Education and Training

PRIM&R Webinar Series!

Focus on the Revised Common Rule 

 

May 25 - Primer on the Common Rule

June 1 - Informed Consent

June 8 - Exemption Categories and Select Types of Review

June 15 - Biospecimens and Identifiable Private Information

June 22 - Implications for SBER

All Webinars above will be located in St. Augustine Center (SAC) Room 110 from 1pm - 2:30pm 

See below for more detailed information

 

PRIM&R Webinar Series

 

General Info:

PRIM&R’s upcoming webinar series, Focus on the Revised Common Rule. Developed and presented by experts in the field, these webinars offer in-depth analysis of the most pressing areas of change for human research protections professionals seeking to understand the revised Rule. Please review PRIM&R’s revised Common Rule webpage for background information about the revised Common Rule: https://na01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.primr.org%2Fcommonrule%2F&data=02%7C01%7Cjoanna.myerson%40villanova.edu%7Ced759dcc09304d4c081608d488ce040a%7C765a8de5cf9444f09cafae5bf8cfa366%7C0%7C0%7C636283865788670700&sdata=7T6WDXd%2BYmG1NV7PlZ9Ca0oR%2BEUBPhRlrGnPZux%2FhrQ%3D&reserved=0.

 

Recorded versions of the webinars will be available within a couple of weeks after the broadcast. If you have questions about the webinars or other educational events, email IRB@villanova.edu.

 

Specific Webinars:

 

SBER Network Virtual Roundtable

  • Discussion of International Research
  • Date & Time: April 27th 2-3pm
  • Location: Rosemont Room, Connelly Center

 

Primer on the Revised Common Rule

  • This webinar provides an overview of the major changes presented in the Rule as well as an explanation of the rulemaking process.
  • Date & Time: May 25th 1-2:30pm
  • Location: St. Augustine Center (SAC) Room 110

 

Informed Consent

  • Discussion on the changes to the Common Rule and its impacting on informed consent.
  • Date & Time: June 1st 1-2:30pm
  • Location: St. Augustine Center (SAC) Room 110

This webinar will discuss new elements of the Rule impacting informed consent, including: 

Changes in the basic and additional elements of the informed consent

New requirement that consent documents begin with a concise presentation of key information, presented in a manner that facilitates the subject's understanding

New broad consent option for the collection, storage, and secondary research use of biospecimens or identifiable private information

Changes in the criteria for waiver of informed consent related to screening/recruitment and research involving the use of identifiable biospecimens and/or data

Clarifications regarding the determination of who is a legally authorized representative

Increased clarity regarding requirements/methods for documentation of informed consent

 

Exemptions and Select Types of Review

  • Discussion on the changes to the Common Rule and its impact on review.
  • Date & Time: June 8th 1-2:30pm
  • Location: St. Augustine Center (SAC) 110
  • This webinar will examine and discuss key operational and administrative provisions in the new Rule, including:

Activities classified as "not research"

New exempt categories for low-risk studies

Limited IRB review

Changes related to expedited review

Circumstances under which continuing review is no longer required

Elimination of the option for FWA holders to check the box, and potential impacts on review

 

Biospecimens and Identifiable Private Information

  • Discussion on the changes to the Common Rule and the impact on exempt categories and identifiable private information.
  • Date & Time: June 15th 1-2:30pm
  • Location: St. Augustine Center (SAC) Room 110

 

  • This webinar will discuss provisions specific to research with biospecimens and identifiable private information under the new Rule. Specific topics will include

The expansion of exempt categories that allow:

Use and recording of identifiable information

Secondary use of identifiable biospecimens and information

Storage, maintenance and secondary research use of identifiable private information and biospecimens

New, limited IRB reviews for select exempt categories

The role of HIPAA

New elements in informed consent related to research with biospecimens and identifiable private information

 

 

Implications for SBER

  • Discussion on the changes to the Common Rule and the impact for social behavioral research
  • Date & Time: June 22nd  1-2:30pm
  • Location: St. Augustine Center (SAC) Room 110
  • This webinar will discuss elements of the new Rule that will impact oversight of SBER, including:

New definitions of research to exclude scholarly and journalistic activities

The expansion of exempt categories that allow:

Use and recording of identifiable information

Storage, maintenance and secondary research use of identifiable private information

Broad consent for identifiable private information

Exemptions for research involving benign behavioral interventions