coe-fac: Questions about Revised Common Rule

[Dawn Rowe]

In preparation for implementation of the revised Common Rule going into effect January 19th, 2018, RCS in collaboration with members of the institutional board are seeking questions about the changes in the regulations from researchers in the College of Education and other colleges conducting research involving human subjects. As Vice Chair of the IRB, I have been charged with collecting questions from researchers in the College of Education specifically. I have developed a link to a Qualtrics survey in which you can enter all your questions, https://oregon.qualtrics.com/jfe/form/SV_50B2OExeNKClykd. The questions will be compiled into a question and answer document that will be developed and disseminated by RCS. Please take a moment to submit your questions.

If you are not familiar with the revised regulations, you can review the Common Rule Web page found here: http://rcs.uoregon.edu/content/research-involving-human-subjects/changes-to-common-rule. The webpage covers some of the key changes including:

  *   Revisions and additions to the exempt review categories and the addition of a limited IRB review process for some exempt research

  *   Changes to continuing review requirements, including elimination of continuing review for many studies that pose minimal risk to participants
  *   Changes to the informed consent process and form, including a new requirement for presenting key information and a new requirement for clinical trials to post the informed consent form on a public website
  *   Additional provisions for handling, storage and maintenance of identifiable information and biospecimens
  *   Requirements for single-IRB oversight starting in 2020 for most collaborative research projects.  Note: NIH has separate single-IRB requirements for multi-center studies which go into effect in late January 2018.

Please follow the survey link to ask your questions about the revised common rule: https://oregon.qualtrics.com/jfe/form/SV_50B2OExeNKClykd
Thank you,

---
Dawn A. Rowe, Ph.D.
Research Associate Professor/Technical Assistance Provider
University of Oregon
National Technical Assistance Center on Transition
541-346-8412
drowe3 at uoregon.edu
http://transitionta.org/

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