New Draft Guidance on Exculpatory Language in Informed Consent Documents

The Office for Human Research Protections (OHRP) is collaborating with the Food and Drug Administration (FDA) to produce a new joint guidance on exculpatory language in consent documents for research. Availability of the draft guidance was announced on 7-September, 2011. The finalized version will supersede OHRP’s 1996 guidance on this topic; the FDA Information Sheets will also be updated.

The current regulations on informed consent state the following:

No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative [of the subject] is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.

The new guidance explores and refines the concept of exculpatory language, narrowing the focus to statements that constitute (or appear to constitute) a waiver of liability for negligence. The agencies have provided examples of acceptable language dealing with research use of biospecimens, future commercial development and compensation for research-related injury. Any language that would appear to release an investigator, institution, sponsor or other party from “malpractice, negligence, blame, fault or guilt” will continue to be unacceptable.

For more information, please see the Federal Register notice which includes a link to the draft guidance document.

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