Whicher Danielle, Wu Albert W
Patient Centered Outcomes Research Institute (PCORI), 1919 M Street, NW, Suite 250, Washington, DC, 20036, USA.
Johns Hopkins Bloomberg School of Public Health, 624 N. Broadway, Baltimore, MD, 21205, USA.
Patient. 2015 Dec;8(6):477-82. doi: 10.1007/s40271-015-0141-0.
National regulations governing human subjects research differ with regard to whether they require survey research to be overseen by institutional ethics boards or committees. In cases where ethical review has been waived, or was provided by an individual or group other than an institutional ethics board, journals may question the appropriateness of the waiver or alternative review when making determinations about whether to accept the manuscript for publication. The purpose of this article is to provide guidance for journals to consider when making determinations about the necessity of ethical review for survey research projects. We review the functions of ethics oversight and consider the importance of those functions within the context of survey research. In survey research, no intervention is delivered to research participants. As a result, there is no risk of physical harm to individuals who participate. However, there can be a risk of informational or psychological harms. In situations where there is greater than minimal risk of informational or psychological harms, the survey research should have received institutional ethics oversight. Additionally, survey research projects that enroll vulnerable individuals with diminished autonomy should receive institutional ethics oversight. We hope that this article leads to further guidance on this subject by authoritative group such as the International Committee of Medical Journal Editors.
关于人类受试者研究的国家法规在是否要求调查研究由机构伦理委员会或委员会进行监督方面存在差异。在伦理审查被豁免的情况下,或者由机构伦理委员会以外的个人或团体提供伦理审查的情况下,期刊在决定是否接受稿件发表时可能会质疑豁免或替代审查的适当性。本文的目的是为期刊在决定调查研究项目伦理审查的必要性时提供指导。我们回顾了伦理监督的功能,并在调查研究的背景下考虑这些功能的重要性。在调查研究中,不会对研究参与者进行干预。因此,参与研究的个人不存在身体伤害的风险。然而,可能存在信息或心理伤害的风险。在信息或心理伤害风险大于最小风险的情况下,调查研究应该接受机构伦理监督。此外,招募自主性降低的弱势群体的调查研究项目也应该接受机构伦理监督。我们希望本文能促使国际医学期刊编辑委员会等权威团体就这一主题提供进一步的指导。