Program in Research Ethics

Program Leader: Toby Schonfeld, Ph.D.


Dr. Schonfeld's work in Research Ethics focuses on empirical and theoretical investigations that strive to ensure human subjects protections. She developed and implemented a Contraception Policy for the local IRB to standardize the format and language regarding contraceptive requirements on research protocols. This pioneering work led to several presentations and a publication, and engendered an empirical pilot study investigating women's preferences and willingness to participate in research based on contraceptive requirements. Work on this project continues with a pending grant application.

A related project involves pregnancy testing requirements for women who are participating in research protocols. We conducted a needs assessment to evaluate the frequency and consistency of pregnancy testing requirements in protocols that come through the UNMC IRB, and from there developed a pregnancy testing policy for use in future protocols.

Other work in research ethics by Center faculty includes works on payment for participating in research,  identifying and evaluating benefit in pediatric research,  revisions of international guidelines for the conduct of research, issues in informed consent and data disclosure, ethical access to participants for research, and the inclusion of pregnant women in research.

Additionally, education on issues of human subjects research is conducted yearly for clinical fellows enrolled in the Clinical Research Center Symposium. Program faculty also delivers related education in the Responsible Conduct of Research for graduate students on campus. Dr. Schonfeld contributed to the recent Clinical Translational Science Award (CTSA) application that is pending with the NIH, and she serves as the Research Ethics liaison for CCORDA.