Peter Vasilenko

President and Consultant, Apex Ethical Services

Dr. Peter Vasilenko is the President of his HRPP/IRB consulting company, Apex Ethical Services, LLC. Previously, Dr. Vasilenko was the Program Director at the Alion HRPP Accreditation Services program and the Vice President for Accreditation at the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Dr. Vasilenko also spend 19 years at Michigan State University, including roles as IRB Chair and Director of the HRPP, as well as a Full Professor and researcher in the MSU-College of Human Medicine, Department of Obstetrics, Gynecology and Reproductive Biology.

Dr. Vasilenko is internationally recognized for his leadership and expertise in education and regulations related to human research protections. He has had extensive experience as an IRB Chair and IRB Member in both the university and hospital setting. In his work with the two accreditation programs, Dr. Vasilenko helped develop Standards for human research protection used worldwide and worked with hundreds of clients to evaluate and improve their HRPPs and IRBs. He is an author on 39 published articles, 67 published abstracts, and 261 presentations.



  •  Thursday, April 27, 2017
  • 10:00 AM PDT | 01:00 PM EDT,
  • 90 Minutes
  • ¤139.00
Developing and Maintaining Complete IRB Policies and Procedures

Written and complete policies and procedures are imperative to any well-functioning Institutional Review Board and Human Research Protection Program. SOPs must include all regulatory requirements. This webinar will cover regulatory requirements and guidance on written materials. In addition, the discussion will include how HRPP accreditation Standards can help with writing complete SOPs and include best practices. The presentation will include what SOP's you should have for your organization and your type of research, and the format and content of SOP's. Why you should periodically review and revise your SOP's and how to use your SOPs for IRB education will also be covered. Attendees that are developing their SOP's or interested in reviewing and improving their existing SOPs will find this webinar extremely valuable.

  •  Thursday, May 18, 2017
  • 10:00 AM PDT | 01:00 PM EDT,
  • 90 Minutes
  • ¤139.00
Principles of IRB Review: Ensuring Both Ethical Review and Regulatory Compliance

This webinar will discuss how IRBs can review research to fulfill the regulatory requirements as well as conduct appropriate and complete ethical review of research protocols. Many examples will be provided distinguishing between what must be done to fulfill the regulatory requirements and what should be done for ethical review. For example, having and completing a checklist may fulfil and even document compliance with regulations, but have the content of those items on the checklist been adequately discussed and issues resolved? The discussion will include issues related to the composition of the IRB, conduct of IRB meetings, criteria for approval of research, evaluation of an individual protocol and voting. In addition other HRPP functions will be discussed including education, evaluation of IRB members and staff, quality improvement and annual review of the HRPP/IRB. Attendees will learn the issues to consider to ensure complete review of protocols, optimal IRB function, regulatory compliance and fulfillment of ethical responsibilities for the protection of human subjects in research.

  •  Wednesday, May 31, 2017
  • 10:00 AM PDT | 01:00 PM EDT,
  • 60 Minutes
  • ¤139.00
Quality Improvement in Human Research Protection Programs:Metrics and Monitorings

This webinar will discuss how implementing a targeted quality assessment and quality improvement program for a human research protection program and IRB can greatly improve efficiency, compliance, and consistently. While auditing and quality improvement are not regulatory requirements, they are considered best practice that are usually an important part of any program at an organization. HRPP accreditation programs have standards requiring audit and quality improvement which can be useful templates for any HRPP. Many examples of potential areas of QA/QI targeted issues will be discussed. In addition, the discussion will include the development and use of metrics as part of your QA/QI program.





  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤179.00
Developing and Maintaining Complete IRB Policies and Procedures

Written and complete policies and procedures are imperative to any well-functioning Institutional Review Board and Human Research Protection Program. SOPs must include all regulatory requirements. This webinar will cover regulatory requirements and guidance on written materials. In addition, the discussion will include how HRPP accreditation Standards can help with writing complete SOPs and include best practices. The presentation will include what SOP's you should have for your organization and your type of research, and the format and content of SOP's. Why you should periodically review and revise your SOP's and how to use your SOPs for IRB education will also be covered. Attendees that are developing their SOP's or interested in reviewing and improving their existing SOPs will find this webinar extremely valuable.

  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤179.00
Principles of IRB Review: Ensuring Both Ethical Review and Regulatory Compliance

This webinar will discuss how IRBs can review research to fulfill the regulatory requirements as well as conduct appropriate and complete ethical review of research protocols. Many examples will be provided distinguishing between what must be done to fulfill the regulatory requirements and what should be done for ethical review. For example, having and completing a checklist may fulfil and even document compliance with regulations, but have the content of those items on the checklist been adequately discussed and issues resolved? The discussion will include issues related to the composition of the IRB, conduct of IRB meetings, criteria for approval of research, evaluation of an individual protocol and voting. In addition other HRPP functions will be discussed including education, evaluation of IRB members and staff, quality improvement and annual review of the HRPP/IRB. Attendees will learn the issues to consider to ensure complete review of protocols, optimal IRB function, regulatory compliance and fulfillment of ethical responsibilities for the protection of human subjects in research.

  • Recorded
  • View Anytime
  • ¤179.00
Quality Improvement in Human Research Protection Programs:Metrics and Monitorings

This webinar will discuss how implementing a targeted quality assessment and quality improvement program for a human research protection program and IRB can greatly improve efficiency, compliance, and consistently. While auditing and quality improvement are not regulatory requirements, they are considered best practice that are usually an important part of any program at an organization. HRPP accreditation programs have standards requiring audit and quality improvement which can be useful templates for any HRPP. Many examples of potential areas of QA/QI targeted issues will be discussed. In addition, the discussion will include the development and use of metrics as part of your QA/QI program.

  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤379.00
Developing and Maintaining Complete IRB Policies and Procedures

Written and complete policies and procedures are imperative to any well-functioning Institutional Review Board and Human Research Protection Program. SOPs must include all regulatory requirements. This webinar will cover regulatory requirements and guidance on written materials. In addition, the discussion will include how HRPP accreditation Standards can help with writing complete SOPs and include best practices. The presentation will include what SOP's you should have for your organization and your type of research, and the format and content of SOP's. Why you should periodically review and revise your SOP's and how to use your SOPs for IRB education will also be covered. Attendees that are developing their SOP's or interested in reviewing and improving their existing SOPs will find this webinar extremely valuable.