Ethics Changes Proposed For Human Research Subjects

In a long-awaited move, the Department of Health & Human Services has proposed significant changes to a set of requirements for protecting human research subjects known as the Common Rule. Among the most important modifications are tighter informed consent requirements to ensure that study participants understand the scope of the research. This includes requiring consent to use blood or tissue samples that were originally collected for another purpose—even if the donor is anonymous. Another change would alter ethics reviews conducted by institutional review boards (IRBs). The proposal would narrow the scope of IRB reviews to the most potentially harmful research while exempting some nonharmful studies that currently require review. It would also force only one IRB review for multisite research projects. The Common Rule revision would govern human subjects work across HHS, which includes NIH, and 15 other agencies. HHS is currently seeking comments on the changes, and the agency expects to host webinars and a town hall meeting in Washington, D.C., in October.