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A1.0100 OVERVIEW OF UK RESEARCH ENVIRONMENT - page 23 / 23

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A1.0050

administrative procedures with the ORI Director, who evaluates and investigates the concerns raised and determines what actions, if any, should be taken by the ORI and/or the IRB to address the issue. The ORI Director is responsible for resolving issues raised as quickly, fairly, and amicably as possible through cooperative exchange of information with pertinent units and personnel involved in the UK HRPP. The Director forwards suggestions or concerns about ORI and IRB administrative procedures that are not resolved at the level of the Director to the VPR, who shall be the final deciding authority.

A1.2500 Suggestions, Concerns, and Questions on Rights, Safety, and Welfare of Subjects Participating in Specific Studies and/or Allegations of Noncompliance

It is ORI and IRB policy to provide a safe, confidential, and reliable channel for current, prospective, or past research subjects or their designated representatives to discuss problems, concerns, and questions; obtain information; or offer input with an informed individual who is unaffiliated with a specific research protocol. Each IRB-approved informed consent document includes the ORI Research Compliance Officer’s toll-free phone number (1-866-400-9428) as a subject’s primary contact point for this purpose. The ORI and IRB monitor any concerns/complaints that are received for issues of noncompliance. Issues involving noncompliance are brought to the attention of the IRB Chair, the IRB, and the ORI Director. The procedure for handling noncompliance is outlined in the “Noncompliance” SOP.

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