Focus on the Revised Common Rule

Focus on the Revised Common Rule Webinar Series

Overview

The recordings from PRIM&R’s Focus on the Revised Common Rule webinar series are available for purchase. Developed and presented by experts in the field, these webinars offer convenient, affordable, in-depth analysis of the most pressing areas of change for human research protections professionals seeking to understand the revised Rule.

PRIM&R offers these webinars individually as well as in a discounted bundle of all five on-demand webinars. In addition, we offer discounted bundles of four webinars tailored for professionals who review either biomedical or social, behavioral, and educational research (SBER).

 Webinar viewers holding the Certified IRB Professional (CIP®) credential may apply 1.5 continuing education credits from each webinar towards CIP recertification. Learn More »

Included Webinars

PRIM&R's Primer on the Revised Common Rule

2017

Speakers: P. Pearl O'Rourke, MD and Heather Pierce, JD, MPH

On January 19, 2017, the Office of the Federal Register published a revised Federal Policy for the Protection of Human Subjects, marking the first significant changes to the Federal Policy for the Protection of Human Subjects, or "Common Rule," since 1991. These changes will have important and wide-reaching implications for the human subjects research enterprise. However, the Rule arrives under a cloud of uncertainty: A new presidential administration takes over the reins of the federal government on January 20, and it is unclear whether they will use available avenues to overturn the new Rule. Whether or not the new Rule survives long enough to be implemented, the issues it addresses are important to the future of the research oversight community.

Informed Consent

2017

Speakers: Jeremy Corsmo, MPH, CIP, CHRC and Paula McAllister, PhD, CIP

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
Exemption Categories and Select Types of Review

2017

Speakers: Karen Christianson, RN, BSN, CCRP and Paula McAllister, PhD, CIP

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

2017

Speakers: P. Pearl O'Rourke, MD and Heather Pierce, JD, MPH

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

2017

Speakers: Elizabeth Buchanan, PhD and Jeffrey Cohen, PhD, CIP

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 informatio
    • Storage, maintenance and secondary research use of identifiable private information
  • Broad consent for identifiable private information
  • Exemptions for research involving benign behavioral interventions

Access Webinar Bundles

Webinar bundles are available to individual PRIM&R members at no cost. For a fraction of the cost of this bundle, become a member to watch the included webinars and gain dozens of other member benefits. 

Nonmembers can purchase individual or group access to this webinar bundle using the order form below. Each webinar is also availalbe individually. 

Individual nonmember rates:

  • Full bundle: $640
  • Biomedical bundle: $540
  • SBER bundle: $540

Group nonmember rates:

  • Full bundle: $1,325
  • Biomedical bundle: $1,000
  • SBER bundle: $1,000

Already a PRIM&R member? Log in using the button at the top right of the screen for access to webinar bundles.

Thank You to our Supporters!

PRIM&R thanks FTI ConsultingSchulman IRBEvisions, and WIRB for supporting this webinar series.