Implementing the Revised Common Rule

January 29, 2018 / Albuquerque, NM

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Overview

Ending five and a half years of rulemaking and speculation, the US Department of Health and Human Services (HHS) and 15 other Federal Agencies released a final revision of the Federal Policy for the Protection of Human Subjects, or "Common Rule," on January 19, 2017. These are the first revisions to the Common Rule since it was promulgated in 1991. What are the implications of these revised regulations for IRB program operations? What changes need to be made in administrative processes and procedures to promote compliance with the new federal policy? This interactive program will provide a practical, hands-on journey through the revised regulations, allowing participants to not only review the changes to the Rule but to discuss and identify best practices for implementation.

Audience:

This course is targeted for various audiences, including

  • IRB administrators and staff
  • IRB chairs, vice chairs administrators, and members
  • Research administrators
  • Research coordinators, scientists, and project managers
  • Investigators, postdoctoral fellows, and graduate students
  • Academic, industry, or clinical research personnel

The content is appropriate for those new to the topic as well as those with knowledge or experience in implementing the Common Rule.

Learning Objectives:

  • Compare the 2018 revised federal policy regulations with the pre-2018 Common Rule
  • Identify areas in IRB operations that require change
  • Discuss strategies for implementing and interpreting the revised Common Rule regulations

Speakers:

Elizabeth A. Buchanan, PhD
Acting Director, Office of Research and Sponsored Programs
University of Wisconsin Stout

Ada Sue Selwitz, MA
Executive Integrity/Compliance Advisor
Office of the Vice President for Research
University of Kentucky

Certificates of Attendance and Continuing Education Credit

Certificates of attendance for the Implementing the Revised Common Rule workshop will be available upon completion of the electronic course evaluation. 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.

Implementing the Revised Common Rule is eligible for up to 6 continuing education credit hours

CE Credit for Certified IRB Professional (CIP®) Recertification
CIP Credit labelImplementing the Revised Common Rule workshop participants holding the CIP® credential who wish to apply the 6 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 Implementing the Revised Common Rule has received such advance recognition, and may be counted towards these 15 hours. Additional information about CIP® recertification can be found here.

If you would like to receive a certificate of attendance for a previous PRIM&R conference, please email info@primr.org with the following information:

  • Full name
  • Email address
  • Conference name and date(s)
  • Dates and hours of attendance
  • Certificates will be delivered via email approximately three weeks after receipt of request

Electronic Materials

Materials for this course will be available electronically 1-2 weeks prior to the event. Printed materials will not be provided. Links to access materials online will be sent to the email address we have in our system from registration@primr.org. If you believe your institution will block email messages from registration@primr.org, please add this email address to your safe sender list, or provide your personal email address instead.

Please note that if you wish to have hard copies of these materials, you must print them prior to attending the workshop. Additionally, please bring paper and pen and/or a fully charged laptop to take notes. There may or may not be a place to print at no cost while onsite and it's highly recommended that you print and/or download these materials prior to attending the workshop.

If you don't receive the link and password to the materials by January 19, 2018, please contact asavannah@primr.org.