Making Sense of the Undue Burden Interpretation of Minimal Risk

"Making Sense of the Undue Burden Interpretation of Minimal Risk." The American Journal of Bioethics, 14(9), pp. 1–2

ACKNOWLEDGMENTS

This article is the work product of an employee of the National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). However, the statements, opinions, or conclusions contained herein do not necessarily represent the statements, opinions, or conclusions of NIEHS, NIH, or the U.S. government. ▪

Notes

1 . It is worth noting that the research regulations adopted by many countries other than the United States also include the concept of minimal risk. See Kopelman (2004).

2 . Nonbeneficial research, also known as nontherapeutic research, is research that is not expected to provide the subjects with any direct medical benefits.