How To Write a Medical Case Report: Step 3 - Submit to ACHE IRB

Why IRB? Your case report involves a human so it must be approved by ACHE's IRB (Institutional Review Board). Even if you are a student rotating at a clinical site that has its own IRB, you need to involve ACHE's IRB. You as the investigator "should not make independent determinations of exemption or exclusion of IRB review".¹ Also, IRB appproval is a federal requirement for human research.²

ALL ACHE EMPLOYEES AND STUDENTS MUST GO THROUGH ACHE'S IRB. Period.

Please note that many journals and conferences require an IRB letter or form of acknowledgement (reference/permit number) prior to publishing a case report.

About ACHE's IRB:

• Meetings of the full ACHE Institutional Review Board occur once monthly, except for July and December. Full review application are due the 1st Friday of the month, with the IRB review occurring on the 2nd Friday.
• Expedited and exempt can be submitted any time, but give the IRB at least two weeks to review.
• Please ensure timely submission of IRB applications by the deadlines to avoid delays in reviewing applications.
• Find more information about the IRB process, go to MyACHE if you are an ACHE employee or ACHE Connect if you are an ACHE student.
• Questions? Email IRB@achehealth.edu.

Mistake #1: Incomplete Protocol Descriptions

• Problem: Applications lack sufficient detail for reviewers to fully understand the study.
• How to Avoid It: Provide clear, step-by-step methods, recruitment plans, and timelines.

Mistake #2: Consent Forms Too Technical

• Problem: Consent documents are written above the average participant’s reading level.
• How to Avoid It: Use plain, accessible language (around an 8th-grade level) and include all required elements found in the template for your review type.

Mistake #3: Missing Data Security Information

• Problem: Data storage, access, and destruction plans are not fully addressed.
• How to Avoid It: Specify security measures such as passwords, encryption, locked storage, and retention timelines.

Mistake #4: Vague Recruitment Plans

• Problem: Recruitment methods are described in general terms without supporting materials.
• How to Avoid It: Clearly outline recruitment steps and include copies of emails, flyers, or scripts.

Mistake #5: Outdated Forms

• Problem: Applications are submitted using older versions of IRB documents.
• How to Avoid It: Always download the most current forms and templates from the IRB website.

Mistake #6: Missing Signatures

• Problem: Applications are submitted with missing signatures.
• How to Avoid It: Faculty and Staff applications must have a minimum of 2 signatures – the PI and program Dean. Student applications require one more – an on campus ACHE faculty sponsor. Make sure to allow time to collect the appropriate signatures in your application process. A submission without signatures will not be reviewed.