■ Investigators: An investigator receives comments from a manuscript reviewer who suggests that her research methods were not ethical. The study involved a social networking analysis of alcohol use, and the IRB determined that it was exempt from the requirements of the Common Rule. The investigator is seeking an assessment of whether her study was unethical. ■ IRB: Investigators propose a study about posttraumatic stress disorder. Potential participants to recruit would be identified from publicly available records of serious automobile accidents. The IRB had rejected this proposal on several occasions because of the recruitment method, but now requests input from the research ethics consultation service about ethical issues related to recruitment and privacy. ■ Sponsor: A research sponsor is developing a new drug that would be used for a disease that primarily affects infants. The IRB is reluctant to approve the study because it believes further efficacy data from adults is necessary before approving a study involving infants. The sponsors want to understand the ethical issues involved in order to decide how to respond. ■ Research participant: A 50-year-old man enrolled in a study of pulmonary fibrosis was informed that he had a hereditary form of the disease, and thus his children were at increased risk. The man had given up his daughter for adoption when she was an infant and, as an adult, she had requested that he not contact her again. He is unsure whether or how to communicate with her about her risk of developing the disease and the possible influence of certain behaviors, such as smoking.
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