provide details • Keep in mind that most HREC members are not researchers and will not be familiar with your research, so please use plain language and ensure that all technical terms, jargon and acronyms are clearly defined • Provide all necessary attachments where indicated • Your completed application must be submitted to your School Research Committee (SRC) for review The SRC Chair will then forward your application to the Research Office for HREC sub-committee review Applications without SRC approval will not be considered • Data collection must not commence until written approval has been provided by the HREC subcommittee • Please note: The HREC sub-committee may decide the application does not qualify for as “Low Risk” and will therefore require a Full Review application or may find the study requires substantial changes prior to the commencement of the study • The HREC will not grant retrospective ethics approval i.e data collection has commenced Application for Low Risk Ethical Review of a Research Project involving a Retrospective Analysis of Patient Data HREC Reference Number (Research Office use only) 1.1 Project Title: 1.2 Project Type: (Type ‘X’ to options that apply) Student Research Project PhD Honours Masters MD Other 1.3 Expected commencement date: Estimated project completion date: 1.4 School / Institute: 1.5 Research Team Details a) Staff Research Project Chief Investigator / Supervisor: (must be UNDA staff member with responsibility for the UNDA arm of the project) Name Mailing Address UNDA Email Indicate what this researcher will in the context of this project Supervise data collection Collect the data Other (outline below) Describe the relevant experience this researcher has specific to this project Phone Low Risk - retrospective analysis of patient data application form (updated May 2018) Page b) Co-Investigator / Student: Name Mailing Address UNDA Email Indicate what this researcher will in the context of this project Supervise data collection Collect the data Other Describe the relevant experience this researcher has specific to this project Phone Phone Phone c) Co-Investigator / Student: Name Mailing Address UNDA Email Indicate what this researcher will in the context of this project Supervise data collection Collect the data Other Describe the relevant experience this researcher has specific to this project d) Co-Investigator / Student: Name Mailing Address UNDA Email Indicate what this researcher will in the context of this project Supervise data collection Collect the data Other Describe the relevant experience this researcher has specific to this project (Copy and paste boxes for additional researchers) 1.7 Research Project Location a) Where is the location of the data that researchers are seeking to collect? Low Risk - retrospective analysis of patient data application form (updated May 2018) Page b) Is permission required to gain access to the data? YES NO If YES, specify from whom and attach a copy of the approval letter c) Describe how the data will be collected 1.8 Other HREC Approvals [Refer to NS 5.2.8] a) Does this project have approval by another HREC/s? Does this project have approval by another HREC/s and/or will this project be submitted to another HREC/s for review? YES NO If YES, provide the name of the HREC/s, and indicate the status of the application at each (i.e submitted, approved, deferred or not approved) Indicate which committee you consider to be the primary HREC for this project and why Attach copies of approval letters and any relevant correspondence 1.9 Monitoring of Research Conduct [Refer to NS Chapter 5.5 regarding researchers’ responsibilities for monitoring of research projects.] How will the Chief Investigator/Supervisor monitor the conduct of the research team to ensure that the research project complies with the protocol set out in this application, the University policy Code of Conduct for Research and the National Statement? Project Details 2.1 Keywords Provide a list and definitions for any project specific technical terms and acronyms which may assist the HREC to understand this application Term Lay Explanation 2.2 Target Participant Group a) Who are the participants, whose individual datasets you are seeking to collect? (Type X to all options that apply) Low Risk - retrospective analysis of patient data application form (updated May 2018) Page Adults (over the age of 18 years) Women who are pregnant and/or the human foetus (NS 4.1) Children and Young people (anyone under the age of 18 years) (NS 4.2) People in dependent or unequal relationships (NS 4.3) People highly dependent on medical care (NS 4.4) People with a cognitive impairment, an intellectual disability or mental illness (NS 4.5) People who may be involved in illegal activities or residents of custodial institutions (NS 4.6) People identifiable by their membership of a cultural, ethnic or minority group Other [Provide details below in b] Aboriginal and/or Torres Strait Islander people and/or communities (NS 4.7) 2.3 Aims of and Justification for the Research Project [Refer to NS Section , 5.2.5, 5.2.6] • State clearly the Aims/Research Questions/Hypothesis of the research project • Explain clearly the importance/significance of the research project • Provide a brief description of relevant background, current research/literature review 2.4 Research Project Design [Refer to NS Section 3.2 on Ethical considerations specific to databanks.] a) Clearly specify the information that will be collected about each individual and used for this project b) How many individual datasets are anticipated to be collected, and on what basis is this number considered sufficient to address study aims? Justification of sample size for quantitative studies is usually based on a power calculation (Consult a statistician if unsure or use an online sample size calculator e.g http://powerandsamplesize.com/ ) c) Outline how the data will be analysed to achieve the aims of the project Low Risk - retrospective analysis of patient data application form (updated May 2018) Page Waiver of Consent [Refer to NS Chapter 2.3 on qualifying of waiving conditions of consent.] 3.1 Why the benefits of the research justify any risks of harm associated with not seeking consent? NS 2.3.10b 3.2 Why is it impractical to obtain consent? NS 2.3.10c 3.3 Is there any reason for thinking that participants would not consent if they were asked? Why you believe this is so? NS 2.3.10d 3.4 How will the participant’s privacy be protected? NS 2.3.10e 3.5 Explain how confidentiality of participants and their data will be protected in the dissemination of research results NS 2.3.10f 3.6 Will the results of the research have significance for the participants’ welfare? YES NO If Yes, how will the information arising from the research be made available to the participants? NS 2.3.10g Data Management and Dissemination of Research Outcomes [Refer to Chapter of the Australian Code for the Responsible Conduct of Research and University policy ‘Code of conduct for research’] 4.1 How and where will the data, collected specifically for this research project, be stored during the research project? 4.2 How and where will the data, collected specifically for this research project, be stored following completion of the research project? Low Risk - retrospective analysis of patient data application form (updated May 2018) Page 4.3 How will the research project outcomes be disseminated at the end of the project? (E.g thesis, journal article, book, web page, conference paper, the media etc.) Declaration by the Research Team • The information provided in this application is truthful and to the best of my/our knowledge, accurate • The research project will be conducted in accordance with this application, National Statement on Ethical Conduct in Human Research, The University of Notre Dame Australia’s policies and the Australian Code for the Responsible Conduct of Research Name of Researcher Signature of Researcher Date Checklist Please check that the following documents are attached to your application Documents Tick Low Risk review checklist Permission letter to access data / Site-Specific approval letter (Section 1.7b) HREC approval letter (Section 1.8) Reference List (Section 2.3) Low Risk - retrospective analysis of patient data application form (updated May 2018) Page 7 Declaration by School Research Committee (SRC) Applications not approved by the SRC will not be considered The SRC has reviewed this project and considers the methodological/technical and ethical aspects of the proposal to be appropriate to the tasks proposed YES NO The SRC considers that the researcher has the necessary qualifications, experience and facilities to conduct the research set out in the attached application, and will be able to deal with any emergencies and contingencies that may arise YES NO SRC Comments/Provisos: Name of SRC Chair Signature Date Note: If the SRC Chair is also a named researcher on this project, the declaration must be signed by another authorised member of the SRC The SRC must forward the original application, including relevant attachments to the Research Ethics Officer for review by a HREC sub-committee Low Risk - retrospective analysis of patient data application form (updated May 2018) Page
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