All modifications to human subjects research must receive prior IRB approval before subjects are involved in the revised protocol. Prior to implementation, modifications must be submitted on a Research Amendment Form and reviewed and approved by an IRB committee or the IRB Office.
An Assent document is used for children aged 7-17 or cognitively impaired adults who are unable to provide legal consent, but allows them to provide their understanding and agreement to research participation.
For research conducted in languages other than English, the Illinois IRB must have all versions of the research material [e.g. consents, recruitment, instruments, etc.] in both English and non-English to be retained in the research file.
This template includes Authorization for the use of Protected Health Information. This template should be used for research conducted with HIPAA-protected data.
This template should be used as a consent document for simple survey or questionnaire research. This document should be used when a signature will not be collected. For example, for an online survey the participant reads this consent cover letter which informs them about the study and if they agree to participate, they proceed and complete the survey. Consent is implied by the fact that the participant completed the survey, or participated in the focus group, or answered the interview questions. To utilize this form, a Waiver of Documentation of Consent must be requested on the Informed Consent Process Form.
This is a standard consent document template to be used for adult participants in social behavioral or biomedical research. This standard template is geared towards minimal risk research. Please review the Supplemental Consent Language document for additional consent requirements for greater than minimal risk research and other study-specific requirements.
A debriefing document is needed when a study involves deception, incomplete disclosure, or studies designed in such a way that providing complete background information will invalidate the study. The debriefing document is provided to the participant following their participation to give them full information about the study. An Alteration of Consent is required in order to use deception or incomplete disclosure in research. Submit a Waiver of Informed Consent Form as it includes the Alteration of Consent request.
This form should be completed and submitted as part of the IRB application for any project that has involvement in any capacity from the Department of Defense.
The completion or termination of a study is a change in activity and must be reported to the IRB.
At the time a study is complete or discontinued, the investigator must submit a Final Project Report.
This form can be used by participants, research staff, and others to report potential complaints or concerns about research. Individuals can choose to remain anonymous. You also have the option of being known to OPRS, but anonymous to the researcher.
This form should not be used by a researcher informing OPRS about a complaint made by a research participant. In that case, the researcher should follow standard reporting guidelines by using a Report Form application.
This template can be used to obtain informed consent without a signature. This template is similar to the Consent Cover Letter template, but includes more details for potentially more involved research than one simple survey. Consent is implied by the fact that the participant completed the survey, or participated in the focus group, or answered the interview questions. To utilize this form, a Waiver of Documentation of Consent must be requested on the Informed Consent Process Form.
The Parental Permission form is the consent document that is used when the research participant is a child and the consent is being provided by the parent/guardian.
State radiation safety regulations require that all radiation administered to humans must be “authorized by a licensed practitioner of the healing arts.” This includes research as well as medical care.
This form should be submitted as soon as an investigator becomes aware they are leaving the University of Illinois at Urbana-Champaign and are engaged in human subjects research on active IRB protocols.
It is the responsibility of the principal investigator (PI) to ensure continued approval of his or her human participant research study. This form should be completed and returned to firstname.lastname@example.org to ensure proper processing of the protocol renewal.
The Report Form (RF) application is used to submit problems, events, or information issues to the IRB for review. These may include Adverse Events, Protocol Deviations, Reports of Non-Compliance, and Unanticipated Problems.
List all investigators engaged in the research study, including those from other institutions.
This document contains additional consent template language that can be added to consent documents depending on specific situations. Specifically, this document includes all consent requirements for Greater than Minimal Risk research. This document also includes a Table of Contents for ease of use finding the language you need.