Required Findings amp; Determinations Tulane University New 需要发现amp；测定杜兰大学新.ppt

* * * * * * * * * * * Conflict of Interest Initial review made by Chair or designee Chair makes recommendation that the disclosed financial interest is: not acceptable (in which case the financial interest must be divested or other action taken); or acceptable with some form of management (such as disclosure, restrictions on the activities of the investigator, or such other form as determined appropriate); or acceptable without any need for management. ? HRP Associates, Inc. Conflict of Interest IRB makes final determination regarding COI management. Possible management plans: Disclosure to subjects through the consent process Modification of the research protocol or safety monitoring plan Monitoring of research by independent reviewers Disqualification of the conflicted party from participation in all or a portion of the research Appointment of a non-conflicted Principal Investigator Divestiture of significant financial interests Severance of relationships that create actual or potential conflicts. Prohibition of the conduct of the research at the hospital ? HRP Associates, Inc. Noncompliance Definition failure to comply with or adhere to rules, regulations, policies and standards of conduct that govern human subject research, failure to follow the determinations of the IRB, failure to follow institutional policies. Noncompliance may be minor or serious, or it may be sporadic or continuing. Noncompliance Serious noncompliance. Noncompliance which increases risks to participants, decreases potential benefits, or compromises the integrity of the human research protection program. Research being conducted without prior IRB approval is always considered serious noncompliance. Noncompliance Continuing noncompliance. A pattern of noncompliance that suggests a likelihood that without intervention instances of noncompliance will continue. Failure to respond to a request to resolve an episode of noncompliance. Noncompliance The IRB makes a determination about