Log Off
Instructions:

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.


Please Remember:

You may not start your research until you receive a written communication from the LCC IRB confirming that the research meets exemption criteria.


Step 1 - EXEMPT SCREENING QUESTIONS

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 (*).

     
    A. For research involving special populations, interventions or manipulations
     
    1. Does your research involve pregnant women, fetuses, prisoners or the mentally ill or incapacitated? *
    Yes
    No
     
    2. Does your research involve using survey or interview procedures with children, minors < 18 years old? *
    Yes
    No
     
    3. Does your research involve the observation of children in settings where the investigator(s) will participate in the activities being observed? *
    Yes
    No
     
    B. For research using survey procedures, interview procedures, observational procedures and questionnaires (Note: Exemption is not allowed in surveys or interviews with children.)
     
    1. If data are to be recorded by audiotape or videotape is there potential harm(1) to subjects if the information is revealed or disclosed? *
    Yes
    No
     
    2. If the subjects are to be identifiable either by name or through demographic data, is there potential harm to participants if the information is revealed? *
    Yes
    No
     
    3. Will collection include sensitive data (e.g. illegal activities, or sensitive themes such as sexual orientation, sexual behavior, undesirable work behavior, or other data that may be painful or very embarrassing to reveal, such as death of a family member, memories of physical abuse? *
    Yes
    No
     
    C. For research using existing or archived data(2), documents, records, or specimens only
     
    1. Will any data, documents, records or specimens be collected from subjects after the submission of this application? *
    Yes
    No
     
    2. If the data, documents, records, or specimens are originally labeled in such a manner that subjects can be identified, directly or indirectly through identifying links, is the investigator recording the data in such a manner that subjects can be identified, directly or indirectly through identifying links (i.e., demographic information that might reasonable lead to the identification of individual subjects – name, phone number; or any code number that can be used to link the investigator’s data to the source record – medical record number or hospital admission number? *
    Yes
    No

 

(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.

© Lakeland Community College