The Network was recently contacted by a requestor from a state health department planning to conduct blood testing for health surveillance purposes. Public health surveillance is the ongoing systematic collection, analysis and interpretation of health and other data to inform public health efforts. (View a CDC policy describing the distinction between public health research and surveillance, and consult legal counsel in your jurisdiction to confirm that particular activities meet the definition of surveillance.)
The health department planned to host clinics to facilitate blood testing and send questionnaires to attendees prior to the clinic. The requestor had several questions related to these activities:
1. Is the Department of Health required to obtain informed consent to collect relevant demographic and health data via a questionnaire prior to the clinic?
Generally, the law does not pose a barrier to collection of demographic and health information for public health purposes, including surveillance and investigation. Once the information has been collected, health departments have a responsibility to protect privacy, and consent may be required if the Department wishes to disclose individually identifiable information or use or share such information for research.
2. Can informed consent for the blood draw and informed consent for the public health questionnaire be combined, so as to only require one consent?
As noted above, the law does not require public health departments to obtain consent to collect data for non-research public health purposes. However, a knowing and voluntary consent is necessary to obtain blood specimens. If the government takes a biological specimen without consent, this might be considered a “search” under the 4th Amendment of the U.S. Constitution, and thus, would require a warrant. Similarly, if the government retains the specimen, this might be considered a “seizure.” This issue is discussed in the Public Health Collection, Use, Sharing, and Protection of Information Issue Brief, which is part of the Association of State and Territorial Health Officials (ASTHO) Public Health and Information Sharing Toolkit. (See Section III, Legal Authority for Public Health Investigations).
Although the requestor was not proposing to provide medical care, consent is necessary to perform a procedure on a patient, since otherwise the procedure may be considered a common law battery.
This is a list of general requirements for consent to be considered informed:
Competent - Legal capacity to make a decision
Voluntary - Decision freely made by individual
Informed – Decision-making based on knowledge
Understanding - Individual understands information needed to give informed consent (alternatives, benefits, risks)
Consent need not be in writing unless specifically required by law. However, a written record will provide proof of consent. Because the purpose of a written consent form is to provide proof of consent, the form should clearly indicate each element to which an individual is consenting. Here is an example of a consent form used by the CDC for SARS testing.
3. Can the Department retain and store blood samples collected during the proposed clinics? If so, must the Department obtain informed consent for retention and storage?
The Department may store the blood samples provided that it has obtained knowing and voluntary consent from the individuals and then may use them consistent with the purpose and uses specified in the consent. At a minimum, a public health department will want to inform individuals of the purpose for which it is collecting the samples, that providing them is voluntary, how long the samples will be stored, how the samples will be used while retained, whether test results will be returned to individuals, what will be done to safeguard the samples, what will be done with them when they are no longer needed (e.g. destroyed, returned to the individual, etc.), and who individuals might contact if they have any questions. For some of these consent items, it might be helpful to look at Michigan’s consent brochure and consent form for secondary research use of newborn screening dried blood samples.
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