Introduction

The Massachusetts Life Sciences Center (MLSC) is a quasi-state agency committed to advancing the life sciences ecosystem in Massachusetts. MLSC seeks a vendor to serve as the central IRB for the MLSC Biobank Program, which is being launched to establish a statewide, disease-specific biobank. In the first phase, the disease areas of focus will be colorectal cancer and Alzheimer’s disease and related dementias. More than ten academic medical centers will participate in sample collection. For this endeavor, we will need a central IRB vendor managing and coordinating with all the other collection sites and institutions.

Scope of Services

The selected vendor will provide central IRB services to support the establishment and ongoing operation of the MLSC Disease-Specific Biobank. The Biobank will involve multiple academic medical centers, community hospitals, and research partners across Massachusetts. The awardee will be responsible for ensuring that all protocol reviews, amendments, and continuing reviews are conducted in compliance with federal, state, and institutional regulations.

The scope of work includes, but is not limited to, the following:

1. Central IRB Review and Oversight

· Serve as the single IRB of record for all participating sites, including academic medical centers and community health systems.

· Conduct initial review and approval of the biobank master protocol, consent forms, and associated participant materials.

· Ensure compliance with FDA regulations, the Common Rule, HIPAA, state privacy laws, and any relevant institutional requirements.

2. Multi-Site Coordination and Onboarding

· Support onboarding and reliance agreement execution with each participating institution.

· Maintain documentation of reliance agreements and communication with institutional HRPP/IRB offices.

· Provide orientation and guidance to site investigators and study staff regarding IRB processes and requirements.

3. Consent and Participant Privacy Materials

· Review and approve standardized informed consent forms, assent forms (as applicable), and privacy authorization language, short consent forms for not as common languages as needed

· Ensure that consent language meets the biobank’s requirements for broad data and sample use, including future unspecified research, re-contact, and withdrawal procedures.

· Support translation and culturally appropriate materials, as needed.

4. Protocol Amendments and Continuing Review

· Conduct timely review of all protocol amendments, updated consent documents, revised operational workflows, and any new sample or data collection elements.

· Provide annual continuing review and ongoing oversight reports.

· Maintain version control and ensure timely distribution of approved documents to all participating sites.

5. Adverse Event and Non-Compliance Reporting

· Receive, review, and track any unanticipated problems involving risk to participants, serious or non-compliance events, or other reportable issues.

· Provide direction on corrective and preventive actions as needed.

· Communicate required reports to regulatory authorities, if applicable.

· Template for CAPAs, tracking adverse events and deviations

6. Turnaround Time and Service Levels

· Meet agreed-upon turnaround times for protocol reviews, amendments, reliance agreements, and reportable events.

· Provide transparent service metrics and communication timelines.

7. Documentation, Records Management, and Audit Support

· Maintain complete regulatory documentation of all IRB decisions.

· Provide audit-ready records to the biobank operations team and regulatory agencies, if required.

· Ensure secure record storage, confidentiality, and controlled access.

· Copies of applicable documents, including the protocol, outcome letters, local context review form(s), and consent forms specific to each recruiting site

8. Systems and Communications

· Provide an electronic IRB management platform with role-based access for multiple institutions.

· Ensure user support, training, and technical assistance for site personnel.

· Maintain clear communication channels and designated points of contact for escalations  

Term

The engagement will be for a five (5) year term with options to renew

Contact

For questions regarding this RFP, contact: BioBank@masslifesciences.com

This solicitation does not constitute an obligation to fund any proposals. The MLSC reserves the right to modify or cancel this RFP at any time and may request further clarifications or conduct interviews as part of the selection process. 

Program Overview

The MLSC is particularly seeking to enhance and/or expand training programs that address critical skills and talent supply gaps facing the sate’s life science industry. Such programs include those focused on Biomanufacturing, MedTech, Advanced Manufacturing, and other key careers in the life sciences ecosystem in Massachusetts. Applicants must have at-least one industry partnership that ensures that the program is responding to a direct hiring need.

Furthermore, the MLSC is committed to increasing diversity, equity, and inclusion within the life sciences workforce and will prioritize investments in programs that serve underrepresented populations.

Program Eligibility

Applicants must be a Massachusetts legally organized:

• Life Science company (“Company”) located in the Commonwealth of Massachusetts
• and regisered to do business in Massachusetts. A Certifcate of Good Standing from
• the Massachusetts Secretary of State and Certifcate of Good Standing from the
• Massachusetts Department of Revenue are required for the submission
• Community-Based Organizations (CBOs), including CBOs relying on a fscal agent
• Community Colleges, Colleges, and Universities
• Comprehensive and Vocational High Schools, including Vocational Schools ofering an
• after-hours or Career Technical Initiative evening training program
• For-Profit Entities
• Non-Profit Entities
• Municipalities
• Workforce Development Organizations
• MassHire Workforce Investment Boards and Career Centers

Please review detailed program eligibility and application evaluation process here: Eligibility and Evaluation Process

If you have any questions regarding the application process, Email: Pathmaker@masslifesciences.com