Forms, Documents and Resources

This log should be used to track adverse events throughout the course of the study and to document the PI’s determination if the event(s) require prompt reporting to the IRB as a possible Unanticipated Problem.

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.

This worksheet can be used by researchers to conduct a self-audit of any social or behavioral science project.  This worksheet may also be useful to assist with data monitoring or preparation for OPRS PAM or an external audit.

Researchers planning to collect, analyze, or bank human cells, tissues, fluids, DNA, or other human biological samples, whether taken prospectively or retrospectively with regard to IRB approval, must complete this form and include it with a New Protocol Application form.

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 checklist can be used to ensure all consent requirements are included in your consent document.  The Common Rule sets forth general requirements for documentation of informed consent. An informed consent form approved by the IRB and signed by the participant or the participant’s legally authorized representative should be used to document informed consent. A written copy should be given to the person signing the informed consent document.

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.

If the human subjects study involves creating or sending data and/or samples to a repository or database to be saved for future research uses, this form is required.

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.

One option for use to document the research staff and what research activities the PI has delegated to others. Also meets the requirements for a Staff Signature Log. Other options are also available.

One option for use to document the research staff and what research activities the PI has delegated to others. Also meets the requirements for a Staff Signature Log. Other options are also available.

One option for use to document the research staff and what research activities the PI has delegated to others. Also meets the requirements for a Staff Signature Log. Other options are also available.

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.

This log should be used to track deviations from the protocol, IRB policies, or regulations.  The PI’s determination can also be documented as to whether the deviation meets the IRB’s prompt reporting criteria.

If the project involves the investigation of any devices, mobile applications or algorithms, the study may be subject to the Food and Drug Administration (FDA) regulations.

If this human subjects study involves the use of any drugs, biologics, supplements, or cosmetics, the study may be subject to the Food and Drug Administration (FDA) regulations.

This form must be submitted for every project that uses an external IRB. This form is used for the UIUC HRPP to review study information that UIUC is required to review and approve.  This application is not reviewed by the IRB, although OPRS staff members conduct the HRPP review on behalf of the institution. 

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.

Research studies involving genetic testing should submit this form. Genetic testing means a test of a person's genes, gene products, or chromosomes. 

This worksheet can be used by researchers to conduct a self-audit of any health science or biomedical research project.  This worksheet may also be useful to assist with data monitoring or preparation for OPRS PAM or an external audit.

This form should be completed and submitted if an alteration or waiver of HIPAA authorization is being requested. Do not complete this form if HIPAA authorization will be obtained from the research subjects or if another institution collaborating in the research will provide HIPAA authorization.

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.

Informed consent is the process by which potential participants are provided important information about the research study.

International research conducted by the University of Illinois at Urbana-Champaign investigators falls under the University purview and guidelines. Research projects must also be reviewed and approved by the local equivalent of an IRB.

All human subjects research projects must be reviewed and approved before human subjects are recruited or involved in research activities. All projects must be presented on a New Study Application Form.

There are many activities that do not require IRB review. However, oftentimes funders, journals, or academic committees still want evidence that an IRB has been consulted. This form can be used to request a determination that a project is Not Human Subjects Research.