Precursor Preference in Surfactant Synthesis of Newborns

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Precursor Preference in Surfactant Synthesis of
Newborns

• Second Joint
• Subpart D ReferralJune 29, 2005

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Sara F Goldkind, MD, MAFDABioethicist Office
of the CommissionerOffice of Pediatric
Therapeutics
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Possible Recommendations the PAC Can Make to the
Commissioner/Secretary

• Recommend allowing the protocol to proceed
  because it satisfies 46.404/50.51, 46.405/50.52,
  or 46.406/50.53
• Recommend allowing the protocol to proceed, with
  modifications, because it would satisfy
  46.404/50.51, 46.405/50.52, or 46.406/50.53
• Recommend allowing the protocol to proceed, with
  or without modifications, because it would
  satisfy 46.407/50.54
• Recommend that the protocol not be allowed to
  proceed, providing specific reasons

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Findings to Support 46.407/50.54 Recommendation

• The research presents a reasonable opportunity to
  further the understanding, prevention, or
  alleviation of a serious problem affecting the
  health or welfare of children
• The research will be conducted in accordance with
  sound ethical principals, and
• Adequate provisions are made for soliciting the
  assent of children and permission of their
  parents or guardians, as set for the in
  46.408/50.55

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HHS and FDA Regulations regarding allowing a
protocol to proceed under
are comparable.
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After Todays PAC Meeting

• PAC recommendations will be transmitted by the
  Office of pediatric therapeutics, with comments,
  to FDA Commissioner (along with PES summary)
• The FDA Commissioners determination will be
  transmitted by OHRP, with comments, to the
  Assistant Secretary for Health (along with PACs
  recommendation and PES summary)
• The ASH will make the final determination on
  behalf of HHS Secretary

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Possible Determinations of Secretary/Commissioner

• Research in fact satisfies 46.404/50.51 or
  46.405/50.52 or 46.406/50.53
• Support the research under 46.407/50.54 as
  submitted
• Support the research under 46.407/50.54 with
  required and/or recommended modifications
• Do not support the research