Submitting your IRB protocol: avoiding common oversights

There are many resources to guide you when submitting your IRB protocol, including on the ERIK website, the Investigator’s Manual, Knowledgebase articles and an FAQ. After time in the system, there are a few common oversights in submission preparation that if avoided, will help expedite review.

General

• Ensure the named principal investigator (PI) has PI eligibility.
• Only the PI may submit a new submission; PI proxies can respond to clarifications/modifications.
• Use the “Training” tab in the Huron IRB system to confirm study team COI completion and CITI training status before submission.
• Use the UPDATE button instead of the ADD button to upload a revised clean version of any Word documents previously submitted. Other document types require a tracked version and the revised document.
• If adding a general comment to submissions that have not yet been assigned to an IRB coordinator, enter it without notification.

Initial Submissions

• Complete the appropriate template located in the Huron library and submit applicable appendices as specified throughout the protocol (e.g., children, partial waiver of HIPAA research authorization).
• Make sure the Huron protocol number is added to all template headers (e.g., protocol, appendices, consent documents).
• When acronyms and/or technical language are included, complete the “Abbreviations/definitions” section.
• Ensure that responses about privacy and confidentiality distinguish between the privacy of the participant and the confidentiality of their information/data.
• Upload the protocol and all appendices in the “Attach the protocol” field. You can use the help text throughout for guidance.
• If a study includes informed consent, at least one person on the study team should have “involved in consent” indicated unless only the PI will obtain consent, which should be clearly stated in the protocol.
• If a monetary incentive will be provided to participants, list the “Study Funding Source” of the incentive. Select “Ohio State University Internal Award” for internal funds.
• Obtain departmental approval prior to resubmission when a new study requesting exemption is determined to be non-exempt.
• Upload recruitment materials for each recruitment method (email, flyer, social media post) described in the protocol.
• Upload all data collection forms, code keys, data spreadsheets, questionnaires, surveys, request forms, etc. to the “Other attachments” field.

Continuing Review (CR) Submissions

• Complete and upload the HRP-215-FORM – Continuing Review Supplement for all CR and study closure submissions.

Modifications

• If revising a migrated study, review the modification scenarios for migrated studies before submitting the modification request.
• Ensure that each change described in the SmartForm includes a rationale and that all changes are specified.
• Address whether current participants will be reconsented if the modification involves consent changes.

Multi-site Research

• Ensure that study-wide documents are uploaded to the “Study-Related Documents” SmartForm section while documents used only at Ohio State are uploaded to the “Local Site Documents” section. Collaborating site-specific documents are uploaded with pSite submissions.