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Governing law for medical research subjects is 45 CFR 46.116, the "Common Rule". It does not state privacy is required in studies. It states that under informe
by droithomme 14y ago
Governing law for medical research subjects is 45 CFR 46.116, the "Common Rule". It does not state privacy is required in studies.
It states that under informed consent, all test subjects must consent to the research and be given in writing "a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental", "a description of any reasonably foreseeable risks or discomforts to the subject", "a description of any benefits to the subject or to others which may reasonably be expected from the research", "a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject", "a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained", and several other things.
Should Dr. Boaler's "statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained" assure total confidentiality of individual subjects within the study, then she should maintain it, assuming she is complying with all requirements under the Common Rule. However, this issue of individual medical test subjects does not in any way prevent the identification of the particular facility at which the research was done, nor does it in any way prohibit other researchers from discovering that information on their own.
It is extremely interesting that Dr. Boaler believes her work falls under 45 CFR 46.116 since that means she has retained records documenting that she acquired this written consent and made these disclosures to all her test subjects, in addition to a rather vast number of other requirements that are far above and beyond the normal protocol for testing curriculums in schools. It's curious too given that §46.101(b) of the statute specifically excludes educational studies from the requirements:
> (b) Unless otherwise required by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy:
> (1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
There can be no doubt that this exclusion applies to the scope of this study given that it is a classroom study on efficacy of math curriculums.