Brief Agenda and Discussion Points

Having adequate information is paramount for making informed decisions across an institution’s biosafety program. It serves as the foundation upon which reasoned judgments are built, enabling individuals to weigh options, anticipate consequences, and mitigate risks effectively. Informed decision-making promotes confidence, minimizes uncertainty, and enhances the likelihood of favorable outcomes. Moreover, it fosters accountability and transparency, ensuring that decisions align with federal expectations, goals, values, and ethical standards. In essence, the availability of accurate, relevant information empowers the committee to navigate complexities with clarity and purpose, ultimately leading to accurate interpretations, better risk mitigation and ultimately greater success.  During this session, we will define the information that should be gathered in the protocol form that’s needed for the IBC to perform a thorough review. Participants are encouraged to submit (wggreer@umich.edu) questions regarding the defined topic PRIOR TO the event.  During each session, attendees will be encouraged to discuss their own institutions practices and ideas.

Brief Agenda (Subject to Change)

1. Sample Protocol Questions
   1. Based on meeting minutes requirements, and
   2. Based on benchmarking information.
   3. A sample for screening tool for determining what’s NIH Guidelines Exempt.

2. Reviews; the importance of IBC diversity

3. The Protocol Review Process
   1. NIH Guidelines requirements
   2. Administrative reviewers
   3. Primary reviewers
   4. Designated member reviewers

Programs Support

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Presenter(s) Biographies:

Standing BSAA Faculty

Bill Greer, Assistant Vice President for Research, University of Michigan

Bill graduated from The Pennsylvania State University in 1985 with a degree in Microbiology.  He currently oversees the animal care and use, biosafety, lab safety, controlled substances, and autonomous systems research compliance programs.  His previous roles included the Associate Director for Research Compliance, IACUC Vice-Chair, and Biosafety Committee Chair at The Pennsylvania State University, and the production manager and safety director at Intervet, State College, PA (Formally Tri Bio Laboratories). Bill has overseen animal care and biosafety programs for over 30 years. 

In 2005, he organized and held the very first research administrators Best Practice Meeting, which establish a venue for research oversight professionals to informally meet and discuss programmatic concerns.  He continues to facilitate at least five annual Best Practice meetings covering both biosafety and animal care and use programs.  In 2010, he chaired the founding committee for the non-profit education based IACUC Administrators Association (IAA), and continues to serve as the organization’s president and chair of the board of directors.  Since 2007, Bill has served as ad hoc consultant to AAALAC Council where he performs institutional program reviews, assessments, and status determinations.  He served as a member of the Council of Certified Professional IACUC Administrators (CCPIA).  Bill continues to serve as an educator for the IBC and IACUC Administrative communities and has lectures at multiple venues including PRIM&R, AALAS, BTAA, and C3, as well as facilitates IBC and IACUC Best Practice Meetings.

Jonah Lee, BS, MS, PhD, Senior Associate Director, University of Michigan

Dr. Lee brings experience and a proven track record in the biomedical sciences and academic research administration to provide thought leadership, program oversight, and process optimization with specific attention to researcher/user-experience coordination across the Animal Care & Use Program.

In collaboration with other U-M research administrative departments and academic department leadership, Dr. Lee is charged with the strategic development of research engagement infrastructure and resource support. Dr. Lee has an extensive background in the life sciences, where his research focus involves stem cell biology and regenerative medicine in aging skeletal muscle. Along with his postdoctoral research at the Center for Muscle Biology at the University of Kentucky, and his work at U-M, his animal research experience includes considerable diversity in both small and large animal models across multi-departmental, federally funded research projects. 

Andrew Maksymowych, Ph.D., Associate Director, Biosafety Programs

Andrew has been at the University of Pennsylvania since 2006.  He is Penn’s Associate Director for Biological Safety Programs, Penn’s Institutional Biosafety Officer, IBC Administrator, and the Institutional Contact for Dual Use Research.  He sits on the Vice Provost’s for Research, Human Research Advisory Committee, the Human Stem Cell Research Advisory Committee, and the Cadaver and Body Parts Oversight Committee.  Andrew obtained his B.S. and M.S. degrees from Villanova University, and his Ph.D. in Biochemistry from Bryn Mawr College.  He has more than 20 years of teaching and 35 years of research experience.  A major portion of which included oversight of research safety and compliance programs.  Prior to his journey at Penn, he held a faculty appointment at Thomas Jefferson University where his research focused on the analysis of structure-function relationships in proteins, including protein toxins that poison the human nervous system.  Most recently, the mechanism of action of botulinum neurotoxins.  Andrew attended his first Best Practice Meeting in 2015 and has since been continually involved with Biosafety Administrator’s Association.

Raymond F. Scheetz, MS, RBP

Ray is currently the Institutional Biosafety Officer and a Compliance Manager at The Penn State University College of Medicine in Hershey, Pa, located in the Research Quality Assurance office a division of the College of Medicine Office of Research Affairs.  He is responsible for the oversight of all Biosafety compliance aspects within the College of Medicine, providing ancillary reviews of IACUC and IRB protocols, biosafety training and required annual lab surveys, administration liaison for research lab activities and emergencies, and operation of the equipment and asset management plan. He is a member of the College of Medicine Institutional Biosafety Committee, Research Mission team and COVID 19 Ramp up Research task force.  Ray also serves as a Biosafety consultant for CBS (Clinical Biosafety Services)/Shield Consulting.  Formally the Lab Manager in the Department of Microbiology and Immunology at the Penn State College of Medicine for 25 years.  Responsibilities included the Management of the BL3 facility located within the Department.

Please Note that the meeting time is EASTERN TIME ZONE