To explore the neuropsychological correlates of the capacity to consent to research and to appoint a research proxy among persons with Alzheimer’s disease.
Design, Setting, and Participants
Interview study of 77 persons with Alzheimer’s disease recruited through an Alzheimer’s disease research center and a memory disorder clinic.
The capacity to consent to two research scenarios (a drug randomized clinical trial and a neurosurgical clinical trial) and the capacity to appoint a research proxy were determined by five experienced consultation psychiatrists who rendered categorical judgments based on videotaped interviews of the MacArthur Competence Assessment Tool-Clinical Research (MacCAT-CR) and the Capacity to Appoint a Proxy Assessment (CAPA). Mattis Dementia Rating Scale-2 (DRS-2) was used to assess neuropsychological functioning.
The capacity to appoint a proxy and to consent to the drug randomized clinical trial, as determined by a majority or greater opinion of the 5-psychiatrist panel, were predicted by Conceptualization and Initiation/Perseveration subscales whereas the capacity to consent to a neurosurgical randomized clinical trial was predicted by the Memory subscale. Furthermore, the more lenient individual psychiatrists’ judgments were predicted by the Conceptualization subscale whereas the stricter psychiatrists’ judgments were predicted by the Memory subscale.
How experienced psychiatrists view Alzheimer’s patients’ capacity for consenting to research and for appointing a proxy may be related to the patients’ conceptualization and memory functioning. More explicit and standardized guidance on the role of short term memory in capacity determinations may be useful.
decision-making capacity; neuropsychology; Alzheimer’s disease
Clinical trials involving children previously considered unethical are now considered essential because of the inherent physiological differences between children and adults. An integral part of research ethics is the informed consent, which for children is obtained by proxy from a consenting parent or guardian. The informed consent process is governed by international ethical codes that are interpreted in accordance with local laws and procedures raising the importance of contextualizing their implementation.
In Zimbabwe the parental informed consent document for children participating in clinical research is modeled along western laws of ethics and requires that the parent or legally authorized representative provide consent on behalf of a minor. This article highlights the experiences and lessons learnt by Zimbabwean researchers in obtaining informed consent from guardians of orphaned children participating in a collaborative HIV clinical trial involving the Medical Research Council, United Kingdom and four centers, three of which are in Uganda. Researchers were faced with a situation where caregivers of orphaned children were not permitted to provide informed consent for trial participation. The situation contrasted with general clinical practice where consent for procedures on orphans is obtained from their caregivers who are not legal guardians.
The challenges faced in obtaining informed consent for orphans in this clinical trial underscores the need for the Zimbabwe ethics committee to develop an ethical and legal framework for pediatric research that is based on international guidelines while taking into account the cultural context. The Medical Research Council of Zimbabwe has since started the process that is expected to involve critical stakeholders namely the community including children, ethicists, the legal fraternity and researchers.
This article examines the attitudes of 97 women from the St. Louis City Drug Court who previously participated in an HIV prevention study. Data from the previous study indicated that the women met multiple criteria for vulnerability in research. Federal regulations require that such participants be provided with “additional safeguards.” The survey explored the following questions: (1) What are participants’ attitudes toward commonly proposed additional safeguards for vulnerable participants in research, and (2) Are attitudes toward safeguards related to participants’ previous compliance with an HIV prevention protocol? Preferences regarding safeguards in research were not significantly related to participants’ compliance in the previous study. Most participants wanted researchers to take extra measures not only to provide consent information, but to ensure that they are not high on drugs, that they understand relevant information, and that they retain consent information at each visit. Most participants wanted researchers themselves, and not a third party, to assume this responsibility.
Research ethics; Research protections; HIV prevention; Community attitudes; Drug court; Longitudinal study; Qualitative study
Legislation demands the establishment of client councils in Dutch nursing homes and residential care facilities. The members of those councils are residents or their representatives. Client councils have the right to participate in the strategic management of long-term care facilities. More specifically, they need to be consulted regarding organisational issues and a right to consent on issues regarding daily living of residents, including CQ-index research. CQ-index research concerns a method that measures, analyses and report clients' experiences about the quality of care. Research questions were: 'Do client councils exercise their rights to be consulted and to give their consent?' and 'What is the role of client councils in the process of measuring clients' experiences with the CQ-index and what is their opinion about the CQ-index?'
Postal questionnaires were sent to members of 1,540 client councils of Dutch nursing homes and residential care facilities. The questionnaire focussed on background information and client councils' involvement in decision-making and strategic management.
The response rate was 34% (n = 524). Most councils consisted of seven members (range: 5 to 12 members). One out of four members participating in the client councils were clients themselves. Although councils have a legal right to be consulted for organisational issues like finance, vision, annual report, and accommodation, less than half the councils (31-46%) reported that they exercised this right. The legal right to consent was perceived by 18 to 36% of the councils regarding client care issues like food and drink, complaints registration, respectful treatment, and activities. For CQ-index research, only 18% of the client councils perceived a right to consent. Their rights to choose an approved contractor -who performs CQ-index research- and indicating improvement priorities, were hardly used.
Client councils play a rather passive role in determining the policy on quality of long-term care. Therefore, specific attention and actions are needed to create a more proactive attitude in councils towards exercising their rights, which are already supported by legislation.
Consumer participation; empowerment; patients' rights; long-term care
The conduct of biomedical research involving the participation of human beings implicates a variety of ethical concerns pertaining to such values as dignity, bodily integrity, autonomy, and privacy. These ethical concerns have been translated into a complex regulatory apparatus in the USA, containing specific legal provisions concerning such matters as participant safety, informed consent, and confidentiality. A topic of particular interest for pathologists is the handling of human tissue specimens that may be used for present, or stored for future, research purposes. This article examines the ethical and legal ramifications of obtaining and storing tissue samples for research purposes, with special attention to the issues of informed consent and confidentiality.
ethics; law; research; tissue
Although critically ill patients represent a vulnerable group of individuals, guidelines in research ethics assert that ethically acceptable research may proceed with such vulnerable subjects if additional safeguards are in place to minimize the risk of harm and exploitation. Such safeguards include the proper obtainment of informed consent that avoids the presence of the therapeutic misconception and the assessment of decisional capacity in critically ill patients recruited for research. Also discussed in this review are additional safeguards for such vulnerable subjects, as well as the issues involved with proxy consent. Heightened awareness to principles of ethics and provision of additional safeguards to enhance protections of vulnerable subjects would help to maintain the public trust in the research endeavor.
This paper explores the use of advance directives in clinical dementia research. The focus is on advance consent to participation of demented patients in non-therapeutic research involving more than minimal risks and/or burdens. First, morally relevant differences between advance directives for treatment and care, and advance directives for dementia research are discussed. Then attention is paid to the philosophical issue of dementia and personal identity, and the implications for the moral authority of research advance directives. Thirdly, a number of practical shortcomings of advance directives for non-therapeutic dementia research are explored and attention is paid to the role of proxies. It is concluded that upon a closer look the initial attractiveness of advance directives for dementia research is lessened, and that it is doubtful whether these instruments can compensate for the lack of subject consent in case of non-therapeutic dementia research involving more than minimal risks and/or burdens for the incompetent demented subject.
The Medicines for Human Use (Clinical Trials) Regulations 2004, which came into force in the UK in May 2004, cover the conduct of clinical trials on medicinal products. They allow a legal representative (a person not connected with the conduct of the trial) to consent to the participation of incompetent adults in medical research. Currently, very little is known about how such representatives will make their decisions.
We have experience with proxy consent for older adults in a large, national trial. From 2445 potentially eligible but incapacitated patients, proxy, relative assent resulted in trial participation of only 87 (3.6%) patients. The reasons for this were that a large number of incapacitated patients had no relative available for assent (2286), but also a high proportion of relatives approached refused to provide assent (72/159, 45.3%). In comparison, 17.7% of patients declined participation in the trial.
Proxy consent allowed only a small increase in trial recruitment of incapacitated patients. The fact that a greater proportion of relatives than patients refused to provide assent implies that they were more cautious than the patients themselves, or perhaps used different criteria, when making their decision.
In future research involving incapacitated older patients there is likely to be heavy reliance on proxy consent provision by legal representatives. Our findings imply that consent decisions of legal representatives will not necessarily reflect those of patients themselves.
assent; incapacitated adults; informed consent; proxy consent
Research involving persons with impaired decision-making capacity, such as persons with Alzheimer’s disease, remains ethically challenging, especially when the research involves significant risk. If subjects incapable of consenting to research studies were still able to appoint a research proxy, it would allow for an appointed surrogate, rather than a de facto surrogate, to represent the subject.
To assess the extent to which persons with Alzheimer’s disease retain their capacity to appoint a research proxy.
Design, Setting, and Participants
188 persons with Alzheimer’s disease were interviewed for their capacity to appoint a proxy (CAP) for research and to provide consent to two hypothetical research scenarios, a lower risk randomized clinical trial testing a new drug (drug RCT) and a higher risk randomized clinical trial testing neurosurgical cell implants using a sham control condition (neurosurgical RCT). Categorical capacity status for each subject was determined by independent videotape reviews of capacity interviews by five experienced psychiatrists.
Main Outcome Measures
Categorical capacity determinations for the capacity to appoint a research proxy, capacity to consent to a drug RCT, and capacity to consent to a neurosurgical RCT.
37.7% (40/106) of those deemed incapable of consenting to the drug RCT and 54.4% (86/157) of those deemed incapable of consenting to the neurosurgical RCT were still found capable of appointing a research proxy. Very few subjects (7/186, 3.8%) were deemed capable of consenting to the neurosurgical RCT by all five psychiatrists.
A substantial proportion of AD subjects thought incapable of consenting to lower or to higher risk studies have preserved capacity for appointing a research proxy. Since so few subjects are found to be unequivocally capable of providing independent consent to higher risk AD research, providing for an appointed surrogate even after the onset of AD, which might best be done in the very early stages of the illness, may help address key ethical challenges to AD research.
The prediction of susceptibility to heritable breast, ovarian and colon cancer raises important legal and ethical concerns. Health care professionals have a duty to disclose sufficient information to enable patients to make informed decisions. They must also safeguard the confidentiality of patient data. These duties may come into conflict if a positive finding in one patient implies that family members are also at risk. A legal distinction is made between a breach of confidentiality and the legitimate sharing of information in a patient's interest or to prevent harm to a third party. Physicians also have a fiduciary duty to warn. Other issues concern the legal liability assumed by genetic counsellors, whose disclosures may influence decisions about childbearing, for example, and the risk of socioeconomic discrimination faced by people with a known genetic susceptibility. Traditional ethical orientations and principals may be applied to these and other questions, but feminist ethics will likely have particular importance in the development of an ethical stance toward testing and counseling for heritable breast and ovarian cancer.
The author discusses the demographic aging of Canada and outlines how the Canadian Constitution and the Charter of Rights and Freedoms are likely to affect the care and treatment of nursing home residents. Because physical freedom and personal autonomy have been given such a high value in the constitution, civil and legal rights will be protected for all residents in nursing homes, and procedural safeguards will become mandatory in the next few years for patients who refuse treatment and for those who are deemed to be incompetent. Physicians and other caregivers will increasingly be removed from the role of substitute decision-maker for incompetent patients, and patient representatives, court-appointed guardians and courts will assume this responsibility. Judicial safeguards such as impartial hearings, appeals to the court and the principles of natural justice will become commonplace in nursing homes.
The conference was organized in part to dispel some of the misinformation that interferes with cooperative efforts of attorneys and physicians to redress the malpractice situation. During discussion of the hypothetical case, participants identified how medical decision-making responsibilities were allocated among health care providers caring for the patient. Panel members suggested ways in which medical decision making might be affected by non-medical factors such as third-party reimbursement (e.g., selection of inpatient or outpatient setting, the opportunity to discuss issues related to informed consent prior to the day of a procedure) and potential malpractice litigation (e.g., documentation in charts, use of diagnostic procedures). The characterization of decision-making roles and responsibilities differed somewhat for purposes of malpractice litigation; that is, which caregivers might be named as defendants. Panel members reconstructed the development of the medical incident into a legal case. Plaintiff's attorney commented that it is often a hospital employee who advises the family to consult an attorney and described some of the constraints on information gathering (e.g., the rule of "discovery" requiring that suit be filed before defendants can be forced to give statements about what happened, insurance contract provisions prohibiting physicians from talking without legal counsel present to persons who indicate that they plan to file suit). He also briefly explained the rationale for the contingency fee arrangement in these cases. Describing the role of the medical expert witness and the need to review the medical record, he outlined the process of deciding whether to pursue a malpractice case. In making this decision, plaintiff's attorney evaluates the facts to identify issues in the case, to determine if there are deviations from the standard of care, and to try to predict jury reaction. If a suit is filed, defense attorneys employed by the hospital, insurance company, or individual defendants will decide, based on facts including coverage limits, possible publicity, and likelihood of successful prosecution, whether the case should be settled and for what amount. Interests represented by the defense attorneys differ and may affect settlement strategies. Physician feelings of concern for the patient/family or desire for vindication will, to varying degrees, be factors in the decision to try or settle a case. Panel members explored several important policy issues. Among these were the effect of malpractice cases on doctor-patient communications and ethical issues concerning expert witnesses.(ABSTRACT TRUNCATED AT 400 WORDS)
Illnesses that cause cognitive impairment are a considerable health problem in the United States. These include Alzheimer’s disease, Huntington’s chorea, cerebrovascular disease, psychiatric disorders, chronic alcoholism, and AIDS dementia complex. Illness associated with cognitive impairment may cause great suffering to the affected patients and their families. Research involving individuals who may be at risk for or have cognitive impairment is necessary to improve our understanding of these illnesses. For example, this may occur during efforts to develop effective therapies to treat them. However, research with participants who have cognitive impairment presents additional ethical concerns because they may be vulnerable to coercion. Therefore, nurse researchers must not only understand the principles of informed consent (i.e., autonomy, beneficence, nonmaleficence, and justice), but also the additional safeguards provided in the common rule to protect cognitively impaired participants in research. These safeguards include advanced informed consent, legal representative, and assent. Gaps exist in federal regulations related to adhering to these safeguards such as how to assess for decision-making capacity and variations on who can be a legal representative. The nurse researchers have potential roles as educators and advocates in research involving participants with cognitive impairment.
informed consent; vulnerable populations; cognitively impaired; code of federal regulations; safeguards; decision making capacity
Understanding the perception of patients on research ethics issues related to biobanking is important to enrich ethical discourse and help inform policy.
We examined the views of leukemia patients undergoing treatment in clinics located in the Princess Margaret Hospital in Toronto, Ontario, Canada. An initial written survey was provided to 100 patients (64.1% response rate) followed by a follow-up survey (62.5% response rate) covering the topics of informed consent, withdrawal, anonymity, incidental findings and the return of results, ownership, and trust.
The majority (59.6%) preferred one-time consent, 30.3% desired a tiered consent approach that provides multiple options, and 10.1% preferred re-consent for future research. When asked different questions on re-consent, most (58%) reported that re-consent was a waste of time and money, but 51.7% indicated they would feel respected and involved if asked to re-consent. The majority of patients (62.2%) stated they had a right to withdraw their consent, but many changed their mind in the follow-up survey explaining that they should not have the right to withdraw consent. Nearly all of the patients (98%) desired being informed of incidental health findings and explained that the information was useful. Of these, 67.3% of patients preferred that researchers inform them and their doctors of the results. The majority of patients (62.2%) stated that the research institution owns the samples whereas 19.4% stated that the participants owned their samples. Patients had a great deal of trust in doctors, hospitals and government-funded university researchers, moderate levels of trust for provincial governments and industry-funded university researchers, and low levels of trust towards industry and insurance companies.
Many cancer patients surveyed preferred a one-time consent although others desired some form of control. The majority of participants wanted a continuing right to withdraw consent and nearly all wanted to be informed of incidental findings related to their health. Patients had a great deal of trust in their medical professionals and publically-funded researchers as opposed to profit-based industries and insurance companies.
Biobank; Tissue repository; Cancer patient perspectives; Consent; Withdrawal; Anonymity; Incidental findings; Return of results; Ownership; Trust
Health Canada and the Canadian-Italian Physicians Association recently spent $20,000 to send 4 Canadian cancer specialists to Italy to check out the "miracle" anticancer cocktail prepared by an Italian physician. Most doctors remain decidedly sceptical about this latest "cure," but Charlotte Gray says their suspicions count for little when an issue like this captures the imagination of the public and their politicians.
Little is known about patients’ views surrounding the ethical and legal aspects of managing pacemakers (PMs) and implantable cardioverter-defibrillators (ICDs) near the end of life. Patients with hypertrophic cardiomyopathy (HC) are at heightened risk of sudden cardiac death and are common recipients of such devices. Patients with HC recruited from the membership of the Hypertrophic Cardiomyopathy Association were surveyed about their clinical histories, advance care planning, legal knowledge, and ethical beliefs relating to the withdrawal of PM and ICD therapy. The mean age of the 546 patients was 49.1 years, 47% were women, and 57% had ICDs. Only 46% of the respondents had completed an advance directive, only 51% had a healthcare proxy, and cardiac implantable electrical devices (CIEDs) were commonly not addressed in either (92% and 58%, respectively). Many patients characterized deactivating PMs or ICDs as euthanasia or physician-assisted suicide (29% for PMs and 17% for ICDs), and >50% expressed uncertainty regarding the legality of device deactivation. Patients viewed deactivation of ICDs and PMs as morally different from other life-sustaining therapies such as mechanical ventilation and dialysis, and these views varied substantially according to the CIED type (p <0.0001). The respondents expressed concerns regarding clinical conflicts related to religion, ethical and legal uncertainty, and informed consent. In conclusion, patients who have, or are eligible to receive, CIEDs might require improved advance care planning and education regarding the ethical and legal options for managing CIEDs at the end of life.
The use of placebos in therapy or research poses ethical questions. What are the benefits and the costs in ethical terms of condoning deception of the patient or subject? What does the deception mean for the patient's or subject's right to give informed consent to his treatment?
Doctors are rightly expected to disclose to their patient facts which would in their judgement best enable him to give informed consent to treatment. On occasion, the degree of this disclosure may be limited by the need to avoid hazarding the success of treatment of an unstable patient whose condition threatens his life, but doctors should have no right to withhold information just to prevent a patient refusing consent to therapy. No such limitation should apply in experiments where full disclosure must operate to enable the subject to give his informed consent.
The potential medical benefits for the patient of placebo therapy have to be weighed against all the ethical costs of the deception and dishonesty involved, including the longer term repercussions on doctor/patient trust: similar ethical costs may arise in experiments involving the use of placebos without disclosure of this as a possibility to the subject. Deception is ethically degrading to both parties not only being a breach of trust, but denying the moral autonomy of the patient or subject to make his own choice.
The writer concludes that placebos should be used only with full disclosure and consent whether in therapy or in research, and that this need not impede the success of either.
Despite being the fastest growing and the most cognitively impaired age group, the oldest olds are under-represented in clinical research. The purpose of this study was to describe the design, methods, and baseline characteristics of the survey population and investigate possible differences in demographic, cognitive, functional, and behavioral characteristics between oldest old with and without any performance on cognitive tests and between oldest old alive and those deceased prior to the interview.
The Monzino 80-plus Study is a prospective door-to-door population-based survey among 80 years or older residents in the municipalities in the province of Varese, Italy. Dementia cases were identified with a one-phase design. Trained psychologists interviewed both the subject and a proxy informant. The interview included a comprehensive standardized questionnaire together with an array of rating scales and a multidomain cognitive battery to assess cognitive and functional ability, behavioral disturbances and mood.
Information was available for 2,139 of the 2,428 registered individuals aged 80 years or older. Main baseline characteristics of the population are reported and discussed. In comparison with those living, elderly persons who had died before the first visit were older, had twice the rate of institutionalization, poorer cognitive performance and competence, and significantly greater instrumental and basic functional disability. The percentage of elderly persons, alive at baseline, without Mini-Mental State Examination rose rather evenly with age. Moreover, they had significantly worse cognitive competence and functional ability, and reported higher prevalences of depressive symptoms and problem behaviors than those with Mini-Mental State Examination.
Prospective investigation of a large population of oldest old can contribute significantly to understanding the relations between age, cognitive decline, and dementia occurrence. Use of informant-based instruments in surveys in the oldest old is crucial in assessing everyday functioning and changes, especially in participants with no cognitive test performance available. Failure to include information on deceased elderly would underestimate, increasingly with age, the prevalence of cognitive and functional disability in the elderly population.
This article considers some of the ethical and legal issues relating to the ownership and use – including for commercial purposes – of biological material and products derived from humans. The discussion is divided into three parts: after first examining the general notion of ownership, it moves to the particular case of possible commercial use, and finally reflects on the case in point in the light of the preceding considerations. Units of cord blood donated altruistically for transplantation and which are found unsuitable for storage and transplantation, or which become unsuitable while stored in biobanks, are taken as an example. These cord-blood units can be discarded together with other biological waste, or they can be used for research or the development of blood-derived products such as platelet gel. Several ethical questions (eg, informed consent, property, distribution of profits, and others) arise from these circumstances. In this regard, some criteria and limits to use are proposed.
bioethics; biological specimen banks; cord-blood stem cell transplantation; ethics; informed consent; legislation
Sharing knowledge and experience internationally can provide valuable information, and comparative research can make an important contribution to knowledge about health care and cost-effective use of resources. Descriptions of the organisation of health care in different countries can be found, but no studies have specifically compared the legal and formal organisational systems in Sweden and China.
To describe and compare health care in Sweden and China with regard to legislation, organisation, and finance.
Literature reviews were carried out in Sweden and China to identify literature published from 1985 to 2008 using the same keywords. References in recent studies were scrutinized, national legislation and regulations and government reports were searched, and textbooks were searched manually.
The health care systems in Sweden and China show dissimilarities in legislation, organisation, and finance. In Sweden there is one national law concerning health care while in China the law includes the "Hygienic Common Law" and the "Fundamental Health Law" which is under development. There is a tendency towards market-orientated solutions in both countries. Sweden has a well-developed primary health care system while the primary health care system in China is still under development and relies predominantly on hospital-based care concentrated in cities.
Despite dissimilarities in health care systems, Sweden and China have similar basic assumptions, i.e. to combine managerial-organisational efficiency with the humanitarian-egalitarian goals of health care, and both strive to provide better care for all.
The aim of this study is to assess and evaluate the capacities for understanding, appreciation and reasoning of legal minors with psychiatric disorders and their parents and their competence to consent or assent to participation in clinical trials. The beliefs, fears, motivation and influencing factors for decision-making of legal minors and parents were also examined.
Using the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), an instrument developed for adults whose capacities to consent are unclear, we provided information about clinical trials and assessed understanding, appreciation and reasoning. We adapted this tool for legal minors and examined 19 children and adolescents between the ages of 7 and 15 with attention deficit/hyperactivity disorder (ADHD) or ADHD combined with oppositional defiant disorder (DSM-IV 314.00/314.01/312.8) enrolled in clinical trials. Parents were also examined using the MacCAT-CR.
Facts such as the procedures involved in trials or their duration were well understood by legal minors, but more abstract issues like the primary purpose of the trial were not understood by children and adolescents or by many parents. Legal minors also had difficulties understanding the nature of placebo and the probability of receiving placebo. Children's and adolescents' decisions were influenced by fears about their disorder worsening and by problems in their relationship with their parents. Parents wanted the best therapy for their children in order to minimize problems in school.
Legal minors and parents need to be informed more precisely about specific issues like placebo and the primary purpose of trials. In general, the reasoning of children and adolescents was influenced by their experience with their disorder and decision making was based on reasonable arguments. Their fears were based on everyday experiences such as school performance or family relationships.
Obtaining a patient's consent is a routine daily process for physicians, although many are unaware of the scope of this legal obligation. In 1980 the Supreme Court of Canada changed the law relating to informed consent; promotion of patient autonomy shifted the focus from a standard of professional disclosure to one of a "reasonable patient." Physicians have a legal obligation to disclose to patients specific information, the scope of which is determined by a court on the basis of a reasonable patient's expectation and the circumstances of the case. This gives rise to many controversies in the practice of clinical medicine. It is difficult for physicians to know which treatment risks require disclosure, since this is decided by a court in a retrospective analysis of the evidence. Will the court recognize exceptions to the duty of disclosing information? If several health care professionals are involved in a patient's care who has the duty to disclose information? Can this duty be delegated? This paper provides physicians with guidelines that are consistent with the promotion of patient autonomy and comply with the doctrine of informed consent. In addition, it suggests ways of improving awareness of the doctrine and procedures to ease its application.
The legal requirements and justifications for collecting patient‐identifiable data without patient consent were examined. The impetus for this arose from legal and ethical issues raised during the development of a population‐based disease register. Numerous commentaries and case studies have been discussing the impact of the Data Protection Act 1998 (DPA1998) and Caldicott principles of good practice on the uses of personal data. But uncertainty still remains about the legal requirements for processing patient‐identifiable data without patient consent for research purposes. This is largely owing to ignorance, or misunderstandings of the implications of the common law duty of confidentiality and section 60 of the Health and Social Care Act 2001. The common law duty of confidentiality states that patient‐identifiable data should not be provided to third parties, regardless of compliance with the DPA1998. It is an obligation derived from case law, and is open to interpretation. Compliance with section 60 ensures that collection of patient‐identifiable data without patient consent is lawful despite the duty of confidentiality. Fears regarding the duty of confidentiality have resulted in a common misconception that section 60 must be complied with. Although this is not the case, section 60 support does provide the most secure basis in law for collecting such data. Using our own experience in developing a disease register as a backdrop, this article will clarify the procedures, risks and potential costs of applying for section 60 support.
The ethical-legal framework of research biobanking activities is still scarcely defined in Italy, and this constitutes a major obstacle to exploit the potential benefits of existing bioresource patrimony at the national and international levels.
Biobanking and Biomolecular Resources Research Infrastructure (BBMRI), which aims to become a major interface between biological samples and data and top-level biological and medical research, is undertaking the crucial transformation to the ERIC (European Research Infrastructure Consortium) legal entity. In this scenario, there is a need to address the national legal and ethical concerns that are strictly correlated with the use of human biosources in research across European countries participating (and not) in BBMRI. In this perspective, this article aims to review the legal framework applying to research biobanking in Italy, including both “soft” nonbinding instruments and binding regulations. Since ethical and societal aspects impact biobanking research activities, the article discusses both the critical ethical and legal open issues that need to be implemented at the national level.
Ethical guidelines suggest that, when enrolling dementia patients in research, alterative decisionmakers (proxies) should base their decision on a “substituted judgment” of how the patient would have decided. If unable to make a substituted judgment, proxies are asked to decide based on the patient’s best interests. This mixed-methods study is the first to examine explicitly whether and to what degree proxies differentiate between these two approaches, and what considerations influence their mode of decisionmaking.
Interview study regarding enrollment of relative in hypothetical clinical trial of an investigational drug for Alzheimer’s disease (AD). Participants were randomized to respond to questions about one of four hypothetical clinical trials that differed by levels of described risk and potential benefit.
Proxy decisionmakers (n=40).
Open-ended and rating-scaled items.
Half of the proxies agreed with both of two rating-scaled items asking about different approaches to decisionmaking—i.e., agreeing that they would decide based on how their relative would have decided, and agreeing that they would decide based on what they believed was in their relative’s best interests. Narrative responses elaborated on themes within the following three major domains: Substituted Judgment, Best Interests, and Weighing Substituted Judgment and Best Interests. Substituted Judgment was framed as honoring the patient’s wishes and values. Best Interests was described as a perceived duty to maintain quality of life and avoid burdens or risks. Weighing the two standards emerged as a challenging, yet important, way of honoring wishes while maintaining quality of life. An unexpected theme was the attempt by alternative decisionmakers to discern their loved one’s current, vs. premorbid, research preferences.
Tensions exist between abstract ethical principles regarding decisionmaking “standards” and their translation into research decisions.