Preparing an Initial Submission

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.

IRB Submission Steps

The IRB has templates, guidance documents, and other resources available for preparing your IRB submission. Please use the information under “Researcher Resources” and in the steps below to prepare your submission.

To request a consultation with HSPPO staff, please contact the IRB Analyst for your study type (exempt, expedited, full board) or email hsppofc@louisville.edu for guidance.

Human subjects research requires review by the IRB. This is research that involves interacting with participants or with their identifiable data and/or specimens. This includes interacting with participants remotely (e.g. survey research). Human subjects research may fall under three different categories: Exempt Review, Expedited Review, or Full Committee review if the project does not fit under an exempt or expedited review category. Studies that require Full Committee review should be submitted two weeks prior to the meeting date. 

The following examples may be activities that are not considered human subjects research. 

  • If you believe your project is NOT human subjects research and would like an official determination from the IRB office, you can prepare a written protocol/project description and submit it following Step 5 below. Select “Non-Human Subjects Research Application” in iRIS. The IRB will review the protocol and send a letter indicating whether or not the project meets the definition of human subjects research. Examples of this would be:
  • Case reports by University of Louisville definition are medical information collected and presented on up to five patients to highlight an interesting treatment, presentation, or outcome. They generally result from retrospective review of the medical record. In this regard, case reports differ from research in which data are collected with intent to evaluate a specific hypothesis. Case reports must be submitted to the IRB for acknowledgement based on local policy. Case Reports are covered on page 85 of the HSPPO Policy Manual. Follow Step 5 below and select the “Case Report” application in iRIS. The written case report must be attached to the submission in iRIS.

Step 1: Prepare your research protocol.

Step 2: Determine the informed consent process to be used.

  • Signed informed consent – Required for research that is greater than minimal risk. Generally required for research with interventions.
  • Unsigned informed consent (aka preamble) - Used for minimal risk research that meets specific criteria outlined in the regulations. Generally used for survey, focus group, and interview research but can be used in other scenarios as deemed appropriate by the IRB.
  • Waiver/alteration of informed consent - Used for minimal risk research where it’s not practical to obtain consent and specific criteria in the regulations are met. Generally used for research using retrospective data and/or specimens. This request is made in the IRB application form. No additional templates or forms are needed.
  • Assent form - if the study involves participants between the ages of 7-17 an assent form is needed.

Step 3: Does the study involve viewing or collecting protected health information?

  • If you  are using a signed consent form (discussed in Step 2) the IRB template consent form includes a HIPAA Research Authorization. This gives the researcher permission to utilize protected health information for the study as described in the document.
  • If you need to view or collect protected health information prior to obtaining informed consent/HIPAA Research Authorization from research participants, a HIPAA partial waiver is needed. This is generally used when you need to screen medical records to identify potential participants to approach for the study.
  • If you have requested a waiver of consent for minimal risk research utilizing PHI, a HIPAA complete waiver request is needed. This is used when it’s not practical to obtain consent and a signed HIPAA research authorization from participants. This is generally used for research using retrospective data and/or specimen.

Step 4: Ensure your research team members have completed all of the requirements under “Before you Begin.”

Step 5: Prepare your IRB submission in iRIS:

Login to https://iris.louisville.edu

Under “Study Assistant”

  • Click “add a new study”
  • Click “IRB Application”

Follow the instructions in the IRB application form. The questions will branch based on your responses.

When you complete the iRIS IRB application you will be able to upload your consent forms and other study documents.

Step 6: Submitting your study to the IRB and routing it to the appropriate individuals:

All initial submissions must be signed off by the principal investigator. You do not need to include sub-investigators or co-investigators in the final signoff. Future submissions on the study can be submitted the IRB by anyone on the study team.

For full board, expedited, and exempt research the department assigned Scientific and Scholarly Merit Reviewer and Department Chair must sign off on the study in iRIS. This information is entered in the IRIS application, section 3.4. If your departmental signoff is responsible for signing off in both roles then enter their name and from the drop down box choose “Scientific Reviewer/Department chair”.  If you have two departmental signoffs, please first enter the “Scientific Reviewer” and then the “Department Chair”.  Specific instructions for routing your application to the appropriate individuals can be found here.

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.

FDA - EXPANDED ACCESS, EMERGENCY USE, HUMANITARIAN USE (HUD)

Expanded Access is when investigational drugs, biologics, or devices are made available, under certain circumstances, to treat patient(s) with a serious disease or condition who cannot participate in a clinical trial. Expanded Access can be permitted by the FDA for individuals, intermediate size groups or widespread treatment, each under specific criteria. [21 CFR 312.300 (Subpart I)]

“Compassionate Use” has commonly been used to refer to expanded access. The term ‘Compassionate Use’ is used in the FDA guidance for Single Patient/Small Group Access to a device.

All Expanded Access, except Emergency Use, requires prior IRB review and approval.

DRUGS

Prior approval from the FDA is required (either a new IND or a protocol amendment to an existing IND).

DEVICES

The sponsor should submit an IDE supplement to the FDA requesting approval for a protocol deviation.

DRUGS

Submit IND safety reports promptly, and annual reports if the protocol continues for one year or longer.

DEVICES

Sponsor must submit semi-annual progress reports to the FDA until the filing of a marketing application. After filing, progress reports must be submitted annually [21 CFR 812.150(b)(5)].

Use of an investigational article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval [21 CFR 56.102(d)].

Contact the sponsor to obtain permission to use and obtain test article.

Contact FDA for DRUGS

Emergency use may be requested by telephone, facsimile, or other means of electronic communications.

DEVICES

No prior approval from FDA is required for shipment or emergency use of investigational devices.

IRB

Emergency Use is exempt from prior IRB review and approval, provided it is reported to the IRB within 5 working days after the use. Contact IRB if you have any questions.

IRB:

Must be reported to the IRB within 5 working days after the use:

FDA:
Drugs: Physician or sponsor must submit a new IND, or amendment to an existing IND, within 15 working days of FDA’s authorization of the use. Clearly mark “Emergency IND” on top of Form 1571.

Devices with IDE:

Sponsor is responsible to report the use after receiving sufficient information from the physician.

Devices with no IDE: Physician must report the use within 5 working days.

A device intended to benefit patients by treating or diagnosing a disease or condition affecting fewer than 4,000 individuals in the United States per year.