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According to an answer to this post, the legality of asking someone questions about what they experienced after consuming a drug changes if the questioner initiated the consuming of the drug, in which case it’s medical research and has to conform to medical research regulations, vs. if you ask after they already took a drug, in which case it can be seen as market research and not medical.

What law dictates what defines “medical research” and rules such as the one above?

Is it 45 CFR?

Thank you

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    It isn't really possible to answer until you a clear upon why you want to know, because different definitions apply for different reasons. The definition for exemptions from the Controlled Substances Act is not the same as the definition for the practice of medicine definition is not the same as the scope of a human subjects committee review requirement at a university. Words don't have legal meaning outside a particular context and inquiry.
    – ohwilleke
    Mar 8, 2022 at 16:53
  • Why I want to know is because there are medical issues I want to work on and I want to know what options exist for researching them, i.e. if getting a Ph.D. first is strictly necessary or if that can come over time. Of the three sub-aspects you mentioned I am most interested right now in what the legal definition of “medical research” is, how the law has set boundaries on what that is. Then I can use that to learn more what the requirements to do it are. Thank you Mar 9, 2022 at 11:33

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What is and what isn't a medical trial is a decision of the FDA, and they outline their process on their own website.

The FDA is allowed to regulate under a repeatedly updated set of laws since its inception:

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"Medical research" is not, per se, subject to IRB regulations so no part of that law defines "medical research". However, 45 CFR Part 46 is how one arrives at an answer to the question of whether institutional review is required. You primarily must determine if the research on human subjects is

conducted, supported, or otherwise subject to regulation by any Federal department or agency that takes appropriate administrative action to make the policy applicable to such research.

The definition of research in fact could exclude certain actions that look like "medical research", because of an exemption that

the following activities are deemed not to be research... Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority.

If the questioner was authorized by a public health authority as a form of "health surveillance", the question is not research. Also, §46.104 defines various forms of "exempt research". The main point here is that it does not come down to "defining medical research", it comes down to specifying whether the research is subject to the IRB approval regulation.

In that section, in (d)(3)(i) there is a real possibility that the question is not subject to the IRB requirement. There is an exemption for

Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection

subject to one of three criteria that define "no risk" (anonymous, would not harm the subject if revealed, or is subject to a 'limited review').

However, the condition you set, that the question is asked by the person who administered the drug, changes the practical outcome, because the "asking a question" part may not be regulated, but the "administering a drug" part could be. It is when a drug manufacturer conducts tests on a new drug and the survey is part of the efficacy and safety review. It is not when your doctor suggests that you take two aspirin and call him in the morning to report any adverse effects.

The other thing to bear in mind is that institutions can impose requirements than are more strict than are mandated by the law, as a precaution.

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  • Thank you, that’s a very detailed, technical, precise answer. So it seems you are saying that the law defines my question in terms of “that which is subject to regulation”, and it likely is subject to regulations “if it poses a risk”. From then on it’s not this specific law but the IRB regulations that act essentially as the law. Is that correct? Thank you Mar 9, 2022 at 11:50

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