All Lakeland Community College (LCC) research using living human subjects, or samples or data, obtained from them, directly or indirectly, with or without their consent, must either be approved in advance by LCC's Institutional Review Board (IRB), or be found to meet narrow criteria for exemption from IRB oversight by the IRB. This Form will help the Primary Investigator (PI) to determine if the project is likely to meet the criteria for exemption, present the case for an exemption, and document the decision on the request.
NOTE: A determination of Exempt status does not release the researcher from exercising prudent practice in protecting the interests of research subjects. Exempt or not, the project must be conducted in a manner consistent with the Ethical Principles and Guidelines for the Protection of Human Subjects (The Belmont Report)
IRB applications for research protocols that fall into the appropriate exempt categories will be reviewed by the IRB Chair, or the Chair's Designee when appropriate. Exempt IRB applications are reviewed as they are submitted and usually take three weeks for feedback from the IRB. Turn-around time largely depends on the investigator's response time to the IRB's request for clarification or revision.
Please review and complete questions. If at any time in this reading process it becomes clear to you that your human subjects research protocol does not meet the requirements for exemption, STOP and contact the chair for the Expedited or Full IRB Application form appropriate to the risk level of your research.
You may not start your research until you receive a written communication from the LCC IRB confirming that the research meets exemption criteria.
Please complete the following questions. If you answer YES to any of the questions A through C below, STOP and contact Dr. Karen A. Reed, Interim Associate Provost for Teaching and Learning, at kreed37@lakelandcc.edu. If you answer NO to all questions A through C below, continue to complete this claim of exemption packet. Required questions are marked with an asterisk (*).
(1)Harm to subjects means that any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or can be damaging to the subjects' financial standing, employability, or reputation.
(2)Existing data means the items exist before the research was proposed or was collected prior to the research for a purpose other than the proposed research.