Magaret, Craig A. http://orcid.org/0000-0002-5056-2664
Li, Li http://orcid.org/0000-0002-7112-9309
deCamp, Allan C. http://orcid.org/0000-0003-1404-4322
Rolland, Morgane http://orcid.org/0000-0003-3650-8490
Juraska, Michal http://orcid.org/0000-0002-0920-2915
Williamson, Brian D. http://orcid.org/0000-0002-7024-548X
Ludwig, James http://orcid.org/0000-0003-3500-3490
Molitor, Cindy
Benkeser, David http://orcid.org/0000-0002-1019-8343
Luedtke, Alex
Simpkins, Brian http://orcid.org/0009-0002-1044-0053
Heng, Fei http://orcid.org/0000-0002-6701-7873
Sun, Yanqing http://orcid.org/0000-0002-3140-4572
Carpp, Lindsay N. http://orcid.org/0000-0003-0333-5925
Bai, Hongjun http://orcid.org/0000-0002-3501-3974
Dearlove, Bethany L. http://orcid.org/0000-0003-3653-4592
Giorgi, Elena E.
Jongeneelen, Mandy
Brandenburg, Boerries
McCallum, Matthew http://orcid.org/0000-0001-8398-8330
Bowen, John E.
Veesler, David http://orcid.org/0000-0002-6019-8675
Sadoff, Jerald http://orcid.org/0000-0002-4839-3013
Gray, Glenda E.
Roels, Sanne
Vandebosch, An
Stieh, Daniel J. http://orcid.org/0009-0003-8523-1528
Le Gars, Mathieu
Vingerhoets, Johan http://orcid.org/0000-0001-5939-9501
Grinsztejn, Beatriz
Goepfert, Paul A. http://orcid.org/0000-0001-8441-5737
de Sousa, Leonardo Paiva http://orcid.org/0000-0001-9004-5154
Silva, Mayara Secco Torres
Casapia, Martin http://orcid.org/0000-0002-5972-0948
Losso, Marcelo H. http://orcid.org/0000-0002-4273-4833
Little, Susan J. http://orcid.org/0000-0002-7645-9737
Gaur, Aditya
Bekker, Linda-Gail http://orcid.org/0000-0002-0755-4386
Garrett, Nigel http://orcid.org/0000-0002-4530-234X
Truyers, Carla
Van Dromme, Ilse
Swann, Edith
Marovich, Mary A.
Follmann, Dean http://orcid.org/0000-0003-4073-0393
Neuzil, Kathleen M. http://orcid.org/0000-0001-9480-2714
Corey, Lawrence http://orcid.org/0000-0002-2179-2436
Greninger, Alexander L. http://orcid.org/0000-0002-7443-0527
Roychoudhury, Pavitra http://orcid.org/0000-0002-4567-8232
Hyrien, Ollivier
Gilbert, Peter B. http://orcid.org/0000-0002-2662-9427
Article History
Received: 16 May 2023
Accepted: 29 February 2024
First Online: 11 March 2024
Competing interests
: ALG reports contract testing from Abbott, Cepheid, Novavax, Pfizer, Janssen, and Hologic and research support from Gilead and Merck. JS declares support for the submitted work from the Janssen Pharmaceutical Companies of Johnson & Johnson and partial support (in the form of funding to his institution) from BARDA for the submitted work, declares support within the past 36 months from the Janssen Pharmaceutical Companies of Johnson & Johnson and BARDA funding for part of this work, has patents (US 11,384,122 B2) on invention of the Janssen COVID-19 vaccine, and has Johnson & Johnson stock and stock options. SR had partial support from the Department of Health and Human Services BARDA (in the form of contract payments to his institution) for the submitted work, has stock and/or stock options in Johnson & Johnson, and is an employee of Janssen Pharmaceutica NV. AV had partial support from BARDA (in the form of contract payments to her institution) for the submitted work, had all patent rights (US 11,384,122 B2) transferred to Johnson & Johnson, has stock and/or stock options in Johnson & Johnson, and is an employee of Janssen Pharmaceutica NV. DJS had partial support from the Department of Health and Human Services BARDA (in the form of contract payments to his institution) for the submitted work, has stock and/or stock options in Johnson & Johnson, and is an employee of Janssen. MLG had partial support from BARDA (in the form of contract payments to his institution) for the submitted work, has patents (US 11,384,122 B2) on the invention of the Janssen COVID-19 vaccine, has shares in Johnson & Johnson, and is an employee of Johnson & Johnson. JV has stock and stock options in Johnson and Johnson and is an employee of Janssen Pharmaceutica NV. CT and IVD both had partial support from BARDA (in the form of contract payments to their institution) for the submitted work, hold stock in Janssen Pharmaceuticals, and are employees of Janssen Pharmaceutica NV. BB and MJ have been partially supported by the Department of Health and Human Services BARDA (under the agreement HHSO100201700018C) for the submitted work, have stock and/or stock options in Johnson & Johnson, and are employees of Janssen Vaccine and Prevention B.V. No other authors have competing interests.
: The COV3001 (ENSEMBLE) study was reviewed and approved by the following local ethics committees and IRBs: <b>Argentina:</b> ANMAT—Administración Nacional de Medicamentos, Alimentos y Tecnologia Médica (Capital Federal, La Plata, Ramos Mejia—Buenos Aires; Ciudad Autonoma de Buenos Aires), Comite de Etica Dr Carlos Barclay (Capital Federal, Buenos Aires; Ciudad Autonoma de Buenos Aires), Comision Conjunta de Investigacion en Salud—CCIS (La Plata, Ramos Mejia–Buenos Aires), Comite de Bioetica de Fundacion Huesped (Ciudad Autonoma de Buenos Aires), Comité de Docencia e Investigación DIM Clínica Privada (Ramos Mejia, Buenos Aires), Comité de Ética en Investigación Clínica y Maternidad Suizo Argentina (Ciudad Autonoma de Buenos Aires), Comité de Ética en Investigación de CEMIC (Ciudad Autonoma de Buenos Aires), Comite de Etica en Investigacion DIM Clinica Privada (Ramos Mejia, Buenos Aires), Comite de Etica Hospital Italiano de La Plata (La Plata, Buenos Aires), Comite de Etiica en Investigacion Hospital General de Agudos J.M. Ramos Mejia (Ciudad Autonoma de Buenos Aires), Comitéde ética del Instituto Médico Platense (CEDIMP) (La Plata, Buenos Aires), IBC Fundacion Huesped (Ciudad Autonoma de Buenos Aires), IBC Helios Salud (Ciudad Autonoma de Buenos Aires), IBC Hospital General de Agudos J.M. Ramos Mejia (Ciudad Autonoma de Buenos Aires): <b>Brazil:</b> ANVISA—Agência Nacional de Vigilância Sanitária (Salvador, Bahia; Barretos, Campinas, São Paulo, São Jose Rio Preto, Ribeirão Preto, São Caetano do Sul—São Paulo; Santa Maria, Porto Alegre—Rio Grande do Sul; Natal, Rio Grande do Norte; Para, Pará; Belo Horizonte, Minas Gerais; Rio de Janeiro, Nova Iguaçu—Rio de Janeiro; Curitiba, Paraná; Brasília, Distrito Federal; Campo Grande, Mato Grosso do Sul; Criciúma, Santa Catarina; Cuiabá, Mato Grosso), CONEP—Comissão Nacional de Ética em Pesquisa (Salvador, Bahia; São Paulo, São Paulo; Santa Maria, Rio Grande do Sul; Para, Pará;), CAPPESq—Comissão de Ética de Análise para Projetos de Pesquisa—HCFMUSP (São Paulo, São Paulo), CEP da Faculdade de Medicina de São José do Rio Preto—FAMERP (São Jose Rio Preto, São Paulo), CEP da Faculdade de Medicina do ABC/SP (São Paulo, São Paulo), CEP da Fundação Pio XII—Hospital do Câncer de Barretos/SP (Barretos, São Paulo), CEP da Liga Norteriograndense Contra o Câncer (Natal, Rio Grande do Norte), CEP da Pontificia Universidade Catolica de Campinas/PUC Campinas (Campinas, São Paulo), CEP da Real Benemérita Associaçao Portuguesa de Beneficência—Hospital São Joaquim (São Paulo, São Paulo), CEP da Santa Casa de Misericórdia de Belo Horizonte (Belo Horizonte, Minas Gerais), CEP da Secretaria Municipal De Saúde do Rio de Janeiro—SMS/RJ (Rio de Janeiro, Rio de Janeiro), CEP da Universidade de São Caetano do Sul (CEP da Universidade de São Caetano do Sul, São Paulo), CEP da Universidade Federal de Mato Grosso do Sul—UFMS (Campo Grande, Mato Grosso do Sul), CEP da Universidade Federal de Minas Gerais (Belo Horizonte, Minas Gerais), CEP do Centro de Referência e Treinamento DST/AIDS (São Paulo, São Paulo), CEP do do INI-Ipec/Fiocruz (Rio de Janeiro, Rio de Janeiro), CEP do Grupo Hospitalar Conceição/RS (Porto Alegre, Rio Grande do Sul), CEP do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto/USP (Ribeirão Preto, São Paulo), CEP do Hospital de Clinicas da Universidade Federal do Parana—HCUFPR/PR (Curitiba, Paraná), CEP do Hospital de Clínicas de Porto Alegre/HCPA (Porto Alegre, Rio Grande do Sul), CEP do Hospital Geral de Nova Iguaçu (Nova Iguaçu, Rio do Janeiro), CEP do Hospital Municipal São José (Criciúma, Santa Catarina), CEP do Hospital Pró-Cardíaco/RJ (Rio de Janeiro, Rio de Janeiro), CEP do Hospital Sírio Libanês (São Paulo, Sao Paulo), CEP do Hospital Universitário Júlio Muller / MT (Cuiabá, Mato Grosso), CEP do Hospital Universitário Professor Edgard Santos—UFBA (Salvador, Bahia), CEP do Instituto de Cardiologia do Distrito Federal (Brasília, Distrito Federal), CEP do Instituto de Infectologia Emílio Ribas/SP (São Paulo, Sao Paulo), CEP do Instituto de Saude e Bem Estar da Mulher—ISBEM/SP (São Paulo, Sao Paulo), CEP em Seres Humanos do HFSE—Hospital Federal dos Servidores do Estado (Rio de Janeiro, Rio de Janeiro), CONEP—Comissão Nacional de Ética em Pesquisa (Brasília, Distrito Federal, Salvador, Bahia; Belo Horizonte, Minas Gerais; Cuiabá, Mato Grosso; Campo Grande, Mato Grosso do Sul; Nova Iguaçu, Rio Janeiro—Rio Janeiro; Barretos, Campinas, Sao Jose Rio Preto, São Caetano do Sul, Sao Paulo, Ribeirão Preto—Sao Paulo; Porto Alegre, Rio Grande do Sul; Natal, Rio Grande do Norte; Curitiba, Paraná; Criciúma, Santa Catarina): <b>Chile:</b> Comité de Ética de Investigación en Seres Humanos (Santiago, Region Met), Comité Ético Científico Servicio de Salud Metropolitano Central (Santiago, Region Met), Instituto de Salud Pública de Chile (Santiago, Region Met; Talca, Temuco), Comité Ético-Científico Servicio de Salud Metropolitano Sur Oriente (Talca, Santiago), Comité de Evaluación Ética Científica Servicio de Salud Araucanía Sur Temuco (Temuco), Comité Ético Científico Servicio de Salud Metropolitano Central (Viña del Mar): <b>Colombia:</b> CEI de la Fundación Cardiovascular de Colombia (Floridablanca), Comité de Ética en Investigación Clínica de la Costa (Barranquilla), INVIMA—Instituto Nacional de Vigilancia de Medicamentos y Alimentos (Colombia) (Barranquilla), Comite de Etica en Investigacion de la E.S.E. Hospital Mental de Antioquia (Santa Marta), Comite de Etica en la Investigacion CAIMED (Bogotá), INVIMA–Instituto Nacional de Vigilancia de Medicamentos y Alimentos (Colombia) (Bogotá), Comite Corporativo de Etica en Investigacion de la Fundacion Santa Fe de Bogota (Bogotá), Comité de Ética e Investigación Biomédica de la Fundación Valle del Lili (Cali), Comite de Etica e Investigacion IPS Universitaria (Medellin), Comite de Etica en Investigacion Asustencial Cientifica de Alta Complejidad (Bogotá), Comite de Etica en Investigacion Biomedica de la Corporacion Cientifica Pediatrica de Cali (Cali), Comité de Ética en Investigación Clínica de la Costa (Barranquilla), Comite de Etica en Investigacion de la E.S.E. Hospital Mental de Antioquia (Barrio Barzal Villavicencio), Comite de Etica en Investigacion del area de la Salud de la Universidad del Norte (Barranquilla), Comite de Etica en Investigacion Medplus Centro de Recuperación Integral S.A.S (Bogotá), Comité de Ética en Investigaciones CEI-FOSCAL (Floridablanca), Comite de Etica en la Investigacion CAIMED (Bogotá), Comite de Etica para Investigacion Clinica(CEIC) de la Fundacion Centro de Investigacion Clinica CIC (Medellin), Comite de Investigaciones y Etica en Investigaciones Hospital Pablo Tobon Uribe (Medellin), INVIMA—Instituto Nacional de Vigilancia de Medicamentos y Alimentos (Colombia) (Barranquilla, Bogotá, Cali, Floridablanca, Medellin: <b>Mexico:</b> CEI del Hospital Civil de Guadalajara Fray Antonio Alcalde (Guadalajara, Jalisco), CEI Hospital La Mision (Tijuana, Baja California Norte), CI del Hospital Civil de Guadalajara Fray Antonio Alcalde (Guadalajara, Jalisco), CI Hospital La Mision (Tijuana, Baja California Norte), Comite de Bioseguridad del Instituto Nacional de Salud Publica (Mexico, Distrito Federal; Cuernavaca, Morelos), Comite de Etica en Investigacion del Instituto Nacional de Salud Publica (Mexico, Distrito Federal; Cuernavaca, Morelos), Comité de Bioseguridad del Hospital La Misión S.A. de C.V. (Tijuana, Baja California Norte; Oaxaca, Oaxaca; Merida, Yucatán; Tijuana, Baja California Norte), Comité de Bioseguridad de la Coordinación de Investigación en Salud (IMSS) (Mexico, Estado de Mexico), Comité de Bioseguridad de Médica Rio Mayo (CLINBOR) (Mexico, Distrito Federal), Comité de Bioseguridad del Hospital Universitario “Dr. José Eleuterio González” (Monterrey, Nuevo León), COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) (Cuernavaca, Morelos; Mexico, Distrito Federal; Monterrey, Nuevo León; Oaxaca, Oaxaca; Merida, Yucatán), Comite de Etica de la Fac de Med de la UANL y Hospital Universitario “Dr. Jose Eleuterio Gonzalez” (Monterrey, Nuevo León), Comite de Etica en Investigacion de la Unidad de Atencion Medica e Investigacion en Salud S.C. (Merida, Yucatán), Comite de Etica en Investigacion de Medica Rio Mayo S.C. (Mexico, Distrito Federal), Comite de Etica en Investigacion de Oaxaca Site Management Organization, S.C. (Oaxaca, Oaxaca), Comite de Etica en Investigacion del Centro Medico Nacional Siglo XXI (IMSS) (Mexico, Estado do Mexico), Comité de Investigación de la Coordinación de Investigación en Salud (IMSS) (Mexico, Estado do Mexico), Comite de Investigacion de la Unidad de Atencion Medica e Investigacion en Salud S.C. (Merida, Yucatán), Comite de Investigacion de Oaxaca Site Management Organization, S.C. (Oaxaca, Oaxaca), Comité de Investigación del Hospital Universitario José Eleuterio González (Monterrey, Nuevo León), Comite de Investigacion Medica Rio Mayo, S.C. (Mexico, Distrito Federal): <b>Peru:</b> Comite Nacional Transitorio de Etica en Invest. de los Ensayos Clinicos de la enfermedad COVID-19 (Iquitos - Maynas, Loreto; Lima, San Miguel—Lima), INS—Instituto Nacional de Salud (Peru) (Lima, San Miguel—Lima; Callao; Iquitos— Maynas, Loreto): <b>South Africa:</b> Department Agriculture, Forestry and Fisheries (DAFF) (Port Elizabeth, Mthatha—Eastern Cape; Cape Town, Worcester—Western Cape; Durban, Ladysmith, Vulindlela— KwaZulu-Natal; Johannesburg, Pretoria, Mamelodi East, Soweto, Tembisa—Gauteng; Rustenburg, Klerksdorp—North West; Bloemfontein, Free State; Middelburg, Mpumalanga; Dennilton, Limpopo), Pharma Ethics (Port Elizabeth, Eastern Cape; Durban, Ladysmith—KwaZulu-Natal; Cape Town, Western Cape; Pretoria, Mamelodi East, Johannesburg, Tembisa—Gauteng; Rustenburg, Klerksdorp—North West; Bloemfontein, Free State; Middelburg, Mpumalanga; Dennilton, Limpopo), SAHPRA—South African Health Products Regulatory Authority (Port Elizabeth, Mthatha—Eastern Cape; Cape Town, Worcester—Western Cape; Durban, Ladysmith, Vulindlela—KwaZulu-Natal; Johannesburg, Pretoria, Mamelodi East, Soweto, Tembisa—Gauteng; Rustenburg, Klerksdorp—North West; Bloemfontein, Free State; Middelburg, Mpumalanga; Dennilton, Limpopo), WIRB (Mamelodi East, Pretoria—Gauteng; Ladysmith, KwaZulu-Natal; Bloemfontein, Free State; Cape Town, Western Cape; Dennilton, Limpopo), Wits Health Consortium (Soweto, Johannesburg—Gauteng; Ladysmith, KwaZulu-Natal; Mthatha, Eastern Cape), Wits Institutional Biosafety Committee (Soweto, Pretoria, Johannesburg, Tembisa—Gauteng; Rustenburg, Klerksdorp—North West; Mthatha, Eastern Cape), University of Cape Town HREC (Cape Town, Worcester—Western Cape); University of Cape Town Institute of Infectious Disease & Molecular Medicine (Cape Town, Worcester—Western Cape), University of Cape Town Institutional Biosafety Committee (Cape Town, Worcester—Western Cape), SAMRC Human Research Ethics Committee Scientific Review (Durban, KwaZulu-Natal), Sefako Makgatho University Research Ethics Committee (SMUREC) (Pretoria, Gauteng), University of KwaZulu-Natal Institutional Biosafety Committee (Durban, KwaZulu-Natal), University of KwaZulu-Natal Ethics (Durban, Vulindlela—KwaZulu-Natal), University of Stellenbosch Ethics Committee (Cape Town, Western Cape), University of KwaZulu-Natal Institutional Biosafety Committee (Vulindlela, KwaZulu-Natal): <b>United States:</b> Advarra IBC (Detroit, MI; Chapel Hill, NC; Boston, MA; Seattle, WA; Winston-Salem, NC; Austin, TX; Peoria, IL; Huntsville, AL; Long Beach, CA; Tucson, AZ), Biomedical Institute of New Mexico—IBC (Albuquerque, NM), Birmingham VA Medical Center—Alabama- IBC (Birmingham, AL), Clinical Biosafety Services (Hollywood, FL), Columbia University IBC (New York, NY), Copernicus Group IRB (Austin, Dallas, Houston, San Antonio—TX; Rochester, New York, Bronx, Binghamton—NY; Hillsborough, Hackensack, Newark, New Brunswick—NJ; West Palm Beach, Coral Gables, Hollywood, Miami, Orlando, Gainesville, Tampa, Hallandale Beach, Pinellas Park, The Villages, Jacksonville, Deland—FL; Fort Worth, Dallas, San Antonio—TX; Norfolk, Charlottesville—VA; Matairie, New Orleans—LA; Nashville, Knoxville, Memphis, Bristol – TN; Cincinnati, Cleveland, Columbus, Akron—OH; Detroit, Ann Arbor, Grand Rapids—MI; Philadelphia, Pittsburgh—PA; Stanford, San Diego, San Francisco, Oakland, Long Beach, Anaheim, Sacramento, West Hollywood—CA, Las Vegas, Reno—NV; Chicago, Peoria—IL; Omaha, NE; Mobile, Birmingham, Huntsville—AL; St Louis, Greer, Kansas City—MO; Boston, MA; Harrisburg, SD; Decatur, Atlanta, Savannah—GA; Baltimore, Rockville, Annapolis—MD; New Haven, Hartford—CT; Chapel Hill, Raleigh, Fayetteville, Charlotte, Durham, Winston-Salem—NC; Indianapolis, Valparaiso, Evansville—IN; Seattle, WA; Aurora, CO; Lexington, Louisville—KY; Murray, West Jordan, Salt Lake City – UT; Phoenix, Tucson, Glendale —AZ; Spartanburg, Columbia, North Charleston, Anderson, Charleston, Mount Pleasant—SC; Portland, Medford, Corvallis —OR; Albuquerque, Gallup—NM; Little Rock, AR; Jackson, MS; Newport News, VA, Minneapolis, MN; Lenexa, KS), WIRB (Hackensack, NJ; Dallas, TX; Baltimore, MD; Chicago, IL; Aurora, CO; Winston-Salem, NC; Minneapolis, MN; Orlando, Miami, Gainesville – FL; Philadelphia, Pittsburgh—PA; Boston, MA; St Louis, MO; Bronx, New York, NY; New Brunswick, NJ; Phoenix, AZ; Birmingham, AL; Louisville, KY; Albuquerque, NM; New Orleans, LA; Baltimore, MD; San Francisco, CA; Tampa, FL; Aurora, CO; Columbia, SC; Decatur, GA; Reno, NV; Raleigh, NC; Little Rock, AS), Clinical Biosafety Services (Dallas, San Antonio—TX; San Diego, CA; Lexington, KY; Murray, UT; Greer, Kansas City, St Louis—MO; Rockville, MD; Las Vegas, NV; Cincinnati, Columbus, Akron—OH; Phoenix, Tucson, Glendale—AZ; North Charleston, Anderson—SC; Orlando, Pinellas Park, The Villages, Miami—FL; Birmingham, AL; Valparaiso, Evansville—IN; Lenexa, KS), Columbia University IBC (Bronx, New York), Durham VA Medical Center-IBC (Raleigh, NC), Emory University IRB (Decatur, GA), Environmental Health and Safety Office (Atlanta, GA), Institutional Biosafety Committee (New Orleans, LA), James A. Haley Veterans Hospital_IBC (Tampa, FL), Jesse Brown VA Medical Center- IBC (Chicago, IL), Mass General Brigham IBC (Boston, MA), Mount Sinai- Icahn School of Medicine IBC (New York, NY), New York Blood Center-IBC (New York, NY), OHSU IBC (Portland, OR), Partners Institutional Biosafety Committee (Boston, MA), Rocky Mountain Regional VA Medical Center-IBC (Aurora, CO), Rush University Medical Center (Chicago, IL), Rush University Medical Center-IBC (Chicago, IL), Rutgers Institutional Biosafety Committee (New Brunswick, NJ), Saint Louis University IBC (St Louis, MO), Saint Michael’s Medical Center IRB (Newark, NJ), Southeast Louisiana Veterans Health Care System IBC (New Orleans, LA), St. Jude Children’s Research Hospital IBC Committee (Memphis, TN), St. Jude Children’s Research Hospital IRB (Memphis, TN), Stanford University Administrative Panel on Human Subjects in Medical Research (Stanford, CA), Temple University – IBC (Philadelphia, PA), The University of Chicago Institutional Biosafety Committee (Chicago, IL), UAMS IBC (Little Rock, AS), UIC IBC (Chicago, IL), University of Alabama at Birmingham Institutional Biosafety Committee (Birmingham, AL), University of Arkansas IRB (Little Rock, AS), University of Kentucky Biological Safety (Lexington, KY), University of Kentucky IRB (Lexington, KY), University of Louisville IRB (Louisville, KY), University of Miami-IBC (Miami, FL), University of Mississippi Medical Center IRB (Jackson, MI), University of Pennsylvania Institutional Biosafety Committee (Philadelphia, PA), University of Pittsburgh IBC (Pittsburgh, Pennsylvania), University of South Florida IRB (Tampa, FL), University of Utah Institutional Biosafety Committee (Salt Lake City, UT), University of Utah IRB (Salt Lake City, UT), UTHealth—IBC (Houston, TX), VA Baltimore Research & Education Foundation (BREF)- IBC (Baltimore, MD), VA Central Arkansas Veterans Healthcare System-IBC (Little Rock, AS), VA James J. Peters Department of VA Medical Center-IBC (Bronx, NY), VA Medical Center - Atlanta-IBC (Decatur, GA), VA Medical Center San Francisco- IBC (San Francisco, CA), VA North Florida/South Georgia IBC (Gainesville, FL), VA North Texas Health Care System IBC (Dallas, TX), VA San Diego Healthcare System IBC (Phoenix, AZ), VA Sierra Nevada Health Care System-IBC (Reno, NV), Vanderbilt University Instituitional Review Board (Nashville, TN), Washington University IBC (St Louis, MO), WCG IBCS (Houston, TX; Orlando, FL), Western Institutional Review Board (San Diego, CA; Detroit, MI; New Orleans, LA; New York, NY), WIRB - IBCS Services (Chicago, IL; New Orleans, LA; Oakland, CA; Minneapolis, MN; Columbus, OH; Lexington, KY), WJB Dorne VA Medical Center-IBC (Columbia, SC).