Forms, Documents and Resources

Students attending an institution of higher learning are not directly mentioned in the federal regulations as a vulnerable population.  However, the University of Illinois Urbana-Champaign IRB considers students of the research institution to be a vulnerable population because students may be vulnerable to coercion or undue influence. 

It is the obligation of the IRB to consider the study design and overall quality of a study in order to effectively evaluate the risk-benefit ratio. If the IRB cannot determine that the risk-benefit ratio of a study is acceptable, it cannot approve the protocol under applicable ethical codes and regulations.  

The IRB must consider the general criteria for IRB approval for all studies, including those that involve children.  Federal regulations require additional safeguards when approving research involving children.  

In some cases, the IRB may provide additional safeguards for research involving economically or educationally disadvantaged individuals.

Neonate: Newborns from the time of delivery up until 28 days old. The IRB may have additional considerations for the research that involves children and neonates.

Federal regulations require additional safeguards when approving research involving pregnant women and fetuses. 

Federal regulations place additional safeguards on research that involves prisoners as participants. The IRB reviews all research involving prisoners using the expertise of a prisoner representative (with no association to the prison involved in the research) and who is a member of the IRB.

The IRB must conduct an assessment of the risks to participants in order to determine whether a study is approvable.

The University of Illinois Urbana-Champaign IRB has determined that data in the datasets in this guidance document has been stripped of identifiers and is publicly available. As a result, research using this data does not rise to the level of "human subjects research" under the federal Common Rule and University policies, and therefore, does not require IRB review.

In order for a record (or research data set) to be considered de-identified, each of the 18 identifiers must be removed. 

This guidance outlines the specific determinations the IRB must make to approve a waiver or alteration of informed consent.

Federal regulations may require additional safeguards for research involving wards of state.  In Illinois wards are called "Youth in Care".

This log can be used to document blood draw attempts.  In some cases the IRB may require this log to be completed and submitted as part of the data or safety monitoring plan.

This log should be used to document participant screening/eligibility, enrollment, and withdrawal from the research study.

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.

This log can be used to document planned or unplanned contact with research participants.

This log should be used to document study-specific trainings of the research team (e.g. training on study protocol).

The witness signature page is intended to be used in unanticipated situations when a participant is able to give full consent for participation in a research study, however, a witness to the consent process is necessary.  Such situations may include: 

• The participant is illiterate and must have the consent document read aloud
• The participant is visually impaired and must have the consent document read aloud
• The participant is physically unable to write and cannot sign the consent document