Halikas v. University of Minnesota

Citations: 856 F. Supp. 1331; 1994 U.S. Dist. LEXIS 9835; 1994 WL 363100Docket: 3:94-mg-00448

Court: District Court, D. Minnesota; July 8, 1994; Federal District Court

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James A. Halikas, M.D., a tenured professor at the University of Minnesota, filed for a preliminary injunction against the University and its Institutional Review Board (IRB), claiming violations of his rights related to his medical research on Gamma Hydroxybutyrate (GHB) for addiction treatment. The court, presided by District Judge Rosenbaum, denied the motion after hearing oral arguments on May 31, 1994. 

Halikas's research received initial IRB approval in 1992, but concerns arose in August 1993 when a faculty member questioned the validity of informed consent, the potential coercion of subjects, and the adequacy of alternatives offered to participants. In response to these allegations, Halikas voluntarily terminated the study and notified the IRB. Despite this, on September 10, 1993, the University issued a press release announcing an investigation into the study, although the IRB had not formally voted to conduct one. The IRB officially began its investigation on October 13, 1993, and on November 12, 1993, requested that Halikas transfer his research responsibilities to another researcher, effectively suspending his human subjects research. Jurisdiction for the case was based on federal statutes allowing for civil actions against state actors.

On October 19, 1993, the University informed the FDA of the IRB's suspension of Dr. Halikas's research, prompting the FDA to begin its own investigation on October 21, 1993. Following notification of the investigation, Dr. Halikas retained legal counsel. The IRB committee heard testimonies from two counselors who allegedly translated for the GHB Opium Study, which Dr. Halikas contested, asserting that they were involved in a different program and that he was not notified about their testimony. He claimed he was denied the opportunity to cross-examine witnesses. On December 7, 1993, the IRB presented Dr. Halikas with concerns regarding informed consent documentation and compliance with FDA regulations, including unreported changes in the study's protocol. Dr. Halikas met with the IRB panel on January 31, 1994, where he addressed their concerns for two hours but again requested to cross-examine complainants and access IRB documents, both of which were denied. He was informed that no written records of the committee hearings existed prior to his testimony. The IRB concluded its findings on March 21, 1994, and the FDA released its report in April 1994. Despite the University’s policy to cover legal fees for researchers under investigation, Dr. Halikas's requests for payment have gone unfulfilled. On May 18, 1994, Dr. Halikas filed suit seeking to prevent the dissemination of the IRB's findings, a retraction of prior communications, indemnification for legal fees, and redress for alleged due process violations under 42 U.S.C. 1983, along with claims of regulatory and contractual breaches. He sought injunctive relief and attorneys' fees under relevant federal statutes. The analysis for his request for a preliminary injunction will follow the Dataphase criteria, which includes assessing irreparable harm, balancing injuries, likelihood of success on the merits, and public interest.

The Court declines to grant Dr. Halikas the requested injunction after evaluating the Dataphase factors. Dr. Halikas argues that without the injunction, he will suffer irreparable harm to his reputation and career due to actions taken by the University and the Institutional Review Board (IRB), which have hindered his ability to conduct human medical research. He also claims he will face irreparable harm if the University does not cover his legal fees, which he asserts is necessary for his defense before the FDA, seeking an order for the University to adhere to its Indemnification Policy. While the Court acknowledges that a ban on research could harm Dr. Halikas, it points out that he voluntarily abandoned his GHB Opium Study before the IRB's suspension. The University’s counsel indicated that the IRB's suspension could potentially be reversed, though it is unclear if an application for reversal has been submitted. The Court refers to precedent from Sampson v. Murray, which concluded that harm to reputation and income does not constitute irreparable injury necessary for injunctive relief. It finds that Dr. Halikas's claims do not warrant such relief since financial losses are remediable through legal channels. 

Furthermore, the Court considers the significant interest of the University of Minnesota Medical School in maintaining the integrity of its research, emphasizing the IRB's essential role in protecting public welfare. The IRB must operate within defined procedural limits, which the Court determines it did in this case. It notes that Dr. Halikas had worked with vulnerable subjects and acknowledges an instance where he exceeded the approved GHB dosage under the study’s protocol and failed to promptly inform the IRB of this deviation, which the Court views as a serious issue.

Federal regulations mandate that an Institutional Review Board (IRB) report any suspension or termination of research approval, including the rationale for such actions to the investigator, institutional officials, and the FDA, as outlined in 21 C.F.R. 56.113. Granting Dr. Halikas's motion would force the IRB to breach this regulation and compromise its protective role. The Court concludes that an injunction would hinder the IRB's ability to safeguard public interests, with the balance of injury strongly opposing the issuance of such relief.

In assessing the likelihood of success on the merits, which is critical for injunctive relief, the Court finds Dr. Halikas has only a slim chance of prevailing. The IRB operates under federal regulations and the University of Minnesota’s General Assurance Agreement, which define the due process standards for human subjects research. Although Dr. Halikas cites the University’s tenure code and hospital by-laws, these are not part of the federal regulatory framework governing the IRB.

According to 21 C.F.R. 56.108(a), the IRB must maintain written procedures for conducting initial and ongoing research reviews and reporting findings. The Court determines the IRB has sufficiently adhered to these procedures and applicable regulations, ensuring procedural due process was met. Dr. Halikas received multiple written notifications of the charges against him, was informed of his right to counsel during IRB proceedings, and testified for over two hours. He was also invited to submit written documentation and identify supporting witnesses. Though he claims he was denied the opportunity to cross-examine witnesses and access IRB documents, such rights are not stipulated in the governing regulations, which do not equate IRB proceedings to criminal trials.

Dr. Halikas entered into an employment contract and conducted his research under the University’s regulatory framework, receiving due process accordingly. The probability of success on the merits does not support granting a preliminary injunction.

The public has a significant interest in preserving the integrity of research involving human subjects, especially for vulnerable populations. The Court finds that preventing the IRB from reporting its investigation results would jeopardize public safety and impede crucial oversight functions. Thus, the public interest strongly favors denying the injunction, leading the Court to reject Dr. Halikas's request after reviewing all relevant factors.

Dr. Halikas's potential claim against the University for damages due to contractual or procedural violations cannot be pursued in federal court, as the University is a state institution. Federal courts are restricted from awarding past damages against state entities under the Eleventh Amendment to the U.S. Constitution, as established in Schuler v. University of Minnesota, where the court denied such claims against state institutions. This situation is further supported by the case of Sherman v. Curators of the University of Missouri, which reinforced the principle that the Eleventh Amendment prohibits federal lawsuits against state universities for damages.

Plaintiff's motion for a preliminary injunction is denied, and the claim for damages is dismissed without prejudice. Federal regulations require that institutions conducting medical research on human subjects establish an Institutional Review Board (IRB), with required approvals for studies involving new or investigational drugs. Dr. Halikas was involved in 21 research projects, with the GHB Opium Study being the only active project suspended. There are specific reporting obligations to the University and FDA concerning research suspensions. Dr. Halikas alleges violations of several federal regulations related to the lack of written procedures for hearings, improper expedited review of the study, failure to notify about suspensions, and not maintaining records of proceedings. The University of Minnesota has procedures in place for handling complaints regarding human subject research, which include written complaints directed to an administrator, investigation protocols, and oversight by dedicated committees. These committees are responsible for ensuring the protection of human subjects' rights and welfare and have the authority to suspend research if protections are inadequate.