Author: ldowney

CITI Training Manual 4.24.23

All IRB applications must be submitted via IRB Manager by one of the submission deadlines below at 5:00 p.m. No exceptions. The IRB is no longer accepting paper applications for initial applications, renewals, amendments, or terminations.

Here are the dates for the 2024-2025 Academic Year

Consent Forms- Needed Information

1. Title of the Study
2. Names and Affiliations of the Primary Investigator
• If a student is conducting the study, state the student’s information first.
3. Purpose of the Study
• Describe the general purpose of the study.
4. Subject Selection Criteria
• Describe how the subjects were chosen.
5. Study Procedures
• In chronological order, describe what the subject will be asked to do (an activity, completing a survey).
• Describe the total length of time for participation (how long, how often).
• If applicable, explain that the investigator will be audiotaping or videotaping, and if this is optional.
6. Potential Risks and Discomforts
• Describe any potential for psychological, social, legal or financial risk or harms to the subject and their probability as a direct result of participation in the research and/or from breach of confidentiality. (Remember: There is no such thing as risk-free human subject research.). If the subject might be upset in responding to the study topics you must include a free service they can contact to speak with about that issue.
7. Potential Benefits
• Describe any expected benefits to the subjects themselves (clearly state if subject will not benefit directly from the study).
• Describe any expected benefits to society and/or science.
8. Cost and Compensation
• Describe any cost to the subject (include time spent).
• Describe any compensation the subject will be offered as a result of participation in the research (if partial participation will result in partial compensation, explain). Also see section 11.
9. Future Use of Data
If working with identifiable and or de-identified data:

• Explain that identifiable private information/de-identified data may be retained and used for additional or subsequent research, and if this is optional. State when data will be destroyed.  the standard is five years
– OR –
• State that the data collected will not be distributed for future research, even with the identifiers removed (note that some funders and journals require de-identified data to be made available to others post research/publication).
• Standard length of time is 5 years and then will be destroyed.
•
10. Confidentiality
• Describe the level to which subject information will be kept confidential (describe procedures that will be used to safeguard data, including where it will be kept, who will have access to it and at what point it will be destroyed; note the difference between anonymous and confidential).
11. Participation and Withdrawal
• State clearly that participation is voluntary and that the subject may refuse to answer any questions or withdraw from the study at any time without penalty (including loss of benefits to which they would otherwise be entitled).
12. Contact Information
• Give the contact information of the principal investigator and supervised researcher (if applicable) for questions about the study.
• Give the contact information of the Roosevelt University IRB Chair Dr La Vonne Downey, ldowney@roosevelt.edu 312-322-7112) for questions about the subject’s rights as a human subject or concerns about the research.
13. Subject Consent
Example
I have read (or had read to me) the contents of this consent form and have been encouraged to ask questions. I have received satisfactory answers to my questions. I understand that my participation is voluntary and that I may withdraw my participation at any time without penalty. I voluntarily agree to participate in this study.
__ I do __ I do not give you permission to make audio/video recordings of me during this study (if applicable).
__ I do __ I do not give you permission to retain and use my data for future research (if applicable).
• Signatures of subject and investigator. The subject must be able to have a copy of this form.

What is Needed in a Consent Form