Approximately one third of all FDA-approved drugs carry a boxed warning in the manufacturer’s full prescribing information. Clinical trial consent forms document and facilitate the study participant’s consent process. Bhattacharya et al (2015) assessed whether boxed warning risks were fully disclosed to study participants on consent forms. The authors identified 44 boxed warning risks applicable to 57 protocols involving 17 study drugs. Of the 57 protocols, 43 (75%) involved participants with life threatening diseases. Of the corresponding 57 consent forms, 36 (63%) did not disclose boxed warning risks. The rate of nondisclosure of l or more boxed warning risks in a consent form was 81% for non-sponsored research, 56% for industry sponsored research, and 50% for government agency sponsored research.
Giving study participants proper study disclosures is important for the safety of the patient. IRBs should implement strategies to ensure these boxed warnings are appropriately disclosed. To read more on this issue, the JAMA article may be found here.