Stricter rules for conducting human trials approved at U of M

Author:
Updated:
Original:

An action plan to improve the safety of patients involved in University of Minnesota human trials was approved by the Board of Regents.

The U has been under fire after a series of scathing reports about the way its Department of Psychiatry recruited patients into its drug trials, following investigations into the death of Dan Markingson in 2004.

Earlier this week, the university released a plan to tighten up procedures concerning its human testing trials. The new guidelines are designed to better protect patients while reducing conflicts of interest and upholding ethical standards.

This plan will cost $7.8 million to implement over the next year – $2.3 million of which are ongoing costs. It was approved unanimously by the Board of Regents Friday.

"With our actions today, the Board of Regents has directed implementation of a bold and comprehensive plan that protects patients, and creates a strong culture of accountability and transparency," said Board Chairman Richard Beeson in a news release. "It charts the right course for the future of medical research at this University, and we will oversee its full implementation."

More information about what changes the action plan will bring can be found here, and they include the implementation of a new system to determine whether a prospective patient is of sound enough mind to agree to be enrolled on a program.

In 2004, it was found that Dan Markingson – who was a diagnosed schizophrenic – was given a choice of either enrolling in a U of M drug trial funded by AstraZeneca, or face being committed. His mother also objected to his enrollment. He later took his own life while on the program.

The plan also calls for more independent oversight, after the university was accused of being misleading about its human trials failures. The Star Tribune notes it will also bring an end of researchers taking payments from companies sponsoring their work.

The newspaper reports university scientists were previously permitted to do research for drug companies while serving as paid consultants at the same time.

Next Up

124906958_401361401236047_6293747214536025849_o

Pandemic pushes need for cybersecurity and I.T. professionals to forefront

University of Wisconsin-Superior is helping meet demand with online master’s programs

Screen Shot 2020-12-03 at 5.01.58 PM

Body found floating in Minnesota River in Shakopee

Efforts to identify the deceased are underway.

Hennepin County Government Center

Judge finds suspect guilty in 1991 murder of young Minneapolis woman

A 58-year-old man from South St. Paul, who was 29 at the time, has been found guilty of stabbing a 20-year-old woman

northfield community education center

Northfield school fires employee who allegedly gave melatonin to infant

It's against district policies to give a child anything without a parents' permission.

state hockey tournament, mshsl

MSHSL approves 3 calendars to start winter sports as soon as Dec. 21

The start date will depend on whether the state shutdown is lifted.

hydrocodon-DEA

Drug overdose deaths up 31% in the first half of 2020

Overdose deaths started to increase sharply in March, which coincides with the state-ordered lockdown for the COVID-19 pandemic.

los ocampos

Video: Vehicle crashes into St. Paul restaurant

The fire department is on scene addressing a gas leak.

covid-19, coronavirus

Latest county infection rates are sky-high throughout Minnesota

Kandiyohi County is one of the hardest hit counties in the state.

Jenna Fish

Family's warning after teen's tragic death from CO poisoning at Thanksgiving

A 17-year-old girl from Delano died after Thanksgiving due to carbon monoxide poisoning.

Plainview

More than $12K donated to MN gym owner who refused to close

The small business is located in town in Wabasha County.

radio station, microphone

MPR, The Current launch new weekly segment called 'The Warming House'

The program will feature feel-good entertainment amid the pandemic.

Related