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

2. 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.

3. 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

4. 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

5. 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)

6. 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

7. 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

8. 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

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