Last week we discussed the basic principles outlined by the Fair Information Practices (FIPs) and the Belmont Report. This week, we’re taking on their areas of convergence.
Similarities Between FIPs and Belmont Report
Both the FIPs and the Belmont Report were published in relatively close proximity to one another, and for good reason. Prior to these reports, few laws or regulations existed to protect the privacy or rights of patients. The FIPs were originally put forth as a solution to quell the “growing privacy concerns over computerized databases maintained in both the public and private sector”. Branching from the Nuremberg code, further codes also set out to protect research subjects and serve as a guide to researchers, but these codes often conflicted with each other and most situations were too complex to be covered completely. The Belmont Report, in an attempt to bridge this gap, includes a section detailing the ethical dilemmas and shortfalls of proper treatment of human subjects in the course of research studies.
Values: Autonomy and Fairness
The FIPs state that “the dominant conceptualization of privacy in data protection regimes around the world is control over personal information”. A user, or subject, is given control over their personal information when they are given notice of a company’s information practices; the user or subject is then determined to have given permission to data processors to collect and use their information as specified in the notice.
Similarly, the Belmont Report’s first principle of Respect for Persons places focus on the importance of acknowledgement of a subject’s autonomy. Respecting an individual’s autonomy includes ensuring that the subject voluntarily participates in the research and is given sufficient information on the risks, benefits, and procedures of the research. The second half of this principle, to protect those with diminished autonomy, is not as straight forward. Examples of individuals who may fall into this category include those of immature age, those suffering from illness, and those diagnosed with a mental disability. This aspect of the principle is much harder to discern, for each subject who falls into this category requires a different extent of protection for different periods of time. To determine the extent of protection, the likelihood of benefits and risk of harm should be evaluated.
Subjects’ Rights to Awareness
The FIPs attempt to ensure subject awareness of data collection methods through the use of its principles. Most specifically, the Openness Principle requires that data collectors are transparent about data collection practices and policies, and the Use Limitation Principle requires data collectors to obtain consent for all uses and disclosures of subject data. These principles, although vague, begin to bridge the gap between subjects and data collectors by keeping the subjects aware of how their data is being used.
The Belmont Report focuses heavily on this ideal. The report’s subsection of “Informed Consent” is broken down into three main facets: Information, Comprehension, and Voluntariness. The first of these facets, Information, establishes terms for disclosure to ensure that subjects are given sufficient information to be fully aware of the procedures, risks, benefits, purpose(s), and voluntary nature of the research study. Further within this subsection, the topic of incomplete disclosure is also covered. In these instances, relevant information about the study, excluding risks associated with study procedures, is withheld from the subject because it would affect the outcomes of the research. Studies employing incomplete disclosure methods must have plans in place for debriefing subjects after the completion of the research. Following this, the second facet, Comprehension, states that subjects must be allowed to take ample time to comprehend the information given to them, and this information must be given in an organized manner. In certain cases, comprehension tests or third party evaluations of comprehension may be used to ensure that subjects are fully aware of all aspects of the research. The third and final facet, Voluntariness, requires that subjects must give their full consent without coercion, threat, or undue influence.
Focus on Consent
Both the FIPs and the Belmont Report emphasize the importance of obtaining a subjects’ proper consent, although each accomplishes this through different means. The FIPs’ eight main principles lay out a checklist of guidelines for data collecting entities to follow, all of which relate to subject consent and awareness in some way. Meanwhile, the Belmont Report describes the basic principles all researchers should follow before honing in on how to ensure that subject consent and clear understanding is achieved. These requirements for proper subject consent overlap tremendously with the requirements for subject awareness, as discussed in the subsection above, since most methods for ensuring subject awareness involve a focus on subject consent.
Requirements for Data Collectors
Unsurprisingly, each set of principles also includes recommendations for data collectors on how to treat subject data with care to ensure that subjects are provided proper protections. For the FIPs, these recommendations come directly from its principles. For the Belmont Report, however, the recommendations for ethical treatment of subjects in medical studies must be translated to also protect subjects’ data when this information is used in research. These protections are similar to those already understood and outlined within the report, for a subject releasing their data for research must be afforded the same respects, protections, and considerations as a subject undergoing a medical procedure for research.
Want to learn more about FIPs and the Belmont Report? Next week, we’ll address differences between these sets of principles that guide the Arcus approach to privacy.