Rivera Suzanne M, Goldenberg Aaron, Rosenthal Beth, Aungst Heide, Maschke Karen J, Rothwell Erin, Anderson Rebecca A, Botkin Jeffrey, Joffe Steven
Case Western Reserve University, Cleveland, OH, USA
Case Western Reserve University, Cleveland, OH, USA.
J Empir Res Hum Res Ethics. 2015 Dec;10(5):449-56. doi: 10.1177/1556264615610199.
To advance scientific knowledge about human diseases and effective therapeutic treatments, investigators need access to human biospecimens and associated data. However, regulatory and procedural requirements may impede investigators' efforts to share biospecimens and data within and across institutions. Although a number of studies have explored experiences and attitudes of study participants and others about biospecimen and data sharing, less is known about investigators' perspectives. We conducted an electronic survey to learn about investigators' experiences and attitudes about research with biospecimens and associated data. A total of 114 practicing scientists from a pool of 60 university medical schools with Clinical and Translational Science Awards (CTSAs) funded by the National Institutes of Health (NIH) participated. We found a high degree of variability in investigators' experiences with institutional review boards (IRBs) when seeking approval to conduct biospecimen research, as well as differences in approaches to informed consent for the collection of specimens. Participants also expressed concerns that the risks of biospecimen research may be overestimated by IRBs. This research suggests that the current regulatory environment for human research protections may require reconsideration with regard to standards for collection, use, and sharing of biospecimens and data.
为了推动有关人类疾病和有效治疗方法的科学知识发展，研究人员需要获取人类生物样本及相关数据。然而，监管和程序要求可能会阻碍研究人员在机构内部和跨机构共享生物样本和数据的努力。尽管已有多项研究探讨了研究参与者及其他人员对生物样本和数据共享的经历与态度，但对于研究人员的观点却知之甚少。我们开展了一项电子调查，以了解研究人员对使用生物样本及相关数据进行研究的经历和态度。共有来自60所获得美国国立卫生研究院（NIH）临床和转化科学奖（CTSA）资助的大学医学院的114名在职科学家参与了此次调查。我们发现，研究人员在寻求开展生物样本研究的批准时，与机构审查委员会（IRB）打交道的经历存在很大差异，在样本采集知情同意的方式上也有所不同。参与者还表达了对IRB可能高估生物样本研究风险的担忧。这项研究表明，当前人类研究保护的监管环境可能需要在生物样本和数据的采集、使用及共享标准方面重新加以考量。
