Ethical Standards to Obtain Ethics Approval

Date:  2021-03-15 03:49:24
7 pages  (1758 words)
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This essay has been submitted by a student. This is not an example of the work written by our professional essay writers.
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This essay has been submitted by a student. This is not an example of the work written by our professional essay writers.

Working Title of Proposal or summary of study scope: Proposal attached? ___ Yes ___No Academic Honesty Declaration signed? ___Yes ___ No

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

In the blue 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 yellow column the ETHICS REVIEWER (supervising faculty member) will enter YES, NO, or NA to confirm or challenge the RESEARCHERS 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 orange column, the RESEARCHER (student) will respond to each of the ETHICS REVIEWERS concerns to explain where/how each of the reviewers' concerns was met in the resubmitted materials.

Researchers 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 Reviewers 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.

Researchers response to Ethics Reviewer

Researcher must use this column to explain how and where each of the Ethics Reviewers' 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 studys risks and burdens can be discerned? Yes

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

3. Will data be stored securely with adequate provisions to maintain the confidentiality of the data? 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? No

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. Yes

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

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

9. Has the researcher proactively managed any potential conflicts of interest? Note that student researchers may not utilise research assistants to recruit participants or collect research data on behalf of the researcher. Yes

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

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? Yes

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? Yes

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. Yes

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

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

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

17. Will informed consent be appropriately documented? Yes

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

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

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

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

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

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

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

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

26. Does the PIS include a description of reasonably foreseeable risks or discomforts? No

27. Does the PIS include a description of anticipated benefits to participants and/or others? Yes

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]) Yes

29. Does the PIS describe how privacy will be maintained? Yes

30. Does the PIS disclose all potential conflicts of interest (specifying that this study is separate from the researchers other professional role)? No

31. Do the consent documents preserve the participants legal rights? Yes

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? Yes

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? Yes

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? Yes

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? YesETHICS APPROVAL DECISION

THIS DOCUMENT MUST BE POSTED IN THE GRADEBOOK AFTER THE SUPERVISING FACULTY MEMBER HAS RENDERED A DECISION. THE APPROPRIATE ETHICS PATHWAY(S) MUST ALSO BE ENTERED INTO THE MiTSA , eg LOCAL, EXPEDITED OR IOREC APPROVAL(S)

The supervising Faculty Member will mark an X next to box A, B, or C. If box A or B is marked, then the supervising faculty member will also mark an X next to the applicable subcategory (1, 2, 3, etc.):

A. APPROVED VIA EXPEDITED (LIGHT TOUCH) ETHICS REVIEW:

As the supervising faculty member, I confirm that all applicable criteria 1-35 above are met with either a Yes or N/A.

I understand my responsibilities as supervisor, and will ensure to the best of my abilities that the student investigator abides by the University's policy on Research Ethics at all times.

I affirm that the research activities fall entirely within the parameters of the design indicated with an X below (1, 2 or 3) that the International Online Research Ethics Committee has authorized faculty members to approve via the expedited (light touch) review:

1. analysis of public documents, artifacts, behaviour or data;

2. secondary analysis of existing data that is privately held but released for research purposes (with all identifiers removed);

3. surveys or interviews of non-vulnerable adults on non-sensitive topics (i.e., no potential to participants of coercion, distress, loss of work/school time, damage to professional reputation). Vulnerable populations include children, clinic patients, prisoners, military personnel, facility residents, anyone over whom the researcher holds authority (e.g., students, subordinates), anyone who might feel undue pressure to participate in the study, and any individuals with severe enough mental disabilities to interfere with capacity to consent to the study.

B. REFERRED TO ETHICS COMMITTEE:

As the supervising faculty member, I am referring this study to the full ethics committee (IOREC) because [mark 1, 2, 3, 4 or Other below].

I will email the students ethics application and all attachments as a single zip file to the ethics committee via [email protected], copying the DOS (or Programme Director where this exists).

The ethics committee accepts applications until 5 pm Liverpool timezone on the 3rd Thursday of every month.

Decisions and feedback will be emailed to the student and DA within 5 business days after the 4th Thursday of the month.

1. the researcher proposes to collect data from vulnerable individuals such as children, clinic patients, prisoners, military personnel, facility residents, anyone over whom the researcher holds authority (e.g., students, subordinates), anyone who might feel undue pressure to participate in the study, and any individuals with severe enough mental disabilities to interfere with capacity to consent to the study.

2. some (potential) participants may find the research topic or premise sensitive

3. participants jobs or livelihoods may be placed at any risk by the study activities

4. the participants culture and/or international location suggest that extra participant protections may be necessary

Other: _____

c. C. REVISIONS REQUIRED:

The student needs to revise the proposal and ethics materials to address the concerns in the yellow column and resubmit to me before I can select A or B above.

Footnotes

 

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