[Federal Register Volume 68, Number 114 (Friday, June 13, 2003)]
[Notices]
[Pages 35414-35415]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-14941]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Solicitation of Public Review and Comment on Research Protocol: 
Characterization of Mucus and Mucins in Bronchoalveolar Lavage Fluids 
From Infants With Cystic Fibrosis

AGENCY: Department of Health and Human Services, Office of the 
Secretary, Office of Public Health and Science, Office for Human 
Research Protections.

ACTION: Notice.

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SUMMARY: The Office for Human Research Protections (OHRP), Office of 
Public Health and Science, Department of Health and Human Services 
(HHS) is soliciting public review and comment on a proposed research 
protocol entitled ``Characterization of Mucus and Mucins in 
Bronchoalveolar Lavage Fluids from Infants with Cystic Fibrosis.'' The 
proposed research would be supported by a grant awarded by the National 
Heart, Lung, and Blood Institute, National Institutes of Health. Public 
review and comment are solicited regarding the proposed research 
protocol pursuant to the requirements of HHS regulations at 45 CFR 
46.407.

DATES: To be considered, written or electronic comments on the proposed 
research must be received on or before 4:30 p.m. July 28, 2003.

ADDRESSES: Submit written comments to: Ms. Kelley Booher, Division of 
Policy, Planning, and Special Projects, Office for Human Research 
Protections, 1101 Wootton Parkway, Suite 200, The Tower Building, 
Rockville, MD 20852, telephone number (301) 402-5942 (not a toll-free 
number). Comments also may be sent via facsimile at (301) 402-0527 or 
by email to: [email protected].

FOR FURTHER INFORMATION CONTACT: Dr. Leslie K. Ball, Office for Human 
Research Protections, The Tower Building, 1101 Wootton Parkway, Suite 
200, Rockville, MD 20852; telephone (301) 496-7005; fax (301) 402-0527; 
email [email protected].

SUPPLEMENTARY INFORMATION: All studies conducted or supported by HHS 
which are not otherwise exempt and which propose to involve children as 
subjects require institutional review

[[Page 35415]]

board (IRB) review in accordance with the provisions of HHS regulations 
for the protection of human subjects at 45 CFR part 46, subpart D. 
Pursuant to HHS regulations at 45 CFR 46.407, if an IRB reviewing a 
protocol to be conducted or supported by HHS does not believe that the 
proposed research involving children as subjects meets the requirements 
of HHS regulations at 45 CFR 46.404, 46.405, or 46.406, the research 
may proceed only if the following conditions are met: (a) The IRB finds 
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 (b) the Secretary, 
after consultation with a panel of experts in pertinent disciplines 
(for example: science, medicine, education, ethics, law) and following 
opportunity for public review and comment, determines either: (1) That 
the research in fact satisfies the conditions of 45 CFR 46.404, 46.405, 
or 46.406, or (2) that the following conditions are met: (i) The 
research presents a reasonable opportunity to further the 
understanding, prevention, or alleviation of a serious problem 
affecting the health or welfare of children; (ii) the research will be 
conducted in accordance with sound ethical principles; and (iii) 
adequate provisions are made for soliciting the assent of children and 
the permission of their parents or guardians, as set forth in 45 CFR 
46.408.
    HHS received a request from the University of North Carolina at 
Chapel Hill's (UNC) Office of Human Research Studies and Dr. Terry Noah 
pursuant to the provisions of HHS regulations at 45 CFR 46.407. The 
proposed research protocol would be funded by the National Heart, Lung, 
and Blood Institute, National Institutes of Health (NIH), under grant 
number P50 HL 60280 (SCOR in Pathogenesis of Cystic Fibrosis), 
principal investigator, Dr. Richard Boucher, and has been adapted from 
a sub-study contained within this grant, entitled, ``Project IV: Airway 
Surface Liquid Composition of Humans In Vivo.'' Dr. Terry Noah, the 
principal investigator of the adapted sub-study, proposes a 
longitudinal study of the changes in bronchoalveolar lavage fluid 
(BALF) of infants diagnosed with cystic fibrosis in the neonatal 
period. The proposed study would enroll infants with a clinical 
diagnosis of cystic fibrosis in the neonatal period and would obtain 
BALF from these infants via flexible fiberoptic bronchoscopy at 3 time 
points: (1) After diagnosis, within the first 6 weeks after birth; (2) 
at 6 months of age; and (3) at 12 months of age. The goals of the 
proposed study are to: (a) Quantify mucin in BALF and compare 
quantities before infection vs. after infection onset in cystic 
fibrosis; (b) correlate mucin quantity with measures of infection 
(quantitative bacteriology) and inflammation (cell numbers, neutrophil 
products, and inflammatory cytokines); and (c) isolate mucus plugs and 
characterize their histology before and after infection, in order to 
more accurately describe early relationships among mucus obstruction, 
infection and inflammation.
    After reviewing this research proposal UNC's Committee on the 
Protection of the Rights of Human Subjects (CPRHS), which serves as 
UNC's IRB, determined that this research could not be approved under 45 
CFR 46.404, 46.405, or 46.406, but was suitable for review under 45 CFR 
46.407. The UNC CPRHS found that the research represented more than a 
minor increase over minimal risk and did not appear to offer the 
prospect of direct benefit to subjects, but found that the research 
presented a reasonable opportunity to further the understanding, 
prevention or alleviation of a serious problem affecting the health or 
welfare of children.
    Experts in relevant disciplines have reviewed this protocol and 
each have provided recommendations to the Secretary of HHS. Public 
review and comment are hereby solicited pursuant to the requirements of 
45 CFR 46.407. The Secretary of HHS will consider the experts' 
recommendations and the public comments in making a final determination 
regarding whether or not HHS should support this research.
    In particular, comments are solicited on the following questions: 
(1) What are the types and degrees of risk that this research presents 
to the subjects; (2) what are the potential benefits, if any, to the 
subjects and to children in general; (3) does the research present a 
reasonable opportunity to further the understanding, prevention, or 
alleviation of a serious problem affecting the health or welfare of 
children; (4) if conducted as proposed in the above-cited protocol, 
would the research be conducted in accordance with sound ethical 
principles; and (5) have adequate provisions been made for soliciting 
the assent of children and the permission of their parents or 
guardians? In formulating a response to question (4), commenters may 
wish to consider whether the proposed protocol satisfies all the 
requirements under HHS regulations at 45 CFR 46.111 (criteria for IRB 
approval of research).
    All written comments concerning this matter should be submitted to 
Ms. Kelley Booher, Division of Policy, Planning, and Special Projects, 
Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, 
The Tower Building, Rockville, MD 20852, telephone number (301) 402-
5942 (not a toll-free number). Comments also may be sent via facsimile 
at (301) 402-2071 or by email to: [email protected]. Materials 
available for review on the OHRP web page (available at: http://ohrp.osophs.dhhs.gov/panels/407-02pnl/pindex.htm) include: 
Correspondence from the principal investigator and UNC referring the 
proposed research protocol to the Secretary of HHS for consideration 
under 45 CFR 46.407; correspondence between the UNC CPRHS and the 
principal investigator; the UNC CPRHS deliberations on the proposed 
research; correspondence between OHRP and UNC; relevant excerpts of the 
NIH grant application; the parental permission document; review of 
proposed research by the Cystic Fibrosis Foundation's Data and Safety 
Monitoring Board; UNC's bronchoscopy complication data; and reports 
from each of experts pursuant to 45 CFR 46.407. A paper copy of the 
information referenced here is available upon request.

    Dated: June 5, 2003.
Cristina V. Beato,
Principal Deputy Assistant Secretary for Health.
[FR Doc. 03-14941 Filed 6-12-03; 8:45 am]
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