Which aspects of human-subjects research rules are actually laws rather than conventions? 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.
According to the NIH, there are in fact a number of laws in the US regulating human research, as opposed to codes and conventions (although the majority does consist of the latter). 1962 - Milestone: Kefauver-Harris amendments to the 1938 Food, Drug, and Cosmetic (FD&amp;C) Act, [Public Law 87-781; 76 Stat. 788-89] This amendment was important in establishing that human testing was necessary in drugs and therefore provided for the regulation of human testing, after the thalidomide scandal caused a number of preventable birth defects due to insufficient human testing. The FDA describes the law as (emphasis mine): ... The Kefauver-Harris Drug Amendments also asked the Secretary to establish rules of investigation of new drugs, including a requirement for the informed consent of study subjects. The amendments also formalized good manufacturing practices, required that adverse events be reported, and transferred the regulation of prescription drug advertising from the Federal Trade Commission to the FDA. 1974 - Milestone: National Research Act The National Research Act legally justifies and grants the NIH the power to set up boards to regulate human medical research: SEC. 102. (a) Congress finds and declares that (1) the success and continued viability of the Federal biomedical and behavioral research effort depends on the availability of excellent scientists and a network of institutions of excellence capable of producing superior research personnel ; (2) direct support of the training of scientists for careers in biomedical and behavioral research is an appropriate and necessary role for the Federal Government ; and (3) graduate research assistance programs should be the key elements in the training programs of the institutes of the National Institutes of Health and the Alcohol, Drug Abuse, and Mental Health Administration. (b) It is the purpose of this title to increase the capability of the institutes of the National Institutes of Health and the Alcohol, Drug Abuse, and Mental Health Administration to carry out their responsibility of maintaining a superior national program of research into the physical and mental diseases and impairments of man.
The current version of copyright law in the PRC is here. Art. 10 states what is protected, which includes the standard rights of distribution, copying, modification and so on (which makes software cracking illegal). Article 22 gives the equivalent of the Fair Use limitation on copyright protection: a work may be exploited without the permission from, and without payment of remuneration to, the copyright owner, provided that the name of the author and the title of the work are mentioned and the other rights enjoyed by the copyright owner by virtue of this Law are not infringed upon for 12 specific reasons (translation into Braille or a minority national language, free public performances, quotation to make a point end so on), which includes some potentially applicable reasons (1) use of a published work for the purposes of the user's own private study, research or self-entertainment (6) translation or reproduction, in a small quality of copies, of a published work for use by teachers or scientific researchers in classroom teaching or scientific research, provided that the translation or reproduction is not published or distributed (7) use of a published work by a State organ within the reasonable scope for the purpose of fulfilling its official duties It is unclear what "State organ" refers to and it is unlikely that a university is a "State organ". It is unlikely that (1) and (6) are interpreted as an across-the-board "education exception" to copyright, but that could be an avenue for legality. The standard misconception of copyright law is that anything done for educational purposes is allowed, and the PRC law seems to have at least the seeds of such a misunderstanding. However... software protection is subject to separate regulation in Decree No.339 of the State Council, an English version being here. The regulations recapitulate the basics of copyright protection; software cracking is regulated under Art. 23, which says that anyone who commits any of the following acts of infringement shall, in light of the circumstances, bear civil liability by means of ceasing infringements, eliminating ill effects, making an apology, or compensating for losses:... (5)to alter or translate a piece of software without the authorization Art. 24 continues, saying that it is forbidden (3) to knowingly circumvent or sabotage technological measures used by the copyright owner for protecting the software copyright; (4) to knowingly remove or alter any electronic rights management information attached to a copy of a piece of software That covers cracking. Article 30 covers the situation of someone using pre-cracked software: A holder of copies of a piece of software that neither knows nor has reasonable grounds to know that such copies are infringing ones does not bear liability of compensation but shall cease the use of, and destroy, the infringing copies. Nevertheless, if the cease of use or the destruction of such copies is likely to cause heavy losses to him, the holder of such copies may, after paying reasonable remuneration to the software copyright owner, continue to use such copies. A mere user who is discovered simply has to stop, unless they should have known that the copy was illegal in which case they would be responsible for compensating the rights holder – I have no idea what the standards are for having reasonable grounds to know.
That GDPR Disclaimer is no protection in some jurisdictions: the applicable laws to that situation in germany for example don't care about the GDPR: Cold calling, mailing, or e-mailing private people to advertise services all is handled by the same law: Without the consent it is expressly illegal under §7 of the law against unfair competition (Gesetz gegen unlauteren Wettbewerb UWG) and such cases are rather Slam-Dunk if the origin can be made out. The punishment can be a 300.000 € fine. The fact that to email someone you need their e-mail address and that e-mail addresses and private addresses are by default considered personally identifiable information is making it worse for the advertizer: Without either an exception (there is none available to cold-emailing) or special allowance of the person the data belongs to, you violate §4 of the federal data protection law (Bundesdatenschutzgesetzes BDSG) just by handling their e-mail address. That's a separate crime from the UWG one, adding up to another 300.000 € fine under §43 BDSG - or even up to 2 years in prison under §44 BDSG! Oh, and if the email does not contain a proper sender's address, that's another chance for a huge fine under the UWG... So, GDPR is your least trouble, if you violate the marketing laws of a country, or their own data privacy laws. A disclaimer means nothing as the act of sending the mail, even to an unintended addressee, is what is illegal and the law as written does not give a damn about 'I didn't want to advertise to that person' when in fact you sent them unwanted advertisements. Oh, and the very repository you suggest? It would violate the very same §4 BDSG and be illegal for processing private data if it was not actively asked to do that by the end user. As a result, that database is useless: It does kick back all people not in its database. Its database is incomplete because only few people give their address to that database as people not aware of the database never add their data on their own. So it regularly violates §4 BDSG with every German citizen's e-mail address it gets and kicks back, and claiming those addresses would be OK, it throws the company trying to check the database under the bus because they rely on data that is impossible to be reliable. tl;dr Don't do cold-(e)-mail marketing. You throw yourself into boiling oil with a lit torch in hand. further reading Other laws banning such behavior I had listed here, and I quote myself: The US has the CAN-SPAM-Act, which illegalizes sending unsocialised advertisements. You may NOT send a mail if any of the following is true: it has no opt-out the email was gained by 'harvesting' contains a header not matching the text contains less than one sentence the adressee does not have any relation to you In fact, you are liable for a 5-digit fine per infringing e-mail in the US. The FTC itself suggests to never buy e-mail lists - as E-mail harvesting or generating any possible e-mail adress itself is illegal.
The interpretation of state rules of civil procedure is a matter purely for state courts. Whether a state procedural rule (or even substantive approaches to jurisdiction) violates federal law, including the U.S. Constitution, is a question of federal law, but state courts are still competent to answer such questions that arise in the process of state litigation, subject only to precedent from the Supreme Court of the United States. I may be starting to just repeat things now, but even if the legal issue you're interested in (the extent to which trial courts are divested of jurisdiction during non-frivilous interlocutory appeals in matters controlled by the FAA) is substantive or jurisdictional rather than procedural, Federal circuits do not bind state courts. However, the Supreme Court of the United States can provide binding prcedent on federal law that state courts must apply. I could see the reasons in Coinbase being written broadly enough to apply to both state and federal proceedings.
The law is really bad at protecting whistleblowers From my understanding of US law, this is not unauthorised access to a computer: the reporter made a legitimate request to a remote computer, that computer provided data,the reporter accessed the supplied data on their own computer. However, pointing out the failures of people in power is fraught even if it is not illegal. It is certainly within the Governor’s power to authorise an investigation of the reporter. On the face of the law, it seems reasonable to suspect that what was done might be a violation so there is nothing legally wrong with initiating an investigation. I suspect that such a broad interpretation of the law would fall foul of the First Amendment which may partly explain why it wasn’t prosecuted: the government doesn’t want to find out. Similarly they can issue press releases, which, due to the First Amendment, don’t have to be true, just not defamatory. Saying it’s a possible violation is true and not defamatory. Saying the reporter was an evil person who is only doing this for political purposes is a statement of opinion and not defamatory. It’s a fact of the world that people with power can use that power in ways that are malicious, unethical, and unfair but not necessarily illegal.
It is not obvious that is it illegal in Washington state. Everett WA has local ordinances against "lewd conduct" (there are versions of this at the state level and in most municipalities). Having sex and masturbation are included in the class of "lewd acts", and are also included in "sexual conduct". An activity is "obscene" if three things are true. First, the average person, applying contemporary community standards, would find, when considered as a whole, appeals to the prurient interest and when considered as a whole, and in the context in which it is used, lacks serious literary, artistic, political or scientific value. I think having sex or masturbating could pass these two tests. The third condition is that the act explicitly depicts or describes patently offensive representations or descriptions of... [sex, masturbation, or excretion] The prohibition is more narrow: A person is guilty of lewd conduct if he or she intentionally performs any lewd act in a public place or under circumstances where such act is likely to be observed by any member of the public. If lewd conduct were completely illegal, you could not excrete or have sex withing the city limits. Now we have to turn to the definition of "public place": an area generally visible to public view, and includes streets, sidewalks, bridges, alleys, plazas, parks, driveways, parking lots, automobiles (whether moving or not), buildings open to the general public, including those which serve food or drink or provide entertainment and the doorways and entrances to buildings or dwellings and the grounds enclosing them, and businesses contained in structures which can serve customers who remain in their vehicles, by means of a drive-up window Focusing not on the probable intent but on the words, it is primarily defined as "an area generally visible to public view". Your house qua building is probably generally visible to public view, as is a public toilet or hotel. The inside of your bedroom is probably not generally visible to public view, nor is the inside of a toilet stall. While the building is probably a public place, a closed stall within the building does not meet the definition (nor does a hotel room). It might however qualify under the clause "or under circumstances where such act is likely to be observed by any member of the public". The statute does not give a definition of "observe", but under ordinary language interpretation, observation may be seeing or hearing. Silent sex, masturbation or defecation might not qualify as being public. Obviously, excretion in a stall of a public bathroom cannot be a lewd act, presumably because the average person does not generally consider ordinary excretion as appealing to the prurient interest: but there could be contexts where it does. Another avenue for prosecution is the Indecent Exposure state law which is when one intentionally makes any open and obscene exposure of his or her person or the person of another knowing that such conduct is likely to cause reasonable affront or alarm. It is totally non-obvious that sex or masturbation in a toilet stall is "open". There is a slippery slope regarding quiet sex or masturbation w.r.t. knowing that the conduct is likely to cause reasonable affront or alarm. Because the contexts where sex and masturbation are not clearly spelled out by statutory law, the matter would depend on how courts had interpreted previous cases. There have been arrests in Washington of people having bathroom sex, but I don't know if anyone has ever or recently-enough been convicted for having quiet sex out of view in a toilet stall, or similar place. There is a potentially applicable case, Seattle v. Johnson, 58 Wn. App. 64, which seems to involve public sex, and the conviction was overturned because the complaint was defective, in not including the element "that the defendant must know 'that such conduct is likely to cause reasonable affront or alarm'". It is not clear from the appeal what the act actually was – it probably was for public nudity. There is also an decision by the state appeal court division 3 (not publicly available) in Spokane v. Ismail which, in connection with a charge of public urination declares that "A toilet stall is not a public place. The center of Riverfront Park during the lunch hour is a public place", in connection with an ordinance just like the Everett one against public lewd acts.
This question shows a misconception of GDPR. GDPR creates an obligation not just towards the data subject but also towards the authorities of the relevant state(s). The data subject cannot waive your responsibility to safeguard data, document internal processes, etc. GDPR is not a blanket ban on the handling of personally identifying information (PII). Informed consent is one of the ways to get permission to process and store this data. If your data subjects are prepared to give your sweeping permissions, ask for consent (informed, revocable, etc.), document the consent, and go from there. The data subject does not get to decide what classification data falls under. If you collect, say, medical data, then you are subject to increased restrictions and safeguards.
This sounds completely incorrect to me. First, subsequent research is not normally a "derivative work" for the purpose of copyright, since copyright doesn't protect your ideas but only the particular form in which you have expressed those ideas. Second, as the owner of the copyright, you can permit anyone to make any sort of copy or derivative work, or sell, assign, or license the ability to do so to other parties, without regard to whether the work has been published. The real reason that nonpublication of your work would stifle further research is that researchers will not have access to it.