Initial Submissions

The following is a list of people designated as "Department Chairperson Signature" and "Scientific/Scholarly Merit Reviewer Signature" for each department/division. iRIS allows for 2 signatures per department or division. The first signature is the person who performs the Scientific or Scholarly Merit Review. The Second signature is the Department Chairperson or someone designated by the Department Chairperson to sign off for the department. For studies being conducted by hospital staff only, internal SSMR review will be accepted as a paper form attached to the IRB submission. Please review the list of the SSMR Department Chairs (Excel) frequently as it may be updated.

The IRB’s primary concerns in the review of research are that:

  • risks are minimized for participants and are reasonable when compared to benefits to the individual and/or to society;
  • participant selection is equitable so that the benefits and burdens of research are equitably shared;
  • privacy and confidentiality are protected; and
  • participants are adequately informed of what their participation will entail so that they can make an informed decision about whether to participate.

IRB Submission Standards

The IRB has minimum submission standards that must be met in order for your study to be assigned to a reviewer. Please review the IRB submission standards and initial submission checklist

BEFORE SUBMITTING A PROTOCOL

Studies that meet the definition of Human Subject Research (HSR) must be submitted to the IRB and must receive IRB approval before any study activities take place. This document may assist you in determining whether your study meets the definition. For additional information on certain student projects, pilot studies, oral history projects, or quality assessment/quality improvement projects, see:

For help in determining whether your project requires HSR approval, call the HSPPO at 502-852-5188.

A pilot study is a preliminary investigation of the feasibility of the study which would not contribute to generalizable knowledge and therefore is not considered research. However, if the researcher plans to use the pilot data for research purposes, IRB review is required.

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The University of Louisville supports a wide range of both undergraduate and graduate student research projects using human subjects – from course-related research exercises to Ph.D. dissertation studies. The University of Louisville IRBs require a student to have a faculty mentor serve as the PI on their human subjects research submission.  The student can then be listed as the Co-PI for the study.

Student protocols must have the departmental Scientific and Scholarly Merit review completed within the iRIS system. Additionally, the department chair is required to sign off as well. This routing is done within the iRIS system and help documents are available if needed.

SUBMITTING A PROTOCOL

Biomedical Protocols

Conducted by personnel within, or conducted through, the School of Medicine (SOM), the School of Dentistry (SOD), or otherwise involving any medical procedure or use of personally identifiable health information are submitted on the Biomedical protocol application.

SBE - Nonmedical Protocols

For research not being conducted by personnel within, or conducted through, the SOM, SOD or the hospitals (e.g., protocols from the Schools of Education, Engineering, Physical Sciences, Humanities, Law and Business) are submitted on the Nonmedical protocol application.

A protocol is a written description of the research an investigator intends to conduct. The information provided in the IRB Application is a summary of the information provided in the protocol. It’s very important that the information provided in the IRB Application is consistent with the study protocol. Know which areas should be addressed in the protocol to describe what the investigator intends to do [PDF file].

Before starting an iRIS application, investigators must identify the appropriate Review Type. This determines which questions are prompted within the application.

Exempt review

Studies meeting specific criteria (pdf). These studies are exempted from IRB continuing review - not from initial review. The IRB determines whether the claim for exemption is appropriate and whether it will be granted. Exemption from IRB continuing review continues unless the protocol is to be modified such that it no longer will meet the criteria for exemption.

Expedited review

Minimal risk studies meeting specific criteria (pdf). Protocols are generally reviewed by one primary IRB reviewer. Protocols approved under Expedited review are subject to IRB continuing review.

Regular “convened” review

Protocols that involve more than minimal risk or do not meet the criteria for Exempt or Expedited. They are reviewed at a convened IRB meeting. Examples of protocols requiring initial regular review are studies using FDA investigational test articles, randomized double-blind placebo-controlled studies, Phase I, II, III and IV clinical trials, and studies using x-rays and other significant risk devices.

There are six types of initial submission applications within the iRIS system:

APPLICATION TYPE
USED FOR
IRB Application
New Biomedical or SBE studies. The application routes based on whether the study is biomedical in nature or social behavioral education research.
Case Report
Generally medical information collected and presented on three to five patients to highlight an interesting treatment, presentation, or outcome.
Emergency Use (EU)
An Emergency Use application would be submitted by a physician who wishes to use an investigational drug or device on a patient for whom the physician feels this is the best course of treatment. Although not considered research, the IRB must review and acknowledge the request for EU.
IRB Authorization Agreement (IAA)
An IAA is an agreement signed between two institutions to allow one of the IRBs to be the IRB of Record for the study. An IAA application is submitted when another institution will be the IRB of Record.
Not Human Subjects Research (NHSR)
An NHSR application is submitted to the IRB to allow for review of a project that the PI believes to be NHSR. A determination is made through the IRB office and an official determination of NHSR is sent to the PI.

The following is a list of people designated as "Department Chairperson Signature" and "Scientific/Scholarly Merit Reviewer Signature" for each department/division. iRIS allows for 2 signatures per department or division. The first signature is the person who performs the Scientific or Scholarly Merit Review. The Second signature is the Department Chairperson or someone designated by the Department Chairperson to sign off for the department. For studies being conducted by hospital staff only, internal SSMR review will be accepted as a paper form attached to the IRB submission. Please review the list of the SSMR Department Chairs (Excel) frequently as it may be updated.

CONSENT

FDA-regulated research

FDA regulations do not provide for a waiver or alteration of the informed consent process; the only exceptions to the informed consent requirements are for clearly defined circumstances of emergency use of a test article, and waivers granted for planned emergency research.

Non-FDA-regulated research

The IRB may approve a:

  • Waiver/Alteration of consent or a
  • Waiver of Documentation (signature requirement) if the research meets regulatory criteria.

 

Investigators are encouraged to recruit and include all segments of the community in research, including individuals whose primary language is not English. A general requirement for informed consent is that the 'information that is given to the subject or the representative shall be in a language understandable to the subject or the representative' [45 CFR 46.116 21; CFR 50.20].

When all of the participants in a study (i.e., the target population) are anticipated to be non-English speaking, a full translated consent is strongly encouraged. Use of the short form consent process and documents requires prior IRB approval.

Generally, a child 7 - 17 years old should sign an assent form.

CLINICALTRIALS.GOV

AFTER SUBMITTING A PROTOCOL

NO. WAIT for IRB Approval! You may not begin your project until you have been notified of the IRB's approval. The IRB process takes about a month to review a new protocol, depending on the review type. Be sure to allow time for the IRB to review and approve your protocol before you begin your research.

Under no circumstances should you interpret a lack of communication from the IRB as an approval. You can view your protocol status in the iRIS system by logging in, clicking on STUDY ASSISTANT, and looking at MY STUDIES.

Additionally, if your research is taking place in a hospital facility (e.g. Kentucky One Health, Norton’s Healthcare) you are required to get study clearance from their research office before you begin your research.