Related Pages Protecting Participants in Clinical Trials 1 A collection of material about the ways in which clinical trials participants are protected before and during the conduct of a study.

After both research participants and investigators voiced concerns that informed consent documents for clinical trials were becoming too long, complicated, and difficult to understand, the National Cancer Institute (NCI), along with the Office for Protection from Research Risks (now the Office of Human Research Protections ²) and the U.S. Food and Drug Administration, formed an Informed Consent Working Group to propose solutions.

The Working Group included a diverse group of experts: physicians, nurses, patient advocates, Institutional Review Board (IRB) members, ethicists, legal experts, communication experts, and representatives of the pharmaceutical industry.

In 1998, the group issued its "Recommendations for the Development of Informed Consent Documents for Cancer Clinical Trials." The recommendations are used by investigators writing consent documents and by IRBs reviewing such documents. In addition, a consent form template was created that includes all of the federally required elements for the document, including the explanation of the research procedures, related risks and possible benefits, alternatives to participation, and the rights of research participants.