Sunday, June 17, 2012

Clinical Trial Ethical Underpinnings: reflecting on a pediatric anthrax vaccine trial / Sci Am Blogs

In her third excellent Scientific American blog post, Infectious Disease doctor Judy Stone has delved into the ethical and regulatory framework under which clinical research must be conducted.  Dr. Stone provides a succinct historical overview of the important documents, and how they were enshrined in regulations guiding the conduct of research in humans.  For readers unfamiliar with The Declaration of Helsinki, the Belmont Report, and the Nuremberg Code, this is important information.  Did you know that informed consent is a relatively new, post World War II phenomenon?

The addition of children as routine research subjects is even newer, dating back only 10-15 years.

Given this context, Dr. Stone explores how the proposed trial of pediatric anthrax vaccine fails to comply with the existing norms and regulations:
... How does the proposed pediatric vaccine trial fit with the precepts outlined above? 
First, the Belmont principle “respect for persons” is violated, in that this vaccine trial, using the adult anthrax vaccine (AVA) has known serious risks and other potentially unknown risks in kids, and no benefit. We won’t even know if any antibodies formed would be protective.

Belmont principle of benefits to the participant is violated since there are none. Furthermore, U.S. regulations (45 CFR 46, Subpart D) state that children may not be exposed to risk if a medical experiment does not offer them a direct benefit. Even the NBSB report notes “Currently, U.S. children are not at immediate risk from anthrax and would not benefit directly from pre-event AVA [anthrax vaccine] administration”…There is only the potential future benefit...

And it appears that the Belmont principle of justice will be violated. A vulnerable population will be used without assent. (How many kids would willingly take a painful course of five injections, even without worry of other side effects?) How will the children’s continued participation be ensured? Coercion? Or bribes? Reportedly, the study is to be done in New York City, where there are 9/11 first responders who would be willing to volunteer their children. These parents, traumatized by 9/11, are unlikely to be able to review an informed consent form critically or objectively. Would there be such enthusiastic parents in rural America? I doubt it. I like the biting suggestion by Dr. Anthony Robbins, “How about the children of people who have the national security clearance required for the government to share with them all the evidence that adds up to a “credible threat?” With that information in hand, these parents would be able to make the choice-an informed decision for their children-that the rest of the public surely cannot.” ...

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