Australian human research ethics committee members' confidence in reviewing genomic research applications.

Human research ethics committees (HRECs) are evaluating increasing quantities of genomic research applications with complex ethical considerations. Genomic confidence is reportedly low amongst many non-genetics-experts; however, no studies have evaluated genomic confidence levels in HREC members specifically. This study used online surveys to explore genomic confidence levels, predictors of confidence, and genomics resource needs of members from 185 HRECs across Australia. Surveys were fully or partially completed by 145 members. All reported having postgraduate 94 (86%) and/or bachelor 15 (14%) degrees. Participants consisted mainly of researchers (n = 45, 33%) and lay members (n = 41, 30%), affiliated with either public health services (n = 73, 51%) or public universities (n = 31, 22%). Over half had served their HREC [Formula: see text]3 years. Fifty (44%) reviewed genomic studies [Formula: see text]3 times annually. Seventy (60%) had undertaken some form of genomic education. While most (94/103, 91%) had high genomic literacy based on familiarity with genomic terms, average genomic confidence scores (GCS) were moderate (5.7/10, n = 119). Simple linear regression showed that GCS was positively associated with years of HREC service, frequency of reviewing genomic applications, undertaking self-reported genomic education, and familiarity with genomic terms (p < 0.05 for all). Conversely, lay members and/or those relying on others when reviewing genomic studies had lower GCSs (p < 0.05 for both). Most members (n = 83, 76%) agreed further resources would be valuable when reviewing genomic research applications, and online courses and printed materials were preferred. In conclusion, even well-educated HREC members familiar with genomic terms lack genomic confidence, which could be enhanced with additional genomic education and/or resources.

Institutional Ethics Committees.

In hospitals throughout the United States, institutional ethics committees (IECs) have become a standard vehicle for the education of health professionals about biomedical ethics, for the drafting and review of hospital policy, and for clinical ethics case consultation. In addition, there is increasing interest in a role for the IEC in organizational ethics. Recommendations are made about the membership and structure of an IEC, and guidance is provided for those serving on an IEC.

Content review of pediatric ethics consultations at a cancer center.

BACKGROUND/OBJECTIVES: Ethical challenges in pediatric oncology arise at every stage of illness. However, there are sparse data on the content of and reason for ethics consultations in the field. We sought to evaluate the content and characteristics of ethics consultations in pediatric patients at a cancer center. DESIGN/METHODS: We retrospectively identified ethics consultations performed for patients diagnosed with cancer at ≤21 years of age who were treated in the Department of Pediatrics from 2007 to 2017. Using an established coding schema, two independent reviewers analyzed the content of ethics consultation notes and identified core ethical issues and relevant contextual issues. Demographic, clinical, and consultation-specific data were also collected. RESULTS: Thirty-five consultations were performed for 32 unique patients. The most commonly identified ethical issues were obligation to provide nonbeneficial treatment (29%) and resuscitation preferences (26%). Communication conflicts were the most commonly identified contextual issue (40%). There were two themes that emerged repeatedly but were not a part of the original coding schema-four consultations (11%) that involved physicians questioning their obligation to provide potentially toxic treatment in the setting of poor patient/parent compliance, and two consultations (6%) related to complex risk-benefit analysis in the setting of an invasive procedure with uncertain benefit. CONCLUSIONS: Pediatric ethics consultations are infrequent at this specialty cancer hospital. Ethical issues focused on treatment and end-of-life care and included a diversity of communication conflicts.

Instrumento de Marcação de Abdominoplastia / Abdominoplasty Marking Instrument

Introdução: A abdominoplastia, um dos procedimentos de cirurgia plástica mais comuns no Brasil, ficou em quarto lugar no ranking mundial, segundo dados da International Society of Aesthetic Plastic Surgery. Diversas técnicas cirúrgicas visam restaurar o contorno abdominal. A indicação da técnica utilizada deve visar a melhoria da deformidade individual presente no abdome. A marcação da abdominoplastia se faz por meio de régua, transferidor, compasso, fio de náilon, palito, canetas e/ou azul de metileno, de acordo com a preferência do cirurgião. O objetivo é produzir um instrumento cirúrgico com a finalidade de otimizar o tempo de marcação no procedimento de abdominoplastia. Métodos: O estudo foi aprovado pelo Comitê de Ética em Pesquisa, foram desenvolvidos desenhos gráficos para identificar cada uma das partes do instrumento, foi realizada a busca de anterioridade e, posteriormente, realizado o pedido de patente. Resultados: Foi desenvolvido um instrumento para marcação da abdominoplastia, que configura uma régua horizontal que recepciona uma régua vertical no seu ponto médio e duas réguas pivotantes com transferidor basal, todas essas peças milimetradas e com vazado central, que permitem o risco nessa região com o azul de metileno ou caneta afim e, por conseguinte, a marcação do procedimento de abdominoplastia. Além disso, também funciona como compasso e de cujas laterais derivam réguas pivotantes com transferidor de grau basal. Conclusão: O instrumento desse estudo foi criado para minimizar a quantidade de material utilizado e otimizar o tempo da marcação da abdominoplastia.

Introduction: Data from the International Society of Aesthetic Plastic Surgery indicate that abdominoplasty is the fourth most common plastic surgery performed worldwide. Several surgical techniques aim to restore the abdominal contour. The indication for the technique used should aim to improve any individual deformity present in the abdomen. Abdominoplasty marking is done using a ruler, protractor, compass, nylon thread, toothpick, pen, and/or methylene blue, according to the surgeon's preference. Here we aimed to produce a surgical instrument that optimizes the abdominoplasty marking procedure. Methods: The study was approved by the ethics research committee. Graphic designs were developed to identify each part of the instrument, a precedence search was performed, and a patent application was requested. Results: We developed an abdominoplasty marking instrument consisting of a horizontal ruler that receives a vertical ruler at its midpoint, two pivotal rulers with a basal protractor, all marked in millimeters, and a central area that allows marking in this region with methylene blue or a pen. Moreover, it acts as a compass and features side pivotal rulers derived from a basal grade protractor. Conclusion: The instrument developed in this study was designed to minimize the amount of material used and optimize abdominoplasty marking time.

Ethical obligations in fertility treatment when intimate partners withhold information from each other: an Ethics Committee opinion.

Clinicians should encourage disclosure between intimate partners but must maintain confidentiality in cases where there is no prospect of harm to the partner and/or offspring. In cases where one member of a couple refuses to disclose relevant health information to the other partner and there exists a risk of harm to the unaware partner and/or offspring, clinicians may refuse to offer care and should decline to treat if full informed consent is not possible due to lack of disclosure.

Disclosure of sex when incidentally revealed as part of preimplantation genetic testing (PGT): an Ethics Committee opinion.

Clinics may develop a policy to disallow selecting which embryos to transfer based on sex and choose to use only embryo quality as selection criteria. Clinics may also develop a policy to use randomization to select those embryos for transfer if more embryos suitable for transfer are available than can be transferred.

Fertility preservation and reproduction in patients facing gonadotoxic therapies: an Ethics Committee opinion.

Chemotherapy and radiation therapy often result in reduced fertility. Patients receiving gonadotoxic treatment should be informed of options for fertility preservation and future reproduction prior to such treatment. Reproduction in the context of cancer also raises a number of ethical issues related to the welfare of both patients and offspring. This document replaces the document titled, "Fertility preservation and reproduction in patients facing goandotoxic therapies," last published in 2013.

Child-rearing ability and the provision of fertility services: an Ethics Committee opinion.

Fertility programs may withhold services from prospective patients on the basis of well-grounded reasons that those patients will be unable to provide minimally adequate or safe care for offspring. This document was reviewed and updated; this version replaces the previous version of this document, last published July 2013 (Fertil Steril 2013;100:50-53).

EsPRit: ethics committee proposals for Long Term Medical Data Registries in rapidly evolving research fields - a future-proof best practice approach.

BACKGROUND: Long-term data collection is a challenging task in the domain of medical research. Many effects in medicine require long periods of time to become traceable e.g. the development of secondary malignancies based on a given radiotherapeutic treatment of the primary disease. Nevertheless, long-term studies often suffer from an initial lack of available information, thus disallowing a standardized approach for their approval by the ethics committee. This is due to several factors, such as the lack of existing case report forms or an explorative research approach in which data elements may change over time. In connection with current medical research and the ongoing digitalization in medicine, Long Term Medical Data Registries (MDR-LT) have become an important means of collecting and analyzing study data. As with any clinical study, ethical aspects must be taken into account when setting up such registries. This work addresses the problem of creating a valid, high-quality ethics committee proposal for medical registries by suggesting groups of tasks (building blocks), information sources and appropriate methods for collecting and analyzing the information, as well as a process model to compile an ethics committee proposal (EsPRit). METHODS: To derive the building blocks and associated methods software and requirements engineering approaches were utilized. Furthermore, a process-oriented approach was chosen, as information required in the creating process of ethics committee proposals remain unknown in the beginning of planning an MDR-LT. Here, we derived the needed steps from medical product certification. This was done as the medical product certification itself also communicates a process-oriented approach rather than merely focusing on content. A proposal was created for validation and inspection of applicability by using the proposed building blocks. The proposed best practice was tested and refined within SEMPER (Secondary Malignoma - Prospective Evaluation of the Radiotherapeutics dose distribution as the cause for induction) as a case study. RESULTS: The proposed building blocks cover the topics of "Context Analysis", "Requirements Analysis", "Requirements Validation", "Electronic Case Report (eCRF) Design" and "Overall Concept Creation". Additional methods are attached with regards to each topic. The goals of each block can be met by applying those methods. The proposed methods are proven methods as applied in e.g. existing Medical Data Registry projects, as well as in software or requirements engineering. CONCLUSION: Several building blocks and attached methods could be identified in the creation of a generic ethics committee proposal. Hence, an Ethics Committee can make informed decisions on the suggested study via said blocks, using the suggested methods such as "Defining Clinical Questions" within the Context Analysis. The study creators have to confirm that they adhere to the proposed procedure within the ethic proposal statement. Additional existing Medical Data Registry projects can be compared to EsPRit for conformity to the proposed procedure. This allows for the identification of gaps, which can lead to amendments requested by the ethics committee.

[The impact of the EU Regulation 536/2014 on the tasks and functioning of ethics committees in Germany]. / Die EU-Verordnung 536/2014 und ihr Einfluss auf die Aufgaben und Arbeitsweisen der Ethikkommissionen in Deutschland.

The EU Clinical Trial Regulation 536/2014 (CTR) and its implementation in Germany led to substantial changes of the established, well-accepted and effective system of reviewing clinical trial applications by ethics committees (ECs), which impair their independence. For the first time, the German federal legislator specified in detail the composition, functioning, tasks and responsibilities of ECs. ECs have to be registered with the federal drug authority BfArM and if an EC does not perform properly the registration can be withdrawn. In addition, the drug authorities may override the negative opinion expressed by an EC. The ECs will also lose their financial autonomy as the fees will be fixed by the federal government. The tasks and responsibilities of the ECs remain almost entirely unchanged, however. The ECs remain involved in the assessment of both parts of the application dossier. Part I is assessed together with the drug authorities, the drug authorities having the lead. The assessment of part II remains the sole responsibility of the EC. As the deadlines for the assessment became rather short, in particular for multinational trials, and the communication with the sponsor will be in writing only, the established procedures of ECs have to be modified. Up to now it was common to verbally discuss problematic issues with the sponsor. The CTR is focused on written communication with the sponsor via the EU portal. ECs, their office staff and chairpersons will need considerable professionalism and respective training. The future workflow requires substantial IT support. The ECs and the Association of Medical Ethics Committees in Germany will do their utmost to protect efficiently the research subjects and to promote Germany as a major destination for clinical research.

Ethical Principles, Process, and the Work of Bioethics Commissions.

Shortly after the Presidential Commission for the Study of Bioethical Issues was constituted in 2010 and days before the commission members were to join a conference call to discuss possible topics for their deliberation, Craig Venter held a press conference announcing that his lab had created a synthetic chromosome for a species of mycoplasma and had inserted this genetic material into organisms of another species of mycoplasma (the genes of which had been deactivated), transforming the host species into the donor species. While not overtly claiming to have "created life in the test tube," Venter's publicity seemed cleverly designed to provoke the media into reporting his discovery in just that way. The resulting uproar caused President Obama to give his new bioethics commission the assignment of investigating the ethics of the emerging field of synthetic biology. The commission went right to work. It formed working groups to deliberate about parts of the report, feeding ideas and language to the staff members who would do the actual writing, and then present the working group suggestions to the commission as a whole for public deliberation at open meetings. One of those working groups was charged with coming up with ethical principles that would guide the analysis. Having served as a member of that working group, I report here on the process by which these principles emerged and reflect upon the suitability of that process for the work of public bioethics commissions.

A Review of the Scientific Misconduct Inquiry Process, Ankara Chamber of Medicine, Turkey.

The aim of this study is to review the inquiry process used in scientific misconduct cases in the Ankara Chamber of Medicine between the years 1998 and 2012. The violations of the "Disciplinary Regulations of the Turkish Medical Association" have been examined by keeping the names of the people, institutions, associations and journals secret. In total, 31 files have been studied and 11 of these files have been identified as related to scientific misconduct. The methods of inquiry, the decisions about the need for an investigation process, the types of scientific misconduct, and the adjudication processes have all been reported. Furthermore, the motives of researchers who made allegations, the study approaches of investigators, and the objections to the decisions about guilt and innocence have also been examined. Based on the findings obtained, the reasons for scientific misconduct and the distribution of responsibilities among the people in the inquiry process have been discussed. A major conclusion is the need to standardize the process of conducting inquiries about scientific misconduct cases for the regional chambers of medicine in Turkey.

Cross-border reproductive care: an Ethics Committee opinion.

Cross-border reproductive care (CBRC) is a growing worldwide phenomenon, raising questions about why assisted reproductive technology (ART) patients travel abroad, what harms and benefits may result, and what duties health-care providers may have in advising and treating patients who travel for reproductive services. Cross-border care offers benefits and poses harms to ART stakeholders, including patients, offspring, providers, gamete donors, gestational carriers, and local populations in destination countries. This document replaces the previous document of the same name, last published in 2013 (Fertil Steril 2013;100:645-50).

Provision of fertility services for women at increased risk of complications during fertility treatment or pregnancy: an Ethics Committee opinion.

This opinion addresses the ethics of providing fertility treatment to women at elevated risk from fertility treatment or pregnancy. Providers ethically may treat women at elevated risk provided that they are carefully assessed; that specialists in their medical condition are consulted as appropriate; and that patients are fully informed about risks, benefits, and alternatives, including oocyte and embryo donation, use of a gestational surrogate, not undergoing fertility care, and adoption. Providers also may conclude that the risks are too high for them to treat particular patients ethically; such determinations must be made in a medically objective and unbiased manner and patients must be fully informed of the decision. Counseling of women who wish to initiate fertility treatment with underlying medical conditions that confer increased risk during treatment or pregnancy should incorporate the most current knowledge available, being cognizant of the woman's personal determinants in relation to her reproductive desires. In such a way, both physician and patient will optimize decision making in an ethically sound, patient-supportive context.

Towards a competency assessment tool for nurses in ethics meetings.

BACKGROUND: Nurses require specific knowledge, skills and attitudes to participate competently in various forms of ethics meetings. The literature does not state the contents of the knowledge, skills and attitudes nurses need for ethics meetings. Without such a competency profile, it cannot be assessed in how far nurses actually possess these qualities for ethics meetings. OBJECTIVE: Corroborating an existing profile of the requisite knowledge, skills and attitudes in the form of a questionnaire contributes to the development of a tool to determine the competence nurses need for ethics meetings. QUESTION: In how far can this profile be confirmed by a quantitative follow-up in a random sample? DESIGN: A questionnaire was developed to determine in how far nurses with prior involvement in ethics meetings recognise the earlier competency profile as important and comprehensive. PARTICIPANTS: It was made available to subscribers of the digital newsletter of three widely read nursing journals in the Netherlands. Data collection and analysis took place in the spring of 2013. ETHICAL CONSIDERATIONS: Care was taken to state explicitly in the questionnaire that participation in the survey was completely voluntary and anonymous. FINDINGS: To a high degree, nurses with involvement in ethics meetings recognise the knowledge, skills and attitudes from the earlier interviews when presented as a survey. DISCUSSION: Although the sample was small, the respondents and the results reflect known characteristics of nurses serving on ethics meeting. CONCLUSION: This may be helpful to recruit and prepare nurses for professional ethics in nursing care, and to develop a tool to assess to what extent nurses actually possess competence for ethics meetings.