Trust and confidence: towards mutual acceptance of ethics committee approval of multicentre studies

AIMS: To compare issues raised by Human Research Ethics Committees (HREC) during the ethics review process and to determine the length of time taken to gain HREC approval for multicentre research studies. METHODS: Review and analysis of HREC documentation and correspondence for all multicentre research studies were conducted through three HREC under the auspices of Cancer Trials Australia, Melbourne, Victoria, Australia, between November 1997 and March 2001 to determine the variance of documentation, correspondence and recommendations across the three HREC and the time taken for study approval. RESULTS: Thirty-one projects were submitted to any two of the HREC (16 studies) or all three HREC (15 studies). The median time for study approval at an individual HREC was 75 days, but it was 111 days for approval at all participating sites. There were 554 clarifications or comments made by the reviewing HREC, the majority of which had no significant bearing on the ethical or scientific calibre of the study. There was only one study in which a significant protocol change was requested by a HREC. CONCLUSIONS: Multicentre study approvals are delayed when submitted to multiple HREC. The three HREC raised similar issues without substantive differences in their recommendations. A process for the mutual acceptance of HREC recommendations could facilitate multicentre research.     

FDA批准大麻二酚用于治疗难治性癫痫的审评思路分析

FDA于2018年6月25日批准Epidiolex口服溶液用于治疗难治性癫痫,其活性成分是来源于大麻的高纯度原料大麻二酚。本文通过对FDA关于Epidiolex的审评过程进行分析,结合其审评制度探索FDA在人用经验、化学制造和控制(chemistry,manufacturing,and control,CMC)、非临床、临床等方面的审评思路。同时对FDA关于植物来源高纯度药物审评的重点及特点进行阐述,目的是为我国天然药物研究和技术审评提供有益的参考。     

医务人员道德推脱与道德决策关系

目的探讨医务人员道德推脱与道德决策的关系以及组织承诺在两者之间的调节作用。方法采用整群抽样的方法对江西省5所三甲医院的286名医务人员进行问卷调查,采用SPSS 16.0进行数据分析。结果医务人员道德推脱、道德识别、道德判断、道德意图、组织承诺平均分分别为（88.10±16.78）、（18.53±3.47）、（13.47±3.58）、（30.43±9.95）、（67.28±8.57）分;不同学历的医务人员道德推脱、道德判断得分差异均有统计学意义（P<0.05）,不同年龄医务人员道德识别、道德判断得分差异均有统计学意义（P<0.05）;医务人员道德推脱与道德识别呈负相关（r=-0.349,P<0.05）,与道德判断和道德意图均呈正相关（r=0.301、0.211,P<0.01）;组织承诺对道德推脱和道德识别之间的关系产生显著的调节作用,对道德判断和道德意图产生直接作用。结论医务人员道德推脱与道德决策存在显著相关,组织承诺在道德推脱与道德识别关系中存在调节作用。     

我国卫生改革的医学道德意义和伦理原则

在我国卫生改革全面展开的基础上，探讨了卫生改革具有的医学道德意义，并提出了卫生改革应遵循的伦理原则，其目的在于推进卫生改革的深化和健康发展。     

5.2 Ethics, equity and global responsibilities in oral health and disease

The charge of this Section is ethics and global responsibilities in oral health and disease. Oral health is determined by the same factors as those for general health. To a limited extent, the level of oral health care and dental education. The philosophy and organization of the health care system and dental education, therefore, are key determinants of oral health. Dental education has expanded in many countries where there has been an increase in wealth. Unfortunately, there has been no concomitant increase in the number of dental educators. This is a problem throughout the world. This present situation raises certain ethical issues with regard to professional responsibilities. It also raises some important questions for dental education. This Section has chosen to focus its efforts on examining two issues:

• • What can be done within dental schools?

       

Minimising harm in violence risk assessment: Practical solutions to ethical problems?

Despite enjoying a higher level of safety from many dangers than that experienced in any previous historical epoch, there is widespread public concern in the world's richer societies over a series of other threats and risks. This paper focuses on the problem of personal violence and the development of a body of research designed to inform assessment of its likelihood in individual cases. The paper provides an overview of the evidence from research in both mental health and criminal justice supporting the general validity of risk assessment, and an account of some of the obstacles that arise when such procedures are implemented in practice. This overview is followed by consideration of a series of ethical conflicts emerging from the use of risk assessment procedures; and an outline of some current proposals and other possible departures that may contribute to their resolution.     

An Ethical Dilemma: The Dishonest Doctor

The process of sloving an ethical dilemma is presented through use of a case study involiving a dishonest doctor and a cancer patient. The described decision making process contributes to compliance with the Joint Commission on Accreditation of Healthcare Organization standard regarding ethics and patient care. Curtin's ethical decision-making framework is employed in this described process. Ethical principles and philosophies are considered in attempting to find the best ethical solution for the dilemma detailed in the case study.
Source material is from personal experience and observation as well as published literature. In addition to being a JCAHO standard, the author concludes that a decision-making framework is useful in solving ethical dilemmas.     

Attitudes toward live donor kidney transplantation and its commercialization

Development of live donor kidney transplantation (LDKT) programs has intensified debate regarding acceptability of certain donor categories and potential commercialization. Concerning these issues, we surveyed the views of medical and nursing staff caring for patients with renal failure and renal transplant recipients and donors. Participants were recruited from a tertiary transplant unit and invited to complete an anonymous questionnaire. Four hundred and sixty-four participants completed the questionnaire (42% response). One hundred and sixty-eight (36.2%) were health care professionals and 296 (63.8%) patients; 85.6% of participants were willing to donate to their children, 80.2% to siblings, 80.8% to parents, 72% to a non-blood-related relative or friend, and 15.3% to a stranger. If participants had hypothetical renal failure, they were prepared to accept a kidney from a parent (79.5%), sibling (78.7%), child (56.3%), a non-blood-related relative or friend (79.3%), or stranger (54.1%). Regarding commercialization, responders' attitudes were that the donor should not accept financial reward (29.1%), be compensated for expenses only (60.6%), or should receive a direct financial reward (10.1%). For non-directed donation, 23.5%, 55.6%, and 20.7% were not in support of reward, compensation only, and financial reward, respectively. While live kidney donation was accepted by the majority of individuals surveyed, only the minority approved of commercialization.     

Iatrogenic sexual dysfunction and the protective withholding of information: in whose best interest?

In recent years a growing body of evidence has highlighted the impact of neuroleptics and antidepressants on sexual function. Research from a service user's perspective suggested that service users are dissatisfied with the information that they received on drugs, and would like more education, in particular, on the side effects of medication that impact on sexual function. This paper reports some of the findings of a grounded theory study that explored how psychiatric nurses responded to issues of sexuality in practice. Emphasis within the paper is given to how nursing staff addressed the side effects of drugs that impact on sexual function. Findings suggested that nurse addressed the issue of prescribed medication and sexual function in practice, using a 'Veiling Sexualities Cycle', which had three subcategories: 'Hanging the Veil', 'Lifting the Veil' and 'Re-veiling'. In the light of contemporary mental health policy, findings from the study are discussed and recommendations for practice and education made.