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Institutional Review Board (IRB)

The Ohio Department of Health Institutional Review Board (IRB) is a governmental health-related entity composed of members from several state agencies. As dictated by federal rule, all research activities involving human subjects must be reviewed and approved by an IRB unless the research falls into a category of exemption established by federal regulation.

In accordance with FDA regulations, the IRB reviews human subjects research proposals to ensure risks have been minimized and the potential for benefit has been maximized before human subjects participate in the research. The IRB also ensures, when required, that human subjects only volunteer to participate in research after providing legally effective informed consent.

Investigators may not solicit subject participation or begin data collection until they have received approval from the appropriate IRB or written concurrence that research has been determined to be exempt from IRB review.

Detailed information can be found at the United States Department of Health and Human Services, Office for Human Research Protection website: http://www.hhs.gov/ohrp/.

All ODH data released as part of an approved IRB protocol must follow the ODH Data Policies and Standards.  A general data confidentiality form can be downloaded here. For specific program's confidentiality forms contact the program you are working with.

All applicants must fill out the IRB Application Form (pdf version) or (word version) and submit it to the address listed below.

IRB meetings are held the 4th Tuesday of every month January through October and the first Tuesday of December. Your IRB Application Form and all other documents must be received at least 14 calendar days prior to the meeting date for it to be considered at the next meeting.

IRB Forms:

IRB forms have been updated Dwecember 2013.  No old versions will be accepted.  Please submit all forms electronically if possible.

New applications must contain the following in the application packet:

IRB Application Form - use with all applications

Additionally, you may submit:

IRB Expedited Request Form - for requests that fit the requirements for an expedited request (see definition on form)  Very few IRB applications are eligible for expedited review.  Requests for previously collected data must meet the criteria of being already de-identified AND made available to the public.  All expedited requests for ODH data must be reviewed and certified as meeting the qualifications for an expedited review by the ODH data steward.  It is the investigator's responsibility to obtain this signature prior to submission to the IRB for consideration.  Expedited requests not using ODH data will be assessed on a case-by-case basis.

OR

IRB Exemption Request Form - for requests that fit the requirements for an exemption (see definition on form)

AND

IRB Confidentiality Form - must be completed for all research staff who will be handling data

IRB Curriculum Vitae Form - must be completed for all research staff who will be handling data

All previously approved protocols may use the following:

IRB Protocol Change or Renewal Form - for requesting renewals or making changes to previously approved protocols

 

 

Mailing Address

Ohio Department of Health
ODH Institutional Review Board
Socrates Tuch, MA, JD, Chairman
246 North High Street
Columbus, OH 43215

Telephone: (614) 995-0775 for Lisa Heinbach or (614) 644-0663 for Pam Leimbach
E-mail: ODHIRB@odh.ohio.gov

Last Reviwed: 9/29/2014