Human Subjects Review
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Human Subjects Coordinator, University of Illinois Institutional Review Board
This is the video of the presentation by Ron Banks of Campus IRB staff explaining several aspects of how human subjects filings are handled and where you can get help with your IRB preparation. Take time to watch this and review the PowerPoint presentation.
© 2012 The Board of Trustees of the University of Illinois
UIUC and College of Education policy on human subjects research states that all research and data collection activities that are conducted at, or sponsored by, the University of Illinois, whether funded or un-funded and whether conducted by UIUC faculty or others, must comply with federal policy for the protection of human subjects. This includes pilot projects; student early research, thesis, or dissertation projects; student non-degree-related projects; faculty projects; independent studies; case studies; research placed in the schools; and course projects that involve human subjects. This policy applies regardless of whether the research will be conducted in the state of Illinois, elsewhere in the United States, in cyberspace, or in any foreign country.
The College of Education's Human Subjects policy also requires that human subjects review requirements must be completed before students can pass their early research requirement, master's or doctoral preliminary oral examination.
All research projects must be submitted to the UIUC Campus Institutional Review Board (IRB). This includes research that is externally funded (where funding for the project has been obtained from a source outside UIUC), research that involves more than minimal risk (where the risks to subjects from the research are greater than those of everyday life), research involving prisoners, and other specific types of research as well as those that are exempt or are eligible for expedited review.
Campus IRB links:
Review procedures and requirements:
Campus IRB deadlines:
- Video 1: Human Subjects Protection History - Human Subjects Research Ethics and the Belmont Report
- Video 2: Recruiting Procedures and Inclusion & Exclusion Criteria (IRB-1, Sections 10 & 11)
- Video 3: Research Procedures (IRB-1, Section 12)
- Video 4 – Data Collection, Security, and Management (IRB-1, Section 19)
- Video 5: Informed Consent, Risks and Benefits (IRB-1, Sections 20 - 24)
There is one primary human subjects form called the IRB-1. The IRB-1 is the form that is used for the majority of human subjects research projects. The General Letter for Coursework Project is available for faculty only when they are instructing a course where all students are doing the same small, investigation.
Once submitted to Campus IRB, the human subjects form and other documents relevant to the research will be reviewed to determine whether they are complete and clearly respond to the questions outlined in the IRB-1. If not, requests for additional or revised information will be made. Once the forms are complete and in order the researcher will be notified of the project's approval as soon as possible by letter in campus mail or e-mail. The researcher may not proceed with their research until the approval letter is received.
There may also be an additional Research Placement Form required if the research is conducted in schools, or uses the Educational Psychology subject pool.
Research Project Title Change
We are pleased to announce that in the interest of reducing paperwork, there is a simplified process for changing the title of your research project. Providing there are no other changes to the project you may send an e-mail to OSURR@education.illinois.edu clarifying the approved name for the project and then the new name. A signed modification form is no longer needed - the email and confirmation of receipt will suffice. If you have any questions please call 217-333-3023.
Please use the College of Education intranet to enter and update your research project status.
This report MUST be submitted in order to provide a summary for school districts and other organizations at the end of the academic semester or at other times when a status report is required. We have recently moved to an electronic reporting process that allows the researcher to provide relevant information directly to the project file in the OSURR database.
1. Log on to the College of Education Intranet using your active directory (AD) password.
2. Select (OSURR) Human Subjects Projects. Your list of approved projects should appear. If you do not see a project listed, email OSURR@education.illinois.edu.
3. Select 'EDIT' on the far right of the project to view the record of what OSURR has on file.
4. Carefully review the project title, it MUST be an EXACT match to your IRB, if there has been a revision or you would like to make a title revision, enter the new title in the Feedback box at the bottom of the screen.
5. Follow the instructions in the form to review and submit updates for each section. You will need to: (1) select a Project Status; (2) provide a Project Update telling us about your reserach experience; (3) Anecdotal Information that may be helpful for district or school administrators; (4) Collaborative Research Response; (5) Research Benefits feedback; and (6) Services Provided to complete the Status Report Update.
6. If there is anything else regarding that specific project you want to communicate to OSURR, please use the Feedback box for that project instead of a separate email.
7. After entering all changes, press the 'SAVE' button to submit your Report. Further changes or updates can be submitted to OSURR at any time using the Feedback box.
All research and data collection activities conducted by College of Education faculty and students which involve human subjects are subject to review. Completing the Human Subjects Training Module will increase your understanding of the research activities subject to review and how to complete the IRB forms.
The term "exempt" refers to research that may be reviewed through a process called expedited review that does not involve the full human subjects committee. This process is generally faster than a full review.
"Exempt" does not mean that human subjects requirements have been waived for a particular research project or that the researcher does not have to complete a human subjects form. Researchers are not permitted to declare that their own research projects or those of their students are exempt; this is a decision that can be made only by the designated human subjects reviewer.
The human subjects form (IRB-1) should provide a brief, but complete description of the proposed research. It should respond adequately to all relevant questions. Handwritten forms are not acceptable and researchers are advised to maintain a back-up copy on their computer or disk to facilitate revisions.
Human subjects reviewers are checking primarily for compliance with protection of human subjects protocol along with clarity in the description of proposed research. The reviewer will also provide a quick check for spelling, language or grammatical errors and will contact the researcher with any questions or suggestions to revise the document. Since this document may be seen by others outside of the university it is important that the approved draft is of the highest quality possible.
The Campus Institutional Review Board Basic Elements of Informed Consent checklist is a useful tool for considering your proposed project in terms of the general requirements for obtaining informed consent from research subjects
Contact OSURR if you have any questions.
Most forms require revisions and the researcher will be notified, usually by e-mail, within fourteen days after their human subjects form is submitted. The length of the review process then depends on how quickly the researcher makes the necessary revisions and resubmits the form and other documents.
Once your research has received human subjects approval, you and your faculty advisor will both receive a formal approval letter through email.
Please contact OSURR with any questions.
I am planning to do my master's thesis research in an elementary school. Do I have to complete both the IRB-1 form and the Research in Schools form?
Yes. The IRB-1 form is designed to provide approval for human subjects research. The Research in Schools Form provides summary information that will be helpful for placing your research in the appropriate school. It is also forwarded to the Directors of Research, and classroom teachers, at the district level. This service is available only to College of Education researchers.
Yes. You should submit your competed application, with all necessary attachments to Campus IRB at irb.illinois.edu.
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