In the same issue, investigators at the Cleveland Clinic and McMaster University report on a prospective observational trial to explore the effect of the timing of obtaining consent. They monitored the timing of seeking informed consent for a moderate- to high-risk trial of clonidine and aspirin in patients undergoing non-cardiac surgery and found that, contrary to expectations, patients did not have increased anxiety or decreased understanding if they are asked on the same day as the surgery is due to take place.
"This is the first study, to our knowledge, to specifically compare the impact of consenting on the day of surgery with consenting before that time on patient comprehension," observes lead investigator Daniel I. Sessler, MD, of the Department of Outcomes Research, Cleveland Clinic. "From a practical perspective, consenting before the day of surgery appears preferable, but proposing moderate- to high-risk research on the day of surgery itself does not compromise essential elements of the consent process."
In an accompanying Editorial, Barbara A. Koenig, PhD, of the Institute for Health & Aging, University of California, San Francisco, notes that both articles focus on just a single component of human research protection: the informed consent process. "We must reform a system that valorizes the informed consent process to the exclusion of other elements of human research participant protection," says Dr. Koenig.
"I applaud efforts to conduct empirical research interrogating standard informed consent practices and we need more well-designed studies," Koenig comments, referring to the study by Sessler and colleagues. "However, current efforts to reform the conduct of human research rest too heavily on revising the informed consent process and place too much emphasis on disclosure of risk or poten
|Contact: Rachael Zaleski|
Elsevier Health Sciences