The Expanding Purview: Institutional Review Boards and the Review of Human Subjects Research

The implications of the institutional review board (IRB) system's growing purview are examined. Among the issues discussed are whether IRBs are censoring research and whether the IRB review process fundamentally alters the research that is being conducted. The intersection between IRB review and free speech is also explored. In general, it is argued that the review system for human subjects research (HSR) should be modified in order to limit the scope of IRB review.     

Waivers of parental consent for sexual minority youth

ABSTRACT

The Society for Adolescent Health and Medicine emphasizes the need for research to focus on the health outcomes of sexual minority youth (i.e., lesbian, gay, bisexual, transgender, queer). However, sexual minority youth (SMY) are often less willing to participate in research studies where parental consent is required due to potential victimization and discrimination. This is a major concern given that more research is needed to understand the health needs of this population, especially in terms of suicide, substance use, and HIV prevention. The National Suicide Prevention Strategy classifies SMY as a high-risk group, emphasizing the need to explore suicide risks (along with other health outcomes) among this group. However, this high-risk classification also increases the safeguards necessary to conduct research with this population. Many researchers have argued for waivers of parental consent, but such waivers present with several ethical implications. This article discusses ethical principles, risks, benefits, safeguards, and potential alternative approaches to waivers of parental consent for SMY. We conclude by emphasizing the need for policy changes to allow parental consent waivers for research targeting SMY.     

生物遗传资源的法律保护研究

生物遗传资源是包含生物遗传功能材料的资源;这种材料应该是＂活体＂,对我们具有实际的或者潜在的价值。生物遗传资源的权利主体应为相应的资源所属国和特定的自然人群体。在使用生物遗传资源的过程中,权利主体享有同意权。对于生物遗传资源的开发利用,权利主体可要求获得相应的利益。对于生物遗传资源的保护,我们不可能直接采取专利权的保护模式,只能间接采取专利权的保护模式。我们应参考印度、乌干达等公法规制国家的立法,强调对生物遗传资源保护的公法规制,以专门立法的形式对生物遗传资源进行保护。     

目的论证成与自生证成——大卫·施密茨证成国家的两种方式

一般意义上讲,证成国家的理论是针对无政府主义者对国家的反对,证明国家的存在是审慎理性的,道德上可接受的。大卫·施密茨（David Schmidtz）在其文章“证成国家”中给出了证成国家的两种方式,即目的论的证成与自生证成,前者在于说明国家的存在是有益的,并优于无政府状态,而后者在于说明国家的产生过程没有侵犯道德边界。     

基因专利的惠益共享

本文结合典型案例,讨论了基因专利惠益共享问题,包括基因专利权的归属、基因资源主权原则、基因专利惠益共享方式、知情同意权等,最后对我国相关立法提出了建议,主要包括统一基因资源保护和管理立法,严格相关法律责任、在专利法中规定遗传资源来源披露制度和知情同意制度等。      

知情同意——病人的权利与立法——兼谈对《执业医师法》第26、37条的修改

目的探讨我国病人的知情同意权立法状况.方法分析了病人知情同意权的内涵、性质、行使形式.结果我国病人的知情同意权尚未得到有效的法律保护.结论建议修订<执业医师法>,加快制定包括知情同意权在内的病人权利法,以最大限度地保障病人的权利.     

目前遗传资源和传统知识法律保护机制国际探索的成就与不足——评CBD事先知情同意机制和FAO农民权机制

传统知识是长期以来传统部族在长期的生产生活实践中创造出来的知识、技术、经验的总称,是一种知识形态和知识产品。CBD等国际组织对遗传资源及有关传统知识的保护进行了多年的探索,在保护机制上取得了一定的创新。CBD开创的事先知情同意机制和FAO开创的农民权机制为其代表。两种机制均在物权层面设计了遗传资源及有关传统知识的保护规则,但前者具有较强的保障力,后者基本上还是一种道义意义上的权利。但只有提供知识产权保护方能充分实现传统部族在传统知识上的利益。     

论侵权行为法中受害人的同意

在侵权行为法中,受害人同意是指,受害人就他人特定行为的发生或者他人对自己权益造成的特定损害后果予以同意并表现在外部的意愿。它可以是明示的,也可以是默示的。合法有效的受害人同意包括以下几项要件:必须有明确具体的内容;真实的、自愿的;受害人具有同意能力;加害人尽到充分的告知、说明义务;不得违反法律的强行性、禁止性规定以及公共秩序、善良风俗。合法有效的受害人同意能够作为违法阻却事由或抗辩事由,从而免除加害人的侵权责任。但是,受害人对于犯罪行为的同意既不能免除加害人的刑事责任,也不能免除民事责任。受害人的同意与受害人故意、自甘冒险、免责条款之间既存在相同点,也有不同之处。     

Patients’ competence to consent to neurobiological research

Progress has been made defining the standards for determining subjects’ competence to consent to research: abilities to communicate a choice, understand relevant information, appreciate the nature of the situation and its consequences, and manipulate information rationally. Available data show clearly that persons with mental illness display a spectrum of decisionmaking abilities, with many performing well, but some doing quite poorly. More attention now is required to identifying the degree of capacity required for competent consent to projects with varying risk/benefit characteristics. Practical means are also required for screening for subjects with impaired capacities, attempting to improve their performance, and providing substituted consent when their deficiencies are intractable.     

Sexuality,Adolescence and the Criminal Law

SUMMARY

The provisions in the German Criminal Code protecting sexual self-determinationeven after several penal law reforms-are still criminologically not yet coherently structured and carry some contradictions. Recent research implies that in the section of the German Criminal Code establishing sexual offences three very divergent forms of deviant behavior are lumped together in an undifferentiated way: violent offences, infractions of moral norms and commercialization of sexuality (the latter in most cases in the form of organised crime). Some offences lack empirical justification in the sense of a concept of protection, for example due to the fact that damage caused to victims is not proven. In addition the establishment of age limits turns out as a difficult task, i.e., when consensual (love) relations of adolescents and of young adults are concerned. International efforts to approximate (sexual) offences legislation carry the risk that reasoned, criminologically analysed and empirically justified regulations are sacrificed to populistic diffused mainstream-thinking.