Frequently Asked Questions - Human Subjects Research

Any project undertaken by Ohio University faculty, staff, and students that meets both the federal regulatory definition of "research" and "human subject" must be submitted for review and receive an approval prior to beginning any research activities with human participants.

To submit for IRB review you must complete the appropriate form using Cayuse.

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. Step-by-step guides can be found here. 

No. The purpose of IRB review is to ensure that the research complies with applicable federal and state regulations and Ohio University policies and procedures, and is designed to adequately protect the rights, privacy, and welfare of the participants. For this reason, IRB review and approval (or exempt determination) must be granted before researchers begin recruitment, data collection, or any interaction with potential participants. 

You should submit at your earliest opportunity to allow sufficient time for review, especially if you expect to have deadlines such as travel dates or graduation. Every submission is different with regard to how long it takes to be approved, depending on the nature of the study. Submissions are routed for review in a first in/first out basis and turnaround times are influenced by current submission volume. Many studies qualify for exempt or expedited review which occur on a rolling basis, and studies that are deemed to be greater than minimal risk, or don't otherwise fit an exempt or expedited category, will be reviewed in a convened IRB meeting (Biomedical or Social/Behavioral). 

Description of review levels and turnaround times

Meeting schedule and deadlines

A "not human subjects research" determination can be obtained by submitting the project in Cayuse Human Ethics using the Initial Submission form. This is the only way to receive an official determination about a project from the Office of Research Compliance. While we are happy to discuss your projects via phone, email, or meetings, these conversations do not constitute a formal determination.

For more information about "not human subjects research" determinations, please see: https://www.ohio.edu/research/compliance/human-subjects/nhsr 

Maybe. In addition to any U.S., state, local, and Ohio University requirements, international research is also subject to the relevant laws of the country where the research takes place. For online/virtual research, this means wherever the participants are located at the time of the research procedures. Often, countries outside the U.S. require local IRB review for all, or only certain kinds, of research. Or, they may require a local investigator to help guide the research. 

In addition to research laws, data privacy laws, such as the General Data Protection Regulation (GDPR) in the EU, may be applicable. Ultimately it is the researcher's responsibility to be aware of and comply with these regulations. 

There are also cultural and language considerations. All of this information should be incorporated into your IRB submission. For more information about international research at Ohio University, please see: https://www.ohio.edu/research/compliance/international-research 

Yes. All researchers conducting human subjects research must complete the required online human subjects training module in CITI. If your primary email address for your CITI account is your OHIO email address, the training will import into Cayuse automatically.

For more information about training requirements, CLICK HERE.

To access the CITI training, CLICK HERE.

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 

External investigators will not have access to Cayuse Human Ethics. To provide documentation of CITI training for external researchers, please ask them to provide a copy of their completion report (the one that lists the modules, rather than the certificate) and upload this in section 5 of your Cayuse submission.

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.

Yes. Most survey research qualifies for exempt category 2 (as long as it does not enroll minors), but sometimes requires expedited review. Consent form templates are available here: https://www.ohio.edu/research/compliance/informed-consent 

For online surveys, such as Qualtrics, it is common to paste the consent form language into the landing page of the survey and have the participant click "I consent" to begin the survey. 

Anonymous means entirely without name OR any direct or indirect 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. In person research can almost never be considered anonymous. 

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, or sent from an institutional email address
• 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 guidance on the letter of support, see https://www.ohio.edu/sites/default/files/sites/research/compliance/guidance/Guideline-The.Letter.of_.Support-V2-2.24.23.pdf 

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

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 submit a deferral request in Cayuse Human Ethics and provide a copy of the IRB approval from the other institution. You may include multiple Ohio University researchers on the same deferral request for the same study. You may not begin human subjects research activities until you have received approval of the deferral. 

Guidance on submitting a deferral

More about IRB reliance

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." Complete the submission, submit, and certify. 

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.