Participation in medical research comes with inherent risks that must be disclosed to study subjects, especially when that risk is death.
This, among other issues, was the reason behind the cancellation of a UBC clinical trial back in 2002.
The study, conducted between Vancouver General Hospital, UBC and St. Paul’s hospital, was designed to test the effects of two different catheter treatments and two different fluid management protocols in patients with acute respiratory distress syndrome, a life-threatening inflammation of the lungs. The trial was sponsored by the U.S. National Heart, Lung and Blood Institute and, after being suspended in 2002, was shut down in 2003 by the U.S. Office for Human Research Protections (OHRP).
The study was discontinued due to concerns with the protection of subjects participating in the research. A number of issues with the trial were raised in the letter from the OHRP, some more serious than others. Of the more grievous allegations, it was not disclosed to the patients that the actual purpose of the study was to see if there was a change in death rate in those in the different treatment groups. Furthermore, death was not listed as a risk of the research and it was not stated that subjects could have a higher risk of death by participating.
Following further failure to meet OHRP regulations in 2009 and early 2010, UBC changed some of its procedures to better comply with U.S. Department of Health and Human Services ethics policies. According to Laurel Evans, director of ethics for Research Services at UBC, the biggest of the changes regarded clarifying patient reporting procedures.
“Our policies and procedures changed very little, as a result of the [OHRP] audit. Most of the issues were around documentation of approval,” said Evans in an email interview. "We did change our SOPs (standard operating procedures) so that the reporting procedures were clearer.”
Evans also said that, through these changes, the ethical review process has been made more robust.
“We spent millions developing and implementing the RISe on-line system specifically to ensure that we have complete records," said Evans. “We were the first in the country to have an online system.”
The Research Ethics Board (REB) has been split into several separate entities: behavioural studies now have their own REB and institutional REBs have been formed including those for UBC-O, Children and Women’s Health Centre and the B.C. Cancer Agency.
Modifications are made to processes and guidance rules when either the U.S. or Canadian governments make changes and standard operating procedures are reviewed and updated regularly.
“They are never considered final," said Evans. “They are in the process of being completely re-reviewed right now."
According to Evans, UBC has not cancelled any studies for not meeting ethics standard, but suspended several while they were sorting out compliance issues since the OHRP audit.