Chmielewski Comments on Updates to Common Rule
08 March 2019
Wolters Kluwer Health
Partner Monica Chmielewski was quoted in an article for Wolters Kluwer Health, “Strategic Perspectives: Compliance with Common Rule burden-reduction provisions might be disruptive,” about the implications of recent updates to the Common Rule and their effects on clinical research.
Chmielewski pointed out that the implementation of a policy requiring the use of single Institutional Review Boards (sIRBs) for clinical research involving multiple study sites requires IRBs to determine which one will serve as the reviewing organization. She also noted that IRBs are working together to participate in collaborations in order to agree which will serve as the sIRB and which will cede review. The IRB chosen to serve as the sIRB often requires an agreement with an indemnification commitment and will try to disclaim liability and damages, she said.