RE: Vanderbilt apology - informed consent, etc.

[DamschenGA <damschenga@mkf.ornl.gov>]

The answers so far bring to mind some questions:

1) Was "informed consent" as currently applied the accepted practice at the
time of the study? I was under the impression (from some ancient class I
took) that the thinking at the time was to not tell subjects everything that
was being done if there was minimal risk because there was concern that the
experiment results would be skewed. So, for example, you would tell a
subject that you were giving them iron supplements, but not that there were
tracers involved. This comes back to the old thread about attempting to hold
earlier researchers to current standards and punishing them (or the
workers/institutions following them) for not following current practices 20
- 30 - 40 - 50 years ago.

2) How much dose (maternal and fetal) are we talking about here? Enough for
the experiment to have been a credible cause of cancer in the children?

3) How many children of the women who were NOT given the tracer died of
cancer?

4) An apology may be appropriate, but what, exactly, did Vanderbilt
apologize for? Following accepted practice at the time?

If accepted practice/protocols for the time were not followed, then redress
is certainly due the plaintiffs. However, if the researchers were operating
under accepted best practice for the time and did not place the mothers or
their children at discernible risk, then I have a BIG problem with paying
$10,000,000 and apologizing for a program that probably saved the mothers
and their children from the developmental and physical problems associated
with chronic iron deficiency during pregnancy (not to mention helping
alleviate those problems for hundreds of mothers since the study by
improving our understanding of iron metabolism).

I think that the people who probably REALLY owe the apology, are the ones
who planted the idea that this tracer experiment may have caused the deaths
of the children. Tragedies happen in life and we don't always get to have
someone to blame them on. It is a tragedy that the women lost their
children, but if the issue is really "informed consent" or lack thereof 50+
years ago and not the iron tracers being the probable cause of the deaths,
isn't the diversion of $10,000,000 from research at Vanderbilt a much worse
travesty than not telling the women that they might be taking trace amounts
of radioactive iron? How much research will now be stopped or not started to
pay for this decision? At what cost in actual (as opposed to hypothetical)
suffering?


-Gary Damschen
>Definitely my own opinion.