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Concerns or Suggestions
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ORI/IRB Administrative Procedures
Investigator Concerns About IRB Decisions
Subject Concerns or Suggestions
ORI/IRB Administrative Procedures
In accordance with the Office of Research Integrity (ORI) and the Institutional Review Boards' (IRB) commitment to continuous improvement in its policies, practices and procedures, there is a process to formally register suggestions, concerns and/or complaints regarding the ORI and /or the IRB administrative procedures. Issues raised will be resolved as quickly, fairly and amicably as possible through cooperative exchange of information.
Suggestions or concerns regarding the ORI and IRB administrative procedures should be filed with the Director of ORI, Ada Sue Selwitz, who will evaluate and investigate the concerns raised and determine what actions, if any, should be taken by the ORI, IRB and/or the investigator to address the issue. Ada Sue Selwitz may be contacted by phone (859) 257-2978 or email selwitz@uky.edu. Suggestions or concerns regarding the ORI and IRB administrative procedures that can not be resolved at the level of the Director of the ORI will be forwarded to the Vice President for Research, who shall be the final deciding body.Investigator Concerns About IRB Decisions
Suggestions or concerns raised by a Principal Investigator regarding a specific IRB submission or decision should be resolved by direct communication between the investigator and the IRB committee (see Initial Full Review SOP, Expedited Review SOP, Exempt Review SOP, and/or Noncompliance SOP).
Subject Concerns or Suggestions
It is IRB policy that a safe confidential, and reliable channel for current, prospective, or past research participants, their representatives or others, is provided that permits them to discuss problems, concerns, and questions; obtain information; or offer input with an informed individual who is unaffiliated with the 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.