Does the PIS describe how privacy will be maintained ?

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Last Updated: 30-Aug-23
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1. Are participant recruitment and data collection steps adequately described, such that the study`s risks and burdens can be discerned?

2. Will the research procedures ensure privacy during data collection?

3. Will data be stored securely with adequate provisions to maintain the confidentiality of the data (see Footnote regarding the requirement for electronic files to be stored on the University network drive)?

4.How long will personal data be kept for (this should be no longer than necessary for the purposes of the research, and normally only until full anonymization has taken place)?How long will anonymized research data be kept for?

5. If participants` names or contact info will be recorded in the research records, are they absolutely necessary ?If so, explain how and when anonymization of the data will be carried out

6. Do the research procedures and analysis/write-up plans include all possible measures to ensure that participant identities are not directly or indirectly disclosed? For secondary data analyses, the proposal must clearly state when/how de-identification will occur.

7. Have all potential psychological ,relationship , legal , economic/professional , physical , and other risks been fully acknowledged and described?

8. Have the above risks been minimized as much as possible?

9. Has the researcher proactively managed any potential conflicts of interest ? Note that student researchers may notutilise research assistants to recruit participants or collect research data on behalf of the researcher.

10. Are the research risks and burdens reasonable, in consideration of the new knowledge that this research design can offer?

11. Is the research site willing to provide an Authorisation Letter (or email) granting permission for all relevant data access, access to participants, facility use, and/or use of personnel time for research purposes?

12. Will any data be transferred into or outside of the EU? If so, please explain how this will be conducted, why this is necessary, and outline the safeguards in place to protect the data.

13. Applicable for student researchers: Will this researcher be appropriately qualified and supervised in all data collection procedures?

14. Is participant recruitment coordinated in a manner that is non-coercive ? Coercive elements include: leveraging an existing relationship to "encourage" participation, recruiting in a group setting, extravagant compensation, recruiting individuals in a context of their treatment or evaluation , etc. A researcher must disclose here whether/how the researcher may already be known to the participants and explain how perceptions of coerced research participation will be minimized .

15. If anyone would be excluded from participating, is their exclusion justified? Is their exclusion handled respectfully and without stigma ?

16. Where the researcher proposes to use an interpreter, has adequate consideration been given to the interpreter`s training regarding confidentiality and principles of informed consent, etc.?

17. Do the informed consent procedures provide adequate time to review the study information and ask questions before giving consent?

18. Will informed consent be appropriately documented?

19. Is the participant information sheet (PIS) written using language that will be understandable to the potential participants?

20. Does the PIS include an understandable explanation of the research purpose?

21. Does the PIS explainthe sample`s inclusion criteria in such a way that the participants can understand how/why THEY are being asked to participate?

22. Does the PIS clearly state that participation is voluntary?

23. Does the PIS convey that the participant has the right to decline or discontinue participation at any time?

24. Does the PIS include an understandable description of the data collection procedures?

25. Does the PIS include an estimate of the time commitment for participation?