As Arkansas Children’s and the Arkansas Children’s Research Institute continue the process of reworking their corporate structure, the IRB will notice some changes in some research-related documents.
Arkansas Children’s has made a new HIPAA authorization template available for Arkansas Children’s researchers. You’ll notice at least two changes on the template. First, its format is closer to the plain language consent form template, so it may be easier for subjects to understand. Also, the template requires that letters revoking the HIPAA authorization be sent to the Health Information Management department, rather than directly to the PI. Health Information Management is to notify the PI if a revocation letter is received. Arkansas Children’s Research Institute researchers will also need to obtain a partial waiver of HIPAA for recruitment purposes only to be able to access medical records before contacting subjects.
These changes stem from the fact that under the new structure, Arkansas Children’s Hospital and Arkansas Children’s Northwest are “covered entities” under HIPAA, and the Arkansas Children’s Research Institute is not. What this means is that the Arkansas Children’s Research Institute will be treated as an outside organization seeking access to protected health information held by Arkansas Children’s.