In its continuing efforts to assist research faculty and staff in the performance of clinical trials, the Office of Human Research (OHR) is pleased to announce a new web-based tool.  The Informed Consent (IC) Language Library is designed to assist in the development of informed consents by providing lay language for procedures, risks, and terms.

Known as the IC Library, it is a dynamic tool and will continue to grow as additional procedures/terms are identified. Existing language will be routinely reviewed and may be revised as appropriate. Users of the site are encouraged to submit terms and definitions to be screened and added to this database.

The language in the IC Library has been reviewed by the University of Pennsylvania Institutional Review Board (IRB) and is considered “approvable.” This means that for most studies, use of this language as provided will be approved by the IRB. However, the IRB may require modifications to the language for some studies.

The IC Library integrates two separate listings–a procedures library and a medical terms library which are presented in two separate groupings.  Procedures are listed first, followed by medical terms. The procedures listing provides descriptions and risks in lay language. The medical terms listing provides general descriptions of terms, also in lay language.

The Office of Human Research, in conjunction with the Office of Regulatory Affairs, is pleased to be launching the IC Library tool in February, 2006.

The Office of Human Research was established in 2001. Its mission is to promote human research for the advancement of healthcare while ensuring the highest level of research participant safety and facilitating the highest quality research.

 

In an effort to clarify a statement we published in the January 17 issue, the language contained in the IC Library should not be considered “approveable” by the IRB. The release should have stated that, “The IC Library was developed to assist investigators meet Federal regulations on human research protections which require consent documents to be written in language that is understandable to the prospective research subject. While the library is seen by the School of Medicine as a valuable resource that may help an investigator improve the readability of the informed consent document, the IRB may still exercise its authority to require changes to the informed consent document.”

                           —Office of Human Research