Application Questionnaire: Faculty members, staff members, and students planning research projects involving human subjects are responsible for beginning the review process by submitting the necessary paperwork to Julie Paterson, Senior Compliance Coordinator. Any Project(s) involving the use of Human Subjects in research – whether funded or unfunded – require specific approval and sign-off by the appropriate LMU committee: the Institutional Review Board (IRB).
Human Subjects Research is defined as any activity intended to obtain and record information from or about individuals for research purposes. This includes both direct contact with a subject and indirect contact, such as analysis of subject data. Please follow the process below for submitting all IRB applications. For your application to be reviewed, all components must be present. Please submit the required documents in the order listed below to: Julie Paterson, Senior Compliance Coordinator, Institutional Review Board Office, University Hall, Suite 1718, firstname.lastname@example.org, 310-258-5465.
Application materials must be received by the 1st of the month to be considered for review at that month’s meeting. Please note that it may take up to four (4) weeks to process, review, and render a decision on your protocol. Please do not staple any items included in your IRB Application materials. Please submit single sided copies only. Please call or email the Senior Compliance Coordinator with questions: email@example.com, 310-258-5465.
Please note: As of January 21, 2019 all researchers must use the new Informed Consent Form template provided below, and in the "Forms" section. Please discard any other versions of this template and use the most current version. There are now templates provided for Parent Permission and Child Assent as well.
1. IRB Application Cover Sheet
• Please fill out all fields.
• Check any box that applies to your study.
• Fill in the field stating what you plan to do with your study results.
• Obtain all required signatures.
• Click here for Application Cover Page.
2. Human Subjects Research Protections Certification
• Please complete the Collaborative Institutional Training Initiative (CITI) offers a very popular Protection of Human Subjects CITI Course.
The National Institutes of Health (NIH) offers Protecting Human Research Participants (PHRP) NIH PHRP Online Course. It is also accepted. Please click on the link to register for and complete the certification course.
• Attach your Certificate of Completion to the application packet.
• If you previously completed one of these courses, attach your certificate to subsequent applications. Certifications are valid for five (5) years from date of issue.
• If you are a student, you and your faculty advisor must both submit a CITI or NIH certificate of completion.
• Statement on RCR training: National Science Foundation (NSF) funded projects only.
3. Application Submission Questionnaire
• Please complete the Application Submission Questionnaire.
• For all questions that are not pertinent to your study, write “N/A.”
4. Informed Consent Form
• As indicated in the IRB Application Questionnaire, please attach the Informed Consent Form altered to suit your study.
• This form is only a template and is invalid without information particular to your research.
5. Human Subjects Bill of Rights
• All Human Subjects must be given the Experimental Subjects Bill of Rights.
• Please read this document and include a copy in your application packet.
6. Additional Attachments
• As indicated in the Application Submission Questionnaire, if you are planning on administering surveys or questionnaires include these in your application packet.
• Please also include a selected bibliography of references relevant to your study.
7. Renewal Applications
• Please submit a fresh Cover Page with the proper signatures.
• Summarize your research activities during the previous granting period: the number of subjects studied and any adverse reactions encountered; benefits derived; difficulty obtaining subjects or in obtaining informed consent; and approximate number of subjects required to complete the study.
If your study is to be conducted off-site, IRB approval or a letter of permission with your IRB application from the host institution is required and must be must be included. The letter of permission be on official letterhead, signed by the head of the institution, and include a brief description of the participant population, a summary of the research to take place, and information about when and where the data will be gathered.