Forms

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.

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.

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.

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.

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 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.

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. 

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 irb@illinois.edu 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. 

A safety monitoring plan must be designed for greater than minimal risk studies to minimize threats to the safety and welfare of the research participants. 

The University of Illinois at Urbana-Champaign IRB ensures that additional safeguards are included in the research design to protect the rights and welfare of research participants who have limited autonomy and are at risk for coercion and undue influence.

This form should be used when requesting a full Waiver of Informed Consent (no consent) or when requesting an Alteration of Informed Consent (some elements are missing, full information is not disclosed to participants, or deception is used).