Adverse Event Reporting

Amendment Submissions

Other Event Reporting

Renewal Submissions

Termination of Protocol
 
 
last updated 1/10/08

The majority of protocols require a full review, but if you believe your new research project qualifies for expedited review, fill out and attach supplemental form E to your submission to request such a review. If you believe your study can be exempted from review, fill out only the “Claim of Exemption” and submit this along with a copy of the grant that may be funding the research. The IRB will then notify you if indeed your study qualifies as exempt or if you will need to submit a full protocol submission.

The IRB will make the final decision regarding level of review.

Submissions are due by 5 PM on the deadline date, unless otherwise noted. Please check the Submission and Meeting Dates page for the most current deadlines. 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.

It is the responsibility of the Investigator to ensure that research is approved prior to initiation.

Forms

Form	Purpose	Version date	Posted
Protocol Submission Form	New submissions	APRIL 2007	4/19/07
Claim of Exemption	Exemptions	APRIL 2007	4/19/07
Supplemental Form A	Co-investigators	APRIL 2007	4/19/07
Supplemental Form B	Other research personnel	APRIL 2007	4/19/07
Supplemental Form C	Research involving children	March 2007	4/19/07
Supplemental Form D	Research involving drugs	October 2005	4/4/06
Supplemental Form E	Request for expedited review	August 2006	4/19/07
Supplemental Form F	Research involving devices	3/13/2006	4/4/06
Supplemental Form G	Genetic testing and/or sample banking	October 2007	11/29/07
Supplemental Form H	Radioactive drugs/devices	December 2007	1/10/08
Supplemental Form I	Advertising on U of C webpages	October 2005	4/4/06
Supplemental Form J	Research involving prisoners	March 2006	4/4/06
Supplemental Form K	Research involving pregnant women, fetuses, and/or fetal tissue	July 2006	7/12/06
Supplemental Form N	Research involving nonviable neonates	March 2006	4/4/06
Supplemental Form O	Oral/alteration of consent/authorization	October 2006	1/18/07
Supplemental Form P	Proxy consent request		4/19/07
Supplemental Form Q	Research involving drugs	03/08/06	4/4/06
Supplemental Form R	Resubmission	August 2006	4/19/07
Supplemental Form W	Waiver of consent/authorization	August 2006	1/18/07

 Request to obtain PHI Form - to be submitted to Medical Records office

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Submission

What to include with a new protocol submission

What to include with a chart review proposal  

Detailed protocol narrative outline

What to include/not to include in advertisements

Studies involving cancer patients

What is PHI?

Consent

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)

HIPAA Elements to Include in Written Consent

Sponsor Statements Regarding Research Related Injury

Instructions to Obtaining Proxy Consent 

Healthcare Surrogate Act Certification

Enrollment of Non-English-speaking subjects