UNC HCHS Coord Center IRB Approval Notice

Youngblood, Marston E Jr
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IRB
Thursday, December 05, 2013 3:48 PM
Cai, Jianwen
Youngblood, Marston E Jr
IRB Notice

To: Jianwen Cai
Biostatistics
From: Non-Biomedical IRB
Approval Date: 12/05/2013
Expiration Date of Approval: 12/04/2014
RE: Notice of IRB Approval by Expedited Review (under 45 CFR 46.110)
Submission Type: Renewal
Expedited Category: 7.Surveys/interviews/focus groups,2.Minimal blood draw,3.Noninvasive biospecimens,4.Noninvasive clinical data
Study #: 07-1003
Study Title: Hispanic Community Health Study
This submission has been approved by the IRB for the period indicated.
Study Description:
The Collaborative Studies Coordinating Center (CSCC) is the Data and Statistical Coordinating Center for the
Hispanic Community Health Study (HCHS). This study is designed to document health status in four Hispanic
communities around the United States and to obtain baseline measures of pulmonary function, cardiovascular
function, metabolic status, oral health, and measures of neurocognitive and psychological
functioning. Approximately 16,000 adults of 18 to 74 years, will be enrolled at four centers over a 36 month
period, and will be followed for 36 months to assess health outcomes.
The CSCC does not directly enroll or directly contact any HCHS participants. It is responsible for coordinating
the administration of the multi-center study, designing, developing and maintaining a data management system
that provides appropriate confidentially and security for subjects’ data in the study database (described in detail
in section A.4.10), overseeing quality assurance and quality control of study procedures such as by hosting
training sessions and performing site monitoring visits, subcontracting for the procurement of study medication
and placebo, producing all study data reports, including those for study monitoring by the Observational Study
Monitoring Board (created by NHLBI), and for generating the statistical analysis for manuscript publication of
the study.

Regulatory and other findings:
This research meets criteria for a waiver of consent entirely according to 45 CFR 46.116(d) as the data are being
collected at the local sites using their own IRB approved consent forms.
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Investigator’s Responsibilities:
Federal regulations require that all research be reviewed at least annually. It is the Principal Investigator’s
responsibility to submit for renewal and obtain approval before the expiration date. You may not continue any
research activity beyond the expiration date without IRB approval. Failure to receive approval for continuation
before the expiration date will result in automatic termination of the approval for this study on the expiration
date.
Your approved consent forms and other documents are available online at
http://apps.research.unc.edu/irb/irb_event.cfm?actn=info&irbid=07-1003.
You are required to obtain IRB approval for any changes to any aspect of this study before they can be
implemented. Any unanticipated problem involving risks to subjects or others (including adverse
events reportable under UNC-Chapel Hill policy) should be reported to the IRB using the web portal at
http://irbis.unc.edu.
This study was reviewed in accordance with federal regulations governing human subjects research, including
those found at 45 CFR 46 (Common Rule), 45 CFR 164 (HIPAA), 21 CFR 50 & 56 (FDA), and 40CFR 26
(EPA), where applicable.
CC:
Marston Youngblood, BiostatisticsIRB Informational Message - please do not use email REPLY to this address

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