The Bioethics Office focuses on emerging ethical issues in clinical translational research where clear regulatory standards or professional points of agreement concerning the conduct of research may be lacking. The Bioethics Office provides guidance in these areas through three main channels.
First, the Bioethics Office serves as a critical resource for addressing ethical issues, such as those regarding the ethical conduct of stem cell research, large genomic studies, and biorepositories. A key component of the Bioethics Office is the network of Research Ethics Consultation Services. This network of experts provides CTSC investigators with convenient access to high-level specialists with the knowledge and expertise required to manage ethical issues in translational research, that is, issues which go beyond mere regulatory compliance or transcend available professional guidance.
Second, the Bioethics Office supports the work of the CTSC Research Subject Advocates (RSAs). Our RSAs conduct protocol reviews, monitor adverse events, evaluate HIPPA compliance, and review consent documents and procedures. RSAs schedule direct observations of subject recruitment and consent conversations on request or as needed, such as for studies involving high-risk or vulnerable populations. Furthermore, RSAs provide education and training on human research ethics generally and specific issues such as informed consent to investigators, study coordinators, research assistants, community members, and other clinical translational researchers in the Cleveland metropolitan area.
Third, the Bioethics Office provides expanded educational opportunities in research ethics for clinical and translational scientists, young investigators, and trainees. Education and training include: (a) conflicts of interest; (b) collaborative research (including research with industry); (c) policies surrounding human subjects and animal research; (d) data acquisition, management, sharing, and ownership; (e) mentor/mentee relationships and responsibilities; (f) responsible authorship and publication; (g) research misconduct and the policies for handling research misconduct; (h) responsible peer review; and (i) the role of scientists in society, including reflections on the ethical, environmental, and societal impacts of scientific research.
Core Resource Leadership
Research Subject Advocates