What are the major implications for researchers?
The Privacy Rule is extremely complex and requires that CPMC IRB put into place new policies and procedures. Clinical research is one area that is uniquely impacted by the regulations. From a clinical investigator perspective, the new regulations will affect how you access existing health information (medical/database record reviews) and how you handle identifiable information created as part of clinical research. In practical terms the major changes are as follows: • In addition to informed consent requirements, investigators will need to obtain an authorization, with more detailed information, in order to use and release identified protected health information for research. An authorization form is a separate document along with the informed consent and experimental bill of rights • The criteria that the IRB will use to waive the authorization and informed consent for medical record, database reviews, and use of specimens in research have become much more stringent. You will be asked
