IRB Approval
IRB Approval
If you plan to do any human subjects research (obtaining specimens or data through intervention or interaction with living participants or their identifiable private information), it must be reviewed and approved by an IRB (Institutional Review Board). An IRB is a review body established to protect rights and welfare of human subjects recruited to participate in biomedical or behavioral/social science research. You must submit both your initial study for approval as well as any modifications before implementing them; certain studies are also subject to continuing (or annual) reviews depending on the nature of the research and its associated risks.
The purpose of the IRB is to ensure that investigators are adequately performing their responsibilities of assuring protection of participants’ rights and safety through 1) adequate design and conduct of research and 2) oversight of all research processes/procedures and research personnel involved.
If you plan to serve as personnel on a study involving human subjects, you should first complete human subjects training. The easiest way is to do the Human Research Protection Program (HRPP) training in Oracle (search “HRPP Basic Module”). This will teach you about the most important requirements for human subjects research and how to apply for IRB approval, and it is required for any key personnel listed on an IRB study. You will have to renew your training every 3 years.
You must apply for IRB approval BEFORE conducting human subjects research, through the Vanderbilt IRB portal. Generally, your PI will be the PI on the IRB, and you might be listed as other key study personnel. It is possible for a student to serve as PI on an IRB, but they must have a faculty advisor and their department chair must still sign off on it. There are a few categories of human subjects research that require varying degrees of IRB approval, and the first step to approval is figuring out which category your study falls under.
The categories are as follows:
Exempt: The study is exempt from the requirement that it receives full or expedited IRB review.
● Requires submission of request for exemption
● You can find the categories of exemption here: https://www.vumc.org/irb/exempt-categories-effective-january-19-2019
● Exemption will not apply to studies which have interventions, collect biospecimens, link to personally identifiable data, or involve vulnerable populations (except few instances regarding educational studies in children in the classroom)
● Limited IRB Review is required for some categories of exemption to ensure that provisions are in place to protect privacy of subjects and maintain confidentiality of data
○ Conducted using expedited review mechanisms (see below)
Expedited review: Research is minimal risk (probability and magnitude of harm or discomfort anticipated are not greater than those ordinarily encountered in daily life or during performance of routine physical or psychological examinations or tests).
● Generally, studies qualifying for expedited review do not require continuing review
● Examples:
○ Drugs and medical devices for which IND is not required or IDE is not required
○ Collection of blood samples by stick (the specific volumes and frequency allowed are dependent on participant size and age)
○ Prospective collection of biological specimens for research by noninvasive means
○ Data collection through noninvasive procedures routinely employed in clinical practice
○ Research on materials previously collected
○ Data collection through voice and video mechanisms
○ Behavior surveys
Full committee IRB review: Required for everything deemed greater than minimal risk.
Regardless of type of review, you must provide these documents to committee:
KSP (key study personnel) and human subjects protection training
● Information about the individuals performing the study and their roles
● Input info on IRB application
Research application (including COI statement)
● Information about the study purpose, activities, and risks
● Input info on IRB application
Protocol
● More specific information about the study activities, risks, and participants
● Sample protocols for health sciences and behavioral studies: https://www.vumc.org/irb/tool-kit
● Document you upload
● Here is what is required in the protocol (for health sciences):
Investigator's brochure (drug studies)
Consent and assent forms
● These are the forms you will use to consent participants
● Sample ones located here: https://www.vumc.org/irb/applications-and-consents
● Document you upload
● NOTE: Consenting can be done on paper, in-person or electronically. If you go the electronic route, consent forms can be made nicely in RedCap, along with surveys to collect participant info if relevant to your study
Advertisement and recruitment materials
● Any flyers or emails you will send to recruit participants must be approved
● Documents you upload
Data collection tools (surveys)
● Documents you upload
Grant applications
Sometimes required:
● Study related info provided to participants (reminders, instructions, etc.)
● Supporting documents for FDA regulated products
● Letters of support
● Adverse event, protocol deviation, safety report
In addition to submitting an IRB application for your study, you must also submit any amendments (changes) to the IRB before implementing them and might need to do yearly updates (not required for expedited, minimal risk studies). You will also be required to report back to the IRB how many people you enroll and will be responsible for maintaining records for at least 3 years from the date that the IRB is closed (longer for certain types of data). Here is the link to the full VUMC IRB Policies document, which may be a helpful reference guide for any specific questions.
