Guest Ethics Presentation

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19 Terms

1
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when does research require ethics clearing

  • anything that collects data from human participants

  • when useing data used for another purpose (secondary analysis)

  • working with another uni (even if they have clearance, you still need from UW)


2
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TCPS core principles

  • respect for persons

  • concern for welfare

  • justice


3
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TCPS core principles : respect for persons

participants have a right to informed consent. process should be clear

4
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TCPS core principles: concern for welfare

  • minimum unecessary risk

  • consider impact of research and findings


5
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TCPS core principles : justice

  • fair, equitable treatment

  • scope based on study’s objective and not on manipulation or easy access

  • exclusion shouldnt be based on un unrelated factors (gender, age)

  • consider vulnerability


6
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two ethics review levels of uwaterloo

  • full research ethics board (REB) review

  • delegated REB review


7
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two ethics review levels of uwaterloo: full research ethics board (REB) review

  • used when risk is greater than minimal

  • monthly meetings with deadlines


8
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two ethics review levels of uwaterloo: delegated REB review

  • delegation of authority from REB, used in minimal risk research

  • no deadlines


9
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what is minimal risk

when possible harms in the research doesnt exceed harm of his or her everyday life (in relation to the research)

10
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possible participant risks

  • psychological

  • phsysical

  • reputational (like illegal)

  • community (like indigenous groups)


11
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how in advance to submit ethics clearance

4-6 weeks for minimal risk study

12
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process of submitting ethics clearance

complete TCPS2 2022 training → fill application → supervisor submits app → repond to revisions/clarifications

13
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ethical recruitment

  • materials undergo ethics review

  • give ORE (office of research ethics) the how when where and who

  • language should convey voluntariness and be understandable

  • no large incentives ppl would take risks for


14
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purpose of consent forms

  • inform participant

  • document agreement

  • obtrain permission for quoting and photography


15
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when might consent not be collected in writing and be another method

  • less than minimal risk

  • not the norm of the culture

  • adversely affects participant welfare

  • no practical for design

    • mail back questionare, online study, ethnography


16
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guildlines for maintaining privacy of participants

  • deidentify data asap → encrypt with identifiers

  • securely store codes seperate from data

  • require authentication for database access

  • securely store data

  • store on local drive vs network

  • avoid using laptops for personal data


17
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what cases does the researcher need clearance for mitigating their own risk

oversea travel → outlined in policy 33


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what if you change ur study after clearance

changes (study protocol or material) must be approved

19
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what issues need to be reported if they arise despite ethics clearance

  • adverse events → hault research pending investigation

  • protocol deviation

  • incidental/secondary findings → hault research of the participant