Institutional Review Board (IRB)
What Is an IRB
An IRB is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in human subject research. It protects human subjects who participate in observational or experimental studies or whose personal information will be examined by researchers. The IRB also protects researchers by preventing them from engaging in activities that could cause harm. The IRB legally protects the research institution from the liability that could occur because of research activities. By federal law, all human subjects research must be submitted for review to the IRB.
Larkin Health System IRB
Larkin Community Hospital has an established IRB Committee. Members of the community as well as the hospital serve on this committee. A draft calendar has been provided as a guide but please confirm exact dates with the department of research. The committee meets no less than quarterly to review IRB protocols. To ensure compliance with the FDA, an IRB manual has been developed which formalizes the operational process for all IRB research protocols done within the Larkin Health System. Please review the applicable section of the IRB Manual for specific questions or contact the department of research and academic affairs directly via email at irb@larkinhospital.com.
IRB Forms
Larkin’s IRB uses different forms to document compliance with all applicable laws, regulations and guidelines. All forms are incorporated herein by reference. Investigators should contact the research department to resolve any questions on completing any of the forms.
LCH IRB Meeting Agenda and Minutes
LCH IRB Protocol Submission Form
LCH Adult Informed Consent Form
LCH Spanish Adult Informed Consent Form
LCH Parental Consent Form (ENG)
LCH Adolescent Assent Form (ENG)
LCH Conflict of Interest Declaration
LCH Request For Determination (RFD) Form
LCH Application for Modification of Approved Research
LCH Translation Certification Form
LCH Annual Continuation-Study Closure Report
How to Submit a Research Protocol
Once you have completed the Research Submission Form, it will be reviewed to determine if the protocol involves Human Subjects Research. If it does, you will be notified that your study needs IRB review.
At that time, to comply with federal regulations and with IRB guidelines, the Principal Investigator (PI) of the protocol is required to complete the following items: IRB Submission Form, Informed Consent Form)s) as well as copies of all research instruments such as questionnaires, survey’s, interviews, etc. After completion of these documents, submit this IRB submission packet to the Department of Research and Academic Affairs at irb@larkinhospital.com.
The submission packet will be reviewed for accuracy and completeness. It will then be scheduled for IRB review at the next upcoming IRB committee meeting. Please note that the IRB meets no less than quarterly and you cannot proceed with your research protocol until after it has been approved by the IRB. Please plan so that your approval does not conflict with your research project implementation plan.
IRB Actions
The IRB can take several actions regarding review of your protocol. These include: exempt from review, expedited review or Full IRB review. The IRB reserves the right to postpone review of protocols at convened meetings due to incompleteness or needed revisions. A brief description of these actions is included below for reference.
- Exempt: Includes reviews of existing data collections, specimens, documents as long as the patient data is not identifiable. It is reviewed by the IRB Chair or designated official.
- Expedited: Involves minimal risk of harm or discomfort is no more than encountered in daily life, routine physical exam, or psychological exam. Clinical studies of drugs and medical devices when research is not a new drug application, or device is cleared for marketing and is in accordance with approved label use. Data collection noninvasive procedures employed in routine clinical practice. Materials collected solely for research purposes. Continuing review of previously done research investigation. Carried out by the IRB chair or designee.
- Full IRB Review: When IRB determines risk is more than minimal, chair disapproves the research. When research is not complete within one year.
