Ethical Review of Human Research at APIC 1. National Statement on Ethical Conduct in Human Research The National Statement on Ethical Conduct in Human Research 2007 (Updated May XXXXXXXXXXNational...

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Ethical Review of Human Research at APIC 1. National Statement on Ethical Conduct in Human Research The National Statement on Ethical Conduct in Human Research 2007 (Updated May 2015) (National Statement) recognises that human research involves a wide range of studies that have different levels of risks and potential benefits. The National Statement notes that higher education institutions are responsible for establishing procedures for the ethical review of human research that depend on the level of risk involved in a project. The National Statement establishes different levels of required ethical review, based on the degree of risk involved which may be: · Harm, where studies with a risk of harm must be reviewed by a fully constituted Human Research Ethics Committee (HREC); · Discomfort; and · Inconvenience Researchers and Human Research Ethics Committees (HRECs) are required to determine the existence, likelihood and severity of risks based on the research methodology and design, participant population and research activity. The National Statement identifies three levels of risk at or below which research involving human participants can be approved other than by a Human Research Ethics Committee. These three levels are ‘Exempt’, ‘Negligible Risk’, and ‘Low Risk’. i. Exempt Research [see National Statement 5.1.22, page 70] Institutions are permitted to exempt from ethical review research that (a) poses negligible risks (see below) and (b) involves the use of existing collections of data or records that contain only non-identifiable data about human beings. ii. Negligible Risk Research [see National Statement 2.1.7, page 15] Research is ‘negligible risk’ if there is (a) no foreseeable risk of harm or discomfort to participants or (b) if there is a foreseeable risk, the risk is no more than inconvenience. Examples of Negligible Risk Research include and are not limited to research based on or involving: · information from existing de-identified datasets; · historical archives and public records; · data collected from internet sites; · questionnaires and surveys on non-controversial, non-personal issues that only include basic and de-identified demographic data; and · unobtrusive observational studies (i.e. with no form of intervention) of people undertaking non-sensitive or benign activities in a public space (e.g., observing the number of adults and children people crossing at a particular intersection). iii. Low Risk Research [see National Statement 2.1.6, page 15] Research is classified as ‘low risk’ where the only foreseeable risk is one of discomfort. Where the risk is more serious than discomfort, even if unlikely, the research is not low risk. Examples of Low Risk Research include and are not limited to research based on or involving: · personal interviews or focus groups with participants containing non-controversial, impersonal, and non-sensitive questions conducted in professional environments (e.g., corporate offices during business hours); and · questionnaires or surveys containing questions about participants’ experiences, thoughts, opinions and beliefs; Research with humans that involves risk of harm or likelihood of harm must be reviewed by a fully constituted Human Research Ethics Committee (HREC). For research involving only risk of inconvenience or discomfort (i.e. negligible risk or low risk), Institutions may establish alternative ethical review process. At APIC, a process is in place to assess only exempt, negligible risk and low risk research. As the College does not have a fully constituted HREC, research assessed as above low risk cannot be conducted at the College unless an application has been approved by a fully constituted HREC elsewhere. Thus, only applications that a researcher assesses to be exempt, negligible risk or low risk should be submitted for review at APIC. If a project is assessed by the APIC Research Ethics Committee (REC) to be above low risk the study will not be allowed to proceed. The procedure for applying for approval to conduct research at APIC is outlined below. 1. The researcher considers the ethical issues associated with the research and completes the Research Risk Checklist. If any question is answered ‘yes’ the research cannot be reviewed and approved by the APIC REC. 2. If all questions are answered ‘no’ the project IS eligible for review under the Low or Negligible Risk Assessment process. The researcher completes the Low or Negligible Risk Assessment application form, including section 2, Research Proposal, and submits the form with the relevant attachments to the REC through the APIC Ethics Officer ([email protected]). 3. The application and checklist will be assessed by the chair of the REC and one other REC member to evaluate risk. Those projects agreed to be exempt, low, or negligible risk will be approved to proceed and will receive a letter noting that the project is approved to go ahead. Those projects evaluated to include risk of harm will not be approved to proceed and feedback will be provided to applicants. Please note: The principal researcher listed on the application must be an APIC staff member. In the case of student research, this will be either the research supervisor or the coordinator of the unit in which the student is enrolled. The principal investigator is responsible for the completeness of the application and for ensuring all attachments are included with the application. Incomplete applications will not be approved. Research Risk Checklist Principal Researcher[footnoteRef:1] / Research Supervisor: [1: Please note that for student projects the principal researcher is the student’s supervisor or the unit coordinator.] Title Name Campus Institutional Address Telephone Facsimile Email Qualifications Research experience Other Researchers[footnoteRef:2] / Student Researcher: [2: Please add as many as needed] Title Name Institutional Address Telephone Facsimile Email Qualifications Research experience If the researcher is a student, state the course and unit of study that they are enrolled in Please answer all of the following questions below: a. Research is exempt if it involves the use of existing collections of data or records that contain only non-identifiable data about human beings? Yes No · Does the research meet the classification for exempt research? If the answer to the question above is “YES”, go to Section 3 of the Low or Negligible Risk Assessment Application Form and sign the declaration, otherwise continue with the checklist. b. Does the research involve any of the following? Yes No · Participants are identifiable or re-identifiable · Some form of deception is involved · The procedure involves experimental manipulation or includes the presentation of any stimulus other than question-asking · The project involves interventions and/or therapies, including clinical and non-clinical trials and innovations, human genetics or human stem cells c. Will participants be actively recruited from any of the following groups Yes No · People aged under 18 years · People whose ability to give informed consent is impaired for any reason, such as communication difficulties, cognitive problems, emotional concerns or physical limitations. · People who are Indigenous Australians · Females who are pregnant · People involved in illegal activities which are the focus of the research study (e.g., drug use, bribery) d. Please indicate whether any of the following topics will be covered in part or in whole? Yes No · 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 · eating disorders · illicit drug taking · substance abuse · self-report of criminal behaviour · any other psychological disorder · suicide · gender identity · sexuality · race or ethnic identity · any disease or health problem · fertility · termination of pregnancy e. Are the following procedures to be employed? Yes No · Use of personal data obtained from Commonwealth or State Government Department/Agency with participant consent · deception of participants or concealing the purpose of the research · covert observation · audio or visual recording without consent · recruitment of a third party or agency (e.g., asking the person to give information about someone else, such as an employee) · Withholding from one group specific treatments or methods of learning from which they may ‘benefit’ (eg in medicine or teaching) · any psychological interventions or treatments · administration of physical stimulation / invasive physical procedures / pain · administration of substances to be swallowed (e.g., capsules) · exposure to ionising radiation · tissue sampling, collecting bodily fluid, use of records (e.g., educational or medical) where a person can be identified or data linked f. Other risks? · a conflict of interest may exist (e.g., financial or other relationship) · Are there any potential risks to the researcher? (e.g. research conducted in unsafe environments or trouble spots)? · Are there any potential risks to non participants in the research, such as, participant’s family members and social community (e.g. effects of biography on family and friends or infectious disease risk to the community)? g. Does the research target people in the following categories? Yes No · persons with a psychological disorder · persons with a physical disability or medical condition · Children and/or young people without parental or guardian consent · residents of a custodial institution · persons Unable to give freely an informed consent because of difficulties in understanding information provided (eg language difficulties, NESB) · members of a socially identifiable group with special cultural or · religious needs or political vulnerabilities · persons in a dependent relationship with the researcher (eg lecturer/student, doctor/patient, teacher/pupil and professional/client) · participants able to be identified in any final report or publication when consent has not been given h. Will any of the research be conducted outside Australia? If yes, please specify which country or countries. i. Does the research involve any of the following: Yes No · 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 IF ALL ANSWERS TO THE CHECKLIST ARE NO PLEASE COMPLETE THE LOW OR NEGLIGIBLE RISK