FDA and OHRP Issue Draft Guidance on Exculpatory Language in Informed Consent – Agencies Acknowledge the Common Practice of Obtaining Biological Specimens from Subjects Without Compensation, and Propose Appropriate Language

September 19, 2011

By Anne Marie Murphy

FDA and the Office for Human Research Protections ("OHRP") have jointly announced the issuance of a draft guidance document on “Exculpatory Language in Informed Consent.”  HHS and FDA regulations have long prohibited the use “exculpatory language” in informed consent documents for clinical research that is federally funded or regulated by the FDA.  Exculpatory language means language that causes a study subject to waive or appear to waive a legal right or release or appear to release those conducting the study from liability.  For example, an informed consent form that asks the study subject to waive the right to compensation for any injury that may be sustained in the study would be prohibited. 

Earlier guidance from the agencies said that language that asks a study subject to waive any rights to a biological specimen obtained during the study was likewise prohibited.  The new draft guidance takes a different position.  Recognizing that it has long been common industry practice to obtain such specimens from study subjects without compensation, and noting that there are no federal or state laws or policies that suggest study subjects have any legal right to such compensation, the new guidance concludes that language in an informed consent form is not “exculpatory” if it informs subjects that by agreeing to allow the use of their specimens in research, they are giving up any legal right to their specimens. 

The draft guidance includes several examples of statements that would be acceptable and examples that would be exculpatory and therefore prohibited.  For example, the agencies consider the following statements acceptable to be included in a consent form: 

“Although the results of research, including your donated materials, may be patentable or have commercial value, you will have no legal or financial interest in any commercial development resulting from research”;

“By agreeing to this use, you are giving up all claims to any money obtained by the researchers from the commercial or other use of these specimens.”

Comments on the draft guidance should be submitted by November 7, 2011.