Human Subjects Review
The School of Education protects the privacy of our research subjects when conducting research. All faculty and student research must (by UD and federal policy) receive Human Subjects approval and clearance. The UD Human Subjects in Research web site provides information on the protocol review and approval procedures.
All proposals for research involving human subjects (children and adults) should be submitted via the IRBNet web site. All needed forms are available in the documents Library on IRBNet (under University of Delaware IRB – Documents for Researchers). Information on how to register for IRBNet and using the IRBNet system can be found here.
Human Subjects Research Training
UD will only accept online completion of training in the protection of Human Subjects from the Collaborative Institutional Training Initiative (CITI) Program as proof of fulfillment of the training requirement. In addition, it is required that all personnel actively engaged in research maintain their trained status by completing a refresher course every 3 years.
Information on dates for campus-wide training and online training (CITI program) on Research with Human Subjects that is required of all investigators, advisors, and research staff can be found here.
Specific questions about protocol submission and using IRBNet may be addressed by sending an email to firstname.lastname@example.org or by calling the UD Research Office at 831-2137.
Review of Research Meeting Criteria for Expedited Review
When appropriate, proposals for studies that meet the criteria for expedited review will be forwarded by the Research Office to the School of Education’s Human Subjects Review Committee. These proposals are reviewed on a rolling basis and can be submitted at any time. Researchers should plan to submit proposals at least one month before research activities are planned to begin.
- Research Involving Human Subjects Checklist (School of Education)
- Human Subjects Research Data Storage Guidelines
- Estimating the Readability of Consent and Assent Forms
Frequently Asked Questions
How long does it take for a project to be approved? You should allow at least one month for your project to be reviewed, for feedback to be sent, and for changes to be made (if needed). Projects may take less time to review and to be approved, depending on the type of research.
Does my advisor need to sign off? Yes, advisors (or dissertation committee chairs) must review and approve any research protocols. Within IRBNet, share the submission materials (called a “package” within IRBNet) with your advisor. If he or she cannot be located in the IRBNet system, it may be because he or she has not activated an account.
Do I need HSR approval for a project that is a class assignment? Not usually. Course projects for undergraduate and master’s students are typically not related to human subjects research. Some course projects for doctoral students are designed to support progress towards research goals. If your course project will result in a research study or activities related to a research study (e.g., pilot data), you should consult your advisor and/or a member of the SOE Review Committee for guidance.
Where are the forms I need? All forms can be found on IRBNet in the Documents Library.
What if I want to make a change to my research plan? You should submit an amendment describing the changes you want to make. The Amendment form can be found on IRBNet.
There is a problem with my project. What kinds of problems do I need to report to the IRB? Adverse events and unanticipated problems must be reported to the IRB. More information about these events can be found here. A form for reporting adverse events is found within IRBNet Documents Library.
Examples of problems that need to be reported could include (a) stolen or lost computers or drives that contained personally identifiable information about research participants, (b) having a participant enrolled in a research study when he or she did not consent or have necessary parental consent, (c) when a participant is injured while participating in a research study, or (d) when it’s learned that a research assistant has not completed HSR training prior to working on a research project with identifiable data.
Do I need to submit for IRB approval if I am using someone else’s data? Maybe, it will depend on the type of data and the extent to which the data are anonymous or contain personally identifiable information. You should consult the IRB Office.
Who should I contact if I want to work with students in the undergraduate programs? If you are interested in conducting a research study with UD undergraduates in the School of Education, you should contact Dr. Laura Glass to discuss the study and to get any necessary information.
I want to do research on the students in my class. Is that allowed? Yes, but there additional ethical considerations when the participants in your research study are also your students. See the Research Involving Human Subjects (School of Education) document for additional information.
I want to conduct research at a local school. What documents do I need? You must receive appropriate permission from a school district or other officials to engage in research activities (even if these activities may fall under your job responsibilities). Some schools or districts will require an additional application and approval process. You should secure written permission from other sites and submit it (with the proposal at the time of submission, if available, or as soon as possible).
I want to conduct research at another college or university. Is that allowed? Yes, but you must contact the IRB Office (if there is one) at that institution to determine how to proceed. This could involve submitting an IRB Proposal through that institution’s IRB or submitting a copy of the UD IRB approval. It is the PIs responsibility to follow any requirements at other sites.
Do SOE proposals ever require full board approval? Yes, any study that involves activities that have risk associated with them or that involve special populations may require full board approval. In this case, the study is reviewed at the monthly meeting and the PI (and advisor, if applicable) attends the meeting. Examples of research activities that might require full board review include studies of individuals who are in prison or juvenile justice settings or studies that ask questions about sensitive topics that could pose risks if the information was disclosed (e.g., involvement in activities such as underage drinking).
Please contact Dr. Al Cavalier, the SOE liaison for Human Subjects, at email@example.com if you have questions about the Human Subjects approval process.