Implementation and coordination of an ethics framework in HBM4EU - Experiences and reflections.

Human biomonitoring involves the use of human samples and data to investigate exposure to environmental chemicals and their impact on human health. HBM4EU developed a coordinated and harmonized approach involving 29 countries in Europe plus Israel. Addressing ethical issues has been an indispensable prerequisite, from the application phase, grant agreement, project performance to the closing of the project. HBM4EU has established a better understanding of the ethics in such projects and the need for a standardised way of reporting and handling of ethics and data exchange, securing compliance with ethics standards, transparency, transferability and sustainability. The main reflections were: KNOWLEDGE: Ethics awareness, norms and practices are dynamic and increased throughout the project, much learning and experience is achieved by practice and dialogue. ATTITUDE: Rules and standards were very diversely known and needed to adhere to local practices. ASSISTANCE: Good results achieved from webinars, training, help desk, and individual consultations. STANDARDISATION: Was achieved by templates and naming convention across documents. MANAGEMENT: The establishment of the SharePoint directory with uploading of all requested documents assisted collaboration and exchange. Also, a designated task for ethics within the management/coordination work package and the enthusiasm of the task leader were essential. COMPLIANCE: Some, but not all partners were very good at complying with deadlines and standards. TRANSFERABILITY AND SUSTAINABILITY: All documents are archived in the SharePoint directory while a system assuring updating is recommended. TRANSPARENCY: Assured by public access to annual ethics reports. The ethics reports bridged to the annual work plans (AWPs). EVALUATION: The Ethics Check by the Commission was successful.

Results Communication in Breast Milk Biomonitoring Studies: A Scoping Review and Stakeholder Consultation.

Researchers investigating breast milk contamination face substantive ethical dilemmas regarding how biomonitoring results should be conveyed, with limited guidance available to help them. To identify effective processes for undertaking such research, we sought to critically assess practices being followed in reporting results. To consider how researchers have reported on this and related ethical issues, we searched three English-language databases for articles published between 2010-2016 on measuring presence of pesticides in breast milk. Data on report-back processes and discussed ethical issues were charted from retained articles (n=102). To deepen our understanding of issues, we further consulted authors (n=20) of retained articles through an online survey. Quantitative data from surveys were tabulated and qualitative data were analyzed thematically. Of 102 articles, only two mentioned sharing results with subjects, while 10 out of 20 survey participants confirmed that they had indeed conducted report-back in their studies. Articles discussing ethical considerations were few (n=5), although researchers demonstrated awareness of common ethical debates to inform report-back decisions. Our review suggests that greater explicit attention should be given to practices of engaging study subjects and their communities in contamination studies so that an evidence base on best ethical practices can be more readily available.

Which Nanobasics Should Be Taught in Medical Schools?

The progressive growth in nanotechnology approaches to diagnostics and therapeutics, especially for cancer, necessitates training physicians in nanoethics. This article explains why it is critical for medical education to include instruction in nanotechnology, nanomedicine, nanotoxicology, and nanoethics and suggests basic concepts educators can use to infuse curricula with this content.

Should a Psychiatrist Prescribe a Nanodrug to Help Parents Monitor a Teen's Adherence?

This case explores ethical questions about tracking medication adherence in a 16-year-old patient with schizophrenia. Relevant stakeholders are the teen, the parents, and society. How those stakeholders' interests should be considered is explored here in the context of the psychiatrist's professional care management responsibilities and the burdens each stakeholder must bear over the course of the patient's care.

Should Trackable Pill Technologies Be Used to Facilitate Adherence Among Patients Without Insight?

Aripiprazole tablets with sensor offer a new wireless trackable form of aripiprazole that represents a clear departure from existing drug delivery systems, routes, or formulations. This tracking technology raises concerns about the ethical treatment of patients with psychosis when it could introduce unintended treatment challenges. The use of "trackable" pills and other "smart" drugs or nanodrugs assumes renewed importance given that physicians are responsible for determining patients' decision-making capacity. Psychiatrists are uniquely positioned in society to advocate on behalf of vulnerable patients with mental health disorders. The case presented here focuses on guidance for capacity determination and informed consent for such nanodrugs.