The contribution of professional autonomy in advancing ethical behaviour: A narrative review of studies in nursing.

AIM: This article explores moral disagreements between nurses and physicians; specifically, we aim to analyse professional nurses' practice in navigating these conflicts. BACKGROUND: Nurses face morally challenging situations while caring for patients when their views on treatments and care may contradict those of physicians. It is important that nurses represent patients' perspectives and are partners in the care decision-making process. EVALUATION: A narrative review was conducted by including peer-reviewed articles in English. A literature search was conducted using the Web of Science database and Google Scholar search engine from 1 December 2021 to 10 February 2022. KEY ISSUES: A total of 27 articles published between 2009 and 2021 were included in the analysis. The following themes were explored in this article: areas in which moral disagreements occur and how these disagreements shape physician-nurse relationships, differences in the status of professional autonomy in nursing in the Baltic states and Nordic countries, and potential directions for nurses' involvement in the decision-making process regarding moral disagreements in nursing practice. CONCLUSIONS: Moral disagreements between nurses and physicians most often occur in situations related to treatment and/or care strategies as well as end-of-life decisions. Nurses' participation in the decision-making process and physicians' willingness to consider nurses' perspectives play a fundamental role in navigating moral conflicts because nurses possess a body of knowledge about their patients that differs from that of physicians. This knowledge is just as worthy as physician knowledge. Considering the level of professional autonomy in specific regions, nurses' involvement in decision-making regarding particular patients' care in the Baltic states seems to be relatively low compared to that in the Scandinavian countries, where nurses have a much wider space for independent decision-making. IMPLICATIONS FOR NURSING MANAGEMENT: Complex moral situations that require the input of both physicians and nurses must be examined and addressed. Several processes may assist in fostering nurses' contributions to decision-making, among which training to effectively deal with morally complex situations and creating an atmosphere conducive to collaboration between physicians and nurses are particularly important.

Health Humanities in Medicina: The Auxiliary Stance.

At the core of medicine is the idea to help fellow human beings by improving or even restoring their health [...].

Controversies between regulations of research ethics and protection of personal data: informed consent at a cross-road.

This paper explores some key discrepancies between two sets of normative requirements applicable to the research use of personal data and human biological materials: (a) the data protection regime which follows the application of the European Union General Data Protection Regulation (GDPR), and (b) the Declaration of Helsinki, CIOMS guidelines and other research ethics regulations. One source of this controversy is that the GDPR requires consent to process personal data to be clear, concise, specific and granular, freely given and revocable and therefore has challenged the concept of 'broad consent', which has been widely applied in the context of biobanking. Another source of controversy is the interplay between regulations of research ethics and protection of personal data related to the secondary use of personal data and biological materials. In this case, the GDPR 'research condition' provides an alternative to re-consent for the use of previously collected personal data and biological materials. Although the mentioned controversies have been raised in the legal literature, they have not been explicitly addressed from the research ethics perspective. Should consent be regarded as a priority legal basis for personal data processing in health data research? Can broad consent still be a suitable legal ground for biobanking? What should be the role of research ethics provisions that differ from the GDPR standards, and what should be the role and function of research ethics committees in the changing environment of health data research? These are the ongoing controversies to be explored in the paper.

Biobanks and Individual Health Related Findings: from an Obstacle to an Incentive.

Despite the benefits biobanks are expected to bring, there have recently been concerns raised that the public and private non-profit biobanks still prevailing in Europe often fail to reach their initial objectives due to a variety of reasons, including a shortage of funding and insufficient utilization of collections. The necessity to find new ways to manage biobanks has been clearly recognized and one way to do this is to follow the success of some commercial direct-to-consumer genetic testing (DTC GT) companies in the biobanking field. This paper is focused on a double role the return of individual health related findings (IHRF) detected through the biobanking activities can play in the management of biobanks. These findings can be seen as an untapped opportunity to offer health related information to biobank participants. At the same time, the IHRF policy can also serve as an additional tool that can improve biobanking governance. This paper aims to consider diverse IHRF approaches as well as to explore some key ethical concerns related to them. In particular, it reveals how different accounts of personal autonomy shape consent policies related to IHRF and emphasizes ethical controversies related to the commercial DTC GT initiatives as well as some non-profit biobanks.

Implementation of the EU clinical trial regulation transforms the ethics committee systems and endangers ethical standards.

The upcoming Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use (Regulation), which will replace the current Clinical Trial Directive at the end of 2021, has triggered a significant reform of research ethics committee systems in Europe. Changes related to ethics review of clinical trials in the EU were considered to be essential to create a more favourable environment to conduct clinical trials in the EU. The concern is, however, that the role of the research ethics committees will weaken in at least some of the Member States because the new Regulation allows narrowing down the scope of ethics review as compared with the currently valid Clinical Trial Directive. Although the new Regulation may lead to faster approval procedures for clinical trials, which is especially relevant in the context of pandemics, high-quality ethics reviews integrating methodological aspects of a clinical trial should nevertheless be ensured. To maintain high research ethics standards as well as to foster measures to mitigate potential negative consequences of the reform, it is therefore of vital importance to start debating and sharing the reflections about the potential consequences of these transformations and trends as soon as possible.

Integrating public health programs and research after the malaria vaccine implementation program (MVIP): Recommendations for next steps.

BACKGROUND: In February 2020, international controversy arose about the ethical acceptability of the WHO Malaria Vaccine Implementation Program (MVIP). Whereas some have argued that this program must be seen as research that is not in line with international ethical standards, notably regarding informed consent and local ethical review, some WHO representatives consider the MVIP as a public health implementation program that need not adhere to these standards. METHODS: We performed a case analysis in light of the 2016 CIOMS International Ethical Guidelines for Health-related Research involving Humans. FINDINGS: We argue that the MVIP has a substantial research component, and that it is prudent to therefore apply ethical norms for research involving humans, such as the CIOMS guidelines. Accordingly, we agree that the ethical requirements of informed consent and independent ethical review have not been met. In addition, we are concerned that the study might not meet CIOMS's social value requirement. RECOMMENDATIONS: We urge WHO to release more details about the process that led to the MVIP program and make the MVIP protocol publicly available. The full protocol should be assessed by the relevant ethics committees, new and already enrolled parents should be informed about the uncertainties under investigation and given a real opportunity to consent or refuse (continued) participation, communities should be engaged, and aspects of MVIP that require alteration in light of ethical review should be altered, if possible. Furthermore, in order to improve good ethical practices, it is necessary to engage in international debate regarding the integration of research and public health programs. Procedurally, vaccine implementation programs that combine both prevention and research should involve the wider international ethics community and ensure participation of the target populations in setting the proper conditions for launching such programs.

Perish or Publish Dilemma: Challenges to Responsible Authorship.

Controversies related to the concept and practice of responsible authorship and its misuse have been among the most prominent issues discussed in the recent literature on research integrity. Therefore, this paper aims to address the factors that lead to two major types of unethical authorship, namely, honorary and ghost authorship. It also highlights negative consequences of authorship misuse and provides a critical analysis of different authorship guidelines, including a recent debate on the amendments of the International Committee of Medical Journal Editors (ICMJE) authorship definition. Empirical studies revealed that honorary authorship was the most prevalent deviation from the responsible authorship standards. Three different modalities of honorary authorship were distinguished: gift authorship, guest authorship, and coercive authorship. Prevalence of authorship misuse worldwide and in Europe was alarmingly high, covering approximately one third of all scientific publications. No significant differences were reported in authorship misuse between different health research disciplines. The studies conducted in North America highlighted the most effective means to cope with unethical authorship. These were training in publishing ethics, clear authorship policies developed by medical schools, and explicit compliance with the authorship criteria required by the medical journals. In conclusion, more empirical research is needed to raise awareness of the high prevalence of authorship misuse among scientists. Research integrity training courses, including publication ethics and authorship issues should be integrated into the curricula for students and young researchers in medical schools. Last but not least, further discussion on responsible authorship criteria and practice should be initiated.

Application challenges of the new EU Clinical Trials Regulation.

PURPOSE: The purpose of this paper is to discuss the challenges of the upcoming policy change in the field of clinical drug trials due to the shift from the Clinical Trials Directive 2001/20/EC to the new Clinical Trials Regulation 536/2014, adopted in 2014. Although it is expected that the new EU Clinical Trials Regulation will increase Europe's competitiveness in clinical research, the paper argues that some measures to assure protection of research subjects should be taken before the Regulation comes into application in 2018. METHODS: The methods used in this paper are comparative analysis of legal documents and related academic papers. RESULTS: The new Regulation serves as an efficient means to harmonize the clinical drug trial evaluation procedures across the EU. However, its application also raises potential challenges regarding interests and safety of research subjects: first, due to the possibility of skipping the assessment and balancing of benefits and risks from the scope of ethical review and limiting such a review to only Part II issues of the assessment report; second, due to direct applicability of the Regulation's rather vague and too general requirements for investigator's qualifications which does not allow the assessors (ethics committees and (or) competent authorities) to introduce higher qualification requirements for the investigators conducting high-risk clinical drug trials in the national legislation. CONCLUSIONS: There is an urgent need to raise awareness and facilitate debate on potential application challenges of the new Regulation.

International Capacity-Building Initiatives for National Bioethics Committees.

During the last two decades, national bioethics committees have been established in many countries all over the world. They vary with respect to their structure, composition, and working methods, but the main functions are similar. They are supposed to facilitate public debate on controversial bioethical issues and produce opinions and recommendations that can help inform the public and policy-makers. The dialogue among national bioethics committees is also increasingly important in the globalized world, where biomedical technologies raise ethical dilemmas that traverse national borders. It is not surprising, therefore, that the committees are established and active in the technologically advanced countries. There have also been a few international capacity-building initiatives in bioethics that have had a dual task: networking among existing national bioethics committees and helping establish such committees in those countries that still lack them. The problem is that, due to a lack of information, it is not clear what problems and challenges committees face in the transitioning societies often characterized as low- and middle-income countries.

Research ethics review: identifying public policy and program gaps.

We present an analytical framework for use by fellows of the Fogarty International Center-sponsored Advanced Certificate Program in Research Ethics for Central and Eastern Europe to identify gaps in the public policies establishing research ethics review systems that impede them from doing their job of protecting human research subjects. The framework, illustrated by examples from post-Communist countries, employs a logic model based on the public policy and public management literature. This paper is part of a collection of papers analyzing the Fogarty International Center's International Research Ethics Education and Curriculum program.

'Mirroring' the ethics of biobanking: what should we learn from the analysis of consent documents[corrected]?

Biobanks have been recognized as a key research infrastructure and how to approach ethical questions has been a topic of discussion for at least a decade by now. This article explores the characteristics of donors' participation in European biobanks as reflected in the consent documents of a selection of different biobanks from various European countries. The primary aim of this study is to understand how donors are informed about their participation in biobanking. Also the paper discusses what the most important thematic issues of information are to be given to the biobank participants and how this information should be presented in the consent documents. For these purposes, we analyse consent documents from 14 biobanks in 11 countries for six ethically relevant issues: (1) model of consent, (2) scope of future research, (3) access to medical data, (4) feedback to the participants, (5) consent withdrawal, and (6) role of research ethics committee. In order to compare different trends of informing donors of human biological material and medical data, we interpret the six analysed issues in the context of respect to donor's autonomy paradigm. Although the results of the paper reflect the heterogeneity of biobank consent document policies applied in different European countries, we uncovered some trends and suggested several examples of good practices to balance the interests of the donors with those of the researchers and future patients.

Building research ethics capacity in post-communist countries: experience of two Fogarty training programs.

The post-Communist countries of Central and Eastern Europe and Central Asia are at various stages of development with respect to their capacity to protect human research participants. We examined the impact of two Fogarty-funded programs in this region, the Union Graduate College-Vilnius University Advanced Certificate Program and the Case Western Reserve University Master's Degree Program, by surveying these programs' graduates and by examining alumni activities. Alumni have served in leadership roles on research ethics committees, developed and taught new courses in research ethics, and contributed to scholarship. However, political, social, and economic challenges impede the ability of graduates to maximize their effectiveness. Additional curricular attention is needed in research methodology, policy development and implementation, and the interplay between research ethics and human rights.

Turning residual human biological materials into research collections: playing with consent.

This article focuses on three scenarios in which residual biological materials are turned into research collections during the procedure of procuring these materials for diagnostic, therapeutic or other non-research purposes. These three scenarios differ from each other primarily because they employ different models of consent: (a) precautionary consent, which may be secured during the collecting procedure; (b) the presumed consent model, which may be applied during the collection of materials; and (c) consent for research use of identifiable human biological materials, which may be skipped entirely. These scenarios offer additional sources of biological samples for research purposes and at the same time seem to offer even more flexibility in terms of stringency of consent as compared with the more traditional models of broad consent in prospective research collections and the waiver of consent in retrospective research. Our discussion leads us to think that precautionary consent is preferable to presumed consent and no consent when handling issues of consent in the use of residual human biological materials for research. However, such precautionary consent should not be construed as blanket, unrestricted consent for any future use.

Realizing benefit sharing - the case of post-study obligations.

In 2006, the Indonesian government decided to withhold avian flu samples from the World Health Organization. They argued that even though Indonesian samples were crucial to the development of vaccines, the results of vaccine research would be unaffordable for its citizens. Commentaries on the case varied from alleging blackmail to welcoming this strong stance against alleged exploitation. What is clear is that the concern expressed is related to benefit sharing. Benefit sharing requires resource users to return benefits to resource providers in order to achieve justice. One benefit sharing tool within health research is the duty to provide a health care intervention which has been proven to be beneficial (or alternative benefits) to research participants after a study has been concluded. This duty is generally known as a post-study obligation. It was enshrined in the Declaration of Helsinki in 2000 and re-emphasized in 2008. Yet, there are few, if any, examples of good practice. In this article, we analyse the obstacles to giving more bite to benefit sharing provisions in health research through ethical review. We conclude that the provision of post-study access to healthcare interventions is not a promising mechanism when monitored through research ethics committees. Alternative benefit provision is preferable if one focuses on achieving compliance. However, even the latter faces challenges, which we address in specific recommendations.

Does the "new philosophy" in predictive, preventive and personalised medicine require new ethics?

This paper maps the ethical issues that arise in the context of personalised medicine. First, it highlights the ethical problems related to increased predictive power of modern diagnostic interventions. Such problems emerge because the ability to identify individuals or groups of individuals that can potentially benefit from a particular therapeutic intervention also raises a question of personal responsibility for health-related behaviour and lifestyle. The second major area of ethical concern is related to health prevention and distributive justice. The paper discusses the ethical challenges brought by the personalised medicine in the context of the Additional Protocol to the Convention on Human Rights and Biomedicine concerning Genetic Testing for Health Purposes. Finally, it notes that the issue of consent in the context of biobanks, the need to rethink the prevalent models of research designs and to communicate relevant findings to the donors of biological materials deserve further discussion.

Twenty years of human research ethics committees in the Baltic States.

Two decades have passed since the first attempts were made to establish systematic ethical review of human research in the Baltic States. Legally and institutionally much has changed. In this paper we provide an historical and structural overview of ethical review of human research and identify some problems related to the role of ethical review in establishing quality research environment in these countries. Problems connected to (a) public availability of information, (b) management of conflicts of interest, (c) REC composition and motivation of REC members, and (d) differing levels of stringency of ethical review for different types of studies, are identified. Recommendations are made to strengthen cooperation among the Baltic RECs.