Strengthening Research Integrity Oversight and Ethical Review of Critical HIV Research in China

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PROJECT SUMMARY/ABSTRACT Scientific research capacity has grown enormously in China in recent years, and China has since become the largest contributor to the literature. However, recent discoveries of research misconduct, which have had a negative impact on Chinese scientists and their US collaborators, related to inadequate ethical review, neglect for human subjects protections, and publication fraud have highlighted China's under-developed research ethics capacity and infrastructure. China must act now to instill the principles of responsible conduct of research (RCR) in its next generation of scientists. The National Center for AIDS/STD Control and Prevention (NCAIDS) at the Chinese Center for Disease Control and Prevention (China CDC) has a long history of conducting critical HIV research in priority areas and is dedicated to continuing this mission into the future. Moreover, it is committed to leading the way for China in elevating research integrity to the international standard, not only by serving as an example, but also by helping other domestic institutions improve in this area. The capacity building strategies proposed herein are crucial next steps toward achieving this broader, long-term goal, and are also in line with the goal of the Fogarty International Center (FIC) HIV Research Training Program “to strengthen the human capacity to contribute to the ability of institutions in low- and middle-income countries (LMIC) to conduct HIV- related research on the evolving HIV-related epidemics in their country and to compete independently for research funding.” Building on existing institutional structures and resources at NCAIDS, China CDC, 2 aims are proposed. The proposal's first aim is to strengthen research integrity oversight of manuscripts at NCAIDS and at Anhui Medical University (AMU) and Kunming Medical University (KMU). To achieve this aim, 3 activities are proposed: (1) publication ethics workshop, where researchers at all levels will receive training on issues including plagiarism (how to avoid, detect, and remedy it), acceptable citation practices, and institutional and international expectations for ethical publication, (2) publication ethics case study e-learning modules will be developed and continually be updated to cover new cases and/or new forms of ethics violations, and (3) internal pre-submission manuscript review, a new process that will be developed and launched for the purpose of evaluating manuscripts The proposal's second aim is to strengthen ethical review of research proposals for the protection of human subjects at NCAIDS and AMU and KMU. To accomplish this aim, an additional 2 activities are proposed: (4) institutional review board (IRB) apprenticeships, whereby IRB members from AMU and KMU spend 3 days at NCAIDS working directly with NCAIDS IRB members and (5) IRB workshops, where NCAIDS AMU and KMU IRB members attend each other's IRB meetings and then put on a workshop-style event where critical review and for science quality, writing quality, and integrity of reporting, ensuring compliance to ethical standards. suggestions on areas of potential improvement are provided.