HHS Revisits Standard for Informed Consent in Experimental Treatments

Medical research, conducted recently on approximately 2,000 premature children born with anemia, has sparked an ethical debate over how much doctors must tell patients and their parents regarding the risks of medical research. The study aimed to uncover the most appropriate time to administer a blood transfusion to premature babies in order to reduce their risks of death and brain damage. Extremely premature babies received different dosages of oxygen in order to find the dosage that most effectively lowers the risk of blindness and death for premature children generally. The ethical debate concerns whether the parental consent form adequately informed the parents about the parameters of the study.

The Department of Health and Human Services conducted a forum recently to consider whether the consent form in this study, and others like it, contain enough information on the health risks for the subjects of experimental treatments. Parents may be under the mistaken impression that their children are receiving “the best possible care,” and do not understand that their children are undergoing experimental treatment. Experimental treatment focuses on discovering the best treatment for all patients with a particular disorder, as opposed to the best treatment for the particular individual enrolled in the experiment.

Read more here.


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