5 ms·

The Maryland House Bill 917 is at http://mlis.state.md.us/2002rs/billfile/hb0917.htm http://mlis.state.md.us/2002rs/billfile/hb0917.htm . The gist of it is: (a

by dalke 12y ago

The Maryland House Bill 917 is at http://mlis.state.md.us/2002rs/billfile/hb0917.htm http://mlis.state.md.us/2002rs/billfile/hb0917.htm . The gist of it is: (a) Compliance with federal regulations. -- A person may not conduct research using a human subject unless the person conducts the research in accordance with the federal regulations on the protection of human subjects. (b) Scope to include all research. -- Notwithstanding any provision in the federal regulations on the protection of human subjects that limits the applicability of the federal regulations to certain research, subsection (a) of this section applies to all research using a human subject. My problem is, I'm not sure what MD 917 (b) means. I'll start with §46.102 (a) (1) at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.101 http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#... : > (a) (1) Research that is conducted or supported by a federal department or agency, whether or not it is regulated as defined in §46.102, must comply with all sections of this policy. Is MD 917 (b) supposed to mean that §46.102 (a) (1) applies to all human research in Maryland? I believe that's the case, because §46.102 (a) (2) only applies to those organizations which are regulated by a federal department, so would already be covered under the law. Section §46.102 (b) has a list of human research which is exempt. The most relevant for Facebook and OkCupid appears to be: > (2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. [Note: does not apply to children.] If A/B testing falls under 'educational tests' or 'survey procedures' then it's exempt. Otherwise - and this is another tricky part - §46.102 (c) says "Department or agency heads retain final judgment as to whether a particular activity is covered by this policy." Who is the department head for Facebook and OkCupid? §46.102 (a) defines it as: > (a) Department or agency head means the head of any federal department or agency and any other officer or employee of any department or agency to whom authority has been delegated. MD 917 doesn't have the information for how to interpret §46.102 outside of the federal context for which it was written. An alternative interpretation of MD 917 (b) is that no human testing is exempt, including §46.102 (b) (2) which allows surveys. Instead, all testing must go through an IRB. However, if that's the case then the other exceptions of §46.102 (b) are also no longer allowed, including > (4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. which would require IRB review for every historian working out of previously published materials. Therefore, I don't think this alternative interpretation is correct. Which means I don't know if MD 917 really applies to OkCupid or Facebook. (The Facebook research was published in a journal which follows the Common Rule compliance; I presume the journals have a way to resolve the question of what "department head" means when there is no department head - it must have come up before. I only investigated MD 917 compliance here.) _EDIT_ : The MD attorney general clarified this at http://www.oag.state.md.us/Healthpol/hb917letter.pdf http://www.oag.state.md.us/Healthpol/hb917letter.pdf . > Implicit in the federal regulations, and therefore in House Bill 917's mandate for compliance with these regulations, is the requirement that a person have in place a reasonable process for determining whether research falls within one of the exempt categories. So determining if A/B testing is exempt comes down to if there's a reasonable process for determining if it's exempt. It's not clearly illegal.

dragonwriter 12y ago
> My problem is, I'm not sure what MD 917 (b) means. Probably Annotated Code of Maryland Section 13-1601(b), added by House Bill 917, means exactly what it says. "Notwithstanding any provision in the federal regulations on the protection of human subjects that limits the applicability of the federal regulations to certain research, subsection (a) of this section applies to all research using a human subject." (emphasis added) > §46.102 (b) has a list of human research which is exempt. But those exemptions are a provision of the federal regulations which limits the applicability of the federal regulation to certain research, and so are expressly excluded from the part of the regulation incorporated into Maryland law by Section 13-1601(b). > Otherwise - and this is another tricky part - §46.102 (c) says "Department or agency heads retain final judgment as to whether a particular activity is covered by this policy." This, again, is a provision of the federal regulations which limits the applicability of the federal regulation to certain research (to those things not excluded by the relevant funding department/agency head), and so are expressly excluded from the part of the regulation incorporated into Maryland law by 917(b). So there's no need to figure out how it applies -- it doesn't. > However, if that's the case then the other exceptions of §46.102 (b) are also no longer allowed Note that, if you go through the link you posted and click on the final passed (Third Reading) version of the bill and note the edits from the prior version, that prior version of the bill had express language incorporating the exceptions in 45 CFR § 46.102(b) as exceptions to the Maryland law, and this was stricken in favor of the language now present expressly disregarding any exceptions in the federal regulations. This makes it pretty clear that, whether or not this is desirable, the legislative intent was very expressly not to incorporate the exceptions in 45 CFR § 46.102(b).
- dalke 12y ago
  I suspect my edit was too late for you to read. I added a link to http://www.oag.state.md.us/Healthpol/hb917letter.pdf http://www.oag.state.md.us/Healthpol/hb917letter.pdf , where the attorney general describes exemptions: > Therefore, under the applicable federal regulations, a person may conduct research in an exempt category without, for example, obtaining review by an institutional review board. A Maryland researcher likewise may do so under House Bill 917, because such a person is conducting the research “in accordance with the federal regulations on the protection of human subjects” and, consequently, does not violate the prohibition in § 13-1602(a) of the Health-General Article. This is dated May 2, which is after the bill passed both houses and before it was signed by the governor. This seems like the exemptions in §46.102 (b) are all allowed under MD law.

by dalke 12y ago

dragonwriter 12y ago

> My problem is, I'm not sure what MD 917 (b) means. Probably Annotated Code of Maryland Section 13-1601(b), added by House Bill 917, means exactly what it says. "Notwithstanding any provision in the federal regulations on the protection of human subjects that limits the applicability of the federal regulations to certain research, subsection (a) of this section applies to all research using a human subject." (emphasis added) > §46.102 (b) has a list of human research which is exempt. But those exemptions are a provision of the federal regulations which limits the applicability of the federal regulation to certain research, and so are expressly excluded from the part of the regulation incorporated into Maryland law by Section 13-1601(b). > Otherwise - and this is another tricky part - §46.102 (c) says "Department or agency heads retain final judgment as to whether a particular activity is covered by this policy." This, again, is a provision of the federal regulations which limits the applicability of the federal regulation to certain research (to those things not excluded by the relevant funding department/agency head), and so are expressly excluded from the part of the regulation incorporated into Maryland law by 917(b). So there's no need to figure out how it applies -- it doesn't. > However, if that's the case then the other exceptions of §46.102 (b) are also no longer allowed Note that, if you go through the link you posted and click on the final passed (Third Reading) version of the bill and note the edits from the prior version, that prior version of the bill had express language incorporating the exceptions in 45 CFR § 46.102(b) as exceptions to the Maryland law, and this was stricken in favor of the language now present expressly disregarding any exceptions in the federal regulations. This makes it pretty clear that, whether or not this is desirable, the legislative intent was very expressly not to incorporate the exceptions in 45 CFR § 46.102(b).

dalke 12y ago
I suspect my edit was too late for you to read. I added a link to http://www.oag.state.md.us/Healthpol/hb917letter.pdf http://www.oag.state.md.us/Healthpol/hb917letter.pdf , where the attorney general describes exemptions: > Therefore, under the applicable federal regulations, a person may conduct research in an exempt category without, for example, obtaining review by an institutional review board. A Maryland researcher likewise may do so under House Bill 917, because such a person is conducting the research “in accordance with the federal regulations on the protection of human subjects” and, consequently, does not violate the prohibition in § 13-1602(a) of the Health-General Article. This is dated May 2, which is after the bill passed both houses and before it was signed by the governor. This seems like the exemptions in §46.102 (b) are all allowed under MD law.