Category: News

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.)
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 .
– 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.

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 2023-2024 Academic Year

CITI Training Manual 4.24.23

Hello everyone! Welcome to the first blog post of the semester!

What is deception? Deception is just simply providing false information to the participants of the study. 

What is incomplete disclosure? Incomplete disclosure is a type of deception where the real purpose of a study/research is not given to the participants of said study. 

These two things are extremely important to distinguish in a study because it will most definitely make a difference in how the study is reviewed by the IRB. In some cases, deception is necessary because prior knowledge of the true aim of the study may alter responses from the participants. For example, a study examining how emotions affect decision making may not inform participants of the study they’re being studied based on their emotions because the researcher wants authentic reactions. The IRB reviews studies that involve deception because participants cannot fully consent to a study if they are given false information. The IRB has to determine whether the study needed to use deception, or if they study could be completed without it. All studies using deception require a debriefing script, describing the true aim of the study and making sure that the participant gives permission to gives permission for their data to be used for the study. 

As far as incomplete disclosure, it may be necessary in some cases, only when the researcher documents that it is justified under criteria of federal regulations. Use of incomplete disclosure generally includes minimal risk, the safety and welfare of the participants must be not affected. However, these research techniques might raise concerns for the IRB because it involves manipulating the participant’s ability on whether they want to participate in the study or not. The IRB also discourages use of these techniques if there are better alternatives to yield the researchers’ desired results, if it doesn’t protect the participants interests, and if the risk of participation is not clear to the participant. 

If you are unsure if your study involves deception or incomplete disclosure, please contact the IRB at (312) 341-2449 or dsomerville@roosevelt.edu.

You have submitted and received approval for your IRB application (yay!). Now you have to submit another form to make changes to your original study (amendment), acknowledge a reliance agreement with another institution, request a continuation for your study (renewal/termination form) or terminate your study (renewal/termination form).

All subsequent forms submitted have to be processed through the study page of the initial submission. The initial application established a study page with your study number. Your study number should be connected to every form that is submitted for that particular study thereafter.

You access your study page by clicking on the hyperlinked study number on your home page. Once you click on your study number, that will take you to a page that looks like this.

Notice that your study number is at the top of the page. When you look on the side column, you will notice the “start x form” in the side toolbar (circled below). Push “start x form” on your study page and that will take you to the next screen.

You will see all of the forms you can use in relationship to your study number. From here, you should be able to submit your form.

If for some reason you are not able to access your study page, please contact the IRB Office.

Here is a short video that provides instructions.

If it’s been weeks since you’ve submitted your IRB form and you are wondering why you haven’t heard back yet, there is a likely chance that you haven’t completed the submission process.

Each form requires two steps for submission: sign and submit. If you have seen a screen that asks for you to enter your username and password, then you haven’t signed off on your form. If you haven’t seen a submit screen, then you haven’t actually submitted your form.

Here is what you should look for.

After you enter your information in the form, push “next” at the bottom of your form. On the next screen you will see a page that asks for you to sign off on your form. Push “sign” and this will take you to a screen that asks for your username and password, same as when you log on to IRBManager. Once you complete that step, you should see this screen.

This screen verifies that you have actually signed your form. You will need to push next again to go to the next screen.

When you push “submit” your form will be sent to the next level of review. If you are a student, your faculty advisor will receive the form. If you are a faculty or staff researcher, your form will go to the IRB Office.

Once you see the above screen, your form has been submitted.

If you have completed these steps and you require your faculty advisor to sign off on the form, please make sure that your faculty advisor has done so. Once they have signed off on the form and you still haven’t heard back in two weeks, then please reach out to the IRB Office to make sure that your form has been reviewed.

You submitted your IRB application, Renewal or Termination and may not be sure sure why you haven’t heard back from the IRB. Here are a few reasons why this may be the case:

• You are a student whose faculty advisor did not sign off on your study. This is the most common issue for why this happens. Every student study submitted to the IRB requires approval from your faculty advisor. If you haven’t been in touch with your faculty advisor, check  in with them to find out if they actually reviewed your study after your submission to the IRB. Faculty advisors are now responsible for agreeing to providing proper oversight over student research that requires IRB approval and to provide a one-page plan on how they will monitor student research projects. Once a faculty advisor completes that process and actually pushes the “submit” button, then the project comes to the IRB for review. If your study is sent back to you during the pre-review, review, and post-review stage (if a full board study), then your faculty advisor is required to review and submit it again before the IRB reviews your changes. Keep in contact with your faculty advisor to make sure that they are actually responding to emails received from IRBManager.
• You are a PI with a different submitter for your study. The IRB application has a place to indicate whether the person is the submitter and/or PI. If that person is one in the same, then the submission should move forward without an issue. If a student or staff person submits a study on behalf of someone else, then the system requires that the PI sign off on the study prior to IRB review. The IRB Office sees numerous studies at this stage all the time.  Please be sure to check for emails from the IRB Office, or research@roosevelt.edu. You likely have been sent an email that requires your attention and response.  Once you receive an email notification from the IRB, please go into your study, review it and push “submit” to complete the submission process.
• You did not use your actual Roosevelt University email address to submit your study. All study information is tied to your Roosevelt profile. The system recognizes this information for everyone to have single sign-on access through Roosevelt and to access your CITI training information. Any submitter that uses a personal email address while accessing IRBManager or providing contact information for the IRB Office to process is creating a situation that confuses the system’s ability to recognize you as a submitter. Applications submitted with private contact information are not processed by the system and require the IRB Office to delete the second contact information and for the submitter to begin again with another form.
• You didn’t actually complete the submission process by pushing “submit”. We have found that many submitters simply do not push “submit”.  The submission will only be completed once this task is completed.
• You received an email notification requesting changes to your application that you haven’t responded to. Please be sure to check your emails to make sure that you are being responsive to any feedback, questions, or required changes to your study.
• If you have addressed any or all of the above concerns and you are still haven’t received a response in 5-10 business days following your submission, please check in IRBManager to see if there has been a status change to your submission. If it shows as “under review” please call or email the IRB Office to inquire about the status of your study for exempt or expedited studies. If your level of review is full board, please know that it will be reviewed at the next full board meeting. If your level of review is exempt or expedited, it will be reviewed by one or two IRB reviewers, which should not take as long. Please contact the IRB Office (dsomerville@roosevelt.edu) if the review time has been longer than 10 business days for your exempt or expedited study.