约翰霍普金斯大学与人类相关研究的伦理学培训指南

美国约翰·霍普金斯大学彭博公共卫生学院与人类相关研究的伦理学培训指南

本指南是用于培训将要参加与人类有关研课题的工作者。本指南主要是帮助约翰霍普金斯大学的项目负责人对其他相关研究人员进行培训，使他们的研究行为符合伦理学要求，并以符合伦理要求的方式去：1) 取得研究对象的知情同意， 2) 通过对研究对象进行个人或小组的面谈、检查、身体测量，或以其他直接接触的渠道收集数据 (以下简称“调查员”)。本指南所采用的特定的内容和语言水平，是为了帮助项目负责人向调查员传达基本的研究准则和相应的行为标准。

详见附件

Lecture Notes

306.665.01 RESEARCH ETHICS AND INTEGRITY: U.S. AND INTERNATIONAL ISSUES
Health Policy and Management
Kass, Nancy

Acquaints students with an introduction to ethical theory and principles, including ethics requirements when conducting research with human subjects in the U.S. and/or developing countries. Through lectures and small group case discussion, the following topics are covered: ethical theory and principles; informed consent in research; Institutional Review Boards; the just selection of research participants; cultural relativism; genetic research; ethical issues in vaccine research; ethics and human rights; appropriate use of placebos; what is owed to research participants, communities, and countries after research is completed; the use of animals in research; and scientific and academic integrity. Students in this course select to be in the U.S. track or the international track. While most lectures are identical for the two tracks, case discussions and assignments are different. The international track is geared toward international and American students conducting research in developing country settings. This course satisfies the NIH's and the School's requirement for training in the responsible conduct of research.

Ethics Issues in Human Subjects Research in Developing Countries
Nancy Kass and Andrea Ruff
(340.667.11)
This course will introduce those enrolled to ethical principles and formal codes of ethics, to key ethical issues that arise in international research. Ultimately, the course will be case-based to enable course participants to work through ethical challenges posed by research conducted in developing countries. Each daily session will be divided between a formal lecture and a case discussion. Case studies will be discussed in small groups and will be based on actual research projects in developing countries, including both clinical and epidemiological/observational research. The course is geared towards U.S. and international faculty, researchers, and students who conduct or fund research in developing country settings and to those who sit on IRBs/research ethics boards. Student evaluation is based on case study exercises and class participation. (2 academic credits)

> Introduction to Ethical Analysis (100 KB)

> Cases and Codes (307 KB)

> Assessment of Risks and Benefits (180 KB)

> Respect for Persons and Informed Consent (219 KB)

> Informed Consent and Cultural Relativism (92 KB) Guest Lecturer: Nancy Kass

> Introduction to Institutional Review Boards (IRBs) (121 KB)

> Protection and Access (156 KB)

> Justice in Research Ethics: International Issues (601 KB) Guest Lecturer: Nancy Kass

> Research Ethics and Human Rights (87 KB) Guest Lecturer: Chris Beyrer
> Coercion and Undue Inducement in Research: Money and Other Offers (167 KB) Guest Lecturer: Neal Dickert