ABOUT

IRB

ETHICS COMMITTEE

 


To organizations conducting health research is essential to include fundamental ethical principles in the design and implementation of research involving humans. These ethical principles are universal and transcend geographical boundaries, cultural, economic, legal and political. Should guide the conduct of those who plan, conduct and sponsor such research on issues such as safety procedures, risks and benefits for people, freedom of choice to participate fully informed volunteers, confidentiality, responsibilities in the management of adverse effects, and the solution of these problems.


Chairman of the Board and Director of Research
Dr. Jorge Sanchez

 

Secretary
Mr. Jose Ojeda


IMPACTA has established an Institutional independent Bioethics since 2001, composed of persons of recognized standing and professional ability.

 

 

This Committee is certified by the Office for the Protection of Human Subjects in Research of the Department of Health and Human Services to the Population of the United States and by the National Institute of Health of Peru.

 

 

Research protocols running on Impacts are under consideration by the Committee for review, approval or observation, also this committee reviews protocols for IMPACTA partner institutions and research centers that did not have a committee of, and to seek the review.

 

 


Médico Cirujano

 

  • ■ Especialista en cirugía digestiva.

  • ■ Especialista en trauma, emergencias y cuidados críticos.

  • ■ Candidato a maestro en Gobierno y Gerencia en salud (UPCH)

  • ■ Candidato a maestro en Medicina con mención en cirugía (UNMSM).

  • ■ Presidente del comité de Trauma de la Sociedad de Cirujanos del Perú.

  • ■ Miembro de la Junta Directiva de la Sociedad Panamericana de Trauma como representante del Perú.

  • ■ Docente de la Universidad San Martín de Porres.

  • ■ Docente de la Universidad San Juan Bautista.

  • ■ Miembro del Comité Institucional de Bioética desde el 09 de septiembre de 2010

  • ■ Capacitado  en Buenas Prácticas Clínicas.

  • ■ Capacitado en Protección de Sujetos Humanos.


Enfermera
Maestra en Salud Pública
Candidata a Doctor en Salud Pública

 

■ Secretaria de la COREMUSA callao
■ Coordinadora de Proyectos del Convenio Hipólito Unanue.
■ Asesoría Técnica para Auditorias de estrategias Sanitarias de Tuberculosis e ITS VIH/Sida en la región Callao.
■ Jefa de la Oficina de Inteligencia Sanitaria de la Sanidad de la Policía Nacional del Perú.
■ Consultora para Diseño Metodológico del Taller de Vigilancia Social e Incidencia Política para la descentralización de TARGA en el Callao/ Asociación Corazones Chalacos.
■ Consultoría para la elaboración del Plan Estratégico de la Red Inter confesional Peruana en Respuesta al VIH/SIDA de la Pastoral de Salud.
■ Miembro del Comité Institucional de Bioética desde el 22 de julio de 2010.
■ Perito en asuntos metodológicos
■ Capacitado  en Buenas Prácticas Clínicas.
■ Capacitado en Protección de Sujetos Humanos.


Cirujano Dentista
Maestría en Salud Pública (c)

 

■ Diplomado en Bioética de Investigación Universidad San Martin de Porres, Facultad de medicina Humana
■ Diplomado en Bioética en Investigación Biomédica, Colegio Médico del Perú y Universidad Nacional Federico Villareal.
■ Administrador de la Oficina de Protección de Sujetos Humanos en Investigación de la Asociación Civil Impacta Salud y Educación.
■ Miembro del Comité Institucional de Bioética desde el 20 de noviembre de 2001.
■ Perito en asuntos éticos.
■ Capacitado en Buenas Prácticas Clínicas


(Andean Comprehensive International Program of Research on AIDS) (2003-2007)

 

The CIPRA Andino was a consortium of Peruvian Civil Partnership Impacts Health and Education, Universidad Peruana Cayetano Heredia (UPCH), Naval Medical Center Research Detachment U.S. (NMRCD), and the University of Washington (UW). The main activities focused on strengthening the structure and tools that are serving as a platform for the development of HIV research in Peru. This program consisted of four components: Administrative, Biostatistics and Data Management and Informatics, Laboratory and Training, as well as three research projects.

The Administrative component generated tools that allow the strengthening of research operations including: software for monitoring of budgets and procurement, updating SOPs, strengthening the existing Community Advisory Committees (CAB) and support the CAB in the city of Guayaquil in Ecuador, development and maintenance of an Information Center HIV / STD among others.


The component of Biostatistics, Data Management and Informatics allowed improvement and SISCITAS software update which allows the management and monitoring of research activities. This component helped to consolidate the data management center in IMPACTA. 

 

The laboratory component has implemented new technologies, including the method of detection of HIV viral load by PCR Taq-Man, Catch of immunoglobulin G (IgG) - BED-enzyme immunoassay (EIA) - BED for incident HIV diagnosis resistant HIV testing and using the platform in IMPACTA ViroSeq. The training component has developed a training program for researchers and staff in Good Clinical Practice, Good Laboratory Practices, Protection of Human Subjects and Procedures Specific Study Protocol. These training modules have been used for monitoring the implementation of national and international projects.

 

Project 1: Phase II, randomized, double-blind, placebo-controlled trial of acyclovir for the reduction of HIV acquisition among High-Risk HSV-2 seropositive, HIV seronegative.


3A Survey Population Impact Assessment of interventions against HIV / STD.


3B Project Implementing a third generation sentinel surveillance among men who have sex with men at high risk of contracting HIV, type 1 in the Andean Region.  


(HIV Vaccine Trials Network - HVTN) (2000 - Present)

 

In the Year 2000 IMPACTA HVTN enters the network to develop and implement clinical trials, from evaluating experimental vaccines for safety and the ability to stimulate immune responses, to testing vaccine efficacy. (See more information)

 


(HIV Prevention Trials Network HPTN) (2000 - Present)

 

IMPACTA participation in HPTN Network has been focused on developing strategies for new and innovative research to reduce HIV acquisition and transmission. (see more information).

 

 


(AIDS Clinical Trials Group - ACTG) (2003 - Present)

 

In 2003 IMPACTA Group enters AIDS Clinical Trials to develop and conduct scientifically rigorous translational research and clinical trials to (1) investigate the viral and immune pathogenesis of HIV-1 infection and its complications, (2) evaluate drugs and novel strategies for the treatment of HIV-1 infection, (3) evaluate interventions and strategies for treating and preventing joint infections related to HIV and co-morbidities, and (4) to disseminate the results to improve care and reduce or eliminate the morbidity and mortality associated with HIV-1 infection and its complications. (see more information)

 


(INSIGHT) International Network for Strategic Initiatives in Global HIV Trials (2004 Update)

 

Since joining the network INSIGHT IMPACTA has contributed to the definition of optimal strategies for the treatment of HIV and other infectious diseases through a global network of clinical research. (see more information)

 


(Microbicides Trials Network - MTN) (2011 - Present)

 

IMPACTA enters the Microbicide Trials Network seeking to contribute to reducing the sexual transmission of HIV through the development and evaluation of products used orally or applied topically. (see more information)

 


(2011 - Present)

 

IMPACTA is part of this consortium funded by the European Union in order to develop a new vaccine strategy for HIV prevention and control of HIV infection via vaccination based on transcutaneous and / or needle-free mucosa. (See more information)

 


Médico Cirujano

Doctor en Medicina - marzo de 1989

 

■ Especialista en Medicina Interna
■ Especialista en Enfermedades Infecciosas y Tropicales
■ Docente Principal Medicina Interna en la Universidad Mayor de San Marcos.
■ Representante del Perú en el Comité de VIH-SIDA de la Asociación Panamericana de Infectología.
■ Miembro del Consejo Consultivo de la Fundación Instituto Hipólito Unanue.
■ Fellow of the American College of Physicians.
■ Conferencista en el Perú y en muchos países latinoamericanos.
■ Autor de varias publicaciones de investigación clínica.
■ Investigador Científico en Salud.
■ Miembro del Comité Institucional de Bioética desde el 09 de septiembre de 2010
■ Capacitado  en Buenas Prácticas Clínicas.
■ Capacitado en Protección de Sujetos Humanos.


Medica Cirujana
Maestra en Docencia Universitaria
Maestra en Ciencias Biomédicas Tropicales
Candidata Doctorado en Educación

 

■ Especialista en Infecciosas y Tropicales
■ Pediatra.
■ Profesora Asociada Departamento de Medicina Humana y Pediatría de la  Universidad Nacional Mayor de San Marcos.
■ Miembro del Comité Científico del Cuerpo Médico del Instituto de Salud del Niño.
■ Miembro del Comité Institucional de Bioética desde el 13 de diciembre de 2011
■ Investigadora Científico en Salud.
■ Capacitado en Protección de Sujetos Humanos.


Cesante
Ama de Casa

 

■ Técnica Especialista profesional en Contabilidad Gubernamental.
■ Secretario Comercial
■ Entrenamiento a los Colaboradores del IRB: Sitio de Formación de Investigaciones en Protección de Sujetos Humanos (13) módulos, 08 de julio 2002.
■ Miembro del Comité Institucional de Bioética desde el 10 de abril de 2001
■ Representante de Comunidad
■ Colegio Médico del Perú – Consejo Nacional Comité de Vigilancia Ética y Deontológica – I Congreso Internacional de Bioética. septiembre de 2013.
■ Colegio Médico del Perú – Consejo Nacional Comité de Vigilancia Ética y Deontológica – Introducción a la Integridad Científica. septiembre de 2013
■ Capacitada en Protección de Sujetos Humanos en Investigación.


Psicólogo (Bachiller)

 

■ Especializado en Psicología Clínica.
■ Director ejecutivo y fundador  de la organización ESPACIO COMÜN / EPICENTRO)
■ Investigador en diversos programas de salud sexual.
■ Experiencia en planificación, organización y ejecución de intervenciones en campo y actividades comunitarias, además de creación y ejecución de talleres.
■ Conducción de Webinar “Diálogos en Línea” USAID PERU “Nuevas alternativas de prevención del VIH/SIDA”  USAID PERU /Embajada de USA.
■ UNIDEC – CITBM - Educador comunitario para las redes HVTN y HPTN en el trabajo comunitario con poblaciones TGB de Lima.
■ Experiencia en manejo conductual y social
■ Miembro del Comité Institucional de Bioética desde 08 de julio de 2010.
■ Capacitado en Protección de Sujetos en Investigación.
■ Capacitado en Buenas Prácticas Clínicas.


Professionals who had the responsibility of the position for years.

 

PAST PRESIDENTS


• Andres Paredes (2001-2002)


• Juan Carlos Checkley (2002-2004)


• Gloria Nichtawitz (2004-2005)


• Andrew Predes (2005-2010)


• Elfer Valdivia (2010)


• James Gutierrez (2010-2012)

 

 

CURRENT PRESIDENT


• Ricardo Herrera Medrano(2013-Present)


Ecónomo (Bachiller)
Abogado
Policía Nacional del Perú

 

■ Representante de la comunidad HSH Epicentro, Ad Honorem.
■ Director del Área comunitaria de Epicentro,
■ Instructor auxiliar (abogado).de la Inspectoría General PNP:
■ Jefe de la Biblioteca Especializada. De la Escuela de Altos Estudios Policiales.
■ Representante de comunidad y perito legal en el Comité Institucional de Bioética de Impacta.
■ Miembro del Comité Institucional de Bioética desde el 24 de enero  de 2017
■ Capacitado en Protección de Sujetos en Investigación.


Abogado
Maestría en Derecho Internacional Económico.
Maestría en Gerencia Pública

 

■ Abogado Asesor del consejero Gonzalo García en el Consejo Nacional de la Magistratura.
■ Jefe de la Asesoría Legal del Consejo Ejecutivo del Poder Judicial
■ Abogado Asesor de la Secretaria General de la Fiscalía de la Nación.
■ Miembro del Comité Institucional de Bioética desde el 09 de julio de 2013
■ Perito en asuntos legales
■ Capacitado en Protección de Sujetos en Investigación.


We are a non-profit institution dedicated to research in the fields of health and human behavior, consisting of multidisciplinary teams engaged in promoting the welfare of individuals and society.

 

We want to achieve permanent improvements in the knowledge that contribute to the proliferation of development options, health and education, for the benefit of the study populations and the community at large.

IMPACTA be recognized by employees, customers, investors and the general public as the leading research institution in the Andean region. It will be recognized as the center of reference in the field of biomedical research, sexual health promotion, development and community education. To do so, remains Impacta institutional values honesty, tolerance, respect for people and the promotion of intellectual curiosity.


 

The Institutional Committee on Bioethics is an independent body of support, whose mission is to promote and protect respect to participants in clinical research studies, their inalienable rights, his true and integral good, the dignity of the person and it compatible with institutional ethics.

 

The vision is to be an Institutional Bioethics forefront autonomous, recognized by society as a national and international reference in the context of ethical dilemmas in safeguarding human rights.


The Clinical Trials Unit IMPACTA PERU (PERU IMPACTA CTU) is formed to evaluate HIV vaccines, prophylaxis and antiretroviral treatment optimization and reduction of HIV risk behaviors. A consortium of researchers from the Asociacion Civil Impacta Salud y Educacion and the Asociacion Civil Selva Amazonica (ACSA), focused on developing science and new knowledge in order to improve the health of populations affected by HIV / AIDS, through prevention and risk reduction and better treatments for the management of HIV / AIDS, complications, and sexually transmitted diseases (STDs).

 

The CTUS consists of a Program Administrative Core (Core CTU), three Clinical Research Locations (CRS) to 4 affiliated research networks, the group treatment studies in adults (ACTG), the network of vaccine studies HIV (HVTN), the network of HIV prevention study (HPTN) and microbicide studies network (MTN).

 

The Core Administrative formed by the Governance Committee Scientific (CGC) and its resource units: Administration, Clinical Research Laboratory, Biostatistics, Data and Medical Informatics and Community Involvement, whose function is to provide the administrative, technical and scientific support for the implementation and implementation of projects at the headquarters of clinical research.

 

Currently the program has three Research Offices (CRS), two located in the city of Lima and one in the city of Iquitos.

 

CRS Barranco (IMPACTA), is located in Barranco, in this CRS the projects are mainly CRS Treatments for HIV / AIDS, complications, and sexually transmitted diseases and vaccines for the prevention of HIV / AIDS and treatment for HIV / AIDS, complications and sexually transmitted diseases.

 

CRS San Miguel (IMPACTA), is located in, in this CRS ​​the projects are mainly Treatments for HIV / AIDS, complications, and sexually transmitted diseases and studies Microbicides for prevention of HIV acquisition. (See more information)

 




IMPACTA began its activities more than one decade ago, thanks to the enthusiasm, determination and efforts of the founders, our Administration and Finance Manager Mr. Jose Ojeda and great researcher on issues of medicine and epidemiology Dr. Jorge Sanchez. Both began in the first seat Grimaldo del Solar in Miraflores district as administrative center and clinical research efforts.

 


It was inaugurated on July 04, 2000 as an institution. , And named after Civil Partnership IMPACTA honor health and education in the health of people with HIV and their families. Throughout its history, impacts has been active in research and development has been one of the main supporters to continue the fight against this relentless disease.

 


With more than one decade of experience in health, we have advanced technology equipment that enable thorough examinations and diseases attend and receive timely treatment, processing samples in real time, requiring complete checkups with shorter hospital stay. Leading with modernity in the teaching area, we conducted theoretical lectures and practical conference with domestic and foreign exhibitors. We expanded preventive promotional tasks through medical campaigns to different districts of Lima and beyond.


• Regulation of the Institutional Bioethics Committee Impacta.


• Clinical Trials Regulations INS


• Belmont Report


• Code of Federal Regulations Title 45 Public Welfare Department of Health and Human Services Part 46 Protection of Human Subjects in Research


• Declaration of Helsinki


The achievements

 

The Civil Partnership Impacts Health and Education, to established itself since its founding as an institution that develops science and technology in the field of health of the populations most vulnerable to infection with one of the greater stigma and discrimination as HIV infection.

 

Impacts associated with major research networks, not only working hard on a scientific level, but also supports the creation of new clinical research and strengthening community-based organizations.

 

 

 



ETHICS COMMITTEE

 


To organizations conducting health research is essential to include fundamental ethical principles in the design and implementation of research involving humans. These ethical principles are universal and transcend geographical boundaries, cultural, economic, legal and political. Should guide the conduct of those who plan, conduct and sponsor such research on issues such as safety procedures, risks and benefits for people, freedom of choice to participate fully informed volunteers, confidentiality, responsibilities in the management of adverse effects, and the solution of these problems.


COMMUNITY ADVISORY COMMITTEE

 

In health research requires collaboration between researchers and the community involved in the studies. The approach based participatory research proposes a model community to promote the active involvement of representatives of the community in all stages of the research process. A proven effective way to understand and articulate the needs of the community is the organization and promotion of Community Advisory Committees (CAC).

 

Impact has the support of a CAC includes representatives from diverse communities who participate selflessly serving as a bridge between research and community members. The CAC helps to improve processes such as recruitment and retention of participants, and protecting the rights of volunteers in studies, among other topics. Many times the CAC has helped identify potential problems for researchers designing clinical trials or more ethical, feasible, and appealing for volunteers.

More detail and information Community Advisory Committee this link