How to Get an IRB Approval in the First Pass

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Presentation transcript:

How to Get an IRB Approval in the First Pass Priscilla Adler Director, Office of Research Integrity MedStar Health Research Institute

I have no real or apparent conflicts of interest to report. Priscilla N. Adler, MBA, CCRP I have no real or apparent conflicts of interest to report.

Key Factors Retrospective Study Clear and concise study objectives, hypotheses, endpoints and study procedures Demonstrate the use and storage of the PHI collected, what it will be used for and how it will be stored and/or destroyed when research is completed Consistency throughout forms and protocol

Key Factors Prospective Investigator Initiation Projects Study meets requirements for scientific merit with clear and concise study objectives, hypotheses, endpoints and study procedures Demonstration of adequate safety monitoring plan detailing methods and necessary precautions for protecting the patients (safety and confidentiality). An informed consent written well and at the required reading level (8th grade for most adult cardiology studies) Consistency throughout submission forms, specifically between the protocol, HIPAA waiver requests and consent forms

Key Factors for Reviewers Clear and concise study objectives, hypotheses, endpoints and study procedures An informed consent written well and at the required reading level (8th grade for most adult cardiology studies) Consistency throughout submission forms, specifically between the protocol, HIPAA waiver requests and consent forms Demonstration of adequate safety monitoring or precautions for protecting the patients (both of safety and protected health information)

Common Errors Incorrect or missing forms Required consent template language not included or altered Inadequate data and safety monitoring plan Required signatures not obtained Grammar, punctuation and spelling

Best Practices Use the correct application form(s) Be precise in your language Pay attention to grammar and spelling Avoid submitting on the deadline day Obtain the necessary signatures Include a complete protocol with your application

Best Practices (cont) Have someone independent of the research proof-read your documents Ask the IRB staff for a pre-review Submit all appendices, recruitment materials and consent documents

Conclusion Ask Questions Follow Directions Complete each form Use lay language QA your work