Interactions with OSP, NIH and Guidance on Records and Records Maintenance

 Registration is closed for this event

The Biosafety Administrators Association (BSAA) is a professional organization promoting collaboration, professional development, and continuing education in biosafety research compliance across diverse sectors like academia and industry. It serves as a hub for knowledge exchange and networking. Faculty focus on understanding applicable regulations, maintaining compliant biosafety research programs, and developing effective and efficient practices for program management.

Overall, the BSAA ensures well-rounded professional development opportunities for individuals at various stages of their careers in biosafety administration, equipping them with the expertise needed to effectively navigate the complexities of the field.

Brief Agenda and Discussion Points

Dr. Katherine Harris from the Office of Science Policy (OSP), NIH will be our guest speaker for the March 20, 2024 BSAA webinar titled “Interactions with OSP, NIH and some Records Keeping Guidance”. During this session, she will provide some regulatory updates from OSP, some guidance on records content and retention, and discuss the circumstances IBCs should consider when down grading containment levels (e.g., BSL2 to BSL1). She will be available to discuss the general information around the defined topics and answer general questions. However, questions regarding specific circumstances around registrations for exam should be addressed through direct conversations between OSP and institutions. Please feel free to send Bill Greer ( suggestions for any additional questions.

Brief Agenda (Subject to Change)

  1. An OSP regulatory update; upcoming changes to the NIH Guidelines
  1. Records retention requirements: How long should an institution maintain programmatic records?
  1. What information needs to be included in meeting minutes?
  1. What information needs to be in the incident reports?
  1. IBC registrations with OSP and the maintenance process (i.e., annual reports)
  1. Process to request containment levels reductions from OSP

Webinar Objectives

The objective of each webinar is to provide participants the opportunity to hold engaging conversations on practical tried and tested program management/operation techniques to achieve a desired goal.  To help initiate discussions, a member of the research compliance community will present ideas that focus on the topic of choice.  Colleagues will then participate in open discussions and help to refine and validate proposed practices.  Participants are encouraged to submit ( questions regarding the defined topic PRIOR TO the event.  During each session, attendees will be encouraged to discuss their own institutions practices and ideas.

Programs Support

Joining and maintaining a membership with the BSAA ensures a myriad of benefits, including access to exclusive program discounts. Staying connected guarantees ongoing opportunities to save on essential programs, resources, and services that can significantly impact your professional development and organizational efficiency.

BSAA activities are supported through memberships and event attendance fees.  We ask that you please become a new member or maintain your membership status (memberships are renewed annually).  If you are a current member of the BSAA, you are free to attend webinars at no charge.  Individuals that are non-members or those with expired memberships will be asked to provide $75 in support for each webinar they attend.

Presenter(s) Biographies:

Guest Speaker

Dr. Kathryn Harris is the Senior Outreach and Education Specialist (contractor) in the Office of Science Policy (OSP) at the National Institutes of Health (NIH). Kathryn joined NIH in 2004. In her current role, she develops national and regional programs of stakeholder relations, education, and outreach strategies relevant to the oversight of recombinant and synthetic nucleic acid molecule research and research that has dual use potential. In addition, she advises on biosafety and biosecurity policy issues. She received her Ph.D. from Cornell University and completed two years of postdoctoral training at Washington University in St Louis. Prior to joining NIH, she was the Biological Safety Officer at Northwestern University. She is a registered biosafety professional was a founding member and first president of the Midwest Area Biosafety Network.

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: the Webinar will be held at 3:00PM EASTERN TIME ZONE

March 20th, 2024 from  3:00 PM to  4:30 PM
Event Fee(s)
Nonmember's Attendance Fee $75.00
Member's Attendance Fee $0.00