Table 1.
Institutional research ethics board approval timelines
| NETWORK LOCATION (IREB TYPE) | DATE IREB SUBMITTED | DATE AND TYPE OF IREB APPROVAL | TYPE OF SUBMISSION | FURTHER REQUESTS FROM THE IREB | COMMENTS |
|---|---|---|---|---|---|
| Edmonton, Alta (university) | May 22, 2008 | Jul 11, 2008, approval in principle | Expedited | More detailed protocol | IREB approval in principle; able to access funds but no human subjects |
| Jul 22, 2008, more details provided | Oct 3, 2008, approval with limitations | Expedited; no request for potential future data linkage included in submission | That laboratory data not be collected | Unable to extract laboratory data from EMR without explicit patient consent | |
| Feb 16, 2009 | Jul 17, 2009 | IREB expedited request to collect laboratory data | Amendment as requested | Full approval | |
| Oct 9, 2008 | Dec 23, 2008 | Operational approval for first site recruited | Further information regarding privacy and ethics | Full operational approval | |
| Dec 3, 2008 | Dec 9, 2008 | Operational approval for second site recruited | None | Full operational approval | |
| Calgary, Alta (joint university and health region) | May 28, 2008 | Jul 3, 2008 | NA: applicants may not select the type of submission | None | Full approval |
| Toronto, Ont (university) | May 29, 2008 | Aug 7, 2008 | Expedited | None | Full approval |
| Kingston, Ont (joint university and affiliated teaching hospital) | May 7, 2008 | May 9, 2008 | Initial expedited approval | None | Full expedited approval |
| Feb 20, 2009 | Mar 9, 2009 | Amendment for extension of project and associated project deliverables | None | Full board approval | |
| Apr 1, 2009 | Apr 25, 2009 | Annual re-approval | None | Full expedited approval | |
| Aug 24, 2009 | Aug 24, 2009 | Updated patient information poster and adaptation of option 2 for regional data processing and data transfer | None | Full expedited approval | |
| London, Ont (university) | Jul 18, 2008 | Aug 29, 2008 | Expedited | None | Full approval |
| Quebec (hospital ethics and scientific committee of the university) | Oct 2008 | Not approved at this stage; revisions requested | Full board | Verbal discussions and e-mail exchanges with a representative of the CAIQ continued until Jan 2009 and outcome indicated that individual patient consent was required During this time additional clarifications were requested pertaining to items of data collected |
Full patient consent required |
| Feb 2009 | Apr 30, 2009 | Full board | A letter from the Chair of the CPCSSN project was requested confirming that no linkages would be formed between data from the Q Net and other national databases | Full patient consent required | |
| Aug 2009 | Aug 30, 2009 | Amendment | Further discussions with the CAIQ in Aug 2009 clarified the legal status of our clinic within the CSSS Laval. Site was told they could obtain permission from the DSP. A letter from the project chair was requested stating that there would be no linkages between data from the Q Net and other national databases during phase 2 | Waiver of full informed consent approved | |
| Newfoundland (university) | May 26, 2008 | Jun 10, 2008 | Full board | None | Full approval with limited clarifications |
| Nova Scotia (health authority–based)* | Jun 1, 2009 | Jul 27, 2009 | Expedited | None | Can collect only medication lists related to chronic diseases |
| Manitoba (university)* | Apr 13, 2009 | Jun 5, 2009 | Expedited | None | No issues |
CAIQ—Commission d’accès à l’information du Québec, CPCSSN—Canadian Primary Care Sentinel Surveillance Network, CSSS—Centres de santé et de services sociaux, DSP—Direction de santé publique, EMR—electronic medical record, IREB—institutional research ethics board, NA—not applicable.
*
Networks joined the CPCSSN project after March 2009.