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Scope Checker - Do I need ethics approval?

UTas and DHHS are committed to ensuring that all research is conducted at the highest ethical standard. Researchers should be aware that the constraints governing research practices are there for the protection of research particpants, researchers, and the broader research community.

Both the Human Research Ethics Committees of the  HREC (Tas) Network are constituted in accordance with the guidelines set out in the National Statement on Ethical Conduct in Human Research 2007.

According to this document, some types of research can be exempted from ethical review; others can be given expedited review on the basis that they constitute only low risk, whilst others must be reviewed by a fully constituted HREC.

The Scope Checker below will help you to determine if your research can be exempted from ethical review, or, if it must be reviewed, help you determine which level of review it needs, and which committee of the Network it should be reviewed by. 

If your research is exempt from review, the Scope Checker will automatically generate a certificate of exemption, stating the reason your research is exempt. 

You should print TWO copies of the certificate and of this page showing your responses to the questions. Send one signed copy to the address on the certificate and keep the other for your records.

If you have any questions about the scope checker you should contact the Executive Officer of the HREC (Tas) Network on 6226 7479 or email human.ethics@utas.edu.au

To start the scope checker click here

 



 


 

Is the activity scientific work involving animals or human research?

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1. Does the activity involve the participation of people or the use or access to people’s data or tissue? This includes researchers having access to people's personal documents or other materials, the collection and use of their body, organs, tissues or fluids (including exhaled breath), and/or access to their information as part of an existing published or unpublished source or database.

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2. Is the activity archival research? A large proportion of activity involving the analysis of documents, publicly available information, or previously collected data may be outside the scope of the HREC (Tasmania) Networks ethics arrangements.

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2a) Is the information identified personal information?

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3. Is the work being conducted solely for administrative or service delivery purposes within the University of Tasmania and/or the Tasmanian Department of Health and Human Services?

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3a) Is the primary aim of the project to report or publish information beyond the University of Tasmania or the Tasmanian Department of Health and Human Services? Publication is the primary aim if the work will not be done if publication is prohibited. If the project will be done anyway then publication is a secondary aim.

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3b) Will the information obtained be recorded in such a manner that participants can be identified, directly or through identifiers linked to the subjects, and that identification is likely to be considered problematic or a cause for concern by the participants?

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4) Can the work be characterised as quality assurance or an audit, rather than human research? An activity is understood to be quality assurance where the primary purpose is to monitor evaluate or improve the quality of health care delivered by a health care provider (an individual, a service or an organisation)

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4a) Will the prior consent of the participants (including individuals, service providers and the host organization) be obtained - and an appropriate record of this consent retained?

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4b) Does the proposed quality assurance activity pose any risks for participants beyond those of their daily routine (or routine care if medical patients?) Risks include not only physical risks but also psychological spiritual and social harm or distress eg stigmatisation or discrimination.

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4c) Does the proposed quality assurance activity impose a burden on participants beyond that which would be experienced in their usual routine? Burdens may include intrusiveness, discomfort, inconvenience or embarrassment eg persistent phone calls, additional hospital visits or lengthy questionnaires.

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4d) Is the proposed quality assurance activity to be conducted by a person who does not normally have access to the participant’s records for clinical care or a directly related secondary purpose?

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4e) Does the proposed quality assurance activity risk breaching the confidentiality of any individual’s personal information, (beyond that experienced in the provision of routine care in the case of medical research)?

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4f) Is the proposed quality assurance activity to take place in a hospital setting, or to involve people receiving medical care?

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4g) Does the proposed quality assurance activity involve any clinically significant departure from the routine clinical care provided to participants?

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4h) Does the proposed quality assurance activity involve randomisation or the use of a control group or placebo?

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4i) Does the proposed quality assurance activity seek to gather information about the patient beyond that collected in routine clinical care? Information may include observations, blood samples, additional investigations etc.

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4j) Does the proposed quality assurance activity potentially infringe the rights, privacy or professional reputation of carers, health care providers or institutions?

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5. Is the work a practical exercise or test that is conducted for teaching purposes in a University administered facility? Procedures which involve educational tests (cognitive, diagnostic, aptitude or achievement), survey procedures, interview procedures or observation of public behaviour, conducted in a Utas administered facility, for the purposes of teaching/learning may be exempt from approval from the HREC (Tasmania) Network.

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5a) Will the information obtained be recorded in such a manner that participants can be identified, directly or through identifiers linked to the subjects, and that identification is likely to be considered problematic or a cause for concern by the participants (eg it might affect their grades)?

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5b) Is the primary aim of the acitivity to collect data to be published or reported beyond the University of Tasmania?

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5c) Will the information obtained be recorded in such a manner that any disclosure of the participants' responses outside the research team could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants' financial standing, employability or reputation?

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5d) Will the research deal with sensitive aspects of the participants' own behaviour, such as sexual preference, illegal conduct, use of alcohol, drug use, or includes information about health status

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5e) Does the research subject participants to any risks beyond inconveneience?

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6. Is the work a routine experiment or procedure conducted for teaching purposes in a University administered facility? Routine procedures (such as the collection of a blood sample for teaching/learning purposes) are generally outside the scope of the HREC (Tas) Network.

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6a) Will the activity be conducted by an appropriately qualified / experienced / licensed person?

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6b)Will the activity be covered by an appropriate biosafety clearance?

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6c) Will the information obtained be recorded in such a manner that participants can be identified, directly or through identifiers linked to the subjects, and that identification is likely to be considered problematic or a cause for concern by the participants ?

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6d) Will the information obtained be recorded in such a manner that any disclosure of the participants' responses outside the research team could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants' financial standing, employability or reputation?

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6e) Will the research deal with sensitive aspects of the participants' own behaviour, such as sexual preference, illegal conduct, use of alcohol, drug use, or includes information about health status?

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6f) Does the research subject participants to any risks beyond inconvenience?

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7. Is the work / data collection conducted by a student only for teaching / learning purposes? Data collection conducted by students purely for the purposes of teaching / learning (eg to enhance their understanding of an issue) is generally outside the scope of the HREC (Tas) Network unless it falls into a category covered by one of the sub-questions below.

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7a) Will the results be published / presented in any way other than a paper / product produced purely for assessment purposes ?

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7b) Can the participant group be characterised as vulnerable? Vulnerable participant groups include people in dependent or unequal relationship with researchers, people highly dependent on medical care, people with a cognitive disability or mental illness, children and young people, people in other countries, and pregnant women.

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7c) Will the information obtained be recorded in such a manner that participants can be identified, directly or through identifiers linked to the subjects, and that identification is likely to be considered problematic or a cause for concern by the participants?

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7d) Will the information obtained be recorded in such a manner that participants can be identified, directly or through identifiers linked to the subjects, and that identification is likely to be considered problematic or a cause for concern by the participants?

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7e) Will the research deal with sensitive aspects of the participants' own behaviour, such as sexual preference, illegal conduct, use of alcohol, drug use, or includes information about health status?

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7f) Does the research subject participants to any risks beyond inconvenience?

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8) Does your research involve any of the following; the use of invasive physiological and/or medical interventions; research involving the use of human tissue (including blood, reproductive or other tissues); human genetic research; or patients, staff or resources of any hospital in Tasmania (public or private)?

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8a) Has your research already been approved by another NHMRC recognised Australian HREC?

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8b) Is your research a clinical trial? (A clinical trial is a form of human research designed to find out the effects of an intervention, including a treatment or diagnostic procedure. A clinical trial can involve testing a drug, a surgical procedure, other therapeutic procedure and devices, a preventative procedure or a diagnostic device or procedure)

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8c) Does your research involve an innovation in clinical practice or complementary medicine? (An innovation is defined as a new diagnostic or therapeutic method that aims to improve health outcomes but which has not yet been fully assessed for safety and/or efficacy. The spectrum of innovations may range widely from minor variations or extensions of existing methods to new indications, through to completely novel technologies)

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8d) Does your research involve the administration of medication or placebo beyond the normal routine care of the participant (if under medical care)?

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8e) Does your research involve the collection of human tissue samples beyond the normal routine care of the participant (if under medical care)? Human tissue samples include blood and other bodily fluids.

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8f) Does your research involve the use of gametes and/or human embryos?

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8g) Does your research involve the use of human stem cells?

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8h) Does you research involve genetic testing?

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8i) Does your research involve the deception of participants, including concealing the purposes of research, covert observation and/or audio or visual recording without consent?

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8j) Does your research involve the participation of people without their prior consent?

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8k) Does your research involve withholding from one group specific treatments or methods of learning from which they may benefit?

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8l) Does your research involve the access or use of medical records where participants can be identified or linked to their records in some way?

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8m) Does your research involve the use of ionising radiation?

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8n) Does your research involve the use of personal data obtained from a Commonwealth or State Government Department/Agency without the consent of the participants e.g. getting a list of addresses from the Australian Electoral Commission?

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8o) Does your research specifically target any of the following groups of people; (specifically target means they are the central group of participants, as opposed to potentially being incidentally recruited as part of the general population)
  • Women who are pregnant and the human foetus
  • Children and young people
  • Those highly dependent on medical care who are unable to give consent
  • People with a cognitive impairment, intellectual disability or mental illness
  • People who may be involved in illegal activities or residents of custodial institutions
  • Aboriginal and Torres Straight Islander Peoples
  • People in other countries
  • People who are unable to give informed consent because of difficulties in understanding an information sheet (ie non English speakers etc)

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8p) Does your research pose any risks for participants under medical care beyond those of their routine care? (Risks include not only physical risks but also psychological, spiritual and social harm or distress eg stigmatisation or discrimination)

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8q) Does your research involve the discussion of any of the following topics whether by interview or as part of a questionnaire or survey; Parenting practices, sensitive personal issues, sensitive cultural issues, grief death or serious traumatic loss, depression mood states or anxiety, gambling, eating disorders, illicit drug taking, substance abuse, psychological disorders, suicide, gender identity, sexuality, race or ethnic identity, fertility, termination of pregnancy?

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8r) Does your research involve the potential disclosure of illegal activities or criminal behaviour?

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8s) Are there any specific risks to the researcher (i.e. will the research involve the use of hazardous materials or be undertaken in a politically unstable area)?

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8t) If your research will take place in an overseas setting do any of the following apply: is the research to be undertaken in a politically unstable area? Does it involve sensitive cultural issues? And/or: will the research take place in a country in which criticism of the government and institutions might put participants and/or researchers at risk?

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8u) Does your research explore potentially confidential business practices or seek to elicit potentially confidential commercial information from participants?

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8v) Does your research explore potentially divergent political views or involve the collection of politically sensitive information?

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9) Is the research conducted under the auspices of the University of Tasmania (eg for a University degree, a grant administered by the University, or for a planned publication or report where the author(s) will cite their role within the University) or that is conducted under the auspices of the Department of Health and Human Services? This may include commercial research and consultancy work if the researcher(s) will be using University of Tasmania equipment or resources, or will be covered by University of Tasmania indemnity/insurance for the work.

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9a) Has your research already been approved by another NHMRC recognised Australian HREC?

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9b)Does your research involve the discussion of any of the following topics whether by interview or as part of a questionnaire or survey; Parenting practices, sensitive personal issues, sensitive cultural issues, grief death or serious traumatic loss, depression, gambling, mood states or anxiety, eating disorders, illicit drug taking, substance abuse, psychological disorders, suicide, gender identity, sexuality, race or ethnic identity, fertility, termination of pregnancy?

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9c) Does your research involve the potential disclosure of illegal activities or criminal behaviour?

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9d) Does your research involve the use of personal data obtained from a Commonwealth or State Government Department/Agency without the consent of the participants e.g. getting a list of addresses from the Australian Electoral Commission?

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9e) Does your research involve the deception of participants, including concealing the purposes of research, covert observation and/or audio or visual recording without consent?

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9f) Does your research involve the participation of people without their prior consent?

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9g) Does your research involve withholding from one group specific treatments or methods of learning from which they may benefit?

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9h) Does your research involve the access or use of personal records where participants can be identified or linked to their records in some way?

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9i) Does your research involve the use of ionising radiation?

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9j) Are there any specific risks to the researcher (i.e. will the research involve the use of hazardous materials or be undertaken in a politically unstable area)?

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9k) Does your research specifically target any of the following groups of people; (specifically target means they are the central group of participants, as opposed to potentially being incidentally recruited as part of the general population)
  • Women who are pregnant and the human foetus
  • Children and young people
  • Those highly dependent on medical care who are unable to give consent
  • People with a cognitive impairment, intellectual disability or mental illness
  • People who may be involved in illegal activities or residents of custodial institutions
  • Aboriginal and Torres Straight Islander Peoples
  • People in other countries
  • People who are unable to give informed consent because of difficulties in understanding an information sheet (ie non English speakers etc)

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9l) If your research will take place in an overseas setting do any of the following apply: is the research to be undertaken in a politically unstable area? Does it involve sensitive cultural issues? And/or: will the research take place in a country in which criticism of the government and institutions might put participants and/or researchers at risk?

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9m) Does your research explore potentially confidential business practices or seek to elicit potentially confidential commercial information from participants?

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9n) Does your research explore potentially divergent political views or involve the collection of politically sensitive information?

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