All research, whether clinical, epidemiological, health services, or social science, involves issues related to pro-tecting privacy and confidentiality. In fact, in some research the invasion of privacy or breaches in confiden-tiality are the only research-related risks to which partic-ipants might be exposed (e.g., some anthropological, psychological, and historical research studies; records review studies; and secondary analysis of existing data).
Privacy and confidentiality, however, tend to be poorly
understood concepts, often mistakenly used interchange-ably, and either ignored or inappropriately handled by investigators and IRBs.11
Privacy refers to persons and to their interests in con-trolling access of others to themselves (Boruch and Cecil 1979). In the research context, privacy refers to how investigators collect or access identifiable data from par-ticipants. Protection of privacy naturally follows as an application of the ethical principle of respect for persons, because in respecting the personhood and autonomy of individuals, investigators must be sensitive in the ways in which they interact with participants who are deciding whether to reveal or withhold information. Americans value their privacy and are concerned about the circum-stances under which they share information about them-selves and, once shared, how the information will be handled (IOM 2000).
Confidentiality, on the other hand, refers to identifi-able data and relates to agreements between the partici-pant and the investigator about how the participartici-pant’s data will be handled and to whom it will be disclosed. It is an extension of the concept of privacy.12 Participants are concerned about unauthorized or inadvertent disclosures of their data, and although participants and the public are generally supportive of research, they often want to be assured that they are in control of access to their infor-mation and that potential breaches in confidentiality are minimized.13
Current federal regulations incompletely address pri-vacy and confidentiality issues in research. IRBs may only approve a research study when the research study is judged to have adequate provisions to protect the privacy of participants and to maintain the confidentiality of data (45 CFR 46.111(a)(7); 21 CFR 56.111(a)(7)). Federal regulations do not provide any additional requirements, stipulate acceptable protection provisions, or define the terms.
Some federal departments have established additional protections relating to privacy and confidentiality that are applicable to research. The Department of Education complies with the Family Education Rights and Privacy Act of 1974, which is designed to protect student records from disclosure without consent from parents or students over 18 years of age. In addition, the Protection of Pupil
National Bioethics Advisory Commission
Rights Amendment gives parents the right to consent for their children to participate in sensitive research. The Department of Justice provides additional regulatory pro-tections for prisoners (28 CFR 512) that give prisoners control over their data, require at least one prisoner and a majority who are not prison personnel to be members of the IRB reviewing the research, and prohibit prison administrators from accessing research data.
Additional confidentiality protections are provided in the National Center for Educational Statistics Confidentiality Statute and the Public Health Service Act for the Centers for Disease Control and Prevention’s (CDC’s) assurance of confidentiality. These statutes limit the use of research data to those purposes for which the participants consent and prohibit the disclosure of identifiable data to anyone without the consent of participants.
The Health Insurance Portability and Accountability Act of 199614 required that legislation regarding stan-dards for the privacy of individually identifiable health information be enacted by August 21, 1999, or DHHS would be required to issue regulations. Because Congress did not pass such legislation, on December 20, 2000, DHHS announced regulations entitled “Standards for Privacy of Individually Identifiable Health Information,”
which became effective April 14, 2001. Although these regulations provide some confidentiality protections for individually identifiable health information, their appli-cation in the research context is limited because the regulations apply only to health plans, health care clear-inghouses, and health care providers. The regulations outline conditions under which individually identifiable health information held by any of the three entities may be disclosed without the individual’s authorization to investigators. Such disclosures may be made if an IRB or
“privacy board” (as defined in the rule) approves a waiver of authorization based on certain criteria, if the informa-tion is sought solely for review preparatory to research, or if the research is on a decedent’s information.
Notwithstanding these additional federal protections of privacy and confidentiality, there is little federal guidance for IRBs and investigators regarding the protection of privacy and confidentiality.
Privacy
Respecting privacy involves more than seeking informed consent from participants to access their data.
Obtaining informed consent serves a vital role in provid-ing participants with control over whether they will allow investigators to have access to them and to data about them. Privacy is influenced by the culture and individual circumstances of participants, the nature and context of the research, and the particular social and political envi-ronment in which the research and use of the data will occur. Individuals have different views on what is considered private. For example, telling an investigator about one’s sexual practices is acceptable to some partic-ipants, but highly offensive to others. It may be even more difficult to respect a participant’s privacy when he or she is different from the investigator in terms of age, ethnicity, locale, socioeconomic status, or gender.15
Privacy refers to the ways and circumstances in which investigators access information about participants.
Consent processes can protect the aspect of privacy that deals with seeking permission to access data, but other research procedures are needed to protect the aspect of privacy related to the circumstances surrounding the actual accessing of that data. Privacy can be respected by using procedures such as written questionnaires rather than face-to-face interviews, by using techniques in which responses are signaled on the telephone touch pad rather than verbally during telephone interviews, or by using private rooms for disrobing for clinical examina-tions. To respect privacy is to let participants control the access of others to themselves, to provide conditions in which the investigator’s inquiries are welcome, and to provide an opportunity for participants to decline or restrict access.16
To breach privacy is to violate participants’ space or to intrude where one is not welcome or not trusted. In fact, the mere act of contacting people about participating in a research study may be a violation of their privacy, partic-ularly when the prospective participants are identified as having a stigmatizing condition (e.g., HIV/AIDS, drug addiction). Research in which management gives consent to conduct research on employees, or deception research, in which participants are led to behave in a way that they would not wish to be seen, are examples of invasions of
privacy.17Although there are few publicized cases of vio-lations of privacy, the invasion of privacy may cause any of the following harms: psychological (e.g., worry, irrita-tion, fear, embarrassment, self-doubt), legal (e.g., arrest), social (e.g., stigmatization), or economic (e.g., blackmail or unemployment).18
Because privacy concerns vary by type and by context of research, as well as by the culture and individual circumstances of participants, investigators should be well informed and mindful of participants’ cultural norms. Investigators also need to be aware of the various research procedures and methods that can be used to respect privacy. In addition, a clear, comprehensive regu-latory definition of privacy along with guidance for protecting privacy in various types of research is needed.19 NBAC proposes the following as a regulatory definition of privacy: Privacy interests are persons’ interests in controlling access of others to themselves and to information about them. Privacy and confidentiality have long been concerns of social scientists and oral historians, and many professional societies for these disciplines have developed ethics codes and guidance describing specific privacy and confidentiality issues and protections for their disciplines (e.g., psychology, anthropology, and oral history).20 In developing new guidance, policymakers should consult existing codes and guidance.
Guidance can be instrumental in helping investigators and IRBs raise concerns and issues about privacy, how-ever it cannot be expected to provide all of the solutions.
It is incumbent on investigators and IRBs, therefore, to tailor research procedures to protect privacy as appropriate for each research study. In addition, IRBs and investigators must be familiar with a variety of procedures and methods that prevent violations of privacy.
Confidentiality
Applied to research, confidentiality, like privacy, is a complex, multifaceted issue. Privacy is an agreement between the investigator and participant regarding dis-closures of the participant’s identifiable data and how that data will be handled. Confidentiality involves informing the participant about mandatory reporting requirements (e.g., reports of child abuse), plans for sharing identifi-able data with other investigators or interested parties
(e.g., FDA), and the extent to which confidentiality can be protected by law—that is, investigators could be sub-poenaed to release identifiable data. In addition, state law must be taken into account in describing confidentiality protection. IRBs and investigators are expected to be knowledgeable about applicable state laws involving privacy and confidentiality, which vary in their coverage of types of data and disclosure requirements.21
Confidentiality also involves informing participants about how the data will be managed. Inherent in this disclosure is review by the IRB of the actual procedures used to ensure protection of confidentiality, which include those used in handling and transmitting data, eliminating linkages of data and identifiers, storing raw data (e.g., questionnaires, records, abstract forms) and data sets, and planning for long-term storage and use, including sharing the data with other investigators.
Research procedures unrelated to data management but generally related to research might compromise confidentiality. For example, reimbursing participants by check or reporting results back to participants could provide a link between the research and the participants that would not otherwise exist. In longitudinal studies, calling or mailing participants might identify them with a research study. IRBs and investigators should review all of the proposed research procedures for possible compromises to confidentiality.
Making stronger legal protections available to all investigators could enhance confidentiality protections.
In examining such options and designing such protections, mandatory federal or state reporting requirements (e.g., mandatory child abuse disclosures) should be considered.
In addition to the federal statutes mentioned earlier, another mechanism available to protect confidentiality is the Certificate of Confidentiality. Under the Public Health Service Act, DHHS agencies may issue Certificates of Confidentiality to investigators authorizing them to with-hold identifiable data about research participants that may be summoned under federal, state, or local civil, judicial, administrative, legislative, or other proceedings.
DHHS regards the certificate’s protection as superceding state law, and some case law supports this position.22 However, Certificates of Confidentiality do not provide the same degree of protection as that provided under
National Bioethics Advisory Commission
CDC’s and the Department of Education’s National Center for Educational Statistics Confidentiality Statutes, because although certificates protect against compulsory disclosures by the investigator, they do not prohibit investigators from making disclosures unauthorized by the participant.
In addition, certificates, which are specific to a research study and not to an investigator or institution, are issued sparingly and only when it is determined that the data are sensitive and that issuance will increase study participation. Stronger confidentiality protections are needed for all research involving sensitive, identifi-able data. At a minimum, Certificates of Confidentiality should be issued on request to investigators when it is determined that the research involves sensitive, identifi-able data and no other legal protections apply. Much stronger protection of confidentiality would be afforded if a mechanism such as a Certificate of Confidentiality also prohibited investigators from making unauthorized disclosures, however, such additional protection should be imposed cautiously because it may entail serious costs, as investigators would not be able to share data with others without the participant’s permission.
Like privacy, confidentiality concerns vary by research type and context, and no one set of procedures to protect confidentiality can be developed that would cover all types of research contexts. IRBs and investigators must tailor confidentiality protections to the specific circumstances and methods used in each specific research study. A recent Institute of Medicine (IOM) report describes procedures investigators can easily adopt to reduce the risks associated with breaches of confiden-tiality (IOM 2000). This report suggests that IRBs con-sider recommending or requiring such procedures when appropriate and it encourages IRBs and investigators to consider using strong confidentiality protections to reduce some of the violations associated with privacy. A clear, comprehensive definition of confidentiality along with guidance for protecting confidentiality in various types of research is needed. NBAC offers the following definition of confidentiality: Confidentiality is the protec-tion of identifiable data through agreements between participants and investigators about who may have access to the data and how the data will be managed in order to control access.
Recommendation 5.4:Federal policy should be developed and mechanisms should be provided to enable investigators and institutions to reduce threats to privacy and breaches of confidentiality.
The feasibility of additional mechanisms should be examined to strengthen confidentiality protections in research studies.
Summary
Once an IRB has determined that risks of a given protocol are reasonable in relation to potential benefits, no person should participate in that research without his or her voluntary informed consent (or that of an appropriate representative). However, for some studies that pose minimal risk, it might be possible to waive this require-ment. The process of informed consent involves investiga-tors making appropriate disclosures about their research and participants developing a good understanding of the information provided and their choices regarding partic-ipation in a study. Participating in the process of informed consent is one of the best ways investigators can demonstrate their concern and respect for those they wish to enroll in a study.
In this report, NBAC reinforces previous recommen-dations from earlier reports by recommending that the process of providing information and ensuring compre-hension should be emphasized, rather than the docu-mentation of the decision to give consent, and that both the information and the way it is conveyed—while meet-ing full disclosure requirements—should be tailored to meet the needs of the participants in a particular research context. NBAC also recommends that documentation requirements should be adapted for varying research settings and that the criteria for deciding when informed consent is not necessary should be clarified to better ensure that participants are protected. Finally, because there are no clear policies on protecting privacy interests and confidentiality in the research context, the informed consent process alone is sometimes insufficient for protecting the rights and welfare of participants. Federal policy should be clarified and strengthened in this area to assist investigators in ensuring that the interests of participants are protected.
Notes
1 See Vanderpool, H., “Unfulfilled Promise: How the Belmont ReportCan Amend the Code of Federal Regulations Title 45 Part 46—Protection of Human Subjects.” This background paper was prepared for NBAC and is available in Volume II of this report.
2 Ibid.
3 Ibid.
4 Ibid.
5 NBAC Town Meetings: February 9, 2000, Houston, Texas;
April 5, 2000, Pittsburgh, Pennsylvania; May 3, 2000, Orlando, Florida; June 7, 2000, Chicago, Illinois; August 14, 2000, Portland, Oregon.
6 Informed consent requirements pertaining to research involving children are not addressed in the Common Rule. However, DHHS regulations include specific requirements relating to research involving children (45 CFR 46 Subpart D). DHHS regulations require that “when in the judgment of the IRB” children are capa-ble of providing assent (their affirmative agreement to participate), they are asked to do so. In addition, at least one parent or guardian and in some instances both parents or guardians are required to give permission for the child to participate in the research. NBAC has not addressed ethical issues pertaining to children participating in research. Attention should be given to the ethical standards and regulatory requirements for adequately protecting children.
7 It should be noted that special provisions exist for waiving consent in the context of emergency research.
8 Ibid.
9 Ibid.
10 See Schwartz, J., “Oversight of Human Subject Research: The Role of the States.” This background paper was prepared for NBAC and is available in Volume II of this report.
11 See Goldman, J., “Privacy and Confidentiality in Health Research.” This background paper was prepared for NBAC and is available in Volume II of this report.
12 See Sieber, J., “Privacy and Confidentiality: As Related to Human Research in Social and Behavioral Science.” This background paper was prepared for NBAC and is available in Volume II of this report.
13 See Goldman, J., “Privacy and Confidentiality in Health Research.” This background paper was prepared for NBAC and is available in Volume II of this report.
14 Pub. Law 191, 104th Congress.
15 See Sieber, J., “Privacy and Confidentiality: As Related to Human Research in Social and Behavioral Science.” This back-ground paper was prepared for NBAC and is available in Volume II of this report.
16 Ibid.
17 Ibid.
18 See Goldman, J., “Privacy and Confidentiality in Health Research.” This background paper was prepared for NBAC and is available in Volume II of this report.
19 In DHHS’ response to NBAC’s report, Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, it was noted that NBAC’s recommendations regarding identifiability and privacy might be inconsistent with proposed medical record rules promulgated by DHHS.
20 Anthropology: http://www.aaanet.org/committees/ethics/
ethcode.htm; Psychology: http://www.apa.org/ethics/code.html;
Oral History: http://www.dickinson.edu/organizations/oha/
evaluationguidelines.html. Each last accessed September 4, 2000.
21 See Schwartz, J., “Oversight of Human Subject Research: The Role of the States.” This background paper was prepared for NBAC and is available in Volume II of this report.
22 Peoplev. Newman(32 N.Y.2d 379, 298 N.E.2d 651, 345 N.Y.2d 502, 1973).
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