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Concept: Business ethics

168

BACKGROUND: Due to the important role of depression in major illnesses, screening measures for depression are commonly used in medical research. The protocol for managing participants with positive screens is unclear and raises ethical concerns. The aim of this article is to identify and critically discuss the ethical issues that arise when a positive screen for depression is detected, and offer some guidance on managing these issues. DISCUSSION: Deciding on whether to report positive screens to healthcare practitioners is both an ethical and a pragmatic dilemma. Evidence suggests that reporting positive depression screens should only be considered in the context of collaborative care. Possible adverse effects, such as the impact of false-positive results, potentially inappropriate labelling, and potentially inappropriate treatment also need to be considered. If possible, the psychometric properties of the selected screening measure should be determined in the target population, and a threshold for depression that minimises the rate of false-positive results should be chosen. It should be clearly communicated to practitioners that screening scores are not diagnostic for depression, and they should be informed about the diagnostic accuracy of the measure. Research participants need to be made aware of the consequences of the detection of high scores on screening measures, and to be fully informed about the implications of the research protocol. SUMMARY: Further research is needed and the experiences of researchers, participants, and practitioners need to be collated before the value of reporting positive screens for depression can be ascertained. In developing research protocols, the ethical challenges highlighted should be considered. Participants must be agreeable to the agreed protocol and efforts should be made to minimise potentially adverse effects.

Concepts: Ethics, Morality, Business ethics, Moral psychology

45

A novel Protocol Ethics Tool Kit (‘Ethics Tool Kit’) has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval.

Concepts: Clinical trial, Effectiveness, ClinicalTrials.gov, Clinical research, Ethics, Clinical trial protocol, Business ethics, Institutional review board

30

Research on the history of anatomy in the Third Reich has often concentrated on the influence of the National Socialist (NS) regime on anatomists and their consequent unethical activities. Only recently, the focus has shifted to NS victims whose bodies were used for anatomical purposes. As a first approach to learning more about the victims, this study investigated the persons whose names Hermann Stieve, chairman of the Anatomical Department at the University of Berlin, had listed after using their bodies for his research. The study draws a group portrait and recounts selected biographies of the 174 women and eight men on the list. Most women were of reproductive age, two-thirds were German and a majority was executed for political reasons. Among the executed were at least two pregnant women. The corrected names, biographical data, and nationalities of all persons on the list are published here. None of them volunteered to be dissected, nor were the anatomists at the time interested in the victims' personal background. Future work will have to focus on the investigation of further biographies so that numbers can be turned back into people. This history is a reminder to modern anatomy that ethical body procurement and the anatomists' caring about the body donor is of the utmost importance in a discipline that introduces students to professional ethics in the medical teaching curriculum. Clin. Anat. 26:3-21, 2013. © 2012 Wiley Periodicals, Inc.

Concepts: Ethics, Anatomy, Human anatomy, Business ethics, History of anatomy, Nazi Germany, Nazism, Nazi Party

29

An Essay by A. Cecile Janssens and Peter Kraft discusses the limitations inherent in research involving collection of self-reported data by self-selected participants, and makes proposals for upfront communication of such limitations to study participants.

Concepts: Ethics, Business ethics

28

ABSTRACT:: The increasing use of electronic health records (EHRs) allows for sharing of information across clinicians, quick access to laboratory results, and supports for documentation. However, this environment raises new issues of ethics and privacy, and it magnifies other issues that existed with paper records. In developmental-behavioral pediatrics (DBP) practice, which relies heavily on a team approach to blend pediatrics, mental health, and allied health, these issues are even more complicated. In this review, we highlight the ethical and privacy issues in DBP practice related to EHR use. Case examples illustrate the potential risks related to EHR access, confidentiality, and interprofessional collaboration. Suggestions to mitigate some of the ethical and privacy issues associated with EHRs at both an administrative level and a clinician level are included. With the expected increase in the adoption of EHRs by DBP clinicians in the near future, professional standards will need to be defined, and novel technological solutions may offer additional safeguards. Until then, professionals and organizations are responsible to uphold the standards of ethical practice while promoting effective information exchange to facilitate clinical care.

Concepts: Health care, Medicine, Philosophy, Ethics, Philosophy of life, Morality, Electronic health record, Business ethics

26

Although primarily used for social networking and often used for social support and dissemination, data on social media platforms are increasingly being used to facilitate research. However, the ethical challenges in conducting social media research remain of great concern. Although much debated in the literature, it is the views of the public that are most pertinent to inform future practice.

Concepts: Philosophy, Ethics, Business ethics, Social media

26

To review the belief’s of Jehovah’s Witnesses regarding the use of blood and blood products, and how to ensure that those patients professing to be Jehovah’s Witnesses are treated ethically.

Concepts: Ethics, Business ethics, Blood transfusion, Jehovah's Witnesses, Jehovah, Social philosophy

23

Formal training in pharmacy ethics is relatively new in Croatia, and the professional code of ethics is more than 20 years old. Very little is known about how practicing pharmacists implement ethical considerations and relevant professional guidelines in their work.

Concepts: Ethics, Business ethics, Aristotle, Applied ethics, Professional ethics

15

Through the widespread availability of location-identifying devices, geolocalisation could potentially be used to place athletes during out-of-competition testing. In light of this debate, the WADA Ethics Panel formulated the following questions: (1) should WADA and/or other sponsors consider funding such geolocalisation research projects?, (2) if successful, could they be proposed to athletes as a complementary device to Anti-Doping Administration and Management System to help geolocalisation and reduce the risk of missed tests? and (3) should such devices be offered on a voluntary basis, or is it conceivable that they would be made mandatory for all athletes in registered testing pools? In this position paper, the WADA Ethics Panel concludes that the use of geolocalisation could be useful in a research setting with the goal of understanding associations between genotype, phenotype and environment; however, it recognises that the use of geolocalisation as part of or as replacement of whereabouts rules is replete with ethical concerns. While benefits remain largely hypothetical and minimal, the potential invasion of privacy and the data security threats are real. Considering the impact on privacy, data security issues, the societal ramifications of offering such services and various pragmatic considerations, the WADA Ethics Panel concludes that at this time, the use of geolocalisation should neither be mandated as a tool for disclosing whereabouts nor implemented on a voluntary basis.

Concepts: Following, Phenotype, Device, Ethics, Potential, Business ethics, Socrates, Privacy

10

Young children with cancer are treated with interventions that can have a high risk of compromising their reproductive potential. ‘Fertility preservation’ for children who have not yet reached puberty involves surgically removing and cryopreserving reproductive tissue prior to treatment in the expectation that strategies for the use of this tissue will be developed in the future. Fertility preservation for prepubertal children is ethically complex because the techniques largely lack proven efficacy for this age group. There is professional difference of opinion about whether it is ethical to offer such ‘experimental’ procedures. The question addressed in this paper is: when, if ever, is it ethically justifiable to offer fertility preservation surgery to prepubertal children? We present the ethical concerns about prepubertal fertility preservation, drawing both on existing literature and our experience discussing this issue with clinicians in clinical ethics case consultations. We argue that offering the procedure is ethically justifiable in certain circumstances. For many children, the balance of benefits and burdens is such that the procedure is ethically permissible but not ethically required; when the procedure is medically safe, it is the parents' decision to make, with appropriate information and guidance from the treating clinicians. We suggest that clinical ethics support processes are necessary to assist clinicians to engage with the ethical complexity of prepubertal fertility preservation and describe the framework that has been integrated into the pathway of care for patients and families attending the Royal Children’s Hospital in Melbourne, Australia.

Concepts: Hospital, Surgery, Fertility, Philosophy, Ethics, Puberty, Morality, Business ethics