It is difficult to apply U.S. Federal Code of Regulation’s criterion for “minimal risk,” because benchmarks of minimal risk have not been quantified. Our goal was to examine the psychological risks of several day-to-day activities. Using the Self-Assessment Manikin (SAM), we assessed the state valence and arousal of 432 patients and employees at a large Midwestern Department of Veterans Affairs medical facility before and after they had their blood drawn, saw their primary care physician or mental health provider, or took part in an exercise class. Exercise was associated with near-large to large salutary effects (Cohen’s d = 0.76-1.17); other effects were small or moderate in positive directions (Cohen’s d = 0.02-0.51). Our findings are a promising start toward establishing benchmarks and quantifying the psychological harms of minimal risk activities. Estimates such as these may help researchers determine whether their own research exceeds minimal risk.
|Original language||English (US)|
|Number of pages||8|
|Journal||Journal of Empirical Research on Human Research Ethics|
|State||Published - Feb 1 2019|
- minimal risk
- patient surveys
- pre–post test observation
- psychological distress
- research participation
- research subjects/psychology
PubMed: MeSH publication types
- Journal Article
- Observational Study
- Research Support, U.S. Gov't, Non-P.H.S.