Together with large biobanks of human samples, medical registries with aggregated data from many clinical centers are vital parts of an infrastructure for maintaining high standards of quality with regard to medical diagnosis and treatment. The rapid development in personalized medicine and pharmaco-genomics only underscores the future need for these infrastructures. However, registries and biobanks have been criticized as constituting great risks to individual privacy. In this article, I suggest that quality with regard to diagnosis and (...) treatment is an inherent, morally normative requirement of health care, and argue that quality concerns in this sense may be balanced with privacy concerns. (shrink)

Many high-risk medical devices earn US marketing approval based on limited premarket clinical evaluation that leaves important questions unanswered. Rigorous postmarket surveillance includes registries that actively collect and maintain information defined by individual patient exposures to particular devices. Several prominent registries for cardiovascular devices require enrolment as a condition of reimbursement for the implant procedure, without informed consent. In this article, we focus on whether these registries, separate from their legal requirements, have an ethical obligation to (...) obtain informed consent from enrolees, what is lost in not doing so, and the ways in which seeking and obtaining consent might strengthen postmarket surveillance in the USA. (shrink)

The clinical introduction of medical devices often occurs with relatively little oversight, regulation and (long-term) follow-up. Some recent controversies underscore the weaknesses of the current regime, such as the complications surrounding the metal-on-metal hip implants and the scandal surrounding the global breast implant scare of silicone implants made by France's Poly Implant Prothese (PIP) Company. The absence of national registries hampered the collection of reliable information on the risks and harms of the PIP breast implants. To warrant long-term (...) safety, a case can be made for mandatory post-marketing surveillance by means of the establishment of compulsory registries. In this edition of Public Health Ethics, Schofield calls for debate on how such a registry system should be initiated and maintained and how it would relate to the ethical requirement of consent. Here we use breast implant registries as a case to discuss whether and when a so-called ‘thick opt-out’ would be an appropriate method to include people in medical device registries. We conclude that a thick opt-out procedure for medical device registries is only justifiable in cases where inclusion does not involve burdens (or very low), when it does not involve a sensitive subject and when the data are stored anonymously (or at least not directly linked to the medical record). Otherwise, inclusion should be sought by means of an opt-in. (shrink)

Much biomedical research cannot be performed without recruiting human subjects. Increasingly, volunteer registries are being developed to assist researchers with this challenging task. Yet, volunteer registries raise confidentiality issues. Having recently developed a registry of volunteers, the authors searched for normative guidance on how to implement the principle of confidentiality. The authors found that the protection of confidentiality in registries are based on the 10 key elements which are elaborated in detail in the Canadian Standards Association Model (...) Code. This paper describes how these 10 detailed key principles can be used during the developmental stages of volunteer registries. (shrink)

In 2017 Ploug and Holm argued that anonymizing individuals in the Danish circumcision registry was insufficient to protect these individuals from what they regard as the potential harms of being in the registry. We argue that Ploug and Holm’s fears in each of the areas are misguided, not supported by the evidence, and could interfere with the gathering of accurate data. The extent of the risks and harms associated with ritual circumcision is not well known. The anonymized personal health data (...) supplemented with the circumcision registry will enable more precise research into the medical consequences of ritual circumcision, and allow parents to make more fully informed decisions about circumcision with minimal, if any, adverse consequences. (shrink)

Research into personal health data holds great potential not only for improved treatment but also for economic growth. In these years many countries are developing policies aimed at facilitating such research often under the banner of ‘big data’. A central point of debate is whether the secondary use of health data requires informed consent if the data is anonymised. In 2013 the Danish Minister of Health established a new register collecting data about all ritual male childhood circumcisions in Denmark. The (...) main purpose of the register was to enable future research into the consequences of ritual circumcision. This article is a study into the case of the Danish Circumcision Registry. We show that such a registry may lead to various forms of harm such as 1) overreaching social pressure, 2) stigmatization, 3) medicalization of a religious practice, 4) discrimination, and 5) polarised research, and that a person may therefore have a strong and legitimate interest in deciding whether or not such data should be collected and/or used in research. This casts doubt on the claim that the requirement of informed consent could and should be waived for all types of secondary research into registries. We finally sketch a new model of informed consent – Meta consent – aimed at striking a balance between the interests in promoting research and at the same time protecting the individual. Research participants may have a strong and legitimate interest in deciding whether or not their data should be collected and used for registry-based research whether or not their data is anonymised. (shrink)

BackgroundThe amount of research utilizing health information has increased dramatically over the last ten years. Many institutions have extensive biobank holdings collected over a number of years for clinical and teaching purposes, but are uncertain as to the proper circumstances in which to permit research uses of these samples. Research Ethics Boards (REBs) in Canada and elsewhere in the world are grappling with these issues, but lack clear guidance regarding their role in the creation of and access to registries (...) and biobanks.MethodsChairs of 34 REBS and/or REB Administrators affiliated with Faculties of Medicine in Canadian universities were interviewed. Interviews consisted of structured questions dealing with diabetes-related scenarios, with open-ended responses and probing for rationales. The two scenarios involved the development of a diabetes registry using clinical encounter data across several physicians' practices, and the addition of biological samples to the registry to create a biobank.ResultsThere was a wide range of responses given for the questions raised in the scenarios, indicating a lack of clarity about the role of REBs in registries and biobanks. With respect to the creation of a registry, a minority of sites felt that consent was not required for the information to be entered into the registry. Whether patient consent was required for information to be entered into the registry and the duration for which the consent would be operative differed across sites. With respect to the creation of a biobank linked to the registry, a majority of sites viewed biobank information as qualitatively different from other types of personal health information. All respondents agreed that patient consent was needed for blood samples to be placed in the biobank but the duration of consent again varied.ConclusionParticipants were more attuned to issues surrounding biobanks as compared to registries and demonstrated a higher level of concern regarding biobanks. As registries and biobanks expand, there is a need for critical analysis of suitable roles for REBs and subsequent guidance on these topics. The authors conclude by recommending REB participation in the creation of registries and biobanks and the eventual drafting of comprehensive legislation. (shrink)

Several high-profile episodes have recently thrust drug safety and the pharmaceutical industry's practices into the spotlight. Merck's recall of the drug Vioxx, for instance, was a major news event. GlaxoSmithKline's suppression of data linking suicidal behavior among children to Paxil also galvanized tremendous public attention. What differentiates these events from the usual evolving process of scientific knowledge, and marks them with an aura of “scandal,” are questions about the propriety of corporate behavior. Who knew what, and when did they know (...) it? Concerns are growing about the potential for industry sponsors to suppress negative results from clinical trials research. Scientists, medical journal editors, legislators, and the public have called for greater transparency in the conduct of clinical trials and the drug approval process. (shrink)

Several high-profile episodes have recently thrust drug safety and the pharmaceutical industry's practices into the spotlight. Merck's recall of the drug Vioxx, for instance, was a major news event. GlaxoSmithKline's suppression of data linking suicidal behavior among children to Paxil also galvanized tremendous public attention. What differentiates these events from the usual evolving process of scientific knowledge, and marks them with an aura of “scandal,” are questions about the propriety of corporate behavior. Who knew what, and when did they know (...) it? Concerns are growing about the potential for industry sponsors to suppress negative results from clinical trials research. Scientists, medical journal editors, legislators, and the public have called for greater transparency in the conduct of clinical trials and the drug approval process. (shrink)

The review system on research with human participants in the Netherlands is characterised as a decentralised controlled and integrated peer review system. It consists of an independent governmental body, the Central Committee on Research Involving Human Subjects (or Central Committee), which regulates the review of research proposals by accredited Medical Research Ethics Committees (MRECs). The legal basis was founded in 1999 with the Medical Research Involving Human Subjects Act. The review system is a decentralised arrangement since most research (...) proposal are reviewed by the 30 accredited MRECs in the country. It is a controlled system in which the Central Committee is responsible for the accreditation and oversight of the MRECs and can make legally binding directives for these committees. The assessment of research proposals is an integrated peer review process in which all documents of the research file are reviewed by experts in one committee only. A small number of research proposals are assessed by the Central Committee and not by accredited MRECs. These proposals are on specific research categories such as gene therapy, cell therapy and embryo research. The review of research with surplus human embryos is regulated separately in the Embryos Act. The Central Committee provides support to the accredited MRECs and to researchers and sponsors. It is currently developing an internet portal to reduce the bureaucracy and make the review process more efficient and transparent. The Central Committee stimulates confidence on medical research in society by providing a public trial registry with core data on reviewed research proposals. (shrink)

Cancer registries are an important part of the public health infrastructure, since they allow to monitor the temporal trends of this illness as well as facilitate epidemiological research. In order to effectively set up such registries, it is necessary to create a system of data collection that permits to record health-related information from patients who are diagnosed with cancer. Given the sensitive nature of such data, it is debated whether their recording should be based on consent or whether (...) alternative arrangements are possible (eg, opt-out systems where information is automatically collected but patients can later withdraw). In the recent reform of the Swiss cancer registration legislation, the lawmaker set out to implement rules about the recording of data in cancer registries that would allegedly go beyond a consent-based model, in order to balance accurate registration with respect of patient rights. However, by analysing the operational norms of the new legislation and comparing them with those of other systems, it emerges that the Swiss rules de facto closely resemble a system of registration based on informed consent—in partial contradiction with the objective pursued by the lawmaker. In this paper, we show how the details of a policy are crucial to determine its true nature and we highlight some critical elements—from an ethical standpoint—of the recently reformed Swiss policy on cancer registration. (shrink)

Research drawn from data contained in medical records is a common and immensely important means of scientific investigation in epidemiology and health services research. It provides valuable knowledge regarding risk factors for disease, the safety of pharmaceuticals and medical procedures, and the quality of medical care. Electronic information technology has greatly enhanced the capability of conducting research using medical records, but it has also generated increasing concern about invasions of privacy. Both practical and scientific considerations militate (...) against soliciting consent for population-based observational research. Retrospective review of existing medical records, especially with large samples, poses insuperable barriers to locating human subjects in order to obtain their informed consent. When efforts are made to obtain informed consent for prospective research drawn from disease and treatment registries, mounting evidence has accumulated that substantial selection biases are introduced into the data, as those who consent are not necessarily representative of the population of relevant patients. (shrink)

The enrolment of children and adolescents in health research requires that attention to be paid to specific assent and consent requirements such as the age range for seeking assent; conditions for parental consent (and waivers); the age group required to provide written assent; content of assent forms; if separate assent and parental consent forms should be used, consent from emancipated young adults; reconsent at the age of adulthood when a waiver of assent requirements may be appropriate and the conditions for (...) waiving assent requirements. There is however very little available information for researchers and ethics committees on how to navigate these different issues. To provide guidance to research initiatives, the SickleInAfrica consortium conducted a thematic analysis of a sample of research ethics guidelines and procedures in African countries, to identify guidance for assent requirements in health research. The thematic analysis revealed that 12 of 24 African countries specified the age group for which assent is required. The minimum age for written assent varied across the countries. Five countries, Algeria, Botswana, Cameroon, Nigeria and The Democratic Republic of Congo require consent from both parents/family council in certain circumstances. Botswana, Nigeria, South Africa and Uganda have specific assent/consent requirements for research with emancipated minors. South Africa and Algeria requires re-consent at onset of adulthood. Five countries (Botswana, Cameroon, Nigeria, South Africa and Tanzania) specified conditions for waiving assent requirements. The CIOMS and the ICH-GCP guidelines had the most comprehensive information on assent requirements compared to other international guidelines. An interactive map with assent requirements for different African countries is provided. The results show a major gap in national regulations for the inclusion of minors in health research. The SickleInAfrica experience in setting up a multi-country SCD registry in Africa highlights the need for developing and harmonising national and international guidelines on assent and consent requirements for research involving minors. Harmonisation of assent requirements will help facilitate collaborative research across countries. (shrink)

Media attention to retracted research suggests that a substantial number of papers are corrupted by misinformation. In reality, every paper contains misinformation; at issue is whether the balance of correct versus incorrect information is acceptable. This paper postulates that analysis of retracted research papers can provide insight into medical misinformation, although retracted papers are not a random sample of incorrect papers. Error is the most common reason for retraction and error may be the principal cause of misinformation as well. (...) Still, one-quarter of retracted papers are fraudulent, and misinformation may also arise through fraud. This paper hypothesises that error and fraud are the main sources of misinformation and that error is more common than fraud. Retraction removes misinformation from the literature; bias is non-retracted misinformation. Bias arises when scientific impropriety results in false research findings. Impropriety can involve experimental design, data collection, data analysis, or data presentation. Yet impropriety also arises through earnest error or statistical naiveté; not all bias is fraud. Several measures are proposed to minimise misinformation in the medical literature, including: greater detail in the clinical trial registry, with rigorous definition of inclusion and exclusion criteria and primary endpoints; clear statistical criteria for every aspect of clinical trials, especially sample size; responsibility for data integrity that accrues to all named authors; increased transparency as to how the costs of research were paid; and greater clarity as to the reasons for retraction. Misinformation can arise without malicious intent; authors of incorrect papers are owed a presumption of incompetence, not malice. (shrink)

Background In earlier work, we found important selection biases when we tried to obtain consent for participation in a national stroke registry. Recognizing that not all registries will be exempt from requiring consent for participation, we examine here in greater depth the reasons for the poor accrual of patients from a systems perspective with a view to obtaining as representative sample as possible. Methods We determined the percent of eligible patients who were approached to participate and, among those approached, (...) the percent who actually consented to participate. In addition we examined the reasons why people were not approached or did not consent and the variation across sites in the percent of patients approached and consented. We also considered site variation in restrictions on the accrual and data collection process imposed by either the local research ethics board or the hospital. Results Seventy percent of stroke patients were approached, with wide variations in approach rates across sites (from: 41% to 86%), and considerable inter-site variation in hospital policies governing patient accrual. Chief reasons for not approaching were discharge or death before being approached for consent. Seventeen percent of those approached refused to participate (range: 5% to 75%). Finally, 11% of those approached did not participate due to language or communication difficulties. Conclusion We found wide variation in approach and agree rates across sites that were accounted for, in part, by different approaches to accrual and idiosyncratic policies of the hospitals. This wide variation in approach and agree rates raises important challenges for research ethics boards and data protection authorities in determining when to waive consent requirements, when to press for increased quality control, when to permit local adaptation of the consent process, and when to permit alternatives to individual express consent. We offer several suggestions for those registries that require consent for participation. (shrink)

Register-based research can provide important and valuable contributions to public health research, but involves ethical issues concerning the balance of public health benefits and individual autonomy. This study aimed to describe the opinions of the Finnish public about these issues.

Pharmaceutical companies fund the bulk of clinical research that is carried out on medications. Poor outcomes from these studies can have negative effects on sales of medicines. Previous research has shown that company funded research is much more likely to yield positive outcomes than research with any other sponsorship. The aim of this article is to investigate the possible ways in which bias can be introduced into research outcomes by drawing on concrete examples from the published literature. Poorer methodology in (...) industry-funded research is not likely to account for the biases seen. Biases are introduced through a variety of measures including the choice of comparator agents, multiple publication of positive trials and non-publication of negative trials, reinterpreting data submitted to regulatory agencies, discordance between results and conclusions, conflict-of-interest leading to more positive conclusions, ghostwriting and the use of seeding trials. Thus far, efforts to contain bias have largely focused on more stringent rules regarding conflict-of-interest (COI) and clinical trial registries. There is no evidence that any measures that have been taken so far have stopped the biasing of clinical research and it’s not clear that they have even slowed down the process. Economic theory predicts that firms will try to bias the evidence base wherever its benefits exceed its costs. The examples given here confirm what theory predicts. What will be needed to curb and ultimately stop the bias that we have seen is a paradigm change in the way that we treat the relationship between pharmaceutical companies and the conduct and reporting of clinical trials. (shrink)

As in other countries, the traditional doctor-patient relationship in the Japanese healthcare system has often been characterised as being of a paternalistic nature. However, in recent years there has been a gradual shift towards a more participatory-patient model in Japan. With advances in technology, the possibility to use digital technologies to improve patient interactions is growing and is in line with changing attitudes in the medical profession and society within Japan and elsewhere. The implementation of an online patient engagement (...) platform is being considered by the Myotonic Dystrophy Registry of Japan. The aim of this exploratory study was to understand patients’ views and attitudes to using digital tools in patient registries and engagement with medical research in Japan, prior to implementation of the digital platform. We conducted an exploratory, cross-sectional, self-completed questionnaire with a sample of myotonic dystrophy patients attending an Open Day at Osaka University, Japan. Patients were eligible for inclusion if they were 18 years or older, and were diagnosed with MD. A total of 68 patients and family members attended the Open Day and were invited to participate in the survey. Of those, 59 % submitted a completed questionnaire. The survey showed that the majority of patients felt that they were not receiving the information they wanted from their clinicians, which included recent medical research findings and opportunities to participate in clinical trials, and 88 % of patients indicated they would be willing to engage with digital technologies to receive relevant medical information. Patients also expressed an interest in having control over when and how they received this information, as well as being informed of how their data is used and shared with other researchers. Overall, the findings from this study suggest that there is scope to develop a digital platform to engage with patients so that they can receive information about medical care and research opportunities. While this study group is a small, self-selecting population, who suffer from a particular condition, the results suggest that there are interested populations within Japan that would appreciate enhanced communication and interaction with healthcare teams. (shrink)

In the last couple of years, serious controversies have raised doubts over the reliability of research supporting the efficacy and safety of Selective Serotonin Reuptake Inhibitors, popular drugs used for the treatment of depression and a variety of related conditions. These controversies have also evoked concerns over the promotional tactics used by industry to promote these drugs. In another article in this volume, David Healy argues that the tactics highlighted by these and some other recent controversies in psychiatry have brought (...) medical research itself to the level of commercial publicity. In the following article, I provide some additional first-hand information about controversies in which David Healy was involved. I then situate these controversies within the context of the increasing commercialization of medical research. I discuss how the controversies highlight the failure of existing regulatory regimes in curbing inappropriate industry influence over research. I critically analyse some of the measures recently promoted by the medical research community, such as the introduction of a clinical trial registry, and I indicate why these measures are insufficient. In conclusion, I highlight how a more radical reform of the clinical trials scene is needed. (shrink)

Gebhardt in his brief report1 pleads for patient organisations to establish databanks on medical complications. Given the references and the lack of argumentation, there is substantial danger of misinterpretation of the current situation, which in turn may frustrate the process of increased transparency. We would therefore like to respond to this by giving background information and reasons for some of the choices that were made with respect to the registry of complications mentioned by Gebhardt.First, a distinction needs to be (...) made between an error and an adverse outcome, which are often confused. From Gebhardt’s reference to the journalist’s article which discusses the same registry of adverse outcomes, but with the title referring to errors, both Gebhardt and the journalist think errors and adverse outcomes are the same thing. However, an error refers to the process in which something has gone wrong, a substandard performance, regardless of the outcome. It has been explained by others that such a judgement may have a degree of subjectivity.2 An adverse outcome refers to the outcome which is unwanted but does not necessarily imply that an error has been made. This is why the term “adverse outcomes” is used rather than …. (shrink)

Several studies have observed an inverse relationship between attention deficit hyperactivity disorder -related behavior of children, as reported by parents or teachers, and the amount of green space in their residential environment. Research using other, more objective measures to determine ADHD prevalence is scarce and could strengthen the evidence base considerably. In this study, it is investigated whether a similar beneficial association will be observed if the use of ADHD-related medication is selected as an outcome measure. More specifically, registry data (...) from a health insurance company on the reimbursement of ADHD-related medication in 2011 were available for 248,270 children between 5 and 12 years of age. Amounts of green space within 250 and 500 m of the home address were calculated. Multilevel logistic regression analyses for the prevalence of use were conducted, including the following covariates: sex, age, urbanity of the neighborhood, neighborhood socioeconomic status, and percentage of people with a non-Western migration background in the neighborhood population. Results showed that the amount of green space was inversely related to the prevalence of use of ADHD medication. Moreover, the relationship was strongest among children living in the least wealthy neighborhoods and absent among those living in the wealthiest neighborhoods. Results also show that in less wealthy neighborhoods, there is, on average, less green space available nearby: children who are likely to benefit most from nearby green space tend to have the least of it. (shrink)

As long-term childhood cancer survivors are at risk for late effects, ongoing medical care is crucial to detect and treat physical illnesses as early as possible. However, previous research from around the world has shown that many adult survivors did not participate in long-term medical follow-up. This study aimed to provide insight into German survivors’ care situation, with a particular focus on barriers to follow-up care. We investigated a sample of adult CCS drawn from the German Childhood Cancer (...) Registry’s oldest cohort. Our analyses included data from a standardized medical examination, a self-report questionnaire, and in-depth interviews with a subsample. Half of the participants reported participating in some kind of medical follow-up. In a logistic regression analysis, attendance of medical follow-up care was associated with higher age. Reasons for non-attendance were assigned to four categories: lack of information about medical follow-up and/or its purpose, termination by the health care provider, structural barriers, and emotional-motivational aspects. The interviews contributed to a better understanding of how these reported barriers played out in the care of individual survivors. Further, they revealed that some survivors currently in medical follow-up had had periods without follow-up care in the past—which were also in many cases related to a lack of information, both on the part of health care providers and CCS themselves. The results indicated that a large proportion of long-term CCS do not receive the recommended follow-up care. Further, there is a great need for more information regarding the aims of long-term medical follow-up and available offers. This is an important prerequisite for CCS to make informed decisions. (shrink)

Physicians and other health care providers owe ethical and legal duties to patients to maintain the secrecy of the information learned during the course of patient care. This obligation is fulfilled by limiting access to such information to only those involved in the patient's care-that is, to those within the “circle of confidentiality.” As a general rule, providers may only disclose to others with the written prior consent of the patient. Exceptions may be “ethically and legally justified because of overriding (...) social considerations,” when permitted or compelled by law. For example, eleven states permit providers to disclose identified records to approved researchers.’ Many states compel disclosure in cases where a patient threatens serious bodily harm to another; require reporting to health or law enforcement authorities of communicable diseases, gunshot or knife wounds, or child abuse; and mandate reporting of cancer or other health care cases to state registries. (shrink)

Physicians and other health care providers owe ethical and legal duties to patients to maintain the secrecy of the information learned during the course of patient care. This obligation is fulfilled by limiting access to such information to only those involved in the patient's care-that is, to those within the “circle of confidentiality.” As a general rule, providers may only disclose to others with the written prior consent of the patient. Exceptions may be “ethically and legally justified because of overriding (...) social considerations,” when permitted or compelled by law. For example, eleven states permit providers to disclose identified records to approved researchers.’ Many states compel disclosure in cases where a patient threatens serious bodily harm to another; require reporting to health or law enforcement authorities of communicable diseases, gunshot or knife wounds, or child abuse; and mandate reporting of cancer or other health care cases to state registries. (shrink)

This paper considers the bioethics of estranged biological kin, who are biologically related people not in contact with one another (due to adoption, abandonment, or other long-term estrangement). Specifically, I am interested in what is owed to estranged biological kin in the event of medical need. A survey of current bioethics demonstrates that most analyses are not prepared to reckon with the complications of having or being estranged biological kin. For example, adoptees might wonder if a lack of contact (...) with biological kin could someday affect their medical care (or affect the medical care of their biological relatives). Estranged biological kin, such as adoptees, present us with a chance to think about human connection. After sketching several organ-donation and adoption tropes, I argue that a feminist analysis of vulnerability and dependency is helpful for understanding the confusing ties of estranged biological kin. I conclude by proposing a medical registry that would put adoptees and others in touch with their estranged biological kin on a medically as-needed basis. (shrink)

The featured case discussion on the role of consent and individual autonomy in the PIP breast implant scandal raises interesting and important questions regarding the right of patients (and individuals in general) to decide whether to have their personal data included in medical registries and used for research. The fate of the National Breast Implant Registry, following the introduction of a policy that demanded formally recorded informed consent, is particularly enlightening. Combined with the (ex post) fact that reliable (...) and comprehensive data would have been useful in this specific case, it clearly illustrates the dangers of overemphasizing individual autonomy in observational research. The issue is timely, as the European Commission has recently proposed a new Data Protection Regulation (European Commission, 2012) that may have serious implications for registry based research. In this commentary, I will first discuss two aspects of the regulatory framework that arguably contribute to the problematic situation and then offer an alternative view on why requiring consent should not be the default position in this kind of research. (shrink)

_The International Committee of Medical Journal Editors (ICMJE) is a working group of editors of selected medical journals that meets annually. Founded in Vancouver, Canada, in 1978, it currently consists of 11 member journals and a representative of the US National Library of Medicine. The major purpose of the Committee is to address and provide guidance for the conduct and publishing of biomedical research and the ethical tenets underpinning these activities. This advice is detailed in the Committee's _ (...) Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication (URM)._ Recently, the ICMJE has adopted an interventionist role to ensure transparency of conflict of interest revelations in the conduct and publication of industry supported research. It also pursues a policy for the lodgement with trial registries of specified details of Phase III clinical trials. Failure to comply would jeopardise publication of trial outcomes in ICMJE member journals. This policy has resulted in the coming on stream of trial registries, international agreement on trial minimal datasets and compliance with trial registration requirements._. (shrink)

We respond to Morgan and Feeley’s critique on our article “Mass Media in Organ Donation: Managing Conflicting Messages and Interests.” We noted that Morgan and Feeley agree with the position that the primary aims of media campaigns are: “to educate the general public about organ donation process” and “help individuals make informed decisions” about organ donation. For those reasons, the educational messages in media campaigns should not be restricted to “information from pilot work or focus groups” but should include evidence-based (...) facts resulting from a comprehensive literature research. We consider the controversial aspects about organ donation to be relevant, if not necessary, educational materials that must be disclosed in media campaigns to comply with the legal and moral requirements of informed consent. With that perspective in mind, we address the validity of Morgan and Feeley’s claim that media campaigns have no need for informing the public about the controversial nature of death determination in organ donation. Scientific evidence has proven that the criteria for death determination are inconsistent with the Uniform Determination of Death Act and therefore potentially harmful to donors. The decision by campaign designers to use the statutory definition of death without disclosing the current controversies surrounding that definition does not contribute to improved informed decision making. We argue that if Morgan and Feeley accept the important role of media campaigns to enhance informed decision making, then critical controversies should be disclosed. In support of that premise, we will outline: (1) the wide-spread scientific challenges to brain death as a concept of death; (2) the influence of the donor registry and team-huddling on the medical care of potential donors; (3) the use of authorization rather than informed consent for donor registration; (4) the contemporary religious controversy; and (5) the effects of training desk clerks as organ requestors at the Department of Motor Vehicles offices. We conclude that organ donation is a medical procedure subject to all the ethical obligations that the medical profession must uphold including that of transparency and truthfulness. (shrink)

The International Committee of Medical Journal Editors is a working group of editors of selected medical journals that meets annually. Founded in Vancouver, Canada, in 1978, it currently consists of 11 member journals and a representative of the US National Library of Medicine. The major purpose of the Committee is to address and provide guidance for the conduct and publishing of biomedical research and the ethical tenets underpinning these activities. This advice is detailed in the Committee's Uniform Requirements (...) for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication . Recently, the ICMJE has adopted an interventionist role to ensure transparency of conflict of interest revelations in the conduct and publication of industry supported research. It also pursues a policy for the lodgement with trial registries of specified details of Phase III clinical trials. Failure to comply would jeopardise publication of trial outcomes in ICMJE member journals. This policy has resulted in the coming on stream of trial registries, international agreement on trial minimal datasets and compliance with trial registration requirements. (shrink)

Mass media campaigns are widely and successfully used to change health decisions and behaviors for better or for worse in society. In the United States, media campaigns have been launched at local offices of the states’ department of motor vehicles to promote citizens’ willingness to organ donation and donor registration. We analyze interventional studies of multimedia communication campaigns to encourage organ-donor registration at local offices of states’ department of motor vehicles. The media campaigns include the use of multifaceted communication tools (...) and provide training to desk clerks in the use of scripted messages for the purpose of optimizing enrollment in organ-donor registries. Scripted messages are communicated to customers through mass audiovisual entertainment media, print materials and interpersonal interaction at the offices of departments of motor vehicles. These campaigns give rise to three serious concerns: (1) bias in communicating information with scripted messages without verification of the scientific accuracy of information, (2) the provision of misinformation to future donors that may result in them suffering unintended consequences from consenting to medical procedures before death (e.g, organ preservation and suitability for transplantation), and (3) the unmanaged conflict of interests for organizations charged with implementing these campaigns, (i.e, dual advocacy for transplant recipients and donors). We conclude the following: (1) media campaigns about healthcare should communicate accurate information to the general public and disclose factual materials with the least amount of bias; (2) conflicting interests in media campaigns should be managed with full public transparency; (3) media campaigns should disclose the practical implications of procurement as well as acknowledge the medical, legal, and religious controversies of determining death in organ donation; (4) organ-donor registration must satisfy the criteria of informed consent; (5) media campaigns should serve as a means of public education about organ donation and should not be a form of propaganda. (shrink)

Introduction No consent for health and medical research is appropriate when the criteria for a waiver of consent are met, yet some ethics committees and data custodians still require informed consent. Methods A single-blind parallel-group randomised controlled trial: 1129 families of children born at a South Australian hospital were sent information explaining data linkage of childhood immunisation and hospital records for vaccine safety surveillance with 4 weeks to opt in or opt out by reply form, telephone or email. A (...) subsequent telephone interview gauged the intent of 1026 parents (91%) in relation to their actions and the sociodemographic differences between participants and non-participants in each arm. Results The participation rate was 21% (n=120/564) in the opt-in arm and 96% (n=540/565) in the opt-out arm (χ2 (1 df) = 567.7, p<0.001). Participants in the opt-in arm were more likely than non-participants to be older, married/de facto, university educated and of higher socioeconomic status. Participants in the opt-out arm were similar to non-participants, except men were more likely to opt out. Substantial proportions did not receive, understand or properly consider study invitations, and opting in or opting out behaviour was often at odds with parents' stated underlying intentions. Conclusions The opt-in approach resulted in low participation and a biased sample that would render any subsequent data linkage unfeasible, while the opt-out approach achieved high participation and a representative sample. The waiver of consent afforded under current privacy regulations for data linkage studies meeting all appropriate criteria should be granted by ethics committees, and supported by data custodians. Trial registration number Australian New Zealand Clinical Trials Registry ACTRN12610000332022. (shrink)

This issue of the Report is far ranging, with essays on the nature of the U.S. government's responsibility toward Indian tribes, a medical school's commitment toward applicants who are immigrants, the difficulty of developing a transparent national registry of clinical trials, and the ethical problems embedded in the topic of global health. Two items in the issue revolve around physicians’ role in upholding the value placed on reproduction. Another small set of pieces within this issue of the Report examines (...) the intractability of the debate over how to define death. (shrink)

Despite concerns about the relationships between health professionals and the medical device industry, the issue has received relatively little attention. Prevalence data are lacking; however, qualitative and survey research suggest device industry representatives, who are commonly present in clinical settings, play a key role in these relationships. Representatives, who are technical product specialists and not necessarily medically trained, may attend surgeries on a daily basis and be available to health professionals 24 hours a day, 7 days a week, to (...) provide advice. However, device representatives have a dual role: functioning as commissioned sales representatives at the same time as providing advice on approaches to treatment. This duality raises the concern that clinical decision-making may be unduly influenced by commercial imperatives. In this paper, we identify three key ethical concerns raised by the relationship between device representatives and health professionals: impacts on healthcare costs, the outsourcing of expertise and issues of accountability and informed consent. These ethical concerns can be addressed in part through clarifying the boundary between the support and sales aspects of the roles of device representatives and developing clear guidelines for device representatives providing support in clinical spaces. We suggest several policy options including hospital provision of expert support, formalising clinician conduct to eschew receipt of meals and payments from industry and establishing device registries. (shrink)

Background: Both anxiety and depression in family caregivers of advanced cancer patients are common, and they have a negative influence on both the FCs and the patients. Some studies suggested that a variety of interventions could alleviate the psychological symptoms of FCs. However, there is no consensus on much more effective methods for intervention, and relatively high-quality research is blank in psychological problems of these population in China. The validity of mindfulness-based stress reduction and psychological consultation guided by the needs (...) assessment tool in the psychological status of caregivers will be compared in this study to select a more suitable intervention for the FCs of advanced cancer patients in China.Methods and Analysis: A randomized N-of-1 trial would be conducted at the Cancer Hospital, Chinese Academy of Medical Sciences. Fifty eligible FCs of advanced cancer patients will be recruited, and all will receive three cycles of psychological intervention treatment, with each cycle including both of MBSR and psychological consultation guided by the NST. MBSR and psychological consultation guided by the NST will be compared with each other in each cycle, and the intervention sequence will be based on the random number table generated after the informed consent has been completed. Each treatment period is 2 weeks, and the interval between different treatment cycles or treatment periods is 1 week. The self-reported scales are measured at the beginning and end of each treatment period, including the Self-Rating Anxiety Scale, the Self-Rating Depression Scale, Distress Thermometer, Zarit Burden Interview, Chinese version of the Medical Outcomes Study 12-item Short Form, and Family Carer Satisfaction with Palliative Care scale.Dissemination: The protocol of the study was approved by the Institutional Review Board of the Ethical Committee of the Cancer Hospital, Chinese Academic of Medical Science. The results will be published in a peer-reviewed medical journal. The study is registered at Chinese Clinical Trials Registry with the trial registration number chiCTR2000033707. This study employs an innovative methodological approach on the effectiveness of MBSR and psychological consultation guided by the NST for psychological status of FCs of advanced cancer patients. The findings of the study will be helpful to provide high-quality evidence-based medical data for psychological intervention of FCs of advanced cancer patients, and guide clinicians on best quality treatment recommendations. (shrink)

The aims of this study were to examine the effectiveness of a range of smartphone apps for managing symptoms of anxiety and depression and to assess the utility of a single-case research design for enhancing the evidence base for this mode of treatment delivery. The study was serendipitously impacted by the COVID-19 pandemic, which allowed for effectiveness to be additionally observed in the context of significant community distress. A pilot study was initially conducted using theSuperBetter app to evaluate the proposed (...) methodology, which proved successful with the four finishing participants. In the main study, 39 participants commenced, with 29 finishing the intervention phase and completing post-intervention measures. At 6-month follow-up, a further three participants could not be contacted. This study used a digitally enhanced, multiple baseline across-individuals single-case research design. Participants were randomly assigned to the following apps:SuperBetter,Smiling Mind,MoodMission,MindShift, andDestressify. Symptomatology and life functioning were measured at five different time points: pre-baseline/screening, baseline, intervention, 3-week post-intervention, and 6-month follow-up. Detailed individual perceptions and subjective ratings of the apps were also obtained from participants following the study’s completion. Data were analyzed using visual inspection, time-series analysis, and methods of statistical and clinical significance. Positive results were observed for all apps. Overall, more favorable outcomes were achieved by younger participants, those concurrently undertaking psychotherapy and/or psychotropic medication, those with anxiety and mixed anxiety and depression rather than stand-alone depression, and those with a shorter history of mental illness. Outcomes were generally maintained at 6-month follow-up. It was concluded that a diverse range of evidence-based therapies offered via apps can be effective in managing mental health and improving life functioning even during times of significant global unrest and, like all psychotherapies, are influenced by client features. Additionally, this single-case research design is a low-cost/high value means of assessing the effectiveness of mental health apps.Clinical Trial Registration: The study is registered with the Australian and New Zealand Clinical Trials Registry, which is a primary registry in the World Health Organization Registry Network, registration number ACTRN12619001302145p. (shrink)

Background Previous reports have described that simple cognitive training using reading aloud and solving simple arithmetic calculations, so-called “learning therapy”, can improve executive functions and processing speed in the older adults. Nevertheless, it is not well-known whether learning therapy improve a wide range of cognitive functions or not. We investigated the beneficial effects of learning therapy on various cognitive functions in healthy older adults. Methods We used a single-blinded intervention with two groups (learning therapy group: LT and waiting list control (...) group: WL). Sixty-four elderly were randomly assigned to LT or WL. In LT, participants performed reading Japanese aloud and solving simple calculations training tasks for 6 months. WL did not participate in the intervention. We measured several cognitive functions before and after 6 months intervention periods. Results Compared to WL, results revealed that LT improved inhibition performance in executive functions (Stroop: LT (Mean = 3.88) vs. WL (Mean = 1.22), adjusted p =.013 and reverse Stroop LT (Mean = 3.22) vs. WL (Mean = 1.59), adjusted p =.015), verbal episodic memory (logical memory: LT (Mean = 4.59) vs. WL (Mean = 2.47), adjusted p =.015), focus attention(D-CAT: LT (Mean = 2.09) vs. WL (Mean = -0.59), adjusted p =.010) and processing speed compared to the waiting list control group (digit symbol coding: LT (Mean = 5.00) vs. WL (Mean = 1.13), adjusted p =.015 and symbol search: LT (Mean = 3.47) vs. WL (Mean = 1.81), adjusted p =.014). Discussion This RCT can showed the benefit of learning therapy on inhibition of executive functions, verbal episodic memory, focus attention, and processing speed in healthy elderly people. Our results were discussed under overlapping hypothesis. Trial registration “This trial was registered in The University Hospital Medical Information Network Clinical Trials Registry (UMIN000006998).”. (shrink)

BackgroundAlthough a large number of clinical trials on interventions demonstrating efficacy (or lack thereof) are conducted annually, much of this evidence is not accessible to scientists and clinicians.ObjectivesWe aimed to determine the publication rate of posttraumatic stress disorder (PTSD) trials that have been registered in clinical trial registries, and the factors associated with publication.MethodsTrials, completed on January 15, 2015, were identified via the US National Institutes of Health clinical trials registry, the European Union Clinical Trials Register and the WHO (...) International Clinical Trials Registry Platform. A systematic search for publications (published by the end of March 2018) related to each of the registered trials were then performed.ResultsFour hundred and thirty-eight of 1982 potentially eligible trials were included. Only 34% of interventional trials were registered prior to initiation, 9% were registered within 2 months of starting and 20% after trial completion. Of the 438 included trials, 72% had generated peer-reviewed publications, while an additional 7% had disseminated results in some other form (such as on the trial database), 26 months after trial completion. Randomisation of a trial was the only factor individually associated with publication, in logistic regression analysis (p < 0.001). Intervention type, university as sponsor and study registration prior to completion were factors that influenced the time to publication, using Cox regression (p < 0.001).ConclusionsThis study underscores the importance of timely and accurate publication and dissemination of trial results, in order to avoid the potential waste of resources and to ensure research integrity and patient safety. We suggest that authors and journal editors adhere to conditions set out by the International Committee of Medical Journal Editors and that more diligent data sharing is encouraged through prospective trial registration and trial reporting websites. (shrink)

Finland has aimed to make itself an international leader in genomic research and related business and, in working towards that goal, has enacted biobank legislation. The Biobank Act requires biobanks to gain approval, be supervised, and register at the national level. Numerous other laws may also apply in any given research setting, such as the Personal Data Act, the Medical Research Act, and the Act on Medical Use of Human Organs and Tissues. In terms of privacy protection, anonymization (...) is generally not permitted under Finnish law and therefore most biobanks pseudonomize data and samples. However, the broad understanding of what is identifiable data in Finland has created difficulties in sharing with non-EU countries. Furthermore, consent to biobank research is only applicable to the sample and related data, not to data stored in other health-related registries, and consent is only to the field of research for that particular biobank. These restrictions impede the sharing of samples and data for research. (shrink)

The outsourcing and offshoring of clinical trials has expanded a global field of experimental activity. This essay addresses the competitive logic and social norms by which a field of human subjects research for drug development has taken form. The clinical trials industry and its move to low- and middle-income countries serve as a telescope into the global clinical trial and how it is crafted and made to work in different locales. Lives often depend on new medical commodities as they (...) enter the value chains of transnational medicine and capital. Transparency remains a key problem. The essay explores the politics of creating centralized registries through which the scope of this experimental enterprise might be known. As the engine of pharmaceutical research molds itself to international and national regulatory norms, detection of adverse risk can be deferred or minimized. The essay also points to policy gaps with respect to how the benefits and insecurities of global experiments are distributed as well as to emergent political practices of care and accountability. (shrink)

Many if not most sperm donors in the early years of IVF donated under conditions of anonymity. There is, however, a growing awareness of the ethical cost of withholding identifying parental information from donor children. Today, anonymous donation is illegal in many jurisdictions, and some jurisdictions have gone as far as retrospectively invalidating contracts whereby donors were guaranteed anonymity. This article provides a critical evaluation of the ethics and legality of anonymous donation. We defend Australian and British legislation that has (...) outlawed donor anonymity, and we argue for the establishment of a central registry that provides donor children with the ability to easily and reliably access identifying information about their donor parents. (shrink)

In Japan, discussion concerning advance directives (ADs) has been on the rise during the past decade. ADs are one method proposed to facilitate the process of communication among patients, families and health care providers regarding the plan of care of a patient who is no longer capable of communicating. In this paper, we report the results of the first in-depth survey on the general population concerning the preferences and use of ADs in Japan. A self-administered questionnaire was sent via mail (...) to a stratified random sampling of 560 residents listed in the residential registry of one district of Tokyo, Japan (n = 165,567). Association between correlating factors and specific preferences toward ADs was assessed using contingency table bivariate analysis and multivariate regression model to estimate independent contribution. Of the 560 questionnaires sent out, a total of 425 participants took part in the survey yielding a response rate of 75.9 %. The results of the present study indicate that: 1) the most important components to be addressed are the specifics of medical treatment at the end of life stage and disclosure of diagnosis and prognosis; 2) the majority of participants found it suitable to express their directives by word to family and/or physician and not by written documentation; 3) there is no strong need for legal measures in setting up an AD; 4) it is permissible for family and physician to loosely interpret one's directives; 5) the most suitable proxy is considered to be a family member, relative, or spouse. Multivariate analysis found the following five factors as significantly associated with preferences: 1) awareness regarding living wills, 2) experience with the use of ADs, 3) preferences for end-of-life treatment, 4) preferences for information disclosure, and 5) intentions of creating a will. Written ADs might be useful in the Japanese setting when the individual either wishes: 1) to not provide a lot of leeway to surrogates and/or caregivers, and/or 2) to ensure his or her directives in the cases of terminal illness, brain death, and pain treatment, as well as regarding information disclosure. (shrink)

Homeopathy is a non-traditional medical treatment which came to Europe a few hundred years ago and is presently attributed to the complementary and alternative medicine. Although the assessment of evidence on effectiveness of homeopathic medicinal products has been very contradictory, homeopathy in practice is the only form of alternative medicine that has received certain legal recognition. The paper focuses on the study of the legal regulation of homeopathy in the European Union and in national law. The author analyses the (...) contents of the concept of ‘homeopathic medicinal product’ and the EU legal norms on harmonisation of procedures for registry of homeopathic medicinal products in the Member States. It is concluded that the market of homeopathic medicinal products in the EU still lacks coherence and unity. (shrink)

Organ transplantation and donation has been a perennial topic of discussion in medical ethics since transplantation first became possible. In this issue there are two articles discussing ways in which the number of organ donations could be increased in an ethically acceptable way. De Wispelaere and Stirton identify the de facto ‘family veto’ as one major problem in cadaveric organ donation . They suggest that one way of overcoming this problem would be through a specific advance commitment device which (...) can increase the chance that a person's prior commitment to donate is actually acted upon when the person has died. Their concrete suggestion is that potential donors who register with organ donor registries should not only register their intention to donate but should also appoint a designated second consenter . The DSC would be a person that was committed to upholding the donor's decision after the death of the donor. The …. (shrink)

Background: The rapid pace of progress in medical research, the consequent need for the timely transfer of new knowledge into practice, and the increasing need for ethics support, is making the work of Ethics Committees (ECs) ever more complex and demanding. As a response, ECs in many countries exhibit large variation in number, mandate, organization and member competences. This cross-sectional study aims to give an overview of the different types of activities of Italian ECs and favour discussion at a (...) European level.Methods: A questionnaire was emailed to all Italian Ethics Committees contained in the national Registry of the Ministry of Health, enquiring whether the EC was conducting, or planning to conduct, 4 specific activities. A telephone interview was conducted to determine reasons for failure to respond.Results: Response rate was 53% (101 respondents out of 191). 20% of ECs restrict their responsibilities to research protocol review, 25% also offer ethical consultation to institutions, support on individual health care decisions and promotes educational initiatives, while the remaining 50% conduct a few of the examined activities to varying degrees. Large variation was observed across different types of hosting institutions and geographical locations.Conclusions: A common European model should be developed, defining EC functions, member selection modalities, necessary member competences, decision-making criteria and measures for work verification. In the absence of sound empirical evidence, it would be interesting to study the effectiveness and efficiency of the different existing models. (shrink)

Introduction In 2007, a national review committee was instituted in The Netherlands to review cases of active ending of life for newborns. It was expected that 15–20 cases would be reported. To date, however, only one case has been reported to this committee. Reporting is essential to obtain societal control and transparency; the possible explanations for this lack of reporting were therefore explored. Methods Data on end-of-life decision-making were scrutinised from Dutch nation-wide studies (1995, 2001 and 2005), before institution of (...) the committee. Physicians received a questionnaire about their medical decision-making for stratified samples of deceased infants up to 1 year, drawn from the central death registry. Results In 2005, 58% of all deaths were preceded by an end-of-life decision, compared with 68% in 2001 and 62% in 1995. The use of drugs with a possible life-shortening effect tended to be lower. In 2005, all four cases in the study in which an infants' life was actively ended were preceded by a decision to forego life-prolonging treatment. In three cases, the infant's life expectancy was short; one case involved a longer life expectancy. Discussion The expected number of cases is probably an overestimation due to changes in medical practice such as the tendency to attribute less life-shortening effects to opioids. The lack of reports is probably also associated with requirements in the regulation; it may be difficult to fulfil them due either to time constraints or the nature of the suffering that is addressed. If societal control of active ending of life is considered useful, changes in the regulation may be needed. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Organ Transplant AllocationPat Milmoe McCarrick (bio)The introduction of the antibiotic, cyclosporin, which enhances the success rate of transplantation surgery, has resulted in the steady growth of organ transplantation since the mid-1980s. This growth increasingly focuses ethical interest on both the procurement and the allocation of human organs. Not everyone who might benefit from organ transplants can receive them since the number of patients in need of organs far exceeds (...) the number of organs available. Each year the waiting list for transplants increases by 20 percent, but the number of donated organs has remained stable for the past five years (Lawry 1994).Organ transplantation surgery performed on rock stars, sports heroes, politicians, and television celebrities brings questions about the fair allocation of scarce resources to the attention of everyone. Abigail Trafford, editor of Washington Post Health, wonders whether "new livers for hard livers" can be deserved when not enough organs are available for everyone who needs them. Writing about the dilemma of just allocation of organs, she calls famous recipients "poster patients" or "health care celebrities of medical catastrophe" (Trafford 1994). Personal responsibility—the viewpoint that "medical treatment should not be an entitlement program for profligate living"—is an emerging moral consideration according to Trafford. Deciding whose standards and values should apply to the allocation of organs raises many questions. Popular arguments for keeping the current criteria for allocation include: these patients are sick and therefore should be treated, regardless of the cause of their illness; former substance abusers should be able to benefit from their present abstention; physicians should treat anyone who is ill; and although many human illnesses may be caused by individual behavior, such behavior is not always used as a reason to deny care (Trafford 1995).Prior to 1984, when the government established regulations governing organ transplantation, organs routinely were given to the patients of the surgeons who excised them (Prottas 1994). In an effort to achieve a more equitable method of distribution, Congress passed the National Organ Transplant Act of 1984 (Pub. [End Page 365] L. No. 98-507, amended by Pub. L. No. 100607 and Pub. L. No. 101-616), which established a national Organ Procurement and Transplantation Network (OPTN) to improve the effectiveness of organ procurement, organ distribution, and transplant activities. The United Network for Organ Sharing (UNOS) received the federal government contract to be the OPTN.UNOS and its 66 regional organ procurement organizations (OPOs) around the nation have carried out the mandate since 1986. It requires hospitals that receive Medicare or Medicaid funds and perform transplants to belong to the network and to allocate organs according to network policies. UNOS maintains the national computer registry to match donor organs with individual recipients. In distributing organs, UNOS is required by law to use a fair and equitable system based on accepted medical criteria. UNOS regularly reevaluates its policies to ensure that organ donation and recipient selection meet criteria of efficiency and equity (UNOS Update 11 (8), 1995).At the end of June 1995, 278 transplant centers were in operation in the United States: almost all of them (247 centers) transplanted kidneys; 167 did hearts; 119, pancreases; 114, livers; 93, heart-lung; 88, lungs; 26, intestines; and only 19 centers performed pancreas islet cell transplants (UNOS Update 11 (8): 28, 1995). The number of patients waiting for organ transplants in July 1995 totalled 41,075: 29,274 were waiting for a kidney transplant; 4,937, liver; 3,298, heart; 1,816, lung; 1,223 kidney-pancreas; 240, pancreas; and 211, heart-lung (UNOS Update 11 (8): 40-41, 1995).OPOs are located in different geographic areas across the country, each with different organ needs, lengths of waiting lists, or with lists in areas with large older populations making it more difficult to find suitable donors. Black recipients often wait longer due to complex reasons including sensitization or rarer blood and antigen types (UNOS 11 (8): 31-32, 1995). When an organ becomes available, the OPO involved identifies a potential recipient from the UNOS list and offers it to the patient's surgeon. If no match can be made locally, the organ is next offered within a UNOS region, and finally, to... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 13.1 (2003) 51-52 [Access article in PDF] Congress Considers Incentives for Organ Procurement Alexander S. Curtis [Tables]During the 108th Congressional session, several bills pertaining to ethical incentives for organ donation likely will be introduced. In some cases, they will be similar to bills before the 107th Congress (see Table 1). Bills in both the House of Representatives and the Senate address the establishment and (...) maintenance of donor registries, financial reimbursements for medical and nonmedical expenses incurred by qualifying donors, the presentation of commemorative medals, and tax credits.A bill entitled "Gift of Life Congressional Medal Act" (introduced last year by Senate majority leader Bill Frist (R-TN) as Senate Bill 325), and its corresponding bill of the same title (passed in the House of Representatives last year as H.R. 708), would establish a congressional commemorative medal honoring "any organ donor, or the family or family member of any organ donor." The medal is to be designed and struck with "suitable emblems, devices, and inscriptions" by the Secretary of the Treasury. The eligible donor or donor's family member would be presented with the medal by the Secretary of Health and Human Services. This bill would establish qualifying donations as those of human kidneys, livers, hearts, lungs, pancreases, or any other organ, but excludes corneas and eyes.Another bill, introduced by Representative Michael Bilirakis (R-FL) entitled "Organ Donation Improvement Act" (H.R. 624), would award grants or contracts to states, transplant centers, and qualified organ procurement organizations for the purpose of providing travel, subsistence, and incidental nonmedical expenses to individuals who make living donations. In order to receive reimbursement, the donating individuals must reside in states other than the states in which the intended recipients reside and the annual income of those receiving the organs cannot exceed $35,000. The bill also would appropriate $15,000,000 to make grants to states and public and nonprofit entities for the purpose of carrying out studies, public education demonstrations, and outreach activities "designed to increase the number of organ donors within the state." The bill would be effective from time of enactment through 2005. [End Page 51]Two other bills proposed within the House of Representatives in 2002 called for amendment to the Internal Revenue Code. The "Gift of Life Tax Credit Act (introduced as H.R. 1872 by Representative James Hansen (R-UT)) and the "Help Organ Procurement Expand Act" (introduced as H.R. 2090 by Representative Chris Smith (R-NJ)) present a refundable credit to individuals or to the estates of those who agree either to be living donors or to donate their organs upon death. The "Gift of Life Tax Credit Act" refunds $10,000 to the estates of eligible individuals "for the taxable year which includes the date of the individual's death." The "Help Organ Procurement Expand Act" offers a refund of $2,500 to qualified persons. Donations of kidneys, livers, pancreases, islet cells, lungs, and intestines are accepted, however several conditions restrict permissible donors. The "Gift of Life Tax Credit Act" requires that the legally competent individual's death not be due to a suicide and that the intention to donate was clearly declared. The "Help Organ Procurement Expand Act" prohibits donations from individuals who were killed with physician assistance, died as a result of a suicide, have been indicted or convicted of a felony or a misdemeanor offense, or are actively under criminal investigation for a possible felony offense. The "Help Organ Procurement Expand Act" also restricts procuring organs from unborn children or human fetuses and under circumstances in which the living donor would be subject to "unacceptable levels of medical risk of death or permanent debilitation." Alexander S. Curtis is a research assistant at the Kennedy Institute of Ethics, Georgetown University, Washington, DC. He received his bachelor's degree from Miami University.... (shrink)