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|
Bibliographical noteFunding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The Center for Chronic Disease Outcomes Research is a VA Health Services Research and Development (HSR&D) Service Center of Excellence (Center grant number HFP 98-001). MM and DV were supported by VA HSR&D award (number 14-004). MRP was supported by a VA HSR&D Research Career Scientist Award (number RCS 10-185). The funding agency had no role in the design, data collection, analysis, data interpretation, article writing, or decision to submit the article. MM obtained funding; designed the study; oversaw data collection, analysis, interpretation; and drafted the article. DV collected the data and, along with SMK-F and MRP, contributed to analysis and interpretation of data and subsequent article revisions. All authors read and approved the final article. MM and DV had full access to the data.
© The Author(s) 2018.
- minimal risk
- patient surveys
- pre–post test observation
- psychological distress
- research participation
- research subjects/psychology