Office of Research Compliance

Frequently Asked Questions - Human Subjects Research 


Q. How do I submit for review?

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

https://leo.research.ohio.edu/secure/leo/IRB/home.leo

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.

Q. When should I submit?

A.  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.

Q. Is there any training required?

A.  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.

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

A.  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.

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

A.  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.

Q.  What if I only have a draft of my questionnaire?

A.  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.

Q.  What is the difference between anonymous and confidential?

A.  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.

Q.  When is a letter of support needed?

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

- Must be on letterhead from the entity providing it;

- 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.

Q.  What is a Corresponding Investigator (CI)?

A.  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.

Q.  When is an advisor required for a submission?

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

Q.  How do I close a study?

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

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.