Monthly Centre Meetings 2019
Notices: introduction to the new ICF template ; TCPS Update to be released in April, 2019; new OCREB REC: Maret Oser-Tamm
Reminders: updating study contacts in CTO stream; the OCREB meeting has been moved to April 5, 2019. [to avoid a conflict with the date of the CAREB 2019 annual conference]
- AstraZeneca has hired Dr. José Baselga, the former chief medical officer at Memorial Sloan Kettering, to lead its cancer research unit.
- Who needs to apply the revised Common Rule? https://www.advarra.com/do-i-need-to-comply-with-the-revised-common-rule/
- Compliance for the revised Common Rule is in effect as of January 21, 2019. Review OHRP’s draft guidance on transitioning to the revised Rule to find out how this might affect regulated research at your institution: www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/draft-guidance-revised-common-rule-compliance-dates-transition-provision-45-cfr-46-1011/index.html.
- A list of helpful Q&A’s is available on OHRP’s website and is being updated and expanded regularly. Access them here: www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/revised-common-rule-q-and-a/index.html
- OHRP Frequently Asked Question and Answer (FAQ): “How should IRBs approach the continuing review of research that remains active beyond long-term follow-up or data analysis, but that is eligible for expedited review under categories 8(b) or 9 of the 1998 OHRP Expedited Review List in light of the new provision at §46.109(f)(1)(i) of the 2018 Requirements, which eliminates the requirement for such continuing review unless an IRB determines otherwise. https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/2018-requirements-faqs/index.html
- The Food and Drug Administration (FDA) is extending the comment period for the proposed rule entitled “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations”. The proposed rule can be accessed at https://www.gpo.gov/fdsys/pkg/FR-2018-11-15/pdf/2018-24822.pdf. Comments on the proposed rule may be submitted at https://www.regulations.gov and are now due by February 13, 2019.