Our Dental Research in Detail

The Principal Investigator (PI) is a person who hold the grant and is responsible for the conduct of the research project. If a research project is conducted by a team of individuals, the investigator is the responsible leader of the team and may be called the principal investigator Guideline, I. H. T. (2001). Guideline for good clinical practice. J Postgrad Med, 47(3), 199-203.

• Preparing and submitting the proposal for the project, including its budget and statement of work;
• Carrying out the work, ensuring that all persons working on the project are fully informed of and agree to comply with all applicable terms of the Research Agreement or sponsor’s funding terms;
• Ensuring that all obligations of MSH policies, are met; find the detailed below: http://www.mountsinai.on.ca/about_us/ethicsboard/resource/mshrebterms.pdf/view
• Maintaining scholarly or scientific records and data in accordance with the Research Agreement, sponsor’s funding terms, MSH policies;
• Authorizing all expenditures in accordance with the sponsor’s funding terms and the policies and procedures of the MSH;
• Following all relevant laws, regulations, and MSH policies and procedures in the conduct of the project;
• Informing the chief dentist as soon as possible if the Principal Investigator becomes aware of any circumstances that could prevent satisfactory completion of the project or compliance with any terms and conditions of the Research Agreement or sponsor’s funding terms.

Additional information about researcher qualifications and responsibilities visit: https://www.mountsinai.on.ca/about_us/ethicsboard/policies-and-standard-operating-procedures/

A research proposal is the first step in performing any research and that the topic and approach are sound, so that the PI can gain approval required for proceeding with the actual research. Research proposals should be prepared as follows:

• Cover page: including the project title, name, affiliation and contact information;
• Research protocol: research background and rationale; population; procedures; intervention or treatment; tests and measurements, risks and benefits; proposed data analysis, implications of the research; ethical issues and concerns;
• Timetable for completion of the project;
• Research documents: informed consent forms, questionnaires;
• Author’s curriculum vitae;
• Research budget: must give an accurate assessment of all direct and indirect costs, items and their amounts that are deemed necessary and reasonable. It should be complete; that is, it should include all the costs of any personnel, supplies, and activities required by the project. The project needs to be feasible within the budget presented. If major cost areas are omitted or underestimated, the project, as proposed, will not be considered feasible;
• A detailed statement of required funding (e.g. grant);
• A statement of other funding sources (grant, institution, industry, analytic center or another external source of funding).

Suggested guidelines:

• http://www.mountsinai.on.ca/about_us/ethicsboard/resource/guidelinesforwritingproposalsandconsentforms.pdf/view
• https://www.mountsinai.on.ca/about_us/ethicsboard/policies-and-standard-operating-procedures/

The Zane Cohen Centre at Mount Sinai Hospital is an internationally-recognized clinical research facility, linking a team of gastroenterologists, surgeons, psychiatrists, pathologists and radiologists and their research staff who are leading new research in areas such as IBD, gastrointestinal cancers, and genetic aspects of IBD into one common facility.

Sponsored Proposals:
The sponsored research and collaboration agreement covers financial support for research in a specific area or field. This agreement formally outlines a research partnership, typically with industry, and specifically addresses the scope, nature, budget and intellectual property rights of the relationship. For more information visit the below page: http://www.research.utoronto.ca/forms/sponsored-research-agreement/

Proposals should be submitted by email or by mail to The Department of Dentistry, Mount Sinai Hospital at the following address: [email protected]

Typically this scientific review occurs through a primary evaluation by the research vice-chief and then via the Department of Dentistry, MSH research committee and independent peer reviews at relevant fields. In some cases, the research committee may require the PI to prepare and defend a dissertation proposal. This departmental research proposal defense process will normally satisfy the need for internal scientific review. In cases where no such proposal defense has occurred, the researcher must provide other evidence of the scientific integrity of the proposed research to the research committee. Depending on the proposal’s nature, the following checklists are usually used for further evaluations:

Clinical trials: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/clini/index-eng.php

Quasi-Experimental Studies (non-randomized experimental studies): https://joannabriggs.org/sites/default/files/2019-05/JBI_Quasi-Experimental_Appraisal_Tool2017_0.pdf

Case Control Studies: https://joannabriggs.org/sites/default/files/2019-05/JBI_Critical_Appraisal-Checklist_for_Case_Control_Studies2017_0.pdf

Cohort Studies: https://joannabriggs.org/sites/default/files/2019-05/JBI_Critical_Appraisal-Checklist_for_Cohort_Studies2017_0.pdf

Diagnostic Test Accuracy Studies: https://joannabriggs.org/sites/default/files/2019-05/JBI_Critical_Appraisal-Checklist_for_Diagnostic_Test_Accuracy_Studies2017_0.pdf

Economic Evaluations: https://joannabriggs.org/sites/default/files/2019-05/JBI_Critical_Appraisal-Checklist_for_Economic_Evaluations2017_0.pdf

Prevalence Studies: https://joannabriggs.org/sites/default/files/2019-05/JBI_Critical_Appraisal-Checklist_for_Prevalence_Studies2017_0.pdf

Systematic Reviews: https://joannabriggs.org/sites/default/files/2019-05/JBI_Critical_Appraisal-Checklist_for_Systematic_Reviews2017_0.pdf

Analytical Cross Sectional Studies: https://joannabriggs.org/sites/default/files/2019-05/JBI_Critical_Appraisal-Checklist_for_Analytical_Cross_Sectional_Studies2017_0.pdf

Qualitative Research: https://joannabriggs.org/critical-appraisal-tools

Upon scientific approval, the proposals must be submitted to the Mount Sinai Hospital Research Ethics Board (REB) for all research involving human subjects conducted under the auspices of Mount Sinai Hospital.

REB general forms and guidelines can be found at:

• http://www.mountsinai.on.ca/about_us/corporate-information/ethicsboard
• http://www.mountsinai.on.ca/about_us/ethicsboard/forms-and-guidelines/

For proposals involving human subjects:

• http://www.mountsinai.on.ca/about_us/ethicsboard/resource/applicationforresearchinvolvinghumansubjects.pdf/view

For request to review health records:

• http://www.mountsinai.on.ca/about_us/ethicsboard/resource/healthrecordsapplicationformforchartreview.pdf/view

The proposed budget must give an accurate assessment of all costs, items and their amounts that are deemed necessary and reasonable. It should be complete; that is, it should include all the costs of any personnel, supplies, and activities required by the project. The project needs to be feasible within the budget presented. If major cost areas are omitted or underestimated, the project, as proposed, will not be considered feasible.

You may also refer to the University of Toronto’s Guide to Financial Management for further information on how to construct a budget:

• http://finance.utoronto.ca/wp-content/uploads/2015/11/Research-Administration-Policy-Oct-30-2013.pdf

Generally, the budget categories are expected to cover the following costs:

Helpful information on budgeting for indirect costs can be found in the Indirect Cost section of the VPRI website: http://www.research.utoronto.ca/faculty-and-staff/secure-research-funding/apply-for-funding/#direct-indirect