2010 Webinar: Promoting Science and Safety

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Overview

Promoting Science and Safety: NIH Oversight of Human Gene Transfer Research provided an overview of the NIH Guidelines for Research Involving Recombinant DNA Molecules as they apply to human gene transfer research.

This webinar promoted the professional development of those associated with institutional biosafety committees (IBCs), by providing participants an opportunity to:

  • Discover the range of responsibilities that IBCs have under the NIH Guidelines; 
  • Examine the relationship between IBCs and institutional review boards (IRBs), and how these committees may work together in the oversight of human gene transfer research;
  • Work through case studies designed to clarify federal expectations with regard to biosafety review and surveillance of recombinant DNA and related research;
  • Gain insight into the roles and responsibilities of the Recombinant DNA Advisory Committee (RAC) as a key federal advisory committee; and
  • Understand the requirements of Appendix M, along with the process of protocol submission to the National Institutes of Health Office of Biotechnology Activities (NIH OBA)

Audience

The target audience for this webinar included IBC members and staff, research administrators, biosafety officers, regulatory affairs officers, members and staff of institutional oversight committees (such as IRBs and institutional animal care and use committees (IACUCs)), and others interested in the oversight of recombinant DNA research.

Faculty

Marcia C. Finucane
Marcia C. Finucane is a Certified Biological Safety Professional (CBSP) and currently serves as the University of Kentucky's (UK) biological safety officer and responsible official.  She is the administrator for the institutional biosafety committee (IBC) that registers all research involving recombinant DNA or infectious agents for a campus that includes colleges of medicine, agriculture, engineering, pharmacy, nursing, health sciences, and liberal arts.  Ms. Finucane has been instrumental in the coordination of various compliance committees that oversee research at UK; she directs the biological safety program at UK, developing and conducting educational programs for faculty, staff, and students.  Before joining UK, Ms. Finucane was employed in the private agricultural biotechnology industry in regulatory affairs as a research microbiologist, and as a laboratory safety officer.  Earlier in her career, she gained extensive knowledge in the clinical area as a medical technologist, and then as a university instructor.  The professional knowledge that she gained, combined with her personal experiences owning a farm, have proven to be invaluable in her current position, where she is also responsible for the university's farms and animal facilities.

Allan Shipp
Allan C. Shipp is the director of outreach for the NIH Office of Biotechnology Activities (OBA), and is responsible for establishing improved lines of communication with investigators, sponsors, and institutional biosafety committees (IBCs). He planned the first NIH conference on policy issues concerning IBCs, organized the first national professional development conference for staff and members of IBCs, spoke at workshops and meetings on NIH’s oversight of human gene transfer research, organized focus groups for public consultation on the design of a database on human gene transfer research, initiated electronic communications tools to disseminate information about OBA, and served as a key liaison between senior NIH staff and the extramural community.  Mr. Shipp also works on a range of policy issues, including the oversight and regulation of clinical research and various forms of biotechnology. Before coming to OBA, Mr. Shipp was assistant vice president for biomedical and health sciences research at the Association of American Medical Colleges, where he worked on an array of policy issues including biotechnology, scientific integrity, research training, and human subjects research.  Mr. Shipp was also principal investigator on a project with the Howard Hughes Medical Institute to evaluate the career outcomes of predoctoral and postdoctoral fellows. Mr. Shipp is a former member of PRIM&R’s Board of Directors.