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Understanding the IRB Process

University of Tennessee Health Science Center Institutional Review Board

Overview

UTHSC IRB application

What happens after you submit your application

Types of IRB reviews

PI Response Form

How to track your application

IRB Application Process

IRB Application

IRB Application

IRB Application

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

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).

Routing Application for Signatures

Routing Application for Signatures

Routing Application for Signatures

Routing Application for Signatures

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

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)

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

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

Federal Regulations for Vulnerable Populations

Pregnant Women and Fetuses

Children

Prisoners

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

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

PI Response Form

PI Response Form

PI Response Form

PI Response Form

Tracking Your Application

Tracking Your Application

Tracking Your Application

Tracking Your Application

Tracking Your Application

IRB Websitehttp://www.uthsc.edu/research/research_compliance/IRB/

IRB Websitehttp://www.uthsc.edu/research/research_compliance/IRB/guide

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