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州大学医学院（UMMS）临床研究的基础。无论是由联邦机构、制药行业还是由制药商发起的资助，涉及人类受试者的研究都要接受机构审查委员会工作人员和委员会的仔细审查和考虑。在过去的几年里，UMMS的研究企业规模急剧增长，NIH的资金增加和临床研究的增长（目前共有852项活跃的人体方案）就证明了这一点。这些增加，再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关注。特别是在教育和提高质量这两个领域将得到加强。这将通过扩大和正式化对IRB成员、临床研究研究者及其关键人员的教育和培训，以及沿着一个内部审计周期来实现，以促进研究实施的质量改进。将通过参与协作IRB培训计划的网络教育计划，增强由专业培训师进行的现场培训计划，以提供对人类受试者保护的更深入和更广泛的理解。由研究办公室工作人员举办的系列研讨会将纳入通过内部稽查周期发现的问题，从而确保研究的日常开展符合药物临床试验质量管理规范（GCP）标准。认识到UMMS致力于扩大我们对人类受试者的保护能力，有一个强有力的机构承诺，在这一年的IRB增强资金之外继续这些努力。

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.