united-states medical
Which law dictates what medical research is and the conditions under which it can be carried out?
<p>According to an answer to <a href="https://academia.stackexchange.com/questions/183012/are-you-required-to-have-a-ph-d-to-conduct-a-medical-study-of-some-kind">this post</a>, 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.</p>
<p>What law dictates what defines “medical research” and rules such as the one above?</p>
<p>Is it <a href="https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46" rel="nofollow noreferrer">45 CFR</a>?</p>
<p>Thank you</p>

<p>What is and what isn't a medical trial is a decision of the <a href="https://www.fda.gov/" rel="nofollow noreferrer">FDA</a>, and they outline their process on <a href="https://www.fda.gov/drugs/development-approval-process-drugs" rel="nofollow noreferrer">their own website</a>.</p>
<p>The FDA is allowed to regulate under a repeatedly <a href="https://www.fda.gov/regulatory-information/laws-enforced-fda" rel="nofollow noreferrer">updated set of laws</a> since its inception:</p>
<ul>
<li><a href="https://www.law.cornell.edu/uscode/text/21/chapter-9" rel="nofollow noreferrer">Federal Food, Drug, and Cosmetic Act of 1938</a> (esp. 21 USC chapter 9)</li>
<li>Kefauver-Harris Amendments of 1962 (alterations to 21 USC chapter 9)</li>
<li>Medical Device Amendments of 1976 (more additions and adjustments to 21 USC chapter 9)</li>
<li><a href="https://en.wikipedia.org/wiki/Food_and_Drug_Administration_Amendments_Act_of_2007" rel="nofollow noreferrer">Food and Drug Administration Amendments Act (FDAAA) of 2007</a> (many many revisions to the whole of 21 USC, including chapter 9)</li>
</ul>

<p>&quot;Medical research&quot; is not, per se, subject to IRB regulations so no part of that law defines &quot;medical research&quot;. However, <a href="https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46" rel="nofollow noreferrer">45 CFR Part 46</a> 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</p>
<blockquote>
<p>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.</p>
</blockquote>
<p>The definition of research in fact could exclude certain actions that look like &quot;medical research&quot;, because of an exemption that</p>
<blockquote>
<p>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.</p>
</blockquote>
<p>If the questioner was authorized by a public health authority as a form of &quot;health surveillance&quot;, the question is not research. Also, §46.104 defines various forms of &quot;exempt research&quot;. The main point here is that it does not come down to &quot;defining medical research&quot;, it comes down to specifying whether the research is subject to the IRB approval regulation.</p>
<p>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</p>
<blockquote>
<p>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</p>
</blockquote>
<p>subject to one of three criteria that define &quot;no risk&quot; (anonymous, would not harm the subject if revealed, or is subject to a 'limited review').</p>
<p>However, the condition you set, that the question is asked by the person who administered the drug, changes the practical outcome, because the &quot;asking a question&quot; part may not be regulated, but the &quot;administering a drug&quot; 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.</p>
<p>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.</p>
