4 ms·

A take from the opposite end of the spectrum (ethically and logistically): https://arstechnica.com/science/2017/08/bucking-fda-peter-thiel-funds-patently-uneth

A take from the opposite end of the spectrum (ethically and logistically): https://arstechnica.com/science/2017/08/bucking-fda-peter-thiel-funds-patently-unethical-herpes-vaccine-trial/ https://arstechnica.com/science/2017/08/bucking-fda-peter-th... I wish the author took more seriously the warnings around patient health and safety. Yes, they may not apply to his particular project, but that doesn't make asking about them useless. To take past abuses lightly undermines his overall point. It's done precisely to avoid a situation like the way he delegated responsibility to his PI: "Dr. W had vaguely hoped that I was taking care of it. I had vaguely hoped that Dr. W was taking care of it." The review board shouldn't make vague assumptions about something as critical and necessary as ethical study design.

apsec112 9y ago
There are very serious costs to excessive safety regulation. When it makes drug development more expensive, marginal drugs don't get put through trials, and those drugs then never reach patients. Rational analysis means weighing the cost of each additional safety rule against the benefit. In many cases, there's a lot of evidence that the benefits of the current IRB process are trivial or nonexistent, and the costs are large.
ScottAlexander 9y ago
I take the possibility of serious ethical violations...well, seriously. I'm not sure whether the global cost of IRBs outweighs the benefits. But I'm pretty sure that the sort of regulatory changes OHRP proposed (mentioned in the linked NYT article), where studies like mine with minimal possible risk are exempted from IRB requirements, seem good and important. I also wonder whether it's possible to monitor even the scary studies with lots of potential risks - like the herpes vaccine trial you link to - with a little more common sense and a little bit less insistence on everything being signed in pen.
- zaroth 9y ago
  BTW, welcome [back] to HN. And just wanted to say, I am immensely enjoying very many of your articles and glad to see them making the front page!
harryh 9y ago
Extending rules that are a good idea for some projects to make them apply to all projects is the basis of crappy bureaucracy. It replaces sound human judgement with a set of inflexible rules that must be followed just because they are rules.

apsec112 9y ago

There are very serious costs to excessive safety regulation. When it makes drug development more expensive, marginal drugs don't get put through trials, and those drugs then never reach patients. Rational analysis means weighing the cost of each additional safety rule against the benefit. In many cases, there's a lot of evidence that the benefits of the current IRB process are trivial or nonexistent, and the costs are large.

ScottAlexander 9y ago

I take the possibility of serious ethical violations...well, seriously. I'm not sure whether the global cost of IRBs outweighs the benefits. But I'm pretty sure that the sort of regulatory changes OHRP proposed (mentioned in the linked NYT article), where studies like mine with minimal possible risk are exempted from IRB requirements, seem good and important. I also wonder whether it's possible to monitor even the scary studies with lots of potential risks - like the herpes vaccine trial you link to - with a little more common sense and a little bit less insistence on everything being signed in pen.

zaroth 9y ago
BTW, welcome [back] to HN. And just wanted to say, I am immensely enjoying very many of your articles and glad to see them making the front page!

harryh 9y ago

Extending rules that are a good idea for some projects to make them apply to all projects is the basis of crappy bureaucracy. It replaces sound human judgement with a set of inflexible rules that must be followed just because they are rules.