 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

ExemptExpeditedFull Board 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 DataResearch 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

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

Tracking Your Application

IRB Website

IRB Website