Roberts L W
Department of Psychiatry, University of New Mexico School of Medicine, Albuquerque 87131-5326, USA.
Compr Psychiatry. 1998 May-Jun;39(3):99-110. doi: 10.1016/s0010-440x(98)90068-2.
The study objective was to clarify the ethical basis of psychiatric research by outlining conceptual issues and empirical findings related to the ethics of human experimentation. A systematic review of scholarly and empirical literature covering three decades was performed. The ethics of human research has come to be understood in relation to the principles of respect for persons, beneficence, justice, and the ideal of informed consent. Subjects who cannot fully participate in informed-consent processes are especially vulnerable to exploitation. Current dilemmas stem from insufficient attention to the vulnerabilities of mentally ill research participants, problems in applying ethical concepts and guidelines to psychiatric research, and claims of research misconduct. Empirical studies indicate that (1) psychiatric symptoms significantly affect informed consent, (2) psychiatric patients may possess certain strengths with respect to research involvement, (3) proxy decision-making is problematic, (4) informed consent is also difficult to attain with the medically ill and others, (5) patients are motivated to participate in research by the hope of personal benefit, (6) ethical aspects of research are poorly documented, and (7) institutional review processes may not be adequate to protect vulnerable subjects. Psychiatric research can be performed ethically, according to standards set throughout the biomedical and behavioral sciences, so long as researchers and institutions are respectful of special ethical issues in human experimentation and strive to include vulnerable study participants fully in research decisions. However, many gaps in the empirical literature exist regarding the specific nature and implementation of ethics principles in psychiatric research. Efforts to advance both science and ethics, including the study of ethical dimensions of human research itself, are essential for the future of psychiatry.
本研究的目的是通过概述与人体实验伦理相关的概念问题和实证研究结果，阐明精神病学研究的伦理基础。我们对涵盖三十年的学术和实证文献进行了系统综述。人体研究的伦理已逐渐根据尊重人、有益、公正以及知情同意的理想等原则来理解。无法充分参与知情同意过程的受试者特别容易受到剥削。当前的困境源于对精神病研究参与者的脆弱性关注不足、将伦理概念和准则应用于精神病学研究时存在的问题以及研究不当行为的指控。实证研究表明：（1）精神症状会显著影响知情同意；（2）精神病患者在参与研究方面可能具有某些优势；（3）代理决策存在问题；（4）身患疾病者及其他人群也难以获得知情同意；（5）患者因希望获得个人利益而有参与研究的动机；（6）研究的伦理方面记录不完善；（7）机构审查程序可能不足以保护脆弱的受试者。只要研究人员和机构尊重人体实验中的特殊伦理问题，并努力让脆弱的研究参与者充分参与研究决策，那么按照整个生物医学和行为科学设定的标准，精神病学研究就可以合乎伦理地进行。然而，关于精神病学研究中伦理原则的具体性质和实施，实证文献中存在许多空白。推进科学与伦理，包括对人体研究本身伦理维度的研究，对精神病学的未来至关重要。
