Discharge planning for vulnerable infants and children is a collaborative, inter-disciplinary, decision-making activity that is grounded in the ethical complexities of clinical practice. Although it is a psychosocial intervention that frequently causes moral distress for professionals and has the potential to inflict harm on children and their families, the process has received little attention from ethicists. An ongoing study of the transition of technology-dependent children from hospital to home suggests that the ethical issues embedded in the discharge- (...) class='Hi'>planning process may be concealed by dominant cultural values, institutional policies, clinical standards, historical precedents, and legal regulations. (shrink)

Not all hospital inpatients need the level of care uniquely available in the acute-care setting. In the United States, these longer-term, nonacute inpatients tend to be some combination of chronically ill, poor, homeless, undocumented, uninsured, and disabled—all groups who have struggled for health equity, political recognition, and voice. Even so, these “permanent patients” continue to receive care in one of the most expensive settings. This phenomenon is the result of federal legislation that creates an affirmative duty to care for all (...) able to access our emergency departments without also making safe housing available to all. A handful of federal laws and policies as well as a potpourri of state laws and policies are involved. (shrink)

In any healthcare system in which demand exceeds supply—which means any typical public healthcare system—patients cannot always get the care they want or need when they want or need it. It is also unrealistic to suppose that it will ever be otherwise. There have been such advances in medicine and growth in the population that even if we forgot about all other goods such as education, roads, social services, and so forth and put the entire budget into healthcare, there would (...) still be a gap between supply and demand. Moreover, even if we could by that expedient make them match and had eyes only for health, we still should not. For it is now understood that healthcare is the least important determinant of health, lining up well behind poverty and social status. But if suboptimal care is to be our destiny, we must plan how it is to be delivered. (shrink)

For Lack of a Better Plan: A Framework for Ethical, Legal, and Clinical Challenges in Complex Inpatient Discharge Planning Content Type Journal Article Pages 311-326 DOI 10.1007/s10730-009-9117-6 Authors Jane Jankowski, Albany Medical Center Albany NY 12208 USA Terese Seastrum, Northeast Health 2212 Burdett Ave. Troy NY 12180 USA Robert N. Swidler, Northeast Health 2212 Burdett Ave. Troy NY 12180 USA Wayne Shelton, Alden March Bioethics Institute, Albany Medical College 47 New Scotland Avenue, MC 153 Albany NY 12208-3478 USA (...) Journal HEC Forum Online ISSN 1572-8498 Print ISSN 0956-2737 Journal Volume Volume 21 Journal Issue Volume 21, Number 4. (shrink)

This is a complex case of a younger man with unclear social supports and a disabling diabetic infection that is limiting his ability to be and possibly feel productive. The patient appears to be ha...

Collaboration among nurses and other healthcare professionals is needed for effective hospital discharge planning. However, interprofessional interactions and practices related to discharge vary within and across hospitals. These interactions are influenced by the ways in which healthcare professionals’ roles are being shaped by hospital discharge priorities. This study explored the experience of bedside nurses’ interprofessional collaboration in relation to discharge in a general medicine unit. An ethnographic approach was employed to obtain an in‐depth insight into (...) the perceptions and practices of nurses and other healthcare professionals regarding collaborative practices around discharge. Sixty‐five hours of observations was undertaken, and 23 interviews were conducted with nurses and other healthcare professionals. According to our results, bedside nurses had limited engagement in interprofessional collaboration and discharge planning. This was apparent by bedside nurses’ absence from morning rounds, one‐way flow of information from rounds to the bedside nurses following rounds, and limited opportunities for interaction with other healthcare professionals and decision‐making during the day. The disconnection, disempowerment and devaluing of bedside nurses in patient discharge planning has implications for quality of care and nursing work. Study findings are positioned within previous work on nurse–physician interactions and the current context of nursing care. (shrink)

Discharging a homeless patient from hospital raises ethical issues which are compounded when the patient is from outside the United Kingdom. This article begins with an extended case study of a 30-year-old homeless man from Lithuania describing his complex medical and social needs. It is best practice for all homeless patients to have their housing needs planned for prior to discharge, but this is made more difficult by the United Kingdom’s ‘hostile environment’ policy which creates a subclass of homeless (...) people who are not eligible for support. This means healthcare professionals discharge patients back to homelessness, even when this is likely to adversely affect their health and dignity both directly and indirectly through impairing access to care for chronic conditions. Policies in health and social care which compel professionals to treat some patients with second-class care undermine the ethics of healthcare professions. (shrink)

Using conversation analysis, this study investigates how Japanese rehabilitation team members use their geographic knowledge to search for long-term care facilities for stroke survivors in multidisciplinary team interactions. The study uncovers the orderly use of decision rules during discharge planning activities by exploring the following two questions: What decision criteria are discursively used? In what order are the criteria handled through sequential operations? The data comprise 65 video-recorded rehabilitation team meetings and ethnographic information regarding local care facilities and (...) patients’ residential addresses. The analysis shows that the participants deal with decision criteria in an orderly manner. They identify the type of facility and location preferred by the patient’s family and search for a facility accordingly. Moreover, they routinely select facilities closer to the patients’ and their families’ homes. However, these rules are modified if the family’s choice is inappropriate, or when a facility in a different location is preferred by the family. The study contributes to the conversation analytic understanding of interprofessional decision making and prioritization through the analysis of orderly methods of search procedures interactively accomplished by participants in ongoing medical team interactions. (shrink)

How do we respond to the patient who no longer needs inpatient care but refuses to leave the hospital? Complex hospital discharges commonly involve consideration of legal, financial, clinical, and practical issues. Yet, the ethical and contextual issues embedded in complex inpatient discharges are of concern and have not received adequate attention by medical ethicists. The aim of this work is to encourage clinicians and administrators to incorporate a justice rubric when approaching inpatient discharge dilemmas. This paper presents justice (...) as the ethical principle most neglected in situations involving complex discharges and suggests that a justice focused lens allows clinicians and administrators to move beyond notions of patient autonomy in crafting morally responsible hospital discharge decisions that reflect efficient stewardship of an appropriate share of medically indicated services. This issue deserves additional attention from medical ethicists in the future. (shrink)

Every day around the country, patients are discharged from hospitals without difficulty, as the interests of the hospital and the patient tend to align: both the hospital and the patient want the patient to leave and go to a setting that will promote the patient’s continued recovery. In some cases, however, this usually routine process does not go quite as smoothly. Patients may not want to leave the hospital, or they may insist on an unsafe discharge plan. In other (...) cases, there may simply be no good place for the patient to go. These complex hospital discharge situations often involve ethical, legal, financial, and practical considerations, but the ethical issues inherent in these dilemmas have received only sporadic attention from clinical ethicists at best, leaving patients, providers, administrators, and caregivers unsure about what to do. When the ethical issues are in fact brought to light, analysis usually proceeds based on a consideration of the principles of autonomy, beneficence, nonmaleficence, and justice. However, principled analysis often fails to present patients and providers with a satisfactory solution, as the principles inevitably conflict. In this paper, I argue that difficult discharges are ethical dilemmas worthy of scholarly attention that goes beyond principlism, and I argue that providers and those involved in discharge planning ought to cultivate what philosopher Alasdair MacIntyre calls “virtues of acknowledged dependence” in order to care for these patients and their families. I first trace the current conversation about difficult discharge and show that the principled approach to resolving discharge dilemmas is not sufficient. I then argue that a new approach is needed, and to that end, I offer practical ways in which MacIntyre’s account of the virtues of acknowledged dependence may help patients, providers, and family members to navigate issues of difficult discharge. (shrink)

As a tool for regulating the environment in China, does environmental information disclosure reduce pollutant discharge? To answer this question, we empirically analyzed the emission data of “the three wastes” in unit industrial GDP in 31 provincial units. As a measure to reduce institutional emission, environmental information disclosure only slightly influenced waste discharge reduction in the implementation period of the Eleventh Five-Year Plan of China. Instead, command control and market-based tools significantly affected waste discharge reduction. Representative measures (...) included penalties and charges. With the continuously enhanced pressure of control, environmental information disclosure facilitates the effects of command control tools on waste discharge reduction. Content analysis of environmental information disclosed by sample listed companies in Jiangsu Province was conducted. The disclosure of insufficient environmental information on emission reduction can be attributed to “adverse selection” in system performance and to the limited quality of overall environmental information disclosure. This study provides empirical evidence for Chinese policy makers to improve the system for environmental information disclosure of listed companies. (shrink)

Objectives: To explore mental health service users’ views of existing and proposed compulsory powers.Design: A qualitative study employing in-depth interviews. Participants were asked to respond to hypothetical questions regarding the application of compulsory powers under the Mental Health Act 1983 for people other than themselves.Setting: Community setting in Southeast England.Participants: Mental health service users subject to Supervised Discharge/Guardianship.Results: Participants considered that the use of compulsory powers was justified if there were some ultimate benefit, and if there was evidence of (...) mental health problems, dangerousness, or a lack of insight. However, participants rejected intrusions into their autonomy and privacy.Conclusions: This paper’s participants indicated that the proposed CTO may be unacceptable because it would threaten service users’ autonomy. Service users’ acceptance of proposed changes is conditional and they emphasised the importance of consent; there is no suggestion that consent will be required for the CTO. The findings also have implications for the exploration of mental health service users’ views and how they might contribute to policy, service planning, and research. (shrink)

Some of the most difficult consultations for an ethics consultant to resolve are those in which the patient is ready to leave the acute-care setting, but the patient or family refuses the plan, or the plan is impeded by deficiencies in the healthcare system. Either way, the patient is “stuck” in the hospital and the ethics consultant is called to help get the patient “unstuck.” These encounters, which we call “complex discharges,” are beset with tensions between the interests of the (...) institution and the interests of the patient as well as tensions within the ethics consultant whose commitments are shaped both by the values of the organization and the values of their own profession. The clinical ethics literature on this topic is limited and provides little guidance. What is needed is guidance for consultants operating at the bedside and for those participating at a higher organizational level. To fill this gap, we offer guidance for facilitating a fair process designed to resolve the conflict without resorting to coercive legal measures. We reflect on three cases to argue that the approach of the consultant is generally one of mediation in these types of disputes. For patients who lack decision making capacity and lack a surrogate decision maker, we recommend the creation of a complex discharge committee within the organization so that ethics consultants can properly discharge their duties to assist patients who are unable to advocate for themselves through a fair and transparent process. (shrink)

Although advance care planning can lead to more patient-centered care, the communication around it can be challenging in acute care hospitals, where saving a life or shortening hospitalization is important priorities. Our qualitative study in an acute care hospital in Japan revealed when specifically physicians and nurses start communication to facilitate ACP. Seven physicians and 19 nurses responded to an interview request, explaining when ACP communication was initiated with 32 patients aged 65 or older. Our qualitative approach employed descriptive (...) analysis to identify major themes, which included “initiation by patients” and “initiation by healthcare professionals.” In the latter case, seven specific triggers were identified: when the patients’ medical condition changed in terms of symptom relief, when the patients’ medical condition changed in terms of prognostic prediction, when serious events occurred, when a choice of treatment was presented, when the location for end-of-life care was chosen, when the patients’ cognitive function deteriorated, and when serious events settled down. Within this group of healthcare professionals, physicians were more focused on changes in their patients’ medical condition, whereas nurses focused more on their patients’ desire for a long-term perspective. Nurses encouraged patients to consider ACP themselves, which developed into an approach to respect patients’ autonomy. In acute care hospitals, it appeared to be desirable to have an early discussion where patients could understand the significance ACP, which would matter even after their discharge from the hospital. (shrink)

Se analiza el debate actual sobre el concepto de Escuela de Salamanca. Se muestran las nuevas propuestas de los estudiosos: su carácter global (no solo Salamanca); su alcance interdisciplinar (no solo teológico, también jurídico, económico, sociopolítico, etc); la cuestión de los miembros también experimenta una ampliación, aunque siempre se señala un cierto cordón umbilical con los Maestros salmantinos; todo ello dentro de un marco temporal que se extiende durante el siglo XVI y primera mitad del XVII. Estas nuevas perspectivas no (...) excluyen los elementos tradicionales, sino que amplían y desarrollan el concepto primitivo, pero con carácter inclusivo. Por último, se aborda el tema de las condiciones de posibilidad de la Escuela, que se contextualiza en un ámbito histórico que la hace posible. Al término del estudio se ofrece un posible nuevo concepto de la Escuela, todavía _in fieri_. (shrink)

La psiquiatría nace con el siglo XIX, la fenomenología con el XX. Desde el advenimiento de la segunda ha querido la primera ver en ella una vía para la superación del positivismo que la atenazaba desde su mismo origen. Uno de sus intentos más logrados fue el del psiquiatra Ludwig Binswanger a lo largo de los años veinte del pasado siglo. Recorrió en ese tiempo las Investigaciones lógicas de Husserl y ensayó su acercamiento a la psicología estructural. Proponemos que una (...) deficiente lectura de las posibilidades de la fenomenología ―comprensible en su prematuridad, desgraciada en su ímpetu anti-(neo)kantiano― impidió que reconociera su horizonte trascendental y así pudiera entrever caminos de acceso al mundo, a la persona y a su concreto sufrimiento. Para concluir presentamos el intento que supone el proyecto La mirada filosófica como mirada médica por recuperar aquella problematicidad y ahondar en una aproximación respetuosa al padecer, tal como aparece, sin violentarlo por el concepto. (shrink)

Why mediation? -- What makes bioethics mediation unique? -- Before you begin a bioethics mediation program -- The stages of bioethics mediation -- Techniques for mediating bioethics disputes -- How to write a bioethics mediation chart note -- Mediation with a competent patient : Mr. Samuels's case -- Mediation with a dysfunctional family : Mrs. Bates's case -- A complex mediation with a large and involved family : Mrs. Leonari's case -- Discharge planning for a dying patient : (...) a role-play -- An at-risk pregnancy : a role-play -- HIV and postsurgical complications in the ICU : a role-play -- Treating the dying adolescent : a role-play -- She didn't mean it : a role-play -- Don't tell mama : a role-play -- An at-risk pregnancy : a role-play transcript -- HIV and postsurgical complications in the ICU : a role-play transcript -- She didn't mean it: a role-play transcript -- Don't tell mama : a role-play transcript. (shrink)

Multiple studies have been performed to identify the most common ethical dilemmas encountered by ethics consultation services. However, limited data exists comparing the content of ethics consultations requested by specific hospital specialties. It remains unclear whether the scope of ethical dilemmas prompting an ethics consultation differ between specialties and if there are types of ethics consultations that are more or less frequently called based on the specialty initiating the ethics consult. This study retrospectively assessed the incidence and content of ethics (...) consultations called by surgical vs. non-surgical specialties between January 1, 2013 to December 31, 2018 using our RedCap Database and information collected through the EMR via our Clinical and Translational Science Center. 548 total ethics consultations were analyzed. Our results demonstrate that more surgical consults originated from the ICU, as opposed to lower acuity units, and surgical patients were more likely to have a DNR in place. Surgical specialties were more likely to call about issues relating to withholding/withdrawing life-sustaining treatment, while non-surgical specialties were more likely to call about issues related to discharge planning. There appear to be morally relevant differences between consults classified as the “same” that are not entirely captured by the usual ethics consultations classification system. In conclusion, this study highlights the unique ethical issues experienced by surgical vs. non-surgical specialties. Ultimately, our data can help ethics consultation services determine how best to educate various hospital specialties to approach ethical issues commonly experienced within their field. (shrink)

The debate about health insurance coverage and the related issue of unequal access to health care turn on fundamental questions of justice, but for an individual patient like DM, the abstract question about who is deserving of health insurance becomes a very concrete problem that has a profound impact on care and livelihood. DM's circumstances left him stuck in the hospital. A satisfactory discharge plan remained elusive; his insurance coverage severely limited the number and type of facilities that would (...) accept him; and his inadequate engagement in his own rehabilitation process limited discharge options even further. Despite extensive involvement with the psychiatry, social work, physical therapy, and occupational therapy teams, DM consistently made “bad” decisions. He repeatedly refused antibiotics and did not consistently work with rehab services to improve his strength and mobility. Although the clinicians wanted to provide him with the best care possible, he often seemed unwilling to do the things necessary to achieve this care—or perhaps his depression rendered him unable to do so. He also tended to take out his frustration on staff members caring for him. All of this was, in turn, very frustrating for the staff. It may be easy, however, to make too much of DM's role, to see his choices as more important than his circumstances. A major goal of the ethics consultants was to reframe DM's predicament for the staff members involved in his care. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Working with Patience:An Insight into Dealing with Difficult EmotionsDavid VilanovaAs the most trusted professionals in the nation, nurses are expected to care for their patients with empathy and freedom from bias. The reality is that nurses are human, and some form of implicit bias is inevitable. In my own experience, this issue has reared its head on several occasions. My nursing background is prominently in cardiac and intensive care. (...) Seeing patients at their most vulnerable has become a regular part of my practice. Among some of the most challenging cases for me have been when I assume care of a patient withdrawing from alcohol. As an adult child with close alcoholic family members, many instances of abuse and pain stick with me today and these are brought to the surface when I care for patients with alcohol use disorder. In most cases, I easily find a healthy balance between remaining an understanding-and-empathetic provider and protecting my emotional and mental health as I navigate ethical and moral issues. However, with this patient population, walking that fine line is especially challenging. How do I navigate and manage intensely personal emotions and biases while providing the high-quality care I vowed to deliver regardless of my patient's life choices, addictions, and illnesses? How do I maintain an appropriate level of neutrality and clarity as this patient's behavior and attitude spark emotional triggers? In other words, how do I take care of someone I don't like?Mrs. H was a middle-aged Hispanic woman, barely coherent, but speaking clearly enough that I could understand her slurred speech. Immediate dread washed over me as I realized my assignment included a patient withdrawing from alcohol. The patient's affect, incoherence, and aggression were all too reminiscent of a traumatic past I still work to heal from. My coworkers couldn't understand her insults and obscenities and were therefore unphased except for noting her unruly and erratic behavior. On the other hand, I could understand much of what she was yelling at me and any other staff who bravely walked into her room. My immediate thoughts were that this woman clearly did not want our help. My every attempt to enter her room, speak with her, and provide care were met with an all too familiar rejection and denial that she even had a problem. Yet here she was in a hospital room, and I was her nurse. She verbalized denial of drinking too much when told that she was being treated for alcohol withdrawal. She stated this denial more to herself than to the health care providers in the room, and it was reminiscent of the denial I have seen in my loved ones. This was ironic, I always thought, as the need for such self-deception in and of itself points to the fact that something may be wrong and worth addressing.But denial or not, today, this patient—Mrs. H, was entrusted into my care. She refused treatments and medications, and this put me in a complex ethical predicament—treating a patient that I do not like for the personal issues she reminds me of, and the treatment of a patient against their refusal, as she was deemed incapable of making her own decisions. The latter of these two issues was easiest to put aside. Legally, this patient needed to be treated through her alcohol withdrawal. Once her mental status cleared up, she could sign out against medical advice or choose to remain until a safe discharge plan was in place. There was a protocol and legal guidelines for this situation. However, no guidelines [End Page 10] truly exist when it comes to the management of a patient that you simply do not like. The result can be a near-instantaneous dread each time you must answer that patient's bed alarm, call light, or most basic needs. A negative bias takes over, and it would be an understatement to say that this affects the quality of care. Patients in situations like this—with providers who judge them as I have been guilty of—can easily become subject to derogatory remarks, health inequities, and biased labeling... (shrink)

Ms. X is a person with cerebral palsy and schizophrenia. She has intractable bedsores that are a result of her immobility and to poor wound care related to her delusional thinking. Despite intensive community support, the wounds have worsened to the point that she has needed multiple hospitalizations to prevent systemic sepsis, a life‐threatening condition. She is capable of placement decisions and wishes for independence at home but is incapable of making wound care decisions and does not appreciate that immediately (...) returning home from the hospital, instead of going into a special care facility, would likely result in sepsis. The resulting dilemma about discharge planning highlights the complexity involved in weighing concerns around mental illness and capacity for treatment and placement of care. The extent of the care that is required and available in a community or health care system and the slow but relatively certain progression of the symptoms also make the decision challenging. Two commentaries take very different approaches in exploring the question whether Ms. X should be supported to go home or to a special care facility. (shrink)

Background: Determination of the factors affecting missed nursing care and the impact of ethical leadership is important in improving the quality of care. Aim: This study aims to determine the missed nursing care and its relationship with perceived ethical leadership. Research design: A cross-sectional study. Participants and research context: The sample consisted of 233 nurses, of whom 92.7% were staff nurses and 7.3% were charge nurses, who work in three different hospitals in Turkey. The study data were collected using a (...) personal and professional characteristics data form, the Missed Nursing Care Survey, and the Ethical Leadership Scale. Ethical considerations: The study was approved by the non-interventional ethics committee of Dokuz Eylül University Ethics Committee for Noninvasive Clinical Studies. All participants’ written and verbal consents were obtained. Findings: The most missed nursing care practices were ambulation, attending interdisciplinary care conferences, and discharge planning. According to the logistic regression analysis, sex, the number of patients that the nurse is in charge of giving care, the number of patients discharged in the last shift, and satisfaction with the team were determined as factors affecting missed care. No significant relationship was found between ethical leadership and missed nursing care, and a weak but significant relationship was found between the clarification of duties/roles subscale and missed nursing care. Discussion: Ethical leaders should collaborate with policy-makers at an institutional level to particularly achieve teamwork that is effective in the provision of care, to control missed basic nursing care, and to organize working hours and at the country level to determine roles and to increase the workforce. Conclusion: The results of this study contribute to the international literature on the most common type of missed nursing care, its reasons, and the relationship between the missed care and ethical leadership in a different cultural context. (shrink)

Estimation of discharge flowing through rivers is an important aspect of water resource planning and management. The most common way to address this concern is to develop stage-discharge relationships at various river sections. Various computational techniques have been applied to develop discharge ratings and improve the accuracy of estimated discharges. In this regard, the present study explores the application of the novel hybrid multigene genetic programming-generalized reduced gradient technique for estimating river discharges for steady as well (...) as unsteady flows. It also compares the MGGP-GRG performance with those of the commonly used optimization techniques. As a result, the rating curves of eight different rivers were developed using the conventional method, evolutionary algorithm, the modified honey bee mating optimization algorithm, artificial neural network, MGGP, and the hybrid MGGP-GRG technique. The comparison was conducted on the basis of several widely used performance evaluation criteria. It was observed that no model outperformed others for all datasets and metrics considered, which demonstrates that the best method may be different from one case to another one. Nevertheless, the ranking analysis indicates that the hybrid MGGP-GRG model overall performs the best in developing stage-discharge relationships for both single-value and loop rating curves. For instance, the hybrid MGGP-GRG technique improved sum of square of errors obtained by the conventional method between 4.5% and 99% for six out of eight datasets. Furthermore, EA, the MHBMO algorithm, and artificial intelligence models performed satisfactorily in some of the cases, while the idea of combining MGGP with GRG reveals that this hybrid method improved the performance of MGGP in this specific application. Unlike the black box nature of ANN, MGGP offers explicit equations for stream rating curves, which may be counted as one of the advantages of this AI model. (shrink)

In this article I argue that anti-perfectionist liberals can accept nudging in certain areas: in particular, they can accept nudges aimed at helping people to discharge their nonenforceable duties, and to secure personal autonomy. I claim that nudging is not disrespectful since it does not involve a comparative negative judgment on people’s ability to pursue their plans, and that the judgments that motivate nudging are compatible with treating citizens as free and equal. I also claim that despite being sometimes (...) manipulative, nudging is easy to resist and so it can be employed to pursue legitimate goals. (shrink)

The desire to self-improve is probably as old as humanity: most of us want to be smarter, more athletic, more beautiful, or more talented. However, in the light of an ever increasing array of possibilities to enhance our capacities, clarity about the purpose and goal of such efforts becomes crucial. This is especially true when decisions are made for children, who are exposed to their parents’ plans and desires for them under a notion of increasing wellbeing. In recent years, cognitive (...) enhancement has become a popular candidate for the promotion of wellbeing; welfarists even impose a moral duty on parents to cognitively enhance their children for the sake of their wellbeing. In this article, I aim to show that welfarists are mistaken in inferring such a moral obligation from the potential benefit of cognitive enhancement. In support of this, I offer three arguments: the vagueness of wellbeing as a theoretical concept means it becomes impossible to apply in practice; the link between cognition and wellbeing is far from unequivocal; and quantification issues with regard to cognition make a duty impossible to discharge. In conclusion, I reject the welfarist approach as a justification for a parental moral obligation to cognitively enhance children. (shrink)

The development of information technology (IT) caused a positive result on company productivities. A company tend to employ more experienced information technology workers using attractive compensation. Thus, causing a high level of turnover in IT workforce. This high level of turnover is a disadvantage for the company, because the company loses their skilled workers and have to find other workers to discharge the position. This research attempt to understand turnover behavior using the theory of planned behavior from attitude toward (...) behavior, subjective norm and perceived behavioral control. The objective of this research is to know the effect of attitude toward turnover, subjective norm, perceived behavioral control to turnover intention. Data collection were done using quantitative method by 4 types of instrument; attitude toward behavior, subjective norm, perceived behavioral control and turnover intention. Data were collected from 155 information technology workers in Jakarta and analyzed using multiple regression. The result showed that attitude toward turnover intention, subjective norm, and perceived behavioral control have significant effect to turnover intention. All the predictors accounted 38,8% of variance in turnover intention. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Right Thing to DoJane RogersIn stark contrast to getting my graduate degree in bioethics in which I discovered that I am inclined to favor an ethics based on my religious beliefs, in nursing school I learned that I had to take my religion out of nursing care. As a bioethics student, I read in my textbook, Bioethics: A Systematic Approach, that “… just because an action is rationally (...) allowed does not mean that everyone agrees one ought to act in that way.” Yet often in nursing I found that we nurses knew what was best for our patients, even if they did not. At least, we believed that we did. This general paternalistic belief spread into every area of the care we gave except for one, and that was religion. [End Page 208]As student nurses, we learned to separate our religion from our care to focus on the patient’s religion or spiritual needs. Our patients should never know of our religious beliefs or even if we had a lack of them. We needed to be completely neutral on all religious issues and focus solely on the patient’s preference. If our patients needed spiritual care, we would find someone to provide it and we would incorporate it into the nursing plan of care. Providing care of the whole patient including their religious needs was the definition of a good nurse. Certainly I wanted to be a good nurse, so I swore I would always include the spiritual needs of my patients as part of my care, while never expressing my own.As fate would have it, as a new nurse I found myself overwhelmed running around just trying to give medications, admit and discharge patients, start IV’s, insert catheters, note doctor’s orders and get my charting done. My time was engaged in trying to calm confused and combative patients, running to grab an emesis basin for a patient to throw up in or answering the phone, so thinking about religion or spiritual care for my patients most of the time amounted to “God help me and my patients get through this shift.” My goal of being a good nurse was starting to look dismal as I realized I had no idea if I could find the time or means and ways to incorporate religion into the care I gave, or if it even mattered if I did.Fortuitously for me, most of my patients never mentioned religion, although at times they did leave some nonverbal clues. I could see a rosary laying on a bedside table or a bible or prayer book next to them in bed. While I would make sure their religious item was always within reach, I remained respectful yet distant in religious matters, never offering any spiritual care or assistance. I was quite accepting of my first Mormon patient wearing the garment under the traditional hospital gown. I was appalled when an unconscious Jehovah Witness patient was nearly given blood. When a minister or priest came to visit, I’d excuse myself quickly so that the work of their God could do what I could not or should not do. Occasionally I was asked by family members to call in a minister or a priest or chaplain and I did that with a great feeling of satisfaction as I was surely providing the spiritual care they requested.Eventually however I did start to indulge in highly spontaneous and random acts of religion. These were always done secretly. The patient or family must never know. Thinking it would help I once covertly gave a patient a special rosary I had with Lourdes water in it thinking it might heal him. I waited to see a miracle. It never came. Despite the absence of that miracle I was still hopeful that perhaps my prayers or another rosary could heal or at least help some of my patients. After all, as a nurse I witnessed lots of healings that astounded me. People I never thought would get better sometimes did anyway.Although I was cognizant that some healing was the direct result of superb medical intervention and excellent nursing care, there were always... (shrink)

In this paper the author argues that the Academy of Medical Sciences's ‘Review of the regulation and governance of medical research’ has produced a set of muddled recommendations that could increase complexity and uncertainty in research governance rather than reduce it. Issues discussed in the paper include the additional legal burden placed upon the newly proposed Health Research Agency by the plan for a National Research Governance Service and its system of centralized permissions, the consequences that this may have for (...) the research ethics committees in the discharge of their legal duty, and the unanswered questions surrounding the TGN1412 incident. (shrink)

This study appeared in full in the last issue of Research Ethics Review : 68). MJ's research focuses on those patients with brain damage following trauma such as a road traffic accident. She wants to find out about their experiences of daily life once they have been discharged from hospital. She plans to use a phenomenological approach in which each participant will be asked to take part in a series of in-depth interviews, via email, over a period of about two (...) years. These interviews will allow her to compare participants' experiences in different parts of the UK. MJ has a research partner in Auckland; the two of them are planning a similar series of interviews in New Zealand to allow for comparison between participants' experiences in the two countries. (shrink)

Regina R. is a 12-year-old girl with recently diagnosed insulin-dependent diabetes. Before discharging her from the hospital, her family physician and consulting diabetes specialist try to instruct the girl and her parents in the appropriate program of treatment, including diet, insulin, and regular self-monitoring. However, the parents become upset when they learn what is involved in insulin treatment and inform the family physician they plan to employ the services of an alternative healing clinic that promises to cure their daughter with (...) a combination of herbal potions, macrobiotics, aroma therapy, therapeutic touch, Ayurveda, homeopathy, and guided imagery. (shrink)

Does a victim have to intend to resist oppression in order to discharge her obligation to do so, or is it sufficient to resist oppression intentionally in the course of pursuing other plans and projects of importance to her? I argue that resisting intentionally can be sufficient: given the ways that oppression interferes with the lives of victims, trying to counteract that interference by living the life you want is genuine resistance. Requiring that victims have justice-oriented or agency-preserving reasons (...) before their actions count as resistance will distort or miss a wide range of everyday responses to oppressive burdens. (shrink)

Traditionally, civil law jurisdictions in Scandinavia and the continent of Europe have not been willing to acknowledge the appropriateness of extending bankruptcy relief to consumer debtors and discharging any part of their debts. The opposition was based on the importance of upholding the sanctity of contractual obligations: pacta sunt servanda. This attitude stood in contrast to the fresh start philosophy of US bankruptcy law, which embraced a more forgiving attitude, focusing on the reintegration of the insolvent debtor into society, substantially (...) free of debt, after he has filed for bankruptcy and surrendered his non-exempt property for distribution among his creditors. The relaxation of credit controls and the rapid increase in the number of insolvent debtors in the late 1980s and early 1990s has forced many continental jurisdictions to reconsider their traditional opposition. They have since adopted debt adjustment plans providing various forms of debt relief to overcommitted debtors but only a substantial number of years after the initial proceedings. The American reaction has gone in the opposite direction. With the adoption of the Bankruptcy Abuse Prevention and Consumer Protection Act of 2005, the United States has reversed its century old liberal fresh start tradition. The 2005 Act imposes a formidable means test as well as other preconditions to determine whether a debtor has sufficient discretionary income to pay off twenty percent of his or her unsecured debts under a Chapter 13 plan. If the answer is yes, the debtor is denied the right to file a bankruptcy petition under Chapter 7 of the Bankruptcy Code. This paper asks whether these developments on opposite sides of the Atlantic suggest that facts on the ground are more important than dogma and deeply entrenched beliefs. The author’s answer is that while there is certainly a trend towards convergence between continental European and US approaches to consumer insolvency, it is much too soon to speak of a common culture and a common approach. He notes, however, that Commonwealth jurisdictions have long adopted a means test to determine a debtor’s eligibility for discharge from debt and suggests that continental scholars would have done better to study the Commonwealth experience as embodying a suitable compromise than to flirt with the US fresh start philosophy, only to reject it as too alien to the continental moral sense. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent and informed (...) consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent and informed (...) consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

In this paper, I consider the question of where illegal immigrants should go once their lives have been saved in hospitals and they are ready to be transferred to long-term care situations. I highlight three recent cases in which such a decision was made. In one case, the patient was kept at the hospital, in another the patient was repatriated to his home country, and in the third, the patient was discharged to his family. I consider the relevant moral values (...) and argue that for reasons of fairness we must develop a policy that treats similar cases in similar ways. In order to best uphold patient well-being and minimize costs, the plan proposed here calls for illegal immigrants to be covered by insurance for long-term care. (shrink)

The notion of introspection is unparsimonious and unnecessary to explain the experiential grounding of our mentalistic concepts. Instead, we can look at subtle proprioceptive experiences, such as the experience of agency in planning motor acts, which may be explained in part by the phenomenon of collateral discharge or efference copy. Proprioceptive sensations experienced during perceptual and motor activity may account for everything that has traditionally been attributed to a special mental activity called “introspection.”.