for cause, and for investigator education about compliance. Such improvements may become part of a quality improvement plan. Objective Implementation of this policy will ensure maintenance of the integrity of the UA program to protect human research participants and that the UA IRBs are compliant with federal regulations and AAHRPP standards for accreditation. Responsibility. The Vice President for Research is ultimately responsible for this policy. Enabling parties include the Director of Research Compliance, Research Compliance staff, IRB members and chairs, and investigators, research study personnel, research participants, or others who report allegations of noncompliance. PROCEDURE Submission of Allegations of Noncompliance A person with knowledge or suspicion of investigator noncompliance, including the investigator, reports an allegation of investigator noncompliance to the IRB office, IRB chair, an IRB member, a Research Compliance Specialist (RCS) or the Director of Research Compliance (DRC). Allegations of noncompliance may also arise from (a) IRB discussions at convened meetings, (b) expedited review, (c) reports from the Manager of Research Compliance, (d) comments, questions, complaints, and concerns submitted through the outreach website; and (e) completed Surveys for Participants in UA-Sponsored Research, also available on the outreach website. . Any medium (phone, e-mail, letter, personal visit, etc.) may be used for report of the allegation. Although no form is required, the report should ideally include: The name of the principal investigator or other person charged with the offense; The study title and IRB number if known; The relationship between the alleging party, the investigator, and the research protocol; A description of the nature of the noncompliance (e.g., enrolling participants in an unapproved study; departing from the IRB-approved recruitment script to minimize the risks and increase enrollment) in sufficient detail that the recipient can understand the problem. (It is understood that some reporters may not be fluent in scientific or IRB terminology). A description of the kind and quantity of evidence to support the allegation;
for cause, and for investigator education about compliance. Such improvements may become part of a quality improvement plan. Objective Implementation of this policy will ensure maintenance of the integrity of the UA program to protect human research participants and that the UA IRBs are compliant with federal regulations and AAHRPP standards for accreditation. Responsibility. The Vice President for Research is ultimately responsible for this policy. Enabling parties include the Director of Research Compliance, Research Compliance staff, IRB members and chairs, and investigators, research study personnel, research participants, or others who report allegations of noncompliance. PROCEDURE Submission of Allegations of Noncompliance A person with knowledge or suspicion of investigator noncompliance, including the investigator, reports an allegation of investigator noncompliance to the IRB office, IRB chair, an IRB member, a Research Compliance Specialist (RCS) or the Director of Research Compliance (DRC). Allegations of noncompliance may also arise from (a) IRB discussions at convened meetings, (b) expedited review, (c) reports from the Manager of Research Compliance, (d) comments, questions, complaints, and concerns submitted through the outreach website; and (e) completed Surveys for Participants in UA-Sponsored Research, also available on the outreach website. . Any medium (phone, e-mail, letter, personal visit, etc.) may be used for report of the allegation. Although no form is required, the report should ideally include: The name of the principal investigator or other person charged with the offense; The study title and IRB number if known; The relationship between the alleging party, the investigator, and the research protocol; A description of the nature of the noncompliance (e.g., enrolling participants in an unapproved study; departing from the IRB-approved recruitment script to minimize the risks and increase enrollment) in sufficient detail that the recipient can understand the problem. (It is understood that some reporters may not be fluent in scientific or IRB terminology). A description of the kind and quantity of evidence to support the allegation;
44-I3I-Noncompliance-7-5-2011-1.docx