Human Subject Regulation Decision Charts
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chart 3:
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Wavier or Alteration of Informed consent under Section 46.116(d). Can the Institutional Review Board employ Section 46.116(d) to waive informed consent or alter informed consent elements?
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| 1. Will the research in its entirely involve greater than "minimal risk" (Section 46.102(i))? |
| No. |
| 2. Is it practicable to conduct the research without the waiver/alteration? |
| No. |
| 3. Will waiving/altering informed consent adversely affect subjects' rights and welfare? |
| No. |
| 4. Will pertinent information be provided to subjects later, if appropriate? |
| If No, No Waiver or alteration. |
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