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Human Subjects Protections

 

IRB Workshop  – Research on My Teaching Methods
Wednesday, March 25th, 2015


Overview
The University of Rhode Island Institutional Review Board (IRB) reviews research projects which involve human subjects to ensure that two broad standards are upheld: first, that subjects are not placed at undue risk; second, that they give uncoerced, informed consent to their participation.

With representation from a wide range of scientific disciplines and from outside the academic community, the IRB gives individualized attention to the numerous research projects at the University.

Protocol Review Process The length of the approval process is influenced by several varying factors, such as the complexity of a protocol, the risk of the project to the research subjects, and the completeness of documentation. In all circumstances, early submission combined with accurate documentation will result in an expedited approval.

The IRB application process starts with your submission of the application form, consent forms and other required appendices/materials. The ORI staff pre-reviews your application to make sure all of the necessary materials are there for IRB review. The ORI staff will contact you by email if your application or forms are not sufficient and will let you know what needs to be done to get your application ready for review by the IRB.

Applicants must submit application materials to the IRB at least three weeks prior to the date of the scheduled IRB meeting for all protocols that must be reviewed by the fully convened IRB. Please allow at least 6-8 weeks for protocol review, depending on the complexity of the project, the risk of the project to the research subjects, and the extent of revisions required.
IRB Meetings Schedule

General Guidance

Does My Research Need IRB Review?

• Protocol Review Process Flow Chart and Guide

• What to include in my IRB submission package

• Does My Research Qualify as Exempt Research?

• IRB Meet Schedule and Submission Deadlines

• URI IRB Protection of Human Subjects Policies and Procedures

• For assistance, contact Mary Riedford (mcriedford@mail.uri.edu or 874-4813) or the main Research Integrity Office: 874-4328.

Submission Process and Forms

The Initial Review of Human Subject Research (Initial IRB Application) is required for all research that requires a human subject component (exempt, expedited, and full convened IRB review). What you will notice immediately is the there are many appendices to the Initial IRB Application. Most Principal Investigators (PIs), will seldom use beyond a handful of these. These forms have designed to streamline the review process so all information required for review is submitted at time of application. Our hope is to decrease the review time for researchers.

All information must be submitted through IRBNet. Refer to the link below for required forms and sample documents.

• Forms and Sample Documents

• IRBNet Access and Guidance

Human Subjects Research Training

• Compliance Training

Students
Guidance for Student Researchers

Students as Research Subjects

Assurance

• Federal Guidance

Reporting

• Research Concerns, Unexpected Outcomes and Misconduct

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