For IRB use only IRB File Number: Eastern Illinois University

Institutional Review Board (IRB)

Application for Review of

COURSE PROJECT Research Involving Human Subjects

All Investigators and Sponsors must complete CITI Program training at http://www.citiprogram.org/.

Directions: All items require a response unless otherwise indicated. The completed application should be e-mailed to eiuirb@eiu.edu. Do not submit forms via links to shared drives.

Title of Project:
Estimated Start Date:	Start Date	Estimated Completion Date:	End Date
Is this research being funded by an external source (such as a grant)?	☐ Yes ☐ No
COURSE INFORMATION
Department:	Course #:	Section:
INVESTIGATOR(S):
Principal Investigator:	Status:	Choose an item.
Email:	Phone:
Co-Investigator:	Status:	Choose an item.
Email:	Phone:
1. PROJECT DESCRIPTION: Describe the purpose of this research using layperson’s terms in 50 – 200 words. This description can be similar to an abstract and serves as a snapshot of your research.
2. Will the results of the research be disseminated outside of the classroom?
☐ No ☐ Yes – explain:
PARTICIPANTS:
3. Approximate number of human participants:
4. Check all applicable categories of subjects and controls that will be included in this research:
☐ Students you are teaching, supervising, or observing	☐ Persons with medical, psychological, or mental health conditions relevant to the research
☐ Minors - Age range of minors: Age Range	☐ University/College Students
5. CHARACTERISTICS: Describe the characteristics/demographics of the population you will be studying. Provide inclusion and exclusion criteria. If participants include vulnerable persons, explain why their inclusion is necessary for the research.
STUDY LOCATION:
4. List specific sites, agencies, or platforms to be utilized. If any facility is not owned and operated by EIU, a letter from an appropriate administrator of the facility must be submitted with this application (if facility administrator will not provide a letter until IRB approval is obtained, state that in this prompt).
PROCEDURES:
5. STUDY PROCESS AND PROCEDURES: Describe the research process and all procedures that will be carried out with each group of subjects. Include a description of the research setting, and the estimated total amount of time a subject would spend participating in the research. Indicate whether any procedures are not routine and will be performed specifically for this research project.
INSTRUMENTS, RESEARCH MATERIALS, AND DATA STORAGE:
6. INSTRUMENTS: List all instruments, assessments, or other tools that will be used to collect data, and describe the data/research material that will be obtained from subjects.
7. Will audio or video recording be utilized?	☐ Yes ☐ No
8. Will data be recorded without names or identifiers?	☐ Yes ☐ No
9. DATA SECURITY: Describe how all materials related to the research (i.e. data, subject identifiers and/or signed consent forms) will be kept secure through the duration of the study and who will have access to the materials.
RISK(S):
10. Check all applicable types of risk(s) to subjects that could occur as a result of participation:
☐ Confidentiality/Violation of privacy ☐ Emotional Distress	☐ Physical Injury ☐ Physical/Mental fatigue
☐ Other – Describe below:
11. Describe the processes and procedures that will be in place to protect subjects from the potential risk(s) described in the previous prompt.
INFORMED CONSENT, ASSENT AND WAIVERS: You must attach full text of informed consent document (and assent document or script, when applicable) to this application. Information and guidance for the informed consent and assent processes can be found here.
If your research involves participants who are minors or adults who are decisionally impaired:
12. Will you provide informed consent information to parent/guardian?	☐ Yes ☐ No
13. Will you collect signatures of informed consent from parent/guardian?	☐ Yes ☐ No
14. Will you provide assent information to potential participants? If yes, indicate the method of delivery:	☐ Yes ☐ No
☐ Verbal, utilizing a script ☐ Written, utilizing a letter
15. Will you obtain assent from potential participants? If yes, indicate method of collection:	☐ Yes ☐ No
☐ Participant signature on document ☐ Verbal assent
If your research involves adult participants:
Will you provide informed consent information to potential participants?	☐ Yes ☐ No
Will you collect signatures of informed consent from potential participants?	☐ Yes ☐ No
APPLICATION SUBMISSION:
Investigator Assurance: All boxes must be checked, and the form must be signed, either by pen or electronically
☐ I certify that the information provided for this project is accurate and compiled by me. ☐ I agree to conduct this research as described in this form and in the attached supporting documents, and that no other procedures will be used in this research. ☐ I will request approval from the IRB for changes to the project and/or its dissemination and will not implement the changes until I receive IRB approval for these changes. ☐ I will comply with the IRB policy for the conduct of ethical research. I will promptly report significant or adverse effects to the IRB in writing within 5 days of occurrence. ☐ I certify that I have completed CITI training within 3 years prior to this project’s estimated start date.
Principal Investigator’s Signature:	Date:
Faculty or EAP Staff Sponsor Assurance (required when PI is a student): All boxes must be checked, and the form must be signed, either by pen or electronically
☐ This is to certify that I have reviewed this application and that I attest to the scientific merit of this study and the competency of the investigator(s) to conduct the project. ☐ I assure that the investigator(s) is knowledgeable about the regulations and policies governing research with human subjects. ☐ I agree to meet with the investigator on a regular basis to monitor study progress and compliance with IRB policy for the conduct of ethical research. ☐ I assure that the investigator(s) knows to request approval from the IRB for changes to the project and/or its dissemination and to not implement the changes until IRB approval is received. ☐ I will promptly report any significant or adverse effects that I am made aware of to the IRB in writing within 5 days of occurrence. ☐ I certify that I have completed CITI training within 3 years prior to this project’s estimated start date. ☐ I understand my responsibilities and what is required of me when sponsoring student research
Faculty or EAP Staff Sponsor’s Signature:	Date: