Adverse Event Reporting

New Protocol Submissions

Other Event Reporting

Renewal Submissions

Termination of Protocol
 
 

 last updated 7/8/08

Any change to an approved research study requires the submission of an amendment to the IRB. This applies to changes in any or all of the following:

· the research plan, including number or type of subjects
· consent process and/or consent form
· co-investigators
· other research personnel
· method(s) of subject recruitment, including any change to an approved advertisement.

Submission are due by 5 PM on the deadline date, unless otherwise noted. Late submissions will be reviewed at the next scheduled meeting. Incomplete submissions will not be reviewed until all necessary materials have been received regardless of the date the initial submission was received. Amendments that may be expedited will not be processed until administrator and/or reviewer comments have been addressed and will not be reviewed at a convened meeting unless they are found to be non-expeditable.

Note that if this protocol involves a PI change, the IRB requires the signature of both the departing and the incoming PI on the amendment submission form. 

Forms

Guidance

Submission

• What to include/not to include in advertisements
• What is PHI?

• Written Consent Form Template  revised 4/19/07 (to change IRB mailing address)
  
• Written Consent Form Template (Spanish Translation)  revised 4/19/07 (to change IRB mailing address)
  
• Sponsor Statements Regarding Research Related Injury
• HIPAA Elements to Include in Written Consent
• Instructions to Obtaining Proxy Consent
• Healthcare Surrogate Act Certification
• Enrollment of Non-English speaking subjects