CITI Privacy and Confidentiality SBE
Summary
Although privacy and confidentiality deal with different aspects of a study design, how these two issues are handled translate into issues of trust and security for a research participant.
Certificates of Confidentiality
Certificates of Confidentiality are issued by the National Institutes of Health (NIH) (an agency of the U.S. Department of Health and Human Services [HHS]) to protect sensitive, identifiable research information from forced disclosure. The certificates may be granted for studies collecting information that, if disclosed, could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation. A Certificate of Confidentiality will allow the researcher and others who have access to research records to refuse to disclose identifying information on individual research participants in civil, criminal, administrative, legislative, or other proceedings, whether at the federal, state, or local level. Information that can be protected includes, but is not limited to: Substance abuse or other illegal behaviors Sexual attitudes, orientation, or practices Genetic information Psychological well-being Certificates of Confidentiality may be secured for any sensitive research, regardless of the funding source, so long as the research is relevant to the mission of the NIH/HHS. In fact, the research does not have to be funded. Certificates of Confidentiality do not override the requirement to report the suspicion of child abuse or neglect, or any other state-mandated reporting requirements, such as elder abuse. Other federal agencies, such as the Department of Justice, provide agency-specific protections that apply to research conducted or funded by the agency. Under a policy issued 7 September 2017 (effective 1 October 2017), NIH-funded investigators do not need to apply for Certificates of Confidentiality, nor will they receive a document certificate. The NIH issues Certificates of Confidentiality automatically for NIH funded grants, cooperative agreements, contracts and intramural research projects funded wholly or in part by the NIH that collects or uses identifiable, sensitive information (NIH 2017). Certificates of Confidentiality contain conditions for disclosure of the identifiable, sensitive information that the investigator must comply with, including more restrictive requirements for disclosure in the new policy. The Certificates of Confidentiality policy remains the same for non-federally funded research, in that investigators must apply for a Certificates of Confidentiality from the NIH or other HHS agency for specific research studies. Researchers must inform subjects about the protections and limitations provided with a Certificate of Confidentiality.
Identifying Private Information
Federal regulations (Protection of Human Subjects 2018) define private information to mean "information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record)." • Private information • Rests on subjects' reasonable assumption of privacy Applying the reasonable assumption standard is not a simple task. It would be unreasonable to assume that behavior on a street corner or a public park is private, but reasonable to assume that behavior in our homes is private. However, given that technology makes it possible to film and record conversations from considerable distances, a third kind of space may be emerging: private spaces in the midst of very public ones. Parents taking their children to a city park might justifiably consider it a violation of privacy if the interactions of their children were audiotaped using long-range recording devices. Reasonable assumptions regarding privacy will vary from culture to culture and setting to setting. For example, in some cultures, health information is considered very private, but in others, information about people's health is part of the community dialogue and widely shared. Reasonable assumptions about privacy may vary among generations. The legal maxim that privacy is the "right to be let alone" (Warren and Brandeis 1890) comes from a world where privacy was seen as threatened by, among other things, the technologies that allowed still photographs to appear in mass-circulated newspapers. Now, through social media, people use images to document their behavior and that of their friends and family, sometimes without restricting public access to the images. It may be difficult to discern if and when people feel their use of the Internet is public or private.
Protecting Communications with Subjects
If a study is obviously about stigmatizing conditions, illegal activities, or life experiences that subjects may not want others to know about, communications with the subjects should not reveal their participation in the study to others. To do so would violate the subjects' right to privacy. Study titles should be carefully considered; it is often best if the title does not reveal sensitive information about subjects. A method of communication that is of particular concern is email. Employee email is not secure and some personal accounts may be accessed by anyone in the family. Telephone calls to subjects at home may be of concern. It may be appropriate to script calls carefully so that no information is revealed about the caller or the subject to anyone other than the subject. In some cases, it may be appropriate to remind subjects to prevent possible violations of their privacy in their homes by, for example, closing browsers after completing an online survey on a sensitive topic.
Observational Studies
In some observational studies, researchers participate in the activities being observed and the subjects know that the researchers have dual roles as both participants and as researchers. However, if subjects are observed and private identifiable information is gathered about them without their knowledge and consent, there is a clear violation of their right to privacy. Determining whether covert observation can be considered ethically sound depends on answers to questions such as whether the invasion of privacy is justified by the potential benefit of the study and what, if anything, the subjects will be told after the data are collected. For example, a researcher interested in the effects of subliminal priming on the choice between healthy or unhealthy snacks made available to subjects during a "break" between study tasks, may videotape the subjects during the break without their knowledge. Can the researcher articulate a potential benefit? Should the subjects be given the opportunity to ask that the film of their behavior be destroyed? Focus Groups It is not possible for a researcher to promise confidentiality in a focus group setting." Focus groups are unique settings in which both privacy and confidentiality may be issues. In effect, focus group participants relinquish control of the extent, timing, and circumstances of sharing themselves because other group members may repeat what they say outside the group. This may occur even if researchers emphasize that comments made during the focus group session should not be repeated. Researchers may protect recordings and transcripts themselves, but they have no authority to enlist participants in agreements to appropriately protect the information shared. Researchers can encourage participants to be as honest and open as they can, but when the topic warrants, also should encourage them to remain mindful of the limits on the researcher's ability to protect their privacy. Snowball Sampling Snowball sampling is a recruitment technique in which research participants are asked to assist researchers in identifying other potential subjects. If the topic of the research is not sensitive or personal, it may be appropriate for subjects to provide researchers with names of people who might be interested in participation. If the topic is sensitive or personal, such as the fact that someone was adopted, considerable care should be taken so that potential subjects' privacy is not violated. In this case, subjects assisting with recruiting could provide information about the research to potential subjects, rather than giving the researcher names of potential subjects.
Controlling Access to Private Information
Individuals' ability to control access to their bodies and to their personal information is determined by a variety of factors, including socioeconomic status, age, and circumstance. For example, information about birth records is public information while information about personal stock portfolios is not. Children have different rights to privacy than adults. Institutionalized persons may have significant limitations on their ability to control personal information.
Privacy and Study Questions
Invasions of privacy can occur if subjects are asked questions that they find intrusive. If a survey instrument or an interview script contains questions that individuals are likely to find intrusive, they must be informed about the nature of the questions in advance. • Examples of sensitive nature topics Sexual behavior Childhood abuse Use of psychotropic medications Other personal topics Studies about possible topics that are of a sensitive nature should include a disclosure in the consent form about the sensitive nature of the questions. The survey instrument or interview process must be designed so that subjects may choose not to answer any question that makes them uncomfortable, or that they want to skip for any reason. Cultural standards should be taken into account when designing research. Topics that are considered appropriate in one setting may be offensive and off-limits in another.
Confidentiality
Researchers provide confidentiality to their subjects by appropriately protecting information the subjects disclose. The potential risk of harm to subjects if identifiable data were inadvertently disclosed is the key factor for determining what kinds of protection are needed. The ideal way to protect research data is not to collect information that could identify subjects. Collection of direct identifiers, such as names or email addresses, or indirect identifiers, such as information that could be used to deduce subjects' identities, should be avoided. The only way to render data entirely anonymous is to remove all identifying information from the data and completely disconnect any links between the subjects and data about the subjects. If researchers plan to retain individually identifiable data that could place participants at risk of harm if inadvertently disclosed, researchers need to design procedures to protect the data during collection, storage, analysis, and reporting. These procedures could include creating keys linking subjects' names to unique numbers associated with the data, storing encrypted data on secure servers, removing identifiers when data collection is completed, reporting data in aggregate, and creating misleading identifiers in articles or presentations. Consent forms should clearly explain who will have access to identifiable data, both in the present and in the future, and describe any future uses of the data. The consent forms must also contain a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained. Also, federal regulations require that researchers must include one of the following statements on the consent form (Protection of Human Subjects 2018): A statement that identifiers will be removed from the identifiable private information and that after the data are de-identified they could be used for future research studies or distributed to another researcher; or A statement that the subject's information collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies. For example, if researchers want to show video clips of research subjects during conference presentations or use them in a classroom, the subjects must be asked for permission to use their images in those ways.
Introduction
The Common Rule (45 CFR 46, Subpart A) states that when reviewing research proposals, Institutional Review Boards (IRBs) must determine that there are adequate provisions for protecting the privacy of subjects and maintaining the confidentiality of data. The Common Rule is just one document that directs researchers to consider privacy and confidentiality when conducting research. The guidelines of the American Anthropological Association, the Oral History Association, the American Psychological Association, and the American Sociological Association, identify protecting privacy and ensuring confidentiality as key components of respecting the safety and dignity of research subjects. This module will define "privacy" and "confidentiality." It also will discuss some research methods and topics that raise concerns about privacy, identify some standard methods for providing confidentiality, and discuss relevant laws, other than the Common Rule. Learning Objectives By the end of this module you should be able to: Distinguish between privacy and confidentiality. Identify privacy risks associated with study designs. Identify a range of procedures for ensuring confidentiality. Identify relevant laws regarding the collection of private information. Identify laws that limit the ability to ensure confidentiality.
Definitions
The IRB Guidebook (OHRP 1993) defines privacy and confidentiality. Although privacy and confidentiality are closely related, they are not identical. Privacy is related to methods of gathering information from research subjects; confidentiality refers to the obligations of researchers and institutions to appropriately protect the information disclosed to them. Confidentiality procedures, as described during the informed consent process, allow subjects to decide what measure of control over their personal information they are willing to relinquish to researchers. It is not always the case that identifiable information provided by research subjects must be protected from disclosure. Some subjects want to be identified and quoted. Some agree to have their photographs, audio, or video recordings published or otherwise made available to the public.
Privacy and Reporting Laws
Under the Common Rule, the IRB is tasked with assessing whether the study plan has adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data (Protection of Human Subjects 2018). However, there are other regulations and laws that also address privacy and confidentiality in research. Federal Privacy Laws The Family Educational Rights and Privacy Act (FERPA) protects the disclosure of educational records, while the Health Insurance Portability and Accountability Act (HIPAA) protects against the dissemination of private health information. Generally, under FERPA, the disclosure of these records to researchers involves securing written authorizations from the potential subjects (students or their parents), although in certain clearly defined circumstances, the requirement to secure authorizations may be waived. Researchers in the social and behavioral sciences, as well as the humanities, usually do not generate private health information covered by HIPAA. Rather, they ask for it to be disclosed to them, usually by asking subjects to sign authorizations permitting the disclosure. Most institutions covered by HIPAA have models of authorization forms that they expect researchers to use. State Reporting Requirements State reporting laws may limit the promises of confidentiality that researchers can offer subjects. State reporting laws may cover such matters as specific communicable diseases, the intent to harm oneself or others, and elder abuse. Most state laws identify individuals who must report suspected child abuse and neglect. This requirement should be described when child abuse and neglect might be revealed in a research study. Such studies could involve at-risk youth, school-based interventions, or parenting practices, among others. On the other hand, there are many studies in which it is extremely unlikely that the topic would arise or that the researcher would be in a position to observe neglect or abuse. For example, a study of decision-making strategies using computer-based activities would not generate information about child abuse, and there would be no need to discuss reporting requirements during the consent process. • State reporting laws may cover such matters as: Specific communicable diseases Suspected child abuse or neglect Elder abuse Intent to harm oneself or others Researchers should consult with the reviewing IRB about the laws in the state or local area where the research will occur. International Privacy Laws Researchers conducting research abroad should identify privacy laws at the research site that may be relevant for the conduct of research with human subjects. Regulations such as the European Union General Data Protection Regulation (GDPR) may affect research that is conducted in Europe and even the U.S. Exempt Research The Common Rule now includes considerations for privacy and confidentiality for exempt studies using limited IRB review as a condition of approval, and there are some cases where an exempt study would require a consent form. Researchers should be aware that even exempt studies may need to meet privacy/confidentiality requirements.
Privacy and Research Methods
While not an exhaustive list, the following material highlights some concerns about privacy in the context of research: Observational Studies Focus Groups Snowball Sampling