UMass Boston

All PIs and research personnel must follow the requirements in the Investigator Manual (HRP-103). 

Now that you have received your initial IRB approval, here are the steps to manage your protocol. 

All submission forms are online in Kuali. Any questions can be directed to the IRB team. Please provide your IRB ID number and PI name so that we can best assist you. 

Modification (Amendment)

Per federal regulations, once an IRB protocol has received approval, any subsequent changes to the study must be submitted to the IRB with a modification (amendment) for review and approval by the IRB prior to implementation. If the proposed modification changes any IRB approved documents (e.g., protocol, informed consent form, etc.), the investigator must submit an updated version of each document for IRB review with tracked changes.

For exempt research, modifications do not need to be submitted to the IRB unless the proposed changes could impact the exempt status (e.g., changes that add more than minimal risk to subjects, add a vulnerable population, impact privacy and confidentiality, affect design of research).

Continuing Review (Renewal)

New studies initially approved via expedited review on or after January 21, 2019 under the Revised Common Rule will not have an expiration date and will not require any renewal (with some exceptions such as DOJ-funded research). 

Expedited studies that were initially approved before January 21, 2019 (with few exceptions) will still be issued an expiration date and are subject to continuing review at least annually. The investigator should submit for renewal at least 30 days before the expiration date.

Full board review studies are issued an expiration date and are subject to continuing review at least annually (with some exceptions). The investigator should submit for renewal at least 30 days before the expiration date.

Exempt studies do not expire and are not subject to continuing review.

Reportable New Information

PIs and research staff are required to notify the IRB of any reportable new information within 5 business days of becoming aware of the event. Refer to the Investigator Manual (HRP-103) for a list of information items that require prompt reporting (e.g., information that indicates new or increased risk; failure to follow the protocol due to the action or inaction of the investigator or research staff; breach of confidentiality; non-compliance with the requirements or determinations of the IRB, etc.). 

Final Report (Closure Request)

Submission of a final report (closure request) is required for all non-exempt research in order to formally close your IRB protocol. A protocol may be closed with the IRB once participant enrollment has permanently ended, all research-related interventions and interactions with participants are completed, no additional identifiable private information about the subjects is being obtained, and analysis of private identifiable data is completed.

Investigator Quality Improvement Assessment (Post-Approval Monitoring)

As part of our quality improvement plan to achieve and maintain compliance and targeted levels of quality, efficiency, and effectiveness of the human research protection program (HRPP), the Associate Director of Research Compliance and Integrity in conjunction with the IRB and/or ORSP research compliance staff will follow standard operating procedures for quarterly post-approval monitoring (PAM) of selected active studies. 

SOP: Quarterly Evaluations of the HRPP (HRP-061)

UMass Boston Post-Approval Monitoring (PAM) Program

PAM Review Checklist (sample only)