Ancillary-care responsibilities in observational research: two cases, two issues

Ancillary-care needs have been identified as distinct only in the past few years.7,8 Richardson and Belsky demarcated such care as "that which is not required to make a study scientifically valid, to ensure a trial's safety, or to redress research injuries".7,8 Examples include treatment of schistosomiasis detected in the urine of participants in a malaria study and management of HIV acquired in a preventive HIV vaccine trial.7 Requirements for ancillary care can arise in any study in which people with unmet health needs are enrolled, but no policies or guidelines exist with respect to the researchers' duty to meet such needs.