Forms & Submission Guidelines

All IRB submissions must be submitted in AURA, the University-wide electronic submission system. Please access AURA IRB through the AURA website (http://aura.uchicago.edu).  

If you have any questions regarding how to fill out AURA submission forms, please contact the AURA help desk at AURA-Help@uchicago.edu . You can also contact one of the IRB administrators

Please select a link for more information:

Preparatory for Research and Research on Decedents
Submission Guidance
Informed Consent Guidance

 

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.

 

Submission Guidance

Many new protocols require a full review, but if you believe your new research project qualifies for expedited review, please complete the Expedited Review section on the electronic submission form.

Alternatively, if you believe your study can be exempted from review, request "Exempt" review and fill out only those sections of the electronic submission form that appear in AURA. Please also upload any necessary documentation (e.g. a copy of the grant funding the research). The IRB office will then notify you if indeed your study qualifies as exempt or if you will need to complete the entire protocol submission form.

Concurrent routing documents are required by the deadline, if required for your protocol. Please see the OCR website for more information: http://bsdocr.bsd.uchicago.edu/fac-staff/index.html

The IRB will make the final decision regarding level of review.
Submissions are due by midnight 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.

The following documents are intended to aid researchers in submitting complete protocols to the IRB. Please contact a member of the IRB staff if you have questions about this guidance.

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

Studies involving nursing

What is PHI? - HIPAA-related documentation

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

 

Informed Consent Guidance

January 2018 update: Changes in the Common Rule: The Department of Health and Human Services has issued revisions to the existing Common Rule, the regulations governing human subjects research, including consent process and documentation. As of June 18, 2018, the effective date for the revised Common Rule is now January 21, 2019.

As it is recognized that research consent forms are often lengthy and complex, under the revised Common Rule consent forms will now be required to begin with a “concise and focused” presentation of the key information that will likely help someone considering research participation to make a decision about whether or not to participate in a study. As a result of this and other additional requirements, the IRB office has prepared a new consent form template. The requirement for a concise and focused presentation of key information will be mandatory for any federally funded research once the revised Common Rule goes into effect. The IRB office will notify researchers once the deadline is set for utilizing the new template, which includes the "key information" section. In the interim, new submissions to the IRB may use either the previous or new template.

Written Consent Form/Authorization Template (revised Common Rule) (updated December 2017)

Written Consent Form/Authorization Template (current, pre-2018 Common Rule) (dated July 2017, version 2: includes revisions to "What about confidentiality" section)

 

The following documents are intended to aid researchers in creating consent forms and in obtaining appropriate informed consent. Please contact a member of the IRB staff if you have questions about this guidance.

Required Elements for Informed Consent

HIPAA Elements to Include in Written Consent

Policy on Statements Regarding Research Related Injury
Research-related injury statements are included in the "What are the costs" section of the consent form template.

Instructions to Obtaining Proxy Consent
Proxy consent may be needed on studies involving subjects who are decisionally impaired.

Healthcare Surrogate Act Certification
To be used when obtaining consent for a subject who is decisionally-impaired and who does not have a legally authorized representative.

Enrollment of Non-English-speaking subjects

Checklist for Investigators to Aid in Obtaining Informed Consent

Hints for using the U of C consent form template

Sample assent form

Suggested Lay Language Substitutions, with thanks to the University of Kentucky (document copyrighted by the University of Kentucky)