Monthly Centre Meetings 2019

Monthly Centre Meeting Summary [December 2019]

Notices:

• Breaking 100 in 2019! Highest number of new studies EVER!

For the first time in OCREB’s 16-year history, we broke 100. The 102 new studies submitted to OCREB in 2019 surpass the previous record of 96 submissions in 2017. While that number of studies might seem somewhat low compared to the volume of new studies received by large single-centre REBs, as a central review board, OCREB also receives applications for each new study from multiple participating centres. So far in 2019, OCREB has received close to 300 new centre applications, and the year is not over yet. In addition, the studies submitted to OCREB are high-risk interventional trials, making the combined volume and complexity of the trials challenging to compare. OCREB currently is overseeing 492 approved studies associated with 1,510 active centre-studies and counting.

• January, 2020 teleconference CANCELLED
• New: V3 of the N2/CAREB-ACCER REB SOPs have been posted along with the associated OCREB addenda – please see the table of contents for identification of the revised documents

Reminders:

• Due to the holiday schedule, the deadline for submissions for the January 10, 2020 meeting is Tuesday, December 17, 2019.
• Please note that CAM submissions for a change in PI do not require the submission of participant materials, e.g., consent – updated contact information on other documents are pre-approved and may be completed without changing the version date as per the Guidance for Administrative Changes.
• Career Opportunity -OCREB Executive Director – the posting for Janet Manzo’s replacement is up at https://www.recruitingsite.com/csbsites/oicr/careers.asp and noted on the OCREB website at https://ocreb.ca/about-ocreb/whats-new/. It has also been distributed/posted through N2, CAREB and 3CTN as well as the OCREB network. If you know anyone with the relevant experience and skills, encourage them to apply.

OCREB membership changes – updated November 2019 (see www.ocreb.ca)

New Studies: submitted for the December 13, 2019  meeting (see minutes)

 NOTEWORTHY ITEMS

• Presentation by Diana Kato, Operations Manager, 3CTN: 3CTN’s Achievements and Strategy for Strengthening the Patient’s Voice
• 11/29/2019 – Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry FDA
• OHRP has posted a new video on its public outreach website, About Research Participation, https://www.hhs.gov/ohrp/education-and-outreach/about-research-participation/index.html.
• View “How is Medical Research Different from Medical Care?” at: https://www.youtube.com/watch?v=_L5Tg7ciNNU&feature=youtu.be
• OHRP exemption from the required use of a single IRB, for cooperative research: conducted or supported by HHS agencies other than the National Institutes of Health (NIH), if an IRB initially approved the research before January 20, 2020. OR Cooperative research conducted or supported by NIH if either:
• the NIH single IRB policy does not apply, and the research was initially approved by an IRB before January 20, 2020, or 
• NIH excepted the research from its single IRB policy before January 20, 2020.

Monthly Centre Meeting Summary [November 2019]

Notices: PIA Q 1.12 – scientific review summaries for academic trials

Reminders: study closure requirements, updating centre contact information, updated enrolment targets at centre level

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 November 2019 (see www.ocreb.ca)

New Studies: submitted for the November 08, 2019  meeting

NOTEWORTHY ITEMS

• The Canada profile in ClinRegs now includes the following guidance documents:
  • A Health Canada guidance document providing interpretations of the Food and Drug Regulations (See the Quality, Data & Records Management and Manufacturing & Import sections)
  • The latest revision of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans and an associated new guidance on how to address material incidental findings discovered in the course of research (See Ethics Committee, Scope of Review, Trial Initiation, Safety Reporting, and Informed Consent Documentation Requirements sections)
• Health and Biosciences Sector Regulatory Review Roadmap https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/targeted-regulatory-reviews/health-biosciences-sector-regulatory-review-roadmap.html#a2
• Compensating Clinical Trial Participant: the basics Get the basics with this overview of how a compensation program for clinical trial participants should function and understand what key areas the IRB will be examining closely. The Secretary’s Advisory Committee on Human Research Protections(SACHRP) recommendation to the FDA and Department of Health and Human Services’ Office for Human Research Protections (OHRP). https://www.magiworld.org/resources/journal/2406_New133.pdf
• Yay Canada! Within 120 days of approving or rejecting a new drug, biologic or device application, Health Canada will post clinical study reports on a new government online portal – this may put pressure on the FDA to do the same. HC will post clinical study reports/data on an online portal, similar to the EU Medicines Agency in a move towards transparency in clinical research and increased, appropriate data sharing. https://www.npr.org/sections/health-shots/2019/10/11/769348119/canadas-decision-to-make-public-more-clinical-trial-data-puts-pressure-on-fda

Monthly Centre Meeting Summary [October 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 08, 2019  meeting

NOTEWORTHY ITEMS

• 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

Monthly Centre Meeting Summary [September 2019]

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

Noteworthy Items

• 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.

Monthly Centre Meeting Summary [June 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)

Noteworthy Items:

• 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]

Monthly Centre Meeting Summary [May 2019]

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 10^th, 2019  meeting (see minutes)

Noteworthy Items:

• 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. hc.ich.sc@canada.cahttp://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).

Medical device consultation

• 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 20^th! https://n2canada.ca/?

Note: The April 5, 2019 teleconference has been cancelled.

Monthly Centre Meeting Summary [March 2019]

Notices: The April OCREB meeting was moved to April 5^th, 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

Noteworthy Items:

• 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.

Monthly Centre Meeting Summary [February 2019]

Notices:  introduction to the new ICF template ; TCPS Update to be released in April, 2019

NCWG ICF slides 2019 BOR

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]

Noteworthy Items:

• AstraZeneca has hired Dr. José Baselga, the former chief medical officer at Memorial Sloan Kettering, to lead its cancer research unit.
  Read More…
• 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.