Abstract:
BACKGROUND:Between 2013 and 2016, West Africa experienced the largest ever outbreak of Ebola Virus Disease. In the absence of registered treatments or vaccines to control this lethal disease, the World Health Organization coordinated and supported research to expedite identification of interventions that could control the outbreak and improve future control efforts. Consequently, the World Health Organization Research Ethics Review Committee (WHO-ERC) was heavily involved in reviews and ethics discussions. It reviewed 24 new and 22 amended protocols for research studies including interventional (drug, vaccine) and observational studies. WHO-ERC REVIEWS:WHO-ERC provided the reviews within on average 6 working days. The WHO-ERC often could not provide immediate approval of protocols for reasons which were not Ebola Virus Disease specific but related to protocol inconsistencies, missing information and complex informed consents. WHO-ERC considerations on Ebola Virus Disease specific issues (benefit-risk assessment, study design, exclusion of pregnant women and children from interventional studies, data and sample sharing, collaborative partnerships including international and local researchers and communities, community engagement and participant information) are presented. CONCLUSIONS:To accelerate study approval in future public health emergencies, we recommend: (1) internally consistent and complete submissions with information documents in language participants are likely to understand, (2) close collaboration between local and international researchers from research inception, (3) generation of template agreements for data and sample sharing and use during the ongoing global consultations on bio-banks, (4) formation of Joint Scientific Advisory and Data Safety Review Committees for all studies linked to a particular intervention or group of interventions, (5) formation of a Joint Ethics Review Committee with representatives of the Ethics Committees of all institutions and countries involved to strengthen reviews through the different perspectives provided without the 'opportunity costs' for time to final approval of multiple, independent reviews, (6) direct information exchange between the chairs of advisory, safety review and ethics committees, (7) more Ethics Committee support for investigators than is standard and (8) a global consultation on criteria for inclusion of pregnant women and children in interventional studies for conditions which put them at particularly high risk of mortality or other irreversible adverse outcomes under standard-of-care.
journal_name
BMC Med Ethicsjournal_title
BMC medical ethicsauthors
Alirol E,Kuesel AC,Guraiib MM,de la Fuente-Núñez V,Saxena A,Gomes MFdoi
10.1186/s12910-017-0201-1subject
Has Abstractpub_date
2017-06-26 00:00:00pages
43issue
1issn
1472-6939pii
10.1186/s12910-017-0201-1journal_volume
18pub_type
杂志文章abstract:BACKGROUND:The work of Research Ethics Boards (REBs), especially when involving genetics research and biobanks, has become more challenging with the growth of biotechnology and biomedical research. Some REBs have even rejected research projects where the use of a biobank with coded samples was an integral part of the s...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/1472-6939-7-4
更新日期:2006-04-06 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:Cancer patients are at risk of developing blood clots in their veins - venous thromboembolism (VTE) - which often takes the form of a pulmonary embolism or deep vein thrombosis. The risk increases with advanced disease. Evidence based treatment is low molecular weight heparin (LMWH) by daily subcutaneous inj...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/1472-6939-13-22
更新日期:2012-09-04 00:00:00
abstract:BACKGROUND:The patenting of human genes has been the subject of debate for decades. While China has gradually come to play an important role in the global genomics-based testing and treatment market, little is known about Chinese scholars' perspectives on patent protection for human genes. METHODS:A content analysis o...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-018-0271-8
更新日期:2018-04-24 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:Intensive care physicians often must rely on substitute decision makers to address all dimensions of the construct of "best interest" for incapable, critically ill patients. This task involves identifying prior wishes and to facilitate the substitute decision maker's understanding of the incapable patient's ...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/1472-6939-11-1
更新日期:2010-02-10 00:00:00
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:Clinical Ethics Committees (CECs) are well established at healthcare institutions in resource-rich countries. However, there is limited information on established CECs in resource poor countries, especially in Africa. This study aimed to establish baseline data regarding existing formal CECs in Africa to rai...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-020-00559-2
更新日期:2020-11-18 00:00:00
abstract:BACKGROUND:Few empirical studies have been found that explore ethical challenges among persons in high public positions that are responsible for elder care. The aim of this paper was to illuminate the meaning of being in ethically difficult situations related to elder care as experienced by high level decision-makers. ...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/1472-6939-8-3
更新日期:2007-04-10 00:00:00
abstract:BACKGROUND:Differences in perception and potential disagreements between parents and professionals regarding the attitude for resuscitation at the limit of viability are common. This study evaluated in healthcare professionals whether the decision to resuscitate at the limit of viability (intensive care versus comfort ...
journal_title:BMC medical ethics
pub_type: 杂志文章,随机对照试验
doi:10.1186/s12910-019-0413-7
更新日期:2019-10-22 00:00:00
abstract:BACKGROUND:Respect for confidentiality is important to safeguard the well-being of patients and ensure the confidence of society in the doctor-patient relationship. The aim of our study is to examine real situations in which there has been a breach of confidentiality, by means of direct observation in clinical practice...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-016-0136-y
更新日期:2016-09-02 00:00:00
abstract:BACKGROUND:Expectations of receiving personal health information as a fringe benefit of biospecimen donation-termed diagnostic misconception-are increasingly documented. We developed an instrument measuring conflation of observational biospecimen-based research and clinical care for use with Latino communities, who may...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-015-0041-9
更新日期:2015-07-17 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:Despite the growing recognition for the need to improve the health of prisoners in Canada and the need for health research, there has been little discussion of the ethical issues with regards to health research with prisoners in Canada. The purpose of this paper is to encourage a national conversation about ...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-017-0189-6
更新日期:2017-04-27 00:00:00
abstract:BACKGROUND:Several charters of rights have been issued in Europe to solemnly proclaim the rights of children during their hospital stay. However, notwithstanding such general declarations, the actual implementation of hospitalized children's rights is unclear. The purpose of this study was to understand to which extent...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-015-0021-0
更新日期:2015-05-13 00:00:00
abstract:BACKGROUND:There is continued need for enhanced medical ethics education across the United States. In an effort to guide medical ethics education reform, we report the first interprofessional survey of a cohort of graduate medical, nursing and allied health professional students that examined perceived student need for...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-020-00468-4
更新日期:2020-04-08 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:The use of tissue collected at a forensic post-mortem for forensic genetics research purposes remains of ethical concern as the process involves obtaining informed consent from grieving family members. Two forensic genetics research studies using tissue collected from a forensic post-mortem were recently ini...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-017-0225-6
更新日期:2017-11-29 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: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 progress of electronic health technologies and biobanks holds enormous promise for efficient research. Evidence shows that studies based on sharing and secondary use of data/samples have the potential to significantly advance medical knowledge. However, sharing of such resources for international collabo...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-020-0448-9
更新日期:2020-01-21 00:00:00
abstract:BACKGROUND:Over the past 25 years, there has been growing recognition of the importance of studying the Ethical, Legal and Social Implications (ELSI) of genetic and genomic research. A large investment into ELSI research from the National Institutes of Health (NIH) Human Genomic Project budget in 1990 stimulated the gr...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-016-0121-5
更新日期:2016-07-08 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:Studies on informed consent to medical research conducted in low or middle-income settings have increased, including empirical investigations of consent to genetic research. We investigated voluntary participation and comprehension of informed consent among women involved in a genetic epidemiological study o...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/1472-6939-15-38
更新日期:2014-05-13 00:00:00
abstract:BACKGROUND:The study examined the knowledge and attitudes to personal genomics testing for complex diseases among Nigerians and identified how the knowledge and attitudes vary with gender, age, religion, education and related factors. METHODS:Data were collected using qualitative method in 2 districts of the Federal C...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/1472-6939-15-34
更新日期:2014-04-27 00:00:00
abstract:BACKGROUND:Consenting for retrospective medical records-based research (MR) and leftover tissue-based research (TR) continues to be controversial. Our objective was to survey Saudis attending outpatient clinics at a tertiary care hospital on their personal preference and perceptions of norm and current practice in rela...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/1472-6939-11-18
更新日期:2010-10-18 00:00:00
abstract:BACKGROUND:Implementation science research, especially when using participatory and co-design approaches, raises unique challenges for research ethics committees. Such challenges may be poorly addressed by approval and governance mechanisms that were developed for more traditional research approaches such as randomised...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-015-0072-2
更新日期:2015-11-16 00:00:00
abstract:BACKGROUND:Community consultation is increasingly recommended, and in some cases, required by ethical review boards for research that involves higher levels of ethical risk such as international research and research with vulnerable populations. In designing a randomised control trial of a mental health intervention us...
journal_title:BMC medical ethics
pub_type: 杂志文章,随机对照试验
doi:10.1186/s12910-015-0032-x
更新日期:2015-06-02 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: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