Repeatedly here in comments on this blog and elsewhere we have been told it is unethical to do a vaccinated/unvaccinated study and that it would be against the rules.
Well I went and found the rules and it seems there is an exception.
Special Protections for Children as Research Subjects
A fourth category of research requires a special level of HHS review beyond that provided by the IRB.
45 CFR 46.407 – Research that the IRB believes does not meet the conditions of 45 CFR 46.404, 46.405, or 46.406, but finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children.
If the IRB believes that the research does not meet the requirements of 45 CFR 46.404, 46.405, or 46.406, but finds that it presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children, it may refer the protocol to HHS for review. The research may proceed only if the Secretary, HHS, or his or her designee, after consulting with a panel of experts in pertinent disciplines (e.g., science, medicine, education, ethics, law) and following an opportunity for public review and comment, determines either: (1) that the research in fact satisfies the conditions of 45 CFR 46.404, 46.405, or 46.406, or (2) the following:
•the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children;
•the research will be conducted in accordance with sound ethical principles; and
•adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians, as set forth in HHS regulations at 45 CFR 46.408.
base point being that this research would provide a reasonable opportunity to further the understanding of prevention or alleviation of a serious problem affecting the health or welfare of children. specifically two different issues 1/ autism 2/ vaccination rates.
the major issue is that no specific effort can be made to eliminate subjects due to outside factors.
specifically no specific tests can be made or required of the children before they are placed in the test. basically no pre-screening.
the purpose of this is to make sure that the makeup of the test is typical to the standard makeup of a normally vaccinated children.
Now the truth is that these tests should be done before any vaccine is released into the vaccination schedule. and this test should be done both individually and as a whole across the entire vaccine schedule.
The issue with no pre-screening is that the general consensus at this point is that autism is a combination of genetic and environmental conditions. Pre-screening could potentially eliminate the target group that is being made autistic.
Now the major point behind identifying the causes of autism (and this study could also compare rates of any other diseases found as well) is that by identifying a specific group that is affected could potentially allow that specific group to be removed from the vaccination schedule. If you remove all those affected by vaccines from the vaccination schedule and add those to the few who have legitimate concerns (Amish, religious conviction etc.) you could still maintain herd immunity which would generally achieve the aims of the vaccination schedule.
Basically we are all best served by identifying the causes of the increases in the autistic rates. By identifying the causes we can reduce or eliminate these causes and reduce the increased drain on our health care system and justice system.
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