Guidelines for Researchers

Guidelines to direct you in the ongoing ethics-related management of an approved study are outlined below, in alphabetical order.

Amendments

Any changes in the study protocol, IB, or information sheetconsent form must be detailed on an Amendment Form.

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Annual Review

A detailed progress report must be submitted every year to the REB until the project is completed. The report must include the items detailed in the Annual Progress Report form and the results of any interim analyses or safety committee reports.

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Appeals

A Standing Appeal Board shall be established by the President to adjudicate any1 appeal of a decision reached by the McMaster University Research Ethics Board (MREB), or the joint Hamilton Health SciencesMcMaster Faculty of Health Sciences Research Ethics Board (HHSFHS REB) or the St. Joseph’s Healthcare, Hamilton Research Ethics Board (SJHH REB), provided that decisions rendered by the latter two REBs are specific to an appeal by a McMaster University faculty member under the auspices of their University appointment.

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Clinical Trials: Registration

For investigator-initiated studies, where registration is the responsibility of a McMaster-affiliated PI and funds are held in a McMaster research account, then McMaster University should be identified by the PI as the “Sponsor” (or Hamilton Health Sciences or St. Joseph’s Healthcare Hamilton if the funding is administered through a research account at either of those institutions instead of McMaster) and the funding source (e.g. CIHR, Heart & Stroke, etc.) should be noted as the “Collaborator”.

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HiREB Fees (Industry sponsored studies only)

As of April 1, 2017 the administrative fee has increased to $3,500 (Cdn) and is required for REB review of all industry-sponsored research projects reviewed by the Hamilton Integrated Research Ethics Board (HiREB), whether funding associated with the research project is administered through St. Joseph’s Healthcare Hamilton, McMaster University or Hamilton Health Sciences.

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In Principle Approval (Pro Tem)

The REB provides a mechanism for approval for the purpose of submission to granting agencies. This is not permission to begin research. The REB Chair, or hisher delegate, determines whether or not there are ethical issues which could prevent the project from receiving approval by the full REB.

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Local Principal Investigator

All research reviewed by HiREB requires a Local Principal Investigator (LPI). The LPI must be a staff member of either St. Joseph’s Healthcare Hamilton, Hamilton Health Sciences or McMaster University. The LPI cannot be a student.

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McMaster/Mohawk/Conestoga Coordinated Review

Ethics review for multi-center research presents many challenges to researchers and REBs. In order to minimize the duplication of effort and the time delays associated with concurrent or serial ethics review, the following centers agree to participate in a coordinated ethics review process…

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Protocol Requirements

The research question and methodology must be presented in sufficient detail to permit evaluation of the scientific merit of the project.

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Quality Assurance

For help in determining if your study is QA or research.

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Review Process

Depending on the nature of your submission(s), you may qualify for either an expedited or full board review.

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Safety Reports

All DSMB Reports must be forwarded as soon as they are available and must be accompanied by a letter from the Local Principal Investigator indicating that she accepts the findings and recommendations of the DSMB.

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Sponsor Agreements

Contact information for submission of sponsor agreement funds administered by Hamilton Health Sciences, St. Joseph’s Healthcare Hamilton and McMaster Faculty of Health Sciences.

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Study Completion

It is the investigator’s responsibility to notify the REB using the Study Completion Report form when the study has been terminated, or if the study is cancelled after REB approval has been received. The reasons for cancellation should be stated.

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Unusual Events

The attending physician of the research subject must be notified in the event that unusual or unexpected results are obtained in the study as a whole or in a single subject. A copy of the letter of notification should be sent to the HiREB.

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