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

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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