Frequently Asked Questions - Human Subjects Research

To submit for IRB review you must complete the appropriate form using the electronic LEO IRB system.

The electronic system is set up to allow you to submit for IRB consideration by entering text, and by use of check boxes and drop-down boxes. It also enables you to upload appendices such as consent forms, surveys, recruitment flyers, letters of support, etc.

Research proposals are routed for review in a first in/first out basis. Many studies qualify for exempt or expedited review, and thus go straight to a reviewer. Studies that are deemed to be greater than minimal risk will be reviewed in a convened meeting of one of two committees (Biomedical or Social/Behavioral). Each committee meets once per month and there is a submission deadline to be included on each month's agenda.

Description of review levels and turnaround times

Meeting schedule and deadlines

All researchers conducting human subjects research must complete the online human subjects training module and upload the completion report into the electronic LEO IRB system. The email address on the completion report must match the email address in the LEO IRB system for that individual.

Online training modules

When the CI submits the IRB protocol, the external investigator will receive an email from the LEO system.  The email contains a link that allows entry into the LEO system to review the protocol and to upload their CITI completion report.  The external investigator will receive an email each day until they have successfully uploaded the training.   It is important to use the link in the most recent email as the link in each email is active for a limited amount of time for security purposes. 

No. One of the responsibilities of the IRB is to ensure that selection of participants is equitable and that safeguards are in place to ensure that there is no pressure or coercion to participate. Because this can occur in the recruitment process, you must wait for IRB approval prior to any contact with the participants, including recruitment.

It is necessary for the consent process to occur for a survey, but it doesn't necessarily have to be a formal, signed consent form. A variety of consent form templates are available.

Anonymous means entirely without name OR identifier, so the individual cannot be discerned in any way. No one (not even the researcher) can link an individual person to the responses of that person. Confidential means that the investigator can (or could) identify individuals who participated in a study, perhaps through a code. Although the identities will be recorded, the information will only be used for specific purposes related to the project and outlined to the participant in the consent form.

A letter of support is needed when the study will be conducted at a site outside of Ohio University, e.g., Athens City Schools, Planned Parenthood, etc., or whenever the IRB deems a letter of support is necessary.  A letter of support must meet the following guidelines.

• Must be on letterhead from the entity providing it
• Must contain a date
• Must be signed by an appropriate authority (for example, research in schools requires the letter of support come from the principal or higher)
• Must specifically state what the agency is agreeing to

For more detailed guidance on the letter of support, see the guidance document.

The Corresponding Investigator (CI) serves as the liaison between the research team and the Office of Research Compliance and represents the research team in all decision-making by solely responding to questions, submitting revisions, withdrawing proposals, etc. on behalf of the team. The research team can change who serves as the CI at any time, prior to or after approval. A research assistant cannot serve as the CI.

Whenever a student is listed as the primary investigator, a faculty advisor must be included with the submission.

To close a study in LEO, click "Close Study" on the IRB application page. In the form, indicate the study status as, "Completed (no enrollment, no treatment / intervention, data has no identifiers)."

To close a study in Cayuse, go into the study record, click "new submission," and select "Closure." 

Advisors listed on student research protocols make the following assurances:

• As sponsor on this research application, I certify that the student(s) or guest investigator is knowledgeable about the regulations and policies governing research with human subjects and has sufficient training and experience to conduct this particular study in accordance with the approved protocol.
• I am the responsible party for the legal and ethical performance of the project.
• The proposed research has not started and will not begin until approval is obtained.
• The investigator(s) is knowledgeable about the regulations and policies governing research with human subjects.
• The investigator(s) has sufficient training and experience to conduct this particular study in accordance with the approved protocol.
• I will meet with the investigator(s) on a regular basis to monitor study progress.
• Should problems arise during the course of the study, I agree to be available, personally, to supervise the investigator in resolving them.
• I assure that the investigator will promptly report adverse/unexpected events to the IRB in writing.
• If I will be unavailable, as when on sabbatical or vacation, I will arrange for an alternate faculty sponsor to assume responsibility during my absence.

First, in initial meetings with the student researcher, the advisor can discuss the importance of conducting the study ethically and outline procedures to follow if problems are encountered. Second, the advisor can check in frequently with the student while data are being collected to discuss progress and to ensure that they are following the IRB-approved protocol. These check-ins can be in person, by phone call or by email.

The Office of Research Compliance has consulted with the Ohio University Office of Legal Affairs regarding the legal liabilities for Ohio University faculty listed as an advisor on a student research protocol. If a lawsuit arises out of a student research protocol, the individual advisor cannot be sued in their personal capacity, rather, the lawsuit would have to be filed against the University. Advisors acting in the performance of their duties will not be personally liable unless the Court of Claims finds that their actions were manifestly outside the scope of official responsibilities, or that they acted with malicious purpose, in bad faith, or in a wanton or reckless manner.

Yes, you will need to file a deferral in the LEO IRB system and provide a copy of the IRB approval from the other institution.  Each Ohio University member of the study team must file a separate deferral and you may only be involved with the study after you have received approval of the deferral. Guidance on submitting a deferral

For IRB submissions involving activities covered by the Health Insurance Portability and Accountability Act (HIPAA), you must complete the HIPAA course in Vector. If you have not yet completed HIPAA training, please contact compliance@ohio.edu so that we can assign the course to you. Once the HIPAA course has been added to your profile. Please visit the link provided below to get started.

Student Training login 

Employee Training login 

Students first need to request an account in Cayuse before they will be able to log in or appear in the "find people" search. Students will submit THIS FORM to request an account. Accounts are usually approved in 1-2 business days.