Institutional Review Board (MWMCIRB)

Protecting Patients’ Rights

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. MWMC IRB Member Roster.

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) 383-8786 or contact us by email at MWMCIRB@mwmc.com.

Statement of Compliance

Name of IRB: MetroWest Medical Center
IRB Address: 115 Lincoln Street, Framingham, MA 01702
FWA#: 00003242 / FWA Expiration Date: 10/08/2019
IORG: 00002308 / IORG Expiration Date: 11/26/2017

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.