Review by CPHS – Upon receipt of the allegation of noncompliance, the ORSC Director will determine if the allegation is valid. In order to make the determination of validity, the ORSC Director may solicit additional information about the allegation from study team or requesting the review of the research by the Clinical Research Monitor.

If the allegation of noncompliance is not valid, the ORSC Director will document the allegation and determination. If the allegation of noncompliance is valid, the ORSC Director communicates this information to the Executive Chairperson. The Executive Chairperson determines if the noncompliance is serious or continuing. In order to make this determination, the Executive Chairperson may solicit additional information about the allegation from study team or requesting the review of the research by the Clinical Research Monitor.

If the noncompliance is not serious or continuing, the Executive Chairperson may take no action or may write to the Principal Investigator describing the concern and require the Principal Investigator to give an explanation and outline a corrective action to avoid repeating the noncompliance. If investigator’s reply is not satisfactory, this is handled as serious or continuing noncompliance.

If the noncompliance is serious or continuing, the Executive Chairperson includes the noncompliance for discussion at the next scheduled Executive Committee meeting or convenes an urgent Executive Committee meeting. Executive Committee may decide to take action based on existing information or initiate an investigation by a subcommittee composed of at least 3 members. If any of the members have any conflicting interests, the investigation will be reassigned to another member.

The purpose of the investigation is to explore the noncompliance by assembling and examining relevant information. The subcommittee's charge is to generate a report that summarizes the information considered, conclusions regarding the noncompliance, and recommendations for action. During an investigation, additional information may emerge that justifies broadening the scope beyond the initial allegations.

The subcommittee shall have access to prior records of CPHS activities and documents regarding the specific research on iRIS and Documentum Systems. They will also have access to the monitoring report, if applicable. The subcommittee may obtain documents and other records relevant to the investigation (e.g. researcher's records, medical charts, grant applications, etc.). The subcommittee may interview any persons who may have information relevant to the noncompliance. The subcommittee may draw on the resources of the institution or external consultants to assist in the review of issues that require expertise beyond or in addition to that available on the subcommittee.

The Principal Investigator under investigation will be given an opportunity to submit written comments and to appear before the Executive Committee. At the conclusion of the investigation, the subcommittee will prepare a report summarizing the information it has considered and outlining its conclusion and recommended actions. The subcommittee will submit the report to the Executive Committee. The Executive Chairperson or ORSC Director will write to the Principal Investigator outlining the concerns and request a response.

Outcome of CPHS Review: If the investigator offers a timely and satisfactory explanation for the concern, and Executive Committee accepts, the review process will be considered as completed and the Executive Chairperson will notify the investigator in writing that the research may continue and no further action is required. If the investigator offers an explanation that CPHS rejects, or if the investigator fails to respond within the specified time period, the Executive Committee may make a recommendation for further action that includes, but is not limited to:

• Request for more information before a final decision can be made;
  
• Request that the PI implement changes to the research protocol, procedures and/or informed consent documents;
  
• Request that the PI provide a corrective action plan to avoid a repeated occurrence in the future;
  
• Suspension or termination of CPHS approval for the study;
  
• Place the study on administrative hold;
  
• Review of one, some or all of the investigator’s research studies;
  
• Revision of the frequency of the continuing review process;
  
• Limitation of the types or numbers of studies for which an individual may serve as investigator;
  
• Required additional training of the PI and the research staff;
  
• Disqualification of the PI or member of the research staff from conducting research at UTHSC-H;
  
• Disallowance of research use of data collected;
  
• Notification of research participants regarding study problems (required when information may relate to the participants willingness to continue participation) or re-consent of participants;
  
• Notification of past participants of additional information;
  
• Recommendation to UTHSC-H Administration that further action be taken;
  
• Notification of complainant regarding decisions and/or outcome of the investigation.