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Frequently Asked Questions - Human Subjects Research

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 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

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.

Description of review levels and turnaround times

Meeting schedule and deadlines

Is there any training required?

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, .

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

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.

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.

What is the difference between anonymous and confidential?

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.

When is a letter of support needed?

A letter of support is needed when the study will be conducted at a site outside of ÃÛèÖÊÓÆµ, 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 detailed guidance on the letter of support, see the guidance document.

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 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." 

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 ÃÛèÖÊÓÆµ Office of Legal Affairs regarding the legal liabilities for ÃÛèÖÊÓÆµ 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 ÃÛèÖÊÓÆµ 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 ÃÛèÖÊÓÆµ?

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 ÃÛèÖÊÓÆµ 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

 

 

NEW- How do I complete the HIPAA training requirement?

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.

 

 

I am a student and I can't access Cayuse, or I am trying to add a student to a protocol in Cayuse and I can't find them in "find people."

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 to request an account. Accounts are usually approved in 1-2 business days.