University: study consent forms not falsified

University officials responded to a request for an investigation into a 2002 study.

Emma Nelson

 

After a request for an investigation into research misconduct in a University of Minnesota clinical drug trial, University officials said they investigated and found the concerns are baseless.

After learning of what appeared to be identical copies of consent forms allegedly from families of multiple study participants, University bioethicist Carl Elliott requested an investigation Feb. 20. If the forms were falsified, it would suggest patients might have been enrolled in the trial without their informed consent.

But according to a March 14 University press release, University investigators found no evidence of falsification in the files of the study’s subjects.

“Dr. Elliott’s claims are very serious,” the release said. “That is why the University has investigated the matter thoroughly, and it is why we are clearly and definitively refuting the charges.”

The University’s response

Elliott raised concerns last month about “evaluation to sign consent” forms used in a study, which began at multiple study sites in 2002, of antipsychotic drugs in patients experiencing first-episode psychosis.

The forms determined patients’ abilities to consent to participate in the CAFE study, which was sponsored by AstraZeneca and compared three antipsychotic drugs.

In a Feb. 1 blog post, Elliott linked to two of these forms, both from the files for 26-year-old participant Dan Markingson, who committed suicide in 2004 while enrolled in the study.

In 2005, Markingson’s mother, Mary Weiss, filed a wrongful death lawsuit against the University. Weiss said she never wanted her son in the study.

In the years since his death, Weiss, Elliott and others have raised questions about whether study coordinators coerced Markingson into enrolling in the study.

In his Feb. 1 post, Elliott questioned why two slightly different copies of the same form would appear in Markingson’s file.

Following Elliott’s post, several family members of other study participants responded, saying their relatives’ charts contained identical forms, according to Elliott’s Feb. 20 request for an investigation.

The University’s response said Elliott does not possess “any official clinical or research ‘file’ regarding Markingson,” but that there were a number of “legal proceedings and independent reviews.”

“The implication that there is a single Markingson file that contains divergent ‘evaluation to sign consent’ forms is false,” the release said.

One family allowed Elliott to post their form under the condition of anonymity, according to a Feb. 13 blog post. The form appears nearly identical to the form from Markingson’s file — the answers to evaluation questions and signatures from the study coordinator and witness appear identical.

According to the release, University investigators found that the file of every CAFE study participant “who actively participated in the study” contains a different evaluation to sign consent form.

“There is absolutely no evidence that any of the forms used predetermined photocopied answers,” the release said.

In response to the University’s release, Elliott said in an email that he was “stunned” that the Office of the General Counsel shared the University’s response with the press. Elliott said he believes the correspondence should be confidential under a University policy for reporting research misconduct.

According to the Handling Reports of Research Misconduct policy, a review should “be handled with confidentiality.”

“The purpose of the confidentiality policy is to ensure that whistleblowers are protected from retaliation and intimidation,” Elliott said.

Elliott posted his request for an investigation — as well as Associate Vice President for Research Frances Lawrenz’s email response declining to investigate — publicly March 1 on his blog.

Further action

Earlier this month, Elliott requested copies of consent forms through Minnesota’s public records law.

According to his blog, he requested the evaluation to sign consent forms from the CAFE study as well as the CATIE study, a larger drug trial that was funded by the National Institute of Mental Health and tested the same drugs used in the CAFE study, among others.

Elliott said on his blog that his request hasn’t received a response from the University.

“… [W]ouldn’t this controversy be easily put to rest if the University just made the redacted forms public,” he said, “so that families could compare what the University says it has against what they say they have found in their own records?”

In the meantime, Weiss and friend Mike Howard have created a petition asking Gov. Mark Dayton to appoint an independent panel to investigate possible research misconduct at the University.

To date, more than 1,100 people have signed, including University alumni and academics around the world.