“RESULTS: There are now sufficient data to conclude that immune modulation by psychosocial stressors or interventions can lead to actual health changes, with the strongest direct evidence to date in infectious disease and wound healing. Furthermore, recent medical literature has highlighted a spectrum of diseases whose onset and course may be influenced by proinflammatory cytokines, from cardiovascular disease to frailty and functional decline; proinflammatory cytokine production can be directly stimulated by negative emotions and stressful experiences and indirectly stimulated by chronic or recurring infections. Accordingly, distress-related immune dysregulation may be one core mechanism behind a diverse set of health risks associated with negative emotions”.
REGULATORY UNDERSTANDING OF MINIMAL RISK
“DR. ELLIS: Minimal risk means–this is the regulatory
definition–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. That’s the black-and-white definition and
it’s been more or less unchanged since 1981. It was changed in a
minor way in 1991.
Now, who applies this definition? In general, a quorum of
the Institutional Review Board applies this definition. So in
any case, that is at least three individuals, which must include
So again, minimal risk is not the judgment of any one
individual, ordinarily, it’s the judgment of at least three
individuals, one of whom must be a non-scientist, by regulation,
in the domain of research that I described. Beyond the domain of
research that I described, none of this necessarily pertains.
Let me stop there and say that I think that in practice the
way that minimal risk is applied is, IRB members know it when
they see it. I’m not certain that too many IRB members — well,
I shouldn’t speculate.
We don’t know if IRB members could quote this definition, we
don’t know if they could pull it out on a laminated pocket card,
but we are confident that they know minimal risk when they see
it. Perhaps they could not explain it in the terms of this
definition, but they bring their good sense to the table and they
have a feel for what is greater than minimal risk.”
NGA Establishes New Policy to Pick Analysts’ Brains
” Examining the dynamics of human vision is paramount in NGA’s efforts to advance technology’s role in geospatial intelligence from image production to include image interpretation. Automating this human sense will allow computers to perform basic steps of imagery analysis to lessen the workload for analysts, and thus expedite intelligence production. However, accurately capturing these processes cannot be done with a standard eye exam. Instead, research must be performed on the human brain, not with tissue samples and microscopes, but by advanced methods of tracking brain activity during visual stimuli.”