The Research Proposal -Multi-Centred Study Generated by a Non-Local PI

In this section, we hope to provide you with some assistance for your submission of a multi-centre study generated by a non-local PI (Principal Investigator). 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. 

What is a Multi-Centred Study Generated by a Non-Local PI?

A multi-centre study generated by a non-local PI is defined as study that will be taking place at multiple sites (including the Calgary Health Region site), has not been initiated by a local PI, and is not sponsored by industry, who controls the proprietary rights to the protocol. (This means that the investigators can alter the protocol according to their judgment and that they have full rights to the information derived from the study and its publications.) If the study has been funded by a major granting agency who has provided scientific reviews, please see Submitting a study with a major grant.

If the study has been initiated at a non-CHR site, ethical approval at the site of the initiating investigator must be sought first. Please note that all studies being submitted for review must have a local Principal Investigator.

How do I Submit?

Multi-centre studies generated by a non-local PI are reviewed by the Child Health Scientific Review Committee (CHSRC) on an ongoing basis. You make your submission to the Child Health Research Office (CHRO). 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 CHRO will forward 2 copies to the Office of Medical Bioethics, and will retain 2 copies for scientific, and institutional impact review. Should your protocol require a review for compliance with the Health Information Act, the CHRO will also forward a copy to the Calgary Health Region Information and Privacy Office.

What Happens in the Review Process?

This proposal will be reviewed for institutional impact, scientific and ethical concerns. If applicable, the protocol will also be submitted to the CHR Office of Information and Privacy to assess compliance with the Health Information Act. It will be reviewed for institutional impact and scientific concerns concurrently. Once scientific approval has been given, you will be notified of the approval. The CHRO will promptly forward the study to Conjoint Health Research Ethics Board (CHREB) for ethical review.

The Scientific Review:

In general, the CHSRC reviewers look for the following criteria when judging your proposal on scientific validity and administrative impact:

• Research questions and/or objectives that are clear and attainable.
• Background information and literature review, which justify the conduct of the study.
• A research design that is adequate for the objectives and (where applicable) the hypotheses to be tested.
• Research methods that are appropriate for the study, including: subject selection (sampling, recruitment, inclusion and exclusion criteria, methods of assignment to groups), statistical consideration (sample size and data analysis), data collection (study variables, procedures, measures/instruments), and time frame of the study.
• Itemised, detailed budget information including source of funding and overhead information.
• Protection of human rights and attention to ethical issues (addressed by the CHREB).
• Practical significance and feasibility of the study given the qualifications of the investigator.
• Interventions proposed and patient safety.

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 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

Multi-Centre 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.