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.
Concerns, suggestions, or questions regarding the ORI and IRB administrative procedures should be filed with the Director of ORI, Helene Lake-Bullock, 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. Helene Lake-Bullock may be contacted by phone (859) 257-9428 or email email@example.com.
Concerns, suggestions, or questions regarding the ORI and IRB administrative procedures that cannot 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.
Concerns regarding attempts of undue influence on individuals responsible for the oversight of human subjects research should be reported to the Research Compliance Officer (RCO) who notifies the Vice President for Research (VPR) and the Director of ORI, Helene Lake-Bullock. The VPR, in consultation with the ORI Director, determines the appropriate response to unduly influence or undermine the mission of the IRB. The RCO, Helene Lake-Bullock, may be contacted by phone (859) 257-9428 or email firstname.lastname@example.org.
Concerns, suggestions, or questions 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).
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.
IRB approved informed consent documents for U.S. based studies include the ORI Research Compliance Officer's toll-free phone number (1-866-400-9428) as a subject's primary contact point for this purpose. Contacts listed in the informed consent documents for international or non-English speaking populations are determined on a case-by-case basis.