Whistleblower at UC Davis Fired Allegedly For Reporting IRB Non-Compliance and Ethical Violations

Doctoral Candidate and former UC Davis (UCD) nurse researcher Janet Keyzer has filed a lawsuit against the Regents of the University of California, alleging that she and her husband were terminated from their employment at UC Davis after Ms. Keyzer reported research violations.

According to the suit filed on September 18, Ms. Keyzer began working within the Community Oriented Pain Management Exchange (COPE) in April 2006, which was created to evaluate pain diagnosis and treatment at California State Prisons. It was a federally-funded collaborative effort between UCD, the California Department of Corrections (CDC), and the Correctional Medicine Network at UC San Francisco (UCSF).

Ms. Keyzer observed that the COPE project was not in compliance with standard research requirements involving human subjects. Team members also violated laws regarding confidential medical records and protected health information. Ms. Keyzer wrote and spoke with her supervisor on multiple occasions about the improprieties she witnessed. In response, the team was directed to destroy their paperwork and “trust” those in charge.  On her own, Ms. Keyzer contacted UCD’s Institutional Review Board (IRB), which regulates all  campus research involving human subjects. Ms. Keyzer learned that the COPE project had not received the mandatory IRB review and approval. Ms. Keyzer filed a complaint, which triggered an IRB investigation and hearing at which she was invited to speak.

There are two specific levels to this allegation that seem of particular interest.  First, the violation of the IRB process by the University.  According to her complaint the IRB substantiated all of her claims and concluded that serious research improprieties had occurred at both staff and management levels of the project.  According to attorneys representing her, these claims which include the improper use of personal medical data from twenty inmate records and more concerning the lack of the project undergoing the required UCD Institutional Review Board (IRB) approval, are not in dispute.

The IRB process originated as a safeguard in part to protect human subjects from unethical researchers and clearly the improper use of “prisoner identifier numbers, dates of birth, medical visit dates and details from the inmates’ intake evaluations (including medical and psychiatric histories).”

Moreover, “The Principal Investigator and others on the research team mishandled private medical information even while in the institution, in violation of mandated security and the privacy considerations.”

The complaint suggests that Ms. Keyzer wrote her supervisor to express her ethical and professional concerns with the project.  “In her response Ms. Cottaman acknowledged that, in fact, COPE was operating outside of University IRB policy and claimed she would follow up on the issue.”

What is in dispute is what happened next.  Ms. Keyzer was offered work with on a project scheduled to end in 30 – 90 days, and was told that her employment with UCD would end. Ms. Keyzer filed a grievance, to which UCD offered her a demotion from her Administrative Nurse professional researcher classification to Analyst on another short-term project being managed by the same manager who coordinated the COPE project. Ms. Keyzer rejected the offer, and on December 21, 2007, Ms. Keyzer was notified that she was terminated from her UCD employment, effective November 30, 2007.

The issue of whistleblower retaliation is particularly interesting in this case, because when Ms. Keyzer testified to the IRB board, she was assured that there were whistleblower protections.

According to the minutes from the meeting chaired by John Anderson, MD, with Anthony Perez, Director of IRB Administration submitting the minutes, Ms. Keyser was informed that this subcommittee was charged with fact-finding of what occurred on this project.

Furthermore the minutes reflect:

“She was asked to relate to the subcommittee her role in the project and what occurred. She was also informed that the University has a whistleblower policy against retaliation and if this happens to her, she should contact him directly.”

According to the complaint,

All UCD staff members who worked on the COPE project were transferred to other UCD research projects. Plaintiff was moved to a project scheduled to end in one month. In September 2007, Plaintiff was notified that her University employment would terminate when the project concluded, then scheduled for November 2007. Plaintiff was told that funding for her new research job had run out. However, Plaintiff became aware that the “AHRQ/Battelleproject” was, in fact, continuing and a contract position for the exact research Plaintiff was experienced to conduct existed, and from which she was “laid of£”

She was apparently the only one of the team not hired for another project of equal status and responsibility.  She was offered a lower ranking position, but turned it down. 

“UCD offered her a demotion from her Administrative Nurse professional researcher classification to Analyst on another short-term project being managed by the same manager who coordinated the COPE project. Keyzer rejected the offer, and on December 21, 2007, Keyzer was notified that she was terminated from her UCD employment, effective November 3D, 2007.”

The whistleblower retaliation complaint was filed with the university in January 2008.

“After an 18-month investigation, during which UCD granted itself three (3) extensions and violated the Regents’ own timeline for completing such investigations, UCD concluded in July 2009 that Keyzer’s termination was not related to her whistleblowing on the COPE project.”

What makes this case particularly interesting is a potential loophole in the California Whistleblower Protection Act which

“authorizes a University of California (UC) employee or applicant for employment to recover damages caused by intentional acts of reprisal, retaliation, threats, or coercion only if the University failed to reach a decision regarding a  complaint filed with the University by the injured party, within specified time limits.”

The ruling in Miklosy v. the Regents of the University of California in July 2008 found that University of California (UC) employees who are retaliated against because they report wrongdoing cannot sue for damages under the state’s Whistleblower Protection Act, so long as the University itself reviews the complaints in a timely fashion.

In response, there is now legislation sitting on the Governor’s Desk, authored by Senator Leland Yee that would provide UC employees with the same whistleblower protections and legal standing as all other state employees.

Senator Yee said: 

“This is the classic case of the fox guarding the hen house.  UC executives should not be judge and jury on whether or not they are liable for monetary claims.  This was not the intent of California’s whistleblower law.  In light of the Court’s ruling, it is imperative that we pass SB 219 and immediately correct this statute to protect UC workers from unfair retaliation for rightfully reporting waste, fraud, or abuse.”

While the Court was unanimous in their ruling, three of the seven judges urged the Legislature to consider changes to the law, as the current statute undermines the purpose of the Act.  Justice Kathryn Mickle Werdegar, joined by Chief Justice Ronald George and Justice Carlos Moreno urged the legislature to change the law:

“The court’s reading of the Act, making the University the judge of its own civil liability and leaving its employees vulnerable to retaliation for reporting abuses, thwarts the demonstrated legislative intent to protect those employees and thereby encourage candid reporting.  If the same government organization that has tried to silence the reporting employee also sits in final judgment of the employee’s retaliation claim, the law’s protection against retaliation is illusory.”

According to the press release, in June 2009, Ms. Keyzer and her attorney testified before the Senate JudiCiary Committee on Sen. Leland Yee’s SB 219 to make the Regents more accountable in handling whistleblower retaliation complaints.

In this case, the Plaintiff is arguing that the WBPA does apply since “the REGENTS failed to reach a conclusion regarding her complaint “within the time limits established for that purpose by the regents.”  In essence, the extensions put her out of compliance.

UC Davis has not yet responded to the Vanguard’s request for comments, however, they apparently sent a statement to the Davis Enterprise that indicated that they could not directly to respond to this matter as it is a personnel matter.

‘We can say, however, that when a research grant ends, the university usually offers employees on the grant other comparable vacant positions on other grants,’ the statement read. ‘If there are no vacant positions in the same classification, the employees are eligible for similar alternative positions for which they qualify.

‘The vacant Analyst VII position that Ms. Keyzer rejected was the only vacancy of its kind on campus, and was a 12-month appointment. The position had an identical salary to the Administrative Nurse classification and very similar job duties. There were no vacant Administrative Nurse positions. It is unfortunate that Ms. Keyzer rejected this employment opportunity.’

The lawsuit was filed against the Board of Regents in Alameda County Court.  The Vanguard will be closely watching this case as it relates to a number of very pertinent issues in the community.

—David M. Greenwald reporting