Curious as to how Institutions are handling  the Cures Act Information Blocking as it pertains to clinical research:

 

  1. Have you changed/updated your research informed consents pertaining what subjects will and will not have access too?
  2. Have definitions in Clinical Trial Agreements changed with regards to study results, confidentiality or otherwise?
  3. How are research notes and research results being handled in the EMR?

 

Thanks in advance,

 

Amy

 

Amy L. Casey, MBA, CIP – Executive Director, Human Research & Compliance

Administrator, Institutional Review Board

LOMA LINDA UNIVERSITY HEALTH| Office of the Vice President for Research Affairs

24887 Taylor St. Ste 201 Loma Linda, California 92354

xxxxxx@llu.edu  •  909-651-4658 (or extension 14658) 

 

 

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