Sieber Joan E
Department of Psychology, California State University, Hayward, CA, USA.
Ethics Behav. 2004;14(4):297-304. doi: 10.1207/s15327019eb1404_1.
The federal regulations of human research were written to permit the use of discretion so that research can fit the circumstances under which it is conducted. For example, the researcher and institutional review board (IRB) could waive or alter some informed consent elements if they deem this the morally and scientifically best way to conduct the research. To do so, however, researchers and IRBs would first have to use mature moral and scientific judgment. They might also have to rely on empirical research to discover the most effective way to act on their moral sense (e.g., to discover how best to approach potential research participants and explain the nature and purpose of the research participation for which they are being recruited, to ensure comprehension and competent decision making). On discovering the most ethical way to proceed, they would then need to look to the federal regulations of human research to discover how to document their decision and justify it within that somewhat flexible regulatory structure. Unfortunately, many IRBs and researchers fail to take these sensible steps to solve ethical problems and proceed immediately to a default requirement of the regulations that places science at odds with the regulations and, ostensibly, with ethics. The following articles in this special issue are about the process of learning to engage in ethical problem solving and using the flexibility permitted by the federal regulations. These articles extricate researchers from the mindset that has gotten them into trouble, and, ideally, provoke them to use mature common sense and moral judgment.
联邦人类研究法规的制定允许运用自由裁量权，以便研究能够适应其开展的具体情形。例如，如果研究人员和机构审查委员会（IRB）认为这是开展研究的道德和科学最佳方式，他们可以放弃或改变一些知情同意要素。然而，要做到这一点，研究人员和IRB首先必须运用成熟的道德和科学判断力。他们可能还必须依靠实证研究来发现依据道德感采取行动的最有效方式（例如，发现如何以最佳方式接触潜在研究参与者，并解释他们被招募参与的研究的性质和目的，以确保理解并做出明智决策）。在找到最符合伦理的行动方式后，他们需要参照联邦人类研究法规，以了解如何记录他们的决定，并在这个有些灵活的监管框架内为之辩护。不幸的是，许多IRB和研究人员未能采取这些明智步骤来解决伦理问题，而是立即诉诸法规的默认要求，这使得科学与法规相悖，表面上也与伦理相悖。本期特刊中的以下文章探讨了学习进行伦理问题解决以及利用联邦法规所允许的灵活性的过程。这些文章使研究人员摆脱陷入困境的思维定式，理想情况下，促使他们运用成熟的常识和道德判断力。
