Low Risk Research Review Checklist

Transcription

1 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 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 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) 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

2 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 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 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? If yes is ticked STOP completing this form. Your NEAF application MUST BE SUBMITTED TO the University Human Research Ethics Committee addressing section of the National Statement on Ethical Conduct in Human Research Only a 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 of the National Statement on Ethical Conduct 14_ 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 research about parenting research investigating sensitive personal issues research investigating sensitive cultural issues explorations of grief, death or serious/traumatic loss depression, mood states, anxiety gambling LRRC Version 7 2

3 eating disorders illicit drug taking substance abuse self report of criminal behaviour any psychological disorder suicide gender identity sexuality race or ethnic identity any disease or health problem fertility termination of pregnancy anger management impulse control self esteem domestic violence elderly neglect divorce adults abused as children participant(s) being asked to provide information on another person any similar topic of possible concern use of researcher devised questionnaire researching a sensitive topic (eg.. depression) FORM 2 B. Are any of the following procedures to be employed? use of personal data obtained from organisations (including Commonwealth or State Government Department/Agency) deception of participants concealing the purposes of the research covert observation audio or visual recording without consent recruitment via a third party or agency withholding from one group specific treatments or methods of learning, from which they may benefit (e.g., in medicine or teaching) any psychological interventions or treatments LRRC Version 7 3

4 administration of physical stimulation invasive physical procedures infliction of pain administration of drugs administration of other substances administration of ionising radiation tissue sampling or blood taking collecting body fluid genetic testing/dna extraction use of medical records where participants can be identified or linked drug trials and other clinical trials administration of drugs or placebos potentially humiliating tasks any other similar procedures FORM 2 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? suffering a psychological disorder suffering a physical vulnerability people highly dependent on medical care minors without parental or guardian consent people whose ability to give consent is impaired residents of a custodial institution unable to give free informed consent because of difficulties in understanding information statement (eg language difficulties) members of a socially identifiable group with special cultural or religious needs or political vulnerabilities those in dependent relationship with the researchers (eg lecturer/student, doctor/patient, teacher/pupil, professional/client) 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 LRRC Version 7 4

5 Indigenous Australians small sample size which may lead to participant identification in final report any similar vulnerability concerns FORM 2 5. RESEARCH LOCATION ASSESSMENT Location of interviews: interviews being conducted in participant s home interviews being conducted in an isolated area any other similar concerns 6. RESEARCH IN OVERSEAS SETTINGS ASSESSMENT Does the research involve any of the following: research being undertaken in a politically unstable area research involving sensitive cultural issues research in countries where criticism of government and institutions might put participants and/or researchers at risk 7. SPECIAL CASE ASSESSMENT If you have answered 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) LRRC Version 7 5

6 FORM 2 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: FHEC CHAIR SIGNATURE: If you have answered 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 to one item or more and are T requesting a special case your completed NEAF to ethics@csu.edu for review by the full Human Research Ethics Committee. LRRC Version 7 6