Institutional Review Board (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.
- Additional Research Location
- Amendment to Protocol, ICF, Investigator Brochure (IB)
- Case Review Submission Form
- Change to Investigative Site or Staff
- Chart Review Protocol
- Completion Report
- Continuing Review Form
- Continuing Review HUD
- Disclosure of Financial Conflict of Interest Status
- IND Safety Report
- Miscellaneous Research Submission Form
- MWMC HIPAA Request Authorization
- Protocol Deviation
- Protocol Submission Form
- Protocol Summary Non-Industry
- Protocol Template
- Report of Unanticipated Problem
- SAE Report Form
- Sample Cover Letter for Survey
- Sample Survey Consent
- Site Submission Chart Review
- Site Submission Form Humanitarian Use Device
- Site Submission Form
- Study Transition Form
- Survey Example
- Transfer Checklist
- Waiver of Consent Document
All changes will require IRB approval prior to the implementation of the change, unless the requested change is necessary to reduce immediate risks to human subjects.
- Amendment to Protocol, ICF, Investigator Brochure
- Miscellaneous Research Submission Form
- Report of an Unanticipated Problem
- Unanticipated problems must be reported within 5 days of site becoming aware of them
- If reporting an SAE please complete an SAE Report Form and submit with this report
- If filing a protocol deviation, a Protocol Deviation Form must be submitted
- SAE Reporting Form
- All SAEs must be reported to MWMC within 48 hours of site becoming aware of them
- Protocol Deviation Form
- IND Safety Report
- Additional Research Location Form
- Change to Investigative Site or Staff
Submissions must be fully completed, failure to submit completed packages with all required documents may result in a delay of IRB review.
Please refer to the last page of each form for a checklist of required documents for submission.
Continuing Review
MWMCIRB will require all investigators to complete a final report utilizing the IRB Closure Form when an approved study is completed or closed by the sponsor. In the event a Study Completion Form is not received, the study will be reported to the appropriate authorities (as applicable).
Submissions must be fully completed, failure to submit completed packages with all required documents may result in a delay of IRB review.
Please refer to the last page of each form for a checklist of required documents for submission.
Submission for Investigational Drug, Biologic, Device Studies:
- Site Submission Form
- Additional Research Location Form (if applicable)
- Disclosure of Financial Conflict of Interest
Submission for PI, Resident Research, and Case Studies
- Site Submission Form
- Protocol Summary Non-Industry Form (if applicable)
- Protocol Template
- Disclosure of Financial Conflict of Interest (if applicable)
- Waiver of Consent Form (if applicable)
- HIPAA Waiver (if reviewing patient data)
- Case Review Submission Form
- Additional Research Location
Submission for Retrospective Chart Review
- Site Submission Form Chart Review (see checklist for required documents)
- Chart Review Protocol
- HIPAA Waiver
Submission for Humanitarian Device (HUD)
- MWMC IRB Handbook
- Resident Research Overview
- Office for Human Protections
- Free GCP Training link
- Collaborative Institutional Training Initiative