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Federal regulations require that the informed consent process for studies posing greater-than-minimal risk include information about treatment or compensation for research injury. To fulfill this obligation using lay language that succinctly describes University of California system-wide policy, the UCLA IRBs require the use of standardized wording in consent forms. In order to assist the UCLA research community, OHRPP is releasing two guidance documents related to this standard language.
The first document is for internal UCLA use only. It explains the two allowed variants of the standard language and the prohibition on changes to the language. The document also provides examples of common sponsor requests for changes along with information about how researchers and staff can respond to such requests.
The second document provides a condensed explanation of University policy and the standard wording, and is aimed at industry sponsors. When sponsors wish to negotiate the standard wording, researchers and staff are encouraged to forward the second document to sponsors as an explanation of UCLA IRB policy. This should be done early in the negotiation process in order to avoid submitting non-standard language to the IRB.
It is important to note that the process of informed consent, including the use of this standard language, is most effective when consent documents clearly explain for subjects which procedures they will undergo for research purposes only and which procedures they will undergo as part of standard of care.
Consent forms do not necessarily need information about treatment or compensation for research injury unless the research poses greater-than-minimal risk (based on the definition of minimal risk provided in 45 CFR 46.102(i)). Investigators on sociobehavioral and other non-clinical research projects often do not need to include the section in their consent forms. You may address questions about whether this requirement applies to a particular project to the staff of the IRB that will review the project.
UCLA Guidance- Injury Wording
Industry Guidance- Injury Wording |
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