All research at UCO that involves human subjects, including undergraduate and graduate student projects, are required to obtain Institutional Review Board (IRB) approval prior to beginning the research (see IRB Application webpage for instructions and form). IRB approval is required regardless of whether the activity is funded or not. Failure to obtain IRB approval prior to beginning data collection could jeopardize your data, prevent you from publishing the results, and place the university and yourself in violation of federal regulations which could imperil all federal funding to the university.
All students will need a Faculty mentor as a Co-PI on the IRB application. The faculty mentor must review and approve the IRB application and assume responsibility for the protections specified in the application.
Beginning October 1, 2008, all researchers including students will be required to complete on-line Protecting Human Research Participant (PHRP) training before IRB approval for the project will be granted (see training webpage at http://phrp.nihtraining.com/users/login.php). Copies of the certificate for all project personnel should accompany the IRB application.
Students assisting a faculty member on a research project that has already received IRB approval can be added to the project by addendum. The faculty member should submit an Amendment Application Form indicating the student's name, in what capacity they will be working, and verifying that the student has completed PHRP training. A current PHRP certificate must be submitted. The student should sign and submit the Research Team Personnel Agreement Form available on our website.
For students working on a side project directly related to a faculty member's approved research project, an addendum to the original IRB application with the updated information can request that the side project be added to the original approved study. All relevant changes and additions specified in the application should be outlined in an accompanying letter from the faculty mentor. The student should complete the Research Team Personnel Agreement Form available on our website.
Some classroom exercises do not meet the definition of research and do not fall under the auspices of the UCO IRB. These include in-class activities where 1) the students use each other as subjects, 2) the intent is for educational purposes only and not to add new or expanded knowledge, 3) where the results will not be made public outside the classroom, AND 4) there is minimal risk. These should be projects already developed by the instructor.
When the data are collected from students in class there could still be potential privacy issues, so students should be instructed about the protecting the confidentiality of human subjects' data. Information should be included in the syllabus specifying what the expectations for students are and instructors should be sensitive to potential issues that might arise and have a contingency plan in place. Feel free to discuss these issues with the IRB chair.
For research methods courses where students are offered a limited set of research projects already vetted by the instructor -- e.g., methods and instruments have been used in previous years, a Research Methods Class Protocol can be submitted by the instructor as a single umbrella IRB to cover all of the projects in the class for a given semester (see Pre-designed Projects for Courses Application). Lab instructors must insure that students understand and agree to abide by the rules of the general protocol by having them sign a statement to that effect (use the Research Team Personnel Agreement Form). Instructors are responsible for ensuring that the protocol is followed. All researchers including faculty, staff and students will be required to complete on-line Protecting Human Research Participant (PHRP) training (see training webpage at https://phrp.nihtraining.com/users/login.php). Faculty are encouraged to use the training modules in class and document student completion where appropriate. PHRP certificates and signed Research Team Personnel Agreement Forms must be submitted to the Office of Research Compliance prior to beginning the research.
Group research projects, where groups of students enrolled in a course work together to collect data from individuals outside the classroom, should be submitted with course instructors as the PI and include a list of names and signatures of all group members indicating that they have read and understand the project and rules for protecting human subjects and agree to abide by the IRB regulations (use the Research Team Personnel Agreement Form). Copies of the PHRP certificates for all project personnel should accompany the IRB application.
A special class of data record that is always research is the thesis or project. By accepting a thesis or project, the University disseminates its contents for use by others. Therefore, a thesis or project that involves the use of human subjects must always be submitted for review or for certification.