NPRM Webinar Series: Research with Biospecimens
Madeleine Williams, Thomas Bechert
In this next installment of our NPRM the series, we cover proposed changes specific to research with biospecimens and private identifiable information.
Issues related to research with biospecimens and private identifiable information are represented in many of the proposed changes. Those changes, were they to become part of the Final Rule, would substantially impact how investigators should manage informed consent and repository or data bank operations, for example, and also how IRBs and others involved in human research protections should review research using biospecimens and data.
During the webinar our speakers:
- Re-visit the relevant proposals
- Discuss specific research scenarios
- Highlight the differences between how those scenarios are addressed under the current rule and how they would be addressed under the proposed rule