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Informed Consent
Health information collected in the NHANES is kept in strictest confidence. During the informed consent process, survey participants are assured that data collected will be used only for stated purposes and will not be disclosed or released to others without the consent of the individual or the establishment in accordance with section 308(d) of the Public Health Service Act (42 U.S.C. 242m).
NHANES III
The consent form was signed by participants in the survey, and participants consented to storing specimens of their blood for future research, but the consent form did not specifically mention genetic research. Given the scientific importance of this resource, the CDC/NCHS Ethics Review Board (ERB) initially approved use of the DNA only if the samples were anonymized.
The anonymization requirements proved to be restrictive and difficult to implement, therefore, in August, 2001 the CDC/NCHS ERB approved a revised plan for using these specimens based on the guidelines in the August, 1999 National Bioethics Advisory Commission (NBAC) report on the use of stored biological materials for research. This revised plan included a process that gives researchers the ability to obtain more information associated with specimens for protocols that are determined by the ERB to have minimal risk for harm to the participant.
NHANES 1999 – 2002
The anonymization requirements proved to be restrictive and difficult to implement, therefore, in August, 2001 the CDC/NCHS ERB approved a revised plan for using these specimens based on the guidelines in the August, 1999 National Bioethics Advisory Commission (NBAC) report on the use of stored biological materials for research. This revised plan included a process that gives researchers the ability to obtain more information associated with specimens for protocols that are determined by the ERB to have minimal risk for harm to the participant.