Chairman, Committee on Clinical Investigations
November 22, 2002
Ms. Irene Stith-Coleman
Policy Director
Office of Human Research Protections
The Tower Building, Suite 200
1101 Wootton Pkwy
Rockville, MD 20852
Re: Dr. Gabriel G. Haddad
Study Titled: Sleep Mechanisms in Children: Role of Metabolism
Dear Ms. Stith-Coleman:
The Committee on Clinical Investigations, the Institutional Review Board for Yeshiva University, including the Albert Einstein College of Medicine, reviewed a research protocol entitled Sleep Mechanisms in Children: Role of Metabolism at its regular meeting on November 13, 2002. As you will see from the enclosed research protocol, the participants to be included in this project are healthy children, aged 13 through 17.
On the basis of the procedures involved, including a night of sleep deprivation, extended periods of study by nuclear magnetic resonance spectroscopy, and infusion of (1)C acetate and (2)C glucose, it was determined that the research involved greater than minimal risk, as defined under 45 C.F.R. � 46.102(i). Therefore, it could not be approved under 45 C.F.R. � 46.404. Although the Committee concluded that the research represented only a minor increase over minimal risk, it could not be approved under 45 C.F.R. � 46.405 or 45 C.F.R. � 46.406, since there would be no benefit to individual subjects and, as healthy children, the knowledge to be gained would not relate to the "understanding or amelioration of the subjects' disorder or condition".
The Committee determined that "the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children and that the protocol met the other requirements of 45 C.F.R. � 46.407 and 45 C.F.R. � 46.408. Therefore, I am requesting that the protocol be reviewed by the Secretary for a final determination.
Please let me know if you require additional information.
Sincerely,
Chairman
Committee on Clinical Investigations
cc: Dr. Gabriel G. Haddad
jf/cme