New Protocol Submission

New Protocol Submission Forms
Preparatory for Research and Research on Decedents
Submission Guidance
Informed Consent Guidance

To submit a new protocol to the IRB, please use the following forms. 
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 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 PRINCIPAL INVESTIGATOR to ensure that research has received IRB approval prior to study initiation.

If this is your first submission to the IRB as either a PI or primary contact, you will need to obtain a Unique ID so that we may enter you into the IRB database. Unique IDs can be obtained here.

Protocol Submission Forms
Form	Purpose	Version date
Protocol Submission Form	New submissions	April 2007
Claim of Exemption	Exemptions	April 2007
Supplemental Form A	Co-investigators	April 2007
Supplemental Form B	Other research personnel	April 2007
Supplemental Form C	Research involving children	March 2007
Supplemental Form D	Research involving drugs	October 2005
Supplemental Form E	Request for expedited review	August 2006
Supplemental Form F	Research involving devices	3/13/2006
Supplemental Form G	Genetic testing and/or sample banking	October 2007
Supplemental Form H	Radioactive drugs/devices	December 2007
Supplemental Form I	Advertising on U of C webpages	October 2005
Supplemental Form J	Research involving prisoners	March 2006
Supplemental Form K	Research involving pregnant women, fetuses, and/or fetal tissue	July 2006
Supplemental Form N	Research involving nonviable neonates	March 2006
Supplemental Form O	Oral/alteration of consent/authorization	October 2006
Supplemental Form P	Proxy consent request	not dated
Supplemental Form Q	Research involving drugs	03/08/06
Supplemental Form R	Resubmission	August 2006
Supplemental Form W	Waiver of consent/authorization	August 2006

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Preparatory for Research and Research on Decedents

Request for Research on Decedents	HIPAA Regulations and subsequent institutional policy require that the IRB be notified when research is done on information from deceased individuals. This request should be submitted if your research involves only deceased individuals.
Request for Review Preparatory for Research	This request should be submitted if you intend to view potential subjects' Protected Health Information in order to determine if a protocol is feasible and/or justified before submitting a proposal to the IRB. This service can only be used if you will not be sharing any of this information outside the U of C.

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Submission Guidance

What to include with a new protocol submission

What to include with a chart review proposal ( PDF)

Detailed protocol narrative outline ( PDF)

What to include/not to include in advertisements ( PDF)

Studies involving cancer patients ( PDF)

What is PHI? ( PDF)

Request to obtain PHI Form ( PDF) - to be submitted to Medical Records Office

 

Informed Consent Guidance

Written Consent Form Template  (MS Word) updated 10/2008

Written Consent Form Template (Spanish Translation)  revised 4/19/07 (to change IRB mailing address)

Required Elements for Informed Consent ( PDF)

HIPAA Elements to Include in Written Consent ( PDF)

Sponsor Statements Regarding Research Related Injury ( PDF)

Instructions to Obtaining Proxy Consent ( PDF)

Healthcare Surrogate Act Certification( PDF)

Enrollment of Non-English-speaking subjects ( PDF)

 

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