Standard Operating Procedures

At UMass Dartmouth, the Institutional Review Board (IRB) ensures the ethical conduct of research involving human participants. This page is designed to provide accessible information about our Standard Operating Procedures (SOP) for submitting and conducting research with human subjects.

Use the navigation below to explore key sections of the SOP. Each link leads to detailed information, helping you follow the appropriate guidelines for your research.

Key SOP Sections

Non-Engaged Research
This section explains scenarios where an institution’s involvement in human subjects research does not qualify as engagement, highlighting examples and categories such as recruitment, educational research, classroom projects, program evaluation, quality improvement, social media research, and secondary data analysis that do not require an FWA or IRB oversight.
Research Engagement and IRB Processes
This section defines institutional engagement in human subjects research, outlines the levels of IRB review required (Exempt, Expedited, Full Board, and Reliance), and details post-approval processes, including required reporting, managing noncompliance, lapses in approval, and research closure.
Roles & Responsibilities
Learn about the responsibilities of researchers to ensure compliance with ethical standards and regulations in human subjects research.
Submission Information
Find step-by-step instructions for submitting your research proposal to the IRB, including required forms, documentation, and submission timelines.
Criteria for Approval
This section outlines the essential criteria the IRB must ensure are met to approve research, including minimization of risks, equitable subject selection, informed consent, data monitoring, privacy and confidentiality protections, and safeguards for vulnerable populations, along with specific considerations for deception and protocol completeness.
Fundamental Considerations
This section covers essential topics related to research protocols, including site letters, recruitment and advertising, informed consent (including its elements and waivers), privacy and confidentiality, HIPAA compliance, and data management, including storage, retention, transfer, and ownership of research data.
Protocol Specific Considerations
This section covers detailed considerations for particular research protocols, including studies involving crowdsourcing, internet-based research, vulnerable populations (e.g., children, pregnant persons, prisoners), and sensitive topics, as well as guidance on research tools, survey methods, and ethical concerns related to recruitment and consent.
Review Procedures
Understand how the IRB reviews research proposals, including the types of reviews (Exempt, Expedited, Full Board) and approval criteria. See also: IRB Review Decision Flow Chart
Administrative Procedures
This section details the administrative processes overseen by the DIEC, including pre-meeting preparations, post-meeting tasks, follow-up actions, consultant reviews, and IRB record-keeping requirements.
Additional Regulatory Requirements

Additional Resources

IRB forms and templates
Access and download the necessary forms and templates for IRB submissions.

Contact the IRB Office
Need help? Contact the IRB office for support and guidance.

IRB meeting schedule
View upcoming IRB meeting dates and submission deadlines to plan your submission accordingly.

Stay Informed

Subscribe for updates to stay updated with changes to IRB procedures, forms, or regulations by subscribing to receive notifications.

By following these SOP guidelines, you ensure UMass Dartmouth's commitment to ethical research that safeguards human participants' rights and well-being. We appreciate your adherence to these procedures and your contribution to maintaining the integrity of our research community.

If you have any questions or need assistance, please reach out to the IRB office.