PRIVACY AND CONFIDENTIALITY IN RESEARCH

When people seek the help of healthcare providers, and thus become patients, they exchange some of their privacy for the chance to be healed, diagnosed, and protected from illness. Healthcare providers in turn promise to keep patients' private information confidential by sharing it only with those whose knowledge stands to benefit the patient, unless higher duties require that the promise be broken, or the patient has consented to other uses of the information. When private information is shared not for treatment purposes but in research, the exchange is necessarily different: Research subjects (even those who are also patients) are not the same as patients, and researchers are not the same as persons offering treatment (even if they are also clinicians). The research context may alter not only what information individuals consider private and the extent to which they are willing to share it, but also the potential harms and wrongs that may result from breaches of privacy and confidentiality.

Issues of privacy and confidentiality in human-subjects research can arise in three contexts. First, patient care can give rise to research questions, as when researchers wish to use data from patients' medical records or contact health providers for the names of patients with specific health problems to ask them to participate in research projects. Second, human subjects of biomedical, behavioral, or social science research, as well as persons and groups who may not be research subjects, can be affected in a variety of ways that implicate privacy and confidentiality by the gathering or the use of information for research purposes. Finally, clinical research involving subjects who are also patients has its own particular risks to privacy and confidentiality, as when the media and the public claim a special interest in the first patient-subjects to receive a novel research intervention. In all of these circumstances we must examine the disclosure, sharing, and publication of information, and the interests of researcher, subject, and others, as well as the legal, policy, and practical protections that are available to preserve subjects' privacy and the confidentiality of their private information.

Privacy, as a right belonging to persons, and confidentiality, as an attribute of data that arises from a promise made by healthcare providers or researchers, can readily be seen as intimately related to the moral principles of autonomy, respect for persons, and beneficence, and to the requirement of informed consent. In the United States, federally funded research is governed by consolidated regulations for the protection of human subjects, known as the Common Rule, which require that all research collecting identifiable private information about living individuals be reviewed by an institutional review board. This review must minimize the risks that research poses to subjects, determine that the risks are reasonable in relation to anticipated benefits, ensure that informed consent is obtained, and, "when appropriate," require "adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data." The required informed consent includes "a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained" ("Federal Policy for the Protection of Human Subjects").

According to the Common Rule, if confidentiality is promised by researchers, they must be able to provide it; but confidentiality need not be promised, so long as subjects are informed that confidentiality is not offered and can freely choose to participate based on that knowledge. The ethical baseline thus provided by the Common Rule must then be supplemented by professional codes and other guidelines, as well as by existing federal, state, or local privacy laws (Annas, 2001; Symposium).

Privacy and Professional Codes

Many professional codes discuss the ethics of research and scholarly publication; the attention each gives to privacy and confidentiality necessarily varies, with each such code generally combining an aspirational morality with a particularized professional focus. For example, the Council for International Organizations of Medical Sciences' International Guidelines for Ethical Review of Epidemiological Studies (1991) contains an extensive discussion of confidentiality protection in large data sets, and its International Ethical Guidelinesfor Biomedical Research Involving Human Subjects (2002) includes a confidentiality provision addressing a broad range of data types, sources, uses, and risks of harm. In contrast, the World Medical Association's Declaration of Helsinki (2000) includes only a statement of the importance of respecting "the privacy of the subject [and] the confidentiality of the patient's information"; and the Nuremberg Code (Germany [Territory Under Allied Occupation …], 1949), devoted to the subject's right to consent, does not mention privacy or confidentiality at all.

PRIVACY AND HIPAA. In the United States, regulations implementing federal legislation designed to improve access to health insurance, the Health Insurance Portability and Accountability Act (HIPAA), may have considerable impact on privacy and confidentiality in research using health information. HIPAA's data privacy regulations apply to a specific set of users (covered entities) who generate and maintain personally identifiable health information. This group of users is not coextensive with federally funded researchers, and crosses professional boundaries; thus, HIPAA's privacy rule may have broader application in human subjects research than the federal regulations (Department of Health and Human Services [DHHS]).

In very general terms, the privacy rule's application to research means that personally identifiable health information may not be created or used for research by covered entities and their business associates unless the research subject has specifically authorized the use, the authorization requirement has been waived by a HIPAA privacy board or an institutional review board, or the use falls under a limited set of exceptions (Office of Civil Rights). In many respects, the privacy rule in research conceptually parallels the privacy and confidentiality concerns of institutional review boards and of federal research oversight agencies like the Office for Human Research Protections.

The HIPAA privacy rule may prove extremely helpful in addressing confidentiality problems in health research using large data sets (Barnes and Krauss; Durham). However, HIPAA's focused attention on personally identifiable health information in research may diminish attention to other types of risks to privacy and confidentiality that are posed by research but not considered by HIPAA, such as risks to groups, dignitary harms, or risks arising from interactions themselves, rather than from the resulting data. Because implementation of the HIPAA privacy rule is so new, whether and how it affects overall perspectives on research privacy remains to be seen (Annas, 2002; Kulynych and Korn).

Becoming a Research Subject

Usually, research subjects are enrolled in a study after giving their informed consent to participation. However, subjects in studies that examine information about which there is considered to be a lesser expectation of privacy (e.g., large-scale record abstraction that collects no identifying information, or studies observing public behavior) may never know that they have been the subjects of research. In fact, pursuant to the Common Rule, such studies may be exempted from review by an institutional review board. Violations of privacy may occur in such studies. For example, some subjects may not want researchers to read their records even though only aggregate data are recorded; and some subjects may feel wronged if they know their behavior is being observed for research purposes, even though many strangers who are not researchers observe the same behavior. However, the balance of benefits and harms is generally considered to warrant exempting such studies both from full consideration by an institutional review board and from the informed-consent requirements that would alert subjects to participation (Capron).

In addition, according to the Common Rule, some studies reviewed by institutional review boards may be considered appropriate for waiver or alteration of informed consent requirements. Factors used in determining whether waiving the informed consent requirement is acceptable include the magnitude and likelihood of the risks of harm to subjects in the study, and whether obtaining individual consent is considered impracticable. Large-scale database research that involves no direct contact with subjects, but in which researchers plan to retain information that identifies subjects in order to link, for example, information from a cancer registry to medical and other records and to stored tissue specimens presents an increasingly common scenario throughout the world. Investigators reason that they have no interest in the identities or characteristics of individual subjects, but need identifiers in order to gather, link, and analyze aggregate data. Seeking consent may be considered impracticable because of the cost and difficulty of reaching potential subjects, or because too many negative responses would result in a nonrepresentative sample, thus adversely affecting the validity of any findings. Confidentiality protections in such studies depend on ethically sensitive oversight and robust data security measures. (Berman; Bruppacher and Kaiser; Leufkens; Truter).

As in the case of research that is exempted from the informed consent requirement, research for which the consent requirement is waived may result in privacy violations if subjects would not wish investigators to see and use their personal information, even if only to link data sets. Breaches of confidentiality are of course also possible, but the risk may be lowered if adequate data security plans are in place, and identifying and potentially identifying information is destroyed as soon as it is no longer needed. Perhaps more basic, however, is the question whether sample validity overrides individuals' privacy interests in, at the very least, knowing that they are subjects. With the growth of large-scale research of this type, it is increasingly common to seek subjects' general consent to the prospective collection of data and specimens to be stored for future research (Annas, 2000; National Bioethics Advisory Commission, 1999).

All research requiring access to patients' medical records raises confidentiality concerns when the investigator is not also either a healthcare provider or other person with legitimate reason to inspect medical records. Perhaps the most significant concerns arise when patients are contacted to solicit their research participation by non-provider researchers using contact and diagnosis information they have obtained from medical records without patients' knowledge or permission. A variety of ways of balancing harms and benefits, and of reducing risks to confidentiality, are available to investigators and healthcare providers concerned about the interests of patients who are in the process of becoming research subjects (National Bioethics Advisory Commission, 2001; Office for Human Research Protections; Veatch).

The fact of study participation is generally treated as confidential information; this is especially important when the category of subjects or the purpose of the research carries potential social stigma (e.g., studies of HIV-positive patients, familial mental illness, genetic disease, or drug abuse). Inclusion in the subject pool may be enough to warrant confidentiality protection for potential subjects who decline to participate. Persons approached to participate in some studies may not want others to know that they fall into a category appropriate for inclusion. Others may be concerned that their participation may signal the existence of desirable information about them to employers, insurers, treating health professionals, or other authorities, placing the confidentiality of collected data at particular risk (Melton and Gray).

Privacy and the Researcher–Subject Relationship

Once enrolled, the subject is asked to disclose private information to a researcher. Such disclosure can take place in a variety of ways, from giving up tissue samples to answering extensive questions about personal history and psychology. The subject's judgment regarding the privacy of such information is highly dependent upon the circumstances. Someone enrolled in an addiction-control program may have little difficulty discussing alcohol consumption with health professionals in that program, but may have some hesitation about discussing it with a researcher collecting epidemiological information on the health of the person's county of residence, and even more when it is requested as part of a survey about the effects of television on perceptions about violence. Collection of genetic information may be of particular concern to subjects, because of heightened public awareness of how such information may be regarded and used (Sankar).

Sometimes revealing personal information (e.g., giving a blood sample, disclosing personal habits, recounting a past experience, or discussing physical limitations) can cause psychological or physical distress. According to the Common Rule, subjects must be informed when the research may be painful or address sensitive topics. Subjects must also be informed of their rights to refuse to answer individual questions and to terminate participation in the research at any time ("Federal Policy for the Protection of Human Subjects").

Interview studies raise an additional privacy concern when the information sought concerns persons other than the subject. For example, much survey research asks questions about the habits and activities of the subject's family, household, and associates. Some questions may concern sensitive topics or disfavored or illegal conduct. Although persons other than the subject are not named, they may be identifiable through naming of the relationship to the subject. In at least some such instances, these secondary subjects are research subjects in every respect, and their consent for participation should be sought unless criteria for waiver of consent are met (Botkin). Even if they are not identifiable, they may be wronged, simply because information about them is revealed without their consent or knowledge (Capron). It is likewise possible for some people or groups to become unexpected subjects if collection of information from them about study subjects incidentally reveals important information about the informants—as when studies of medical technologies or practices uncover information about healthcare providers who were not initially considered subjects (King, Henderson, and Stein; Veatch).

A similar concern can arise when others are asked to provide information about study subjects. In long-term studies, some subjects may become decisionally incapacitated, and investigators may turn to others, perhaps family members or institutional caregivers, to provide needed data. This violation of subjects' privacy can be avoided by dropping these subjects from the study, or ameliorated by anticipating the problem and discussing with all subjects the designation of appropriate proxies should that become necessary (National Bioethics Advisory Commission, 1998).

The Promise of Confidentiality

The promise of confidentiality given by researchers to subjects extends not only to the information actually collected but also to whatever information the researcher encounters in the course of the data collection, regardless of whether that information is recorded. Thus, for example, when medical records are abstracted, information read by researchers as part of the abstraction process must be kept confidential, and information conveyed but not used in interviews similarly must not be divulged. Research projects that make use of record abstractors or interviewers generally require them to sign pledges of confidentiality promising that they will discuss no information outside the research project.

The information collected in human-subjects research needs protection not only from careless disclosure but also from intentional disclosure to those with a particular interest in the data. For example, study results may be offered as evidence in civil or criminal litigation, and both plaintiffs and defendants may seek to challenge the research by reexamining the data used or even by reinterviewing subjects. Criminal or social services authorities may seek access to study data that could inform them of ongoing violations. Health insurers may want to know whether those they insure have been tested for HIV or genetic disorders (Holder; Lansing; Symposium; Wing;Yolles et al.) In order to protect subjects from court-ordered disclosure of identifying information in civil, criminal, administrative, or other legal proceedings, federal certificates of confidentiality are available for human-subjects research that collects sensitive information which, if disclosed, could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation. Certificates of confidentiality must be applied for by the investigator, and do not prevent voluntary disclosures by investigators; nonetheless, they can offer considerable protection for subjects (Office of Extramural Research).

Certificates of confidentiality have been expanded from their original focus on criminal justice questions, alcohol and drug use, and mental health, to encompass a broad range of research collecting sensitive information, including genetic information, information about sexual attitudes and preferences, information about sexually transmitted disease, behavioral research, and information about environmental or occupational exposures where litigation may be an issue. They preclude only the release of information that would identify specific individual research subjects and connect their identities with their data (Reatig). The concept of a researcher–subject privilege is not well established in the law, but courts that have considered requests for research data have generally required a strong showing of necessity and the deletion of all information that could lead to identification of subjects, even when the subjects' identities are a critical part of the request.

Confidential or Anonymous?

One way to ensure that confidentiality is not breached is to ensure that the information collected in research is anonymous—that is, that no information that could identify subjects is recorded or retained. Confidentiality can be preserved without anonymity by stripping collected data of identifying information but substituting a subject identification code and creating a secured linkage file that contains information connecting the subject's name and/or other identifying information to the code. The complexities of confidentiality protection can be considerable, especially in large projects, conducted at multiple sites that collect and manipulate data in hard copy or electronic formats, or both. Many different means of protecting confidentiality for different types of data have been devised (Berman; Schiedermayer).

Anonymous research virtually eliminates the risk of breaching confidentiality. However, anonymity may not be practicable or desirable. Researchers may wish to recontact subjects for a follow-up study, or may be conducting a long-term study that requires multiple contacts. Researchers may also wish to retain identifiers for subjects' benefit: Studies may collect health information, such as blood pressure or blood cholesterol levels, that subjects have been promised as an inducement to participation, or investigators may feel the need to inform subjects of potentially dangerous health situations that data collection may uncover. Finally, anonymity may too readily be considered a justification for not seeking participants' consent in studies that can be conducted without their knowledge (Bok).

Giving up anonymity in order to protect subjects' other interests can be highly problematic. HIV research provides an excellent example. Because of the stigma associated with the possibility of membership in an at-risk population and the difficulty in obtaining consents in sufficient numbers, some epidemiological researchers have conducted anonymous studies of the percentage of persons testing HIV-positive in large populations in order to obtain basic information about the spread of the disease. This makes it impossible to identify persons found to test positive, so that they can be counseled and treated. In effect, it precludes offering research subjects the opportunity to become patients.

Similar problems can arise in other research. For example, survey research that includes questions about family violence may uncover instances of recent or ongoing child abuse, but if survey answers have been rendered anonymous, even information gathered in live telephone or computerassisted interviews may have insufficient detail to be reported to social services authorities, no matter how detailed the account of abuse given to investigators (King, Henderson, and Stein). How the tensions between public health goals in collecting data and protection and benefit for research subjects are addressed and resolved in such instances reflects continually shifting balances between the perceived need for epidemiological study, prospects for therapeutic intervention, and societal responses to particular health issues.

The Problem of Unexpected Information

Some researchers resist the idea of anonymous studies out of a felt obligation to offer information, counseling, and treatment to subjects found by the research to be in need of health services (Bayer et al.). But similar concerns can arise in confidential research as well. Studies using gene-trolling technologies like microarray techniques, which can quickly search a DNA sample for a wide range of disease-associated genes, can uncover potentially important health information that is unrelated to the stated goals of the research, thus surprising subjects who consented to research on one health problem with information about another (Berman; Collins). Additional challenges to privacy and confidentiality arise when the unexpected information has health implications for close relatives of the subject, who have not consented to participation and may know nothing about it. And if the research was conducted under a consent waiver, investigators may face the prospect of contacting people who have been involuntary subjects to give them bad news arising from their research participation.

Because the information derived from genetic research can have implications that go beyond those for subjects and their families, unexpected information may prove problematic for communities as well (Beskow; Rothstein). Even expected information may raise important concerns. The privacy interests of communities and groups may be directly and deliberately implicated by large-scale genetic research seeking information about the relationships between genetic characteristics and health outcomes, and both individual subjects and investigators may be ill-equipped to address and assess these risks of harm (Annas, 2000; Collins; Greely).

New Uses for Old Data

Data-sharing problems arise when researchers seek access to previously collected information. Researchers may seek to abstract information from the medical records of both currently and formerly hospitalized patients, or to perform additional tests on samples of blood or tissue obtained for diagnostic purposes. Study subjects may be approached by other researchers, or the data collected about them may be sought for new research uses. Stored research data may even yield information that is thought to be of therapeutic usefulness (Medical Research Council; Tribe).

Each of these examples raises one or more of several recurring problems: Is the new use one that was contemplated in the original consent? Is it one that the person would or would not be likely to find objectionable? Can the person be contacted for a new consent? If not, is proceeding without consent appropriate? If contact is necessary or desirable, does such a contact in itself constitute an unacceptable breach of confidentiality? The use of medical records and blood and tissue specimens for research has been addressed in a variety of ways, including: By asking patients at the time of hospital admission to give blanket consent to confidential or anonymous use of record data; by simply advising patients that such research may be undertaken with the approval of an institutional review board; by permitting researchers to contact patients for consent to specific uses, including long-term storage of identified or anonymized specimens for specified or unspecified research uses; and by using the treating physician to screen researchers' requests. Each of these solutions provides a different moral balance between the burden on researchers and the wrongs, harms, and benefits to subjects (Appelbaum et al.; National Bioethics Advisory Commission, 1999).

Where stored data have a potential therapeutic use, the situation is even more sensitive. A subject who participates in blood and tissue studies does not thereby consent to be contacted with a request to become a bone marrow donor for a specific patient. Such a contact could place considerable pressure on some subjects; others may want to have the opportunity to help, and may feel guilt at not having been afforded it. The temptation to compromise on privacy and confidentiality may be strong here. However, the argument that the needs of the patient should outweigh the privacy interests of a potential donor has not been embraced by the courts that have heard such cases (Davis, 1983; Lansing). As a result, this situation has been addressed, like the use of treatment information for research purposes, by asking research subjects whether they agree to be contacted later should a specific therapeutic need arise.

Publicity, Privacy, and Voice in Research

Publicity is most notably a problem for participants in innovative clinical trials, such as the first recipients of organ transplants, the first subjects to receive a novel intervention or vaccine for HIV infection, or the first subjects to experience an adverse event in a human gene transfer trial. The invasions of privacy threatened by the public interest in the lives of persons suffering from exotic diseases and undergoing unprecedented treatments may constitute civil wrongs if the media cannot claim First Amendment protection (Tribe).

The civil right to privacy is encompassed by several distinct courses of action, including the rights of private persons to be free from intrusion upon their solitude, to keep private information from being made public, and to prevent the publication of true information that places them in a false light (Warren and Brandeis). American society has changed greatly since this understanding of privacy was first outlined in law; yet finding a balance between protecting private information and sharing it remains a profound challenge (Goldman). Indeed, public interest in medical research is such that patient–subjects in clinical trials in high-profile emerging fields like gene transfer research are routinely informed that complete protection of their privacy may not be possible in the face of media interest.

A related threat to privacy and confidentiality is posed by the emphasis on narrative in research and teaching. Publication of research results is permitted, in professional and international codes and regulations, either when the subject has consented or when identifying information has been deleted or altered so as to preclude identification of the subject by readers and audiences, so long as the data are not misrepresented thereby (International Committee of Medical Journal Editors).

In many circumstances, such as in ethnographic research and increasingly in bioethics generally, it may not be possible to disguise case studies and other narratives adequately and still use them pedagogically (Davis, 1991). Well-known cases cannot be disguised at all. The scholarly community and the public have learned much from widespread discussion of Baby Fae, Barney Clark, Jesse Gelsinger, and many others, but not without costs to them and their families. And in less famous cases, even when a stripping of details is sufficient to disguise a patient–subject for a scholarly audience without misrepresenting the data, it may not be sufficient to disguise that person from family, associates, and treating health professionals who may chance to read a publication.

Finally, recognition of the subject by others may not constitute the only or the greatest wrong. Recognizing oneself in a public depiction can produce shame even when no one else knows. Although issues of consent and deception may be entangled with privacy and confidentiality in narrative research (Allen), subjects may be wronged and harmed regardless of whether the depiction is perceived to be accurate or distorted, and whether or not they have consented to the publication (King, Henderson, and Stein).

Some researchers address this complex problem by developing long-term collaborative relationships with subjects. Collaboration can reduce the exclusive control the researcher has over the story by including the subject's voice, but is not always possible, helpful, or desirable. Indeed, the ethics of telling stories has become a primary issue for bioethics itself (Chambers; Davis, 1991). As the problem of privacy and confidentiality in research shows, even in the face of the imperative to increase knowledge, it is important to consider whether some new knowledge is worth sacrificing privacy or confidentiality, and whether some knowledge comes at too great a cost to the rights and interests of those from whom we learn.

nancy m. p. king (1995)

revised by author

SEE ALSO: AIDS: Healthcare and Research Issues; Confidentiality; Informed Consent: Consent Issues in Human Research; Law and Bioethics; Privacy in Healthcare; Research, Unethical; Research Ethics Committees; Research Methodology; Research Policy

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INTERNET RESOURCES

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