Thursday, June 15, 2006

Protecting Subjects in Emergency Research

This story was on the front page of the news section of Usa Today yesterday. It addresses an important ethics issue: how to do research important to patient populations that can't consent.

The PolyHeme Study is being carried out in the Kansas City area, among others. There the researchers made an effort to seek community support, and to get some sense of "community consent." In essence, community leaders stand in for individuals for tests that offer real community benefit. That means the product is being tested in some areas and not in others. It also means that some patients might receive the product without individually consenting. If they benefit, that's a manageable problem. If they don't, it's a real headache.

How do we protect the rights of research subjects where the nature of the problem addressed and the product tested define a context where consent is virtually impossible? And yet these contexts exist, and need the benefits of research.

I've worked with researchers addressing needs in emergency cases in the field. These issues were difficult then, and they're difficult now. At the same time, they need to have our attention. As in these studies, we need to work continually to both meet the immediate medical needs, and also to protect the human rights, of those who may find themselves in those times of need, with no capacity to consent.

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