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1. Missing Attachments 

This is the most common problem that extends overall review time. Researchers commonly submit IRB protocols without attaching required consent forms, recruitment materials, and interview guides/survey instruments. Protocols missing these materials with the initial submission do not receive thorough pre-reviews and their overall turnaround time will be longer. 

2. Use of an Outdated or Incorrect Consent Form Template 

Researchers sometimes try to reuse a consent form from a previous study or to use AI to generate a consent form for them. Both problems usually produce a consent form missing or misstated required elements of a consent form for an OHIO IRB protocol. Researchers should ensure they are using the most current consent form template for either an exempt or full/expedited protocol and following the included instructions. Please see: /research/compliance/informed-consent for the most current version of each consent form template.  

3. Inconsistencies Within the Protocol Form 

Information in one section or question of the form or attachments often affects information in other parts of the protocol. 

For example:  

• Researchers commonly check the box in Section 12 of the form stating, 鈥淚 will obtain signed consent,鈥� while the rest of the Section 12 responses and the consent form itself might indicate a verbal consent only. 

• Researchers might mention interviews as the main study procedure in Section 8 of the form and attach an interview guide. In Section 12, they might attach a consent form discussing focus groups as the study procedure. Which study procedure is actually applicable? The need to resolve these kinds of inconsistencies will usually extend the overall turnaround time for a submission.  

4. Responses to Questions in the Cayuse Form Don鈥檛 Answer the Questions as Posed 

• Copy/paste errors and/or AI use to produce responses to protocol form questions can mean that researchers鈥� responses do not actually answer the questions posed in the Cayuse form.   

• Providing additional information that the protocol form questions do not specifically request often produces contradictions with information elsewhere in the form. Researchers should limit their responses to what the questions are asking.  

• Addressing reviewer comments will often require revisions to the question responses in the Cayuse form; replying to comments alone does not update the protocol.  

  5. Students Must Request Cayuse Accounts Before They Can Access the System or Be Added as Study Personnel 

Students will not have automatic access to the Cayuse system. Investigators with existing access to the system will not be able to add students as study personnel in Section 5 of the Cayuse form using the 鈥渇ind people鈥� search unless the students already have a Cayuse account. Students should use the to request a Cayuse account and will be notified by email once their account has been created and ready to use. Until that confirmation email is received, students will not be able to access the system, and they will receive an error message from Cayuse. Students will not be discoverable using the 鈥渇ind people鈥� search until their Cayuse account has been created and confirmed. Please note that Cayuse account creation is a manual process and may take a few business days. 

6. Uncertified Submissions 

The listed Principal Investigator, plus all Co-Investigators and Advisors listed in the protocol, must certify a new submission in Cayuse before it moves forward to the Office of Research Compliance for pre-review. The Office of Research Compliance does NOT receive your submission until you receive the Notice of Receipt email. You have successfully submitted when you receive the Notice of Receipt email. Subsequent revisions for each submission need only be certified by one eligible study team member. 

7. Requested Revisions/Clarifications are Not Addressed 

Cayuse will prompt researchers to address each pre-review or revision comment before it allows resubmission. But marking a comment as 鈥渁ddressed鈥� without making the corresponding revision to the text in the form or providing the requested clarification will extend the overall time to approval for a submission. 

8. Study Personnel Lack Required Human Subjects Protection Training 

For IRB protocols, either "Group 2 Social Behavioral Investigators and Key Personnel training" or "Group 1 Biomedical Research Investigators and Key Personnel" must have been completed or refreshed within the last three years. You may see other training courses available in CITI, but only these two courses satisfy the training requirements for IRB protocols. Please see: /research/compliance/training if additional guidance is needed. Listed study personnel with edit access for IRB protocols in Cayuse should be able to check the training status of all study team members in Section 5. 

9. Help Text is There for a Reason 

The Cayuse application form itself includes a wealth of helpful information, definitions, and links to guidance for researchers that will answer many commonly asked questions. Researchers often overlook the help text that accompanies many questions in the protocol form.  

10. Ask for Help if You Need Help 

Student investigators are strongly advised to consult their Faculty Advisors first for any assistance needed in responding to pre-review comments and requested revisions. The Office of Research Compliance can also be reached at compliance@ohio.edu for assistance.