Informed consent in gene transfer research

虽然人们对了解研究的风险给予了很大的关注，但对研究的好处却关注得少。本研究的目的是了解参与者（主要研究者（PI）、研究协调员（SC）、受试者和IRBS）如何理解基因转移研究的益处。这项研究的重点是研究和治疗之间的关系，研究人员和临床医生的双重角色，以及参与者对受益的期望。本研究包括与PI、SC、受试者和IRB主席的访谈。它还包括基因转移同意书的内容分析。访谈已经完成，同意书也已经编码。 我们已经完成了对41个IRB访谈数据的初步分析，发现有多种方法可以评估研究的益处。虽然大多数IRB考虑了受试者的获益和社会的获益，但也有少数IRB排除了其中之一。这种变异性令人担忧，因为IRB的主要目标之一是评估风险和获益的平衡。进一步明确IRB应如何考虑获益可能会提高其评估研究的能力。

While there has been much attention given to understanding the risks of research there has been much less attention given to the benefits of research. The purpose of this study is to understand how the participants (Principle Investigators (PIs), Study Coordinators (SC), Subjects, and IRBS) understand the benefits of gene transfer research. The study focuses on the relationship between research and treatment, the dual roles of researcher and clinicians, and the expectations of benefit by the participants. The study includes interviews with PIs, SCs, Subjects, and IRB Chairs. It also includes a content analysis of gene transfer consent forms. The interviews have been completed and the consent forms have been coded. We have completed the initial analysis of the data from the 41 IRB interviews and found that there is a wide range of approaches to evaluating the benefits of research. While most IRBs consider benefits to subjects and benefits to society, there are a few IRBs that exclude one or the other. This variability is concerning since one of the primary objectives of IRBs is to conduct an assessment of the balance of risks and benefits. Further clarity about how benefits should be considered by IRBs may improve their ability to assess research.