Methodsfor safeguarding human subjects in biomedical research were discussedat the latest conference in Weill Cornell Medicine-Qatar’s (WCM-Q) Lawand Medicine series. Titled ‘The Role of Data and Safety MonitoringBoards in Human Subject Research’, the conference brought physicians,researchers and healthcare professionals together at WCM-Q to hearexpert speakers from around the globe explain the ethics and safeguardsused when conducting studies on humans.
The expert speakers includedSusan Ellenberg, professor of biostatistics at the University ofPennsylvania, who explained how statistical analysis and data could beused to monitor and maximise safety of participants in clinical trials. ZoeDoran, head of the clinical trials support group at Mahidol OxfordTropical Medicine Research Unit in Bangkok, discussed the uniquechallenges posed when conducting multinational clinical trials in manydifferent countries at the same time. She also listed the expectationsof data and safety monitoring boards (DSMBs) that oversee these multinational trials. Alsospeaking at the event were Dr Shahrad Taheri, professor of medicine andassistant dean for clinical investigations at WCM-Q, and Dr ZiyadMahfoud, WCM-Q’s associate professor of healthcare policy and research. DrTaheri used his presentation to outline the similarities anddifferences between clinical care and clinical research and illustratedthe importance of clinical trials to clinical practice. DrTaheri delivered a second lecture later in the day about the role thatfunding bodies have on clinical research and how their decision-makingprocesses may impact clinical trials and patient safety. DrMahfoud’s lecture examined the role of DSMBs in human subject researchwith reference to local circumstances in Qatar, explaining that the mainfunctions of the boards are to ensure the safety of the human subjectsand preserve the integrity of the research data. The activitywas accredited locally by the Qatar Council for HealthcarePractitioners-Accreditation Department and internationally by theAccreditation Council for Continuing Medical Education. Theconference concluded with a panel discussion moderated by Dr SunandaHolmes, WCM-Q’s deputy chief administrative officer and associateuniversity counsel, and assistant professor of healthcare policy andresearch. Dr Taheri said: “Conducting human subjects research isincredibly important for identifying the best treatment options.Researchers, however, have a strong duty of care to research subjects toensure that they face no physiological, mental or emotional effects ordistress. DSMBs have a very important role to play in this as theyprovide an impartial viewpoint that provides a detailed critique ofevery facet of the study.”