Quality Improvement in Human Subjects Research

人类受试者研究参与者的安全和福利一直是马萨诸塞大学医学院（UMMS）临床研究的基础。无论是由联邦机构、制药行业还是研究者发起的，涉及人类受试者的研究都要经过机构审查委员会的工作人员和委员会的仔细审查和考虑。在过去的几年里，UMMS的研究规模急剧增长，从NIH增加的资金和临床研究的增长来看，现在总共有852个有效的人体协议。这些增加，加上国家承认有必要加强对人类受试者研究的监督，促使UMMS重新评估和加强我们对人类受试者保护的现有重点。特别是，教育和提高素质这两个领域将得到加强。这将通过扩大和正规化对IRB成员、临床研究调查员及其关键人员的教育和培训，以及一个促进研究行为质量改进的内部审计周期来实现。由专业培训师进行的现场培训将通过参与IRB协作培训计划的网络教育计划而得到加强，从而使对人类受试者保护的理解更加深入和广泛。由研究办公室工作人员举办的一系列研讨会将纳入通过内部审计周期确定的问题，从而确保在良好临床规范（GCP）标准下进行日常研究。认识到UMMS致力于扩大我们对人类受试者保护的能力，有一个强有力的机构承诺，在这一年的IRB增强资金之后继续这些努力。

The safety and welfare of participants in human subjects research has always been the foundation of clinical research at the University of Massachusetts Medical School (UMMS). Whether funded by federal agencies, pharmaceutical industry or investigator-initiated, research involving human subjects receives careful review and consideration by the Institutional Review Board staff and committees. In the last few years the scale of the research enterprise at UMMS has grown dramatically, evidenced by the increased funding from the NIH and the growth in clinical studies, which now total 852 active human protocols. These increases, coupled with the national acknowledgement of the necessity for increased oversight for human subjects research, have prompted UMMS to reevaluate and strengthen our existing focus on human subjects protection. In particular, the two areas of education and quality improvement will be enhanced. This will be accomplished by expanding and formalizing the education and training of both IRB members, clinical research investigators and their key personnel, along with a cycle of internal auditing to promote quality improvement in study conduct. On-site programs, conducted by professional trainers, will be enhanced through participation in a web-based education program through the Collaborative IRB Training Initiative, offering more depth and breadth of understanding of human subjects protection. A seminar series, conducted by the Office of Research staff, will incorporate issues identified through the internal auditing cycle, thus ensuring that the day-to-day conduct of studies is carried out under Good Clinical Practice (GCP) standards. Acknowledging that UMMS is dedicated to expanding our capacity for human subjects protection, there is a strong institutional commitment to continue these efforts beyond this one-year IRB enhancement funding.