Report on Research Ethical Standards of the Institutional Review Board

2021-07-19 20:23:22
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University of Richmond
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Report
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Last Name of Researcher: Towah Date of Review: 11/13/2017

Each of the ethical standards below must be adequately addressed by the researcher in order for this study to be approved by the Institutional Review Board (IRB), on behalf of Walden University.

The IRB REVIEWER uses the yellow column to indicate the revisions that are required for IRB approval.

The RESEARCHER must complete the blue column when resubmitting IRB materials.

Ethics Reviewers assessment:

(In each row, the Ethics Reviewer should either enter Yes, No, or NA. With each No, the reviewer must specify which particular parts of the ethics application require revision or clarification.)

Researcher response:

The researcher must use this column to describe how and where each of the ethics reviewers concerns (in the yellow column) has been addressed. The researchers questions or explanations are also appropriate here, if a researcher wishes for the IRB to reconsider an issue.

The first 13 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. Has each data collection step been articulated such that risks/burdens can be identified? Yes

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

3. Will data be stored securely? Yes

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

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

6. Do the analysis/writeup plans include measures to ensure that participant identities are not directly or indirectly disclosed? Yes

7. Will confidentiality agreements be signed by anyone who may view data that that contains identifiers? (e.g., transcriber, translator) NA

8. Is there a specific plan in place for sharing results with the participants and community stakeholders? No, please explain in item #13 of the application with whom and how the results of the study will be shared, ensuring it is done in a user appropriate format. The issue has been addressed on the application as item #13

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

10. Have the above risks been minimized as much as possible? In other words, are measures in place to provide participants with reasonable protection from loss of privacy, psychological distress, relationship harm, legal risks, economic loss, damage to professional reputation, and physical harm? Yes

11. Has the researcher proactively managed any potential conflicts of interest? No; It is unclear how participants might be clients of the researcher. This should be specified, and the procedures to address the potential conflicts should be more clearly developed. Its also important to understand how potential clients might be recruited its indicated in the protocol that the researcher will be specifically recruiting clients?

Please refer to the attached document which provides information that needs to be considered when conducting research in your own professional setting. A key concern is ensuring any potential for perceived coercion is minimized. To eliminate the conflict of interest in the research, the clients will be excluded from participation in the research.

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

13. Is the research site willing to provide a Letter of Cooperation granting permission for all relevant data access, access to participants, facility use, and/or use of personnel time for research purposes? (Note that some research sites will only release data if a more formal Data Use Agreement is in place, often in addition to a Letter of Cooperation.) Site agreement templates are posted here. It does not seem any are needed, but please clarify how the contact information for potential participants will be obtained. For example, are you relying on publicly available contact information? Individuals from your personal network? Some other method? Contacts information for potential participant will be available through the publicly available contact information such as telephone numbers available in directories and emails available in social media account.

The remaining questions only apply to studies that involve recruiting participants to collect new data.

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. Yes

15. 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? Yes

16. If vulnerable adults might happen to be included (without the researchers knowledge), would their inclusion be justified? Yes

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

18. If the research procedures might reveal criminal activity or child/elder abuse that necessitates reporting, are there suitable procedures in place for managing this? NA

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

20. If the research design has multiple groups, does the research design ensure that all participants can potentially benefit equally from the research? NA

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

22. If an existing survey or other data collection tool will be used, has the researcher appropriately complied with the requirements for legal usage? Yes; please note that the question in the form seems to be answered incorrectly- the instrument were talking about here is a survey instrument, not Microsoft office products ? The issue has been resolved on item #37

Questions 23-40 pertain to the process of ensuring that potential participants make an informed decision about the study, in accordance with the ethical principle of respect for persons.

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

24. Will informed consent be appropriately documented? Yes

25. Is the consent form written using language that will be understandable to the potential participants? Yes

26. Does the consent form explain the samples inclusion criteria in such a way that the participants can understand how/why THEY are being asked to participate? Yes

27. Does the consent form include an understandable explanation of the research purpose? Yes

28. Does the consent form include an understandable description of the data collection procedures? Yes

29. Does the consent form include an estimate of the time commitment for participation? Yes

30. Does the consent form clearly state that participation is voluntary? Yes

31. Does the consent form convey that the participant has the right to decline or discontinue participation at any time? When the researcher is already known to the participant, the consent form must include written assurance that declining or discontinuing will not negatively impact the participants relationship with the researcher or (if applicable) the participants access to services. Yes

32. Does the consent form include a description of reasonably foreseeable risks or discomforts? Yes

33. Does the consent form include a description of anticipated benefits to participants and/or others? Yes

34. Does the consent form describe any thank you gift(s), compensation, or reimbursement (for travel costs, etc.) or lack thereof? Yes

35. Does the consent form describe how privacy will be maintained? Yes

36. Does the consent form disclose all potential conflicts of interest? This cannot be determined until the issue raised in #11 above is addressed. If you may be known to potential participants this needs to be disclosed on the consent form along with a statement indicating this study is separate from that role. Item #11 has been addressed.

37. Does the consent document preserve the participants legal rights? Yes

38. Does the consent form explain how the participant can contact the researcher and the universitys Research Participant Advocate? (USA number 001-612-312-1210 or email address [email protected]). Yes

39. Does the consent form include a statement that the participant should keep/print a copy of the consent form? Yes

40. If any aspect of the study is experimental (unproven), is that stated in the consent form? NA General comments from the IRB reviewer(s) that might not be directly related to research ethics:

(Note: the comments above are offered collegially in the interest of promoting top quality research, and are NOT stipulations for IRB approval.)

FOOTNOTES:

* IRB staff will check this after the IRB reviewer returns the completed feedback form to the IRB office.

 

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