Centre for Medical Ethics, Institute of Health and Society, Faculty of Medicine, University of Oslo, Oslo, Norway.
OHSR Compliance Monitoring Program, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Curr Med Res Opin. 2023 Mar;39(3):341-350. doi: 10.1080/03007995.2023.2175999. Epub 2023 Feb 14.
To conduct a content analysis of IRB webpages of select universities (academic health centers) in the USA that describe post IRB- approval monitoring activities.
This was a qualitative study. Thematic analysis was the method to review the webpage content of selected academic health centers (AHC) within the USA.
Some US academic health "centers" IRB administrative or research compliance offices conduct post- approval monitoring (PAM) of human subjects' research including clinical trials. The goals of this PAM programmes are to (a) ensure compliance to approved protocols, (b) preserve research integrity, (c) manage institutional risks, d) provide advisory/educational support to researchers, (e) recommend corrective actions for identified issues, and most importantly, (f) to protect the safety, rights, and well-being of research participants. Although not a requirement by law, the PAM program has legislative support in the US Code of Federal Regulations as part of the US Office for Human Research Protection's (OHRP) Federal Wide Assurance (FWA). This is especially for institutions that conduct studies funded by the Federal government. PAM on-site checks reveal various incidents of protocol deviations and violations. This includes issues with recruitment processes, informed consent discrepancies, and incidents of non-compliance. When a study protocol is identified as non-compliant, the principal investigator works with the PAM monitor to develop a corrective action plan that would allow the study to become compliant and avoid sanctions from the IRB or the regulatory authority.
REC/IRB post-approval monitoring of clinical trials is a valuable mechanism of protection for research participants while giving educational and quality assurance support to researchers. The program enables early detection and resolution of non-compliance to approved protocols. The impact of the program in the USA requires further exploration.
对美国部分大学（学术健康中心）的机构审查委员会（IRB）网页进行内容分析，这些网页描述了 IRB 批准后监测活动。
这是一项定性研究。采用主题分析法审查了美国部分学术健康中心（AHC）的网页内容。
美国一些学术健康“中心”的 IRB 行政或研究合规办公室对人体研究（包括临床试验）进行批准后监测（PAM）。该 PAM 计划的目的是：（a）确保遵守批准的方案；（b）维护研究的完整性；（c）管理机构风险；（d）为研究人员提供咨询/教育支持；（e）针对已确定的问题提出纠正措施；最重要的是，（f）保护研究参与者的安全、权利和福祉。尽管法律没有要求，但 PAM 计划得到了美国联邦法规法典的立法支持，作为美国人类研究保护办公室（OHRP）联邦范围保证（FWA）的一部分。这尤其适用于进行联邦政府资助研究的机构。PAM 的现场检查揭示了各种方案偏离和违规行为。这包括招聘流程问题、知情同意差异以及不合规事件。当研究方案被确定为不合规时，主要研究者与 PAM 监测员合作制定纠正行动计划，使研究符合规定并避免来自 IRB 或监管机构的制裁。
REC/IRB 对临床试验的批准后监测是保护研究参与者的一种有价值的机制，同时为研究人员提供教育和质量保证支持。该计划能够及早发现和解决不符合批准方案的问题。该计划在美国的影响需要进一步探讨。
