The Research Proposal - Study That May Qualify for Expedited Review Process
In this section, we hope to provide you with some assistance for your submission of your study that may qualify for expedited review process. Please note that these guidelines are for research involving subjects less than 18 years of age at any CHR site. If your project involves adults only, please contact the
Office of Medical Bioethics at 220-7990.
Qualifying for Expedited Review
The decision for a study to qualify for expedited review rests with the Conjoint Health Research Ethics Board (CHREB). Consistent with the Tri-Council Policy Statement and the University of Calgary Policy on Ethics Review of Research Involving Human Subjects, the CHREB makes provision for expedited review of appropriate research protocols submitted to it.
Guidelines applying to decisions regarding which protocols may be eligible for expedited review and approval may be found on the Office of Medical Bioethics website in the document, "Conjoint Health Research Ethics Board Policy on Expedited Review of Research Protocols":
http://www.fp.ucalgary.ca/medbioethics/download.html
Where there is any doubt about the appropriateness of a protocol for expedited review, the protocol will go through the full review process. The final authority for approval for expedited review process rests with the Chair or delegate. If you have any questions as to whether your study may qualify for expedited review, please contact the Child Health Research Office (CHRO) at 955-7241 or CHREB at 220-2297.
How do I Submit?
Possible expedited studies are reviewed by the Child Health Scientific Review Committee (CHSRC) for institutional impact and forwarded to the CHREB requesting expedited review. These submissions are accepted on an ongoing basis. You make your submission to the Child Health Research Office. You submission must include:
- Original + 4 copies of the application form
- Original + 4 copies of the study protocol
- Original + 4 copies of the consent form (templates available on CHREB website)
Upon receipt of your submission, the study will undergo an institutional impact review. The CHRO will forward 2 copies of the submission to the Office of Medical Bioethics. Should your protocol require a review for compliance with the Health Information Act, the CHRO will also forward this to the Calgary Health Region Office of Information and Privacy.
What Happens in the Review Process?
This proposal will be reviewed for institutional impact and will be reviewed by the Chair of the CHSRC. If the Chair feels that the expedited criteria are met then the CHRO will forward the study to CHREB. The CHREB will notify the CHRO if the study has not been accepted as expedited. If expedited, only administrative review by the CHSRC will be carried out. (Please contact the Office of Medical Bioethics for any questions regarding the CHREB review portion). If it is not accepted as expedited, the protocol will follow one of three routes:
- The CHREB will send it for their full board review, and waive the scientific review by the CHSRC.
- The CHREB will send it for their full board review, but request that one scientific officer from the CHSRC provide a scientific review to the CHREB.
- The CHREB will request that the full CHSRC first review the study before full board review by the CHREB.
If you have any questions regarding the process of when your study is accepted for expedited review, please contact the Office of Medical Bioethics. If applicable, the protocol will also be submitted to the CHR Office of Information and Privacy to assess compliance with the Health Information Act. (For more information, please see Health Information Act section of this website.)
Administrative Review
All investigators must submit a list indicating departments or divisions where operations may be affected by the proposed study and obtain signatures of the appropriate Department Head(s) or Officer(s) indicating they have reviewed the project and its budget. This list is included in your application package on page 2. The study budget will be assessed for completeness, appropriate pricing and to ensure that all research related costs are covered. Administrative review will be conducted by the CHSRC.
Ethical Review
For all submissions, ethics approval is obtained from the Conjoint Health Research Ethics Board, University of Calgary . Proposals are forwarded directly to the Conjoint Health Research Ethics Board by the CHRO upon scientific approval. It is important to include a copy of the consent form with your submission to the CHRO.
Sample CHREB consent forms are available from the Office of Medical Bioethics or on their website . If there are ethics concerns, the investigator will be contacted by an ethics reviewer or Chair of the CHREB.
Approvals
Research studies that are approved will receive 2 approval letters:
- Institutional approval from the CHRO (issued before CHREB approval but is contingent on the study receiving CHREB approval)
- Ethics approval from the CHREB
Both approvals must be obtained prior to commencement of your research.
If you have any questions, please contact the CHRO at 955-7241.
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