改善机构审查委员会对社区参与研究提案审查的挑战与建议:一项范围综述。
Challenges and recommendations to improve institutional review boards' review of community-engaged research proposals: A scoping review.
作者信息
Onakomaiya Deborah, Pan Janet, Roberts Timothy, Tan Holly, Nadkarni Smiti, Godina Marina, Park Jo, Fraser Marilyn, Kwon Simona C, Schoenthaler Antoinette, Islam Nadia
机构信息
Vilcek Institute of Graduate Biomedical Sciences, NYU Grossman School of Medicine, New York, NY, USA.
Department of Population Health, NYU Grossman School of Medicine, New York, NY, USA.
出版信息
J Clin Transl Sci. 2023 Mar 31;7(1):e93. doi: 10.1017/cts.2023.516. eCollection 2023.
Academic and community investigators conducting community-engaged research (CEnR) are often met with challenges when seeking Institutional Review Board (IRB) approval. This scoping review aims to identify challenges and recommendations for CEnR investigators and community partners working with IRBs. Peer-reviewed articles that reported on CEnR, specified study-related challenges, and lessons learned for working with IRBs and conducted in the United States were included for review. Fifteen studies met the criteria and were extracted for this review. Four challenges identified (1) Community partners not being recognized as research partners (2) Cultural competence, language of consent forms, and literacy level of partners; (3) IRBs apply formulaic approaches to CEnR; & (4) Extensive delays in IRB preparation and approval potentially stifle the relationships with community partners. Recommendations included (1) Training IRBs to understand CEnR principles to streamline and increase the flexibility of the IRB review process; (2) Identifying influential community stakeholders who can provide support for the study; and (3) Disseminating human subjects research training that is accessible to all community investigator to satisfy IRB concerns. Findings from our study suggest that IRBs can benefit from more training in CEnR requirements and methodologies.
开展社区参与研究(CEnR)的学术研究人员和社区研究人员在寻求机构审查委员会(IRB)批准时常常面临挑战。本范围综述旨在确定与IRB合作的CEnR研究人员和社区合作伙伴所面临的挑战及建议。纳入综述的是在美国开展的、报道了CEnR、明确了与研究相关的挑战以及与IRB合作的经验教训的同行评审文章。15项研究符合标准并被提取用于本次综述。确定了四个挑战:(1)社区合作伙伴未被视为研究伙伴;(2)文化能力、同意书语言以及合作伙伴的识字水平;(3)IRB对CEnR采用公式化方法;(4)IRB准备和批准过程的长时间延迟可能会破坏与社区合作伙伴的关系。建议包括:(1)培训IRB以理解CEnR原则,从而简化并提高IRB审查过程的灵活性;(2)确定能够为研究提供支持的有影响力的社区利益相关者;(3)传播所有社区研究人员都能获取的人类受试者研究培训,以满足IRB的关切。我们研究的结果表明,IRB可以从更多关于CEnR要求和方法的培训中受益。