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. (revised 04-09-2018)

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


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.

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.


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:

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. (revised 04-09-2018)

Department NameDepartment ChairScientific Reviewer
Office of Provost-Ideas to ActionPayette, PattyRhodes, Gale
Vice Provost for Div & Eq OppTaylor-Archer, MordeanTaylor-Archer, Mordean
Provost-Delphi CenterRhodes, GaleRhodes, Gale
Provost-Under Graduate AffMeyer, NicoleMeyer, Nicole
Exec VPR - ResearchMcClain, CraigMcClain, Craig
Exec VPRI - KIESDBarnett, RussBarnett, Russ
VPSA-Career Development CenterErickson, LeslyeErickson, Leslye
LIB - AdminFox, RobertFox, Robert
LIB - Oral HistoryK'Meyer, TracyK'Meyer, Tracy
A&S Air Force ROTCSmekrud, Mark PerrySmekrud, Mark Perry
A&S AnthropologyHaws, JonathanTillquist, Christopher
A&S BiologyFell, RonaldFell, Ronald
A&S ChemistryGrapperhaus, CraigGrapperhaus, Craig
A&S CommunicationFutrell, Allan W.Futrell, Allan W.
A&S Community EngagementHall, DanielHall, Daniel
A&S Comparative HumanitiesHall, AnnHall, Ann
A&S Criminal JusticeVito, GennaroVito, Gennaro
A&S EnglishRidley, GlynisRidley, Glynis
A&S Fine ArtsMassey, Scott L.Massey, Scott L.
A&S Geography/GeosciencesWalker, MargathWalker, Margath
A&S HistoryBeattie, BlakeBeattie, Blake
A&S MathematicsRiedel, ThomasRiedel, Thomas
A&S Modern LanguagesLeidner, Alan C.Leidner, Alan C.
A&S Pan African StudiesJones, RickyJones, Ricky
A&S PhilosophyOwen, DavidOwen, David
A&S Physics and AstronomyJayanthi, Chakram S.Jayanthi, Chakram S.
A&S Political ScienceFarrier, JasmineFarrier, Jasmine
A&S PsychologyMeeks, SuzanneMast, Benjamin
A&S SociologySchroeder, RyanSchroeder, Ryan
A&S Theatre ArtsGawley, KevinGawley, Kevin
A&S Urban & Public AffairsSimpson, DavidSimpson, David
A&S Women's & Gender StudiesPecknold, DianePecknold, Diane
Spd-Bio-EngineeringKoenig, Stephen C.Koenig, Stephen C.
Spd-Chemical EngineeringFried, JoelFried, Joel
Spd-Civil & Environmental EngSun, ZhihuiSun, Zhihui
Spd-Comp Eng. & Comp Sci.Elmaghraby, Adel S.Elmaghraby, Adel S.
Spd-Elec & Computer Eng.Alphenaar, Bruce W.Alphenaar, Bruce W.
Spd-Eng. FundamentalsRalston, PatriciaRalston, Patricia
Spd-Industrial EngineeringAlexander, Suraj M.Alexander, Suraj M.
Spd-Mechanical EngineeringMurphy, KevinMurphy, Kevin
COB-AccountancyStout, WilliamFredriksson, Per
COB-CIS - Comp Info SysBarker, RobertFredriksson, Per
COB-EconomicsVahaly, JohnFredriksson, Per
COB-EntrepreneurshipClouse,Van G.H.Fredriksson, Per
COB-EquinePendingFredriksson, Per
COB-FinanceBrandi, JayFredriksson, Per
COB-ManagementBoyd, LynnFredriksson, Per
COB-MarketingRaju, P.S.Fredriksson, Per
ED-Dean AdministrationLandrum, TimothyLandrum, Timothy
ED-Academic SupportLandrum, TimothyLandrum, Timothy
ED-Leadership, Evaluation and Organizational DevelopmentSun, JeffreyChoi, Namok
ED-Early Childhood & Elementary EduFlint, AmyFlint, Amy
ED-Education Counsel PsychLeach, MarkValentine, Jeffrey
ED-Health and Sports SciencesCaruso, JohnCaruso, John
ED-Middle & Secondary EducationThomas, ShellyThomas, Shelly
ED-Special EducationLandrum, TimothyLandrum, Timothy
Kent School AdminCollins-Camargo, CrystalCollins-Camargo, Crystal
Joint PhD in Social WorkCollins-Camargo, CrystalCollins-Camargo, Crystal
Music AdministrationAmchin, RobertWalworth, Darcy D.
SIGS AdministrationDeMarco, PaulDeMarco, Paul
Campus Health ServicesBressoud, PhillipBressoud, Phillip
Dent - AdminBradley, ThomasSauk, John J.
Dent - General Dentistry and Oral MedicineMetz, MichaelMetz, Michael
Dent - Oral Health and RehabGrant, GeraldGrant, GeraldDent - Ortho, Ped, & Spec CareSilveira, AnibalSilveira, AnibalDent - Perio, Endo & Dent HygHill, MargaretHill, MargaretDent - Surgical & HospitalKushner, GeorgeKushner, GeorgeSCHOOL OF LAWDuncan, SusanCross, JohnSCHOOL OF MEDICINEMedicine - Dean's OfficeShaw, MonicaShaw, MonicaMedicine - Dean’s Office-Community Engagement & DiversityDunn, Kelli BullardDunn, Kelli BullardAHES-HSCJones, VeronnieDavis, DeborahAnatomical Science/NeurobiolgyGuido, WilliamGuido, WilliamAnesthesiologyBoswell, Mark V.Boswell, Mark V.Biochemistry & Molecular BiologyGregg, Ronald G.Gregg, Ronald G.Cancer CenterRoman, JesseMiller, Donald M.Cardiovascular and Thoracic SurgerySlaughter, MarkAustin, ErieDiagnostic RadiologyReed, James C.Reed, James C.Emergency MedicineDanzl, DanielDanzl, DanielFamily and Geriatric MedicineHarper, Diane M.Harper, Diane M.Institute for Cellular TheraputicsIldstad, Suzanne T.Ildstad, Suzanne T.Institute for Sustainable Health and Optimal AgingFaul, AnnaFaul, AnnaMed- ChairmanLederer, EleanorLederer, EleanorMed-CardiologyRittenhouse, JamieGhafgazi, ShahabMed-DermatologyRittenhouse, JamieCallen, Jeffrey P.Med-EndocrinologyRittenhouse, JamieWinters, StephenMed-GastroenterologyHepatology & NutritionRittenhouse, JamieMcClain, Craig J.Med-General Internal MedicineRittenhouse, JamieCasper, BarbaraMed-Infectious DiseasesRittenhouse, JamieRamirez, Julio A.Med-Nephrology (Renal)Lederer, EleanorBrier, MichaelMed-Office of Diversity and InclusionJones, FayeJones, FayeMed-OncologyRittenhouse, JamieMiller, Donald M.Med-PulmonaryRittenhouse, JamiePerez, TamraMed-RheumatologyRittenhouse, JamieRoberts, WilliamMed-U of L Bone Marrow TransRittenhouse, JamieMiller, DonaldMicrobiologyEgilmez, NejatAlard, PascaleNeurological SurgeryWhittemore, ScottWhittemore, ScottNeurologyRemmel, KerriRemmel, KerriOb/Gyn Admin SupportFrances, SeanLei, ZhenminOphthalmology/Visual SciencesKaplan, Henry J.Shao, HuiOrthopedic SurgeryRoberts, CraigSeligson, DavidOtolaryngology and Communicative DisordersBumpous, JeffCash, LizPathologyHattab, Eyas M.Lehman, NormanPediatrics-AdminRabalais, GerardPendingPeds-Adolescent MedicineSchikler, KenBerkenbosch, JohnPeds-AllergyMcCubbin, AdrianaSullivan, JanicePeds-CardiologyHolland, BrianKeller, Brad-if he is the PI then Janice Sullivan MDPeds-Child Development UnitDavis, DebbieSullivan, JanicePeds-Child Evaluation CenterHersh, JosephSullivan, JanicePeds-Child Psychiatry and PsychologyJosephson, AllanSullivan, JanicePeds-Critical CareMontgomery, VickiSullivan, JanicePeds-EndocrinologyWintergerst, KupperSullivan, JanicePeds-Emergency DepartmentStevenson, MichelleCaperell, KerryPeds-Forensic MedicineCurrie, MelissaCurrie, Melissa-if she is the PI then Janice Sullivan MDPeds-GastroenterologyStephen, ThomasSullivan, JanicePeds-General PediatricsLiu, GilKurbasic, MirzadaPeds-Hematology/Oncology (*COG)Raj, AshokSullivan, JanicePeds-Hematology/Oncology (*Non-COG)Raj, AshokSullivan, JanicePeds-Hospitalist/General InpatientGrill, JeffreyCondurache, C. TaniaPeds-Infectious DiseasesMarshall, GaryMarshall, Gary-if he is the PI then Charles Woods MDPeds-InternationalRodgers, GeorgeCondurache, C. TaniaPeds-KCPCRUSullivan, JaniceBerkenbosch, John-if he is the PI then Janice Sullivan MDPeds-MedEdBoland, KimberlyBoland, KimberlyPeds-NeonatalologyDuncan, ScottStewart, Dan-if he is the PI then Janice SullivanPeds-NephrologyHarrison, HaroldSullivan, JanicePeds-PathologyDebski, RobertDebski, RobertPeds-PulmonologyEid, NemrSullivan, JanicePeds-Research InstituteCai, LuEpstein, Paul N.Peds-RheumatologySchikler, KenBerkenbosch, JohnPeds-Sleep MedicineEgambaram, SenthilvelSullivan, JanicePharmacologyHein, DavidArteel, GavinPhysiologyJoshua, Irving G.Joshua, Irving G.Psych-Chair's Office & AdminCasey, David A.Casey, David A.Radiation OncologyWoo, ShiaWoo, ShiaSurgeryMcMasters, Kelly M.McMasters, Kelly M.Surgery - GeneralMcMasters, Kelly M.Richardson, J. DavidSurgery - PediatricMcMasters, Kelly M.Fallat, Mary ElizabethSurgery - PlasticMcMasters, Kelly M.Wilhelmi, BradonSurgery - OncologyMcMasters, Kelly M.Martin, Robert C.Surgery - VascularMcMasters, Kelly M.Dwivedi, AmitSurgery - HandMcMasters, Kelly M.Kutz, JosephUrologyAnkem, Murali K.Ankem, Murali K.SCHOOL OF NURSINGNursing AdministrationHern, MarciaHall, Lynne A.SCH OF PUBL HLTH & INFO SCIPublic Health & Information SciencesBlakely, Craig H.McKinney, WilliamEpidemiology & Population HealthBaumgartner, Richard N.Baumgartner, Richard N.Bioinformatics & BiostatisticsKulasekara, KarunarathnaKulasekara, KarunarathnaHealth Promotions and Behavioral SciWilson, RichardWilson, RichardEnvironmental & Occupational Hlth SciHoyle, GaryHoyle, GaryHealth Management & Systems SciJohnson, ChrisJohnson, ChrisKENTUCKYONE HEALTH FACILITIES If UofL faculty are Pis, UofL Department Chair &
Scientific Reviewer Signatures must be selected
For studies being conducted by hospital staff only, internal SSMR review will be accepted as a paper form attached to the IRB submission.Jewish Hospital & St. Mary's Hospital-KyOne HealthCopeland, StephanieJHSMH-K1H-Frazier RehabCopeland, StephanieJHSMH-K1H-Jewish HospitalCopeland, StephanieJHSMH-K1H-JH Med Ctr EastCopeland, StephanieJHSMH-K1H-JH Med Ctr NECopeland, StephanieJHSMH-K1H-JH Med Ctr SouthCopeland, StephanieJHSMH-K1H-JH-Med Ctr SWCopeland, StephanieJHSMH-K1H-JH Outpatient CtrCopeland, StephanieJHSMH-K1H-JH Rudd Heart LungCopeland, StephanieJHSMH-K1H-JH-Med Ctr SWCopeland, StephanieJHSMH-K1H-JH ShelbyvilleCopeland, StephanieJHSMH-K1H-Our Lady of PeaceCopeland, StephanieJHSMH-K1H-Sts Mary & ElizabethCopeland, StephanieJHSMH-K1H-St Mary Surgery CtrCopeland, StephanieJHSMH-K1H-Health Resource CtrCopeland, StephanieJHSMH-K1H-So Indiana RehabCopeland, StephanieJHSMH-K1H-Taylor Regional HospCopeland, StephanieJHSMH-K1H-VNA Nazareth HomeCopeland, StephanieJHSMH-K1H-Jewish Hospital MeadeCopeland, StephanieJHSMH-K1H-Hand CareCopeland, StephanieJHSMH-K1H-OtherCopeland, StephanieUniversity Medical CenterUniversity of Louisville Hospital-KyOne HealthHooper, MistyULH-CCBHooper, MistyULH-J. G. Brown Cancer CenterHooper, MistyULH-HCOC ServicesHooper, MistyULH-OtherHooper, MistyNORTON HEALTHCARE FACILITIES Rhonda HoffmanNHF-Norton HospitalRhonda HoffmanNHF-Norton Childrens HospitalRhonda HoffmanNHF-Norton Audubon HospitalRhonda HoffmanNHF-Norton Bornwsboro HospitalRhonda HoffmanNHF-Women's & KCH St MatthewsRhonda HoffmanNHF-Norton BrownsboroRhonda HoffmanNHF-Space leased by UL in NHFRhonda HoffmanNHF-Norton Physician PracticesRhonda HoffmanNHF-OtherRhonda Hoffman


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.



When you submit the study, the status will change from DRAFT to PENDING – SUBMITTED FOR INITIAL REVIEW.  If the status doesn’t change from DRAFT, your study has not been submitted to the IRB for review.

Be sure to watch for IRB comments. IRB staff may contact you by email or phone to obtain further information or to inform you of IRB questions/comments that require you to submit a response.  Please check your email daily for IRB comments during the month your protocol is being reviewed. Approval of your project may be delayed if responses to comments are not received promptly.

The iRIS system is the IRB Electronic Submission System and should be accessed for information on current protocols.

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.

PIs must maintain appropriate study oversight, as described in HRPP Policy Ch. 15 Investigator Compliance.


All proposed changes to approved research must be prospectively reviewed and approved by the IRB, (except where necessary to eliminate apparent immediate hazards to subjects).

Certain events and circumstances (for non-Exempt human subject research) must be promptly reported to the IRB. See HRPP Chapter 15 or review the Event Reporting Tab on the HSPPO Website.

The Principal Investigator is responsible for ensuring that (non-Exempt) protocols continuing with human subjects are submitted for continuing review and approval by the IRB before the expiration date of the protocols, and in sufficient time to ensure the non-interruption of studies.

The expiration date is the last day that the protocol is approved (that is, the investigator may conduct research on the expiration date itself, but may not on the next day unless the IRB has approved renewal of the protocol following continuing review).

Researchers are alerted about an expiring protocol two months in advance by an iRIS-generated notice, with a second reminder approximately one month later.
If no continuing review application has been received, an expiration notice is sent out within three business days of the protocol expiration; to keep the protocol active, a continuing review application must be submitted immediately.

It may closed by the IRB due to non-compliance by the Principal Investigator if no response is received within 10 days of lapse of approval. The PI may ask the IRB staff to perform an ‘administrative closure’ or may contact the IRB to discuss options available.


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.


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


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


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


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.


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


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.


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

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.