By Michele Russell-Einhorn, Chief Compliance Officer and Institutional Official, and Judith Carrithers, Director of Regulatory Affairs
Today’s news is filled with stories about the coronavirus, but infectious diseases are part of our global landscape, demanding a regular routine of hand washing and safe sanitary practices. Finding a vaccination that can address new infectious viruses, much like we depend upon a flu vaccination each year, is important to all of us. But even the flu vaccination can miss strains of the flu and result in individuals getting sick despite following medically recommended vaccination procedures. Life is imperfect; medicine is imperfect.
But how do we develop those vaccinations? That’s where research comes in. Emerging infectious diseases can raise certain unique issues for institutional review board (IRB) review and research informed consent. The risks and benefits of any research involving human participants must be evaluated by the IRB and carefully explained in the informed consent form (ICF). But what if we don’t yet fully know the risks and benefits of a vaccination or other treatment because it is just being developed (not an unusual situation in research). At the very least, the researchers should understand the spectrum of risks and present that information in the research ICF. Disclosure is key.