Ethical Requirements for Human Challenge Studies: A Systematic Review of Reasons.

Human challenge studies (HCS) are controlled clinical trials in which participants are deliberately infected with a pathogen. Such trials are being developed for an increasing number of diseases. Partly as a result of the coronavirus disease 2019 (COVID-19) pandemic, there has been a recent ethical debate about the reasons for and against HCS in general, or rather, about the requirements that individual HCS must fulfill to be ethically acceptable. A systematic review was conducted to categorize and summarize such requirements and the reasons given for them. Ethics literature was searched in PubMed, Google Scholar, BELIT, and PhilPapers; eligibility criteria were articles published in a scientific/scholarly journal (original research, reviews, editorials, opinion pieces, and conference/meeting reports). Of 1,322 records identified, 161 publications were included, with 183 requirements (with associated reasons) in 10 thematic categories extracted via qualitative content analysis. In synthesizing and interpreting the requirements and their reasons, three issues emerge as particularly sensitive in the case of HCS: the meaning of the right to withdraw from research procedures, communication of researchers with the public and various stakeholders, and the conditions of informed consent. However, four other issues, not specific to HCS, stand out as the most controversial: the acceptable level of risk to participants, payment of participants, protection of vulnerable groups, and standards for international collaborations. Controversies in these areas indicate that further debate is warranted, possibly leading to more specific instructions in ethics guidance documents.

Collision Kinetics and Electrostatic Dispersion of Airborne Submicrometer Fractal Agglomerates.

Collision and electrostatic dispersion rates of airborne submicrometer TiO(2) agglomerates were measured and compared with the classical collision theory for spheres as well as with models accounting for the agglomerate structure in terms of the fractal dimension and electrostatic effects such as Coulomb and van der Waals interactions. According to the authors' knowledge, this is the first time that the agglomerate fractal dimension and electrostatic effects have been considered simultaneously in determining the collision frequency function of agglomerates. The observed enhancement in the collision frequency of agglomerates was found mainly to be a result of electrostatic particle interactions. Nonspherical particle shape has only a comparatively small influence on the collision probability, on the order of 10-20%. Electrostatic dispersion coefficients of agglomerates were found to be similar to those of spheres. Copyright 2001 Academic Press.