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Comment by derbOac | Hacker News Reader

The answer is no, you don't need permission, but you do incur a legal and ethical risk whenever you do research, and as such, the more you can do to strengthen the legal and ethical arguments in your defense, the better.

IRBs are simply a way to say "I had an independent group of ethical and legal authority review my research and they thought it was ok".

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That is right, and further - I think about IRBs like I do non-profit boards. One of the key tasks of a board is to determine what risk the organization is willing to bear. I think the IRBs at these institutions are 1) following federal laws but 2) making a judgement on the risk the institution is willing to sign up for. For example, for many clinical trials are distributed to multiple "sites" where the trial is actually administered. Many of these sites are universities. What the University of Iowa is willing to bear is different than the University of Michigan and the IRBs reflect that.

With medical device development, the IRB represents the institution taking liability for harm to patients. They're there to make sure they aren't about to kill someone or harm them and get the institution sued.

So they take it pretty seriously. More so in countries where it's easy to sue, though.

It's hard to take the article seriously since

  1) It doesn't even reference the relevant law
  2) The relevant law is so simple and clear

42 USC 289(a) states:

"The Secretary shall by regulation require that each entity which applies for a grant, contract, or cooperative agreement under this chapter for any project or program which involves the conduct of biomedical or behavioral research involving human subjects submit in or with its application for such grant, contract, or cooperative agreement assurances satisfactory to the Secretary that it has established (in accordance with regulations which the Secretary shall prescribe) a board (to be known as an “Institutional Review Board”) to review biomedical and behavioral research involving human subjects conducted at or supported by such entity in order to protect the rights of the human subjects of such research."[1]

To put it succinctly this only relates to any entity which applies for a grant, contract, coop. agreement under chapter 6A of 42 USC.

This in no way relates to private research. It's easy to get hung up on regulation spaghetti code, but regulations cannot exceed the scope of the statutes, which in turn cannot exceed the authority of Congress.

Edit: add source [1] https://www.law.cornell.edu/uscode/text/42/289

Yes, but a university or other institution will often also require IRB review in additional cases, because maybe they don't want to let researchers accidentally cause brain damage just because a billionaire rather than a government is paying.

Also pharma companies.

> To put it succinctly this only relates to any entity which applies for a grant, contract, coop. agreement under chapter 6A of 42 USC.

But the whole point of the article is that there are other cases when you need IRB approval besides this one. That's one of the myths he's busting.

The point that I was making was that there can be no federal law which requires an institutional review board for private research, which was something the author alluded to in the paragraph after the flow chart:

> The government can’t possibly claim to regulate what me and my roommates eat at home! That would be stupid!” Yes, it would be stupid. But who says the world makes sense? Now, would you actually be prosecuted for violating those rules?

Author says "those rules" without actually citing anything.

There is no scenario in which the Secretary of HHS can create rules which would do what the author was suggesting. It is not even something Congress could do, which is why they haven't created a statute which goes beyond their authority in requiring these boards for anything other than research receiving federal funding. If the Secretary were to create such a rule, it would obviously exceed his authority.

> Author says "those rules" without actually citing anything.

The author actually go into how universities make their own rule that potentially affects teachers and students doing research with their own time and resources.

Then I apologize, I evidently misread your original comment.

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