Understanding the IRB Process
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Transcript of Understanding the IRB Process
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Understanding the IRB Process
University of Tennessee Health Science Center Institutional Review Board
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Overview
UTHSC IRB application What happens after you submit your application
Types of IRB reviews PI Response Form How to track your application
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IRB Application Process
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IRB Application
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IRB Application
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IRB Application
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IRB ApplicationExempt Expedited Full Board
Minimal Risk Minimal Risk More than minimal risk
Retrospective Chart Reviews
Collection of blood samples by finger, heel stick, ear stick or venipuncture
Research that involves the use of an unapproved drug
Surveys/Interviews with non-vulnerable populations that includes non-sensitive data
Prospective collection of biological specimens for research purposes by non-invasive means
Research that involves the use of an unapproved device
Analyzing Census Data
Research involving materials that have been or will be collected for non-research purposes
Research on two different teaching strategies
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IRB Application
The application will guide you through the required sections depending on the type of research you are conducting;
Be sure to click Save and Continue to Next Section to save your responses and move to the next section of questions in the application;
Required questions of the application will be marked with an *; If you forget to respond to a question the system will send you a prompt; If you are unsure about a question, please contact the IRB office; Once you have completed the electronic application, the system will
prompt you in the Routing Form to upload any study documents (informed consent form, protocol, questionnaires, etc).
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Routing Application for Signatures
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Routing Application for Signatures
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Routing Application for Signatures
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Routing Application for Signatures
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IRB Receives Submission
IRB assigns IRB Analyst IRB assigns reviewer(s) for submissions requesting
exempt or expedited review IRB assigns a submission to an upcoming IRB
meeting if the submission requires review by the full convened IRB
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Institutional Review Boards
HHS Regulations (45 CFR 46) apply to research conducted by or supported by NIH
FDA Regulations (21 CFR parts 50, 56, 312, and 812) apply to research of unapproved drugs and devices
HIPAA Regulations (45 CFR parts 160 and 164)
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IRB Review
Selection of subjects is equitable Risks to subjects are minimized Risks are reasonable in respect to the anticipated
benefits Informed consent will be secured from subject or
LAR
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IRB Review
Informed Consent will be properly documented Data will be monitored to ensure safety of subjects Adequate provisions are made to protect subject
privacy and confidentiality Appropriate additional safeguards are used to
protect vulnerable subjects
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Federal Regulations for Vulnerable Populations
Pregnant Women and Fetuses Children Prisoners
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IRB Review Process –Exempt & Expedited
Applications
IRB issues an approval letter, an administrative provisos or a deferral letter
IRB Analyst may return application prior to review by Board member to request additional information or ask
for clarification
Applications are assigned to an IRB Analyst and an experienced Board member(s) to review
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IRB Review Process – Full Board Review
IRB issues an approval letter, an administrative proviso letter, a deferral letter, or a disapproval letter
Investigator presents study to the full convened IRB
Researcher returns the PI Response Form to the IRB office before the meeting
PI Response Form sent to investigators to address pre-review recommendations
Applications are assigned to 1-2 Board members for review
Applications are assigned to an IRB Analyst and a meeting agenda
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PI Response Form
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PI Response Form
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PI Response Form
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PI Response Form
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Tracking Your Application
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Tracking Your Application
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Tracking Your Application
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Tracking Your Application
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Tracking Your Application
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IRB Websitehttp://www.uthsc.edu/research/research_compliance/IRB/
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IRB Websitehttp://www.uthsc.edu/research/research_compliance/IRB/guide
s.php