Documentation of the Informed Consent Process Version 2.0
Investigator Tool - Documentation of the Informed Consent Process
Version: 2.0
Date: 04/22/2016 / Office of the Vice Chancellor for Research
Quality Improvement Program
310 AOB (MC 672)
1737 West Polk Street
Chicago, IL60612-7227
Phone:312-996-4995 Fax:312-413-0238
Protocol Title:
Principal Investigator Name: / IRB Protocol # :
Sponsor: / Subject ID:
Study First Presented to Potential Subject / Date: ______
Individual(s) Presenting Study to Potential Subject
Subject Given Opportunity Ask Questions (include brief description)
Subject Given Unsigned Copy for Further Review and Consideration / No
Yes Date: ______
Name of Individual providing copy to Subject: ______
Subject Agreed to Follow up Telephone Contact by Study Coordinator / Yes No N/A
Date/Method of Follow Up Contact and Outcome / Date:
Contact Method:
Potential Subject indicates desire to schedule appointment to sign informed consent and complete screening visit
Potential Subject does not wish to further consider participation
Potential Subject needs more time to make a decision about study participation
Describe the method(s) used to confirm subject understanding of the research / Date: Study staff member(s) present:
Description:
If applicable, indicate relationship of LAR to subject and describe how it was determined this individual is the LAR. / Relationship:
Method by which LAR was determined:
If applicable, in cases where there may be a question of the individual’s capacity to provide consent (e.g., recent administration of pain medication or anesthesia, stroke, recent seizure, positive toxicology screen),indicate who made the determination and the criteria used to ensure the subject has the capacity to consent to study participation. / Printed Name of individual determining capacity______
Signature of individual determining capacity: ______
Criteria used to determine capacity:
If applicable, Subject is non-English speaking. Specify language: / Consent obtained with IRB approved consent document in language understandable to the subject (Per Statute 110 ILCS 305/20, required if research conducted at the College of Medicine).
Consent obtained using Short Form Consent Process.
Name of witness to the Short Form Process
Name of Individual serving as translator in either process (including addressing questions and assessing subject’s understanding
Translator present for consent process (Face to face/in-person)
IVIN (or comparable) translation service utilized for consent process
If applicable, Subject is illiterate, English speaking subject (speaks and understands English but is not able to read or write). / Subject “made their mark” instead of providing a signature on the consent document: Yes No Explain:
Identity of witness to the consent process: ______
If applicable, Subject is physically unable to talk or write, yet retains the ability to understand the study including the risks and benefits of participation when explained verbally, and is able to indicate approval or disapproval to study entry.
*A videotape recording of the consent interview is recommended.* / Describe communication method(s) for determining understanding:
Describe how the subject indicated willingness to enroll in the study:
Identity of witness to the consent process: ______
The consent interview was captured by video tape recording:
Yes No
If applicable, The subject is blind or has motor difficulties precluding them from writing their name but is otherwise able to fully engage in the consent process. / Subject “made their mark” instead of providing a signature on the consent document: Yes No Explain:
Identity of witness to the consent process: ______
If applicable, Research involves children
Parental Permission obtained for child’s participation / Verbal assent obtained as per IRB approval
Written assent obtained as per IRB approval
Assent of the child is not required by the IRB (Waiver of Assent has been approved by the IRB)
Signature of one parent obtained Justification: ______
Signature of both parents obtained
Waiver of Parental Permission has been approved by the IRB (not applicable for FDA regulated research)
Subject/LAR Agreed to Study Participation and Informed Consent Document Signed / Date: Time: ______
Subject/LAR Signed Informed Consent Document prior to the conduct of any study procedures / Yes No Explain:
Copy of Signed Informed Consent Given to Subject / Yes No Explain:
**As a reminder, investigators are responsible for documenting the consent process in the Electronic Medical Record (EMR) according to UIHHSS policy.
Highlighted sections are optional.
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