Lincoln wrote:Not to belabor the obvious, but none of us are doctors (at least the turn your head and cough variety). By a certain level of logic, none of us can be informed, as we lack the education to understand the medical nuances.
Even when MDs explain things to their test subjects, it inevitably involves statistics. Sad to say, but the general public's comprehension of statistics sucks serious rocks. They just don't understand them. Here is another place where "informed consent" is likely impossible.
I am thinking that "informed" here is a specious concept...no doubt a legal one, but not incredibly well defined nonetheless. Do you think the original consent, which covered diabetes "and other psychological and medical tests," was "informed?" If the Indians can't understand what "and other psychological and medical tests" means, can they understand what "diabetes"means? I mean >>really<< means?
Personally...and this is just an internet forum, so opinions are the currency here...that if a person has concerns, the consent needs to be more specific (i.e. "test A and B and only A & B").
Let's again be hypothetical...again because it is a forum, so we can do that. The objection was that the genetic testing revealed a degree of inbreeding and a non-local origin. The original consent was to study diabetes. Suppose that the diabetes testing revealed whatever it did, but simultaneously determined that the diabetes originated from inbreeding. Actually, given the simple facts of genetics, it kind of has to. The effect stemmed in an individual, whose progeny had a reproductive advantage. As the non-diabetes-inducing population died out, it is inevitable that inbreeding will result....maybe between second and third cousins or whatever, but the genetic diversity must be reduced, without outside influence. And, given that this problem is so broad in the population, it seems evident that there was little influx.
In short, even before the diabetes study, the inbreeding is obvious. The diabetes study supported it, given the similarities in the populations' biochemistry, and the subsequent genetic study simply quantified something that was already obvious.
So...is it the quantifying for which informed consent is necessary?
I understand that the objectionable studies required another test, but it didn't require another sample. Nor were the tests done on living beings (which is unlike the Nazis [I invoke Godwin's, by the way]). They were done on non-living matter, freely donated (presumably with informed consent, as nobody seems all that fussed over the diabetes studies).
It seems to me that the best way to avoid dustups like this would be to impose the (stupid in my opinion) rule that samples must be destroyed after the initial tests were done.
Remember that I am an engineer. First, and foremost, I seek to make things work. Thus, I usually simply comply with regulations without worrying about whether they are justified, rational, or effective. This makes me partly unqualified to comment on the science concerns in this question.
However, within that somewhat narrow context, we have a history of guidelines (each more restrictive than the prior) on human research that start with the Nuremburg Code (40s), then the Declaration of Helsinki (60s), the Belmont Report (70s), and the establishment of the National Bioethics Advisory Committee (90s). Along the way, HHS codified a lot of this stuff into CFR 45 and 46. There are other guidelines for the world at large, but the US generally ignores anything "not invented here."
A number of researchers have objected to these guidelines, and have presented some pretty good arguments, for example, for a
presumed consent that might address situations like the one in Arizona
if, and only if, the subjects could be adequately deidentified AND if the subjects could not be found at a later date to obtain new consent. Given our increasing move toward an international economy, with the attendant necessity to observe at least the letter of international laws, I don't expect the US to ever adopt a full
presumed consent.
I believe it was the Belmont Report that contained a phrase something like this (obviously grossly paraphrased by me), "If the consent can be done right, do it, convenience to the researcher be damned!"
As to the question of destroying biological samples, I ask, would you be comfortable deleting your electronic notebook archives as soon as your paper is accepted by
Phys. Rev Ltrs? Of course not, and it gets worse with human biological samples where there is a chance (in this case a big chance) that they fall under HIPAA's medical records policies (Can you say major felony? For each vial?). Most major research outfits have record storage vaults where these things can be kept securely.
Over the years many have raised the question of whether anyone can really give informed consent. I recall lying in a hospital bed once and listening to the anesthesiologist explaining to the person in the next bed that some of the possible outcomes might be brain damage or death. The patient starting bellowing, "What? I'm not doing this!" and refused to sign the form. That's part of why people fib to subjects. One of our local hospitals now offers pre-surgery classes so that people understand, when possible, what is going to happen, what will be done to them, and what the possibilities are. This is a complicated question.
I agree with your comments on statistics. There's little hope there. Even many scientists can't (or won't) understand statistics (they seem unable to distinguish between 1 SD and 3 SD).
However, in the case of the Havasupai, there was a clear path forward for the genetics researchers. They should have taken it. They should have submitted their research proposal to the University IRB for approval. They had within their power the ability to determine if they could do this ethically, and then to do it that way. They were perhaps arrogant, perhaps lazy, but, at the end, wrong.