Oyibo W A, Krugher M, Fagbenro-Beyioku A F
Department of Medical Microbiology and Parasitology, College of Medicine, University of Lagos, Idi-Araba, Lagos.
Nig Q J Hosp Med. 2008 Apr-Jun;18(2):115-9. doi: 10.4314/nqjhm.v18i2.45000.
Researches involving human participants are expected to be conducted professionally to ensure that the research participants are protected from any likely harm. In this regard, the Institutional Review Board (IRB) of an institution plays a very important role in ensuring the safety and rights of research participants. Though most institutions have an IRB that approves research protocols, official policy that all research must be approved is yet to be institutionalized. In addition, training and re-training of members of IRBs is not given sufficient attention. While noting that the functionality of an IRB is hinged on an efficient secretariat that serves as the clearing house for protocols to be approved, some of our IRBs do not have a working secretariat with dedicated staff. Indeed, there are a number of challenges that are capable of undermining the role of the IRBs. Other challenges in the operationalization of IRBs include: poor mechanisms of monitoring of research, financial constraints, poor data archival systems, lack of a standard operational procedure and guidelines for submission and evaluation of protocols etc. As the IRBs are expected to play important roles in research involving human participants especially in clinical and vaccine trials, this paper highlights the role, challenges and requirements for the institutionalization of IRBs.
涉及人类受试者的研究应专业地开展，以确保研究参与者免受任何可能的伤害。在这方面，机构的机构审查委员会（IRB）在确保研究参与者的安全和权利方面发挥着非常重要的作用。尽管大多数机构都有IRB来批准研究方案，但所有研究必须获得批准的官方政策尚未制度化。此外，IRB成员的培训和再培训没有得到足够的重视。虽然注意到IRB的功能取决于一个高效的秘书处，该秘书处作为待批准方案的信息交换中心，但我们的一些IRB没有配备专职工作人员的运作良好的秘书处。事实上，有许多挑战能够削弱IRB的作用。IRB运作中的其他挑战包括：研究监测机制不完善、资金限制、数据存档系统不佳、缺乏标准操作程序以及方案提交和评估指南等。由于IRB预计在涉及人类受试者的研究中，特别是在临床试验和疫苗试验中发挥重要作用，本文强调了IRB制度化的作用、挑战和要求。
