Monthly Centre Meetings 2019
Note: The April 5, 2019 teleconference has been cancelled.
Notices: The April OCREB meeting was moved to April 5th, 2019 due a conflict with the CAREB conference. The meeting deadline is March 19, 2019
Reminders: update to the latest version of CTO stream; attachments in various versions of the application
- Survey of Awareness and perceptions of Canadians on the Benefits and Risks of Clinical Trials: https://journals.sagepub.com/doi/10.1177/2168479018805433#articleShareContainer
- http://cmajopen.ca/content/7/1/E40.full.pdf+html Social license and the general public’s attitudes toward research based on linked administrative health data: a qualitative study
- BSC coordinates an international project to share and reuse cancer genomic data at a global level: https://sciencebusiness.net/network-news/bsc-coordinates-international-project-share-and-reuse-cancer-genomic-data-global-level?utm_source=GA4GH+Member+Newsletter&utm_campaign=9b6e168652-EMAIL_CAMPAIGN_2018_06_22_08_23_COPY_01&utm_medium=email&utm_term=0_d52573ead8-9b6e168652-420486641
- OHRP has launched a webpage with information on the revised Common Rule’s clinical trial informed consent form posting requirement (45 CFR 46.116(h)). This page will be periodically updated with new information and guidance. https://www.hhs.gov/ohrp/regulations-and-policy/informed-consent-posting/index.html.
- The 2019 edition of the International Compilation of Human Research Standards has been released and is now available on-line: http://www.hhs.gov/ohrp/international/compilation-human-research-standards/index.html.
Notices: introduction to the new ICF template ; TCPS Update to be released in April, 2019
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 Review OHRP’s draft guidance on transitioning to the revised Rule to find out how this might affect regulated research at your institution: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.