On Tue, May 17, 2016 at 10:31 AM, Dave Crossland <d...@lab6.com> wrote: > > On 17 May 2016 at 10:17, Chris Leonard <cjlhomeaddr...@gmail.com> wrote: >> >> Source of funding has nothing to do with the applicability of laws and >> regulations on human subjects protection in research. > > > Please explain this. > > Laws are one thing, regulations are another; laws apply to everyone in a > jurisdiction, regulations are self-applied by organizations. > > The HHS regulations page says in its first paragraph that it applies to > research institutions that have DHHS funding. > > The HHS website about page says: > > The Office for Human Research Protections (OHRP) provides leadership in the > protection of the rights, welfare, and wellbeing of subjects involved in > research conducted or supported by the U.S. Department of Health and Human > Services. > > > Sugar Labs is not a research institute and doesn't have DHHS funding, so > these regulations do not apply; they are merely useful reference material.
IANAL, but I'm not sure that HHS would necessarily be the appropriate regulator of relevance, but "official" positions on any form of human subjects research are largely standardized by international conventions and foundational documents like the Nuremburg Code and the Helsinki Declaration. My citation of my own experience in conducting and overseeing *biomedical* human subjects research was merely a cautionary statement by analogy, not a reference to being fully up-to-date on applicable law governing educational research. If I had to guess, and it would only be a guess, I would think the US Department of Education would be a potential regulator of the sort of activities that someone associated with Sugar Labs might consider undertaking. The US Department of Education also subscribes to and enforces ethical principles derived from the commonly cited foundational documents on ethical research, which by themselves do not carry the force of law, but serve as the basis for most law-making in the field of human subjects protection. Unlike HHS, where the regulatory scope is primarily described in Title 21 of the Code of Federal Regulations (CFR), I believe the scope of the Department of Education's regulatory remit is described within Title 34 CFR, more specifically, part 97 (34CFR97 as it would be commonly cited.) http://www2.ed.gov/policy/fund/reg/humansub/part97-2.html#97.101 In reading these documents, one will typically see very specific callouts saying that they apply to federal government employees, etc. to make clear that the Congress does not intend to allow appeals to the general concept of sovereign immunity for activities by the federal government, or doing what Congress often does, exempting itself from the need to comply with a specific law. The purpose of these call-outs are generally to make the coverage of the law broader by specifically saying they do apply to Feds, contractors and funding recipients, rather than narrower. One should never read the CFR and make a determination that it "does not apply to me" without consulting with a lawyer. That way lies madness as well as potential fines and imprisonment. Even in the statements that seem to specifically exempt a particular area, one finds weasel words like "unless otherwise required by department or agency heads" without real guidance as to whether your particular situation falls within the scope of the law or not. It is generally safer to read such arcane legal documents with an eye towards "how might this be construed to apply to me" than with an eye towards "how can I argue on an e-mail list that this does not apply to me". Arguments on an e-mail list and those conducted in the federal or other jurisdictional courts bear little resemblance to each other, much to the chagrin of those who run afoul of laws they thought "did not apply to them". 34CFR97.101c through 34CFR97.101h provide ample examples of the sorts of legalese that is intended to disabuse you of the notion that any given activity is not covered by this or similar laws in some other jurisdiction. Going to an e-mail list for legal advice is a fool's errand, you need to consult with a lawyer if you want to gather data on human people (various data privacy laws MAY apply) and especially children (various human subject and informed consent laws MAY be applicable). Assuming that there are not applicable laws (or regulations granting a particular Federal agency regulatory or enforcement powers) governing an activity like collecting data on how kids use computers in an educational setting is a generally bad idea, YMMV, IANAL, so I will not venture opinions as to whether the relevant law under which a given Federal agency has been granted regulatory authority (by any given CFR Title or part) is FERPA (Family Educational Rights and Privacy Act) or some other bit of statute, that is what lawyers get paid to do and IANAL. cjl _______________________________________________ IAEP -- It's An Education Project (not a laptop project!) IAEP@lists.sugarlabs.org http://lists.sugarlabs.org/listinfo/iaep