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Precursor Preference in Surfactant Synthesis of Newborns

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Recommend allowing the protocol to proceed, with modifications, because it would ... Recommend that the protocol not be allowed to proceed, providing specific reasons ... – PowerPoint PPT presentation

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Title: Precursor Preference in Surfactant Synthesis of Newborns


1
Precursor Preference in Surfactant Synthesis of
Newborns
  • Second Joint
  • Subpart D ReferralJune 28, 2005

2
Sara F Goldkind, MD, MAFDABioethicist Office
of the CommissionerOffice of Pediatric
Therapeutics-and-
  • Bernard Schwetz, DVM, PhD
  • Director
  • Office for Human Research Protections

3
Categories of Subpart D(IRB authorized to
approve protocols)
  • 46.404, 50.51 Not involving greater than minimal
    risk
  • 46.405, 50.52 Involving greater than minimal
    risk but presenting the prospect of direct
    benefit to individuals subjects
  • 46.406, 50.53 Involving greater than minimal
    risk and no prospect of direct benefit to
    individual subjects, but likely to yield
    generalizable knowledge about the subjects
    disorder or condition

4
Categories of Subpart D cont.(IRB must refer to
HHS/FDA)
  • 46.407, 50.54 Research that is not otherwise
    approvable but which presents an opportunity to
    understand, prevent, or alleviate a serious
    problem affecting the health or welfare of
    children, and-
  • Requires that the Secretary of HHS/Commissioner
    of FDA consult with an panel of experts in
    pertinent disciplines

5
Pediatric Ethics SubcommitteeSome potential
considerations
  • Determination of risk
  • Determination of benefit
  • Suggested modifications to protocol
  • Necessary modifications to protocol
  • Suggested modifications to parental permission
    and assent processes and documents

6
Pediatric Ethics SubcommitteeSome potential
considerations
  • Necessary modifications to parental permission
    and assent processes and documents
  • Summary response to the specific questions
  • Determination of approval categories
  • Other pertinent issues

7
Possible Recommendations the PES Can Make to the
PAC
  • 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,
    either with or without modifications, because it
    satisfies 46.407/50.54
  • Recommend that the protocol not be allowed to
    proceed, providing specific reasons

8
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 forth in
    46.408/50.55

9
HHS and FDA Regulations regarding allowing a
protocol to proceed under
21 CFR 50.51 or 45 CFR 46.404
.52 .405 .405
.53 .406 .406
.54 .407 .407
are comparable.
10
After Todays Meeting of the PES
  • Chair summarizes PES review and presents PES
    recommendations to PAC
  • PAC recommendations will be transmitted by the
    Office of Pediatric Therapeutics, with comments,
    to FDA Commissioner (along with Chairs summary)
  • FDA Commissioners determination will be
    transmitted by OHRP, with comments, to Assistant
    Secretary for Health (along with PACs
    recommendation and Chairs summary)
  • The ASH will make the final determination on
    behalf of HHS Secretary

11
Possible Determinations by Secretary/Commissioner
  • Research in fact satisfies the condition of
    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
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