Pediatric Ethics Subcommittee

**Open Meeting**

**September 10, 2004**

**Overview**

On September 10, 2004 the first meeting of the Pediatric Ethics
Subcommittee of the Pediatric Advisory Committee will be held. This
subcommittee was established to address various pediatric ethical
issues, including Institutional Review Board (IRB) referrals under Food
and Drug Administration\'s (FDA) Subpart D regulations as well as joint
referrals under both FDA and the Department of Health and Human Services
(DHHS) Subpart D regulations. This meeting is being held to address a
referral from the National Institute of Mental Health IRB of the
protocol entitled "*Effects of a Single Dose of Dextroamphetamine in
Attention Deficit Hyperactivity Disorder; A Functional Magnetic
Resonance Study.\"* The subcommittee is to provide a recommendation as
to whether the protocol should be approved under 21 CFR 50.54/45 CFR
46.407. That is, the committee is to consider whether the proposed
clinical investigation/research either: (1) in fact satisfies the
conditions of § 50.51/46.404, § 50.52/46.405 or § 50.53/46.406 or (2)
meets the following conditions: (i) presents a reasonable opportunity to
further the understanding, prevention or alleviation of a serious
problem affecting the health or welfare of children; (ii) will be
conducted in accordance with sound ethical principles; (iii) adequate
provisions are made for soliciting the assent of children and the
permission of their parents or guardians, as set forth in §
50.55/46.408.

To prepare you for these deliberations, you will hear a series of
presentations. The topics to be covered include: the Subpart D Expert
panel process, charge to the committee, overview of the protocol,
presentation by the Principal Investigator, comments from the National
Institute of Mental Health IRB representative, and a summary of all
public comments submitted. The subcommittee will then discuss the
protocol as it relates to its approvability under 21 CFR 50.54/45 CFR
46.407.

**Introduction**

In April 2001, FDA published an interim rule to amend its regulations to
provide additional safeguards for children enrolled in clinical
investigations of FDA-regulated products. The interim rule was intended
to bring FDA regulations into compliance with provisions of the
Children's Health Act of 2000. This Act required that within 6 months of
its enactment all research involving children that is conducted,
supported, or regulated by the Department of Health and Human Services
be in compliance with HHS regulations providing additional protections
for children involved as human subjects in research.

Both FDA and HHS regulations provide a process for an IRB to refer to
FDA and/or HHS under § 50.54/§ 46.407 any protocols which the IRB does
not believe meets the requirements of § 50.51/ 46.404, § 50.52/46.405 or
§ 50.53/46.406, and finds presents an opportunity to understand,
prevent, or alleviate a serious problem affecting the health or welfare
of children. Under the Subpart D regulations, a clinical
investigation/research may proceed if the Commissioner and/or Secretary
find, after consultation with a panel of experts in pertinent
disciplines (for example: science, medicine, education, ethics, law) and
following an opportunity for public comment that certain conditions are
met.

The Office for Human Research Protection (OHRP) and the FDA have been
working to develop a unified and comprehensive process for Subpart D
referrals under 21 CFR 50.54 and 45 CFR 46.407. We have agreed to
utilize FDA's Pediatric Ethics Subcommittee and experts designated by
OHRP to handle these referrals. The Pediatric Ethics Subcommittee will
then present its deliberations to the full Pediatric Advisory Committee,
which will then provide a recommendation to the Commissioner of the FDA
and the Secretary of DHHS.

We understand this is a new process and we appreciate your assistance in
participating in a newly defined approach for dealing with complex and
difficult issues. Once we have completed this 1^st^ referral cycle, your
suggestions for improvements will be welcome. If you have any procedural
questions prior to the meeting please feel free to contact the Office of
Pediatric Therapeutics at 301-827-1996.

We look forward to your participation on September 10, 2004, as we
embark on this important activity in pediatric research.

Dianne Murphy, MD

Director

Office of Pediatric Therapeutics