ORIGINAL ARTICLES AND REVIEWS
Ethical issues in public health surveillance: drawing inspiration from ethical frameworks
Carlo PetriniI; Gualtiero RicciardiII
IUnità di Bioetica, Presidenza, Istituto Superiore di Sanità, Rome, Italy
IIPresident, Istituto Superiore di Sanità, Rome, Italy
ABSTRACT
The issues raised by public health surveillance are typical of those involved in public health ethics. Surveillance calls, in particular, for the balancing of individual rights and collective interests, which are often in conflict. One of the issues most closely linked with public health surveillance is the collection and use of personal data for purposes of public concern. Numerous frameworks (proposed by institutions, working groups or single individuals) are available for use in assessing the ethical correctness of public health interventions in general or, more specifically, of public health surveillance. While heterogeneous in nature, these frameworks are nonetheless built on a foundation of common values that are similar to those typically encountered in a clinical setting and to which bioethics has traditionally devoted considerable attention. However, it is necessary to apply these values to the specific context of public health, where the focus is more on the interests of the public at large than on those of the individual.
Key words: bioethics, health surveillance, guidelines, public health
THE CONTEXT: PUBLIC HEALTH, SURVEILLANCE AND ETHICS
In order to focus on the ethical problems posed by public health surveillance a brief illustration of the context is helpful. According to the US Institute of Medicine (IOM) "public health is what we, as a society, do collectively to assure the conditions in which people can be healthy" [1]. In the WHO's definition "surveillance means the systematic ongoing collection, collation and analysis of data for public health purposes and the timely dissemination of public health information for assessment and public health response as necessary" [2].
There are three basic steps to public health surveillance. The first is system development, which comprises two key activities: planning and design. The second step (data collection and analysis) comprises: data collection, collation, analysis and interpretation. The third step is data use, which involves the dissemination of the data collected and its application to public health programmes [3, 4].
Surveillance is recognised as "a foundational tool of public health, serving as the finger on the pulse of the health of a community" [4]. The role of surveillance in the management of public health is crucial, and it follows that the ethical problems it poses are both typical of public health ethics and of considerable significance. The conflict between individual and collective interests is most evident in the control of infectious diseases. The spread of AIDS was historically the most powerful incentive to examine the issue more closely: "in contemporary public health, no condition has pushed us to think about how individual rights relate to public health more than HIV/AIDS" [4]. This conflict between individual and collective interests that is so typical of public health in general and of surveillance in particular poses challenges that differ from those normally encountered in bioethics. This is because bioethics focuses more on the individual patient and on the physician/patient relationship, while in the public health setting the "patient" is the public at large. One of the key questions for ethics in the field of public health surveillance is: "What are the justifications for limiting individual liberty in order to promote the public's health as a common good?" [5]. The contrast appears so sharp as to make public health ethics and clinical ethics seem almost irreconcilable [6]. In actual fact, though, the basic ethical values are not dissimilar and are independent of whether the issue at stake arises within a clinical or a public health context [7]. It is, instead, the practical solutions that may differ, though the underlying values remain unchanged.
In public health ethics the approach to managing the conflict between individual and collective rights varies in accordance with the diverse schools of thought: utilitarianism aims to maximise the benefit for the greatest possible number of people, regardless of its distribution, through the adoption of scientifically controlled measures [8]; deontologism is guided by moral rules and principles [9]; egalitarianism stresses equal access to different goods and fairness among persons of different social backgrounds [10]; contractualism considers fair and morally right decisions based on procedural justice, in which the public is involved in the decision-making processes [11]; individualism gives priority to freedom and autonomy [12]; personalism aims to build the common good by promoting and making the most of the good of individuals while fostering solidarity [13].
The present article does not aim to discuss the theoretical foundations underlying the ethics of public health surveillance: it aims instead to examine some of the frameworks that offer practical suggestions for assessing the ethical propriety of measures.
ETHICAL FRAMEWORKS
A large number of heterogeneous frameworks are available on the subject, including codes, guidelines, checklists, lists of questions. They are drawn from equally varied sources: public institutions, scientific associations, groups of experts, individual authors, etc.
These frameworks are of considerable practical use, as they can be used to verify the agreement between ethical principles and proposed public health measures.
Of the few presented below, some are merely mentioned, others are examined briefly. The decision as to which should be examined more carefully was taken arbitrarily, with a view to highlighting those with more interesting ethical implications.
Some frameworks are concerned with public health in general but offer suggestions that may also be useful in the more specific setting of surveillance, while some are concerned specifically with surveillance.
General frameworks
Among the frameworks concerned with public health in general, some are actually codes, one notable example being the Principles of the ethical practice of public health issued by the American Public Health Association [14]. This document presents 12 such principles, which are intended to guide, but do not prescribe, specific actions. The guidance notes [15] that accompany the principles suggest that the code is intended to cover the entire field of public health, including but not limited to government institutions and schools of public health. Principle 1 lays down the goals for public health as principally addressing "the fundamental causes of disease and requirements for health, aiming to prevent adverse health outcomes". This is reinforced in principle 5 which refers to "policies and programs that protect and promote health". Principle 2 introduces the notion of "community health", which recurs in subsequent principles. For instance: "policies, programs and priorities should be developed and evaluated through processes that ensure an opportunity for input from community members" (principle 3); "advocate and work for the empowerment of disenfranchised community members" (principle 4); "provide communities with the information they [public health providers] have that is needed for decisions on policies or programs" and "obtain the community's consent" (principle 6); "protect the confidentiality of information that can bring harm to an individual or community" (principle 10). However, the code fails to offer a precise definition of community, and this notion thus remains somewhat controversial [16].
Among the guidelines, one example is the Ethics guidelines issued by the American College of Epidemiology. After sketching the "professional role of epidemiologists" this document identifies the following points: minimizing risks and protecting the welfare of research participants; providing benefits, ensuring an equitable distribution of risks and benefits, protecting confidentiality and privacy, obtaining the informed consent of participants; submitting proposed studies for ethical review; maintaining public trust; adhering to the highest scientific standards; involving community representatives in research; avoiding conflicts of interest and partiality; reporting results; respecting cultural diversity [17].
Alongside the codes and guidelines there are legal documents that list criteria for use as practical reference points, including, for instance, the US Model State Public Health Privacy Act [18] and the later Turning Point Model State Public Health Act [19]. The Model Acts were developed over several years during which public health practitioners, national public health organisations and representatives from the public and private sectors at federal, state and local levels were all consulted. The criteria listed in the Model Acts are rooted in the principles of beneficence, respect for persons and justice that are typical of bioethics in general and of North American bioethics in particular [20]. Among the reference criteria listed in the Acts for public health initiatives (including surveillance activities) are:
-Public health purpose. The exercise of any public health authority or power should measurably further or support improving or sustaining the public's health by accomplishing essential public health services and functions;
-Scientifically sound practices. Whenever possible, a state or local public health agency shall exercise its authorities or powers through procedures, practices, or programs that are based on modern, scientifically sound principles and evidence;
-Well-targeted intervention. A state or local public health agency shall strive to design and implement interventions that are well-targeted to accomplishing essential public health services and functions. An agency shall try to avoid using compulsory power in a manner that is over-broad (applying to more individuals than is necessary for the public's health);
-Least restrictive alternative. A state or local public health agency shall employ the least restrictive alternative in the exercise of its authorities or powers, especially compulsory powers;
-Nondiscrimination. State and local public health agencies shall not discriminate in an unlawful manner against individuals on the basis of their race, ethnicity, nationality, religious beliefs, sex, sexual orientation, or disability status;
-Respect for dignity. State and local public health agencies shall respect the dignity of each individual under their jurisdiction, regardless of his/her nationality, citizenship, or residency status; and
-Community involvement. Protecting the public's health requires ongoing public health education and outreach to encourage, facilitate, and promote community participation in accomplishing public health goals" [19].
Among the various documents produced by institutions involved in public health policies, the Framework for the ethical conduct of public health initiatives [21] is of particular interest. This document was prepared by the Ontario Agency for Health Protection and Promotion (Public Health Ontario) and is both extensive and clearly written (and thus applicable to various types of public health measures). In addition, because it highlights the competition between the collective and individual dimensions that, as we have seen, is such a crucial aspect, it is also particularly applicable to public health surveillance. The fact that Public Health Ontario paid special attention to the differences between the individual and the collective dimensions should not come as a surprise: the framework was derived from the "Tri-Council Policy Statement" [22], an instrument that is binding for all research conducted by Canadian institutions that receive funds from the three federal agencies that have adopted it. The document establishes a reference framework for the assessment of all research involving humans in the biomedical, social, anthropological, humanistic and technical fields. Again, the fact that the "Tri-Council Policy Statement" applies to such a heterogeneous range of research is indicative of the fact that the basic values to be respected remain unchanged and do not vary from one discipline to another, though the procedures for their application may indeed vary.
The Public Health Ontario framework lists ten key questions, each of which comprises specific aspects. The ten questions are:
1. What are the objectives of the initiative? How are they linked to potential improvements in public health?
2. Can the objectives be achieved using the proposed methods?
3. Who are the expected beneficiaries of the knowledge gained or other benefits?
4. What are the burdens and potential harms associated with the proposed initiative? Who bears them?
5. Are burdens and potential harms justified in light of the potential benefits to participants and/or to society?
6. Is selection of participants fair and appropriate?
7. Is individual informed consent warranted? Is it feasible? Is it appropriate? Is it sufficient?
8. Is community engagement warranted? Is it feasible? What level of engagement is appropriate?
9. What are the social justice implications of this initiative?
10. What are the potential longer-term consequences? In common with the "Tri-Council Policy Statement" [22] from which it is derived, the framework is founded on widely shared principles cited in all the major institutional reference documents concerning bioethics (codes, declarations, recommendations, etc).
Checklists proposed by experts or working groups are also available: these contain practical questions designed to verify that a planned intervention is consistent with ethical principles.
In 2001 Kass [23] proposed an "analytic tool, designed to help health professionals consider the ethics implications of proposed interventions, policy proposals, research initiatives and programs", consisting of six key questions:
1. What are the public health goals of the proposed programme?
2. How effective is the programme in achieving its stated goals?
3. What are the known or potential burdens of the programme?
4. Can burdens be minimised? Are there alternative approaches?
5. Is the programme implemented fairly?
6. How can the benefits and burdens of a programme be fairly balanced? [23].
The following year Childress, et al. [24] suggested another tool, according to which "regardless of the ethical theories taken as reference, the relevant moral considerations [where public health is concerned] should include":
1. producing benefits;
2. avoiding, preventing, and removing harms;
3. producing the maximal balance of benefits over harms and other costs (often called utility);
4. distributing benefits and burdens fairly (distributive justice) and ensuring public participation, including the participation of affected parties (procedural justice);
5. respecting autonomous choices and actions, including liberty of action;
6. protecting privacy and confidentiality;
7. keeping promises and commitments;
8. disclosing information as well as speaking honestly and truthfully (often grouped under transparency);
9. building and maintaining trust [24].
Another useful example is the guide "to considering the ethical issues in public health practice" by Nieburg, et al [25] and the suggestions put forward by Baum, et al. [26].
Some frameworks focus particularly on human rights. Gostin and Mann, for instance, propose a "human rights impact assessment" that comprises a series of procedures designed to "balance the public health benefits of a policy against its rights burdens" [27]:
Step 1: Clarify the public health purpose;
Step 2: Evaluate likely policy effectiveness (Is the screening program appropriate and accurate? Is the intervention likely to be effective? Is there a better approach?);
Step 3: Determine whether the public health policy is well-targeted;
Step 4: Examine each policy for possible human rights burdens;
Step 5: Determine whether the policy is the least restrictive alternative that can achieve the public health objective;
Step 6: If a coercive public health measure is truly the most effective, least restrictive alternative, base it on significant-risk standard;
Step 7: If a coercive measure is truly necessary to avert a significant risk, guarantee fair procedures to persons affected.
Specific frameworks
Of the frameworks concerned specifically with public health surveillance, the Nine principles for assessing whether privacy is protected in a surveillance society proposed by Pounder [28] and A tool for ethical analysis of public health surveillance plans by the Canadian Institute of Health Research [29] are worth mentioning.
The nine principles proposed by Pounder [28] are:
1. ustification principle: "Information relating to any legislation or policy that involves surveillance (or extension to an existing surveillance policy) is provided so an assessment can be made to ensure that the surveillance can be justified in terms of pressing social needs and measurable outcomes; this information is provided prior to the approval of legislation or policy";
2. approval principle: "Any surveillance is limited to lawful purposes defined in legislation where such legislation has been thoroughly scrutinised by a fully informed Parliament and, where appropriate, informed public debate has taken place";
3. separation principle: "Procedures which authorise or legitimise a surveillance activity are separate from procedures related to the actual surveillance itself; the more invasive the surveillance, the wider the degree of separation";
4. adherence principle: "Procedures which authorise a surveillance activity are professionally managed and audited; staff involved in a surveillance activity are fully trained to follow relevant procedures and that such training is assessed if appropriate; any malfeasance in relation to a surveillance activity can be identified and individuals concerned suitably punished";
5. reporting principle: "A regulator shall determine what records, including statistical records, are retained and maintained concerning a surveillance activity, in order to ensure transparency and accountability to the Regulator, to the public and to Parliament";
6. independent supervision principle: "The system of supervision for a surveillance activity is independent of Government, well financed, and has effective powers of investigation and can delve into operational matters";
7. privacy principle: "Individuals should be granted a right to privacy of personal data which can be enforced by the Data Protection Commissioner and should possess a much simpler right to object to the processing of personal data in appropriate circumstances";
8. compensation principle: "An individual should obtain compensation if a surveillance activity has caused damage, distress or detriment that proves to be unjustified";
9. unacceptability principle: "If the other principles cannot be complied with in relation to a surveillance activity then within a reasonable time:
a) the activity ceases; or
b) alternative steps are taken to bring the activity into conformity with the principles; or
c) Parliament or a Parliamentary Committee approves the non-compliance with the relevant principle".
The Canadian Institutes of Health Research proposed A tool for ethical analysis of public health surveillance plans [29]. This comprises eleven criteria: proportionality, usefulness, transparency, representativeness, equity, participation, independence, stigmatisation, privacy, informed consent, understandability. The checklist is illustrated in Table 1.
COMMON FEATURES
Despite their differences, all the documents cited above refer to values that are typical of public health [4, 30, 31]. These include, in particular an obligation: to improve the public's health, to promote social justice, to produce benefits, to remove harms, to distribute burdens and benefits, to keep commitments, to disclose information truthfully, to respond to suffering. These are accompanied by the obligation to ensure: equity, proportionality (which requires that any restriction to liberty not exceed what is necessary to address the needs of the community), reciprocity (or the obligation to support those who face a disproportionate burden in responding to public health measures), solidarity (which requires liaison among public and private systems to meet public health goals), stewardship (or the obligation to govern scarce resources so as to maximise the benefits and minimise collateral damage), trust between communities and public health professionals, evidence-based actions, justice, accountability of costs and efficiencies, political feasibility, the protection of individuals in the community (e.g. through the right to non-interference, participation of community representatives, respect for autonomy and the protection of confidentiality).
So far as public health surveillance is concerned, one of the problems most frequently mentioned concerns the management of personal information.
The importance of this issue is evidenced by the fact that the paragraph entitled Ethical and legal aspects of surveillance in the brief entry for "Surveillance of disease: Overview" in the International encyclopedia of public health devotes more space to this than to other public health surveillance issues. The entry affirms that: "Surveillance activities often involve surveillance workers handling communities, people, and institutions in terms of health hazard investigation, collection of technical as well as originally private information, and publication of the collected information. It is important that the purpose of surveillance should be known or fully explained as needed to the community or individuals so that the surveillance teams can obtain needed information with good cooperation on the part of the community or individuals. When it is planned, surveillance should ensure that individuals' and agencies' right to privacy will not be violated. In some cases, however, this is not simple, because the right to privacy and the right to know scientific information conflict" [32].
These frameworks highlight the requirement that data collected for surveillance purposes should be acquired, stored, used and disseminated only for legitimate ends. The following are some of the practical suggestions that can be derived either directly or indirectly from the various frameworks:
the collection of data is legitimated in ethical terms if the data are gathered for legitimate public health purposes and if there is a reasonable chance that the objectives will be achieved, bearing in mind current regulations and the available resources;
the collection, storage, use and dissemination of unidentifiable data poses fewer problems than the collection of identifiable data, and should therefore be preferred where it does not jeopardise the achievement of the proposed objectives. For the same reason any data gathered should be limited to the minimum necessary to attain the intended goal: no unnecessary data should be acquired;
the storage of collected data, in a physically and technologically safe environment, should not be prolonged more than necessary. A supervisor should be in charge of the archive and clear rules for access laid down;
when possible, data should be communicated in aggregate form. Any dissemination of data should, obviously, comply with current regulations and have the consent of the interested parties, except where public health requirements call for the transfer of data to the health authorities;
proper communication with all subjects involved should be maintained throughout all phases of surveillance operations. The highest possible level of engagement should be established with subjects.
All of the above confirms the already mentioned similarity between the tools for assessing the ethical compliance of public health initiatives and those for the ethical assessment of clinical research.
These similarities in turn confirm the broad agreement between the criteria governing current practice and those governing research [33]. They also reveal the agreement between clinical ethics and public health ethics [34]. It would thus be preferable to use the expression "ethics in public health" rather than "public health ethics": there is no specific package of ethical requirements: rather, there are general values that should be applied - albeit with the appropriate adjustments - to the public health setting and, more specifically, to public health surveillance.
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Address for correspondence:
Carlo Petrini
Unità di Bioetica, Presidenza, Istituto Superiore di Sanità
Via Giano della Bella 34
00162 Rome, Italy
E-mail: carlo.petrini@iss.it
Received on 9 September 2015.
Accepted on 2 October 2015.