Volume 13, Number 10 January 20, 2006

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New policy improves reporting of adverse events in research

The U of S Ethics Office introduced a new policy Jan. 1 aimed at a more efficient administration of the reporting of serious adverse events (SAEs) that occur in research studies involving human subjects.





And the Office is proposing that the University go further and adopt an institutional monitoring program that would allow its Research Ethics Board (REB) to provide education and offer more help for researchers to meet ethical and regulatory guidelines.

Ethics Office Manager Susan Blum and Biomedical Research Ethics Officer Bonnie Korthuis say the reason for the new policy is to improve the reporting process and put more focus on the SAEs that occur at the University of Saskatchewan.

They say the majority of SAEs occur during clinical trials in biomedical research, such as trials of new medicines. SAEs are any untoward medical occurrence that results in death, is life-threatening, requires hospitalizations results in a disability or birth defect, or poses potential serious harm to research subjects or others.

Blum says of the approximately 1,400 SAEs that are reported to the REB by U of S researchers each year, only about five per cent actually affect Saskatchewan research participants. The rest occur at sites external to the U of S, but researchers are informed about them in case there are any implications for U of S studies. Until now, U of S researchers had to pass along reports to the REB not only on all internal incidents, but also on all of the external incidents. Now, only those external incidents which are “serious and unexpected”, and which the researcher believes may have implications for a U of S study must be reported to the REB.

“The new policy will make the reporting process more meaningful and will allow researchers to focus their attention on those SAEs for which they hold primary responsibility,” Korthuis says. She notes it is the principal investigator’s responsibility to make recommendations on any necessary changes to a research study’s protocol or risk statement, if warranted.

Blum says some universities have a more proactive research ethics monitoring program, and the Ethics Office has just put forward a proposal that one be established at the U of S. It is mandated by regulatory authorities such as Health Canada. She says this would allow the Research Ethics Board to carry out an ongoing monitoring and education function.

For more information, contact communications.office@usask.ca

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