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The serum samples were obtained with waiver of informed consent under section 46.116 d) of the Department of Health and Human Services human subject regulations at 45 CFR 46.
Several states got waivers from section 115 of the Social Security Act, enabling them to help Hurricane Katrina survivors by making treatment available to those who normally would not qualify.
They are known as "1332 waivers" because Section 1332 of the law lays out the process and the standards waivers are supposed to meet.
The study uses de-identified linked administrative data for which we have received a waiver of informed consent under the provisions of section 2.3.6 of the Australian National Statement on Ethical Conduct in Human Research 2007.
It said, in part, that the Department of Health and Human Services: is issuing this information memorandum to notify states of the Secretary's willingness to exercise her waiver authority under section 1115 of the Social Security Act to allow states to test alternative and innovative strategies, policies, and procedures that are designed to improve employment outcomes for needy families.
The waiver authority in section 1115 of the Social Security Act -- where this law lives -- allows states to waive requirements in Section 402.
For example, Vermont's Choices for Care, a global waiver program under Section 1115 of the Social Security Act, consolidates all HCBS and institutional services under a single umbrella.
In section 164.512(i), the Privacy Rule allows for waiver of Authorization when the "research could not practicably be conducted without the waiver" and the "use of the PHI involves no more than a minimal risk to the privacy of individuals".
So-called state innovation waivers, also dubbed Section 1332 waivers after the part of the statute that authorizes them, run five years.
And here is the final sentence of all: "WAIVER OF CERTAIN PROVISIONS IN CONNECTION WITH LOAN MODIFICATIONS — The Secretary shall not be required to apply executive compensation restrictions under section 111, or to receive warrants or debt instruments under section 113, solely in connection with any loan modification under this section".
President Bush should extend the waiver, and seek a waiver of Title IV.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com