Protecting Data Privacy in Health Services Research (2000) / Chapter Skim
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Executive Summary
Executive Summary
Pages 1-19
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Yet these same data are information (often personally identifiable health information) about individuals.
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Indeed, HSR and health care operations form two ends of a continuous spectrum. Some HSR projects are clear examples of research, applying scientific methods to test hypotheses and produce new, gener~The term "efficacy" refers to how reliably an intervention brings about a given result under ideal, controlled conditions.
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The benefits to society of HSR studies include increased understanding of the results of policy changes and other systemic effects of health care delivery systems. The major risks to subjects in HSR are not physical risks, such as unknown side effects of new drugs or invasive medical procedures, but psychosocial and financial risks resulting from improper disclosure of personally identifiable health information from the databases.
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HSR protocols often have characteristics, such as the absence of any physical risk to subjects, that may make them eligible for a waiver of the informed consent requirement or even for exemption from IRB review. Because many HSR projects depend on secondary analysis of databases of records previously collected for another purpose, the investigator may not have the ability to contact the original subjects, and even if locating them is theoretically possible, the number of individuals in question may be far too large to make contacting them practicable.
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The committee hopes that the practices highlighted in the following chapters will facilitate HSR with appropriate and feasible mechanisms for the protection of human subjects, and will stimulate the development and dissemination of more advanced practices in the future. In highlighting the empirical collection of practices, the committee recognized that good principles are already codified in the federal regulations on human subjects protection, but that no amount of codification can provide adequate direction for the day-to-day, study-by-study, work of an IRB.
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One challenge of the future will be to find the best means of disseminating these good ideas. PROJECT AND SCOPE The IOM Committee on the Role of Institutional Review Boards in Health Services Research Data Privacy Protection was formed in December 1999 to gather data on the current and best practices of IRBs in protecting privacy (complete charge is given below)
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1. To gather information on the current practices and principles followed by institutional review boards to safeguard the confidentiality of personally identifiable health information used for health services research purposes, in particular, to identify those IRB practices that are superior in protecting the privacy, confidentiality, and security of personally identifiable health information.
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A key feature of the federal definition of research is whether the activity contributes to generalizable knowledge. In trying to distinguish research from activities such as quality improvement that use similar techniques to analyze personally identifiable health information in databases, however, both the federal regulations and the interpretations of these regulations by the Office of Human Research Protections (OHRP, formerly the Office for Protection from Research Risks, or OPRR)
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· A third issue is what constitutes minimal risk in HSR research and, in particular, what steps to protect confidentiality of data in HSR suffice to allow the project to be considered as minimal risk. The issues of identifiable information and minimal risk have important implications for whether a project may be exempt from IRB review or receive expedited review or whether informed consent of research participants may be waived.
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Institutions that carry out HSR and train health services researchers should require that trainees, investigators, and IRB members receive education, with updates as technology changes, regarding the protection of privacy and confidentiality when using data previously collected for another use. Education is critical not only for IRB members, but also for researchers, technicians, and any other employees who may come into contact with personally identifiable health information.
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Health care or other organizations that disclose or use personally identifiable health information for any purpose including research or other activities using HSR methods should have comprehensive policies, procedures and other structures to protect the confidentiality of health information and should have in place appropriate strong and enforceable sanctions against breaches of health information confidentiality. Access to specific expertise and enhanced general education are important, but the committee also observed that the human element of the research enterprise necessarily includes human potential for error and even malfeasance.
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Recommendation 4-3. Health care organizations that conduct projects applying the methods of HSR to personally identifiable health information for purposes such as QA or QI, disease management, and core business functions as well as for research should have comprehensive policies, procedures, and other structures to protect health privacy when personally identifiable health information is used for research or other purposes.
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Recommendation 5-1. Institutions whose IRBs or other review boards review HSR should ensure adequate administrative support and funding for review bodies and should incorporate improving review operations into overall institutional strategic planning, and organizations that sponsor HSR should also support designating adequate funds for such review.
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, the American College of Epidemiology, the International Society for Pharmacoepidemiology, Public Responsibility in Medicine and Research, the Applied Research Ethics National Association, and others should continue or expand educational efforts regarding the protection of the confidentiality of personally identifiable health information in research. While these recommendations highlight DHHS as the sponsor of this study and a major sponsor of relevant research, the recommendations should be applied by other Common Rule signatory departments and agencies as well.
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The DHHS should continue and expand efforts to encourage holders of personally identifiable health information to make this information available to researchers as public use files after suitable application of techniques to minimize the risks of identifiability. If an organization holding health data has made a dataset publicly available without restriction, as is done with the National Health Interview Survey (NHIS)
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The committee found, however, that such information would be of great use both as a baseline and, if updated periodically, as a basis of continuous policy evaluation. Such a research agenda would likely include current IRB practice as well as new procedures and policies to provide better human subjects protection and also would include monitoring of IRB practices.
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Recommendation 5-9. Health services researchers, and institutions that participate in and benefit from HSR, should voluntarily adopt best practices for IRB review of HSR The committee found that some nations have adopted laws or regulations that allow individuals to exclude their personally identifiable health information from databases, that require written consent from patients for use of health records for research, and that require the anonymization of data for use in any secondary data analysis.
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· Organizations interested in data privacy and high-quality HSR could sponsor a prize competition for best practices in protecting privacy and confidentiality. The methods of HSR, applied to data previously collected for other purposes, have been useful in discovering and demonstrating systemic effects and population-level trends in the organization and delivery of health services.
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