METHODS: A patient advocates-driven program called Patient Advocates for Clinical Research (PACER) conducted trainings focused on GCP for patient-centric research for patients, advocates and ethics committee members. Pre- and post-workshop questionnaires were used to assess the participants\' knowledge of GCP.
RESULTS: The workshop was attended by 116 participants. Of these 91 consented to participate in questionnaire evaluation that assessed participants\' knowledge on ethics committee (EC) functionality, research ethics and data confidentiality. Pre-workshop evaluations highlighted knowledge gaps. Only 16.5% were familiar with the primary ethical consideration for vulnerable populations and 69.2% were knowledgeable about data governance. Post-workshop evaluations demonstrated significant overall response improvement of 5.4% (𝜒2=13.890; p<0.001). The understanding of ethical considerations for vulnerable populations rose by 15.4% (p=0.007), and knowledge of data privacy regulations improved by 11.0% (p=0.041).
CONCLUSIONS: The workshop under PACER initiative highlighted the knowledge gaps in understanding the EC functionality, research ethics and data confidentiality. The workshop effectively fostered participants\' understanding of ethical research practices.
方法:一项名为“患者临床研究倡导者”(PACER)的患者倡导者驱动计划开展了以GCP为中心的患者研究培训。倡导者和道德委员会成员。研讨会前和研讨会后的问卷被用来评估参与者的GCP知识。
结果:116名参与者参加了研讨会。在这91人同意参与评估参与者对伦理委员会(EC)功能的知识的问卷评估中,研究伦理和数据保密。讲习班前评价突出了知识差距。只有16.5%的人熟悉弱势群体的主要道德考虑因素,69.2%的人了解数据治理。研讨会后评估显示,总体反应显着改善了5.4%(?2=13.890;p<0.001)。对弱势群体道德考虑的理解增加了15.4%(p=0.007),数据隐私法规知识提高了11.0%(p=0.041)。
结论:PACER倡议下的研讨会强调了在理解EC功能方面的知识差距,研究伦理和数据保密。研讨会有效地培养了参与者对道德研究实践的理解。