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.
(Subscription required.)
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.
(Subscription required.)
People
Related News
18 April 2024
In the News
Lynn Gandhi Unravels Tax Challenges in Hybrid Work Environments
Foley & Lardner LLP partner Lynn Gandhi offers insights on the taxation challenges a hybrid work environment can pose for human resources and payroll in the Reuters article "Tax attorney: Navigating the nuances of taxation in hybrid work arrangements.”
17 April 2024
In the News
Steven Barth on Allure of Take-Private Deals – 'Public markets aren’t what they’re cracked up to be'
Foley & Lardner LLP partner Steven Barth offers extensive insight on the growing trend of family-owned consumer and retail businesses aiming to go private in the Axios article, “Family-owned companies see allure in take-private deals.”
17 April 2024
In the News
Christopher Ward on Federal Arbitration Act – ‘It matters what a worker does’
Foley & Lardner LLP partner Christopher Ward is quoted in the Law360 article, “Airplane Servicers Nod to Justices, Reiterate That Fueling Isn't Interstate Work.”