Patricia Gordon, MD (CoM)
Navigating regulatory requirements in order to achieve “compliance” with local and federal mandates represents a major source of frustration to investigators conducting clinical and translational research. However the purpose of these regulations and mandates is to assure ethical research conduct in the broadest sense. The goal of the Regulatory Support and Ethics program is to facilitate the process by which novel research ideas are transformed into scientifically and ethically sound research study protocols that are unambiguously in compliance with all regulatory requirements. Our vision is to involve both investigators and regulators into a partnership where values of efficiency, appropriate attention to ethical research conduct and regulatory compliance are continuously balanced. Unless investigators embrace robust human subject advocacy and accept responsibility for comprehensively ethical and lawful research conduct, genuinely ethical research is unlikely to occur. Because Penn State is a leading institution in the field of bioethics, we have built upon this tradition to promote among Penn State faculty and students a full understanding of and commitment to ethical research conduct. In addition, we are streamlining the regulatory process by fully incorporating faculty into the regulatory process to increase their investment and participation in all levels of the regulatory infrastructure.
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