Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
87 Certificate of Confidentiality Applicable to All Study Centers CERTIFICATE OF CONFIDENTIALITY CC-MH-IO-l82 Issued to Virginia Polytechnic Institute conducting research known as The In-Vehicle Driving Behavior and Crash Risk Study (SHRP 2 Naturalistic Driving Study) In accordance with the provisions of section 301(d) of the Public Health Service Act 42 U.S.C. 241(d), this Certificate is issued in response to the request of the Principal Investigator, Dr. Jonathan Antin, to protect the privacy of research subjects by with- holding their identities from all persons not connected with this research. Dr. Antin is primarily responsible for the conduct of this research, which is supported by the Transportation Research Board of the National Academies. Under the authority vested in the Secretary of Health and Human Services by section 301(d), all persons who: 1. are enrolled in, employed by, or associated with the Virginia Polytechnic Institute and their contractors or cooperating agencies and 2. have in the course of their employment or association access to information that would identify individuals who are the subjects of the research pertaining to the project known as The In-Vehicle Driving Behavior and Crash Risk Study (SHRP 2 Naturalistic Driving Study) are hereby authorized to protect the privacy of the individuals who are the subjects of that research by withholding their names and other identifying characteristics from all persons not connected with the conduct of that research. This research study examines driving behaviors such as cognitive awareness, substance usage, fatigue, impairment, and other behavioral and environmental factors associated with collisions. The research uses advanced technologies to collect a spectrum of data on subjects to examine driving and risky behaviors in different environmental conditions to determine their influence at increasing the risk of collisions. A Certificate of Confidentiality is needed because sensitive information will be collected during the course of the study. The certificate will help researchers avoid involuntary disclosure that could expose subjects or their families to adverse economic, legal, psychological, and social consequences. All subjects will be assigned a code number and identifying information and records will be kept in locked files at the Institution. This research is currently underway and is expected to end on 09/30/2013. A P P E n D I x C
88 CERTIFICATE OF CONFIDENTIALITY (continued) As provided in section 301 (d) of the Public Health Service Act 42 U.S.C. 241(d): âPersons so authorized to protect the privacy of such individuals may not be compelled in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings to identify such individuals.â This Certificate does not protect you from being compelled to make disclosures that: (1) have been consented to in writing by the research subject or the subjectâs legally authorized representative; (2) are required by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or regulations issued under that Act; or (3) have been requested from a research project funded by the National Institutes of Health (NIH) or the Department of Health and Human Services (DHHS) by authorized representatives of those agencies for the purpose of audit or program review. This Certificate does not represent an endorsement of the research project by the DHHS. This Certificate is now in effect and will expire on 09/30/2013. The protection afforded by this Confidentiality Certificate is permanent with respect to subjects who participate in the research during the time the Certificate is in effect. Date: 10/14/2010 Patrick Shirdon Associate Director for Management National Institute of Mental Health
