Genetic analysis of the signals within bacterial exported proteins have shown that the information required for proper localization is contained in both the amino‐terminal signal sequence and the mature protein. Several types of signal sequence mutations can be isolated, suggesting that the signal sequence may be involved in more than one step in the export process. Export information within the mature portion of the protein is present at several locations.

The focus of this paper is the ethics of information giving in the context of complex sales. It is argued that, while current theoriesprovide a broad framework for describing the responsibilities of sales agents, they lack adequate descriptions of the conditionscharacteristic of complex sales situations. Without an adequate model of complex sales, ethical theories will fail to provide guidanceto sales agents facing issues that arise from features of sales situations not accounted for in the theories. To motivate this claim,I (...) develop a brief case study in the area of information system sales. The problem can be remedied, however, if the theories take intoaccount the features of complex sales. A tentative list of such features is presented and their relevance to the case is discussed. Oneof the most important to emerge is the epistemic role of the buyer as the judge of competing information. (shrink)

A recurring objection confronting utilitarianism is that its dictates require information that lies beyond the bounds of human epistemic wherewithal. Utilitarians require reliable knowledge of the social consequences of various policies, and of people’s preferences and utilities. Agreeing partway with the sceptics, I concur that the general rules-of-thumb offered by social science do not provide sufficient justification for the utilitarian legislator to rationally recommend a particular political regime, such as liberalism. Actual data about human preference-structures and utilities is required (...) to bridge this evidentiary gap. I offer two arguments to support the availability of such information. First, I contend that ordinary human beings have a clear method of epistemic access to reliable information about commensurable preference-structures. Second, in an attempt to shift the onus of philosophic argument, I show that the utilitarian legislator’s requirements do not differ in kind from those implicitly called upon by the sceptical deontic liberal. (shrink)

Millum and Bromwich provide a thorough and thoughtful analysis of what is required for sufficient informed consent, offering distinct conceptualizations of the ethical requirements of disclo...

According to the standard view of informed consent, a prospective subject's consent to participate in a research study is invalid if the individual fails to comprehend the information about the study standardly disclosed to him. I argue that this involves three mistakes. First, the standard view confuses an ethical aspiration with a minimum ethical standard. Second, it assigns the entire responsibility for producing comprehension in study participants to the investigators. Most importantly, the standard view requires the termination of many (...) otherwise perfectly ethical research studies. This last conclusion follows from appreciating a pervasive phenomenon that is known as the "therapeutic misconception." I argue that a prospective subject's consent to participate in research can be perfectly valid even if he or she does not comprehend the information that investigators are required to disclose. Furthermore, I explain that this alternative view does not in the least compromise the vital goal of ensuring the protection of subjects in research. (shrink)

The purpose of this study is to identify the requirements of computerized Management Information Systems and their role in improving the quality of administrative decisions in the Palestinian Ministry of Education and Higher Education. The authors used the descriptive analytical method and the questionnaire method to collect the data. (247) questionnaires were distributed on the study sample and (175) questionnaires were collected back with a recovery rate of (70.8). The study showed a number of results, the most important (...) of which are: There exist a role for computerized management information system requirements in improving the quality of administrative decisions in the Ministry of Education and Higher Education. This result is due to the existence of the support and attention by the senior management in the Ministry of Education and Higher Education by 65.06%, the physical requirements available for the use of computerized Management Information Systems are available by (72.19%), and the software requirements for the use of computerized Management Information Systems are available at 67.74%. The results found that the human requirements available for the use of computerized Management Information Systems are available at (68.33%). The results showed that the organizational requirements that assist in the use of information systems are available at (64.19%). There are no statistically significant differences between respondents' responses to the role of computerized management information system requirements in improving the quality of administrative decisions in the Ministry of Education and Higher Education attributable to the variables(Gender, academic qualification, age, career level), while there are statistically significant differences in the role of computerized management information system requirements in improving the quality of administrative decisions in the Ministry of Education and Higher Education due to variable years of service. The study concluded that the Ministry of Education and Higher Education is able to cope with the external environmental changes rapidly and the limited time available for the collection and analysis of information. This means that administrative information systems should be used by increasing the approval of senior management on Management Information Systems in making their decisions, and to involve the employees in making any change and keep abreast of technical developments and try to use external bodies to advise in the field of computerized information systems, and work to increase coordination between the different departments of the ministry. (shrink)

We explored the comprehension of the informed consent in 77 cancer patients previously enrolled in randomised phase II or phase III clinical trials, between March and July 2011, at the San Raffaele Scientific Institute in Milano. We asked participants to complete an ad hoc questionnaire and analysed their answers. Sixty-two per cent of the patients understood the purpose and nature of the trial they were participating in; 44% understood the study procedures and 40% correctly listed at least one of the (...) major risks or complications related to their participation in the trial. We identified three factors associated with comprehension of the informed consent: age, education and type of tumour/investigator team. We suggest several possible improvements of how to obtain informed consent that will increase patient awareness, as well as the validity and effectiveness of the clinical trials. (shrink)

It is generally held that doctors and researchers have an obligation to obtain informed consent. Over time there has been a move in relation to this obligation from a requirement to disclose information to a requirement to ensure that that information is understood. Whilst this change has been resisted, in this article I argue that both sides on this matter are mistaken. When investigating what information is needed for consent to be informed we might be trying to (...) determine what information a person would need in order to consent at all, or we might be trying to determine what information a person needs in order to make an informed choice about whether or not to consent. I argue that the obligation to ensure understanding only applies to information generated by the first type of enquiry; but that much of the information generally thought necessary in order for consent to be informed is only required if our concern is with the second type of enquiry. For this reason it is neither the case that doctors and researchers should ensure all the information they provide is understood, nor is it the case that their only obligation is to disclose it. (shrink)

State concussion laws and sport-league policies are important tools for protecting public health, but also present implementation challenges. Both state laws and league policies often require athletes provide written acknowledgement of having received concussion-related information and/or of their responsibility to report concussion-related symptoms. This paper examines these requirements in two ways: an analysis of the variation in state laws and sport-league policies and a study of their effects in a cohort of collegiate football players.

Over-enthusiastic newborn screening has often caused substantial harm and has been imposed on the public without adequate information on benefits and risks and without parental consent. This problem will become worse when genomic screening is implemented. For the past 40 years, there has been broad agreement about the criteria for ethically responsible screening, but the criteria have been systematically ignored by policy makers and practitioners. Claims of high benefit and low risk are common, but they require precise definition and (...) documentation, which has often not occurred, undermining claims that involuntary testing is justified. Even when the benefits and risks are well established, it does not automatically follow that involuntary testing is justified, a position supported by the widespread tolerance for parental refusal of immunizations and newborn screening. (shrink)

Volume 19, Issue 5, May 2019, Page 27-28.

El trabajo ofrece los requerimientos teórico-metodológicos para el desarrollo de habilidades en la obtención de información científica. Se parte del análisis teórico de la información como proceso y resultado de la interacción del sujeto con su realidad y de asumir las habilidades para obtener información científica dentro de las habilidades informativas que pueden potencialmente trabajarse a la luz de las diferentes disciplinas académicas. Finalmente se brindan los fundamentos metodológicos para la implementación de los procedimientos propuestos desde el proceso de enseñanza-aprendizaje (...) en estudiantes universitarios, encaminados a sistematizar las operaciones de estas habilidades genéricas comunes a toda profesión. The work offers the theoretical-methodological requirements for the development of skills in the obtaining of scientific information. It begins with the theoretical analysis of the information as a process and result of the interaction of the subject with the reality and of assuming the skills to obtain scientific information as a part of the informative skills which can be potentially worked by the light of the different academic disciplines. Finally the methodological foundations are offered for the implementation of the procedures proposed from the teaching-learning process in university students, guided to systematize the operations of these generic skills that are common to any profession. (shrink)

The timely feature article by van der Pijl et al 1 highlights not only the widespread frequency with which unconsented episiotomies and other procedures during labour are reported by women but also that there is hardly any discussion in the literature on the ethics of consent for procedures in labour. Those national and international bodies with responsibility for midwifery and obstetric practice need not only to recognise but also act to remedy this unacceptable situation. The studies quoted used the recollection (...) of women in reporting consent or lack of it and, although this is an entirely appropriate measure, it gives no insight into what, if any, informed decision-making the care providers carried out. Such information would be useful to determine how better practice might be achieved. A study into the practice of episiotomies by Dutch midwives and obstetricians is referred to and is not reassuring.2 They frequently expressed surprise that consent should be necessary and women were minimally involved in the decision for performing episiotomy. This and other examples quoted of lack of valid consent have a corrosive effect on the fundamental but fragile trust and necessary trustworthiness of the relationship between the person being cared for …. (shrink)

A study found that women participating in mammography screening were content with the programme and the paternalistic invitations that directly encourage participation and include a pre-specified time of appointment. We argue that this merely reflects that the information presented to the invited women is seriously biased in favour of participation. Women are not informed about the major harms of screening, and the decision to attend has already been made for them by a public authority. This short-circuits informed decision-making and (...) the legislation on informed consent, and violates the autonomy of the women. Screening invitations must present both benefits and harms in a balanced fashion, and should offer, not encourage, participation. It should be stated clearly that the choice not to participate is as sensible as the choice to do so. To allow this to happen, the responsibility for the screening programmes must be separated from the responsibility for the information material. (shrink)

The research aims to identify the impact of the management requirements on operating of computerized management information systems to improve performance, and discuss the perceptions of respondents to develop the performance of employees in the Gaza Electricity Distribution Company, the researchers used the stratified sample method, (360) questionnaires were distributed on the study sample, (306) questionnaires were recoved with a percentage of (85%). The most important findings of the study: computerized MI have a positive impact on the development (...) of performance in the Gaza Electricity Distribution Company systems. The is statistical significance impact between “the physical, software supplies, human and organizational” requirements for the management and operation of computerized management information systems and performance development in the Gaza Electricity Distribution Company. -/- The research also concluded a series of recommendations: the need to strengthen the company's management interest in the use of computerized management information systems in all its components and elements of being an important variable which contributes to the effect on performance development. It's essential that we develop the infrastructure for information technology in general, and computerized management information systems, in particular for the development of performance. Increased interest in providing the material of equipment and devices used in the computerized management information system requirements. Interest in providing technical inputs to the computerized management information systems through keeping pace with technological means and modern techniques and work on the training of personnel to use those systems. And increased attention to human inputs of computerized management information systems "specialists technicians and end-users" through a variety of disciplines working in the field of computerized management information systems. (shrink)

In the half-century history of clinical practice of diagnosing brain death, informed consent has seldom been considered until very recently. Like many other medical diagnoses and ordinary death pronouncements, it has been taken for granted for decades that brain death is diagnosed and death is declared without consideration of the patient’s advance directives or family’s wishes. This essay examines the pros and cons of using informed consent before the diagnosis of brain death from an ethical point of view. As shared (...) decision-making in clinical practice became increasingly indispensable, respect for the patients’ autonomous wishes regarding how to end their lives has a significant role in deciding how death is diagnosed. Brain death, as a fully technologically controlled death, may require a different ethical framework from the old one for traditional cardiac death. With emerging and proliferating options in end-of-life care for those who suffer from catastrophic brain injury, the traditional reasoning that ‘death gives no choice, hence no consent’ requires another examination. Patients facing imminent brain death now have options other than undergoing the diagnostic workup for brain death, such as donation after circulatory death and withdrawal of life-sustaining treatment with maximum comfort measures for death with dignity. Nevertheless, just as in the debate over opt-in versus opt-out organ donation policies, informed consent before the diagnosis of brain death faces fierce opposition from consequentialists urging the expansion of the donor pool. This essay examines these objections and provides constructive replies along with a proposal to accommodate this morally required consent. (shrink)

Volume 20, Issue 6, June 2020, Page 25-27.

In their important and insightful article, Joseph Millum and Danielle Bromwich distinguish two informational requirements for valid consent—the disclosure requirement and the understanding requirem...

Informed consent to medical intervention is fundamental in both ethics and law. But in practice it is often not taken seriously in developing countries. This paper provides an appraisal of informed consent practices in Bangladesh. Following a review of the ethical and legal principles of informed consent, it assesses the degree to which doctors adhere to it in Bangladesh. Based on findings of non-compliance, it then investigates the reasons for such non-compliance through an appraisal of informed consent practices in Bangladesh (...) and provides recommendations aimed at improving such practices. The significance of this paper lies in unveiling the interdependence between the ethical and legal traits of informed consent and their ramifications on strengthening the patient-oriented approach of duty to care. (shrink)

Abstract: According to the Veridicality Thesis, information requires truth. On this view, smoke carries information about there being a fire only if there is a fire, the proposition that the earth has two moons carries information about the earth having two moons only if the earth has two moons, and so on. We reject this Veridicality Thesis. We argue that the main notions of information used in cognitive science and computer science allow A to have (...) class='Hi'>information about the obtaining of p even when p is false. (shrink)

In his recent article ‘Nudging, Informed Consent and Bullshit’, William Simkulet1 convincingly argues that certain types of nudging satisfy Frankfurt’s criteria of bullshit. As a prelude to this argument, Simkulet considers whether recommendations and framing are types of nudging and whether they satisfy the requirement of adequate disclosure essential for a valid informed consent. He defines nudging as the systematic attempt at altering behaviour by non-rational means, and describes adequate disclosure as providing the patient with true information that enables (...) an understanding of treatment options and their risks and benefits. Simkulet argues that recommendations and framing are types of rational persuasion in that they potentially enhance patients’ understanding of treatment options and their risks and benefits. Therefore, not only do they not qualify as nudging, but they may be required in order to secure adequate disclosure. In this brief comment, I focus on Simkulet’s considerations of framing and show that framing may be nudging and that it may violate the requirements of informed consent. The framing of medical information may influence patients’ preferences for treatment. It has been shown that framing information about a risky medical intervention in chance of survival rather than risk of death increases patients’ preferences for the intervention.2 3 In his exploration of framing, Simkulet contends that the fact that people respond differently to …. (shrink)

In his recent article ‘Nudging, Informed Consent and Bullshit’, William Simkulet 1 convincingly argues that certain types of nudging satisfy Frankfurt’s criteria of bullshit. As a prelude to this argument, Simkulet considers whether recommendations and framing are types of nudging and whether they satisfy the requirement of adequate disclosure essential for a valid informed consent. He defines nudging as the systematic attempt at altering behaviour by non-rational means, and describes adequate disclosure as providing the patient with true information that (...) enables an understanding of treatment options and their risks and benefits. Simkulet argues that recommendations and framing are types of rational persuasion in that they potentially enhance patients’ understanding of treatment options and their risks and benefits. Therefore, not only do they not qualify as nudging, but they may be required in order to secure adequate disclosure. In this brief comment, I focus on Simkulet’s considerations... (shrink)

Background Informed consent is often cited as the “cornerstone” of research ethics. Its intent is that participants enter research voluntarily, with an understanding of what their participation entails. Despite agreement on the necessity to obtain informed consent in research, opinions vary on the threshold of disclosure necessary and the best method to obtain consent. We aimed to investigate Australian researchers’ views on, and their experiences with, obtaining informed consent. Methods Semi-structured interviews were conducted with 23 researchers from NSW institutions, working (...) in various fields of research. Interviews were analysed and coded to identify themes. Results Researchers reported that consent involved information disclosure, understanding and a voluntary decision. They emphasised the variability of consent interactions, which were dependent on potential participants’ abilities and interests, study complexity and context. All researchers reported providing written information to potential participants, yet questioned the readability and utility of this information. The majority reported using signed consent forms to ‘operationalise’ consent and reported little awareness of, and lack of support in implementing more dynamic informed consent procedures, such as verbal informed consent, that was fit for the purposes of their studies. Views on Human Research Ethics Committees varied. Some reported inconsistent, arduous inputs on the information form and consent process. Others expressed reliance on HRECs for guidance, viewing them as institutional safeguards. Conclusions This study highlights the importance of transparent relationships, both between researchers and participants, and between researchers and HRECs. Where the relationship with study participants was reported as more robust, researchers felt that they were better able to ensure participants made better, more informed decisions. Where the relationship with HRECs was reported as more robust, researchers were more likely to view them as institutional safeguards, rather than as bureaucratic hindrances. Conscientious and mindful researchers are paramount to ensuring the procedure accommodates individual requirements. This study advocates that when designing ethical informed consent practices, researchers should be integrated as autonomous players with a positive input on the process, rather than, in the worst case, predatory recruiters to be curtailed by information forms and oversight. (shrink)

Background Based on the principle of informed consent, doctors are required to fully inform patients and respect their medical decisions. In China, however, family members usually play a special role in the patient’s informed consent, which creates a unique “doctor-family-patient” model of the physician-patient relationship. Our study targets young doctors to investigate the ethical dilemmas they may encounter in such a model, as well as their attitudes to the family roles in informed consent. Methods A questionnaire was developed including general (...) demographic characteristics, the fulfillment of the obligation to fully inform, who will be informed, and the ethical dilemmas in decision-making. We recruited a total of 421 doctors to complete this questionnaire, of which 368 met the age requirements for this study. Cross tabulation and Pearson’s chi-squared test were used to analyze the differences between types of patients for categorical variables, and a p-value < 0.05 was considered statistically significant. Results Our data shows that only 20 doctors (5.40%) stated “informing the patient alone is sufficient” when it comes to informing patients of their serious conditions. The rest of the participants would ensure that the family was informed. When facing elderly patients with decision-making capacity, the data was statistically different (3.8%; P < 0.001) The primary reason for ensuring that family members be informed differs among the participants. In addition, when family members asked doctors to conceal the patient’s medical condition for the best interests of patients, 270 doctors (73.4%) would agree and cooperate with the family. A similar proportion (79.6%) would do so when it comes to elderly patients. Conclusions (1) Chinese doctors pay extra attention to informing the patient’s family, which may not be in the patient’s best interests. (2) Chinese doctors treat adult (but not elderly) patients and elderly patients differently when it comes to informing family members. (3) When family members request that doctors withhold information from patients “in the best interest of the patient,” the majority choose to comply with the request, although this may cause them distress. (shrink)

The global age has confronted human beings with new and numerous challenges, from global poverty, to labour exploitation, to climate change. Many individuals, aware of such challenges, wish to act in solidarity, and give their contribution to countering them. Acting in solidarity in such contexts can be challenging, however, as which actions are most effective for reaching the desired goal is not obvious. Furthermore, an action that is intended in solidarity at times not only fails to promote the desired objective (...) but proves detrimental to it. In this article, I wish to propose a reflection on a prior duty of solidarity action: the epistemic duty to acquire information about the correct way to promote a cause. By analyzing the anti-sweatshop movement and climate action, I will show how acting in solidarity has significant epistemic requirements that should be considered as part of the solidarity action itself. (shrink)

In the spirit of full disclosure, I have been a member of the Delphi panels discussed in this article (Beskow and Weinfurt 2019) since their inception and was one of the people who was recently int...

Objectives: To examine the willingness of patients to participate in a resuscitation study that requires exception from informed consent and to determine if willingness to participate is associated with demographic and other characteristics.Methods: Adult patients in an emergency department and in a geriatric outpatient clinic were surveyed. Patients were asked to imagine that they presented to an emergency department with cardiac arrest and asked about their willingness to receive a new drug outside of a study, receive a new drug as (...) part of a study and participate in a randomised controlled trial for a new drug. Patients were also asked about participation in studies of invasive procedures.Results: 213 patients from a geriatric clinic and 207 from an emergency department were surveyed. Two thirds of patients from the geriatric clinic and 83% from the emergency department were willing to receive an experimental drug outside of a study. Patients were less willing to participate in a study of the new drug and even less likely to participate in an RCT for the new drug . Patients were less likely to participate in a study of thoracotomy than in a study that required placement of a femoral catheter . Willingness to participate was not associated with trust in the doctors.Conclusions: Study design and invasiveness of the intervention were associated with the willingness of patients to participate in resuscitation studies that require exception from informed consent. (shrink)

Obtaining ‘informed consent’ from every individual participant involved in health research is a mandatory ethical practice. Informed consent is a process whereby potential participants are genuinely informed about their role, risk and rights before they are enrolled in the study. Thus, ethics committees in most countries require ‘informed consent form’ as part of an ethics application which is reviewed before granting research ethics approval. Despite a significant increase in health research activity in low-and middle-income countries in recent years, only limited (...) work has been done to address ethical concerns. Most ethics committees in LMICs lack the authority and/or the capacity to monitor research in the field. This is important since not all research, particularly in LMICs region, complies with ethical principles, sometimes this is inadvertently or due to a lack of awareness of their importance in assuring proper research governance. With several examples from Nepal, this paper reflects on the steps required to obtain informed consents and highlights some of the major challenges and barriers to seeking informed consent from research participants. At the end of this paper, we also offer some recommendations around how can we can promote and implement optimal informed consent taking process. We believe that paper is useful for researchers and members of ethical review boards in highlighting key issues around informed consent. (shrink)

The Office for Human Research Protections was correct in determining that the consent forms for the National Institutes of Health -sponsored SUPPORT study were seriously flawed. Several articles defended the consent forms and criticized the OHRP's actions. Disagreement focuses on three central issues: how risks and benefits should be described in informed consent documents; the meaning and application of the concept of “standard of care” in the context of research; and the proper role of OHRP. Examination of the consent forms (...) reveals that they failed to disclose the reasonably foreseeable risks of the experimental interventions in the study, as well as the potential for differences in the degree of risk between these interventions. Although the concept of “standard of care” may be helpful in determining the ethical acceptability of other aspects of research, such as clinical equipoise, it is not helpful in discussing consent requirements. (shrink)

Over the last few decades, multiple studies have examined the understanding of participants in clinical research. They show variable and often poor understanding of key elements of disclosure, such as expected risks and the experimental nature of treatments. Did the participants in these studies give valid consent? According to the standard view of informed consent they did not. The standard view holds that the recipient of consent has a duty to disclose certain information to the profferer of consent because (...) valid consent requires that information to be understood. The contents of the understanding and disclosure requirements are therefore conceptually linked. In this paper, we argue that the standard view is mistaken. The disclosure and understanding requirements have distinct grounds tied to two different ways in which a token of consent can be rendered invalid. Analysis of these grounds allows us to derive the contents of the two requirements. It also implies that it is sometimes permissible to enroll willing participants who have not understood everything that they ought to be told about their clinical trials. (shrink)

Informed consent is the single most important concept for understanding decision-making capacity. There is a steady pull in the clinical world to transform capacity into a technical concept that can be tested objectively, usually by calling for a psychiatric consult. This is a classic example of medicalization. In this article I argue that is a mistake, not just unnecessary but wrong, and explain how to normalize capacity assessment.Returning the locus of capacity assessment to the attending, the primary care doctor, and (...) even to ethics consultation in today's environment will require a substantial effort to undo a strong but illusory impression of capacity assessment. Hospital attorneys as well as clinical ethicists with a sophisticated understanding of health law can be in the vanguard of this reorientation. (shrink)

Many countries are experimenting with planned (or quasi-) markets to discover if they can efficiently deliver health care in keeping with societal objectives. This paper examines the information requirements of this approach. Information is necessary in order to compare the performance of providers, to support billing, and to monitor access to care. It should be accurate, unambiguous, and resistant to manipulation. We draw on a project to find out how information on hospitalisation could be used in (...) contracting in the British National Health Service. We conclude that the existing British system fails to provide robust measures of how many patients are treated, for what conditions, and with what treatments. We identify some promising remedies, others that are more difficult, and some which may be impossible to implement in any planned market, given the uncertainty of clinical practice. (shrink)

Can heroin addicts give consent to research on trials in which heroin is prescribed to them? Analyses of addicts and informed consent have been objects of debate in several articles. Informed consent requires the agent not only to be competent but also to give consent voluntarily. This has been questioned because of alleged features of heroin addiction. Until recently the discussion has focused on heroin addicts' desires for heroin, whether these are irresistible and thus pose a problem for giving consent. (...) Still, in light of empirical evidence, there seems to be a consensus more or less that the problem is not whether the addicts can resist their desire for heroin. A recent article concentrates specifically on heroin addicts' false assumptions of options and voluntariness. We argue that the prevailing framing of the options in this discussion in terms of heroin and access to it is problematic. The way in which the options are typically laid out suggests an assumption that participation in the research is allegedly based on the addicts' views on using the drug. We argue that this way of presenting the options is, first, a mismatch to the studies carried out and, second, symptomatic of potential misconceptions about heroin addiction and addicts. Furthermore, we also suggest that the account of voluntariness needs to be realistic in order for subjects to be able to give consent voluntarily in actual situations, and for medical research to carry out studies on improving outcomes in addiction treatment in an ethical way. (shrink)

People in extraordinary situations are vulnerable. As research participants, they are additionally threatened by abuse or exploitation and the possibility of harm through research. To protect people against these threats, informed consent as an instrument of self-determination has been introduced. Self-determination requires autonomous persons, who voluntarily make decisions based on their values and morals. However, in nursing research, this requirement cannot always be met. Advanced age, chronic illness, co-morbidity and frailty are reasons for dependencies. These in turn lead to limited (...) abilities or opportunities for decision-making and self-determination. Exclusion of vulnerable people from research projects would disadvantage them by not covering their needs, which would violate the ethical principles of justice and beneficence. Commonly, vulnerability is attributed to social groups. The consequence for individuals, attributed as belonging to such a vulnerable group, is that the principles of respect for autonomy, justice and beneficence are subordinated to the principle of non-maleficence, understood as avoiding the risk to cause more harm than good. In addition, group-specific attribution could lead to stigmatizing because labelling a person as deviation from a norm violates integrity. For clinical nursing research, the question arises how the protection of vulnerable people could be granted without compromising ethical principles. The concept of relational ethics provides a possible approach. It defines vulnerability as the relation between a person’s health status and the extent to which this person is dependent on the researcher and the research context. Vulnerability is not attributed solely to a person but to a situation, meaning the person is viewed in context. By combining vulnerability as a context-related and situational concept with existing approaches of informed consent, the different ethical principles can be balanced and preserved at every step of the research process. (shrink)

Probabilistic theories are a natural framework to investigate the foundations of quantum theory and possible alternative or deeper theories. In a generic probabilistic theory, states of a physical system are represented as vectors of outcomes probabilities and state spaces are convex cones. In this picture the physics of a given theory is related to the geometric shape of the cone of states. In quantum theory, for instance, the shape of the cone of states corresponds to a projective space over complex (...) numbers. In this paper we investigate geometric constraints on the state space of a generic theory imposed by the following information theoretic requirements: every non completely mixed state of a system is perfectly distinguishable from some other state in a single shot measurement; information capacity of physical systems is conserved under making mixtures of states. These assumptions guarantee that a generic physical system satisfies a natural principle asserting that the more a state of the system is mixed the less information can be stored in the system using that state as logical value. We show that all theories satisfying the above assumptions are such that the shape of their cones of states is that of a projective space over a generic field of numbers. Remarkably, these theories constitute generalizations of quantum theory where superposition principle holds with coefficients pertaining to a generic field of numbers in place of complex numbers. If the field of numbers is trivial and contains only one element we obtain classical theory. This result tells that superposition principle is quite common among probabilistic theories while its absence gives evidence of either classical theory or an implausible theory. (shrink)

Informed consent in clinical research is widely regarded as broken, but essential nonetheless. The most recent attempt to reform it comes as part of the first revisions to the Common Rule since it became truly “common” in 1991. This change, the addition of a “key information” requirement for most consent forms, is intended to support and promote a reasoned decision-making process by potential subjects. The key information requirement is both promising and problematic. It is promising because it encourages (...) clarity and honesty about research participation, creativity in information disclosure, and mutual learning through the investigator-subject relationship. It is problematic because those goals — which have remained aspirational since the beginning — may be difficult to achieve in what has become an excessively compliance-oriented regulatory regime. (shrink)

There is a good deal of biomedical research that does not produce scientifically useful data because it fails to recruit a sufficient number of subjects. This fact is typically not disclosed to prospective subjects. In general, the guidance about consent concerns the information required to make intelligent self-interested decisions and ignores some of the information required for intelligent altruistic decisions. Bioethics has worried about the ‘therapeutic misconception’, but has ignored the ‘completion misconception’. This article argues that, other things (...) being equal, prospective subjects should be informed about the possibility of non-completion as part of the standard consent process if it is or should be anticipatable that there is a non-trivial possibility of non-completion and that information is likely to be relevant to a prospective subject's decision to consent. The article then considers several objections to the argument, including the objection that disclosing non-completion information would make recruitment even more difficult. (shrink)

BackgroundIn clinical research, obtaining informed consent from participants is an ethical and legal requirement. Conveying the information concerning the study can be done using multiple methods yet this step commonly relies exclusively on the informed consent form alone. While this is legal, it does not ensure the participant’s true comprehension. New effective methods of conveying consent information should be tested. In this study we compared the effect of different methods on the knowledge of caregivers of participants of a (...) clinical trial on Pemba Island, Tanzania.MethodsA total of 254 caregivers were assigned to receive a pamphlet, an oral information session or a pamphlet and an oral information session about the clinical trial procedures, their rights, benefits and potential risks. Their post-intervention knowledge was assessed using a questionnaire. One group of caregivers had not received any information when they were interviewed.ResultsIn contrast to the pamphlet, attending an information session significantly increased caregivers’ knowledge for some of the questions. Most of these questions were either related to the parasite or to the trial design.ConclusionsIn conclusion, within our trial on Pemba Island, a pamphlet was found to not be a good form of conveying clinical trial information while an oral information session improved knowledge. Not all caregivers attending an information session responded correctly to all questions; therefore, better forms of communicating information need to be found to achieve a truly informed consent. (shrink)