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This editorial introduces articles in this Special Issue, which are based on presentations given at the 2017 meeting of the Global Forum of Bioethics in Research meeting. The main themes presented at the meeting were the use of cluster randomized trials, stepped-wedge cluster randomized trials, and controlled human infection models in research conducted in low-resource settings. The editorial sets out which ethical issues may arise in the context of alternative trial designs and describes the articles in this issue that addresses some or more of the ethical issues, such as justification of the research design, risk-benefit evaluations and consent.

Original publication

DOI

10.1186/s13063-019-3841-2

Type

Journal

Trials

Publication Date

19/12/2019

Volume

20

Addresses

University Medical Center Utrecht, Julius Center for Health Sciences and Primary Care, Utrecht, Netherlands. R.vanderGraaf@umcutrecht.nl.

Keywords

Humans, Therapeutic Human Experimentation, Research Design, Health Resources, Healthy Volunteers