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Human Subjects Division (HSD)

Quick Tips from HSD

Exculpatory Language

Apr 30, 2013 at 12:00am

By regularly reading Quick Tips, you waive your right to ask HSD any questions.

Now what kind of statement is that? It's exculpatory! And per the federal regulations, this kind of language should not be included in consent forms. (See 45 CFR 46.116)

Exculpatory language in a consent form is language which "has the general effect of freeing or appearing to free an individual or an entity from malpractice, negligence, blame, fault, or guilt" according to the draft guidance released by OHRP (Office for Human Research Protections) and the FDA (Food and Drug Administration) on August 19, 2011.

In particular, it is not allowable to use statements that appear to limit or waive the University's liability or the subject's ability to make claims against the University for negative experiences associated with the research.

Here's an example from an actual consent form: "I hereby hold harmless and release and forever discharge the UW from all claims, demands, and causes of action which I, my heirs, representatives, executor, administrators, or any other persons acting on my behalf or on behalf of my estate have or may have by reason of this authorization." Needless to say, Quick Tips' red pencil was called into action on this one!

The regulations allow an interesting exception to this rule: it is acceptable to ask subjects to waive their right to property rights and any profits eventually created because of the research, or future use of their biological specimens. For example, this statement: "I voluntarily and freely donate any and all blood and tissue samples to the UW and hereby relinquish all property rights, title, and interest I may have in those samples."

So don't worry, you can keep sending your questions to HSD. But also, keep reading Quick Tips! We'll never use exculpatory language again.