IRB常见问题

Before most research studies involving human subjects can start, they must be approved by a committee, usually called an "institutional review board" or "IRB."

The IRB reviews proposed research to ensure it is designed to minimize risks to subjects and that these risks are reasonable when compared to the possible benefits of the research. The IRB also reviews the accuracy of the consent form. The IRB may continue to review approved ongoing research, based on the level of risk to subjects.

Human subjects research is any research or clinical investigation that involves human subjects. Research is defined as a systematic investigation, 包括研究开发, 测试与评估, designed to develop or contribute to generalizable knowledge.

Examples of systematic investigations include:

• 调查及问卷
• 访谈和焦点小组
• Analyses of existing data or biological specimens
• 流行病学研究
• Evaluations of social or educational programs
• Cognitive and perceptual experiments
• 医疗图检讨研究

Research results do not have to be published or presented at a professional meeting to qualify the experiment or data gathering as research. The intent to contribute to "generalizable (scholarly) knowledge" makes an experiment or data collection research, 不管出版物是什么. Research that never is published is still research. Participants in research studies deserve protection whether or not the research is published.

If an instructor determines that there is a possibility that a student's proposed research project may result in a formal presentation or publication, he/she should recommend that the student submit the project for IRB review before beginning the study.

以人类为研究对象, an activity must be designed with the intent to develop or contribute to "generalizable knowledge.“很明显, some classroom activities are designed to teach research techniques and have no such intent.

Simulations of human experimentation and course-assigned data collection do not constitute human subjects research if the activities are designed for educational purposes only; and

• The data will not be generalized outside the classroom (reporting of data within the class is acceptable because the activities were performed solely for teaching purposes); and
• The data will not result in a master's thesis, 博士论文, 海报会议, 摘要, or other publication or presentation; and
• The student volunteers or other participants are clearly informed that the activities are an instructional exercise, and not actual research; and
• The project does not involve anything that constitutes more than “minimal risks to the subjects” (see exceptions below); and
• The project does not involve a vulnerable group (see exceptions below).

Exceptions are any activity that is a clinical investigation or involves medical intervention or procedures, even when they are a part of a course curriculum, always constitutes human subjects research and requires prior IRB review and approval. If in doubt, please send questions to irb@roomarea1.net.

There may be instances when a student or instructor wishes to use data for research that was previously collected for educational purposes. An application should be submitted to the IRB when a student or instructor wishes to analyze the data with the intent of contributing to generalizable knowledge. 例子:

• An instructor is surprised at some of the unique findings that appeared when students completed surveys as part of a classroom activity. The instructor would like to do additional analysis on the data and submit it for presentation or publication when the course ends. The instructor's intent has changed and an IRB application is necessary because the instructor will now be analyzing existing data that was collected for a non-research purpose.
• An undergraduate junior sociology major wishes to conduct research in the hopes of having a publication to list on her application to graduate school. She plans to devise an experiment, enroll subjects, analyze the results and write a manuscript. 这是人类研究. Prior IRB review and approval is necessary.

Please allow at least 7-10 days for standard proposal review and 3-4 weeks for proposals requiring full board review.

There are three kinds of reviews: exempt, expedited and full board review.