Certification of IRB review refers to the official notification by the university to the DHHS) that the research activity or project involving human subjects has been reviewed by the IRB. Certification of initial IRB review is incorporated into the text of each Single Project Assurance (SPA) which is then forwarded to the Office for Protection from Research Risks (OPRR).
The IRB shall have authority to suspend or terminate research that is not being conducted in accordance with the IRB's requirements, other institutional and federal requirements, or has been associated with any serious harm to subjects. Concerns regarding the conduct of research must be reported immediately to the Chair of the IRB by any individual having such knowledge. Any suspension or termination of research must include a statement of the IRB's action and the Chair must report its decision promptly to the principal investigator, the Office of Grants and Contracts, and the funding agency, in the case of a sponsored project.
Cooperative research projects are those that involve more than one institution and can be designed to be both multi-site and multi-protocol in nature. In the conduct of such projects, each participating institution is responsible for safeguarding the rights and welfare of human subjects and for complying with all regulations.
Copies of all documentation regarding research reviewed by the IRB also will be maintained in the University Office of Grants and Contracts. All records shall be retained for at least three (3) years. Records relating to funded research conducted shall be retained for at least three years after completion.
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