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This crucial document is the cornerstone for researchers and those involved in human research oversight. It provides a comprehensive guide that ensures the safety, rights, and well-being of research participants are prioritized. Below are specific highlights from the manual.

The IRB Office is updating its policies to align with the recent amendments to the Common Rule. All revised policies will undergo IRB approval. Once endorsed, they will be shared with the college community and incorporated into this manual.

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Outlines of IRB SOP Manuel

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• Purpose of the IRB: The initial sections generally discuss the overarching purpose of the IRB, which includes the safeguarding of human research participants and ensuring that research is conducted in an ethical and compliant manner.
• Structure and Membership: Understand the composition of the IRB, including the roles and responsibilities of its members, their qualifications, and how they are selected.
• Review Process: This section elaborates on the review mechanisms in place, whether full board reviews, expedited reviews, or exemptions. It sheds light on how the IRB reviews research proposals, the criteria for approval, and what researchers can expect during this phase.
• Informed Consent: One of the pivotal aspects of human research is ensuring participants are adequately informed and have willingly agreed to partake. The manual provides guidelines on drafting and obtaining informed consent, including considerations for vulnerable populations and situations where consent can be waived.
• Ongoing Oversight: Research doesn’t end once approved. The IRB requires regular updates and has processes in place for monitoring ongoing research to ensure continued compliance. This might include annual reviews, reporting of adverse events, and more.
• Reporting and Documentation: This segment educates on the need for appropriate documentation, what needs to be retained, and for how long. It also discusses reporting mechanisms for any non-compliance or unforeseen issues that arise during the research.
• Training and Education: Given the ever-evolving nature of research ethics and compliance, this section discusses the mandatory training and continuing education necessary for researchers under the IRB’s purview.
• Closing Studies: Understand the criteria and procedures for concluding a study, ensuring that all obligations have been met and participants are duly informed.
• Audits and Assessments: Learn about the periodic audits the IRB may conduct to ensure ongoing compliance and the continuous improvement of research practices.

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Department of Research

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