PATIENT SAFETY AT ODDS WITH PATIENT PRIVACY? THE CASE OF NATIONAL AND REGIONAL QUALITY REGISTRIES FOR INCAPACITATED
3. Registry-based research
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fore, the practical situation is considered problematic in respect to the uncertain future of the registries which include incapacitated persons.
2.3. The legal situation
As a response to the uncertainties in the legisla‑
tion, the Swedish government did initiate an Inquiry concerning the problem about the right to informa‑
tion in health and social care (31). In a commission report in June 2013, a draft law on new rules in the Patient Data Act was put forth which will enable the processing of personal data of incapacitated persons without their agreement (32). More specifically, the Inquiry on the right information in health and social care proposes an amendment which opens up the possibility also to record personal information from incapacitated persons under certain conditions. Due to this proposal, in October 2014 the Patient Data Act will have a new provision that states that data collection is allowed if the patient, if possible, has been consulted, and if there are no reasons to believe that the patient does not consent the processing of personal data. The health personnel shall assess whether the patient lacks the capacity to respond to personal data processing. If the staff find that such ability is absent, the person making the assessment should try to ascertain the past attitude of the indi‑
vidual, for example by talking to relatives. If there are no reasons to believe that the person would have
ment Committee to propose new legislation; Dir. 2012:72. Beslutsoförmögna personers ställning i hälso‑ och sjukvård, tandvård, socialtjänst.
(31) S 2011:13.
(32) SOU 2013:45 Rätt information — Kvalitet och patientsäkerhet för vuxna med nedsatt beslutsförmåga.
opposed the data registration if he or she had been able to give an opinion on the issue, the registration may be performed (33).
The planned new legislation has, so far, led to little discussion about the pros and cons of register‑
ing these groups of patients and the risk of privacy breaches this could entail. For example, it ought to be investigated further whether the bill is consistent with the requirements in the European Convention on Human Rights and Biomedicine (the Oviedo Convention), which expresses a requirement that a legal representative be provided adult decisions incapable patients (34).
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as a crucial instrument for clinical research, both now and in the future (36).
In the following, I will turn to the accessibility of data in the quality registers. In the article, it is relevant to ask this question: under what conditions is registry‑based research on elderly persons with cognitive impairments allowed? Many national and regional quality registries contain very attractive material to use for different studies in health and medicine but also in other kinds of research, includ‑
ing the behavioural and social sciences.
The key requirement in most codes of research ethics is that certain kinds of research can be conducted only if the person has given his or her informed consent. Corresponding provisions requiring informed consent can be found in sev‑
eral international regulations and codes of ethics regarding research on humans, such as the Declara‑
tion of Helsinki (World Medical Association’s code of ethics for research involving human subjects), European Convention on Human Rights and Biomedicine (the Oviedo Convention), as well as guidelines CIOMS (the Council for International Organizations of Medical Sciences, initiated by WHO and UNESCO). All of these regulations state that biomedical research may be conducted only if the research subject is informed about the study and given the opportunity to voluntarily decide whether they wish to participate. To give informed consent according to these documents, the patient must understand the request of the research team, the nature of the procedure (examination, using
(36) SOU 2008:7, Världsklass! Åtgärdsplan för den kliniska forskningen and SOU 2009:43, Klinisk forskning — ett lyft för sjukvården.
information in personal records etcetera) and the risk — and possible benefits — of participation.
Thus, informed consent demands a fairly compe‑
tent person who can understand the information provided and the choices involved in whether or not to participate. Not everyone, including incapacitated elderly, has such a degree of capacity.
Swedish regulation is influenced by these inter‑
national rules. A law has been in force since 2004 which deals with vetting the ethics of research that involves humans, the Act (2003:460) concerning Ethical Review (Ethical Review Act). It encompasses research involving living persons, but it also covers such areas as research on the deceased, biological material from people, and research that involves dealing with sensitive information about people or personal information concerning criminal offences.
This Act is the principal legislation governing the requirements for research involving human subjects in Sweden. If the research requires permission in accordance with the Ethical Review Act Section 4 1‑3, the rules of informed consent apply. Such research involves either physical intervention on the subject of the research, or research conducted using methods designed to affect the subject mentally or physically, or research that poses a clear risk for physical or mental harm to the subject. If the study instead is subject to permission according to Section 3, the Ethics Review Board determines the appli‑
cable provisions regarding information and consent for each research project (37). The Act governs the
(37) For practical reasons, informed consent is not always requested for registry‑based research. The registries may contain data for several thousand per‑
sons and it is considered difficult to handle procedures for informed consent for
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basic requirements of information and consent that must be met for such research on patients. Section 3 covers many areas of research, including social sci‑
ences, law and medical research, including research based on registries. According to Section 3, an ethi‑
cal review is requested if the research includes the processing of sensitive personal data (as defined by the Personal Data Act) or personal data relating to offences against the law involving crime, criminal convictions, coercive measures or administrative detention.
3.2. Accessibility of data from incapacitated elderly persons
In accordance with other legislation containing consent requirements, a valid informed consent can only be provided by persons who have certain abilities. For example, a person who is severely demented cannot give informed consent to par‑
ticipate in research. If the requirement to obtain informed consent from the research subjects is made unconditional, it will have the consequence that research involving such persons can never take place. An absolute ban is problematic and eliminates possibilities to prevent, treat and relieve sickness and ill health of groups without ability to consent.
For this reason, the most influential research eth‑
ics regulations make exceptions for this group (38).
everyone. Instead, the ethical boards often request that the researchers advertise in newspapers and other media about the project in order to make people aware of the research and be able to drop out of the study. By contacting the research group, the person will be excluded from the study.
(38) Another exception is children under 18 years of age. Special provisions exist for this group as well.
In addition, the Swedish regulation permits persons without ability to consent to be involved, under certain circumstances, in research. According to the Ethical Review Act Section 20, research on adults may be carried out without the consent “if illness, mental disorder, weakened state of health or some other similar circumstance prevents the subject of the research from expressing an opinion.” However, such research assumes that certain special protection conditions are fulfilled. According to Section 21, research may be performed only if the research can be expected to a) result in knowledge that is not possible to obtain through research using informed consent, and b) result in direct benefit to the subject who is the subject of the research. Apart from this main rule, the same section states another possibil‑
ity to do research without informed consent, i.e. if the purpose is to contribute to a result that may be beneficial to the person who is the subject of the research or someone else suffering from a similar disease or disorder, and if the research involves a minimal risk for injury and only slight discomfort to the subject. Even though the research subject lacks capacity for informed consent, the person shall be informed individually, to the greatest possible extent, about the research (39). In addition, the person’s next of kin shall be consulted (and in some cases the trustee). The research may not be conducted if the research subject in any way demonstrates that he or she does not want to participate or if any of those consulted opposes the research participation.
(39) Ethical Review Act Sec. 22.
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The regulation opens up for many questions about its application. Ethical review is being con‑
ducted by six regional ethical review boards. Appeals are handled by the Central Ethical Review Board (the Central Board) (40) In the following, some results form a study of cases from the Central Board will be presented (41).
3.3. Cases from the Central Ethical Review Board
In addition to the regulation mentioned above, case law becomes important for understanding the legal practice and the conditions under which research may take place on persons, when these persons lack the capacity to consent to research participation, due to illness or severe cognitive impairments. The study covers all cases from 2004 to 2012 from the Central Board which focus on elderly persons with cognitive impairments in research — 15 cases in all (42). The cases include both individuals who are patients in health care and individuals who are using other care, such as assisted housing services.
(40) The Central Board is regulated in Förordning (2007:1068) med instruk‑
tion för Centrala etikprövningsnämnden.
(41) There is very little legal research done on cases from the Central Board.
On children, see T. Mattsson, “Delaktighet i vård, omsorg och forskning — Barns beslutsförmögenhet i relation till ålder, mognad och hälsa”, in: Statens institutions‑
styrelse, Tvångsvård ur ett juridiskt perspektiv (Stockholm: Institutionsvård i Fokus, 2014) and J. Schiratzki, “Etik och samtycke i barnforskning”, Förvaltningsrättslig tidsskrift 1 (2011). On incapacitated persons, see L. Broström, M. Johansson, T. Mattsson, “Vilka personer saknar förutsättningar att ge informerat samtycke till att delta i forskning? En rättslig och etisk diskussion rörande etikprövningslagens regler och tillämpning”, Förvaltningsrättslig tidskrift 1 (2014).
(42) The Central Board has decided a total of 400 cases since its start in 2004.
Informed consent, voluntary participation and information confidentiality are central concepts in many cases. The concept of patient safety, on the other hand, is rarely directly discussed in the cases.
However, the ethical discussions often concern patient safety related to risk for injury or discomfort in one way or another. According to the regulation described earlier, the prerequisite for accepting a research project is that it should be expected to result in direct benefit to the subject, or result in something that may be beneficial to the person and, at the same time, involve only a minimal risk for injury and only minor discomfort to the subject of the research.
The overall question for the study involves the conditions under which the Central Board agrees to include incompetent elderly in research studies.
The main reason expressed repeatedly in the cases reviewed is the importance of including elderly with cognitive impairments as a group for scientific reasons and knowledge gain. One such case is a longitudinal and cross‑disciplinary project intended to study the determinants of disease, functional dependency and health care utilisation among the elderly (43). The overall project objective is to study how various factors in older people’s lives affect their physical and mental function. The study includes interviews with personnel and relatives as well as a physician’s examination of each patient. The Regional Board requires that the study adds one condition, which is that persons who have a legal representative should not be included in the study (without explaining
(43) Central Board decision Ö 26‑2007, dated 2007‑09‑20.
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the reason for this restriction). The Central Board objects to this and argues that if people with trustees or guardians are not allowed to participate in the study, the consequence will be that the aim of the study will be distorted. The Central Board finds that the inclusion of persons with severe cognitive impairment has a clear scientific value. It is argued that the invasion of privacy inclusion entails for the research subject would be minimised by the patient’s relatives giving permission, and by that some parts of the participation (like blood tests) are not to be done on people with very severe cognitive impair‑
ment. Thus, the gains of including people with impaired decision‑making competence outweigh the possible invasion of privacy for the individual (44). In similar cases, the Central Board comes to the conclusion that the risks are small and may be out‑
weighed by the knowledge gain (45).
The Central Board sometimes has to deal indi‑
rectly with the question of patient safety for incapac‑
itated persons. One such case is about a randomised, double‑blind, placebo‑controlled multicentre study studying the effect of a new antidepressant com‑
pound. The study is to take place at an elderly care institution, with elderly who are incapacitated. The Regional Board does not want to allow the research because of patient safety reasons. They argue that the study presents high risks for suicide (as a third of patients with diagnosed depression will receive a placebo and one‑third of patients a still relatively untested drug). However, the Central Board is of
(44) Compare Central Board decision Ö 45‑2005, dated 2006‑01‑26 and Ö 42‑2004, dated 2005‑01‑25.
(45) See for example Central Board decision Ö 2‑2010, dated 2010‑03‑04.
another opinion. The Central Board argues that specialists will specifically assess the patient’s suicide risk, and in case of assessed increase in risk the subject’s participation in the study will cease and the patient will be treated with proven medicines.
For this reason, the Central Board finds that the experimental design offers a sufficient degree of patient safety (46).
Several research projects get approval only after excluding persons without capacity to consent. (47) One such application (48) concerns an open clinical evaluation of an ointment to be applied around the genitourinary area twice a day on 50 female patients older than 65 years, who live in retirement homes and who, during the last six months, had at least one clinically diagnosed urinary tract infection. The ointment contains ingredients which according to the study hypothesis is assumed to protect users from urinary tract infections. The Central Board accepts the study only after the study design is changed so that only competent decision‑making persons will be included in the study. The decision contains no discussion about how patients’ decision‑
making powers should be examined. In another case, the Central Board makes the same suggestion not to include incapacitated persons (49). In order to make a correct selection, the Central Board pro‑
poses that all patients who wish to participate in the research study will undergo a structured dementia test. Patients with dementia will then be excluded
(46) Central Board Decision Ö 7‑2009, dated 2009‑04‑20.
(47) See for example Central Board decision Ö 22‑2011, dated 2011‑07‑29 and decision Ö 25‑2011, dated 2011‑09‑22.
(48) Central Board decision Ö 22‑2011, dated 2011‑07‑29.
(49) Central Board decision Ö 45‑2005, dated 2006‑01‑26.
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from the research study. Several cases demonstrate the same theme, i.e. that the Central Board accepts a study only after a revision of the application so that the research will no longer include incapacitated persons.
A research project may not result in direct ben‑
efit to the patient, but according to the regulation described above it should at least involve only a minimal risk for injury and only slight discomfort.
In several cases, the research is denied completely because the risks of the research methods in the study are considered to be able to cause harm. For example, in one case the researchers want to contact by phone such persons older than 70 years. Because of the likelihood that the persons are socially isolated people, a risk is considered to exist that the method will result in an increased mental strain for at least some persons (50). For this risk of harm, the Central Board comes to the conclusion that this risk out‑
weighs the potential gain and therefore rejects the research application.