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IRB Latitude to Approve a Consent Procedure that Alters or Waives some or all of the Elements of Consent
§ 46.116 - An IRB may approve a consent procedure, which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent, provided the IRB finds and documents that:
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C: 1. The research or demonstration project is to be conducted by, or subject to the approval of, state or local government officials, and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and |
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C: 2. The research could not practicably be carried out without the waiver or alteration. |
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D: 1. The research involves no more than minimal risk to the subjects; |
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D: 2. The waiver or alteration will not adversely affect the rights and welfare of the subjects; |
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D: 3. The research could not practicably be carried out without the waiver or alteration; and |
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D: 4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation. |
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