Confidentiality deals with sensitivity
This activity requires IRB review to verify that the risk of identifiability has not occurred or increased. It also requires that an adequate data protection plan for confidentiality is in place. What if the project intends to link data from a new survey to existing individual-level data from public data sources? Whenever appropriate, the subjects will be provided with additional pertinent information about the use of their data. The researcher should inform the research participants of efforts to link their data to public data sources in the process of obtaining consent.
What if the project decides to link data from a new survey to existing individual-level data from public data sources after the survey has been completed? If the level of confidentiality in the new data set created by the linkage is less than that in either of the pre-existing sets, then the change in research design must be examined by either the IRB official or fully convened IRB depending upon whether the initial review was exempt. Following that review, after evaluating the level of risk involved, a waiver of informed consent may be recommended if risk of harm is low and adequate confidentiality procedures are in effect.
The informed consent process should involve a friendly discussion that provides a basis for subjects to decide about participation. Subjects should be able to think about what they have been told and to ask any questions. IRBs and researchers should not defeat the purpose of informed consent by substituting a legalistic consent form for an effective communication process.
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If signed forms are appropriate, signing the form should not be perfunctory, unreflecting and automatic. When written informed consent would be the only identifiable link to research participants, it may increase risk and in some circumstances should be avoided. Research participation in most social-behavioral research involves time and possibly some inconvenience and discomfort.
An adequate informed consent process can sort out those who would gladly participate from those who wish to opt out. Persons may agree to undertake some risks or inconveniences, which they would reject if unilaterally imposed upon them. Informed consent should endure throughout the interaction between investigators and participants, rather than only at the beginning. The initial agreement to participate can be documented in various ways.
When appropriate, usually where risks of harm are substantial, individually signed forms are the "gold standard" of informed consent. Informed consent as a conversation needs to be available throughout the research, as subjects may develop questions or concerns when they are well into the research experience. For example, a discussion of confidentiality may not be really understood until they are asked very personal questions in the research experience.
Subjects should feel free to raise questions at any point in the research. The elements of informed consent include:. Detailed recitation of irrelevant information demeans the communication and is slightly insulting. People are capable of deciding whether to participate in surveys and ethnographic research.
Assurances that there are no risks and descriptions of measures taken to assure confidentiality can be irrelevant, irritating, misleading, and may not decrease the risk of harm. Normal interaction among peers or with persons of higher status than the researcher is not respected by "reading subjects their rights" or by formal or written consent procedures.
Common sense, courtesy and standard social norms should dictate what is communicated when asking such persons to participate in research. Persons should be treated respectfully in accordance with their culture and circumstances. People who are functionally illiterate, who are suspicious of persons who proffer documents or require signatures, or from non-industrialized cultures should be approached in the style that is most comfortable to them.
Protocols for research on such populations should show evidence that the researcher is informed about the culture of the intended research population and has arranged the informed consent and other research procedures accordingly. The emphasis should be on effective communication with appropriate opportunity for exploration, asking questions, achieving clarity and understanding, reflecting and making reasoned decisions. There are different circumstances, which might be reasonable for the IRB to consider.
For example, if the research involves no more than minimal risk the IRB may waive requirements to obtain informed consent. A social scientist proposed a study in which subjects would be asked to discuss privately with their romantic partner a past disagreement. Because the questions are embarrassing, the researcher proposed that complete anonymity, including to the researcher, be preserved.
This was aimed to encourage participation and protect the subjects. The IRB instead required the collection of signed informed consent forms, thereby eliminating the anonymity. Does research conducted as a classroom exercise count as human subjects research? This includes activities, which are intended to lead to published results, or for example, findings presented at a professional meeting.
Classroom exercises, involving interactions with human participants, which are part of an educational program, and are not designed to advance generalizable knowledge, are not covered by this regulation. Similarly, evaluations for quality improvement or assessment of instruction are not considered research so long as they are not designed to create generalizable knowledge. How can research conducted as a classroom exercise be reviewed to protect human participants? Since the Common Rule exempts classroom exercises see FAQ Does research conducted as a classroom exercise count as human subjects research?
However, the IRB typically is the only institutional store of expertise about human subjects protections, and may in principle be involved in such research in an oversight function. The following suggestions are offered as guidance for institutions seeking to protect participants from harm in such situations without overburdening IRBs with needless review responsibilities. The department should specify, in writing, the records it will keep. This may consist of the proposal itself, each reviewer's comments, correspondence with the researcher including requests for revisions and responses to requests.
These records should be open for inspection at any time by the IRB or the designated institutional official. There should be at least one review per year. It is a good idea for one member of the departmental committee to be a formal member of the IRB, to insure appropriate levels of communication between the department and the IRB, and training for the departmental committee. Back to the Top. Two parts of a study were proposed to the Maven University IRB, one to be conducted at the beach, where subjects were to be offered compensation, another to be conducted at the airport, where they were not.
The IRB demanded an explanation of why subjects should be paid at the beach but not the airport. They agreed to the study after the investigator explained that that people at the beach are busy having fun, so you have to offer to pay them to get them to take the time to help you; but people at the airport are bored, and they are often quite happy to have something to fill the time. In some circumstances, with special justification, different participants may be paid different amounts.
Professor Speakwell teaches undergraduate courses in linguistics in which he demonstrates variability in both the syntax and vocabulary of spoken expression across individuals and cultures. Professor Speakwell involves his students in active learning in the classroom. He brings recordings of spoken English to class and calls on students to say whether they find the example grammatical and to explain or guess what the utterance means. He also requires students to code narratives to show the part of speech that various words occupy in utterances.
Professor Researchit, a colleague of Speakwell's, uses these same techniques with undergraduate student volunteers to do research on variables that predict understanding of utterances. Researchit develops a protocol, and obtains IRB approval and students' signed informed consent. Professor Researchit tells Speakwell that he had better get IRB approval and student informed consent since he is doing the same thing.
Is Researchit correct? No, Speakwell is not doing the same thing. Speakwell is teaching, not doing research. Even if Speakwell or some of his students record systematic data and treat this as a classroom experiment, it is being done for teaching and demonstration purposes.
It is part of what students signed up for when they enrolled in Speakwell's class. Just as Speakwell is entitled to give exams, require homework, grade students on classroom participation, and so on, he is entitled to employ this kind of classroom activity as part of his teaching. The requirement of IRB review would be an inappropriate infringement on Speakwell's academic freedom. There is no point in having students sign a consent form. Participation is part of the coursework for which they enrolled. Moreover it would add inappropriately to the IRB workload.
The Federal Regulations are entirely clear on this point. Researchit's project in fact fits the criteria for exemption, because it uses interview procedures that involve no risk of harm. My university does not have an "exempt" category for research, only "expedited" and "full review" categories.
What does this mean in terms of social science projects that the federal government has declared "exempt"? Your university requires that the IRB or some other non-involved person, and not simply the investigator, must confirm that the project is in the exempt category. In order for that determination to be made, the project must be examined by an independent authority. Exempt projects are usually free from continued oversight by the IRB unless the nature of the project changes.
On the other hand, your university may have simply collapsed the exempt and expedited categories of research together. In an expedited review, typically only one experienced member of the IRB committee, or the chair of the committee, will review the project and confirm that the project is indeed minimal risk, or a minor change to a previously approved protocol, and meets the criteria for expedited review.
Many agencies support the Common Rule, meaning they follow the same regulations. Each agency has special expertise in the application of the regulations for relevant research. For example, NSF funds research in the area of experimental economics. An IRB asking how to apply the regulations to experimental economics research could seek guidance from the funding agency supporting those research activities.
Although all agencies follow the same regulations, each agency has different expertise on the application of the regulations to specific cases.
But my institution's assurance is from OHRP. Doesn't that mean that I must get that office's response to my question? No, OHRP will direct inquiries from requestors to the appropriate officials at the funding department or agency. The response of the agency funding a specific research project is the most appropriate government interpretation of the regulations with respect to that project.
The purpose of the federal regulations is to obtain the benefits of research for society while minimizing the risks of harm to human research participants. To further this goal the regulations encourage IRBs to make independent informed judgments, using common sense and expertise to apply a standard set of rules to diverse research situations, and to document the procedure followed in arriving at its judgment.
Informed consent is the procedure by which the researcher respects the autonomy of research participants as discussed in the The Belmont Report. Since written documentation of informed consent can create harm for research participants in some circumstances, it should not be routinely required in all cases.
For example, research should not use signed forms when the focus is on illegal behavior, or on partisan political activity in violent areas, where signed forms may potentially increase risks to the participants. Here the respondent's signed form could expose him or her to harm from state authorities or private vendettas. What if the researcher and the IRB disagree about the risk and appropriate action to be taken in the project? The regulations do not discuss procedures for resolving conflicts between IRBs and researchers.
Each institution should develop a written set of procedures for resolving differences of opinion. For example, perhaps a conversation could be scheduled between the research office administrator, the IRB chair, the researcher, outside consultants if deemed appropriate, and the funding agency representative. The major principles to be respected in any mediation procedure should include:. The advance of scientific research is a vital interest of the United States of America.
Your institution is by definition an important part of the US research effort. The institution should provide enough resources to enable the IRB to:. Remember that the time you spend being helpful before a protocol is finished saves everyone's time, creates goodwill, and earns the IRB a reputation that will make it easier to recruit top notch researchers to your institution and to the IRB membership.
The US institution administering the research has the primary responsibility, normally codified in an Assurance, to ensure that the project complies with US regulations. When an appropriate foreign IRB exists the regulations foresee involving it in reviewing the research. This regulation is most germane to biomedical research, as few foreign countries apply human subjects regulations to social and behavioral science.
In many foreign countries IRBs deal only with biomedical research and will refuse to extend their purview to cover social and behavioral science. In other foreign situations there will be no analogue to an IRB and the concept may be irrelevant. When this situation occurs, the US institution remains the responsible authority and the services of a foreign IRB might not be necessary. Can research proceed at a foreign institution if no foreign IRB has reviewed the research?
When institutions are in foreign locations with no tradition of IRB review of the relevant research, the review of the US institution may be sufficient. If the IRB has concerns about the risk of harm to research participants, the IRB should make a serious effort to involve appropriate cultural expertise in its review by soliciting the cooperation of persons knowledgeable about the customs and language in the society where the research will occur. There are options that can be considered in order to ensure that research proceeds even in the absence of a foreign IRB.
Alternatively, a foreign IRB or ethics board in the country where the research is to be conducted can review the research. An investigator submitted a proposal to the Maven University IRB for an anonymous paper-and-pencil study of attitudes toward a hypothetical case of incest. Due to the sensitive nature of the topic, the IRB wished to ensure that subjects could discontinue their participation at any time. The survey was to be administered simultaneously to numerous subjects in a group setting. The IRB felt that individuals who began the survey, but then changed their minds, would experience undue pressure to continue participating, since leaving early would call attention to the individual's withdrawal from the study.
The IRB therefore instructed the investigator to attach a paper-and-pencil puzzle to the survey packet, along with instructions indicating that, if subjects wished to discontinue their participation at any time, they could work on the puzzle if they so chose. This created a dilemma for the researchers: they felt no obligation to pay compensation to subjects who choose not to participate. Such payments would be costly in research funds, and raise the problem that subjects might chose to participate solely to be compensated for doing puzzles.
On the other hand, inspecting the survey forms to pay compensation to only those who completed the survey would defeat the goal of disguising withdrawal. The researchers argued that there was no harm to subjects who choose not to participate and left the location early, and no need to provide an alternative activity. The notion that there would be undue pressure to continue participating invented a risk where none existed.
Deception in research involves lying to or intentionally misleading subjects. Withholding information may or may not be deception. For example, telling subjects that an urn contains an unspecified number of red and blue balls, and inviting them to participate in an experiment by guessing the number, would not involve deception because the subjects "know what they don't know".
How do you deal with sensitive or confidential information?
Concealing the fact that there is a hidden camera would be deceptive. The distinction is whether subjects have the information to make an informed choice about whether to participate in the research. Secretly filming their behavior denies them the opportunity to consider whether or not they want to be filmed for research. Not telling them how many balls are in the urn is part of the accepted framework for a participant to guess the number. It may be important in some research to withhold the specific theoretical purpose of the research from subjects, in order not to bias their opinions.
If done in a neutral way, it would not be deceptive. If subjects are intentionally led to believe that the research is for a purpose different than the actual purpose, this would be deceptive. Deception potentially poses ethical problems and should be dealt with by weighing the benefits of the research against the harm if any from the deception. Aside from any potential harm to participants, deception can also harm the institution by building the perception among potential subjects that "researchers are liars.
The common rule does not address the compensation of subjects for participation in research. Good ethical practice suggests some guidelines:. A study was proposed at Maven University to conduct a survey using a dietary questionnaire, a motion sickness history questionnaire, and a "disgust sensitivity" survey.
To protect participants, and to preclude any bias, the researchers preferred that participation in the study be anonymous, even to them. Prior to this, the Maven IRB had argued that that a lottery could not be used as compensation, first because it is gambling, and second because it is unfair that not all subjects are paid the same amount.
However, they ultimately agreed that a lottery is an acceptable form of compensation. The researchers argued that a lottery is not gambling, because subjects do not risk their own money. They further argued that it is not unfair to pay subjects differentially, because all have an equal opportunity to win the prize and know that beforehand. Because of the voluntary and anonymous nature of participation, the research is minimal risk, and so the size of the prize should not matter.
The researchers argued that the size of the prize is not as relevant as the expected value. The researchers further argued that the subjects, as Maven U. Goodbar, a professor of sociology, was in the habit of surveying students on their experiences, as both a classroom exercise in survey research techniques as well as a source for his published articles. While he recorded the identity of student respondents sometimes on videotape, other times on paper records , he foresaw no risk because the questions did not deal with sensitive topics.
During one exercise he was astonished to see a student's response describe some sanctioned behavior-plagiarism on the part of the student. He had recorded the student's identity. The Common Rule addresses privacy of information about persons and confidentiality of data. A research project involving individual information about respondents can be exempt under two conditions:. The Common Rule thus explicitly allows social and behavioral science research involving minimal risk to record the identity of respondents in the data.
Whether or not the research is exempt, professional ethics and respect for persons mandate confidentiality unless the participant agrees to release the information. The following techniques for assuring confidentiality are listed on a continuum according to the degree of prospective harm that may occur. The U. The informed consent statement that fulfills the elements required by the Common Rule provides the objective factual information needed to control access satisfactorily. But there is a nonverbal dimension that is at least as important to individuals as they seek to manage their privacy.
Suppose, for example, that a disheveled researcher administered informed consent without establishing rapport and with body language that is "closed" and hostile. He or she would be regarded as having invaded the subject's privacy before even uttering a word. Such a researcher's manner would belie any "respectful" informed consent language. An unconcerned or ritualistic recitation of the informed consent conveys that it is merely a legal maneuver designed to protect the institution - that whatever happens to the hapless subject is of no personal concern to the researcher.
The nature, timing, and delivery of informed consent has important implications for subjects' sense of privacy. For example, a longitudinal or ethnographic study or any research that involves repeated contact between researcher and subject should treat informed consent as an ongoing process of communication in which the nature of the relationship is repeatedly clarified and discussed in an informal, friendly way. Research in which it is easy for the subject to end the relationship e.
Moreover, it reduces response rate and distorts random sampling by eliminating the least literate of potential subjects. Worst of all, it risks, unnecessarily, a breach of confidentiality and harm to subjects if a signature is somehow attached to sensitive data that could as well have been gathered anonymously.
The boundaries between wanted and unwanted information proffered to us by others, as well as between information we will and will not share, are partially defined by sociocultural values. For example, current efforts to survey people's safe-sex practices are made difficult because the very mention of some specific sexual practices quite apart from responding to the survey is taboo or offensive in some subcultures in the United States, but acceptable in others.
On the response side, providing information about one's sexual practices is acceptable to some respondents and highly offensive to others. Some ethnic differences in sense of personal privacy are counter-intuitive to most Americans.
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For example, most Americans consider eye contact a sign of respect and honesty, but ethnic Japanese especially in Hawaii consider a researcher who establishes eye contact as disrespectful. Guessing at cultural nuances of privacy is a poor practice for social researchers. How can researchers learn what is private in cultures and contexts that are foreign to their own personal experience? One solution is to employ research assistants from the same cultural community as the subjects.
However, this sometimes risks a breach of confidentiality disclosure of personal secrets within a close-knit community. Correspondingly, subjects sometimes disclose more sensitive information to a stranger who has established appropriate rapport and promised confidentiality than to a member of their own group. The optimal solution to this problem rests on judicious selection and training of research assistants - training that is designed to produce the most culturally sensitive behavior possible without any actual or apparent risk to confidentiality within the community. Everyone wants to have some choice about those with whom they will interact and what the conditions of that interaction will be.
Early in life, people learn a variety of ways to avoid or evade unwanted interactions. The researcher who is not mindful of the privacy interests of subjects will be lied to, stood up, or complained about. In contrast, the researcher who understands or respects the privacy interests of subjects may find them overwhelmingly forthcoming, and may even find it difficult to end the session. The researcher who understands the sociocultural aspects of privacy looks beyond the immediate scientific need to "get data.
By learning about the norms, beliefs, and culture of the subjects, the researcher can then appropriately express respect, establish trust, and create rapport that makes interaction acceptable. The recruitment of subjects and design of research should be culturally appropriate and should instill sufficient trust that subjects will want to participate candidly. Much of the local ethnography needed to conduct social research effectively cannot be found in textbooks. However, networks of local researchers, educators, and outreach workers can share valuable information about the most appropriate ways to approach members of various cultures.
Individual IRBs would do well to add to their educational web site suggestions of useful contact persons e. To respect privacy is to let subjects control the access of others to themselves: to provide the conditions under which the researcher's inquiries are welcome, and to provide adequate opportunity for people to decline to participate. To breach privacy is to violate people's space, to intrude where not welcome or not trusted, or to seek to control access to people against their wishes - for example, organizational research on employees to which management gives the consent and deceptive research in which the researcher induces the subject to behave in a way the subject would not wish to be observed are invasions of privacy.
An educational resource for IRBs and researchers should discuss practices of recruitment, consent, timing of procedures, research methods, and debriefing in terms of whether they respect privacy or are likely to constitute breaches of privacy. The definition of privacy developed so far works well with theories borrowed from the social sciences that describe the conditions under which access by others is welcome or aversive.
Such theories describe the controls people use to limit the access of others to themselves and the conditions under which those controls are available and likely to be employed. Various theories of privacy are instructive to researchers and need to be incorporated into the education of researchers and IRB members. The following two are offered as examples. Laufer and Wolfe describe how self-ego, environmental, interpersonal, and control-choice factors operate to regulate the experience of privacy.
This elegant analytical framework indicates virtually every element one must consider to understand the privacy of another. The self-ego dimension of privacy refers to the development of autonomy and personal dignity. For young children, being alone is aversive. By middle childhood, time alone is sought to establish a sense of self and autonomy and to nurture new ideas, creating a basis for self-esteem, personal strength, and dignity.
Thus, children in middle childhood have a need and right to privacy not found in infants and younger children. Adults continue to need time alone and develop many means of protecting that privacy. The environmental dimension includes cultural, sociophysical, and life-cycle dimensions. Cultural elements include norms for achieving privacy, e. Sociophysical elements refer to physical settings that offer privacy e. Life-cycle elements vary with age, occupation, available technology, and changing sociocultural patterns.
The kinds of privacy one establishes at one age, under one set of responsibilities, constraints, and technological aids may be unsatisfactory or unavailable in another stage of one's life. The interpersonal dimension refers to how social interaction and information are managed. One's social setting and its physical characteristics provide options for managing social interaction; physical and social boundaries can be used to control people's access to one another.
Young children have no control over their privacy, except through hiding. Later, they learn to use personal, cultural, and physical resources to control their privacy. Events that would threaten one's privacy early in the development of these mechanisms are later so easy to control that they are no longer considered a threat to privacy.
Thompson presents a developmental theory describing how the sense of privacy changes from early childhood through late adolescence, and how youngsters learn to control access by others. Thompson shows that popular ideas about vulnerability decreasing linearly with age are inaccurate: older children are more easily embarrassed, more concerned about personal and informational privacy, and more likely to feel upset if they reveal more than they intended.
However, younger children's sense of privacy is enhanced when their parent is present during a study, while an older child is confident of ability to manage access with the researcher, but wants the parent out of the room. Theories of this nature would have an important role in any effort to foster greater skill in discovering and understanding the privacy interests and privacy management approaches of a given research population.
The concept of privacy is related to the notion of private places that can be used to control access. There are degrees of privacy in relation to places:. In research, only the first category is clearly without ethical concerns. Observational research or participant observation in private places is especially problematic. Individuals, organizations, and cultures all have their own ways of wishing to be perceived, and one's sense of privacy is intimately related to controlling the way one is perceived.
However, researchers are often so focused on getting data that they forget even the norms of their own culture and are still more oblivious to the norms of other cultures. Moreover, researchers typically examine subjects from a critical perspective that may differ from the way their subjects wish to be perceived.
Researchers should be well informed and mindful of the ethnography of their subject population so that their approach is tactful and their critical analysis is objective. Yet, they will still function as outsiders, almost voyeurs, and should compensate for this by carefully masking the identity and location of those whose behavior they critically analyze in scientific publications. In summary, the concepts of privacy offered here do not presume that:. Rather, these concepts lead the researcher to look to theory, methods, and ethnographic information to learn how to respect the interests of a given subject population in controlling the access of others to themselves.
Should IRBs vary the degree of protection of privacy depending on the ethnographic standards of the research population? Clearly, some subgroups have particular concerns about privacy that are not shared by others, and that must be respected for scientific as well as ethical reasons. That is, respect for privacy is not only ethically required, it also encourages subjects to give truthful and unguarded responses.
But what about populations that have diminished expectation of privacy in their everyday life, such as celebrities, prisoners, or citizens in a totalitarian state where privacy protections are few and confidentiality is always in doubt? Respect for privacy means giving people the privacy they would like to have, not the invasions of privacy that are regularly imposed on them. For example, a psychologist studying prisoners or workers in a company where the employer disrespects privacy should respect subjects' privacy even if others do not. The IRB or researcher in doubt about the sense of privacy of a particular population can remove that doubt by asking surrogate subjects drawn from the target population.
For more autonomous populations such as celebrities, the matter may be settled through pilot research and informed consent in which persons can participate or decline based on an accurate understanding of what will be asked of them. A useful, though simple definition of privacy, adapted from, and similar to, that developed by Boruch and Cecil is as follows:.
Confidentiality is an extension of the concept of privacy; it refers to data some identifiable information about a person, such as notes or a videotape of the person and to agreements about how data are to be handled in keeping with subjects' interest in controlling the access of others to information about themselves. This definition provides a clear distinction from privacy, which is vital. For in addition to understanding what is private to given subjects and how that privacy may be respected, the researcher must be able to assure subjects that the access of others to information about themselves will be controlled in a way that is acceptable to them.
Every detail of subsequent data management need not be communicated to subjects, though it should be worked out clearly in the protocol. Some matters such as required disclosure of child or elder abuse, plans for possibly sharing identified data with other scientists, or sharing archives of videotaped data should be part of the informed consent, if relevant.
This definition helps researchers and IRBs to recognize that there are various risks of unintended disclosure, e. It also reminds one that confidentiality is whatever arrangement about disclosure the researcher and subject agree upon, within the constraints of law and ethics. Confidentiality is more than just a promise or an intention on the part of the researcher. It is an arrangement to use certain techniques that are available for controlling the disclosure of identifiable information.
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There may be limits to what can be promised or guaranteed, and these must be discovered and stated at the outset. This definition of confidentiality leads naturally to the immense and growing literature on procedural, methodological, statistical, and legal approaches to assuring the confidentiality of research data. These methods are developed and described in various applied research literatures e. This definition also leads to recognition of the immense advantages of rendering data anonymous, where feasible.
The intelligent use of confidentiality-assuring techniques depends upon understanding what threats to confidentiality may exist or be perceived by subjects, what legitimate uses of the data may be anticipated including sharing with other scientists and agency audit of the data, and what costs and analytic disadvantages may accompany some of these techniques. There is considerable and ever-growing depth to this body of knowledge. When anticipating gathering of any data, and especially sensitive data, it is important to a make early plans concerning the confidentiality-assuring techniques that will be used, b incorporate these appropriately into any consent agreements with subjects and contractual arrangements with subsequent users including funders who wish to audit the data , and c include these details in the IRB protocol.
Within the last two decades, data collection and storage practices have been altered radically. New digital media support a wide range of social relationships such that social scientists, their colleagues, and their subjects need not meet face-to-face and may even reside in different parts of the world. The issues of confidentiality that are emerging are more varied and dangerous than current policy makers can easily anticipate. However, there are also hopeful solutions on the horizon.
Confidentiality - Etikkom
Within another decade or two, issues of confidentiality will be transformed in ways we cannot imagine today. There are now digital communication networks on a global scale and the possibility that hackers with a laptop computer and internet technology could download any electronic data stored on any server anywhere in the world. There are also emerging technologies for protecting communication and personal identity, and there is a whole new cohort of technology-sophisticated privacy activists. New laws that protect data are being developed and tested, and globalization of culture and policy processes is occurring.
These major shifts in technology have already begun to produce an immense literature on the accompanying threats and safeguards to privacy and confidentiality e. Much of this literature is esoteric. It needs to be tracked by specialists who are concerned with the confidentiality of social research data and translated into a body of knowledge that is useful to researchers, research administrators, and IRBs. One relatively old, low-technology form of data collection with which most researchers are familiar illustrates a few of the kinds of problems that will arise with the use of high-technology data gathering.
When data are gathered on videotape, the distinction between persons and their data is blurred. If one observes another on a video monitor, in real time, is this direct observation or data? If the material that is seen in real time on the monitor is taped, does the same image then become data? Can anonymity be complete if there is any visually recognizable aspect of the persons' identity? Risk of deductive disclosure the possibility that someone who already knows the individual will see the tape and correctly deduce that he or she is the subject depicted takes on new meaning with videotaped data.
When data are in videotaped form, special attention must be given to consent and avoidance of incriminating or unnecessarily sensitive material. The researcher should disclose the projects' plans for storage, sharing, and disposal of the tapes. Subjects should have the option of requesting tape erasure if they decide that they have just said or done something they do not want to be retained on tape. The proposed definitions emphasize that privacy and confidentiality are quintessentially behavioral and social phenomena and appropriate topics of scholarship and investigation. Curiously, however, the federal regulations of human research and requirements of IRB review have tended to be treated by researchers as leading to last-minute paper work rather than to the creative use of current privacy and confidentiality-assuring techniques, or the development of new theory or methodology that would make for more ethical human research.
Thus, a main principle developed in the Belmont Report, that research should be performed by competent scientists who apply ethical principles intelligently based on sound scientific knowledge and research skills, seems to be lost on many scientists and IRBs. Part of this problem may be due to the failure to frame the concepts of privacy and confidentiality in ways that would invite innovation and investigation. A wide range of federal and state laws, as well as the Common Rule and other federal regulations, concern privacy and confidentiality in social research.
The federal policy for the protection of human subjects, which formerly pertained only to research funded by the Department of Health and Human Services DHHS 45 CFR 46 Subpart A has now become the Common Rule and has been incorporated into the regulatory structure of 17 federal agencies, 8 of which have additional human subject protections beyond the Common Rule, most of which do not relate directly to privacy and confidentiality.
The Common Rule specifically requires that informed consent include a statement about how confidentiality will be maintained, but it leaves to the IRB and the researcher the subtle matter of understanding what confidentiality is and how it relates to privacy. Moreover, the Common Rule does not define privacy, but defines private information as follows:.
Private information includes 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 which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public for example, a medical record 45 CFR This definition of private information confuses it with confidentiality and fails to convey the notions of personal privacy that are important to ethical research.
It also implies that everyone has the same concerns about others' access to themselves and to identifiable data about themselves. Based upon this confusing set of definitions, 45 CFR Unfortunately, this requirement assumes a level of sophisticated knowledge concerning privacy and confidentiality that many IRBs and researchers do not possess. Subpart B contains protections in research, development, and related activities involving fetuses, pregnant women, and human in vitro fertilization.
Its relationship to privacy arises in connection with Being biomedical in focus, it is not within the purview of this paper. It defines "prisoners" quite loosely to refer to any individual involuntarily confined or detained in a penal institution. This encompasses those sentenced under a criminal or civil statute, detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and any individual detained pending arraignment, trial, or sentencing. In contrast, the Department of Justice provides a more comprehensive set of protections, as outlined below, and pertains only to research conducted within the Bureau of Prisons.
It limits the amount of risk to which prisoners may be exposed. It requires an IRB containing at least one prisoner or a prisoner representative and a majority of the members having no association with the prison apart from their membership on the IRB. A shortcoming of Subpart C is its failure to address the special problems concerning research on incarcerated juveniles who deserve special attention due to issues of distrust, incomprehension, and their often unusual strained or nonexistent relationship with their parents.
Moreover, Subpart D, which deals with research on children, does not offer special guidance regarding research on incarcerated juveniles. It is sensitive to children's personal privacy interests in requiring the child's active assent when assent would be meaningful, as well as parental permission, with either party having veto power. Unlike research on adults, Subpart D requires IRB approval when the research involves surveys, interviews, and observation of public behavior when the investigator participates in the activities being observed.
It sets forth limits to the amount of risk to which children may be exposed in research, and places strict requirements for consent and benefit when any more than minimal risk is involved except where there is no other way to benefit the subject or to study a serious problem affecting children in general. Subpart D recognizes that there are contexts or circumstances in which parental permission is not a reasonable requirement to protect the subjects e. Procedures for selecting guardians or advocates who function in loco parentis are discussed.
The Department of Education provides additional protections regarding respect for privacy and assurance of confidentiality under 34 CFR The Department of Justice has developed an excellent set of additional protections of privacy and confidentiality pertaining to prisoners 28 CFR These are most noteworthy in their emphasis on a creating an impermeable firewall between research data and prison administration, b requiring an IRB membership of at least one prisoner and a majority who are not prison personnel, and c giving prisoners a high degree of control over their identifiable data.
Protections specifically pertaining to privacy and confidentiality are many: The researcher must not provide research information which identifies a subject to any person without that subject's prior written consent to release of the information. Identifiable data cannot be admitted as evidence or used for any purpose in any action without the written consent of the person to whom the data pertains.
Except for computerized data kept at a Department of Justice site, records containing identifiable data may not be stored in, or introduced into, an electronic retrieval system. Access to Bureau of Prison records by researchers is limited by law. No one conducting research may have access to records relating to the subject which are necessary to the purpose of the research without the subject's consent. A nonemployee of the Bureau may receive records in a form not individually identifiable when advance adequate written assurance is given that the record will be used solely as a statistical research or reporting record.
The rise of concern about the amount of governmental record keeping and the potential for abuse through inappropriate and unauthorized use of such records led to enactment of the Privacy Act of This omnibus law governs record keeping and record use in all federal agencies. See in this volume paper by Goldman and Choy for discussion of the Privacy Act of The Privacy Act authorized the examination of privacy issues in diverse environments via the Privacy Protection Study Commission, whose findings have continued to influence concern to balance the interests of individuals, record keeping institutions, and society as a whole.
One outcome has been increased attention to the individual's role in controlling information about himself. In keeping with the overall philosophy of the Privacy Act of , and as an alternative to the omnibus approach to regulation of record keeping taken by the Privacy Act, various laws have been passed that are tailored specifically to privacy in educational settings and to research in educational settings.
The Family Educational Rights and Privacy Act of is designed to protect educational records from disclosure without consent of parents or students over The Protection of Pupil Rights Amendment PPRA gives parents the right to inspect innovative curriculum materials and requires parental consent for students to participate in sensitive research.
An interesting aspect of FERPA and PPRA is that, like the federal regulations of human research, they allow the participating institutions to develop and implement local substantive and procedural requirements that meet minimum requirements established by law. Finally, we discuss legislation that protects identifiable data from subpoena.
FERPA also commonly known as the Buckley Amendment states that "An educational agency or institution shall obtain the written consent of the parent of a student or of the eligible student if 18 or older before disclosing personally identifiable information from educational records of a student, other than the directory information. It includes, but is not limited to, the student's name, address, telephone listing, date and place of birth, major field of study, participation in officially recognized activities and sports, weight and height of members of athletic teams, dates of attendance, degrees and awards received, and the most recent previous educational agency or institution attended.
Educational records refers to records directly related to a student and that are maintained by an educational agency or institution or by a party acting for the agency or institution. Educational records does not refer to records of instructional, supervisory, and administrative and educational personnel that are kept in the sole possession of the maker of the record and are not generally accessible to others.
It also does not include information gathered after the student has ceased attending that institution. FERPA applies to educational agencies or institutions that receive federal funds under any program administered by the Department of Education. This includes all public elementary and secondary schools and virtually all post-secondary institutions. Some degree of IRB discretion exists at the fringes of FERPA's definitions, but generally the Buckley amendment prevents a researcher from inspecting educational records without permission of the parent or of the student after age The Department of Education reports that while it receives quite a few complaints from parents, most contain no specific allegations of fact that would indicate that a violation had actually occurred.
It affects research in various ways by giving parents certain rights regarding Department of Education-funded activities. When first introduced in , it gave parents the right to inspect instructional material used in connection with any research designed to explore or develop new or unproven teaching methods or techniques. PPRA was further amended in Grassley Amendment to remove the terms "psychiatric and psychological examination, testing and treatment," and to clarify PPRA to refer to any survey, analysis, or evaluation that elicits information in the above seven areas.
School children are a convenient captive subject pool, especially in the case of schools located near universities. Laws providing special protections for school children have been enacted largely because overzealous, insensitive, or culturally inappropriate researchers have offended parents. These laws make it easy for school administrators and IRBs to rein in intrusive research on children. Thus, they are highly effective, even though the Department of Education rarely acts on them. Among the children who most need to be served through research and development programs are those whose parents are unlikely to be able to provide their written permission.
Parents who are illiterate, do not speak English, are irresponsible or largely absent from the home, or are unfamiliar with American culture are unlikely to respond to a request for written parental permission. The requirement of a parent's signature invites forgery of parents' signatures by youngsters who want to participate with their friends, and who may be accustomed to signing for illiterate or non-English speaking parents in any case. It also invites poor solutions such as having a youngster do the translation of the consent statement, mentioning such matters as confidentiality to a parent who does not understand the concept.
Most damaging of all, it results in invalid sampling of populations most in need of the kinds of understanding and support that research can help to provide. Parental permission for school-based research often is handled poorly unless the IRB helps by providing useful, well-tested models of good communication - model letters, town meetings, use of adult community members trained to communicate effectively with their peers, tape recorded messages, and so on. Once the IRB has established such mechanisms, their adaptation to new situations may be relatively easy.
However, signed parental permission may remain elusive in some populations even though the parents would not object to their child's participation. It may be appropriate for legislators to consider whether there should be exceptional circumstances e. While the regulations and statutes reviewed above may pertain only to research that is intended to provide generalizable knowledge, intended to be published, or funded by a given agency, in fact most IRBs act on their prerogative to impose more stringent requirements.
For example, most IRBs review master's thesis research which is not funded, does not produce generalizable findings perhaps merely assesses what clients in some kind of treatment program think of the program , and may not be done with publication as a goal. Arguably, some of these projects need not be reviewed at all. However in most contexts such a student research project that involved school children would be subjected to the same stringent requirements e.
It expresses respect for local schools and the standards they would also be likely to apply and teaches researchers to do likewise. Moreover, as a practical matter, it is awkward for an IRB to impose stricter regulations on similar projects that happen to vary with respect to funding. Most IRBs act to protect human research subjects, not simply to follow the letter of the law. Some IRBs describe their more stringent requirements in their single or multiple assurances. Other IRBs, at their lawyers' insistence, describe their requirements as the minimum requirements set forth under the law, but, as an internal policy, impose a broader and more stringent set of requirements.
However, with ever-increasing workloads, IRBs are increasingly tempted to discontinue such extra responsibilities as reviewing proposals that do not even qualify as "research" and imposing strict standards such as FERPA and PPRA when this may make the research much more difficult to carry out and evoke complaints from researchers. Thus, in their laudable attempts to educate researchers and to respect family privacy in research on school children, IRBs are placing themselves in somewhat of a no-win situation by requiring, with some research populations, a standard that may be very difficult to meet and that is not federally mandated.
These observations are based on many years of general observation, as well as on a recent discussion on McWirb. Statutory protection of research data enables researchers to arrange to assure the confidentiality of research records on identifiable individuals from subpoena. Subpoena of social research data is rare. However, if vulnerable data could not be protected from subpoena, there would be a chilling effect, especially on criminological and delinquency research.
The Public Health Service Act PHSA was amended authorizing the researcher's withholding of information concerning the identity of people who are subjects of research on use and effect of drugs. This withholding authority occurs through the issuance of certificates of confidentiality by the Secretary of the DHHS. A amendment broadened its scope to include mental health, biomedical, clinical, behavioral, and social research. Under this amendment, the Secretary of DHHS may authorize persons engaged in biomedical, behavioral, clinical, or other research including research on mental health, including research on the use and effect of alcohol and other psychoactive drugs , to protect the privacy of individuals who are the subject of such research by withholding from all persons not connected with the conduct of such research the names or other identifying characteristics of such individuals.
Persons so authorized to protect the privacy of such individuals may not be compelled in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings to identify such individuals 42 USC a b Various institutes within DHHS are authorized to issue certificates. Since , certificates have become obtainable for research that is not federally funded. DHHS regards a certificate's protection to supercede state law; this position has been challenged and upheld in the New York Court of Appeals People v. Newman 32 N. A certificate does not protect identifiable data of "nonsubjects," that is, other people about whom the subject provides information to the researcher, a point which researchers may fail to clarify in the informed consent.
The certificates only protect against compelled disclosure of subjects' names or other identifiers, coupled with their data. It does not protect a subject who voluntarily consents to disclosure of his or her research record, nor preclude a researcher from reporting the identity of subjects who disclose intentions to harm themselves or others. Moreover, the language of PHSA is rather imprecise, which gives rise to uncertainty.
It offers protection to "names and other identifying characteristics," but the data of a known subject may not necessarily be protected. Melton , p. Knowing that fact, a defense attorney might seek the data of a particular child not the names of participants as a fishing expedition for information intended to impeach the child's testimony. A literal interpretation of the statute would suggest that the subpoena might be enforceable if the data could be shown in some way to be relevant to the proceeding. Although it is also possible - perhaps even probable - that a court would interpret the statute more broadly in keeping with congressional intent, the uncertainty prevents unequivocal offers of confidentiality to participants and, therefore, should be eliminated by a technical amendment.
It is also unclear whether child abuse reporting laws are abrogated by certificates of confidentiality. Is such reporting a "legal proceeding" that cannot be mandated under a certificate of confidentiality? Finally, the certificate of confidentiality must be requested in advance of each research undertaking. Some researchers are unfamiliar with this protection or lack the diligence to make the request. Moreover, subpoenas typically occur for reasons unrelated to the study itself and therefore are not reasonably foreseeable by either the subjects or the investigator.
In short, the protections offered by certificates of confidentiality may be unavailable when needed. It is perhaps unrealistic to expect that legislation will be enacted in the near future that would make all research data privileged information. However, it is reasonable to urge that the language of the PHSA be clarified to indicate exactly what is and is not covered. It is also appropriate that IRBs be provided guidance as to when certificates of confidentiality should be considered.
Given that the Secretary of DHHS may issue certificates for "biomedical, behavioral, clinical or other research," there apparently are no reasonable grounds for refusing a certificate prior to the time that data collection is initiated, unless perhaps it were obvious that some kind of nonresearch work was being recast as research to obtain a privilege against subpoena. Many researchers assume that sending confidential data to a foreign country e. However, the relevant laws are complex, offering only a deterrent from subpoena, not a guarantee of protection.
The Federal Rules of Civil Procedure govern the procedures for discovery, including foreign discovery, in federal cases. Rule 26 b states that parties may obtain discovery of anything that is relevant, not privileged, and admissible or "reasonably calculated to lead to the discovery of admissible evidence. Any party may serve on any other party a request 1 to produce and permit the party making the request 2 to inspect and copy, any designated documents, or 3 to inspect and copy, test or sample any tangible things which constitute or contain matters within the scope of rule 26 b and which are in the possession, custody, or control of the party upon whom the request is served A person not a party to the action may be compelled to produce documents and things or to submit to an inspection.
The courts cannot compel a party to produce data if the party does not have "possession, custody or control" of the documents, but it is unclear what constitutes "control" in the kinds of situations discussed here. If a researcher sends data out of the country for the express purpose of preventing subpoena, would this qualify as loss of control in the eyes of a court? Jason Gilbert , a legal intern at the Federal Judicial Center, offers the following analysis of this question:. While the courts seem to have settled on defining control as when a party has a legal right to obtain something, questions remain for the researcher seeking to give up control of research data to a foreign colleague in an attempt to protect it from being disclosed.
Legal rights to possession can come from a variety of sources, particularly when one is considering intellectual property such as research data. If a researcher were to create a set of data, when exactly would he or she no longer have a legal right to that set of data? What if the researcher gave one part of the data to a colleague? What if the researcher only gave up a small "key" to the data that allowed the individuals who participated in the study to be identified? What if the researcher gave part, or even all, of the data to a colleague but still continued to collaborate with that colleague to perform analysis on the data even though it was not in the researcher's possession?
Would that researcher still have a legal right to get back what he or she had surrendered? While the concept of giving away the legal right of possession is relatively straightforward, the mechanics of how exactly a researcher can give away the legal right to possess his own data particularly if one does not allow for a sale or some type of contract remains unclear. Gilbert also reminds us of some other implications of "loss of control" of data: 1 Transfer of data out of the country would mean loss of all electronic or hard copies in the researcher's possession.
Even if it is done as a safeguard beforehand, the researcher may still be found to have acted not in good faith and be cited for contempt of court. If the researcher can be said to have "lost control" of data by sending it to a colleague in a foreign country, the researcher then puts that colleague at risk of having to respond to a request for the data and having to seek legal means of protecting confidentiality.
However, the rules and procedures of foreign discovery are so complex as to deter discovery. If the person who controls the subpoenaed information resides in a foreign country and is not a national or resident of the United States, the party seeking production must follow certain procedures for foreign production. The United States has ratified various treaties concerning the obtaining of evidence from foreign countries, each having its own procedures. Discovery in a foreign country is a lengthy process.
It involves the sending of a formal "letter of request" by the court where the action is pending to a court in the foreign country, requesting that court to take a deposition or request documents of the person in possession of the desired information. There are various diplomatic and legal approaches to delivering such a request and accomplishing the discovery.
These are time consuming, difficult, and costly and may make discovery of the information too unattractive to pursue. A further protection may come from the courts themselves. Over the years judges have shown sensitivity to researchers' need to protect sensitive data from disclosure. Their concern has been not so much to protect individual subjects as it has been to protect researchers who promised confidentiality and to prevent the chilling effects that excessive subpoena power would have on research in general.
However, the decision to quash a subpoena that would require disclosure of confidential research data is left to the discretion of a judge who must balance conflicting interests. The FOIA concerns the responsibility of government agencies to maintain, organize, and disclose agency records on request by members of the public. There has been much concern about whether this pertains to identifiable research data see, for example, Morris, Sales and Berman, Fraud in government sponsored research has stimulated interest in full disclosure of research data.
The Supreme Court, in Forsham v. Harris US , held that data developed by independent researchers funded by a government agency need not be disclosed. The Shelby Amendment pertains to researchers in institutions of higher education, hospitals, and other nonprofit organizations. Research data are defined as "the recorded factual material commonly accepted in the scientific community as necessary to validate research findings, but not preliminary analyses, drafts of scientific papers, plans for future research, peer reviews, or communications with colleagues" Office of Management and Budget, Moreover, research data do not include materials necessary to be held confidential by a researcher until they are published or similar information which is protected under the law, or information that could be used to identify a particular research subject.
The Shelby Amendment appears to protect research data, but some precautions should be kept in mind. The pressure on the federal government to ensure the integrity of critical research that it sponsors is likely to remain high. Researchers may one day be required to release raw, identifiable data to the sponsoring agency, and those data may be vulnerable to FOIA disclosure. Moreover, the Shelby Amendment pertains only to research grants to nonprofit organizations. The legal standing of research performed by for-profit organizations remains unclear.
In the case of research contracts that require access by the sponsoring agency, it is sometimes possible for researchers to guard against such breach of confidentiality by requesting that audits be performed at the research site and not transferred to a federal agency where they might be obtained by some other party under the FOIA.
Common Rule does not diminish any protections offered by state laws, nor may state law diminish any protections of federal regulations. This interplay of state and federal requirements of human research is set forth elegantly in the commissioned paper "Oversight of Human Subject Research: The Role of the States" Schwartz, While the Schwartz paper focuses primarily on medically related research, the sections on the consent of minors to research participation, the certificate of confidentiality procedure, and the conclusion are especially pertinent to this paper as well.
Of particular importance are Schwartz' points about the state-to-state variability of laws and unpredictability of court decisions, the desirability of creating a DHHS clearinghouse on state regulation of research, and the desirability of seeking greater uniformity of laws governing human research. The fact that many multisite research projects cut across state boundaries increases the importance of these issues. In any event, if NBAC recommends the development of a web-based information and education program for IRBs and researchers, such a project would be enhanced if Schwartz' recommendations were also acted upon.
State laws relevant to privacy and confidentiality in social research include those that mandate reporting and hence require that the informed consent state the limitation to confidentiality that the mandate implies. All states have mandatory reporting of evidence from identifiable subjects of child abuse or neglect and many require reporting of elder abuse or neglect. These state laws are in response to the federal Child Abuse Prevention and Treatment Act of , which required that child protective services be established and that states mandate reporting laws.
By , state laws were in place, along with federally reimbursable child protective services. The history of the literature on child protection and the evolution of these laws may be found in Levine and Levine Who must report and to whom? In most states, it is only helping professionals e.
Researchers might claim that they are not helping professionals, and not bound by the mandate. However, that might not be a winning argument in court. Most researchers are also teachers university professors and may be perceived by troubled subjects as an understanding professional to whom one might reach out for help. Moreover, IRBs would not permit researchers to ignore reportable evidence, and hence would require that they include in their informed consent a statement such as the following:.
What is discussed during our session will be kept confidential with two exceptions: I am compelled by law to inform an appropriate other person if I hear and believe that you are in danger of hurting yourself or someone else, or if there is reasonable suspicion that a child, elder or dependent adult has been abused. Ruja and is discussed in Gil The same sort of warning must appear in the parental permission for research on one's child. Such a warning is certain to muddle the sampling efforts and reduce candor in research on family processes. The exact wording of reporting laws varies from state to state, though each state basically requires helping professionals to report any cases in which there is reason to believe or suspect child abuse - past or present.
It is not clear whether "reason to believe" refers to a clinical hunch or to firm evidence, nor do these laws define what constitutes abuse. This leaves researchers to consider cultural differences, e. The difficulties of defining abuse are many: Estimates of the amount of child abuse run from 1 percent to 30 percent of the U. How is the act perceived by the child - as done to teach an important lesson Corbin, , to cure a disease Gray and Cosgrove, , or out of malice?
Thus, added to the costs of breaching confidentiality is the possibility that both the "victim" and the "perpetrators" will be wronged. Reporting laws vary from state to state with respect to how the professional learns about the suspected abuse. Some state statutes are limited to the child seen by the professional, while in other states a report is required even if the professional learns of it through a third party.
Most statutes require the reporting professional to testify in court proceedings, include a criminal penalty for failure to report, and permit civil action against a professional whose failure to report was followed by injury to the child. However, all statutes provide immunity from a suit when a report made in good faith turns out to be unfounded Levine, What is ethically responsible research behavior with respect to reporting? Should the researcher stop and warn the subject who starts to mention abuse?
Should the researcher listen to what is reported and follow the lawor ignore the law? Should the researcher actively seek and report evidence of abuse and neglect? How much discretion should the researcher use in deciding what should trigger reporting, in relation to the likely outcomes of reporting for the researcher, the project, the institutions involved, the child, the parents, and so on? How should the likelihood of inept handling by the Child Protective Services influence this decision? An inexpensive, simple, safe, and legally acceptable way to study child abuse is through retrospective study of reported cases.
This allows the researcher to trace abuse backward in time from its discovery to its apparent antecedents without accompanying reporting requirements. However, comparison of retrospective versus prospective research approaches on other problems of human behavior show that this is unlikely to lead to valid and useful findings.
By proceeding in the opposite direction selecting a random sample of children and collecting repeated-measure multivariate data with appropriate controls one is likely to find a different set of conditions associated with emerging cases of abuse or neglect Weis, ; Sieber, Given the popular media interest in the topic of child abuse, it is doubly crucial that scientists report valid findings. But the legal barriers to such an approach make it unworkable. This is an area in which IRBs and researchers need wise guidance. Some IRBs may not recognize when there is risk of uncovering evidence of child abuse.
Or if risk is recognized, the ambiguity of state laws concerning reporting can lead to capricious IRB decisions such as rejecting the protocol out of hand or suggesting poor solutions. If the IRB does not have a knowledgeable clinician among its members, it should call upon such a person for advice as needed.
Clinically trained practitioners know how to interpret verbal or behavioral communications, and are able to determine the appropriate action to take. They probably are acquainted with the Child Protective Services agency in their area and with the strengths and weaknesses of its professional staff. They will know how to report suspected abuse in a way that maximizes the likelihood of a beneficial outcome. Researchers who do not have clinical training and who plan research on subjects who might be at risk of harming themselves or others or of being harmed need to plan ahead.
They and their IRB should arrange to have access to a licensed health care practitioner in advance and have a plan for responding to events that seem indicative of relevant harms perpetrated or likely to occur. Since most IRBs frequently review protocols for research that might happen upon evidence of abuse, most IRBs should arrange permanent institutional resources to advise and support researchers in this area in their decision-making.
Without a trained clinician to advise on what constitutes "reasonable evidence," a risk-averse researcher or IRB may over-report to protect themselves from possible prosecution. Both the IRB and the researcher need to be clear that their duty is to make a considered decision in consultation with others qualified to advise. It is not their duty to jump to conclusions and report without consultation or without good advice on the agency to which they should report. IRBs and researchers would also benefit from having carefully developed guidelines concerning the duty to report.
The guidelines should be tailored to the specific state and local situation, and to the particular institutional resources available for consultation. In the short run, it is important that investigators at risk of discovering abuse understand the manifold significance of warning respondents of their duty to report. Federal regulations regarding confidentiality require that subjects be warned of mandatory reporting requirements, and researchers must be ready to respond appropriately to signs of abuse. Realistically, however, this requirement protects researchers, primarily, and not abused children or elders; worse, it hinders efforts to understand the dynamics of abuse.
The message that researchers are required to deliver does not evoke appreciation that society cares about abuse; rather it may be interpreted as something like: "If I discuss such and such they're going to put me in jail and take my kid away from me. In the long run, it might benefit society if reporting requirements for funded research on family processes deemed of great national importance could be altered.
For example, the modified requirement might mandate training in effective parenting or elder care with follow-up supervision and built-in provision for such training and supervision. A warning to this effect might produce better outcomes for science, society, and the families involved. Beyond these somewhat uniform mandatory reporting state laws, the task of informing oneself about the possibly relevant laws in any given state is daunting.
Moreover, some high-profile legal principles "spread" from state to state.