Informed Consent…We Dun' Need No Stinkin' Informed Consent

Hundreds of African American men were murdered, children were fed poisoned Quaker Oats, and honorable soldiers were exposed to toxins. Were these the acts of multiple serial killers? I guess it all depends on how you look at it.

Studies involving human subjects/patients have been a topic of controversy for many years. Government reactions, such as The Declaration of Helsinki, are meant to put controversies to rest; however, recent accusations within an article published in the New York Times are yet another example of weaknesses in controlling human studies.

Apparently, in the late 1980s, the Boston's child-welfare agency developed a policy to allow foster children to enroll in drug trials at a time when there were no approved treatments for children infected with H.I.V. and AIDS. Sounds harmless right? They had acted in good faith and in the interests of the children. However, you must remember; it all depends on how you look at it.

Liam Scheff, a freelance journalist in Boston, charged that the children were put in trials without their parents’ knowledge and were given medications known to cause death. He said that the drugs in question had Food and Drug Administration warnings on them and that they had “caused permanent injury and painful death in adults who have taken the exact same drugs at normal prescribed doses".

As a result, in 2005 the city commissioned the Vera Institute of Justice, an independent nonprofit group, to investigate the claims.

The Vera Institute of Justice found no evidence that any children died as a result of the trials or that the foster children were selected because of their race. Sounds like Liam can put his money where his mouth is, right? We're not done yet.

On the flipside, it was also found that the child-welfare agency had not always followed its own protocols and kept poor records. Sixty-four children participated in 30 medication trials that were not reviewed by a special medical advisory panel.

Moreover, the informed consent forms from biological parents or guardians were missing from the child-welfare files in 21 percent of cases. In some cases handwritten consents were found instead of the official consent forms. No big deal, right?

Wrong! The problem with this case is the issue of enforcement. It's all well and good that we have guidelines and policies set in place, but if researchers do not follow these guidelines, then what use are they? Without informed consent, there is no way to know if the parents/legal guardians knew the details of the study or if they even agreed to the child's inclusion.

The unethical events within this story may not have the same magnitude and lasting effects as the Tuskegee Syphilis Study; however, isn't this story an ethical consideration that must be viewed with same the amount of gravity?

I guess it's all depends on how you look at it…