FORM 2 HUMAN RESEARCH ETHICS COMMITTEE Low Risk Research Review Checklist Please complete the checklist below to ascertain whether your research project would be eligible to be submitted to your Faculty Human Research Committee (FHEC) for ethical review as a low risk research. Student researchers must review the completed checklist with their supervisors. If you answer “YES” to any items in the checklist your project would normally not be eligible for submission to the appropriate Faculty Human Ethics Committee for review (unless you can make a special case – refer section 6) and you should complete an ethics application form NEAF and email it to ethics@csu.edu.au for review by the Human Research Ethics Committee. Please note LOW RISK research can be defined as where the foreseeable risk to participants is no more than one of discomfort. For example: questionnaires and/or surveys, anonymous or otherwise, online etc. involving non-sensitive topics observations, with or without consent For more information, refer to the National Statement on ethical conduct in human research 2007 Chapter 2.1: Risk and Benefit. Timing constraints are not an acceptable reason for seeking expedited review through this process where projects are of more than everyday risk. PROJECT TITLE CHIEF INVESTIGATOR Name (Title/ given name / family name) Qualifications Student No(if applicable) Email address: SUPERVISOR Name (Title/given name / family name) Qualifications School/Research Centre/ External Organisation (of Chief Investigator or supervisor) Level of Study (eg Undergraduate practicum/clinical research project, Honours research project, postgraduate Masters or PhD) Course Subject Title and Code Brief outline of the project (2 lines) LRRC Version 7 1 Last updated –January 2015 Next review January 2016 FORM 2 1. EXTERNAL REQUIREMENTS Is the research being funded by an agency outside the University, which requires Human Research Ethics Committee approval involving community representation? [If you have answered “YES” to this question you must forward the CSU ethics application form to the Human Research Ethics Committee] Is the project hosted/auspiced by an organisation other than CSU If you have answered “No” proceed to point 2. Risk Assessment Is the project seen as being ‘owned’ primarily by the Organisation or CSU If the organisation provide Name of host organisation YES NO YES NO Brief outline of the project (2 lines) Approval process followed including committees/position of person(s) approving the proposal Agreement about Intellectual Property of researcher and organisation 2. WAIVER OF CONSENT Will personal information in medical research, or personal information be accessed without first gaining consent from the individual to access this information? YES NO If yes is ticked STOP completing this form. Your NEAF application MUST BE SUBMITTED TO the University Human Research Ethics Committee addressing section 2.3.9 of the National Statement on Ethical Conduct in Human Research Only an fully constituted HREC may grant waiver of consent for research using personal information in medical research, or personal health information. Other review bodies may grant waiver of consent for other research. Refer section 2.3.9 of the National Statement on Ethical Conduct http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/e72_national_statement_march_2014_141126. pdf 3. RISK ASSESSMENT A. Are any of the following topics to be covered in part or in whole? research involving children and young people YES NO research about parenting YES NO research investigating sensitive personal issues YES NO research investigating sensitive cultural issues YES NO explorations of grief, death or serious/traumatic loss YES NO depression, mood states, anxiety YES NO gambling YES NO eating disorders YES NO illicit drug taking YES NO substance abuse YES NO self report of criminal behaviour YES NO any psychological disorder YES NO suicide YES NO gender identity YES NO LRRC Version 7 2 Last updated –January 2015 Next review January 2016 FORM 2 sexuality YES NO race or ethnic identity YES NO any disease or health problem YES NO fertility YES NO termination of pregnancy YES NO anger management YES NO impulse control YES NO self esteem YES NO domestic violence YES NO elderly neglect YES NO divorce YES NO adults abused as children YES NO participant(s) being asked to provide information on another person YES NO any similar topic of possible concern YES NO use of researcher devised questionnaire researching a sensitive topic (eg.. depression) YES NO use of personal data obtained from organisations (including Commonwealth or State Government Department/Agency) YES NO deception of participants YES NO concealing the purposes of the research YES NO covert observation YES NO audio or visual recording without consent YES NO recruitment via a third party or agency YES NO withholding from one group specific treatments or methods of learning, from which they may “benefit” (e.g., in medicine or teaching) YES NO any psychological interventions or treatments YES NO administration of physical stimulation YES NO invasive physical procedures YES NO infliction of pain YES NO administration of drugs YES NO administration of other substances YES NO administration of ionising radiation YES NO tissue sampling or blood taking YES NO collecting body fluid YES NO B. Are any of the following procedures to be employed? LRRC Version 7 3 Last updated –January 2015 Next review January 2016 FORM 2 genetic testing/DNA extraction YES NO use of medical records where participants can be identified or linked YES NO drug trials and other clinical trials YES NO administration of drugs or placebos YES NO potentially humiliating tasks YES NO any other similar procedures YES NO YES NO suffering a psychological disorder YES NO suffering a physical vulnerability YES NO people highly dependent on medical care YES NO minors without parental or guardian consent YES NO people whose ability to give consent is impaired YES NO residents of a custodial institution YES NO unable to give free informed consent because of difficulties in understanding information statement (eg language difficulties) YES NO members of a socially identifiable group with special cultural or religious needs or political vulnerabilities YES NO those in dependent relationship with the researchers (eg lecturer/student, doctor/patient, teacher/pupil, professional/client) YES NO those in a social/personal relationship (eg friendship) with the researcher/s participants able to be identified in any final report when specific consent for this has not been given YES YES NO NO Indigenous Australians YES NO small sample size which may lead to participant identification in final report YES NO any similar vulnerability concerns YES NO interviews being conducted in participant’s home YES NO interviews being conducted in an isolated area YES NO C. Other Risks Are there any risks to the researcher, (e.g. research undertaken in unsafe, isolated environments or trouble spots)? 4. PARTICIPANT VULNERABILITY ASSESSMENT Does the research specifically target participants from any of the following groups? 5. RESEARCH LOCATION ASSESSMENT Location of interviews: LRRC Version 7 4 Last updated –January 2015 Next review January 2016 FORM 2 any other similar concerns YES NO research being undertaken in a politically unstable area YES NO research involving sensitive cultural issues YES NO research in countries where criticism of government and institutions might put participants and/or researchers at risk YES NO 6. RESEARCH IN OVERSEAS SETTINGS ASSESSMENT Does the research involve any of the following: LRRC Version 7 5 Last updated –January 2015 Next review January 2016 FORM 2 7. SPECIAL CASE ASSESSMENT If you have answered “YES” to an item in the checklist but you still believe that because of the particular nature of the project and the participants your project may still be eligible for expedited review. Please provide details below, or attach an additional sheet. You must then submit these reasons with the checklist to your Faculty Human Ethics Committee (FHEC) for consideration and approval of your special case. SPECIAL CASE DETAILS: RESEARCHER SIGNATURE: …………………………………………………………………………………………………… SUPERVISOR’S SIGNATURE (if applicable) APPROVAL BY FHEC OF SPECIAL CASE The FHEC has met and considered the special case details associated with this project and agree / do not agree that the project can be submitted to the Faculty Human Ethics Committee for review. Other comments: SEHRC CHAIR SIGNATURE: …………………………………………………………………………………………………… If you have answered “NO” to all items, attach this checklist to your completed NEAF and submit to your Faculty Human Ethics Committee (FHEC). Please note the FHEC may forward your application onto the HREC for review if they deem your research not to be low risk. If you have answered “YES” to one item or more and are NOT requesting a special case email your completed NEAF to ethics@csu.edu for review by the full Human Research Ethics Committee. LRRC Version 7 6 Last updated –January 2015 Next review January 2016