All retrospective and prospective research projects must go through some level of review by the Institutional Review Board (IRB) of record.  Generally speaking, students must submit research project proposals to the IRB of record for their respective college of osteopathic medicine; residents, interns, and CORE faculty (in most cases) will submit their project proposals to their respective hospital IRB. To view specific IRB dates per hospital, please click here.

The IRB is a group comprised of medical professionals, administrators, and laypeople; this group reviews research protocols and either approves or rejects a project.  A rejection may occur for several reasons, such as patient safety concerns, feasibility issues, or incomplete documents. 

The aim of the IRB is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of human subjects participating in a research study.  Never collect data until after you have received clearance from the IRB.

There are three levels of IRB review: Exempt, Expedited, and Full committee review. Additional information/explanation of these categories is given below. Note that the level of review that is titled Exempt does not mean that the proposed research is exempt from being reviewed (or submitted to the IRB). Instead, it is one of three possible levels of review to which research is assigned, and this assignment is made by an IRB official. Below is a description of each level:

Exempt Level of Review

There are six specific categories of research that qualify for exempt status (for details, refer to Code of Federal Regulations. Title 45 Public Welfare. DHHS. Part 46. Protection of Human Subjects. Subpart A, Section 46.101 (b)). Typically, studies that qualify for Exempt status (1) involve no more than minimal risk, (2) do not include protected populations (pregnant women, prisoners, minors, institutionalized patients, and/or fetuses) and (3) preclude the gathering or use of identifiable information. Some IRBs expand the list of protected populations to include mentally impaired persons, persons unable to legally consent, and homeless persons.

Studies that qualify for Exempt status must meet at least one of the following categories:

• Normal educational practices and settings
• Anonymous educational tests, surveys, interviews, or observations
• Identifiable subjects in special circumstances
• Collection or study of existing data
• Public benefit or service programs
• Taste and food evaluation and acceptance studies

Expedited Level of Review

This type of review is reserved for studies that involve no more than minimal risk. Such reviews can be conducted by the following persons or a combination of these persons: IRB Chair, IRB members designated by the Chair, or a subcommittee of the IRB. 45 CFR 46 §46.102 defines minimal risk as follows: “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in the daily life or during performance of routine physical or psychological examinations or tests.”

Full Committee Review

Other than those specifically listed above (studies that qualify for Exempt and Expedited levels of review), all research studies are subject to a full committee review.

OU-COM Students

• First, be SURE to complete and submit a CORE Short Form for each and every project you are involved with. This simple step will register your project(s) with the CORE Research Office.
• In most cases, you will be required to complete IRB training. An online training module is available (at no charge). Once you complete the required modules (bio-medical only), print several copies of your completion certificate and send one to the CORE Research Office.
• Several factors will determine the correct path of IRB review for your project:
• Your year of study (MS-I, MS-II, MS-III of MS IV)
• Your location (CORE site/hospital assignment or Athens campus)
• Location of the proposed research project (hospital, private office, campus, etc.)
• Type of study being proposed (retrospective, prospective, meta-analysis, etc.)
• Number and location of all research sites
• Allow adequate time for the IRB process. Depending on the specifics of your project, this process can take several months. Typically, student-based projects are subject to review at the hospital where the student is assigned as well as at Ohio University. OUCOM does not have its own IRB (nor does the CORE). However, once you register your project with the CORE Research Office, staff personnel will help guide you through the IRB process.
• Please do NOT submit research materials to any IRB without first contacting the CORE Research Office.

OU Required Documents

This information is applicable ONLY if you are required to submit materials to the Ohio University IRB.

• IRB Training Module (Required for ALL OU-related research that involves human subject participants)
• Guidelines for Review of Research Involving Human Subjects
  PDF (Portable Document format) (viewer)
  MS Word Format (Help/Instructions for completing the OU IRB Project Outline form)
• OU IRB Project Outline Form (Required for submission to the OU IRB)
  PDF (Portable Document format) (viewer)
  MS Word Format
• IRB Periodic Review Form (Applicable only for continued, previously approved research)
  PDF (Portable Document format) (viewer)
  MS Word Format
• IRB Adverse Event Reporting Form (to be used when reporting adverse events to the OU IRB)
  PDF (Portable Document format) (viewer)
  MS Word Format
• OU-COM checklist (Required for submission to the OU IRB)