Standard Operating Procedures - Chapter 7

IRB ORGANIZATION

7.1	Campus IRB
7.2	Local Review Boards
7.3	Administrative Support
7.4	Resources

7.1 Campus IRB

All funded research conducted by investigators at UMASS, or using resources from UMASS, must be reviewed by the IRB. Meetings are held on regular basis to review all initial research applications, modifications to ongoing research studies, continuing review reports, and adverse event/safety reports.

7.2 Local Review Boards

Local Review Boards, where established, review unfunded protocols. When a Local Review Board is not available, the IRB carries out the review.

7.3 Administrative Support

The HRPO has been established to facilitate and enhance the IRB process including:

• Preparing for and administratively supporting IRB meetings;
• Maintaining files on all human participants research (including copies of all correspondence between the IRB and investigators) that take place at UMASS;
• Maintaining an electronic database management for tracking studies;
• Preparing meeting minutes;
• Maintaining files for full board meeting minutes;
• Screening research studies for completeness prior to initiating the IRB review process;
• Acting as a resource for investigators, providing regulatory information, guidance with forms, and assistance in preparing an application;
• Maintaining the institution’s FWA and IRB membership records;
• Providing staff support to the IRBs for all written correspondence;
• Initiating notices of approval, study closure, continuing reviews, study suspension and termination;
• Maintaining information on federal regulations relating to human participant research; and
• Providing education regarding the IRB process and regulations to UMASS and the community.

7.4 Resources

UMASS provides adequate resources, facilities, and equipment to support the operation of the IRBs and performance of the functions described in this document. The institutional officials continue to assess the resources needed to provide a high quality and well-staffed human participant research program that provides oversight in a timely and professional manner.