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Meeting Information



Project Title: Return of Individual-Specific Research Results Generated in Research Laboratories

PIN: HMD-HSP-17-05         

Major Unit:
Health and Medicine Division

Sub Unit:
Board on Health Sciences Policy

RSO:
Mancher, Michelle

Subject/Focus Area:
Health and Medicine; Policy for Science and Technology


Return of Individual-Specific Research Results Generated in Research Laboratories
December 7, 2017 - December 7, 2017
Webinar


If you would like to attend the sessions of this meeting that are open
to the public or need more information please contact:


Contact Name: Caroline Cilio
Email: ccilio@nas.edu
Phone:
Fax:


Agenda:

Public Webinar -- DRAFT AGENDA

December 7, 2017
2:00–3:30PM ET
90 Minute Webinar

QUALITY STANDARDS FOR REGULATED AND NON-REGULATED BIOMEDICAL RESEARCH LABORATORIES

Session Objectives:
• Explore current standards used in research laboratories to assure the reproducibility of research results or to ensure tests are analytically or clinically valid.
o Identify challenges researchers may encounter when determining whether or how to return results if certain standards are not met (e.g. challenges of interpretation and translation, contextualization, or communication).
• Consider how the innovative culture of a research laboratory does or does not align with the required practices of clinical laboratories to ensure specimen control, assay validity, and reproducibility.
• Discuss the process of CLIA accreditation and explore the barriers or perceived barriers that lead research laboratories to refrain from taking the steps necessary to become certified under CLIA
o Examine the technical and operational requirements and costs (including opportunity costs) of asking research labs to produce at clinical or near clinical laboratory level results (for example, obtaining CLIA certification or getting results confirmed in a CLIA laboratory).
• Discuss the potential utility of more codified guidelines for quality standards that could be used in non-regulated biomedical research laboratories and identify what should be included in such guidelines if they were to be produced.

Moderator: Debra Leonard, University of Vermont

Speakers: (10 minute opening remarks followed by discussion and Q&A)
• Rebecca Davies, University of Minnesota
• Randy Querry, American Association for Laboratory Accredidation