Gov't to review rules about human testing without consent

[indigo girl]

http://blogs.abcnews.com/theblotter/2006/09/government_to_r.html

[pickledpepperRN]

Frightening!

The regulation, approved in 1996, allows experimental testing without consent in the field of emergency medicine research. The first trial under the new rules involved another experimental blood substitute product called HemAssist, which was also tested on trauma patients without consent. That trial was halted after far more patients died who were given HemAssist than those who received standard care. Development of the product was ultimately discontinued.

http://blogs.abcnews.com/theblotter/2006/09/government_to_r.html

[azhiker96, BSN, RN]

I understand why people would object to testing without a subject giving approval. If they don't want that, I respect their opinion. I favor the development of new drugs and treatments and realize that human testing is part of the process. Here's an excerpt from the FDA requirements for testing.

Sec. 50.23 Exception from general requirements. (a) The obtaining of informed consent shall be deemed feasible unless, before use of the test article (except as provided in paragraph (b) of this section), both the investigator and a physician who is not otherwise participating in the clinical investigation certify in writing all of the following

1) The human subject is confronted by a life-threatening situation necessitating the use of the test article.

(2) Informed consent cannot be obtained from the subject because of an inability to communicate with, or obtain legally effective consent from, the subject.

(3) Time is not sufficient to obtain consent from the subject's legal representative.

(4) There is available no alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the subject.

Hindsight is great. If we knew a new product was not going to work as well as current treatments there would be no need to do testing. However, maybe it's better to exclude trauma victims from testing of new treatments. Since we can't approve new treatments without testing though, that means no improvement in how we treat trauma.