Posted by name on January 25, 2001, at 18:12:39
In reply to Re: Institutional Review Board policies, posted by Noa on January 25, 2001, at 16:14:41
THE FOLLOWING ARE EXCERPTS FROM THE USDHHS OFFICE OF HUMAN RESEARCH PROTECTIONS IRB GUIDEBOOK
http://ohrp.osophs.dhhs.gov/irb/irb_guidebook.htm
D. PRIVACY AND CONFIDENTIALITY
http://ohrp.osophs.dhhs.gov/irb/irb_chapter3.htm#e4INTRODUCTION
The possibility that research may invade the privacy of individuals or result in a breach of confidentiality sometimes arises in biomedical and behavioral research. Under certain circumstances, an invasion of privacy or breach of confidentiality may even present a risk of serious harm to subjects (e.g., as when the researcher obtains information about subjects that would, if disclosed by the researcher, jeopardize their jobs or lead to their prosecution for criminal behavior). Under less dramatic circumstances, an invasion of privacy or breach of confidentiality can be a moral wrong, or, at least in theory, provide cause for legal action against a researcher or institution.
Privacy can be defined in terms of having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. Confidentiality pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original disclosure without permission....
Observational Studies. Of all the methods used to locate suitable subjects and obtain data, covert observation and participant observation are especially likely to raise concerns about privacy. Covert observation includes the use of concealed devices to record information for later analysis (e.g., tape recording conversations or videotaping personal interactions) and concealment of the researcher (e.g., behind a one-way mirror) as the behavior of subjects is observed and recorded. In participant observation, the researcher assumes a role in the setting or group being studied. When the purpose of these methods is to gain access to information not ordinarily available to "outsiders," questions of privacy arise. (Similar issues about obtaining information not intended to be disclosed can be raised about many other forms of research that involve deception.)
Several factors may be relevant to an IRB's evaluation of such privacy questions. One is the extent to which the behavior in question is public. Covert observation of public behavior (e.g., observing pedestrians on the street) raises little if any concern about privacy; concealed observation of people in their homes would be quite another matter. Some behavior that occurs in public places may not really be public behavior C the individuals involved have a reasonable expectation of privacy. Research involving covert recording of conversations in public parks or filming of activities in public rest rooms clearly raises invasion of privacy questions. Observational studies in quasi-public places (e.g., hospital emergency rooms or state mental hospital wards) may also raise such concerns.
A question sometimes raised about the use of covert observation in research is whether an ethical issue exists if the subjects never become aware of the invasion of privacy. That is, if subjects are never aware that their behavior has been observed or recorded for research purposes, they can hardly feel embarrassed, guilty, or that their rights have been violated. On the other hand, it can be argued that an invasion of privacy is wrong, whether or not the subjects are ever aware of it. In some cases, subjects may inadvertently learn of their involvement in the research, perhaps when the study is published, and feel that they have been harmed.
Most observational research, except that involving children and minors, is exempt from federal regulations. For studies involving adults, current regulations require IRB review only for the most risky observational investigations C those in which two conditions exist: (1) the observations are recorded in a manner that allows the subjects to be identified, directly or through identifiers linked to them; and (2) the observations recorded, if they became known outside the research, could reasonably place the subject either at risk of criminal or civil liability or cause damage to the subject's financial standing, employability, or reputation [Federal Policy §___.101(b)(2)]. Clearly, in such studies one of the IRB's major concerns should be to determine if it is necessary to record information in a way that entails such risk, and, if so, whether the provisions for maintaining confidentiality of the data are adequate. Observational research involving children and minors must be reviewed by the IRB unless the research involves observations of public behavior when the investigator(s) do not participate in the activities being observed; IRB review is also required where the two conditions described above obtain (i.e., identifiers will be recorded and the observations could place the subjects at risk).
Confidentiality of Research Data. A major set of concerns about confidentiality pertains to the methods used to ensure that information obtained by researchers about their subjects is not improperly divulged. Perhaps because the creation and handling of confidential records is routine in medical institutions, discussions of confidentiality as a special ethical responsibility of researchers have been more prominent in the social sciences than in the biomedical sciences. Nevertheless, the need for confidentiality exists in virtually all studies in which data are collected about identified subjects. It is in the interest of researchers C and essential to the conduct of research on sensitive topics C that researchers be able to offer subjects some assurance of confidentiality. These assurances should be given honestly, which sometimes requires the researcher and the IRB to make explicit provisions for preventing breaches of confidentiality.
In most research, assuring confidentiality is only a matter of following some routine practices: substituting codes for identifiers, removing face sheets (containing such items as names and addresses) from survey instruments containing data, properly disposing of computer sheets and other papers, limiting access to identified data, impressing on the research staff the importance of confidentiality, and storing research records in locked cabinets. Most researchers are familiar with the routine precautions that should be taken to maintain the confidentiality of data. More elaborate procedures may be needed in some studies, either to give subjects the confidence they need to participate and answer questions honestly, or to enable researchers to offer strong, truthful assurances of confidentiality. Such elaborate procedures may be particularly necessary for studies in which data are collected on sensitive matters such as sexual behavior or criminal activities.
In studies where subjects are selected because of a sensitive, stigmatizing, or illegal characteristic (e.g., persons who have sexually abused children, sought treatment in a drug abuse program, or who have tested positive for HIV), keeping the identity of participants confidential may be as or more important than keeping the data obtained about the participants confidential. In such instances, any written record linking subjects to the study can create a threat to confidentiality. Having the subjects of these studies sign consent forms may increase the risk of a breach of confidentiality, because the consent form itself constitutes a record, complete with signature, that identifies particular individuals of the group studied. The Federal Policy allows IRBs to waive the requirement for the investigator to obtain a signed consent form where it will be the only record linking subjects to the research, and where a breach of confidentiality presents the principal risk of harm that might result from the research [Federal Policy §___.117(c)]. FDA regulations allow IRBs to waive the signed consent form requirement only when the research presents no more than minimal risk and involves procedures that do not normally require consent when performed outside the research context [21 CFR 56.109(c)]. If both FDA regulations and the Federal Policy apply to a protocol, the IRB must meet the requirements of both. In this instance, documentation of informed consent can be waived only if the consent form is the sole record linking subjects to the research, the research involves minimal risk, breach of confidentiality is the principal risk of harm and the procedure involved in the research is one that does not normally require consent when performed outside the research context. (Note that the foregoing waiver provisions apply to documentation of informed consent and not waiver of the requirement to obtain informed consent.)
Where data are being collected about sensitive issues (such as illegal behavior, alcohol or drug use, or sexual practices or preferences) protection of confidentiality consists of more than preventing accidental disclosures. There have been instances where the identities of subjects or research data about particular subjects have been sought by law enforcement agencies, sometimes under subpoena, and with the threat of incarceration of the uncooperative researcher. Under federal law (and some state laws), researchers can obtain an advance grant of confidentiality that will provide protection even against a subpoena for research data [Public Health Service Act §301(d)]. Although regulations implementing §301(d) are not in place as of this writing, the PHS has issued an Interim Policy Statement [also called the "Interim Guidance" (May 22, 1989)] that sets forth PHS policy exercising the its authority to grant certificates of confidentiality. Section 301(d) extends to "biomedical, behavioral, clinical, or other research" an earlier authority (in '303 of the Public Health Service Act) that was available only for "research on mental health, including research on the use and effect of alcohol and other psychoactive drugs."
To take advantage of §301(d), the investigator must request a grant of confidentiality from the appropriate official. Protection for research on mental disorders or the use and effects of alcohol and other psychoactive drugs can be obtained from the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute on Drug Abuse (NIDA), or the National Institute of Mental Health (NIMH), which, in 1991, became components of NIH. Certificates of confidentiality for biomedical, behavioral, clinical, or other research that does not fall into these categories are issued by the Assistant Secretary for Health. Protection is available for: (1) direct federal activities (i.e., intramural research); (2) federally-funded activities; and (3) research in the United States that has no federal funding. Under the Interim Policy, protection will be granted "sparingly," and only "when the research is of a sensitive nature where the protection is judged necessary to achieve the research objectives." The Policy defines "sensitive" research as involving the collection of information falling into any of the following categories:(a) Information relating to sexual attitudes, preferences, or practices;
(b) Information relating to the use of alcohol, drugs, or other addictive products;
(c) Information pertaining to illegal conduct;
(d) Information that if released could reasonably be damaging to an individual's financial standing, employability, or reputation within the community;
(e) Information that would normally be recorded in a patient's medical record, and the disclosure of which could reasonably lead to social stigmatization or discrimination;
(f) Information pertaining to an individual's psychological well-being or mental health.
Information in other categories, not listed here, might also be considered sensitive because of specific cultural or other factors, and protection can be granted in such cases upon appropriate justification and explanation.
For studies in which the data to be obtained concern illegal or stigmatizing activities but which are not eligible for these statutory shields against subpoena, careful attention should be given to a series of decisions related to confidentiality: (1) whether the researcher will record subject identifiers at all (including on consent forms); (2) if identifiers are to be collected, whether they will be retained after the data are coded; (3) if identifiers are not destroyed, how are they to be maintained; and (4) what subjects should be told about these matters as part of the informed consent process. Some researchers enlist a third party (sometimes in another country) to act as a custodian of keys to coded identifiers or lists of participants. This approach may provide some protection for the data, but may expose the researcher to legal risks. Where such steps are contemplated, investigators should seek competent legal advice regarding the advisability of such arrangements.
Clearly, different types of studies entail different confidentiality problems. A variety of methods for protecting confidentiality are available for different situations, including situations in which there is a danger of deductive identification of otherwise anonymous subjects on the basis of separate elements of data (e.g., birthdate, occupation, and zip code). A substantial and highly specialized literature has developed on methods for safeguarding confidentiality. Among the available methods for assuring confidentiality are statistical techniques and physical or computerized methods for maintaining the security of stored data. The more sensitive the data being collected, the more important it is for the researcher and the IRB to be familiar with the state of the art in protecting confidentiality.
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