nos-trum. pronunciation: \nos'-trum\. noun. Etymology: Latin, neuter of noster our, ours.
1. a medicine of secret composition recommended by its preparer but usually without scientific proof of its effectiveness.
2. a usually questionable remedy or scheme.
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Sunday, July 4, 2010

If Experimental Subjects Are "Guinea Pigs," Should Children Be Included?

Should children be included in medical research experimental subjects?

The ethical question is whether the benefits of including children, who sometimes are differently affected by drugs or medical treatments based on changes they undergo in development to adulthood, outweigh the prohibition on non-consent to experimentation.

A recent article in BBC News (July 2) makes the case for including children,
"An honest dialogue should explain clinical uncertainty and that, although the possibility of risk cannot be totally eliminated, it is minimised through research regulation. This means that there are extensive measures in place to ensure that studies are well designed, that any possible risk is minimised, and that there are processes to identify harm.  Children deserve the right to participate in research designed to improve outcomes and reduce uncertainty about treatments."
This is not a small matter.  Where the article makes a mistake is in saying "children deserve the right to participate."  Children cannot give consent to be human subjects in the same way competent adults can.  They don't have the requisite ability to decide risks and benefits to themselves.  That's why the law allows parents the authority and responsibility to protect and defend their interests.  And it's not sufficient to say that the parent can give consent.  Parents are charged with the protection of their own child, not with society's best interest in children.

What would you think of parents who said they allowed experimentation on their child, despite some uncertainty about benefit and risk, because society would benefit in the long run?  In my opinion:  unfit to raise children.  On the other hand, if the child has a lethal disease where all treatment has been unfruitful, I can understand taking any chance...but that's a special case.

So, how do we make sure that medical advances include measures to safely benefit children? 

Probably the only answer is to proceed with extra caution, and with even more safeguards than we do with adults.  I once ran a medical center with an active research program--over 60 protocols, most of which required meticulous oversight by an institutional review board.  As director of the IRB, responsibility fell directly on my shoulders to make sure each and every protocol met all ethical standards, that documentation was kept up to date, and safety monitored regularly.  Talk about putting your career on the line.  If even the slightest "t" wasn't crossed, or "i" dotted, the inspectors would shoot you at dawn.

So I agree with the article that there are regulatory safeguards.  I just still have a problem with the ethical issue of autonomy children pose to health care decision-making.

Doc D

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