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Expedited Review Checklist: FOR IRB MEMBER USE ONLY

This checklist is to be completed by an IRB Member when reviewing an application being considered for expedited IRB approval. After reading through the application, carefully answer each of the following questions about the submission. When you "SUBMIT" the review, a copy of the review will be delivered to your email inbox as well as to the IRB Office to be archived. 

7. Type of Submission

Expedited Review of Research

This application is being considered for EXPEDITED REVIEW. Research activities may be reviewed through the expedited review procedure if they... (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the expedited categories. Please CONFIRM the following criteria:

8. Does the research pose no more than minimal risk?
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
9. Breach of Confidentiality:
Would identification of the subjects and/or their responses (data) reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing?
If YES...
Have reasonable and appropriate protections been implemented in the methodology so that risks related to invasion of privacy and breach of confidentiality are no great than minimal?
10. Based on the information in the application, I have made the following determination:

Review of the IRB Application:

11. RESEARCH STATEMENT:
Does this statement provide clear background information and rationale, research hypothesis, and goal(s) of the study?
12. Does the PI and any co-researchers have appropriate expertise to conduct this research?
13. PARTICIPANT POPULATION:
Is the subject selection equitable in relation to objectives, setting, and recruitment methods of the research, and are inclusion/exclusion criteria provided?
14. STUDENTS IN RESEARCH
Will the researcher(s) recruit students from the course(s) they are teaching?
If YES:
In order to avoid coercion, has the researcher followed the guidelines found in Faculty Use of Students in Research on the JCU website.
15. Will any research participants be minors (under 18 years)?
If YES:
Does the application include MINOR ASSENT and PARENTAL CONSENT procedures, either written or oral? See the JCU website for detailed guidance on minor assent: https://jcu.edu/research/irb/informed-consent
16. Have all recruitment materials been included with application?
17. Are all recruitment materials free of spelling and typographical errors?
18. DATA COLLECTION & CONFIDENTIALITY ISSUES
Has the researcher properly described what identifying data will be collected and all the procedures for keeping that data confidential and secure?
19. Has the researcher described a detailed METHODOLOGY for their project?

Elements of Informed Consent: §46.116

These elements must be presented to the potential participant, an adult 18 years or older or the participant's legally authorized representative.

20. Type of Informed Consent:

21. The Informed Consent Checklist: Does the informed consent process include:

a. A statement that the study involves research?
b. An explanation of the purposes of the research?
c. The expected duration of the subject's participation?
d. A sufficient description of all the procedures to be followed?
e. Description of foreseeable risks or discomforts to the subject?
f. Description of any benefits to the subject or to others?
g. Description of how confidentiality/privacy will be maintained?
This includes a description of what identifying information will be collected, and how the data will be treated, stored, and safeguarded.
h. Explanation of any compensation in exchange for participation
i. Statement that participation is voluntary?
This should include a statement that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits.
j. Contact information for the researchers?
This should include an explanation of whom to contact for answers to questions about the research and whom to contact in the event of a research-related injury. This may include providing contact information for mental health counseling or any other applicable resource.
k. Contact information for the JCU IRB?
It should include the language: "If you have any questions about the rights and welfare of research participants, please contact the John Carroll University Institutional Review Board at 216-397-1527 or irb@jcu.edu."
l. All consent documents and study instruments are free of spelling and typographical errors?
This includes both written documents and any online or on-screen text that will be viewed by the study participants.

Approval and Comments:

22. APPROVAL DECISION
The comments or questions that are entered below will be given to the researcher(s) verbatim. If you have separate comments for the IRB Office that you do not  want to share with the researcher(s), please enter those in the "Comments for the IRB Office" section below.
 
23. Continuing Review

Effective July 19, 2018, Continuing Review (CR) is not required for minimal risk research approved by expedited review unless specifically required  by the reviewer(s) at the time of initial approval. Reviewers should evaluate the methodology and the level of risk to decide if CR should be required for this protocol.

If an approval period of less than 365 days is assigned, please designate the approval length in the "Comments for the IRB Office" section below.
 
The comments and questions entered below will not be shared with the researcher(s).
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