2015 Spring Regional Meeting

On April 15-17, 2015, PRIM&R offered two educational programs: Institutional Review Board (IRB) 201 and IRB Administrator 201. The 2015 Spring Regional Meeting took place in Philadelphia, PA.


Institutional Review Board (IRB) 201 and IRB Administrator 201

April 16: 8:30 AM - 4:30 PM
April 17: 8:30 AM - 12:00 PM 
Faculty:

  • Elizabeth Bankert, MA
  • Susan Z. Kornetsky, MPH
  • Ada Sue Selwitz, MA 

View the program agenda.

Are you asking the right questions? Are you identifying and implementing the best solutions? During the IRB Administrator 201 course, attendees learned a framework to ensure they have the knowledge, skills, and strategies to address questions like: 

  • Where do I fit into the IRB/Research Ethics Committee (REC) and how does the IRB/REC fit into my institution’s human research protections program (HRPP)?
  • How do I implement effective communication pathways between stakeholders and the HRPP?
  • Which projects require IRB/REC review?
  • When can informed consent or documentation thereof be waived?
  • What questions should I be asking the Principal Investigator?
  • What are the important elements of an IRB/REC Reliance Agreement and how do I implement and track them?

This one-and-a-half day course provided knowledge to address issues, strategies an IRB/REC administrator and chair can implement, and skills needed to be successful in carrying out responsibilities related to IRB/REC oversight. IRB Administrator 201 serves as an intermediate level course complementing the introductory IRB Administrator 101* course.

What Will I Learn?

After attending this course, attendees were able to:

  • Develop a framework to analyze questions faced in the day-to-day operation of the IRB/REC, and choose solutions that apply ethical principles and applicable federal regulations to these questions
  • Identify administrative issues critical to IRB/REC operations in the current regulatory environment, and apply solutions to these issues
  • Document IRB activities (e.g., minutes, Standard Operating Procedures) to meet federal and HRPP requirements

Who Should Attend?
This program was ideal for mid-level IRB/REC Administrators, IRB/REC Chairs with administrative responsibilities, and anyone interested in learning more about advanced IRB/REC operations. 

CE Credit for Certified IRB Professional (CIP®) Recertification
IRB Administrator 201 participants holding the CIP credential who wish to apply the 9.75 credits from this program toward CIP recertification may submit the Certificate of Attendance they received upon completing the online evaluation as documentation of their participation.

For recertification by CE, CIPs must complete 30 documented hours of continuing education. At least 15 of the 30 hours must either carry credits issued by a recognized accrediting body or have received advanced recognition from the Council for Certification of IRB Professionals (CCIP). Credits from this offering of IRB Administrator 201 have received such advance recognition, and may be counted towards these 15 hours. Additional information about CIP recertification can be found here.

*While attendance at IRB Administrator 101 is not a pre-requisite for this course, it is recommended that learners have an understanding of the functions and components of a HRPP that are covered in an introductory level course prior to attending IRB Administrator 201. 

IRB 201

April 15, 2015:  8:30 AM–4:30 PM
Faculty:

  • Susan Fish, PharmD, MPH
  • Moira Keane, MA, CIP

View the program agenda.

IRB 201 provides the knowledge and skills needed to serve as an effective IRB reviewer. The program  includes information directly relevant to who conduct reviews as part of a convened IRB or through the expedited procedure and teaches skills needed to become experienced IRB chairs, members, and staff. 

What Will I Learn?
After attending this course, you will be able to:

  • Operationalize the ethical principles into criteria for review and approval of human subject research
  • Apply the criteria for IRB approval of research
  • Guide the IRB in the application of the criteria for IRB approval
  • Determine if an activity meets the definition of human research in the regulations and apply appropriate regulations

Who Should Attend?
This program is ideal for IRB members and staff who understand the fundamentals of IRB operations and are interested in obtaining the next level of training*.

CE Credit for Certified IRB Professional (CIP®) Recertification
IRB 201 participants holding the CIP credential who wish to apply the 8.0 credits from this program toward CIP recertification may submit the Certificate of Attendance they received upon completing the online evaluation as documentation of their participation.

For recertification by CE, CIPs must complete 30 documented hours of continuing education. At least 15 of the 30 hours must either carry credits issued by a recognized accrediting body or have received advanced recognition from the Council for Certification of IRB Professionals (CCIP). Credits from this offering of IRB 201 have received such advance recognition, and may be counted towards these 15 hours. Additional information about CIP recertification can be found here.

*While attendance at IRB 101 is not a pre-requisite for this course, it is recommended that learners have an understanding of the fundamentals of IRB operations  that are covered in an introductory level course.

Please note that this course will not cover administrative issues.

Certificates of Attendance

Certificates of attendance for all Spring Regional Meeting courses will be available upon completion of the course evaluation. A link to the evaluation will be emailed to you after the program adjourns.

Such certificates are useful for obtaining continuing education (CE) credits (not continuing medical education credit) from professional associations. Note that guidelines around CE credits may differ, and you should consult the appropriate professional association representative for further guidance.

  • IRB 201 is eligible for up to 6.5 hours of continuing education credits. 
  • IRB Administrator 201 is eligible for 8.0 hours of continuing education credits.