I'm aware that various laws exist regulating research on human subjects (Wikipedia summary here and in linked pages). However, I've had a tough time finding sources that clarify the boundary between legal restrictions and "guidelines". It's also not clear to me to what extent these laws apply to institutions (by governing what kinds of research they can fund/sanction) versus individuals (by governing what kinds of research activities can actually be performed).
So what I'm interested in is:
- Are there laws that make it illegal for an individual to violate or blur the boundaries of human subjects ethics guidelines, even though what is actually done would not be illegal if it did not constitute research? For instance, stopping someone on the street to ask them a question is not in itself illegal; does it become illegal if an individual does it to a lot of people and writes about it as research, without having the sorts of safeguards that an institution's IRB would require? I'm talking here about cases where the acts themselves would not otherwise be in question (e.g., the research doesn't cause physical harm), but only become potentially problematic because they are part of research.
- If research conducted at an institution violates ethical guidelines, is that considered an illegal act by the IRB or the individual, or both (or conceivably neither, if the violation wasn't covered by an actual law)? For instance, if a researcher submits a research proposal and has it approved, and then someone claims the proposal violates human subjects research guidelines, is it the wholly the researcher's fault for doing it, or does the IRB bear culpability for not properly vetting the proposal and alerting the researcher to the problems?
- Is there a specific mechanism for determining what counts as "research" subject to these rules in the first place? That is, is there an accepted legal framework for distinguishing informal information-gathering, not subject to the rules, (e.g., "Hey all my Facebook friends, everybody take this latest web quiz and post your results in comments!"), from bona fide research that is subject to the rules?
- Are there legal distinctions between different subject areas of research? A lot of the stuff I read on the issue mentions motivating cases that involved medical research, like the Tuskegee syphilis experiment. However, it's not clear to me if medical research actually has different legal restrictions than other kinds of research (e.g., sociological interviews or psychological questionnaires).
I'm mainly interested in the legal situation in the US, but would be interested to know about the law on this matter in other countries as well.
Also, I'm aware that in practice it often doesn't matter where the line is between what's actually illegal and what's just disallowed by university guidelines or scholarly consensus, because a researcher's reputation, career, and funding are vulnerable regardless of whether actual laws were broken. (In other words, even if you didn't break any laws, a journal may refuse to publish your paper if it smells a rat.) I'm asking this question on this site because I'm specficially interested in which restrictions on research activity are actually a matter of law, not just convention or institutional self-regulation.