11. Complaints, Non-compliance, and Suspension or Termination of CUHS Approval of Research

11 Complaints, Non-compliance, and Suspension or Termination of CUHS Approval of Research

11.1 Complaints

11.2 Non-compliance

11.2.1 Definitions

11.2.2 Review of Allegations of Non-compliance

11.2.3 Review of Findings of Non-compliance

11.2.4 Inquiry Procedures

11.2.5 Final Review

11.2.6 Additional Actions

11.3 Suspension or Termination

11.4 Reporting

11 Complaints, Non-compliance, and Suspension or Termination of CUHS Approval of Research 

11.1 Complaints 

The CUHS Chair and/or Executive Officer will promptly handle (or delegate staff to handle), and, if necessary, investigate all complaints, concerns, and appeals received by the CUHS from investigators, research participants and others. 

The CUHS Chair or Executive Officer will designate an experienced office staff member to serve as the contact to receive communications from subjects or others, and to respond or, in the case of complaints or concerns, to forward them to the CUHS Chair and/or Executive Officer. 

11.2 Non-compliance 

All members of the University community involved in human subject research are expected to comply with the highest standards of ethical and professional conduct in accordance with applicable federal and state regulations and University, School, and CUHS policies governing the conduct of research involving human subjects. 

11.2.1 Definitions 

“Non-compliance” is defined as failure to comply with any of the regulations and policies described in this document and/or failure to follow the determinations of the CUHS. Non-compliance may be minor or sporadic, or serious and/or continuing. 

“Minor or sporadic non-compliance” is noncompliance that is neither serious nor continuing. 

“Serious non-compliance” occurs when the failure to follow any of the regulations and policies described in this document or a failure to follow the determinations 

potential benefits; or compromises the integrity of the human research protection program. 

“Continuing non-compliance” is a pattern of non-compliance that suggests a likelihood that instances of non-compliance will continue unless the CUHS intervenes. Continuing non-compliance also includes the failure to respond to a request to resolve an episode of non-compliance. 

“Allegation of non-compliance” is an unproved assertion of non-compliance. 

11.2.2 Review of Allegations of Non-compliance 9

Whenever allegations of non-compliance or facts suggesting the likelihood of non-compliance are brought to the attention of the CUHS office, they will be reviewed by the CUHS Chair and/or Executive Officer, who may designate a subcommittee of one or more members to assist in fact gathering. The following documents will be reviewed, as available and appropriate: 

1. All documents that pertain to the purported non-compliance; 

2. The last approval letter from the CUHS; 

3. The last approved CUHS application and protocol; 

4. The last approved consent document; 

5. The last approved Investigator’s Brochure; 

6. The sponsored agreement(s) supporting the research; and 

7. Any other pertinent information (e.g., questionnaires, DSMB reports, etc.). 

Additional information or an audit of the research in question may also be requested. Where appropriate, the Dean’s office and/or the Office of the General Counsel may also be consulted. 

The CUHS Chair and/or Executive Officer review each allegation of non-compliance and make a determination as to whether the allegation of non-compliance has a basis in fact. The CUHS Chair and/or Executive Officer may follow the Inquiry Procedures described below, if needed to make a determination. If the CUHS Chair and/or Executive Officer determine that the allegation of non-compliance has no basis in fact, no further action is taken under this policy. If the CUHS Chair and/or Executive Officer determine that the non-compliance has a basis in fact, it will be handled under Section 11.2.3, Review of Findings of Non-compliance. 

If in the judgment of the CUHS Chair or Executive Officer, any allegations or findings of non-compliance warrant halting the research before completion of any review or investigation the CUHS Chair or Executive Officer may halt the 

research pursuant to Section 11.3, Suspension or Termination, with subsequent review by the CUHS. 

11.2.3 Review of Findings of Non-compliance 

The CUHS Chair and/or Executive Officer review each finding of non-compliance and make a determination as to whether the non-compliance is either serious or continuing. The CUHS Chair and/or Executive Officer may follow the Inquiry Procedures described below, if needed to make a determination. If the CUHS Chair and/or Executive Officer determine that noncompliance is neither serious nor continuing, and the investigator has agreed to a corrective action plan that they deem adequate, no further action is required and the CUHS is informed at the next convened meeting. Otherwise, the Inquiry Procedures described below will be followed and the matter will be presented to the CUHS at a convened meeting. 

11.2.4 Inquiry Procedures 

A determination may be made by the CUHS that an inquiry is necessary based on factors including but not limited to: 

1. Complaint(s) that subjects’ rights may have been violated; 

2. Report(s) that investigator has made material changes to the approved protocol that may implicate subject welfare; 

3. Unusual and/or unexplained harm to subjects in a study; 

4. A federal (OHRP or FDA) investigation or audit of an investigator; 

5. Repeated failure of investigator to report required information to the CUHS. 

The CUHS Chair appoints a subcommittee consisting of CUHS members, and non-members if appropriate, to ensure fairness and expertise. The subcommittee is given a charge by the CUHS, which may include any or all of the following: 

1. Review of protocol(s) in question; 

2. Review federal investigation or audit of the investigator, if applicable; 

3. Review of any relevant documentation, such as research files, correspondence, consent documents, case report forms, subject's investigational and/or medical files etc., as they relate to the investigator's execution of human subjects research; 

4. Interview of appropriate personnel; 

5. Preparation of a written report of the findings, which is presented to the full CUHS; 

6. Recommendation of actions by the CUHS if appropriate. 

The written findings of the subcommittee shall be provided to the investigator so that the investigator has the opportunity to submit a written response and can 

request to appear at the CUHS meeting when the subcommittee report is reviewed. 

11.2.5 Final Review 

The results of the inquiry will be reviewed at a convened CUHS meeting where all members of the CUHS will receive a report from the subcommittee, any response offered by the investigator, a copy of the protocol, the initial application form updated with any changes, and the current consent document. The CUHS will first vote to determine whether the non-compliance is serious or continuing. If the CUHS determines that the non-compliance is neither serious nor continuing, the matter will be referred to the CUHS Chair and Executive Officer to determine a management plan. If the CUHS determines that the results of the inquiry substantiate a finding of serious or continuing non-compliance, it will consider the following actions, and other actions as appropriate: 

1. Requiring a corrective action plan from the investigator; 

2. Verifying that participant selection is appropriate and monitoring of the actual informed consent; 

3. Increasing data and safety monitoring of the research activity; 

4. Requiring a directed audit of targeted areas of concern; 

5. Requiring a status report after each participant receives intervention; 

6. Modifying the continuing review cycle; 

7. Requiring additional Investigator and staff education; 

8. Notifying current subjects, if the information about the non-compliance might affect their willingness to continue participation; 

9. Modifying the protocol; 

10. Modifying the information disclosed during the consent process; 

11. Providing additional information to past subjects; 

12. Requiring current subjects to re-consent to participation; 

13. Suspending the study (See below); 

14. Terminating the study (See below); 

15. Suspending current research involving human subjects for which the investigator is responsible; 

16. Terminating current research involving human subjects for which the investigator is responsible; 

17. Prohibiting the investigator from conducting or supervising research involving human subjects for a period of time determined by the CUHS. 

The investigator is informed in writing of the CUHS determination and the basis for the determination. If the CUHS determines that the non-compliance was serious or continuing, the results of the final review will be reported as described below in Section 12. 

11.2.6 Additional Actions 

A finding of serious or continuing non-compliance may have other results, for example: 

1. Sponsor actions. In making decisions about supporting or approving applications or proposals covered by this policy, the sponsor may take into account, in addition to all other eligibility requirements and program criteria, factors such as whether the applicant has been subject to a termination or suspension as described above, and whether the applicant or the person or persons who would direct or has/have directed the scientific and technical aspects of an activity has/have, in the judgment of the sponsor, materially failed to discharge responsibility for the protection of the rights and welfare of human subjects. 

2. University investigations. The conduct of the investigator or other personnel involved in a study involving human subjects may be the subject of a separate investigation or inquiry pursuant to University policies and procedures as carried out by appropriate University administrative bodies. Such an investigation or inquiry may result in disciplinary consequences up to an including dismissal. 

11.3 Suspension or Termination 

The CUHS has the authority to suspend or terminate approval of research that is not being conducted in accordance with the CUHS's requirements or that has been associated with unexpected serious harm to subjects. When the CUHS suspends or terminates its approval it will include a statement of its reasons in writing and report the suspension or termination promptly to the investigator and as described in Sections 11.4 and 12. 

Suspension of Committee approval: temporarily or permanently withdrawing approval for some or all research procedures short of permanently stopping all research procedures. Suspended research must undergo continuing review. 

Termination of Committee approval: permanently withdrawing approval for all research procedures. Terminated research is closed and does not require continuing review. 

When study approval is suspended or terminated by the CUHS or other person authorized to suspend Committee approval, in addition to stopping all research activities, the CUHS will, as appropriate, inform any subjects currently participating that the study has been terminated. The CUHS will consider whether procedures for withdrawal of enrolled subjects are necessary to protect their rights and welfare. Such procedures might include: (1) Transfer to another investigator, (2) Transfer to standard clinical care, (3) Continuing in the research under the current investigator. If follow-up of subjects for safety reasons is permitted/required by the CUHS, the CUHS will require that the subjects should be so informed and that any adverse events/outcomes be reported to the CUHS and the sponsor. 

Suspending or terminating approval of research that is not being conducted in accordance with the CUHS's requirements or that has been associated with 

unexpected serious harm to subjects will be authorized by the convened committee. The CUHS Chair or Executive Officer are authorized to issue orders immediately suspending Committee approval, in which case the decision will be reported to the convened committee for review. 

11.4 Reporting 

Serious or continuing noncompliance with regulations or with CUHS requirements or determinations, and suspensions or terminations of CUHS approval, will be reported to the appropriate regulatory agencies and institutional officials according to the procedures in Section 12.