Overview of the Lake Erie College of Osteopathic Medicine Procedures for Review of Research Projects Involving Human Subjects

All research projects of LECOM employees and students must be reviewed and approved if they involve the creation of generalizable knowledge about the intrinsic properties of human beings. A clear boundary between intrinsic and extrinsic properties does not exist, but the matter includes most information of which a person becomes aware as a result of the experiences of life. Most oral history, for example, is not human subject research. The requirement for project review bears no relationship to whether a project is or is not externally funded.

The research that is the concern of the federal regulations is defined as “a systematic investigation … designed to develop or contribute to generalizable knowledge." A human subject is “a living individual about whom an investigator … conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. Intervention includes both physical procedures … and manipulations of the subject’s environment … for research purposes.” Interaction involves communication of information. It may be verbal or non-verbal, oral or signed, written or tape recorded. Project review is required when the above definitions of research and human subject are both met.

The project director bears the responsibility for determining if a project needs review. However, the definitions do not provide black and white distinctions. A flow chart is available at Is it Human Subjects? which may be helpful in your determination. If you are uncertain, it is best to contact the LECOM Office of Research. It is the project director’s responsibility to make an informed judgment.

A project, including pilot studies, may not proceed without approval. The following is a summary of the steps by which a project receives approval.

1. All personnel conducting human subject research must complete the Collaborative IRB Initiative (CITI) on-line human subject research course. Each discipline (clinical trial, social/psychological, health sciences) will be required to complete specific modules. You must submit your Certificate of Completion with your study proposal. The Principal Investigator or Project Director should ensure that all key personnel have completed the training prior to submitting the proposal or continuing review. Students whose projects are classified as exempt will not need to complete the CITI training, although their advisors will need to complete the training and turn in their certificate along with their student’s proposal. You can register for the CITI course at www.citiprogram.org.
2. Obtain or download fro the web site the New Study Submission Form or Exempt Application. Completion of this form involves obtaining signatures including that of the dean of your school or college. The completed application is forwarded to the LECOM Office of Research, on the Erie Campus. If the application is forwarded electronically, the signed original of the first page of the approval request form must also be provided before final approval will be granted. Check lists, sample consent forms, and other guidance are also available at the web site.
3. Your project will be given preliminary administrative review and you may receive a telephone or e-mail response if this review indicates that revisions or clarifications will be needed to secure approval. There are three levels of review, exempt review, expedited review, and review by the Human Subject Committee in Erie.
4. Exempt review and approval are provided administratively. Expedited review and approval are provided by the IRB chair or another experienced IRB member. When a project involves more than minimal risk, it must be reviewed and approved by the IRB. Exempt review and approval is often completed in two or three days, expedited review in a week. The IRB meets monthly and full board proposals are due two weeks before the meeting. Approval within three weeks may be expected if all questions can be resolved as a result of one meeting.
5. When all required changes have been made and confirmed by the Chair or Primary/Secondary reviewer, a letter of approval and a signed approval form are created and forwarded to the project director or to the advisor in the case of a student project. The project director may be notified by e-mail prior to the creation of the approval letter and form. He or she may proceed with exempt and expedited projects on receipt of such communication, but is to await the formal documents for projects requiring full IRB review. Funding agencies may require copies of the approval documents.
6. A report form is forwarded with the approval documents. It is also available on the web. Approval of a project can be for no more than a year. When a project will take more than a year, it must be given review for continuance. The report form must be filed in a timely fashion to avoid interruptions of multiyear projects. For IRB-approved projects, this form must be filed a month to six weeks prior to the expiration of approval. When the approval period has expired, the project is no longer approved and may not proceed except as cessation would endanger subjects. The Project Closure Form is used for filing the final report. The final report is best filed as soon as all subject contact is completed unless the data analysis may require re-contact of subjects.