What do revised U.S. rules mean for human research?

Abstract

The updated Common Rule raises many questions

Reviving Human Research in Costa Rica

“…48 However, the likelihood that such a movement would gain traction in Costa Rica is relatively low, given the atmosphere of corporate mistrust that resulted from the alleged abuses of human subjects and suspected conflicting interests that led to the moratorium in the first place. This approach would have the advantage of single CEC review for multisite studies, an approach that recently has been required by NIH policy for federally funded studies and by the recent revisions to the U.S. Common Rule.…”

“…This approach would have the advantage of single CEC review for multisite studies, an approach that recently has been required by NIH policy for federally funded studies and by the recent revisions to the U.S. Common Rule. 48 However, the likelihood that such a movement would gain traction in Costa Rica is relatively low, given the atmosphere of corporate mistrust that resulted from the alleged abuses of human subjects and suspected conflicting interests that led to the moratorium in the first place.…”

Reducing Regulatory Burdens on Research with Human Subjects: A Case Study of the Transition to the Final Common Rule at Boston Medical Center and Boston University Medical Campus

“…The existing Common Rule, referred to here as the 1981 Common Rule because it was last changed in 1981, was recently revised. 2 The Final Common Rule was published on January 19, 2017, with most provisions going into effect on July 19, 2018. 3 The ethical foundation of the Common Rule is the Belmont Report, which established the principles of beneficence, justice, and autonomy as central to human subjects research.…”

“…The existing Common Rule, referred to here as the 1981 Common Rule because it was last changed in 1981, was recently revised. 2 The Final Common Rule was published on January 19, 2017, with most provisions going into effect on July 19, 2018. 3…”