As Arkansas Children’s (AC) and the Arkansas Children’s Research Institute (ACRI) continue the process of reworking their corporate structure, the IRB will notice some changes in some research-related documents.
AC has made a new HIPAA authorization template available for AC 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 (HIM) department, rather than directly to the PI. HIM is to notify the PI if a revocation letter is received. ACRI 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 AC and AC Northwest are “covered entities” under HIPAA and ACRI is not. What this means is that ACRI will be treated as an outside organization seeking access to protected health information held by AC.