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Frequently Asked Questions - Human Subjects Research

Click here to see Description of Review Levels.

Need help? For more information on research involving human subjects, email compliance@ohio.edu or call 740-593-0664.

How do I submit for review?

To submit for IRB review you must complete the appropriate form using the electronic LEO IRB system found at the following link:


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.

When should I submit?

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.

Click here for a description of review levels and turnaround times.

Click here for the meeting schedule and deadlines.

Is there any training required?

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.

Click here to access the online training modules.

What is the process for an external investigator to upload required CITI training?

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. 

Can I go ahead and line up my participants while I'm waiting for approval?

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.

Is it necessary to have a consent form for a survey?

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.

Click here to access the consent form templates.

What if I only have a draft of my questionnaire?

Submit it, clearly marked as a 'DRAFT'. This will give the committee an idea of the types of information you intend to collect. After you have finalized the document, submit it via the electronic LEO IRB system as an Amendment.

What is the difference between anonymous and confidential?

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.

When is a letter of support needed?

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.

What is a Corresponding Investigator (CI)?

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.

When is an advisor required for a submission?

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

How do I close a study?

To close a study, submit a periodic review and indicate the study status as, "Completed (no enrollment, no treatment / intervention, data has no identifiers)."

What do advisors on student research protocols agree to?

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.
What are some commonly taken approaches for faculty advisors listed on student research protocols to ensure that the required oversight is provided to ensure compliance?

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.

What are the legal liabilities for an advisor listed on a student research protocol?

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.

I am an Ohio University faculty, staff, or student. I am collaborating on research at another institution and my colleague has IRB approval from their institution. Do I need to do anything at Ohio University?

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.  For guidance on submitting a deferral, click here.