Monthly Centre Meetings 2019
Notices: QA consents; TCPS2 (2018) interpretation of Article 11.8
Reminders: Consent updates and urgent oral updates; 2020 OCREB meeting schedule
December deadline for the January 2020 meeting: Due to the holiday schedule, the deadline for the January 10, 2020 meeting is Tuesday, December 17, 2019
OCREB membership changes – updated September 2019 (see www.ocreb.ca)
New Studies: submitted for the November 11, 2019 meeting
- N2 QMS materials released
- Trust in Genomics Data Sharing/GA4GH: https://link.springer.com/article/10.1007%2Fs00439-019-02062-0#enumeration
- FDA collaboration with Australia and Canada for concurrent review of cancer therapies: https://www.fda.gov/news-events/press-announcements/fda-takes-first-action-under-new-international-collaboration-australia-and-canada-designed-provide
- OHRP workshop materials: privacy and health research in a data-driven world
Notices: PIA submissions
OCREB membership changes – updated 2019 (see www.ocreb.ca)
New Studies: submitted for the September 13, 2019 meeting (see minutes)
Reminders: translation of ICF documents; new ICF template
- The Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC), and the Social Sciences and Humanities Research Council (SSHRC) are pleased to announce the release of TCPS 2 (2018) – the latest revision of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd edition. TCPS 2 (2018) replaces TCPS 2 (2014) as the official human research ethics policy of the federal research granting agencies.
The Panel on Research Ethics is responsible for the evolution of the Policy. The Panel maintains an ongoing dialogue with TCPS 2 users through its interpretation service and its educational outreach, including the CORE tutorial, webinars, and presentations. To further engage the community, the Secretariat on Responsible Conduct of Research sought public comment on the Panel’s proposed changes between October 2016 and January 2017, and posted the comments they received. These questions and comments informed many of the additions and refinements published in TCPS 2 (2018).
The Secretariat is issuing two resources for TCPS users. “Highlights of Changes” summarizes the revisions to the Policy, and a separate document, “How to Address Material Incidental Findings,” provides guidance on TCPS 2 (2018) Article 3.4. The Secretariat has also taken this opportunity to provide a completely new French translation. A comprehensive index will be added to the website this fall.
The Secretariat no longer provides print copies of TCPS 2 due to environmental concerns. You are encouraged to print or download your own copy of TCPS 2 (2018).
- The new Guidance Document: Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” (GUI-0100)was published online, August 20, 2019 and can be found on the Health Canada website at:https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-clinical-practices/guidance-documents/guidance-drugs-clinical-trials-human-subjects-gui-0100.html
This guidance document will help those involved in the conduct of clinical trials of drugs in human subjects in Canada to comply with Part C, Division 5 of the Food and Drug Regulations (the Regulations) and to understand the International Council for Harmonisation (ICH) Guidance Document: Good Clinical Practice: Integrated Addendum to E6(R1) ICH Topic E6(R2) in the Canadian context.
Note: There will be no teleconferences in July and August 2019.
Reminders: DIL, PCL submissions
OCREB membership changes – updated March 2019 (see https://ocreb.ca/about-ocreb/meetings-and-membership/)
List of studies and study centres – updated 29/05/2019 (see https://ocreb.ca/about-ocreb/investigators-research-teams/)
New Studies: submitted for the June 14, 2019 meeting (see minutes)
- Medical Devices review: Health Canada consultation [see minutes for more information]
- Draft Accelerated reviews guidance: Health Canada consultation [see minutes for more information]
- Release of Draft (Step 2) ICH Guidance: E19 Optimization of Safety Data Collection: Health Canada consultation ICH website
- Taking stock of the implications of genomic advances
- ‘DNA genie left bottle with ancestry testing’, says Wellcome ethics researcher
- Cancer isn’t an ‘invader,’ and you’re not at war with it http://flip.it/FDUIBw
- GA4GH: draft of the revised Data Privacy and Security Policy
- “CRISPR babies”: What does this mean for science and Canada? [see minutes for more information]
Notices: New REC, Carrie Li, DIL submissions, protocol clarification letters, CTO application changes and missing documents, new study submissions
Reminders: wallet cards, provincial amendment implementation at centres, updated annotation application forms, submission of CRs
OCREB membership changes – updated March 2019 (see www.ocreb.ca)
List of studies and study centres – updated 25/04/2019 (see www.ocreb.ca)
New Studies: submitted for the May 10th, 2019 meeting (see minutes)
- The WHO Database of Regulatory Information Tracking of Clinical Trials Registration & Ethics Committees (REGTRAC) is now online and has information about 27 countries. More countries will be added during 2019. http://apps.who.int/trialsearch/regtrac.aspx
- OHRP has added eight new Frequently Asked Questions and Answers (FAQs &As) to its list of “Companion Q&As about the Revised Common Rule.” The new questions include the following three: What is the general compliance date of the revised Common Rule and what does it mean?; Does my institution need to revise its FWA because of the revised Common Rule?; and, After January 21, 2019 (the general compliance date for the revised Common Rule), is the 1998 Expedited Review List still in effect for studies subject to the revised Common Rule? Each of the eight FAQ &As are noted as being new. The Companion Q&As about the Revised Common Rule can be accessed at: https://www.hhs.gov/ohrp/8-new-faqs-added-companion-faqs-revised-common-rule.html
- Health Canada is pleased to announce the implementation of International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Guidance E17: Multi-Regional Clinical Trials. This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Assembly has endorsed the final draft and recommended its implementation by membership of ICH. email@example.com://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html#16
- Health Canada is exploring how to best address longstanding stakeholder concerns regarding the current regulatory framework for medical devices and how it may be unintentionally limiting investigational testing activity in Canada. This issue was prioritized in Health Canada’s Action Plan on Medical Devices, which was published in December 2018. As part of this work, we are conducting a targeted consultation to gain the perspectives of the medical device industry, investigators/researchers, patient groups, physician groups, Research Ethics Board representatives, and granting agencies (N2 memo).
- First U.S. Patients Treated With CRISPR As Human Gene-Editing Trials Get Underway
NPR has learned that a U.S. CRISPR study that had been approved for cancer at the University of Pennsylvania in Philadelphia has finally started. A university spokesman on Monday confirmed for the first time that two patients had been treated using CRISPR. One patient had multiple myeloma, and one had sarcoma. Both had relapsed after undergoing standard treatment.
[Clinical trials | CRISPR | Cancer treatment]
- International Clinical Trials Day 2019 is May 20th! https://n2canada.ca/?
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.