Risk

Minimal risk, according to 45 CFR 46.102 (i), means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

New protocols are reviewed on an individual basis by the CPHS to determine if risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects and the importance of knowledge that may reasonably be expected to result. Each protocol will be assessed into one of the following risk categories:

1. The research involves no more than minimal risk to subjects.
2. The research involves more than minimal risk to subjects:

(i) The risk(s) represents a minor increase over minimal risk,

OR

(ii) The risk(s) represents more than a minor increase over minimal risk.

Benefit

A research benefit is considered to be something of health-related, psychosocial, or other value to an individual research subject, or something that will contribute to the acquisition of generalizable knowledge. Money or other compensation for participation in research is not considered to be a benefit, but rather compensation for research-related inconveniences.

During the CPHS review process, new protocols will be assessed into one of the following benefit categories:

1. The research involves no prospect of direct benefit to individual subjects, but is likely to yield generalizable knowledge about the subject's disorder or condition.
2. The research involves the prospect of direct benefit to individual subjects.

UTHealth’s Compliance Hotline (1-888-472-9868)
For other questions, please call us at 713-500-7943.