Reference no: EM13845033

ETHICS RESPONSE FORM

Each of the ethical standards below must be adequately addressed by the researcher in order to obtain ethics approval.

In the second column, the RESEARCHER (student) should perform a self-check using these 35 questions before submitting the ethics form to the faculty member supervising the study. In each row of the blue column, the RESEARCHER should enter YES, NO, or NA as well as a very brief explanation. The Academic Honesty Declaration must be attached and should be signed and dated.

In the third column the ETHICS REVIEWER (supervising faculty member) will enter YES, NO, or NA to confirm or challenge the RESEARCHER'S self-check on each standard. With each NO, the ETHICS REVIEWER will indicate what revisions are required for ethics approval. The faculty reviewer will also render a decision at the end of this form and return the form to the RESEARCHER.

If the ETHICS REVIEWER (supervising faculty member) is able to approve "as is" then the orange column is left blank.

In the fourth column, the RESEARCHER (student) will respond to each of the ETHICS REVIEWER'S concerns to explain where/how each of the reviewer's concerns was met in the resubmitted materials.

Researcher's ethics self-check In each row, the researcher should confirm compliance with the ethical standard by entering "Yes," "No," or "N/A," along with a brief defense of the response (i.e., stating keywords that point to how the ethical standard has been met).		Ethics Reviewer's assessment:  After the researcher has presented the evidence for compliance with each ethical standard, the Ethics Reviewer should either confirm by entering "Yes" or challenge with "No." With each "No," the reviewer must specify what revisions are needed to obtain ethics approval.	Researcher's response to Ethics Reviewer  Researcher must use this column to explain how and where each of the Ethics Reviewer's concerns (in the yellow column) has been addressed.
Example: Will data be stored securely?	Yes. Data files will be kept on a password protected computer.		No. Please also address how the paper surveys will be secured prior to being entered as electronic files.	Paper surveys will be in a locked file cabinet. Proposal has been updated.

The first 11 questions apply to all studies (even when the researcher is not interacting with participants to collect new data). Hover the mouse over the blue footnoted words to view extra tips and definitions.

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?

4. Will the data be stored for at least 5 years?

5. If participants' names or contact info will be recorded in the research records, are they absolutely necessary?

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 not utilize 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 Authorization Letter (or email) granting permission for all relevant data access, access to participants, facility use, and/or use of personnel time for research purposes? The remaining questions only apply to studies that involve recruiting participants to collect new data (such as surveys, interviews, observations). Please place an X on this line if NONE of the questions in the next section are applicable to the proposed study.

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

13. 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.

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

15. 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.?

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

17. Will informed consent be appropriately documented?

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

19. Does the PIS include an understandable explanation of the research purpose? 20. Does the PIS explain the sample's inclusion criteria in such a way that the participants can understand how/why THEY are being asked to participate?

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

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

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

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

25. Does the PIS describe any thank you gifts, compensation, or reimbursement to participants (for travel costs, etc.) or lack thereof?

26. Does the PIS include a description of reasonably foreseeable risks or discomforts?

27. Does the PIS include a description of anticipated benefits to participants and/or others? 28. Does the PIS explain how the participant can contact the researcher and the university's Research Participant Advocate? (USA number 001-612-312-1210 or email address [email protected])

29. Does the PIS describe how privacy will be maintained? 30. Does the PIS disclose all potential conflicts of interest (specifying that this study is separate from the researcher's other professional role)?

31. Do the consent documents preserve the participant's legal rights? The remaining questions regarding sensitive content and vulnerable populations should be reviewed and addressed by the researcher (student) and faculty reviewer, but must also be confirmed by the International Online Research Ethics Committee before the study may go ahead. Please place an X on this line if NONE of the questions in the next section are applicable to the proposed study.

32. If vulnerable individuals will be specifically sought out as participants, is such targeted recruitment justified by a research design that will specifically benefit that vulnerable group at large?

33. If the researcher happens to also serve in a trusted or authoritative role to the participant (e.g., health care provider, teacher etc.), do the recruitment procedures ensure voluntary participation?

34. If the research procedures might reveal or create an acute psychological state that necessitates referral, are there suitable procedures in place to manage this?

35. If the research procedures might reveal criminal activity, child/elder abuse, or employer policy non-compliance that necessitates reporting, are there suitable procedures in place for managing this? Are limits to confidentiality (i.e., duty to report) appropriately mentioned in the Participant Information Sheet?