A fresh start when drafting HIPAA authorization forms
When creating a new submission that requires a HIPAA research authorization, it can be tempting to pick up the HIPAA form that was approved for a previous study and try to revise it for the new project. Here’s a bit of advice about that: Don’t do it. Really. Start fresh with the HIPAA authorization template that’s available on the UAMS IRB’s New Studies Page instead. This template highlights all the areas that you need to revise to create new form. When you pick up an old form, it’s really easy to overlook something and accidentally leave in language that pertains to a previous study. We’ve seen incorrect study sponsors, wrong PIs, and descriptions of health information that bear no relationship to the current study left in. Also, some of the template boilerplate wording has changed, and if the old wording makes it into a new form, we have to send it back with a contingency to correct it. So please save yourself some time and spare yourself some possible contingencies by starting with a fresh HIPAA template each time.
Also, when drafting a HIPAA form, please make sure the form specifics match your study. For example, if your study is not subject to FDA oversight, there’s no reason to indicate in the form that the FDA may review records. The same goes for a study sponsor — if there is no sponsor, there’s no need to refer to a sponsor possibly reviewing records.