The ethical justification for inclusion of neonates in pragmatic randomized clinical trials for emergency newborn care.

BACKGROUND: Research guidelines generally recognize vulnerable populations to include neonates with the aim of enhancing protections from harm. In practice, such guidance results in limiting participation in randomized clinical trials (RCTs). Yet while medical care of neonates should be based on best research evidence to ensure that safe, efficacious treatment or procedures are used, this seldom happens in contemporary practice. DISCUSSION: The compelling need to generate information on effectiveness and safety of procedures and medications that are already in use during neonatal care has led to increase in calls for pragmatic randomized clinical trials (PCTs). This raises ethical concerns as to whether exclusion of the vulnerable populations from research participations constitutes harm. First, neonates are denied access to both potentially beneficial research outputs and an opportunity to generate data on how interventions or medications perform in diverse clinical settings and inform clinical decision-making. Secondly, risks and harms in PCTs may differ from traditional RCTs, and can be reduced by modifications in study designs. The latter may involve assessment of effectiveness of comparable medication, devices or practices (whose safety data is available), randomization at the group level rather than at the individual level, avoidance of invasive and innovative study procedures, reliance on locally available data on relevant patient outcomes, and employment of procedures that tend to meet the criteria of minimal risk for human subject research. Thirdly, informed consent procedures should be modified from those of traditional RCTs, as neonates in traditional RCTs may be vulnerable to different extents in PCTs. Lastly, regulatory and oversight procedures designed for traditional RCT settings need modification, as they may not be translatable, feasible, appropriate or even ethical to apply in PCTs. CONCLUSION: The principle of justice, commonly interpreted as preventing an inequitable burden of research, should also allow fair access to potential benefits from PCTs for neonates and other vulnerable populations. Under certain conditions, prospective randomized trials involving neonates should be ethically permissible to allow inclusion of neonates in research. This may require modification of the research design, consent procedures or regulations for research oversight.

Gatekeeping hormone replacement therapy for transgender patients is dehumanising.

Although informed consent models for prescribing hormone replacement therapy are becoming increasingly prevalent, many physicians continue to require an assessment and referral letter from a mental health professional prior to prescription. Drawing on personal and communal experience, the author argues that assessment and referral requirements are dehumanising and unethical, foregrounding the ways in which these requirements evidence a mistrust of trans people, suppress the diversity of their experiences and sustain an unjustified double standard in contrast to other forms of clinical care. Physicians should abandon this unethical requirement in favour of an informed consent approach to transgender care.

Narratives and gatekeeping: making sense of triage nurses' practice.

It is well documented that emergency service staff consider some patients to be 'inappropriate attenders'. A central example is 'trivia', denoting patients with medical problems considered too 'trivial' to warrant attention. Although research has repeatedly shown that frontline staff violate guidelines in turning away 'trivial' patients, existing research has paid insufficient attention to why staff are willing to engage in guideline-violating gatekeeping, which may put both themselves and 'trivial' patients at risk. To address this issue, the present article explores nurses' narratives about 'trivial' patients - referred to in this context as 'GP patients' - drawing on fieldwork data from a Norwegian emergency service. The article reconstructs three narrative clusters, showing that nurses' gatekeeping is motivated by concerns for the patient being turned away, for nurses and more critically ill patients, and for the service they work for. Some of the issues embedded in these narratives have been under-analysed in previous research - most importantly, the role of identity and emotion in nurses' gatekeeping, and how patient narratives can function as 'social prognoses' in nurses' assessments. Analysis of these narratives also reveals an antagonistic relationship between nurses and 'trivial' patients that contradicts nurses' ethical guidelines and indicates a need for healthcare reform.

A systematic review of reasons for gatekeeping in palliative care research.

BACKGROUND: When healthcare professionals or other involved parties prevent eligible patients from entering a trial as a research subject, they are gatekeeping. This phenomenon is a persistent problem in palliative care research and thought to be responsible for the failure of many studies. AIM: To identify potential gatekeepers and explore their reasons for gatekeeping in palliative care research. DESIGN: A 'Review of Reasons' based on the systematic Preferred Reporting Items for Systematic Reviews and Meta-Analyses approach and a thematic synthesis. DATA SOURCE: PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature and PsycINFO from 2000 to May 20 2015 were searched. Studies in children (aged <18 years) and patients with dementia were excluded. RESULTS: Thirty papers on gatekeeping in palliative care research were included. Five groups of potential gatekeepers were identified: healthcare professionals, research ethics committees, management, relatives and researchers. The fear of burdening vulnerable patients was the most reported reason for gatekeeping. Other reasons included 'difficulty with disclosure of health status', 'fear of burdening the patient's relatives', 'doubts about the importance or quality of the study', 'reticent attitude towards research and (research) expertise' and 'logistics'. In hospice and homecare settings, the pursuit of comfort care may trigger a protective attitude. Gatekeeping is also rooted in a (perceived) lack of skills to recruit patients with advanced illness. CONCLUSION: Gatekeeping is motivated by the general assumption of vulnerability of patients, coupled with an emphasis on the duty to protect patients. Research is easily perceived as a threat to patient well-being, and the benefits appear to be overlooked. The patients' perspective concerning study participation is needed to gain a full understanding and to address gatekeeping in palliative care research.

The ethics of cluster-randomized trials requires further evaluation: a refinement of the Ottawa Statement.

OBJECTIVES: The Ottawa Statement is the first guidance document for the ethical and scientific conduct of cluster-randomized trials (CRTs). However, not all recommendations are straightforward to implement. In this paper we will reflect in particular on the recommendation on identifying human research subjects and the issue to what extent the randomization process should be disclosed if there is a risk of contamination. STUDY DESIGN AND SETTING: The Ottawa Statement was thoroughly evaluated within a multidisciplinary research team, consisting amongst others of epidemiologists and ethicists. RESULTS: Patients in a CRT may also be considered as research subjects if they are indirectly affected by the studied interventions in a CRT. Second, health care workers are research subjects in CRTs but have a different moral status compared with ordinary research participants. This different status has implications for withdrawal and the choice of the primary objective. Third, modified informed consent for CRTs may be obtained when researchers can demonstrate that disclosure of the randomization process would affect the validity of a CRT. CONCLUSION: Recommendations of the Ottawa Statement on identifying the research subject and providing informed consent can and should be refined.

How organizational context affects bioethical decision-making: pharmacists' management of gatekeeping processes in retail and hospital settings.

Social science studies of bioethics demonstrate that ethics are highly contextual, functioning differently across local settings as actors make daily decisions "on the ground." Sociological studies that demonstrate the key role organizations play in shaping ethical decision-making have disproportionately focused on physicians and nurses working in hospital settings where they contend with life and death issues. This study broadens our understanding of the contexts of ethical decision-making by empirically examining understudied healthcare professionals - pharmacists - working in two organizational settings, retail and hospital, where they act as gatekeepers to regulated goods and services as they contend with ethical issues ranging from the serious to the mundane. This study asks: How do organizations shape pharmacists' identification, negotiation, and resolution of ethical challenges; in other words, how do organizations shape pharmacists' gatekeeping processes? Based on 95 semi-structured interviews with U.S. pharmacists practicing in retail and hospital pharmacies conducted between September 2009 and May 2011, this research finds that organizations influence ethical decision-making by shaping how pharmacists construct four gatekeeping processes: medical, legal, fiscal, and moral. Each gatekeeping process manifests differently across organizations due to how these settings structure inter-professional power dynamics, proximity to patients, and means of accessing information. Findings suggest new directions for theorizing about ethical decision-making in medical contexts by drawing attention to new ethical actors, new organizational settings, an expanded definition of ethical challenges, and a broader conceptualization of gatekeeping.

Law, bioethics and practice in France: forging a new legislative pact.

In France, bioethics norms have emerged in close interaction with medical practices. The first bioethics laws were adopted in 1994, with provisions for updates in 2004 and most recently, in 2011. As in other countries, bioethics laws indirectly refer to certain fundamental values. The purpose of this paper is threefold. First, I shall briefly describe the construction of the French bioethics laws and the values they are meant to protect. Secondly, I will show that the practice of clinical ethics, as reported in a few studies on ART, living organ donation and PGD, challenge the role attributed to doctors as "gatekeepers" of those fundamental values. Thirdly, I will suggest that the quality of medical practices would improve if the law focused on strengthening the tacit pact between doctors and patients, rather than putting doctors in charge of enforcing societal values. Doctors, for their part, would limit their role to what they can do best: provide sufficient patient support and safe care. Against those who argue that we should dispense with bioethics laws altogether, I hold that the laws are useful in order to limit the development of abusive practices. However, a new legislative approach should be adopted which would a positive presumption in favor of patients' requests.

Administrative gatekeeping - a third way between unrestricted patient advocacy and bedside rationing.

The inevitable need for rationing of healthcare has apparently presented the medical profession with the dilemma of choosing the lesser of two evils. Physicians appear to be obliged to adopt either an implausible version of traditional professional ethics or an equally problematic ethics of bedside rationing. The former requires unrestricted advocacy of patients but prompts distrust, moral hazard and unfairness. The latter commits physicians to rationing at the bedside; but it is bound to introduce unfair inequalities among patients and lack of political accountability towards citizens. In this paper I shall argue that this dilemma is false, since a third intermediate alternative exists. This alternative, which I term 'administrative gatekeeping', makes it possible for physicians to be involved in rationing while at the same time being genuine advocates of their patients. According to this ideal, physicians are required to follow fair rules of rationing adopted at higher organizational levels within healthcare systems. At the same time, however, they are prohibited from including considerations of cost in their clinical decisions.