It’s astonishing in retrospect that women in New Zealand diagnosed with an increasingly clear precursor to cervical cancer were left untreated and uninformed in an unethical study that continued for two decades.
Clinical trials often exclude pregnant women, citing additional risks. However, women almost never are asked what they think about participating in those studies and the risks. This is an issue some researchers are working to correct.
Whether the Common Rule changes requirements for handling exempt studies, IRBs might choose to stay involved in these decisions. How they accomplish that depends on the IRB’s policies, procedures, and goals, but one important focus should be on data confidentiality.
The University of Cincinnati developed a two-page informed consent form that could be used in an emergency research study, involving the administration of pain medication to people who were in acute traumatic pain.
An IRB at Purdue University in West Lafayette, IN, has terminated a study of young people with high blood pressure after a youth camp last summer was plagued by multiple incidents of violence and sexual harassment.