2015 Fall Regional Meeting

Supported by:

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Meet us in San Antonio, TX, and choose from three courses, taking place on September 15-18, 2015.

Institutional Review Board (IRB) Administrator 101

September 15, 8:30 AM–4:00 PM
September 16, 8:00 AM–12:00 PM
Faculty:

  • Nancy Olson, JD
  • Ada Sue Selwitz, MA

View the program agenda

IRB Administrator 101 is a one-and-a-half day program that provides a holistic look into the many functions and components of a human research protection program (HRPP). 

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

  • Identify the primary responsibilities of IRB administrators and staff
  • Implement strategies and policies for creating a culture of compliance and ethical responsibility
  • Discuss methods for ensuring administrators and staff support, improve, and strengthen your HRPP

Who Should Attend?
This program is ideal for new administrators, those in need of a “refresher” course, and anyone interested in learning more about IRB operations.


IRB Administrator 201

September 16, 12:30–4:00 PM
September 17, 8:30 AM–4:30 PM
Faculty:
  • Susie Hoffman, RN, BSN, CIP
  • Ada Sue Selwitz, MA

View the program agenda

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

  • Where do I fit into the IRB and how does the IRB fit into my HRPP?
  • How do I implement effective communication pathways between stakeholders and the HRPP?
  • Which projects require IRB 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 reliance agreement and how do I implement and track them?

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

A portion of the program will utilize peer review with the goal of improving local documentation. Attendees are strongly encouraged to bring two hard copies of the following:

  • Your institution’s standard operating procedure (SOP) for expedited review
  • The first page of IRB minutes and redacted review for two studies (approximately three pages)

What Will I Learn?
After attending this course, you will be 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, SOPs) to meet federal and HRPP requirements

Who Should Attend?
This program is ideal for mid-level IRB administrators, IRB chairs with administrative responsibilities, and anyone interested in learning more about advanced IRB 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. This program has received advance recognition from the CIP Council. 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, including: key components of HRPPs, responsibilities of administrators, and strategies and policies attendees can use to develop and/or strengthen their institution’s HRPP. IRB Administrator 201 is an intermediate-level course and 3-5 years prior experience is needed.


Collaborating for Compliance

September 18, 2015:  8:30 AM–12:00 PM
Faculty:

  • Charlotte Coley, MACT, CIP
  • Bruce G. Gordon, MD

View the program agenda 

Research compliance is an institution-wide undertaking. From investigators and research coordinators to IRB members and staff to institutional officials—all roles within an institution's HRPP are key to ensuring high-quality, ethical clinical trials. This intensive, half-day version of the program will provide participants with the tools they need to be effective members of their HRPP by highlighting best practices and common compliance pitfalls. The course is designed for all members of an institution's HRPP.

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

  • Define various aspects of an HRPP and how those aspects interact with each other
  • Understand how the HRPP fits into a comprehensive compliance program
  • Identify benefits of being involved in a larger institutional program 
  • Identify common compliance challenges and collaboratively discuss solutions

Who Should Attend?
The course is designed for all members of an institution's HRPP but places special emphasis on addressing the role and function of researchers and research staff in relation to the IRB. 

CE Credit for Certified IRB Professional (CIP®) Recertification
Collaborating for Complianceparticipants holding the CIP® credential who wish to apply the 4.0 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. This program has received advance recognition from the CIP Council. Additional information about CIP recertification can be found here

Certificates of attendance for all Fall 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. A link to the evaluation will be emailed to you after the program adjourns.

  • IRB Administrator 101 is eligible for 9.5 CE hours
  • IRB Administrator 201 is eligible for 9.75 CE hours
  • Collaborating for Compliance is eligible for 4.0 CE hours

Thank You to the 2015 Fall Regional Meeting Supporter! 

Schulman Associates IRB
www.sairb.com
Schulman Associates IRB provides high quality, rigorous IRB reviews for all phases of research in North America via streamlined processes, customized technology and responsive customer service. We offer dedicated IRB services for research institutions and also offer Clinical Quality Assurance and Human Research Protections consulting via our partner Provision Research Compliance Services.

Interested in supporting PRIM&R's Regional Meetings? Download the prospectus.