... earch: they may feel they have been treated as objects of measurement without respect for their individual values and sense of privacy. In many of the statistical inquiries that have caused controversy, the issue has had more to do with intrusion into subjects' private and personal domains, or with overburdening subjects by collecting 'too much' information, rather than with whether or not subjects have been harmed. By exposing subjects to a sense of being wronged, perhaps by the method of selection or by causing them to acquire self-knowledge that they did not seek or want, statisticians are vulnerable to criticism. Resistance to statistical inquiries in general may also increase. (See also Clauses 3.1, 4.3c, 4.5 and 4.6).
4.2 Obtaining informed consent
Statistical inquiries involving the active participation of human subjects should be based as far as practicable on their freely given informed consent. Even if participation is required by law, it should still be as informed as possible. In voluntary inquiries, subjects should not be under the impression that they are required to participate; they should be aware of their entitlement to refuse at any stage for whatever reason and to withdraw data just supplied. Information that would be likely to affect a subject's willingness to participate should not be deliberately withheld.
The principle of informed consent from subjects is necessarily vague, since it depends for its interpretation on unstated assumptions about the amount of information and the nature of consent required to constitute acceptable practice. The amount of information needed to ensure that a subject is adequately informed about the purpose and nature of an inquiry is bound to vary from study to study. No universal rules can be framed. At one extreme it is inappropriate to overwhelm potential subjects with unwanted and incomprehensible details about the origins and content of a statistical inquiry. At the other extreme it is inappropriate to withhold material facts or to mislead subjects about such matters. (See Clauses 4.3d and 4.4). The appropriate information requirement clearly falls somewhere between these positions but its precise location depends on circumstances. The clarity and comprehensibility of the information provided are as important as the quantity.
An assessment needs to be made of which items of information are likely to be material to a subject's willingness to participate. The following items are among those from which a selection might be made:
(i) purpose of study, policy implications, etc.;
(ii) identity of funder(s);
(iii) anticipated uses of the data, form of publication, etc.;
(iv) identity of interviewer/experimenter and organisational base;
(v) method by which subject has been chosen (sampling frame, etc.);
(vi) subject's role in study;
(vii) possible harm or discomfort to subject;
(viii) degree of anonymity and confidentiality;
(ix) proposed data storage arrangements, degree of security, etc.;
(x) procedures of study (time involved for participant, etc.);
(xi) whether participation is voluntary or compulsory:
(a) if compulsory, potential consequences of non-compliance;
(b) if voluntary, entitlement to withdraw consent (and when that entitlement lapses);
(xii) whether material facts have been withheld (and when or if such facts will be disclosed).
In selecting from this list, the statistician should consider not only those items that he or she regards as material, but those which the potential subject is likely to regard as such. Each party may well have special (and different) interests. As a means of supplementing the information selected, the statistician may choose to give potential subjects a declaration of their entitlement (see Jowell, 1981) which informs them of their right to information but leaves the selection of extra details in the subject's control.
Just as the specification of adequate information varies, so does the specification of adequate consent. A subject's participation in a study may be based on reluctant acquiescence rather than on enthusiastic co-operation. In some cases, the statistician may feel it is appropriate to encourage a sense of duty to participate in order to minimise volunteer bias. The boundary between tactical persuasion and duress is sometimes very fine and is probably easier to recognise than to stipulate. In any event, the most specific generic statement that can be made about adequate consent is that it falls short both of implied coercion and full-hearted participation.
On occasions, a 'gatekeeper' blocks access to subjects so that statisticians cannot approach them directly for their participation without the gatekeeper's permission. While respecting the gatekeeper's legitimate interests statisticians should still adhere to the principle of obtaining informed consent directly from subjects once they have gained access to them. In these cases, statisticians should not devolve their responsibility to protect the subject's interests onto the gatekeeper. They should also be wary of inadvertently disturbing the relationship between subject and gatekeeper.
The principle of informed consent is, in essence, an expression of belief in the need for truthful and respectful exchanges between statisticians and human subjects. It is clearly not a precondition of all statistical inquiry. Nonetheless, the acceptability of statistics depends increasingly not only on technical considerations but also on the willingness of statisticians to accord respect to their subjects and to treat them with consideration (see Clause 4.1). Statisticians should attempt to ensure that subjects appreciate the purpose of a statistical inquiry, even when the subject's participation is required by law.
4.3 Modifications to informed consent
On occasions, technical or practical considerations inhibit the achievement of prior informed consent. In these cases, the subjects' interests should be safeguarded in other ways. For example:
(a) Respecting rights in observation studies. In observation studies, where behaviour patterns are recorded without the subject's knowledge, statisticians should take care not to infringe what may be referred to as the 'private space' of an individual or group. This will vary from culture to culture.
(b) Dealing with proxies. In cases where a 'proxy' is utilised to answer questions on behalf of a subject, say because access to the subject is uneconomic or because the subject is too ill or too young to participate directly, care should be taken not to infringe the 'private space' of the subject or to disturb the relationship between the subject and the proxy. Where indications exist or emerge that the subject would object to certain information being disclosed, such information should not be sought by proxy.
(c) Secondary use of records. In cases where a statistician has been granted access to, say, administrative or medical records or other research material for a new or supplementary inquiry, the custodian's permission to use the records should not relieve the statistician from having to consider the likely reactions, sensitivities and interests of the subjects concerned, including their entitlement to anonymity.
(d) Misleading potential subjects. In studies where the measurement objectives preclude the prior disclosure of material information to subjects, statisticians should weigh the likely consequences of any proposed deception. To withhold material information from, or to misinform, subjects involves a deceit, whether by omission or commission, temporarily or permanently, which will face legitimate censure unless it can be justified.
A serious problem arises for statisticians when methodological requirements conflict with the requirement of informed consent. Many cases exist in which the provision of background information to subjects (say, about the purpose or sponsorship of a study), or even the process of alerting them to the fact that they are subjects (as in observation studies), would be likely to produce a change or reaction that would defeat or interfere with the objective of the measurement. These difficulties may lead statisticians to waive informed consent and to adopt either covert measurement techniques or deliberate deception in the interests of accuracy.
The principles above urge extreme caution in these cases and advise statisticians to respect the imputed wishes of subjects. Thus, in observation studies or in studies involving proxies, the principle to be followed is that mere indications of reluctance on the part of an uninformed or unconsenting subject should be taken as a refusal to participate. Similarly, in the case of secondary use of records, statisticians should have regard to any obligations already owed to subjects. Any other course of action in these cases would be likely to demonstrate a lack of respect for the subject's interests and to undermine the relationship between statistician and subject.
Statistical inquiries involving deliberate deception of subjects (by omission or commission) are rare and extremely difficult to defend. Clear methodological advantages exist for deception in some psychological studies, for instance, where revealing the purpose would tend to bias the responses. But, as Diener and Crandall (1978) have argued 'science itself is built upon the value of truth'; thus deception by scientists will tend to destroy their credibility and standing (see Clause 3.1). If deception were widely practised in statistical inquiries, subjects would, in effect, be taught not to 'trust those who by social contract are deemed trustworthy and whom they need to trust' (Baumrind, 1972).
Nonetheless, it would be as unrealistic to outlaw deception in statistical inquiry as it would be to outlaw it in social interaction. Minor deception is employed in many forms of human contact (tact, flattery, etc.) and statisticians are no less likely than the rest of the population to be guilty of such practices. It remains the duty of statisticians and their collaborators, however, not to pursue methods of inquiry that are likely to infringe human values and sensibilities. To do so, whatever the methodological advantages, would be to endanger the reputation of statistics and the mutual trust between statisticians and society which is a prerequisite for much statistical work. (See Clause 3.1).
For these reasons, where informed consent cannot be acquired in advance, there is a case, where practicable, for seeking it post hoc, once the methodological advantage - of covert observation, of deception, or of withholding information - has been achieved.
4.4 Protecting the interests of subjects
Neither consent from subjects nor the legal requirement to participate absolves the statistician from an obligation to protect the subject as far as possible against potentially harmful effects of participating. The statistician should try to minimise disturbance both to subjects themselves and to the subjects' relationships with their environment.
Harm to subjects may arise from undue stress through participation, loss of self-esteem, psychological injury or other side effects. Various factors may be important in assessing the risk-benefit ratio of a particular inquiry, such as the probability of risk, the number of people at risk, the severity of the potential harm, the anticipated utility of the findings, few of which are usually quantifiable (see Levine, 1975).
When the probability or potential severity of harm is great, statisticians face a more serious dilemma. A statistician may, for instance, be involved in a medical experiment in which risks to subjects of some magnitude are present. If volunteers can be found who have been told of the risks, and if the statistician is convinced of the importance of the experiment, should he or she nonetheless oppose the experiment in view of the risks? In these circumstances, probably the best advice is to seek advice - from colleagues and others, especially from those who are not themselves parties to the study or experiment.
The interests of subjects may also be harmed by virtue of their membership of a group or section of society (see Clause 1.1). So statisticians can rarely claim that a prospective inquiry is devoid of possible harm to subjects. They may be able to claim that, as individuals, subjects will be protected by the device of anonymity. But, as members of a group or indeed as members of society itself, no subject can be exempted from the possible effects of decisions based on statistical findings.
4.5 Maintaining confidentiality of records
Statistical data are unconcerned with individual identities. They are collected to answer questions such as 'how many?' or 'what proportion?', not 'who?'. The identities and records of co-operating (or non- cooperating) subjects should therefore be kept confidential, whether or not confidentiality has been explicitly pledged.
4.6 Inhibiting disclosure of identities
Statisticians should take appropriate measures to prevent their data from being published or otherwise released in a form that would allow any subject's identity to be disclosed or inferred.
There can be no absolute safeguards against breaches of confidentiality, that is the disclosure of identified or identifiable data in contravention of an implicit or explicit obligation to the source. Many methods exist for lessening the likelihood of such breaches, the most common and potentially secure of which is anonymity. Its virtue as a security system is that it helps to prevent unwitting breaches of confidentiality. As long as data travel incognito, they are more difficult to attach to individuals or organisations.
There is a powerful case for identifiable statistical data to be granted 'privileged' status in law so that access to them by third parties is legally blocked in the absence of the permission of the responsible statistician (or his or her subjects). Even without such legal protection, however, it is the statistician's responsibility to ensure that the identities of subjects are protected.
Anonymity alone is by no means a guarantee of confidentiality. A particular configuration of attributes can, like a fingerprint, frequently identify its owner beyond reasonable doubt. So statisticians need to counteract the opportunities for others to infer identities from their data. They may decide to group data in such a was as to disguise identities (see Boruch & Cecil, 1979) or to employ a variety of available measures that seek to impede the detection of identities without inflicting very serious damage to the aggregate dataset (see Flaherty, 1979). Some damage to analysis possibilities is unavoidable in these circumstances, but it needs to be weighed against the potential damage to the sources of data in the absence of such action. (See Finney, 1984).
The widespread use of computers is often regarded as a threat to individuals and organisations because it provides new methods of disclosing and linking identified records. On the other hand, the statistician should attempt to exploit the impressive capacity of computers to disguise identities and to enhance data security.
Bibliography: Obligations to subjects
4.1 Avoiding undue intrusion
Boruch & cecil (1979 & 1982) describe sampling and statistical techniques for preserving privacy. Hartley (1983) outlines the threats to privacy entailed by various sampling procedures. Michael (1984) is a journalistic account of the threats to privacy from all sources in Britain. Mirvis and Seashore (1982) is a general discussion of research in organisations, where questions about the appropriate extent of intrusion and intervention are particularly pressing. Reeves and Harper (1981) is a text on organisation research in a British industrial context. The necessity of some intrusion into the privacy of respondents to collect information that can be obtained only by individual interviews is referred to by Bryant and Hansen (1976).
4.2 Obtaining informed consent
Wax (1979 & 1982) argues for the inappropriateness of required informed consent in ethnographic inquiry, while Capron (1982) defends the requirement. O'Connor (1976) discusses problems of interpreting consent, or lack of it, in hierarchical field settings such as prisons. Bulmer (1982) presents an extended case against covert social inquiry. O'Connor & Barnes (1983) makes a brief defence of some covert research. Singer (1978) and Jowell (1979) report empirical evidence about the differential effects of seeking informed consent from survey respondents. The relevance of the principle of informed consent to statistical inquiries is critically discussed by Dalenius (1983) and questioned by Hansen (1983).
4.3 Modifications to informed consent
Douglas (1979) argues against formal requirements to obtain consent. Geller (1982) makes suggestions about how to avoid having to deceive research subjects. Form (1973) deals at length with relations between scientists and gatekeepers.
4.4 Protecting the interests of subjects
Baumrind (1972) is a plea for priority for the interests of research subjects. Klockars (1979) discusses how to handle these interests when they seem to be anti-social and/or illegal. Freidson (1978) argues in favour of the routine destruction of all identifiers of data about individuals. Okely (1984) discusses the hazards in publishing findings on an identifiable social group in Britain. Loo (1982) gives a case study of research aimed at promoting the welfare of a deprived community. Canada Council (1977) discusses the special problems that arise in research on captive populations and on children. Warwick (1983) examines the particular ethical issues that may arise in some developing countries.
4.5, 4.6 Confidentiality and disclosure of identities
Boruch & Cecil (1979 & 1982) provide technical answers. Hartley (1982) discusses the relation between sampling and concealment. Legal and technical aspects of the protection of statistical data on individuals are presented by Dalenius (1979) and Durbin (1979) in the context of the laws and practices of their respective countries: Sweden and the U.K.
http://isi.cbs.nl/ethics.htm
Отправлено: 23.07.08 05:13. Заголовок: ISI DECLARATION ON PROFESSIONAL ETHICS
