The DFCI IRB has acknowledged a nationwide shortage of Diphenhydramine Injection (IV Benadryl)and has determined that the shortage is not considered serious or continuing non-compliance or an unanticipated problem involving risk to participants or others. Until further notice from the FDA regarding this shortage, oral Benadryl may be provided as an alternative for affected research protocols. During this shortage, issuing of oral Benadryl in place of IV Benadryl does not need to not be reported to the DFCI IRB unless it 1) impacts the research subject adversely or 2) is specifically prohibited in the protocol.
Please keep in mind that the IRB of record for your study may have different reporting requirements. Study teams are advised to contact the IRB of record for the study to request guidance on what needs to be reported and when.