26th Meeting of the Stem Cell Oversight Committee
Minutes
| Chair: | John Williams | |
| Members: | Judy Birdsell | Bruce Brandhorst |
| Donald Evans | Shane Green | |
| Beverly Hanck | Arthur Leader | |
| Daryl Pullman | Cheryl Robertson | |
| Laura Shanner (by phone) | Marc-André Sirard | |
| Guests: | Jocelyn Cook | Chief Science Advisor, Assisted Human Reproduction Canada |
| Susan Zimmerman | Executive Director, Secretariat on Research Ethics | |
| Personnel: | Lynne Cayer | Ethics Policy Advisor |
| Geneviève Dubois-Flynn | A/Director, Ethics Office | |
| Jonathan Faulkner | Manager, Program Planning and Analysis | |
| André Gratton | Deputy Corporate Secretary | |
The Chair called the meeting to order at 09:00 and welcomed everyone to the 26th meeting of the Stem Cell Oversight Committee. All members joined him in welcoming Beverly Hanck, who was recently appointed to the Committee.
Declaration of Conflicts of Interest
No conflicts were declared.
Approval of Agenda
The meeting agenda was unanimously approved.
1. Minutes of the 24th meeting (teleconference) of the Stem Cell Oversight Committee held January 29, 2009.
It was noted that the minutes of the 24th meeting of SCOC, held January 29, 2009, were approved by way of e-mail/fax-back process and were posted on the CIHR website.
1.1 Matters for Action and Business Arising from the 22th - 25th meetings of the Stem Cell Oversight Committee
Geneviève Dubois-Flynn reviewed the Matters for Action which resulted from the 22th - 25th meetings of SCOC and noted that all appropriate actions had been taken.
2. Interagency Advisory Panel on Research Ethics (PRE)
Suzan Zimmerman provided an update to SCOC members on PRE's progress with respect to the incorporation of the Guidelines for Human Pluripotent Stem Cells (the Guidelines) into the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans.
She informed members that the consultation period has been extended to June 30th and thanked members for their comments which will be submitted for the Panel's consideration. SCOC discussed the merits of incorporating the Guidelines into the TCPS by reference, as opposed to direct incorporation into TCPS. The Guidelines may be updated from time to time, and once Health Canada promulgates regulations on the derivation of stem cells from human embryos, SCOC's governance responsibilities may change. Members stressed the importance of communicating to the research community that the TCPS will change as the Guidelines do.
3. Recent Events
Members were informed of matters arising, and decisions made, since its last face-to-face meeting in October 2008:
- At its April 2008 meeting, SCOC reviewed an application proposing the use of four SCOC-approved hESC lines, and one line whose provenance has not been reviewed. The recommendation on the use of the latter line was deferred pending receipt of information from the suppliers that would enable SCOC to determine whether the line was derived in manner that conforms to the Guidelines. Several attempts were made by CIHR staff to contact the provider, but to no avail. SCOC asked that the applicant be informed that CIHR has been unsuccessful in its attempts to contact the suppliers of the line and that the use of those cells will not be approved by SCOC until it receives the information it has requested.
- The Chair approved an extension for a previously SCOC-approved project until SCOC is able to review the renewal project. The investigator provided assurances that the renewal funding will not be used for research that deviates from the previously approved proposal.
- An invitation to attend the Stem Cell Network Annual General Meeting to be held in Montréal November 2-4, 2009, was extended to SCOC and the Chair has agreed to represent SCOC at that meeting.
- An investigator at Toronto's Samuel Lunenfeld Research Institute of Mount Sinai Hospital recently discovered a new method to create pluripotent stem cells from somatic cells without disrupting healthy genes. Members discussed the possibility of using these cells for clinical purposes. SCOC raised the question of the regulation of therapeutic uses of stem cells, and whether the use of gametes derived from human induced pluripotent stem cells (hiPSC) would be regulated under Assisted Human Reproduction Act. SCOC considered whether it should review the Guidelines and Frequently Asked Questions as they relate to the therapeutic uses of those cells. Options for such discussion include inviting guests with expertise in clinical research, clinical therapies, and regulation of research in the clinical sense to the September meeting, and/or liaising with the Stem Cell Network at its Annual General Meeting. SCOC will seek Governing Council's advice as to whether all clinical applications of human pluripotent stem cells should be considered as research, such that provision 8.7.1 of the CIHR Guidelines would apply, in the absence of any other review.
4. Review of Applications
SCOC reviewed four stem cell research applications for conformity to the Guidelines and was satisfied that the use of existing hESC lines is appropriate for the proposed research:
- 1 application to be funded by a research organization
- 1 application to be funded by voluntary health agency based in the United States
- 2 applications to use start-up funds
Application #1
This application, to be funded by a research organization, proposes to recapitulate the development of pancreatic beta cells from pluripotent embryonic stem cells in vitro. The proposed research conforms to the Guidelines and no issues of concern were raised by SCOC.
Recommendation for Application #1:
SCOC recommends that this application be approved for the use of SCOC-approved H9 and CA1 hESC lines.
Application #2
This application, to be funded with start-up funding, proposes to understand what is needed to construct a glucose-responsive insulin-secreting cell. The proposed research conforms to the Guidelines and no issues of concern were raised by SCOC.
Recommendation for Application #2:
SCOC recommends that this application be approved for the use of SCOC-approved CyT49, H1 and H9 hESC lines.
Application #3
This application is a renewal of a project to be funded by voluntary health agency based in the US, initially approved in March 2007. It proposes to study the molecular mechanisms of stem cell differentiation into skeletal muscle and examine the differentiated cells' ability to repair damaged heart muscle in various mouse models. The proposed research conforms to the Guidelines and no issues of concern were raised by SCOC.
Recommendation for Application #3:
SCOC recommends that this application be approved for the use of SCOC-approved H1, H9, CA1 and CA2 hESC lines.
Application #4
This application, to be funded using start-up funding, proposes to understand the molecular basis of pluripotency of human stem cells to improve the differentiation of pluripotent stem cells into desired cell types with high efficiency and purity. The proposed research conforms to the Guidelines and no issues of concern were raised by SCOC.
Recommendation for Application #4:
SCOC recommends that this application be approved for the use of SCOC-approved H1, H9 and hES2 hESC lines.
5. Stem Cell Oversight Committee Review Checklists
The checklists used for SCOC's review of applications is reviewed and amended from time to time.
SCOC reviewed recent refinements to the checklist and made further recommendations for minor improvements.
6. SCOC Review Process
SCOC reviewed suggestions offered by Stem Cell Network Investigators regarding SCOC review process. The suggestions were that:
- the in vitro use of hESC (i.e., outside the living body and in an artificial environment), be reviewed in the same fashion as the in vitro use of human induced pluripotent stem cells (iPS) (i.e., no SCOC review is required).
- all SCOC recommendations for proposals eligible for delegated or teleconference review not require GC approval.
SCOC discussed whether the proposed suggestions to amend its review process meet the test of public scrutiny and sensitivities around stem cell research, and whether there are inherent risks in adopting the suggested processes, since its process is meant to complement, at a national level, the review undertaken by the investigator's own local Research Ethics Board.
A. Reviewing the in vitro use of hESC
SCOC agreed that an important consideration in the use of hESCs is how the embryos from which they were derived were obtained. Nonetheless, a controlled environment is important to hESC research because of embryo sensitivities, as they sometimes extend beyond the derivation of hESC lines. However, concerns about in vivo use of hESCs, and the provenance of those lines, would not apply to the in vitro use of SCOC-approved hESC.
Thus, as a risk management strategy, SCOC will review these grants by delegated review to confirm which hESC lines are being used and that the work proposed will only be conducted in vitro.
B. Requirement for approval under delegated or teleconference review
During SCOC teleconferences, the Committee may consider applications for research using SCOC-approved hESC lines and research involving the engraftment of induced human pluripotent stem cells. Minor amendments, student proposals that are wholly subsidiary to a SCOC-approved project and minor extensions to approved proposals are eligible for delegated review.
The public sensitivities surrounding the issue of stem cell research on human embryos as well as the federal government's approval of the Assisted Human Reproduction Act requires particular vigilance on the part of Governing Council that research is conducted in a manner consistent with the Guidelines. The due diligence offered by the Stem Cell Oversight Committee on the review of applications, including those reviewed by either teleconference or delegated review, and presenting those recommendations to Governing Council for review and approval offers that reassurance to Council, the research community and general public.
7. SCOC Presentation to Governing Council
At its February 2009 teleconference, the Executive Committee of Governing Council requested that a representative of the SCOC attend a meeting of Governing Council to inform members on the processes established by SCOC for its review of pluripotent stem cell research proposals and other ethically sensitive human stem cell research. Art Leader will be representing SCOC at the June meeting of Governing Council
Members suggested that the presentation include the processes and tools established by SCOC for its review of pluripotent stem cell research applications; its ongoing relationship with Health Canada, Assisted Human Reproduction Canada and the Interagency Advisory Panel on Research Ethics; SCOC's recent discussions on its review process; SCOC's observations on the US National Institutes of Health draft guidelines; and seek Governing Council's advice as to whether all clinical applications of human pluripotent stem cells should be considered as research, such that provision 8.7.1 of the CIHR Guidelines would apply, in the absence of any other mechanism of oversight.
8. SCOC Membership Attributes and 2009 Membership Renewal
SCOC reviewed its membership attributes to ensure that it has the requisite skills, competencies, and representation to discharge its responsibilities. In the 2009 membership renewal on the Committee, four members terms are lapsing and cannot be renewed as they have served two consecutive terms, and four members are eligible to serve a second term. As well, CIHR has not been successful in finding a replacement for Sylvie Langlois whose term lapsed December 31, 2008.
SCOC noted the importance of international representation or a member with knowledge of international regulations on the Committee. Noting that the CIHR Conflict of Interest polices and procedures have considerably matured since the inauguration of the Stem Cell Oversight Committee and that the Committee could benefit from the knowledge and expertise of Stem Cell Network Investigators in discharging its responsibility to provide ongoing advice to Governing Council about ethical and scientific issues of human stem cell research, SCOC was prompted to seek the direction and guidance of the Nominating and Governance Committee with respect to its membership. SCOC agreed that, in addition to the current membership renewal process, an open call for nominations be considered.
9. Membership Renewal Update
Members were informed of the SCOC membership renewal process that will be launched this spring.
10. SCOC Terms of Reference
Following exemplary governance practices, the Stem Cell Oversight Committee reviewed its Terms of Reference to determine whether changes were required.
SCOC discussed whether it should hold only one face-to face meeting as opposed to two and hold more teleconferences. Other suggestions included the use of video conferencing and other conferencing tolls. SCOC weighed the alternatives, and decided that meeting face-to-face enables fuller challenging and substantive discussions on policy and emerging issues.
SCOC proposed two changes to its Terms of Reference, specifically that the provisions in its mandate with respect to:
- the establishment of a reporting process by which research approved by SCOC can be assessed for ongoing conformity with the Guidelines; as well as
- creating and maintaining a registry of human stem cell researchers in CIHR-funded Institutions be removed.
SCOC noted the many safeguards already in place to ensure ongoing conformity with the research that it has approved. For example, SCOC's review is intended to complement, at a national level, the review undertaken by the investigator's own institute Research Ethics Board. Furthermore, once human pluripotent stem cell research applications have received CIHR approval, researchers are informed that SCOC be notified of any changes to their research.
With respect to the creation and maintenance of a registry of human stem cell researchers, SCOC noted that although CIHR retains information on all CIHR funded research proposals in its Electronic Information System, it does not specifically maintain a registry of human stem cell researchers in CIHR-funded institutions. Citing privacy issues in creating and maintaining such a registry, SCOC members also questioned its usefulness.
11. October 2008 Meeting Evaluation Results
Members briefly reviewed the evaluations for the October 2008 meeting.
12. Forward Calendar
SCOC reviewed its 2009-2010 meeting calendar.
The 26th meeting of the Stem Cell Oversight Committee adjourned at 16:40.
