Results: survey on the application of the hESC registry

A survey on the impact of the requirement to list human embryonic stem cell lines derived under the auspices of an institution that receives Agency funding was posted on the CIHR website from October 19, 2007 until February 15, 2008. These results were discussed at SCOC’s April 2008 meeting.

1. SCOC suggests that the registry include the following lines to be subdivided into two distinct lists:

i) lines established through research approved by SCOC and with funding from any of the Agencies (not just CIHR). These lines would be listed in the registry and made available by the researcher to other researchers on a cost-recovery basis. Do you agree with this application of the registry?

  Responses 
Yes 29
No   3
Not sure   0

Comments

The following considerations were mentioned:

  • whether cell lines are to be made available to researchers outside of Canada as well;
  • intellectual property; and
  • the timeframe for registry of cell lines (capabilities of individual labs will vary).
ii) lines established through research approved by SCOC and carried out in an institution that receives Agency funding, but whose derivation was not directly funded by an Agency. These lines would be listed in the registry but there would be no requirement for the researchers to make the cell lines available to other researchers on a cost-recovery basis. Do you agree with this application of the registry?

  Responses
Yes 19
No 12
Not sure   1

Comments

It was generally agreed that cell lines should be made available to other researchers. Several respondents noted that the lines should be made available on a cost-recovery basis, regardless of the funding source.

One respondent noted that because privately-derived lines may not be accessible, there is no need to include these on the registry.

2. What do you perceive would be the impact of requiring that all lines established at an institution that receives Agency funding be listed on the registry?

Investigators deriving cell lines suggested that it would have little impact and would be very beneficial to all parties to have a complete registry that includes all hESC lines derived in Canada, regardless of funding. Few labs have access to human embryos that are no longer required for reproductive purposes. However, should induced human pluripotent stem (iPS) cells be included in the registry, the impact would be profound because many lines may be derived in many labs.

Investigators conducting research on existing hESC lines, and an institutional respondent, were concerned with the procedural complications of hESC research in Canada. There was also concern that private funders would not necessarily want their hESC lines listed publicly. Institutional security issues (the respondent did not specify what type of security; be it information or physical) due to the public posting of the information could also be a consideration.

Other investigators conducting research on existing hESC lines felt that this would enable research and foster collaboration. One respondent noted that this application is unlikely to compel researchers to seek funding outside of the Agencies. Another suggested that Canada should consider establishing a central cell bank that would be in charge of the registry and also distributing the lines (such as USA and UK) to ensure that labs are not overburdened with mandatory distribution of cell lines.

Among all other respondents, it was generally agreed that this will enable research and foster collaboration. Intellectual property rights were also raised.

A respondent from the general public cited concerns of misuse of the information by private companies or lobbyists.

3. What information would you want the registry to capture?


  Responses
Stem cell line name (currently provided in Policy Highlights) 29
Source (currently provided in Policy Highlights) 29
Availability 28
Source contact information 25
Other 15

Other:

Investigators that are currently deriving cell lines suggested that there should be a repository that maintains quality control, that individual labs should not be responsible for distribution.

Much of the information given below would not be available at the onset of the derivation of an hESC line. One respondent suggested that some of the information in the registry could be listed privately.

  • MHC and other immune determinant types
  • karyotype
  • relative efficiency of differentiation along specific lineages if tested/information on developmental potential
  • the tests for pluripotency that have been used to characterize the line
  • quality/limitations of the use of the cell line/evidence of genetic stability
  • material transfer agreements
  • original reference of cell line publication (if any)/other publications about the line
  • length of time in culture, passage number
  • exposure to feeder cells/xeno reagents
  • patient-specified restrictions on use

4. Do you have suggestions/comments to make the registry as effective as possible?

It was agreed that the registry must be easy to access, easy to search, easy to add to, and easily expanded (to include more information on individual hESC lines as it becomes available). Suggestions included an online format, perhaps wiki-based. It would be useful if the registry included information about which researchers were using which cell lines.

The information included within the registry should be clearly defined. If the Canadian registry were to apply scientific criteria for comparing methods, and protocols for culture, and a means for all information to come back to a central location, this would be globally unique. If the information were captured carefully, it could be integrated with other national databases in the future. One respondent suggested the establishment of a centralized 'world' registry.

A comprehensive and consistent policy framework should be adopted. The primary goal of the registry should be to promote collaboration and materials sharing. If the registry were to include explicit shipping details, cross-border delays could be minimized.

One respondent suggested that the registry be abandoned.

A respondent from the general public commented that the registry should be funded solely by the government to avoid commercial interests.

5. Would you support the registration of your human embryonic stem cell lines if derived outside of the auspices of an Agency-funded institution, as a representative from a private funding organization?


 

Responses 
Not applicable 10
Yes 15
No   4
Not sure   2

6. Which stakeholder group do you belong to?


  Responses
Researchers developing human embryonic stem cell lines   2
Researchers conducting research involving existing human embryonic stem cell lines 12
Institution receiving any Agency funding   6
Private institution   0
Federal funding Agencies   0
Regulatory federal government departments   2
Private funding organizations   0
General public   5
Other   4

Other:

  • 1 investigator that receives private and public funds and conducts stem cell research
  • 2 ethics/ELSI researchers
  • 1 university faculty

One respondent noted that they both develop hESC lines and conduct hESC studies (selecting both above was not an option).

7. General comments/suggestions?

The primary goal of the registry should be to promote collaboration.

Some expressed concern with the procedural complications of conducting hESC research in Canada. It was noted that there are very few Canadian-derived hESC lines. The registry should not apply to iPS cells, as there will be thousands of human iPS cell lines in Canada within a couple of years.

A member of the general public expressed general concern with the involvement of private companies.

An investigator conducting research on existing lines indicated a desire to know the implications, results and impact of this type of survey.

An investigator conducting research on existing lines noted that it would be useful if researchers could have access to a list of cell lines that have already been approved by SCOC for use in Canada. [Note: this information is available on the Policy Highlights website]