Top Ten Reasons IRB Protocols are Returned to PI Prior to Approval

10. Forms are filled out incompletely or incorrectly

9. Missing forms (e.g. NIH or CITI training; HIPAA Waiver)

8. Lack of access permission letter on agency letterhead

7. Inconsistent information throughout protocol

6. Missing or vague recruitment materials (e.g. recruitment flyer, e-mail invitation, follow-up email)

5. Participant materials at too high readability level

4. Incomplete informed consent form

3. Vague recruitment, informed consent, data collection, data analysis, or data storage/destruction procedures

2. Failure to follow instruction

1. Inadequate participant protection procedures (e.g. privacy, confidentiality)

 

October 21, 2016

Joanne Estes, PhD, OTR/L