Mahendradhata Yodi, Nabieva Jamila, Ahmad Riris Andono, Henley Patricia, Launois Pascal, Merle Corinne, Maure Christine, Horstick Olaf, Elango Varalakshmi
Center for Tropical Medicine, Faculty of Medicine, Gadjah Mada University, Yogyakarta, Indonesia;
Freelance Consultant, Heidelberg, Germany.
Glob Health Action. 2016 Aug 5;9:32474. doi: 10.3402/gha.v9.32474. eCollection 2016.
Good clinical practice (GCP) guidelines have been the source of improvement in the quality of clinical trials; however, there are limitations to the application of GCP in the conduct of health research beyond industry-sponsored clinical trials. The UNICEF/UNDP/World Bank/WHO Special Program for Research and Training in Tropical Disease is promoting good practice in all health research involving human through the Good Health Research Practice (GHRP) training program initiative.
To report the results of piloting the GHRP training program and formulate further steps to harness GHRP for promoting good practices in all health research involving human, particularly in low- and middle-income countries (LMICs).
The objective of this training is to impart knowledge and skills for the application of ethical and quality principles to the design, conduct, recording, and reporting of health research involving human participants based on the level of risk, to ensure a fit-for-purpose quality system. This has been formulated into five sequential modules to be delivered in a 4-day course. Four courses have been organized in the pilot phase (2014-2015). The courses have been evaluated and assessed based on course feedback (quantitative and qualitative data) collected during course implementation and qualitative email-based pre- and post-course evaluation.
Participants were highly satisfied with the course content and its organization. The relevance and applicability of the course content resulted in positive feedback and an articulated willingness to adapt and disseminate the course. Action points to strengthen the training program have been identified, and showed the imminent need to develop a consensus with a broader range of key stakeholders on the final set of GHRP standards and means for implementation.
There is an urgent need to harness the momentum to promote high-quality and ethical health research in LMICs through scaling up GHRP training and further development of GHRP principles into international standards.
良好临床实践（GCP）指南一直是提高临床试验质量的源泉；然而，GCP在行业赞助的临床试验之外的健康研究实施中的应用存在局限性。联合国儿童基金会/联合国开发计划署/世界银行/世界卫生组织热带病研究和培训特别规划正在通过良好健康研究实践（GHRP）培训计划倡议，在所有涉及人类的健康研究中推广良好实践。
报告GHRP培训计划试点的结果，并制定进一步措施，利用GHRP在所有涉及人类的健康研究中，特别是在低收入和中等收入国家（LMICs）促进良好实践。
本次培训的目的是根据风险水平，传授将伦理和质量原则应用于涉及人类受试者的健康研究的设计、实施、记录和报告的知识和技能，以确保建立一个适用的质量体系。这已被制定为五个连续模块，在为期4天的课程中授课。在试点阶段（2014 - 2015年）组织了四门课程。根据课程实施期间收集的课程反馈（定量和定性数据）以及基于电子邮件的课程前后定性评估对课程进行了评估。
参与者对课程内容及其组织高度满意。课程内容的相关性和适用性得到了积极反馈，并且明确表示愿意改编和传播该课程。已确定加强培训计划的行动要点，并表明迫切需要与更广泛的关键利益相关者就最终的GHRP标准集和实施方法达成共识。
迫切需要借助这一势头，通过扩大GHRP培训并将GHRP原则进一步发展为国际标准，在低收入和中等收入国家促进高质量和符合伦理的健康研究。
