Is My Study Human Subject 研究?

Human Subject 研究

A research project must fulfill 这两个 definitions of research 和 human subjects to require IRB review. If, after reading the definition of human subjects research (HSR), you are not sure if you need IRB review, please complete the Human Subjects 研究 (HSR) Determination Form for determination. 尽管如此, DU investigators are encouraged to submit their proposed research to the ORIE for determination of ethical 和 regulatory review requirements. The ORIE will provide the necessary documentation by issuing a formal letter for professional 和 academic endeavors.

Is My Study Human Subjects 研究?

研究 is defined in the Code of Federal Regulations, 45 CFR 46.102(d), as a systematic investigation designed to develop or contribute to generalizable knowledge.

人类的主题 is defined in the Code of Federal Regulations as "a living individual about whom an investigator conducting research 1) Obtains information or biospecimens through intervention or interaction with the individual, 并使用, 研究, or 分析 the information or biospecimens; OR 2) Obtains, 使用, 研究, 分析, or generates identifiable private information or identifiable biospecimens."

The project must meet the definition of both 研究 和 人类的主题 to constitute Human Subjects 研究.

All human subjects research must obtain IRB approval prior to study activities (that includes emailing participants, displaying or distributing recruitment materials, 和 obtaining participant consent).

If you assess your project as 不 human subjects research, or if you are unsure whether your project needs IRB review, you are strongly encouraged to complete the Human Subjects 研究 (HSR) Determination Form.