IRB Forms and Submission Guidelines
For guidance regarding informed consent and/or assent, click here.
Submit signed copies of all required materials via email to: eiuirb@eiu.edu. While email submission is preferred, unstapled paper forms and materials can be delivered to the Office of Research and Sponsored Programs, 1102 Blair Hall during regular business hours.
Once a protocol is received in the Office of Research and Sponsored Programs, it will be reviewed within 10 business days. If a protocol is imprecise or is missing information, it will be returned for correction or completion. Review of corrected protocols will be conducted within ten business days of receipt of the corrected protocol.
Reminder: All Investigators and sponsors in a project must complete CITI Training prior to IRB approval.
To Request a Review of a New Research Project:
A guide and tutorial for the application can be accessed at: IRB Protocol Submission Guide and Tutorial. In addition, each section heading within the application has an embedded hyperlink that will direct you to to its corresponding section within this guide.
2. Relevant supplemental materials must be submitted with the completed application. Supplemental materials can include, but are not limited to:
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- Informed Consent document
- For guidance regarding informed consent and/or assent, click here.
- If applicable, Assent document or script
- Questionnaires, surveys, tests, or other materials that will be administered to subjects
- Recruitment materials (including e-mails, advertisements, flyers, and/or text of social media posts)
- If applicable, written permission from other institutions or agencies involved in the research (e.g., school board, hospital, agency, prison)
- HIPAA Authorization or waiver of Authorization if your proposed study involves protected health information
- Application for IRB Review Addendum: Additional Co-Investigators (if there is more than one co-investigator)
Note: If an individual research project is being conducted to meet the requirements of a research methods (or similar) course, please review the Course Project Requests section on this page. Course projects that are not intended to contribute to generalizable knowledge, do not place the subjects at more than minimal risk, and are not intended for publication are not to be submitted for IRB review via the Application for Review of Research involving Human Subjects.
Course Certification:
When instruction-related research projects involving human subjects are being performed as part of normal course activities, Course Certification is appropriate provided a project meets the following conditions:
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- The project is not intended to contribute to generalizable knowledge
- The project place the subjects at more than minimal risk
- The project is not intended for publication
- The project does not involve subjects who are members of a vulnerable population*
In these circumstances, the instructor should request course certification using the Course Certification Request Form. This request form would apply to all student projects for the course that meet the above criteria. Student research projects cannot begin until course certification approval has been received, and students should conduct only the activities approved by the instructor.
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- This Course Certification form should be submitted every semester by the instructor for each course in which instruction-related research is performed. The form is not intended for use for individual projects.
Course Project Review:
If an instruction-related research project is being conducted to meet the requirements of a research methods (or similar) course, and subjects are members of a vulnerable population*, individual researchers must submit an Application for Course Project Research Review. Student projects of this nature cannot begin until the IRB certifies that the project can proceed.
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- This form must be submitted for each project in a course that meets the criteria for course certification but includes members of a vulnerable population as subjects. Instructors would serve as co-investigators for these projects.
It is entirely possible that a section of a course would have some individual student projects that meet the criteria for Course Certification and other individual student projects that meet the criteria for Course Project Review. In this case, the instructor can submit a Course Certification form for projects that meet Course Certification criteria, and would work with individual students to submit the Application for Course Project Review for projects that involve vulnerable populations.
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- It is also entirely possible (and appropriate) for all student projects in a course to require Course Project Review.
*Vulnerable populations include children, prisoners, pregnant persons, mentally disabled persons, economically or educationally disadvantaged persons, individuals who are unable to give informed consent due to a physical or mental condition, or individuals whose circumstances may make them vulnerable to coercion (e.g., probationers).
Informed Consent Checklist
Informed Consent Template
When participants are minors or persons who are decisionally-impaired:
Guidelines for Assent
Informed Consent Letter to Parents Template
Post IRB Approval Requests:
Modifications to a Research Protocol:
Include any updated research materials and/or supplemental materials.
Continuation of Research:
Include protocol summary, including approved modifications since last review and/or proposed changes and Informed consent forms, permission forms, and assent forms, if applicable
Completion of Research Activities:
When required, submit the Completion of Research Activities form.
To Report Problems Involving Risk, Adverse Effects, or Non-compliance:
The researcher is responsible for informing the IRB of unexpected findings that can affect the risk/benefit ratio. Adverse events are unexpected problems whose nature, severity, or frequency are not described accurately in the study protocol. The IRB should always be informed of any problems or accidents in a study, including a change in risk to, or breach of, confidentiality. Incidents where subjects have been harmed should be reported to the IRB immediately. The death of a participant, whether related to a study or not, should also be reported to the IRB immediately.
Call or e-mail the IRB Chairperson immediately and submit Report of Adverse Effects or Noncompliance to the Office of Research and Sponsored Programs within 20 working days.
For additional information and training, visit the IRB Training webpage.
