Nurmi Sanna-Maria, Halkoaho Arja, Kangasniemi Mari, Pietilä Anna-Maija
Department of Nursing Science, University of Eastern Finland, Kuopio Campus, P.O. Box 1627, 70211, Kuopio, Finland.
Kuopio University Hospital (Science Service Centre), P.O. Box 100, FI 70029 KYS, Kuopio, Finland.
BMC Med Ethics. 2017 Oct 25;18(1):57. doi: 10.1186/s12910-017-0217-6.
Protecting human subjects from being exploited is one of the main ethical challenges for clinical research. However, there is also a responsibility to protect and respect the communities who are hosting the research. Recently, attention has focused on the most efficient way of carrying out clinical research, so that it benefits society by providing valuable research while simultaneously protecting and respecting the human subjects and the communities where the research is conducted. Collaboration between partners plays an important role and that is why we carried out a study to describe how collaborative partnership and social value are emerging in clinical research.
A supra-analysis design for qualitative descriptive secondary analysis was employed to consider a novel research question that pertained to nurse leaders' perceptions of ethical recruitment in clinical research and the ethics-related aspects of clinical research from the perspective of administrative staff. The data consisted of two separate pre-existing datasets, comprising 451 pages from 41 interviews, and we considered the research question by using deductive-inductive content analysis with NVivo software. A deductive analysis matrix was generated on the basis of two requirements, namely collaborative partnership and social value, as presented in An Ethical Framework for Biomedical Research by Emanuel et al.
The findings showed that collaborative partnership was a cornerstone for ethical clinical research and ways to foster inter-partner collaboration were indicated, such as supporting mutual respect and equality, shared goals and clearly defined roles and responsibilities. In addition, the social value of clinical research was an important precondition for ethical clinical research and its realisation required the research partners to demonstrate collaboration and shared responsibility during the research process. However, concerns emerged that the multidimensional meaning of clinical research for society was not fully recognised. Achieving greater social value for clinical research required greater transparency, setting research priorities, shared responsibility for the dissemination and use of the findings and stronger community awareness of the ethics-related aspects of clinical research.
Collaborative partnership and social values are essential for protecting the human subjects and communities involved in clinical research.
保护人类受试者不被剥削是临床研究面临的主要伦理挑战之一。然而，保护和尊重开展研究的社区同样也是一项责任。最近，人们关注的焦点在于开展临床研究的最有效方式，以便通过提供有价值的研究使社会受益，同时保护和尊重人类受试者以及研究开展所在的社区。合作伙伴之间的协作发挥着重要作用，这就是我们开展一项研究以描述临床研究中协作伙伴关系和社会价值如何形成的原因。
采用定性描述性二次分析的元分析设计，以考虑一个新的研究问题，该问题涉及护士领导者对临床研究中伦理招募的看法以及从行政人员角度看临床研究的伦理相关方面。数据由两个独立的已有数据集组成，包括来自41次访谈的451页内容，我们使用NVivo软件通过演绎 - 归纳内容分析来考虑该研究问题。基于伊曼纽尔等人在《生物医学研究伦理框架》中提出的两个要求，即协作伙伴关系和社会价值，生成了一个演绎分析矩阵。
研究结果表明，协作伙伴关系是符合伦理的临床研究的基石，并指出了促进伙伴间协作的方法，例如支持相互尊重和平等、共享目标以及明确界定角色和责任。此外，临床研究的社会价值是符合伦理的临床研究的重要前提，其实现要求研究伙伴在研究过程中展现协作和共同责任。然而，出现了对临床研究对社会的多维意义未得到充分认识的担忧。要为临床研究实现更大的社会价值，需要更高的透明度、确定研究重点、对研究结果的传播和使用承担共同责任以及增强社区对临床研究伦理相关方面的认识。
协作伙伴关系和社会价值对于保护参与临床研究的人类受试者和社区至关重要。
