In addition to requiring a “concise and focused summary of key elements” in consent processes, the Revised Common Rule (RCR) makes a few other changes to consent elements. Under the RCR, the following statements must be included when applicable:
—The subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will share in any of that profit. Studies that collect specimens can involve the later use of those specimens to develop commercialized products. and subjects should know both about that future use and whether they will benefit from it.
—Language indicating whether any clinically relevant results will be disclosed to subjects, and if so, under what conditions. This requirement refers to both individual results of study procedures and overall study findings.
—For studies involving biospecimens, subjects must be informed whether the research will or might include whole genome sequencing. This requirement was prompted by the growing availability of genetic research that can reveal information about individuals and their blood relatives.
Please note that these requirements will not be entirely new to UAMS and ACH researchers, as the IRB has already required similar language to be included in consent forms when applicable.