Department of Psychiatry Special Report

Report Authors Michele Chin-Purcell, Research Integrity and Oversight Programs Moira Keane, Human Research Protection Program Ann Schwind, Medical School Dean's Office Al Willie, Office of Internal Audit Lynn Zentner, Office of Institutional Compliance

Date: September 29, 2009

Summary Introduction: The University of Minnesota is committed to the highest standards of research integrity in all work conducted at our institution. It is because of this that the institution has various mechanisms in place to oversee its research involving human subjects. The Universitys Institutional Review Board (IRB) is charged with reviewing research projects involving human subjects to ensure that two broad standards are upheld: first, that subjects are not placed at undue risk; second, that they give un-coerced informed consent to their participation. It is within this jurisdiction that the IRB may request a review of a units human subjects research. In an IRB Executive Committee letter dated March 16, 2009, to the Vice President for Research, the committee expressed concerns about the conduct of human subjects research in the Department of Psychiatry. The committee requested that the Vice President for Research initiate a thorough review of the Department of Psychiatry program in research with human subjects. The letter listed several instances of concern, as well systemic issues affecting all areas of research compliance. As a result, the Vice President for Research informed Dr. S. Charles Schulz, Head of the Department of Psychiatry, in a letter dated April 30, 2009, of the IRB Executive Committees letter and their concerns, and that he had initiated a formal review. The letter to Dr. Schulz indicated that the review would be conducted by a team consisting of the following individuals: Michele Chin-Purcell, Research Integrity and Oversight Programs (Chair) Moira Keane, Human Research Protection Program Ann Schwind, Medical School Dean's Office Al Willie, Office of Internal Audit Lynn Zentner, Office of Institutional Compliance The review team performed the following tasks: Conducted interviews with faculty and staff to assess the controls, processes and monitoring that takes place involving human subjects. Analyzed activities related to research coordinators, including the training they receive, their interactions with the investigators, and the level of employee turnover. With respect to conflict of interest and conflict of commitment issues, (1) reviewed compliance with Report of External Professional Activities (REPA) and Request for Consultant or Outside Service Agreement (ROC) reporting requirements; (2) determined whether active conflict management plans exist for any Department of Psychiatry employees; and (3) where active management plans exist, determined whether there has been compliance with them. Determined the current status of recommendations from the 2006 Office of Internal Audit of the Department of Psychiatry report.
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Repeated an employee survey that was conducted during the 2006 audit to (1) obtain feedback from all employee groups on a number of topics important to successful project management; and (2) to ascertain whether the corrective action recommended as a result of the 2006 audit has been implemented and found to be effective. Overall Conclusions: Although this review found several instances requiring further follow-up, the review team did not identify any substantive, systemic issues across the department that would suggest risk to the use of human subjects in research studies. The review team found that (1) faculty and staff recognize the need to ensure human subject safety and security; (2) faculty and staff, for the most part, have received the training required for those involved in human subjects research; and (3) monitoring and oversight activities associated with human subjects research appear reasonable. The IRB will, at its discretion, make whatever further determinations and impose whatever further requirements it deems necessary. Specifically the following corrective actions are recommended: 1) The department should take department-wide corrective action to ensure that all staff required to take human subjects training have done so. 2) Representatives from the Clinical Neuroscience Center should work with the Office of Sponsored Projects Administration and Oversight, Analysis and Reporting to examine the allowability of direct charging recurring office supply expenses to individual grants. 3) Representatives from the Clinical Neuroscience Center should work with the Office of Investments and Banking to arrive at a more acceptable and better controlled solution to avoid the co-mingling of personal and University funds in private, non-University bank accounts. 4) The Conflict of Interest Program will contact the Head of the Department of Psychiatry and individuals within the department to follow up on observations made in its review of REPA and ROC compliance. In addition, the team identified these potential opportunities for improvement: ensure staff awareness of effective approaches to use in the context of the consenting and assenting processes; communicate with the IRB to identify best practices associated with departmental oversight; and use the faculty and staff survey results to seek ways to improve the culture and work environment within the department.

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Details of Work Performed, Observations and Conclusions The review teams work was divided into 4 different components: I. Faculty and staff interviews II. Review of compliance with the REPA and ROC reporting processes III. Determining current status of any follow up conducted with respect to recommendations made in a 2006 Internal Audit Report IV. Conducting a faculty and staff survey The following information corresponds to each of the above areas and provides a summary of the observations made, the conclusions reached and the recommendations suggested for next steps or corrective action. Some of the next steps identify tasks that will be followed up on by other administrative functions which are committed to working with the department and to provide follow up on specific concerns raised in this report (eg: Office of Sponsored Projects Administration , Oversight Analysis and Reporting, Conflict of Interest Program, and the Office of Investments and Banking). Recommended improvements in process and communication are offered for consideration by the Head of the Department of Psychiatry, the IRB Executive Committee, and the Vice President for Research. I. Faculty and Staff Interviews Faculty and staff were interviewed in order to assess the effectiveness of the controls, processes, and monitoring implemented by the department that pertain to human subjects research. Specifically, staff were asked about the training they receive, their interactions with the investigators, and the level of employee turnover. A. Approach: The interview process consisted of in-depth interviews using a structured interview format with a random sample of 15 faculty (approximately 34% of the population) and 15 staff (approximately 25% of the population) who work with human subjects. The 15 staff averaged 4.3 years in the department; the 15 faculty averaged 12.75 years. The interviews were designed to provide an assessment of the level of knowledge and understanding these individuals have with respect to: 1. The regulations and policies that govern human subjects research, including the consent process, recruitment and enrollment of human subjects, minimizing risks to study participants and the reporting of unanticipated problems and adverse events; Training of researchers and staff; Staff and principal investigator roles and responsibilities; Hiring of staff and staff turnover; and Department of Psychiatry and IRB support roles.

2. 3. 4. 5.

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The interviewees were also asked to provide their ideas and recommendations for improvement within the department or within other administrative support functions across the institution.

B. Observations and Conclusions: 1. Staffs understanding of the regulations and policies that govern human subjects research Those interviewed appeared to have a good understanding of the recruiting and consent processes, the need to minimize risk to patients and the appropriate means to report complaints and problems. Only one issue was raised in this area. A staff member expressed concern about the ability of a very young person to understand the nature of the research. The staff member therefore had concerns about obtaining assent from this young patient, even when the parent had already given consent. Next Steps: The review team did not see a systemic issue in this area. However, given the one concern raised, the IRB and the Department of Psychiatry should consider whether further action is necessary to raise staff awareness about the sensitivities associated with the consenting and assenting processes with vulnerable populations. The department should also foster an environment that ensures that staff are comfortable raising their concerns at any time. 2. Training of researchers and staff Of the 30 staff interviewed, two had not taken the required human subjects training, but were actively involved in the human subjects consenting process. (Note: Because several interviewees mentioned the use of staff volunteers, 6 volunteer training records were also checked. The records revealed that all 6 had received the requisite training.) Next Steps: The report of the 2006 Internal Audit of the Department of Psychiatry reflects noncompliance with human subjects training requirements. At that time, the recommended corrective action was focused on the staff associated with one principal investigator. The department should take department-wide corrective action to ensure that all staff who are required to take human subjects training have completed it.

3. Staff and principal investigator roles and responsibilities All interviewed were clear about their roles and responsibilities. It was apparent that there was significant variation with respect to that which a principal
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investigator (PI) manages versus that which is delegated to a staff member. Some PIs engage in a very hands-on style of research, while others delegate significant duties to study staff. In addition, there were a wide variety of staff meeting styles with variations in frequency and formality. Some PIs used a very informal approach (e.g.: a 10-minute how are things going conversation) in contrast to others who used a much more formal approach involving agendas and preformatted slides. Staff generally felt that PIs were actively managing and monitoring their projects, and were available for questions whenever the need arose. Next Steps: The review team did not see a systemic issue in this area. 4. Hiring of staff and staff turnover The IRB letter noted that There is a high turnover rate among research coordinators and many lack the necessary skills to provide administrative support to the researchers which results in burden and delays in our capacity to handle their reviews. Based upon the interviews, high turnover was neither unexpected nor seen as problematic. The positions were purposefully filled with highly motivated people who had recently graduated and would likely apply for graduate school or medical school in the near future. The interviews revealed no concerns that people were leaving because of discontent with departmental practices. Next Steps: The review team did not see a systemic issue in this area. The department should be aware, however, that high rates of turnover increase the level of oversight and support needed from the PIs and the department and may contribute to delaying the IRBs review of protocols. 5. Department of Psychiatry and IRB support roles Those interviewed were not readily aware of what department support was available, nor did they seek it. There was general acknowledgement of human resource and accounting support from the department. Most felt that department oversight was adequate, but rather than looking to the department for support of their human subjects research, most faculty and staff look to the IRB staff as the function that should provide that support. In addition, departmental staff at remote sites indicated that they felt some isolation from the rest of department. Next Steps: The review team did not see a systemic issue in this area. The department should, however, contact the IRB and arrange for an opportunity to meet to discuss best practices and identify those it should implement with regard to departmental oversight.

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6. Other observations made during faculty and staff interviews a. Charging of general supplies During the employee interviews, consistent mention was made of the need to charge the sponsored project accounts for all recurring office supplies needed for the projects. Many questioned why the department was not providing funding for some of these costs from departmental sources (i.e. Operations and Maintenance funds or Facilities and Administrative cost recoveries). Because supply-type expenses are generally not an allowable expense on most sponsored projects (prohibited by Office of Management and Budget Circular A-21, section F.6b.(3)), representatives from the Office of Internal Audit performed a limited review of three current department sponsored project accounts to assess current practices. The auditors learned that current practices likely have, in fact, resulted in the charging of these costs to sponsored project accounts. This issue has been discussed with department senior management and the Clinical Neuroscience Center, who maintain that these costs are allowed on the project accounts because they were included in the approved budgets and were necessary to the conduct of the project. Next Steps: This matter has been referred to the Office of Sponsored Projects Administration and Oversight Analysis and Reporting for their review. These offices will work with the department to reach a conclusion on the allowability of these expenses and whether any additional corrective actions need to be taken. b. Research Subject Payments During their employee interviews the review team learned that, while many studies now compensate participants by issuing gift cards from area merchants, some PIs have found it necessary to instead make cash payments. To obtain the funds necessary, project staff obtain an advance payment from University Disbursement Services (usually for several thousand dollars). Under current practices, staff deposit these payments into their personal savings/checking accounts until such time as some or all the funds are withdrawn to make payments to the participants. Next Steps: The review team believes the co-mingling of personal and University funds in private, non-University bank accounts is in violation of the University policy Appropriate Handling of Cash Advances. The review team discussed this with the Universitys Office of Investments and Banking (OIB), which manages all banking and cash management activities. Although OIB acknowledges that alternative options for administering these funds are limited, they have agreed to work with the department to arrive at a more acceptable and better controlled solution.

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Representatives from the Clinical Neuroscience Center should work with the Office of Investments and Banking to resolve this matter. The interviewees shared several ideas and recommendations for improvement within the department and other administrative support functions across the institution. These recommendations have been shared, as applicable, with the Head of the Department of Psychiatry, the Executive Director of HRPP, the Associate Vice President of Sponsored Projects Administration, and the Vice President for Research.

II. Review of the REPA/ROC process A review was performed to examine the overall compliance by department faculty and staff with the Universitys conflict of interest and conflict of commitment policies and procedures. The review process also addressed whether conflict management plans had been developed for department faculty or staff and, where a management plan existed, whether there was compliance with its terms. In addition, the State Board of Pharmacy database was reviewed to determine whether department faculty are identified as having received compensation from one or more pharmaceutical companies. A. Approach: The Conflicts of Interest Program took the following steps: 1. Determined which faculty have active management plans. Of those with conflict management plans in place, the review examined whether the terms and conditions of the plan were being followed. 2. Searched the Board of Pharmacy Database for calendar years 2007 and 2008 to determine whether the database reflected relationships involving department faculty and the pharmaceutical industry which were not reported on REPAs or ROCs. Where compensation was reported, a further review was conducted to determine whether the receipt of the compensation was reported on the individuals REPA.

B. Observations and Conclusions: 1. Current management plans: Only one individual in the department has an active management plan. The management mechanisms of that plan were reviewed and compared with information available on the Minnesota Board of Pharmacy database (Board of Pharmacy Database) for calendar years 2007 and 2008. That review reflected substantial compliance with the plan based on 2007 data. A question has arisen with respect to 2008 data and follow-up with the individual on this issue will be undertaken by the Conflict of Interest Program.

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2. Additional information obtained from the Minnesota Board of Pharmacy Database: Questions have arisen with respect to six faculty members regarding the accuracy and completeness of REPAs and ROCs each filed for 2007 and 2008. These questions involve the possible participation in outside professional activities and the receipt of consulting fees, speakers fees and honoraria that may not have been reported on REPAs or ROCs as required. Next Steps: The Conflict of Interest Program will contact the Head of the Department of Psychiatry and individuals within the department to follow up on these observations.

III. Current status of recommendations from a 2006 Internal Audit In its 2006 audit of the Department of Psychiatry, the Office of Internal Audit issued a report that contained several recommendations rated as essential that specifically addressed topics that were the focus of the review team (e.g. the consenting process, human subjects payments, recordkeeping, and employee training). All of the essential recommendations from that report were previously reviewed by Internal Audit and it was determined that they had been implemented. A. Approach: As part of the current review, implementation of the recommendations related to the above topics were again examined by Internal Audit to ensure that current activities were successfully minimizing previously identified risks. B. Observations and Conclusions: The auditors concluded that current practices were appropriately managing these risks, although the need for continued improvement related to employee training was again raised during the review teams work (see the training comments noted above). Next Steps: There is no additional follow-up needed in this area, other than that already noted above.

IV. Faculty and staff survey The review team conducted a survey of all department employees to assess the control environment within the department. In its 2006 audit of the department, the Office of Internal Audit conducted a standard twelve question employee survey and the review team repeated that survey using the same questions from 2006. This allowed for a direct comparison of the current results to those from 2006, and enabled trends to be easily identified and analyzed.

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A. Approach: Surveys were sent electronically to all 75% time and greater department employees (172 in total). Responses were received from 113 which reflects a 66% response rate, a rate that is higher than the University-wide average. The survey also included a space for the employee to insert any narrative comments they had, and several chose to do so. Survey results were compiled for the department as a whole as well as for the following three individual groups: Faculty/Professional and Academic Administrative (P&A) employees, staff (civil service/bargaining unit) employees and residents.

B. Observations and Conclusions:

Overall results from the survey were generally positive, with responses within acceptable ranges. Compared to the 2006 survey, favorable responses improved by more than 5% for three of the twelve questions, but for three other questions responses were less favorable than in 2006. Substantial improvement was noted in the results from the staff group, with significant improvement noted for eight of the twelve questions. Management attributed this improvement to a variety of actions they have taken to improve communication and participation of these employees in departmental activities, and the results demonstrate their success. The survey results were not as positive for both the faculty/P&A and residents groups. Compared to 2006, faculty/P&A favorable responses decreased by more than 5% for eight of the twelve questions, while the residents group reported decreases of more than 5% on seven of twelve questions. Management believes several changes made to the job duties for the residents group resulted in less satisfaction for these employees compared to 2006. For the faculty/P&A employees, management believes the negative trends can be attributed to increased fiscal and budgetary pressures facing this group, in addition to negative publicity the department has received during the last 1-2 years. Next Steps: The review team believes senior management of the department should use the survey results to seek ways to continue to improve the culture and work environment within the department.

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