UIC Research IRB Templates

All research templates can be found in the UIC Research IRB Library; however, the following are available for your reference. Please note that you will be required to log into UIC Research to view any template listed below.

Formatting file names for study attachments Heading link

Formatting file names for study attachments

In order to facilitate the review of your submission, please use a file name that readily identifies the attached document. File names should include a document name, version number, and date. A brief title or research protocol number can be included, if desired. The following abbreviations for OPRS submissions may also be used:

Initial Review – IR
Continuing Review – CR
Modification – MOD

Please note that mislabeled files may result in rejection of the submission.

Examples of acceptable file names:

Protocol Initial Review v1 1-1-2016.doc
Protocol #2015-2000 CR v#1_1.1.16.doc
Aspirin Study MOD#2 consent 1.1.16 v1.doc
#2015-2000 Recruitment Flyer v1 1-1-2016.pdf
Data Collection Form protocol 2015-2000 v1 1-1-2016.xls
Research Protocol version 1 dated Jan 1 2016

Multiple files of the same type must have distinctive labels.

Examples:

Consent Control Group v1 1-1-2016.doc
Consent Subject Group (focus group) v1 1-1-2016.doc
Consent Subject Group (blood draw) v1 1-1-2016.doc
Assent – ages 7-11_V2_1-15-2016.doc
Assent – ages 12-15_V2_1-15-2016.doc

Standardized instruments or non-UIC documents that do not have a version number and date should be labeled with an identifier and the date of the submission.

Examples:

SCID_1-1-2016 submission.pdf
IRB Approval – non-UIC site – 1.1.16.pdf
Protocol #2015-2000 Investigator Brochure v5 submitted 1-1-16.doc
Aspirin Study sponsor case report form 1-1-16 IR submission.xls

Templates Heading link

Protocol Template

Protocol: Health and Biomedical Research Template (HRP-503) December 10, 2021
Protocol: Social, Behavioral, Educational Research Template (HRP-503a) December 10, 2021
Protocol: Combined Determination-Exempt Template (HRP-503b) July 15, 2024
Protocol: Development Only, Center Grant, Training Grant Template (HRP-503c) March 11, 2024

Informed Consent/Parental Permission/Assent Templates

Consent: Health and Biomedical Research Template (HRP-502a) June 15, 2024
Consent: Social Behavioral and Educational Research Template (HRP-502b) June 15, 2024
Consent: Exemption Template (HRP-502e) June 15, 2024
Consent: Additional Consent Template Language (HRP-502c) June 15, 2024
Assent: Assent Template (HRP-502g)
Consent: UIC External IRB Local Context Language (HRP-502h)
Consent: Humanitarian Use Device (HUD) Template (HRP-502d)
March 1, 2021
Consent: Emergency or Compassionate Device Use Template (HRP-506) March 2, 2022

Health and Biomedical Informed Consent Examples

Clinical Trial Example (HRP-502a.1.)
Minimal Risk Example (HRP-502a.2.)

Social Behavioral and Educational Informed Consent Examples

Interview Example (HRP-502b.1.)

Authorization to Use and Disclose Health Information
The posted consent template includes the authorization language; therefore, a separate Authorization Form is not required.

United Kingdom (UK) / European Union (EU) General Data Protection Regulations (GDPR) Consent Templates

The following templates are only required for research involving the United Kingdom (UK) or European Union/EAA that is subject to the General Data Protection Regulations (GDPR). The GDPR Self-Assessment Tool, which can be found on the EU General Data Protection Regulations (GDPR) website, will instruct you as to which of the following templates is required for your research. Please note that you must be logged into UI Box in order to access the required templates.

GDPR

Template 1: Online Consent Form – No Special Categories

Template 2: Written Consent Form – No Special Categories

Template 3: Online Consent Form – Includes Special Categories

Template 4: Written Consent Form – Includes Special Categories

Template 5: Verbal Consent Form – No Special Categories

Template 6: Verbal Consent Form – Includes Special Categories

Template 7: Colleague Consent Form – No Special Categories

Template 8: Colleague Consent Form – Includes Special Categories

Template 9: Re-Using Previously Collected PD Includes Special Categories

Template 10: Re-Using Previously Collected PD No Special Categories

Template 11: Re-Using PD Previously Collected No Special Categories (Notice Only)