This study takes it as given that because members of society benefit greatly from health research, research—if it is for justifiable purposes, and is conducted with proper protection of subjects—must continue to be allowed controlled access to individuals' health data.
In the compact between health researchers and the public, good-faith respect for privacy, and therefore stewardship of confidentiality, is necessary and expected. (24) The idea of a compact pervades the "Guidelines for the Conduct of Research Involving Human Subjects at the National Institutes of Health," for instance, which are prefaced by the admonition:25
Society has granted a conditional privilege to perform research on human beings. The condition is that it must be conducted in a way that puts the rights and welfare of human subjects first.
In a similar spirit the "Nondisclosure Statement" that all employees of the U.S. National Center for Health Statistics are required to sign declares:26
The success of the Center's operations depends upon the voluntary cooperation of States, of establishments, and of individuals who provide the information required by Center programs under an assurance that such information will be kept confidential and be used only for statistical purposes.
The challenge is to devise criteria, standards, laws, regulations, systems, and professional practices for controlling physical and cyber access to data, managing personal identifiability, and securing informed consent—while, at the same time, facilitating justified research access.
Yes, what is taken to be "justified" is itself a crucial issue. Privacy demands can hardly be judged in isolation. Balance must be sought between the good of privacy and the good of contributing to the improvement of society's health through research.
This "selfishness example" makes the fundamental point more clearly than many tomes of social philosophy:27
Doctor: Here; this medication will help your condition.
Patient: How do you know?
Doctor: A study of 10,000 people's experience showed that it helped 9,247 of them get better.
Patient: Good, I'll take it. But don't let anybody know whether I get better.
Patient-advocacy organizations should be urged to express publicly the willingness of the patients they represent to have themselves or their data studied in research, and in what kinds of research, and under what conditions. Some patient organizations have done this, and some have helped recruit volunteers to studies. Other groups, such as womens' groups and organizations concerned with genetic conditions, have done the same, as has the U.S. Indian Health Service for its constituents.
Relevant basic legal logic was enunciated in 1980 by the U.S. Third Circuit Court of Appeals:28
The factors which should be considered in deciding whether an intrusion into an individual's privacy is justified are the type of record requested, the information it does or might contain, the potential for harm in any subsequent nonconsensual disclosure, the injury from disclosure to the relationship in which the record was generated, the adequacy of safeguards to prevent unauthorized disclosure, the degree of need for access, and whether there is an express statutory mandate, articulated public policy or other recognizable public interest militating toward access.
Similar logic must be applied in balancing individuals' privacy against the potential benefit to society of insights derived by studying individuals' health experience.
Respect for persons will best be served not by insisting on absolute privacy, which is unattainable in modern life anyway, but by seeking informed consent to reasonable use of health information under strictly delimited conditions; by safeguarding personal data carefully; by genuinely affording fair-information-use rights to data-subjects; and by enforcing sanctions against improper use.
(24) The notion of science's compact with society was developed in William W. Lowrance, Modern Science and Human Values, pp. 78–89 (Oxford University Press, New York and Oxford, 1985).
(25) U.S. National Institutes of Health, Office of Human Subjects Research, preface to "Guidelines" brochure (1995).
(26) NCHS Staff Manual on Confidentiality, p. 5.
(27) John P. Fanning, personal communication.
(28) United States v. Westinghouse Electric Corp., 638 F.2d 578 (Third Circuit, 1980).