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Protecting Data Privacy in Health Services Research
study, IRBs, HSR and privacy, and the scope and limitations of the current project. This chapter closes with an overview of the remaining chapters of the report. The remaining chapters describe some current and best practices that the committee learned of pertaining to the protection of confidentiality through the application of technology, implementation of informed policies, and training and support of personnel. Finally, the report suggests further steps that would lead to additional improvements in protection of the confidentiality of HSR, while at the time making oversight by IRBs (or other review boards) more effective and efficient. In this report, “effective oversight” includes the idea that the oversight will be trusted throughout our diversified society and reliable and, thus, able to balance societal benefit and individual privacy. Effective oversight will therefore be an efficient means toward allowing valuable HSR to proceed.
PRIVACY AND RESEARCH
Federal policies on the protection of human subjects in all types of research rest on IRB review of the research proposals and protocols, and on obtaining the informed consent of subjects. Both apply somewhat differently in HSR than in clinical research, which increases the scope and complexity of research oversight in general. IRB review is complicated because HSR studies often have characteristics that cause studies not to require full IRB review and discussion. On the other hand, such independent review of these studies may help ensure that confidentiality is adequately protected. The regulations allowing IRBs to exempt studies from full review are described in more detail in Chapter 2. “Exemption” is a formal term in the regulations applied to studies that have such minimal impact on the subjects that no further oversight by an IRB is needed. For situations of somewhat more, but still small, impact, the proposal might receive expedited review from just one or a few members rather than the entire review board. In general, an IRB representative makes the determination of whether a project might be eligible for exemption or expedited review. Informed consent is complicated because many HSR projects involving analysis of personal health data collected previously for another purpose are eligible for waiver of informed consent. Indeed obtaining informed consent is not feasible for many HSR projects.
The methods of HSR are varied and may include not only secondary analysis of previously collected data, but also primary data collection through surveys and interviews. This report focuses on the secondary analysis of data, including personal health information, that have already been collected for some other purpose, because this type of analysis raises the most challenging ethical issues. In research where investigators collect primary data through surveys and interviews, the subject knows that research is being conducted, can find out more about the research, and has an opportunity to decline to participate. By contrast, in secondary analyses of the type described, individuals may not know that they are subjects of research and may not have the opportunity to decline to participate. The researchers also may be unable to identify subjects individually and, thus, unable to contact them