Protecting People in Research
On Tuesday, January 24th the MCW Office of Research and the Regulatory Knowledge and Research Ethics Program of CTSI sponsored a presentation by Michele Russell-Einhorn, JD, Senior Director, Office of Human Studies at the Dana-Farber Institute. Over 80 participants, including several members of the CTSI Partner Institutions gathered in the MCW Kerrigan Auditorium to hear Ms. Russell-Einhorn present and answer questions about ethical and regulatory priorities when managing human subjects research, the role of the Principal Investigator, approaches to the informed consent process and how to manage unanticipated problems.
Ms. Russell-Einhorn lightheartedly opened her presentation entitled “Managing Research Involving Human Subjects: What, Me Worry?” with an image of Alfred E. Neuman, the Mad Magazine character with the signature line “What, Me Worry?” Then she proceeded to engage the audience in her presentation with significant information regarding ethics and regulations. She gave several scenarios about reporting regulations and some cases in which studies and institutions were suspended for ethics violations. Ms. Russell-Einhorn also presented on two additional types of consent, screening consent and pregnant partner consent. In addition Ms. Russell-Einhorn answered a few questions from the participants and spoke about the roles and responsibilities of the Principal Investigator, the eight elements required for informed consent, the Clinical Laboratory Improvement Amendments requirements, event reporting, and research results.
In conclusion, she shared that the Dana-Farber Institute has an online Common Language for Risks and Events Database available to anyone. Ms. Russell-Einhorn’s presentation is available online via the MCW office of research.