Dissenting Opinion: Against Waiving Parental Permission for Research

To: Mary Faith Marshall, Ph.D, Chairperson, National Human Research Protections Advisory Committee, Department of Health and Human Services

Re: Specific Comment on FDA’s Decision to Adopt HHS 45 CFR 46 Subpart D, EXCLUDING §46.408 (c)

Dissenting opinion of Vera Hassner Sharav, Founder and President, AHRP: Alliance for Human Research Protection, member, Children’s Workgroup of the National Human Research Protections Advisory Committee, Department of Health and Human Services (HHS)

This dissenting opinion reflects the position of AHRP and was prepared in collaboration with Howard Fishman, M.S. W., M.Ed, and John H. Noble, Jr., PhD, AHRP board members.