Abstract:
BACKGROUND:Institutional review boards (IRBs) distinguish health care quality improvement (QI) and health care quality improvement research (QIR) based primarily on the rigor of the methods used and the purported generalizability of the knowledge gained. Neither of these criteria holds up upon scrutiny. Rather, this apparently false dichotomy may foster under-protection of participants in QI projects and over-protection of participants within QIR. DISCUSSION:Minimal risk projects should entail minimal oversight including waivers for informed consent for both QI and QIR projects. Minimizing the burdens of conducting QIR, while ensuring minimal safeguards for QI projects, is needed to restore this imbalance in oversight. Potentially, such ethical oversight could be provided by the integration of Institutional Review Boards and Clinical Ethical Committees, using a more integrated and streamlined approach such as a two-step process involving a screening review, followed by a review by committee trained in QIR. Standards for such ethical review and training in these standards, coupled with rapid review cycles, could facilitate an appropriate level of oversight within the context of creating and sustaining learning health care systems. We argue that QI and QIR are not reliably distinguishable. We advocate for approaches that improve protections for QI participants while minimizing over-protection for participants in QIR through reasonable ethical oversight that aligns risk to participants in both QI and QIR with the needs of a learning health care system.
journal_name
BMC Med Ethicsjournal_title
BMC medical ethicsauthors
Fiscella K,Tobin JN,Carroll JK,He H,Ogedegbe Gdoi
10.1186/s12910-015-0056-2subject
Has Abstractpub_date
2015-09-17 00:00:00pages
63issue
1issn
1472-6939pii
10.1186/s12910-015-0056-2journal_volume
16pub_type
杂志文章,评审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 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:Patient outcome after serious brain injury is highly variable. Following a period of coma, some patients recover while others progress into a vegetative state (unresponsive wakefulness syndrome) or minimally conscious state. In both cases, assessment is difficult and misdiagnosis may be as high as 43%. Recen...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/1472-6939-15-41
更新日期:2014-05-20 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: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:Precision medicine (PM) is an emerging approach to individualized care. It aims to help physicians better comprehend and predict the needs of their patients while effectively adopting in a timely manner the most suitable treatment by promoting the sharing of health data and the implementation of learning hea...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-020-0457-8
更新日期:2020-02-19 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 are often required to act as substitute decision-makers when health care or research participation decisions must be made for an incapacitated relative. Yet most families are unable to accurately predict older adult preferences regarding future health care and willingness to engage in research...
journal_title:BMC medical ethics
pub_type: 杂志文章,随机对照试验
doi:10.1186/1472-6939-13-1
更新日期:2012-01-05 00:00:00
abstract:BACKGROUND:The generation of evidence is integral to the work of public health and health service providers. Traditionally, ethics has been addressed differently in research projects, compared with other forms of evidence generation, such as quality improvement, program evaluation, and surveillance, with review of non-...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/1472-6939-15-61
更新日期:2014-08-08 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:Large-scale linkage of international clinical datasets could lead to unique insights into disease aetiology and facilitate treatment evaluation and drug development. Hereto, multi-stakeholder consortia are currently designing several disease-specific translational research platforms to enable international h...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-019-0359-9
更新日期:2019-03-28 00:00:00
abstract:BACKGROUND:Mobile applications and socio-sexual networking websites are used by outreach workers to respond synchronously to questions and provide information, resources, and referrals on sexual health and STI/HIV prevention, testing, and care to gay, bisexual and other men who have sex with men (GB2M). This explorator...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-017-0216-7
更新日期:2017-11-03 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:A requisite for ethical human subjects research is that participation should be informed and voluntary. Participation during the informed consent process by way of asking questions is an indicator of the extent to which consent is informed. AIMS:The aims of this study were to assess the extent to which pare...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/1472-6939-12-3
更新日期:2011-02-15 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: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:BACKGROUND:Care-dependency constitutes an important issue with regard to the approval of end-of-life decisions, yet attitudes towards assisted suicide and euthanasia are understudied among care-dependent older adults. We assessed attitudes towards assisted suicide and euthanasia and tested empirical correlates, includi...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-017-0233-6
更新日期:2017-12-07 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:The widespread sharing of biologicaConcluding Comments: Teaching Responsible Datal and biomedical data is recognised as a key element in facilitating translation of scientific discoveries into novel clinical applications and services. At the same time, twenty-first century states are increasingly concerned t...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-016-0112-6
更新日期:2016-05-17 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: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 ...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-017-0201-1
更新日期:2017-06-26 00:00:00
abstract:BACKGROUND:In August 2017, Chile lifted its complete ban on abortion by permitting abortion in three limited circumstances: 1) to save a woman's life, 2) lethal fetal anomaly, and 3) rape. The new law allows regulated use of conscientious objection (CO) in abortion care, including allowing institutions to register as o...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/s12910-020-00484-4
更新日期:2020-05-24 00:00:00
abstract:BACKGROUND:Efforts to improve patients' understanding of their own medical treatments or research in which they are involved are progressing, especially with regard to informed consent procedures. We aimed to design a multisource informed consent procedure that is easily adaptable to both clinical and research applicat...
journal_title:BMC medical ethics
pub_type: 杂志文章
doi:10.1186/1472-6939-14-30
更新日期:2013-07-30 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: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: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: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: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: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: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