Office Of Sponsored Programs


Human Subject Regulation Decision Charts

Chart-1 Chart-2 Chart-3

chart 3:


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?


          1. Will the research in its entirely involve greater than "minimal risk" (Section 46.102(i))?
          2. Is it practicable to conduct the research without the waiver/alteration?
          3. Will waiving/altering informed consent adversely affect subjects' rights and welfare?
          4. Will pertinent information be provided to subjects later, if appropriate?
                  If No, No Waiver or alteration.


click here to go back