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 (revised 02-10-17).

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.

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 (revised 02-10-17).

Department NameDepartment ChairScientific Reviewer
SignoffSignoff
PROVOST
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
EXECUTIVE VPRI - Research
Exec VPRI - ResearchMcClain, CraigMcClain, Craig
Exec VPRI - KIESDBarnett, RussBarnett, Russ
VICE PRESIDENT FOR STUDENT AFFAIRS
VPSA-Career Development CenterErickson, LeslyeErickson, Leslye
LIBRARY
LIB - AdminFox, RobertFox, Robert
LIB - Oral HistoryK'Meyer, TracyK'Meyer, Tracy
ARTS & SCIENCES
A&S Air Force ROTCSmekrud, Mark PerrySmekrud, Mark Perry
A&S AnthropologyHaws, JonathanTillquist, Christopher
A&S BiologyFell, RonaldFell, Ronald
A&S ChemistryWittebort, Richard J.Wittebort, Richard J.
A&S CommunicationFutrell, Allan W.Futrell, Allan W.
A&S Community EngagementHall, DanielHall, Daniel
A&S EnglishRidley, GlynisRidley, Glynis
A&S Fine ArtsChan, Ying KitChan, Ying Kit
A&S Geography/GeosciencesHanchett, Carol L.Hanchett, Carol L.
A&S HistoryK'Meyer, TracyK'Meyer, Tracy
A&S HumanitiesWise, Elaine O.Wise, Elaine O.
A&S Justice AdministrationVito, GennaroVito, Gennaro
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 PhysicsChalmers, Joseph S.Chalmers, Joseph S.
A&S Political SciencePayne, RodgerPayne, Rodger
A&S Psych & Brain SciencesMeeks, SuzanneMast, Benjamin
A&S SociologySchroeder, RyanSchroeder, Ryan
A&S Theatre ArtsVandenbroucke, Russell J.Vandenbroucke, Russell J.
A&S Urban & Public AffairsSimpson, DavidSimpson, David
A&S Women's & Gender StudiesTheriot, NancyTheriot, Nancy
SPEED SCHOOL OF ENGINEERING
Spd-Bio-EngineeringKoenig, Stephen C.Koenig, Stephen C.
Spd-Chemical EngineeringFried, JoelFried, Joel
Spd-Civil & Environmental EngMohsen, Jafar P.Mohsen, Jafar P.
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
COLLEGE OF BUSINESS
COB-AccountancyStout, WilliamFredriksson, Per
COB-CIS - Comp Info SysBarker, RobertFredriksson, Per
COB-EconomicsVahaly, JohnFredriksson, Per
COB-EntrepreneurshipClouse,Van G.H.Fredriksson, Per
COB-EquineCapps, TimFredriksson, Per
COB-FinanceSiegel, FrederickFredriksson, Per
COB-ManagementBoyd, LynnFredriksson, Per
COB-MarketingRaju, P.S.Fredriksson, Per
COLLEGE OF ED & HUMAN DEV
ED-Dean AdministrationScott, TerryScott, Terry
ED-Academic SupportScott, TerryScott, Terry
ED-Leadership, Evaluation and Organizational DevelopmentSun, JeffreyChoi, Namok
ED-Early Childhood & Elementary EduFlint, AmyFlint, Amy
ED-Education Counsel PsychLeach, MarkSnyder, Katie
ED-Health and Sports SciencesCaruso, JohnCaruso, John
ED-Middle & Secondary EducationBrooks, PeggyBay-Willlians, Jennifer
ED-Special EducationLandrum, TimothyLandrum, Timothy
KENT SCHOOL
Kent School AdminCollins-Camargo, CrystalCollins-Camargo, Crystal
Joint PhD in Social WorkCollins-Camargo, CrystalCollins-Camargo, Crystal
SCHOOL OF MUSIC
Music AdministrationAmchin, RobertWalworth, Darcy D.
SIGS
SIGS AdministrationDeMarco, PaulDeMarco, Paul
EXECUTIVE VICE PRESIDENT FOR HEALTH AFFAIRS
Campus Health ServicesBressoud, PhillipBressoud, Phillip
DENTISTRY
Dent - AdminSauk, John J.Sauk, John J.
Dent - General Dentistry and Oral MedicineMetz, MichaelMetz, Michael
Dent - Mol. Cell & Cranio BiolGreene, Robert M.Greene, Robert M.
Dent - Oral Health and RehabGrant, GeraldGrant, Gerald
Dent - Ortho, Ped, & GeriatricSilveira, AnibalSilveira, Anibal
Dent - Perio, Endo & Dent HygHill, MargaretHill, Margaret
Dent - Surgical & HospitalAlpert, BrianAlpert, Brian
SCHOOL OF LAWDuncan, SusanCross, John
SCHOOL OF MEDICINE
Medicine - Dean's OfficeShaw, Monica A.Shaw, Monica A.
Medicine - Dean’s Office-Community Engagement & DiversityDunn, Kelli BullardDunn, Kelli Bullard
AHES-HSCJones, Veronnie FayeRowland, Michael
Anatomical Science/NeurobiolgyGuido, WilliamGuido, William
AnesthesiologyBoswell, Mark V.Boswell, Mark V.
Biochemistry & Molecular BiologyGregg, Ronald G.Gregg, Ronald G.
Cancer CenterRoman, JesseMiller, Donald M.
Cardiovascular and Thoracic SurgerySlaughter, MarkAustin, Earl
Diagnostic RadiologyReed, James C.Reed, James C.
Emergency MedicineDanzl, DanielDanzl, Daniel
Family 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, Anna
Med- ChairmanRoman, JesseRoman, Jesse
Med-Cardiovascular MedicineRoman, JesseGhafgazi, Shahab
Med-DermatologyRoman, JesseCallen, Jeffrey P.
Med-Endocrinology, Metabolism & DiabetesRoman, JesseWinters, Stephen
Med-GastroenterologyHepatology & NutritionRoman, JesseMcClain, Craig J.
Med-General Internal Medicine, Palliative Medicine & Medical EducationRoman, JesseCasper, Barbara
Med-Infectious DiseasesRoman, JesseRamirez, Julio A.
Med-Nephrology (Renal)Lederer, EleanorBrier, Michael
Med-Office of Diversity and InclusionJones, FayeJones, Faye
Med-OncologyRoman, JesseMiller, Donald M.
Med-Pulmonary, Critical Care, Sleep Disorders MedicineRoman, JessePerez, Tamra
Med-RheumatologyRoman, JesseRoberts, Neil
Med-U of L Bone Marrow TransRoman, JesseMiller, Donald
Microbiology & ImmunologyEgilmez, NejatAlard, Pascale
Neurological SurgeryNeimat, JosephNeimat, Joseph
NeurologyRemmel, KerryRemmel, Kerry
Obstetrics, Gynecology & Women's HealthFrances, SeanLei, Zhenmin
Ophthalmology/Visual SciencesKaplan, Henry J.Shao, Hui
Orthopedic SurgeryRoberts, CraigSeligson, David
Otolaryngology and Communicative DisordersBumpous, JeffCash, Liz
Pathology & Laboratory MedicineHattab, Eyas M.Elin, Ronald
Pediatrics-AdminRabalais, Gerard P.
Peds-Adolescent MedicineSchikler, KenBerkenbosch, John
Peds-Allergy and ImmunologyLee, GeraldSullivan, Janice
Peds-CardiologyJohnsrude, ChristopherKeller, Brad-if he is the PI then Janice Sullivan MD
Peds-Child Development UnitDavis, DebbieSullivan, Janice
Peds-Child Evaluation CenterHersh, JosephSullivan, Janice
Peds-Child Psychiatry and PsychologyJosephson, AllanSullivan, Janice
Peds-Critical CareMontgomery, VickiSullivan, Janice
Peds-EndocrinologyWintergerst, KupperSullivan, Janice
Peds-Emergency DepartmentStevenson, MichelleStevenson, Michelle
Peds-Forensic MedicineCurrie, MelissaCurrie, Melissa-if she is the PI then Janice Sullivan MD
Peds-GastroenterologyStephen, ThomasSullivan, Janice
Peds-General PediatricsLiu, GilKurbasic, Mirzada
Peds-Hematology/Oncology (*COG)Raj, AshokSullivan, Janice (for both COG and non-COG protocols)
Peds-Hematology/Oncology (*Non-COG)Raj, AshokSullivan, Janice
Peds-Hospitalist/General InpatientGrill, JeffreyCondurache, C. Tania
Peds-Infectious DiseasesMarshall, GaryMarshall, Gary-if he is the PI then Charles Woods MD
Peds-InternationalRodgers, GeorgeCondurache, C. Tania
Peds-KCPCRU/Pharmacology and ToxicolgySullivan, JaniceBerkenbosch, John-if he is the PI then Janice Sullivan MD
Peds-MedEd (4211501723)Boland, KimberlyBoland, Kimberly
Peds-NeonatalologyDuncan, ScottStewart, Dan-if he is the PI then Janice Sullivan
Peds-NephrologyHarrison, HaroldSullivan, Janice
Peds-PathologyDebski, RobertDebski, Robert
Peds-PulmonologyEid, NemrSullivan, Janice
Peds-Research InstituteCai, LuEpstein, Paul N.
Peds-RheumatologySchikler, KenBerkenbosch, John
Peds-Sleep MedicineEgambaram, SenthilvelSullivan, Janice
Pharmacology & ToxicologyHein, DavidArteel, Gavin
Physiology & BiophysicsJoshua, Irving G.Joshua, Irving G.
Psych-Chair's Office & AdminCasey, David A.Casey, David A.
Radiation OncologyMezera, MeganMezera, Megan
SurgeryMcMasters, Kelly M.McMasters, Kelly M.
Surgery - General SurgeryMcMasters, Kelly M.Richardson, J. David
Surgery - Pediatric SurgeryMcMasters, Kelly M.Fallat, Mary Elizabeth
Surgery - Plastic & ReconstructiveMcMasters, Kelly M.Wilhelmi, Bradon
Surgery - Surgical OncologyMcMasters, Kelly M.Martin, Robert C.
Surgery - VascularMcMasters, Kelly M.Dwivedi, Amit
Surgery - HandMcMasters, Kelly M.Kutz, Joseph
UrologyAnkem, Murali K.Ankem, Murali K.
SCHOOL OF NURSING
Nursing AdministrationHern, MarciaHall, Lynne A.
SCH OF PUBL HLTH & INFO SCI
Public Health & Information SciencesBlakely, Craig H.McKinney, William
Epidemiology & Population HealthBaumgartner, Richard N.Baumgartner, Richard N.
Bioinformatics & BiostatisticsKulasekara, KarunarathnaKulasekara, Karunarathna
Health Promotions and Behavioral SciWilson, RichardWilson, Richard
Environmental & Occupational Hlth SciHoyle, GaryHoyle, Gary
Health Management & Systems SciJohnson, ChrisJohnson, Chris
KENTUCKYONE HEALTH FACILITIES If UofL faculty are Pis, UofL Department Chair &
Scientific Reviewer Signatures must be selected
Jewish Hospital & St. Mary's Hospital-KyOne HealthThomas, Rebecca
JHSMH-K1H-Frazier RehabThomas, Rebecca
JHSMH-K1H-Jewish HospitalThomas, Rebecca
JHSMH-K1H-JH Med Ctr EastThomas, Rebecca
JHSMH-K1H-JH Med Ctr NEThomas, Rebecca
JHSMH-K1H-JH Med Ctr SouthThomas, Rebecca
JHSMH-K1H-JH-Med Ctr SWThomas, Rebecca
JHSMH-K1H-JH Outpatient CtrThomas, Rebecca
JHSMH-K1H-JH Rudd Heart LungThomas, Rebecca
JHSMH-K1H-JH-Med Ctr SWThomas, Rebecca
JHSMH-K1H-JH ShelbyvilleThomas, Rebecca
JHSMH-K1H-Our Lady of PeaceThomas, Rebecca
JHSMH-K1H-Sts Mary & ElizabethThomas, Rebecca
JHSMH-K1H-St Mary Surgery CtrThomas, Rebecca
JHSMH-K1H-Health Resource CtrThomas, Rebecca
JHSMH-K1H-So Indiana RehabThomas, Rebecca
JHSMH-K1H-Taylor Regional HospThomas, Rebecca
JHSMH-K1H-VNA Nazareth HomeThomas, Rebecca
JHSMH-K1H-Jewish Hospital MeadeThomas, Rebecca
JHSMH-K1H-Hand CareThomas, Rebecca
JHSMH-K1H-OtherThomas, Rebecca
University Medical Center
University of Louisville Hospital-KyOne HealthHooper, Misty
ULH-CCBHooper, Misty
ULH-J. G. Brown Cancer CenterHooper, Misty
ULH-HCOC ServicesHooper, Misty
ULH-OtherHooper, Misty
NORTON HEALTHCARE FACILITIES Rhonda Hoffman
NHF-Norton HospitalRhonda Hoffman
NHF-Norton Childrens HospitalRhonda Hoffman
NHF-Norton Audubon HospitalRhonda Hoffman
NHF-Norton Bornwsboro HospitalRhonda Hoffman
NHF-Women's & KCH St MatthewsRhonda Hoffman
NHF-Norton BrownsboroRhonda Hoffman
NHF-Space leased by UL in NHFRhonda Hoffman
NHF-Norton Physician PracticesRhonda Hoffman
NHF-OtherRhonda Hoffman

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

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.

CHANGES TO APPROVED PROTOCOLS

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.

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.