IRB SchmaiRB

via The Peej, paying transients for Phase 3 (or earlier!) drug testing.

ATSRTWT

A slice:

The main ethical issues here, of course, are the competence and judgment of the prospective subjects. “When you say ‘money,’ everything else goes out the window,” said Hanif Jackson, a former program supervisor at the Ridge Avenue shelter in Philadelphia, which recently closed down. I heard the same thing from Harvey Bass, a chaplain who has worked at the Sunday Breakfast Rescue Mission shelter for 15 years. He said drug study recruiters often park outside the shelter and approach residents on the sidewalk. Although Bass didn’t think it was his place to warn residents away from the studies, it was clear that he was not exactly a fan. “These guys have no job, no home, and a habit,” he said. “You have people at their lowest state, and they’ll say yes to anything.”

Much of the piece is an indictment of the accuracy of tests involving indigent subjects. Many of them are schizophrenic and therefore resistant to anti-psychotic medication, but:

Volunteers are typically paid $40 to $50 per visit. “The payments are low enough to not be coercive, but they’re enough to supposedly compensate them for the time they’ve spent here, and give them an incentive to come back,” Sfera said. Still, Walters, who has since left South Coast, added that money is what motivates most subjects. “I’d say at least 85 to 90 percent of clients, that’s why they do studies.”

These subjects are cheaper than enlisting, say, college students, and considerably more ethical than, oh... say, exposing Soldiers to treatment without their knowledge or consent (to pick a totally off-the-wall hypothetical example). More subjects for the same price means more precision, following quite naturally from the statutory requirements imposed by the FDA.

Another good quote:

Concepts like “coercion” and “undue influence” are poorly suited for economic transactions, however. Offering desperate people money to take risks to their health may be wrong, but nobody is being coerced. No one is threatening to harm people if they refuse to become test subjects. One parallel would be sweatshop labor. The ethical problem is not that people are coerced into working in sweatshops—people are desperate to work there, under horrific conditions, for pennies. The ethical problem is whether it is acceptable to take advantage of their desperation.

Agreed. This is an ethical problem. Like most (all?) problems, there are no solutions, only tradeoffs. Should the legislature ban testing on transients? Would that make them better off? Is it even true that, "[o]ffering desperate people money to take risks to their health may be wrong," when the alternative is panhandling, exposure, or starvation? Does not their alternative situation already pose risks to their health?

And is the price wrong? Offer them too much money and it's taking advantage of their desperate situation. Offer them too little and it's... taking advantage of their desperate situation. Remove them from consideration at all, and it's forcing them to accept their next available alternative, which by their own economic calculus is worse.

But the real brine this pickle soaks in is one of compos mentis. Whatever the ethical dilemmas of sweatshop labor, at least folks who work in factories in less-developed countries aren't any more (or less) prone to mental illness than the general population. Homeless people have made it through a rather selective filter to land in a bin marked 4F, and are often characterized by debilitating mental disorders. Under the UCC, people with debilitating mental illness don't have capacity, which is legalese for you can't generally enforce a contract (over $500 yadda yadda) against them. In other words, the common law recognizes that mentally ill people aren't suited to make responsible decisions.

And that leaves alternative institutional arrangements still to be considered. For Phase 1 and 2 testing, the manufacturer is still trying to establish safety, which even if you're as skeptical as I am about the charter of the FDA, safety testing is still important prior to a general release. What other population would you target? The elderly? Children? College students? Housewives? Business executives? Longshoremen? Would you ban all testing in humans? Is there a superior path to getting drugs to market? Describe it.

It might be a tragedy that America's homeless population ends up being a collective pincushion for the pharmaceutical industry, but does that speak louder to the collusion of big pharma and the FDA or to the manifold tragedies that lead to homelessness in the first place? There are good ways to advocate on behalf of the indigent. Denying them opportunities is probably not as helpful as exposing the mundane corruptions that are ordinary transfer payments: massive bailouts to well-connected constituents, and payola by the truckload to middle class voters. Given the choice between helping vulnerable populations and securing votes in the next election, politicians tend to act in their own best interests.

I do sometimes wonder if it's ever ethically possible to hire an exceptionally poor person to do anything. Doesn't paying them to any kind of work, even ostensibly honest work, take advantage of their desperate situation? Is there any way to break the Catch-22?