Attitudes toward Post‐Trial Access to Medical Interventions: A Review of Academic Literature,Legislation, and International Guidelines

There is currently no international consensus around post‐trial obligations toward research participants, community members, and host countries. This literature review investigates arguments and attitudes toward post‐trial access. The literature review found that academic discussions focused on the rights of research participants, but offered few practical recommendations for addressing or improving current practices. Similarly, there are few regulations or legislation pertaining to post‐trial access. If regulatory changes are necessary, we need to understand the current arguments, legislation, and attitudes towards post‐trial access and participants and community members. Given that clinical trials conducted in low‐income countries will likely continue, there is an urgent need for consideration of post‐trial benefits for participants, communities, and citizens of host countries. While this issue may not be as pressing in countries where participants have access to healthcare and medicines through public schemes, it is particularly important in regions where this may not be available.     

Uterine Transplantation: Ethical Considerations within Middle Eastern Perspectives

The field of reproductive medicine witnessed a breakthrough in September 2014 with the first successful live birth post uterine transplantation. This success represents the culmination of decades' worth of research on infertility and reproductive medicine. This subject of infertility gathers special attention in the Middle East, as childbearing is given paramount importance in the family unit. And as with any new medical advancement, Middle Eastern people look to their religious authorities for guidance. This paper describes the various ethical quandaries related to uterine transplantation, from a perspective of the religious and societal factors that are unique to the Middle East, and embeds them within the conversation of its alternative solutions.     

Ethical issues associated with HIV phylogenetics in HIV transmission dynamics research: A review of the literature using the Emanuel Framework

The reduced costs of DNA sequencing and the use of such data for HIV‐1 clinical management and phylogenetic analysis have led to a massive increase of HIV‐1 sequences in the last few years. Phylogenetic analysis has shed light on the origin, spread and characteristics of HIV‐1 epidemics and outbreaks. Phylogenetic analysis is now also being used to advance our knowledge of the drivers of HIV‐1 transmission in order to design effective interventions. However, HIV phylogenetic analysis presents unique ethical challenges, which have not been fully explored. This review presents an analysis of what appear to be key ethical issues in HIV phylogenetics in the hope of stimulating further conceptual and empirical work in this rapidly emerging area. We structure the review using the Emanuel Framework, a systematic, holistic framework, which has been adapted for use in developing countries, which bear the brunt of the HIV‐1 pandemic.     

神山森林文化传统的生态伦理学意义

在云南山地民族的传统文化里 ,对绿的图腾和对树的崇拜无处不在 ,神山森林传统已经成为一种生态文化传统 ,几乎所有的民族都会在自己居住的村寨附近选一片葱绿茂密的山林作为自己的风水林或水源林 ,有的甚至作为神山森林顶礼膜拜 ,严禁任何人砍伐和破坏。村寨和神山上的参天古树也往往成为神树和村寨的标记加以崇拜和保护。我们把山地民族这种文化传统称为神山森林文化传统。这是一种朴素的生态伦理观 ,体现一种敬畏生命的生态伦理学 ,有着深刻的自然保护意义。1　神山森林文化的生态学内涵及生态学意义文化 ,是人类对环境的一种社会生态适…     

医德医风与医院履责对

目的 探讨医院医德医风和医生感知的医院责任履行状况对医生自身责任履行的影响。方法 运用自行设计的调查问卷对我国东、中、西3省、直辖市9个地区的128所公立医院医生进行调查。结果 回归分析显示,医德医风和医院履责对医生自身履责解释力均显著。在控制了个体变量与医院地区级别变量之后,医德医风对医生交易、发展、关系与理念责任的履行均具有显著正向影响（P＜0.001）,而医院履责对医生履责的影响有不同的对应性。结论 医院医德医风对医生自身责任的履行有积极促进作用。医院4类责任的履行状况与医生四类责任履行有紧密关联,但对应性略有不同。     

Unequal protection for patient rights: The divide between university and health ethics committees

Despite recommendations from the Cartwright Report ethical review by health ethics committees has continued in New Zealand without health practitioners ever having to acknowledge their dual roles as health practitioners researching their own patients. On the other hand, universities explicitly identify doctor/research-patient relations as potentially raising conflict of role issues. This stems from the acknowledgement within the university sector itself that lecturer/research-student relations are fraught with such conflicts. Although similar unequal relationships are seen to exist between health resarchers and their patients, the patient/subjects are not afforded the levels of protection that are afforded student/subjects. In this paper we argue that the difference between universities and health research is a result of the failure of the Operational Standard Code for Ethics Committees to explicitly acknowledge the vulnerability of the patient and conflict of interests in the dual roles of health practitioner/researcher. We end the paper recommending the Ministry of Health consider the rewriting of the Operational Standard Code for Ethics Committees, in particular in the rewriting of section 26 of the Operational Standard Code for Ethics Committees. We also identify the value of comparative ethical review and suggest the New Zealand's Health Research Council's trilateral relationship with Australia's NHMRC (National Health and Medical Research Council) and Canada's CIHR (Canadian Institute of Health Research) as a useful starting point for such a process.     

Regulating human stem cell research and therapy in low- and middle-income countries: Malaysian perspectives

Many “rising powers” such as India, China, Argentina, Singapore, and Brazil are investing in stem cell technology, joining the traditional leaders in the field, such as the UK, Germany, USA, and Japan. Malaysia is also entering this sector because of the potential medical and economic benefits that the use of stem cell technologies could provide. Like other countries, Malaysia faces the challenge of how to encourage scientific progress and innovation in an ethical manner while at the same time ensuring a safe and accessible market for regenerative therapies. This paper reports on the research findings of semi-structured interviews with local stakeholders to investigate how they perceived and evaluated the current regulatory framework for human stem cell research in Malaysia, and what might be at stake if the state continues with its current regulatory approach.     

Reconsidering paternalism in clinical research

The ethical standards that regulate clinical research have multiple rationales. Among them is the need to protect potential subjects from making imprudent decisions, which extends beyond the soft paternalistic concern to protect people from making uninformed decisions to participate in trials. This article argues that a plausible risk/benefit restriction on clinical trials is presumptively justified by hard paternalism, which in turn is supported by a deeper fairness‐based rationale. This presumptive case for hard paternalism in research is not defeated by the alleged right to participate in clinical trials, by concerns about insult or status, by the need to conduct early phase trials that promise little to no benefit to participants, or by the recognition that some potential subjects are altruistically motivated.