UPIRSO

(redirected from Unanticipated Problems Involving Risks to Subjects or Others)
AcronymDefinition
UPIRSOUnanticipated Problems Involving Risks to Subjects or Others (bioethics)
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References in periodicals archive ?
HHS regulations require prompt reporting to the IRB of "any unanticipated problems involving risks to subjects or others".
On January 15, 2007, The Office for Human Research Protections (OHRP) issued revised "Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events." This guidance provides instructive clarification of definitions for unanticipated problems and AEs, considerations for reviewing and reporting of unanticipated problems and AEs, and appropriate timeframes for reporting unanticipated problems to the IRB, appropriate institutional officials, the department or agency head, and OHRP.