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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

Published online by Cambridge University Press:  01 January 2021

Fanny K. Ennever
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Abstract

Boston Medical Center/Boston University Medical Campus recently reduced certain requirements for human subjects research where this could be done without adversely affecting the rights and welfare of participants, in anticipation of changes in the Final Common Rule. Modifications affected exempt and expedited categories, approval periods, ceding review, Quality Improvement/Quality Assessment activities, and some requirements for pregnant women, prisoners, and children. This case study may assist other institutions in responding to the Final Common Rule.

Type
Independent Articles
Information
Journal of Law, Medicine & Ethics , Volume 46 , Issue 1: The Future of Informed Consent in Research & Translational Medicine: A Century of Law, Ethics & Innovation , Spring 2018 , pp. 164 - 179
Copyright
Copyright © American Society of Law, Medicine and Ethics 2018

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