Among the many blessings HIPAA has rained upon us (ahem) is a requirement pertaining to reviews preparatory to research. “Review preparatory to research” refers to accessing protected health information solely to prepare a research protocol before getting a signed HIPAA authorization or a HIPAA authorization waiver. A review preparatory to research can be done only after a researcher submits a certification to UAMS stating the use or disclosure of PHI is solely for this type of review.
Up until now, the UAMS IRB, the office that receives these certifications, has accepted emailed certifications. The certification form was an attachment to the UAMS Administrative Guide HIPAA Research Policy. Because these emailed forms were difficult to acknowledge and track, and because of our continuing desire to adopt practices compatible with the 21st century, the Review Preparatory to Research Form is to move to CLARA beginning Monday, Dec. 14. After logging in to CLARA, you’ll click the “create a new submission” link at upper left. One of the options on the resulting popup screen will be the “Review Preparatory to Research” form. Complete the form and sign and submit, just like any CLARA form. The form is short — asking only for a list of involved staff, the PHI to be accessed/used, and a signoff. The IRB office will acknowledge receipt of the form through CLARA.
Reminders:
We will no longer accept the emailed form starting Monday, Dec. 14, 2020.
Please be certain to fully describe the PHI you will use/access for the project in the online form. We will send it back for correction if we need more information.
All staff listed on the project should have “managing CLARA submission” and “managing data” listed as a responsibility. This will allow anyone on the staff to respond to contingencies, and accurately reflects who’s doing what for this part of the project.
Arkansas Children’s researchers should continue to follow their own institutional policy/practice for submitting the comparable form. They do not need to submit anything to UAMS if they will not access UAMS records to prepare a research project.
Remember, this CLARA form authorizes only reviews preparatory to research. An actual research project will require a full CLARA new submission, as usual.