OHRP seeks comments on draft guidance on adverse events.(Office for Human Research Protection)

OHRP is soliciting public comment on a draft guidance for IRBs, investigators, research institutions, and HHS agencies that conduct or sponsor research on human subjects, and other interested parties. The document is titled Guidance on Reporting and Reviewing Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others. The draft guidance can be viewed by clicking on the "News" links at the OHRP web site.

For many years the IRB and research communities have requested that federal regulatory agencies provide harmonized guidelines and requirements for reporting adverse events in the context of research involving human subjects. Most recently, the …