ETHICS SELF-CHECK APPLICATION FOR IRB APPROVAL

ETHICS SELF-CHECK APPLICATION FOR IRB APPROVAL

ETHICS SELF-CHECK APPLICATION FOR IRB APPROVAL

Section 1: The researcher must complete the brown column A of the table below to document how the research procedures comply with the university’s 40 ethical standards. Mark “Not Applicable” only when there is no possible way to address that ethical issue.

Section 2: Attach enclosures as indicated in section II (yellow section).

Section 3: Provide electronic signature.

Section 4 (students only): Have your faculty supervisor review the entire form and then provide an electronic signature.

 

IRB approval will be issued when the IRB confirms that there is adequate evidence that the university’s ethical standards have been met, based on this form and the attachments listed in Section II of this form. Within 10 business days of receiving a researcher’s submission, the IRB will notify the researcher of one of the following outcomes:

(a) that the IRB has provided ethics approval based on the submitted documents; or

(b) that the IRB requires revisions and/or additional documentation (will be specified in Column B).

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SECTION I: RESEARCHER’S CONFIRMATION OF ETHICAL STANDARDS COMPLIANCE

 

 A. In this column, the researcher should confirm compliance with each ethical standard by entering Yes, No, or NA, and defending the response by providing supporting details. B. Ethics reviewer will confirm compliance with each ethical standard in this column by entering “Confirmed” or provide a request for revisions. The researcher should enter responses/revisions using a font of a different color.
Sample: Will data be stored securely?

 

 

 Sample response: Yes. Supporting details: Paper surveys will be stored in a locked file cabinet at the researcher’s home. Electronic files will be stored on the researcher’s password-protected computer and backed up on a password-protected hard drive.  
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 recruitment and data collection step[endnoteRef:1] been articulated such that risks/burdens can be identified? (Provide a bulleted list of recruitment and data collection steps in the brown column.) [1: ]    
2. Will the research procedures ensure privacy[endnoteRef:2] during data collection? Describe how. [2: Privacy risks might include unintended breach of confidential information (such as educational or medical records); being observed/overheard by others while providing data; or intrusion on the privacy of others who not involved in study (e.g. participant’s family).]    
3. Will data be stored securely[endnoteRef:3]? Describe how. [3: Secure data storage requires password protection on electronic files and locks for physical data.]    
4. Will the data be stored for at least 5 years? Describe how data disposal will occur.    
5. If participants’ names or contact info will be recorded in the research records, are they absolutely necessary[endnoteRef:4]? Describe why or clarify that data collection is 100% anonymous (which is preferable). [4: Note that consent forms do not require signatures if the participant can indicate consent by some action such as clicking on a link, returning a completed survey, etc.]    
6. Do the research procedures and analysis/writeup plans include measures to ensure that participant identities are not directly or indirectly[endnoteRef:5] disclosed? Describe how. [5: Participant identities might be “indirectly” and unintentionally disclosed if a researcher’s final research report fails to withold demographic details or site descriptions that might permit a reader to deduce the identity of a participant. So the researcher needs to think about which demographic descriptors are most important to collect and report, while ensuring that the identity of individual participants is protected. Also, the name of the site/organization is typically masked in scholarly research though in some cases, the organization can elect to publicize their name along with the research results.]

ETHICS SELF-CHECK APPLICATION FOR IRB APPROVAL