Junta de Revisión Institucional (IRB)

MetroWest Medical Center Institutional Review Board (MWMCIRB)

The MetroWest Medical Center Institutional Review Board (IRB) is duly constituted (fulfilling FDA requirements for diversity), to allow only those IRB members who are independent of the investigator and the sponsor of the trial to vote on the trial, have written procedures for initial and continuing review of clinical trials, prepare written minutes of convened meetings, and retain records pertaining to the review and approval process; all in compliance with requirements defined in 21 CFR (Code of Federal Regulations) Parts 50, 56 and 312.

Our Board is comprised of highly qualified members with significant experience and knowledge in the ethical, scientific and legal aspects of clinical trials.

Our priority is to ensure the safety of human subjects in clinical trials, and we are committed to an ethical and thorough review process.

If you need further information, please feel free to call 508-383-1671/508-383-8786 or contact us by email at [email protected].

Statement of Compliance

Name of IRB: MetroWest Medical Center
IRB Address: 115 Lincoln Street, Framingham, MA 01702
FWA#: 00003242 / FWA Expiration Date: 08/29/2023
IORG: 0002308 / IORG Expiration Date: 06/10/2023

The MetroWest Medical Center Institutional Review Board (IRB) is duly constituted (fulfilling FDA requirements for diversity), allow only those IRB members who are independent of the investigator and the sponsor of the trial to vote on the trial, have written procedures for initial and continuing review of clinical trials, prepare written minutes of convened meetings, and retain records pertaining to the review and approval process; all in compliance with requirements defined in 21 CFR (Code of Federal Regulations) Parts 50, 56 and 312.

The MetroWest Medical Center IRB have met new Institutional Review Board Registration Requirements published in the Federal Register on January 15, 2009 (74 FR 2399 and 74 FR 2358). The new IRB registration requirements became effective July 14, 2009.

The Federal Wide Assurance (FWA) through MetroWest Medical Center delegates the IRB Chair as sole authority to determine what is or isn’t research. Investigators are not permitted to make an exempt determination.

No medical records or patient materials can be reviewed for any research purposes without an exemption letter from the MWMCIRB.

Todos los cambios requerirán la aprobación del IRB antes de la implementación del cambio, a menos que el cambio solicitado sea necesario para reducir los riesgos inmediatos para los sujetos humanos.

Las presentaciones deben completarse en su totalidad , no enviar los paquetes completos con todos los documentos requeridos puede resultar en un retraso en la revisión del IRB.

Consulte la última página de cada formulario para obtener una lista de verificación de los documentos requeridos para su presentación.

Revisión continua

Informe de finalización

MWMCIRB requerirá que todos los investigadores completen un informe final utilizando el Formulario de cierre del IRB cuando el patrocinador complete o cierre un estudio aprobado. En caso de que no se reciba un formulario de finalización del estudio, el estudio se informará a las autoridades correspondientes (según corresponda).

Las presentaciones deben completarse en su totalidad, no enviar los paquetes completos con todos los documentos requeridos puede resultar en un retraso en la revisión del IRB.

Consulte la última página de cada formulario para obtener una lista de verificación de los documentos requeridos para su presentación.

Presentación para estudios de medicamentos, biológicos y dispositivos en investigación:

Presentación de IP, investigación de residentes y estudios de casos

Envío para revisión retrospectiva de gráficos

Presentación de Dispositivo Humanitario (HUD)

Health Professionals

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