McGill University.
Advarra IRB.
Am J Bioeth. 2023 Jun;23(6):75-88. doi: 10.1080/15265161.2022.2063434. Epub 2022 Apr 28.
Institutional review boards, tasked with facilitating ethical research, are often pulled in competing directions. In what we call the protection-inclusion dilemma, we acknowledge the tensions IRBs face in aiming to both protect potential research participants from harm and include under-represented populations in research. In this manuscript, we examine the history of protectionism that has dominated research ethics oversight in the United States, as well as two responses to such protectionism: inclusion initiatives and critiques of the term vulnerability. We look at what we know about IRB decision-making in relation to protecting and including "vulnerable" groups in research and examine the lack of regulatory guidance related to this dilemma, which encourages protection over inclusion within IRB practice. Finally, we offer recommendations related to how IRBs might strike a better balance between inclusion and protection in research ethics oversight.
机构审查委员会的任务是促进伦理研究，但往往会受到相互竞争的方向的影响。在我们所谓的保护-包容困境中，我们承认 IRB 面临的紧张局势，即既要保护潜在的研究参与者免受伤害，又要将代表性不足的人群纳入研究中。在本文中，我们研究了在美国主导研究伦理监督的保护主义历史，以及对这种保护主义的两种回应：包容性倡议和对脆弱性一词的批判。我们研究了我们对 IRB 决策的了解，这些决策与保护和包括“脆弱”群体参与研究有关，并研究了与这一困境相关的缺乏监管指导，这鼓励了 IRB 实践中的保护而不是包容。最后，我们提出了一些建议，涉及 IRB 如何在研究伦理监督中更好地平衡包容和保护。
