Abstract:
BACKGROUND:Expanded access is the use of investigational drugs (IDs) outside of clinical trials. Generally it is performed in patients with serious and life-threatening diseases who cannot be treated satisfactorily with authorized drugs. Legal regulations of expanded access to IDs have been introduced among others in the USA, the European Union (EU), Canada and Australia. In addition, in the USA an alternative to expanded access is treatment under the Right-to-Try law. However, the treatment use of IDs is inherently associated with a number of ethically relevant problems. MAIN TEXT:The objective of this article is to present a coherent framework made up of eight requirements which have to be met for any treatment use of an ID to be ethical. These include a justified need for the use of an ID, no threat to clinical development of the ID, adequate scientific evidence to support the treatment, patient's benefit as the primary goal of the use of an ID, informed decision of a patient, fair access of patients to IDs, independent review, as well as the dissemination of treatment results. CONCLUSIONS:While this framework is essentially consistent with the legal regulations of expanded access of the USA, the EU, Canada and Australia, it is substantially wider in scope because it addresses some important issues that are not covered by the regulations. Overall, the framework that we developed minimizes the risks and threats, and maximizes potential benefits to each of the four key stakeholders involved in the treatment use of IDs including patients, doctors, drug manufacturers, and society at large.
journal_name
BMC Med Ethicsjournal_title
BMC medical ethicsauthors
Borysowski J,Górski Adoi
10.1186/s12910-020-00560-9subject
Has Abstractpub_date
2020-11-18 00:00:00pages
116issue
1issn
1472-6939pii
10.1186/s12910-020-00560-9journal_volume
21pub_type
杂志文章abstract:BACKGROUND:A child is a developing person with evolving capacities that include autonomy, mental (decisional) capacity and capacity to assume responsibility. Hence, children are entitled to participatory (autonomy) rights in South Africa as observed in the Children's Act 38 of 2005. According to section 129 of the Act ...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-016-0150-0
更新日期:2016-11-02 00:00:00
abstract:BACKGROUND:How should clinical ethics support services such as clinical ethics committees (CECs) be implemented and evaluated? We argue that both the CEC itself and the implementation of the CEC should be considered as 'complex interventions'. MAIN TEXT:We present a research project involving the implementation of CEC...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-020-00522-1
更新日期:2020-09-01 00:00:00
abstract:BACKGROUND:Health checks or health screenings identify (risk factors for) disease in people without a specific medical indication. So far, the perspective of (potential) health check users has remained underexposed in discussions about the ethics and regulation of health checks. METHODS:In 2017, we conducted a qualita...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-018-0301-6
更新日期:2018-06-22 00:00:00
abstract:BACKGROUND:Few studies have examined factors associated with willingness of people living with HIV (PLHIV) to participate in HIV treatment clinical trials in Sub-Saharan Africa. We assessed the factors associated with participation of PLHIV in HIV treatment clinical trials research at a large urban clinical and researc...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-020-00516-z
更新日期:2020-08-24 00:00:00
abstract:BACKGROUND:Professional guidelines have addressed ethical dilemmas posed by a few types of nontraditional procreative arrangements (e.g., gamete donations between family members), but many questions arise regarding how providers view and make decisions about these and other such arrangements. METHODS:Thirty-seven ART ...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-017-0177-x
更新日期:2017-02-28 00:00:00
abstract:BACKGROUND:The use of empirical research methods in bioethics has been increasing in the last decades. It has resulted in discussions about the 'empirical turn of bioethics' and raised questions related to the value of empirical work for this field, methodological questions about its quality and rigor, and how this int...
journal_title:BMC medical ethics
pub_type: 杂志文章,多中心研究
doi:10.1186/s12910-017-0239-0
更新日期:2017-12-22 00:00:00
abstract:BACKGROUND:DNR decisions are frequently made in oncology and hematology care and physicians and nurses may face related ethical dilemmas. Ethics is considered a basic competence in health care and can be understood as a capacity to handle a task that involves an ethical dilemma in an adequate, ethically responsible man...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-018-0300-7
更新日期:2018-06-19 00:00:00
abstract:BACKGROUND:The increased use of human biological material for cell-based research and clinical interventions poses risks to the privacy of patients and donors, including the possibility of re-identification of individuals from anonymized cell lines and associated genetic data. These risks will increase as technologies ...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/1472-6939-15-7
更新日期:2014-02-03 00:00:00
abstract:BACKGROUND:Biomarker research is gaining increasing attention focusing on the preclinical stages of the disease. Such interest requires special attention for communication and disclosure in clinical contexts. Many countries give dementia a high health policy priority by developing national strategies and by improving g...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-020-00476-4
更新日期:2020-05-11 00:00:00
abstract:BACKGROUND:Family members do not have an official position in the practice of euthanasia and physician assisted suicide (EAS) in the Netherlands according to statutory regulations and related guidelines. However, recent empirical findings on the influence of family members on EAS decision-making raise practical and eth...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-019-0361-2
更新日期:2019-04-05 00:00:00
abstract:BACKGROUND:Appropriate information and consent has been one of the most intensely discussed topics within the context of biobank research. In parallel to the normative debate, many socio-empirical studies have been conducted to gather experiences, preferences and views of patients, healthy research participants and fur...
journal_title:BMC medical ethics
pub_type: 杂志文章,评审
doi:10.1186/s12910-015-0053-5
更新日期:2015-09-09 00:00:00
abstract:BACKGROUND:Since 2010, the European Journal of Anaesthesiology has required the reporting of five items concerning ethical approval in articles describing human research: ethics committee's name and address, chairperson's name, study's protocol number and approval date. We aimed to assess whether this requirement has h...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-018-0289-y
更新日期:2018-06-08 00:00:00
abstract:BACKGROUND:Moral Case Deliberations (MCDs) are reflective dialogues with a group of participants on their own moral dilemmas. Although MCD is successful as clinical ethics support (CES), it also has limitations. 1. Lessons learned from individual MCDs are not shared in order to be used in other contexts 2. Moral learni...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-018-0335-9
更新日期:2018-12-22 00:00:00
abstract:BACKGROUND:Animal models of human diseases are often used in biomedical research in place of human subjects. However, results obtained by animal models may fail to hold true for humans. One way of addressing this problem is to make animal models more similar to humans by placing human tissue into animal models, renderi...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-019-0345-2
更新日期:2019-01-25 00:00:00
abstract:BACKGROUND:The individual informed consent model remains critical to the ethical conduct and regulation of research involving human beings. Parental informed consent process in a rural setting of northern Ghana was studied to describe comprehension and retention among parents as part of the evaluation of the existing i...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/1472-6939-9-12
更新日期:2008-06-19 00:00:00
abstract:BACKGROUND:In most socialised health systems there are formal processes that manage resource scarcity and determine the allocation of funds to health services in accordance with their priority. In this analysis, part of a larger qualitative study examining the ethical issues entailed in doctors' participation as techni...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-018-0314-1
更新日期:2018-07-24 00:00:00
abstract::The 3rd Pan-African Ethics Human Rights and Medical Law (3rd EHRML) conference was held in Johannesburg on July 7, 2013, as part of the Africa Health Congress. The conference brought together bioethicists, researchers and scholars from South Africa, Zimbabwe, Kenya and Nigeria working in the field of bioethics as well...
journal_title:BMC medical ethics
pub_type:
doi:10.1186/1472-6939-14-S1-S1
更新日期:2013-01-01 00:00:00
abstract:BACKGROUND:Evidence concerning how Japanese physicians think and behave in specific clinical situations that involve withholding or withdrawal of medical interventions for end-of-life or frail elderly patients is yet insufficient. METHODS:To analyze decisions and actions concerning the withholding/withdrawal of life-s...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/1472-6939-8-7
更新日期:2007-06-19 00:00:00
abstract:BACKGROUND:The boundaries between health-related research and practice have become blurred as initiatives traditionally considered to be practice (e.g., quality improvement, program evaluation) increasingly use the same methodology as research. Further, the application of different ethical requirements based on this di...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-015-0039-3
更新日期:2015-07-07 00:00:00
abstract:BACKGROUND:The past 10 years have witnessed a significant growth in sharing of health data for secondary uses. Alongside this there has been growing interest in the public acceptability of data sharing and data linkage practices. Public acceptance is recognised as crucial for ensuring the legitimacy of current practice...
journal_title:BMC medical ethics
pub_type: 杂志文章,评审
doi:10.1186/s12910-016-0153-x
更新日期:2016-11-10 00:00:00
abstract:BACKGROUND:The ethical principle of justice demands that resources be distributed equally and based on evidence. Guidelines regarding forgoing of CPR are unavailable and there is large variance in the reported rates of attempted CPR in in-hospital cardiac arrest. The main objective of this work was to study whether loc...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-019-0439-x
更新日期:2019-12-26 00:00:00
abstract:BACKGROUND:This debate article explores how smart technologies may create a double-edged sword for patient safety and effective therapeutic relationships. Increasing utilization of health monitoring devices by patients will likely become an important aspect of self-care and preventive medicine. It may also help to enha...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-018-0255-8
更新日期:2018-03-06 00:00:00
abstract:BACKGROUND:With a growing number of genetic tests becoming available to the health and consumer markets, genetic health care providers in Canada are faced with the challenge of developing robust decision rules or guidelines to allocate a finite number of public resources. The objective of this study was to gain Canadia...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/1472-6939-10-6
更新日期:2009-06-18 00:00:00
abstract:BACKGROUND:In most Anglophone nations, policy and law increasingly foster an autonomy-based model, raising issues for large numbers of people who fail to fit the paradigm, and indicating problems in translating practical and theoretical understandings of 'good death' to policy. Three exemplar populations are frail olde...
journal_title:BMC medical ethics
pub_type: 杂志文章,评审
doi:10.1186/s12910-016-0129-x
更新日期:2016-07-27 00:00:00
abstract:BACKGROUND:Surgery for intersex infants should be delayed until individuals are able to decide for themselves, except where it is a medical necessity. In an ideal world, this single principle would suffice and such surgeries could be totally prohibited. Unfortunately, the world is not perfect, and, in some places, inte...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-020-00550-x
更新日期:2020-10-29 00:00:00
abstract:BACKGROUND:Plagiarism is considered as serious research misconduct, together with data fabrication and falsification. However, little is known about biomedical researchers' views on plagiarism. Moreover, it has been argued - based on limited empirical evidence - that perceptions of plagiarism depend on cultural and oth...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-020-00473-7
更新日期:2020-06-01 00:00:00
abstract:BACKGROUND:When conducting research with Indigenous populations consent should be sought from both individual participants and the local community. We aimed to search and summarise the literature about methods for seeking consent for research with Indigenous populations. METHODS:A systematic literature search was cond...
journal_title:BMC medical ethics
pub_type: 杂志文章,评审
doi:10.1186/s12910-016-0139-8
更新日期:2016-10-22 00:00:00
abstract:BACKGROUND:Researchers are required to seek consent from Indigenous communities prior to conducting research but there is inadequate information about how Indigenous people understand and become fully engaged with this consent process. Few studies evaluate the preference or understanding of the consent process for rese...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-017-0191-z
更新日期:2017-05-11 00:00:00
abstract:BACKGROUND:Africa continues to bear a disproportionate share of the global HIV/AIDS, tuberculosis (TB) and malaria burden. The development and distribution of safe, effective and affordable vaccines is critical to reduce these epidemics. However, conducting HIV/AIDS, TB, and/or malaria vaccine trials simultaneously in ...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/1472-6939-11-3
更新日期:2010-03-09 00:00:00
abstract:BACKGROUND:Financial relationships between physicians and industry are extensive and public reporting of industry payments to physicians is now occurring. Our objectives were to describe physician recipients of large total payments from these seven companies, and to examine discrepancies between these payments and conf...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/1472-6939-13-24
更新日期:2012-09-26 00:00:00