Guidelines for Researchers

The following guidelines will assist you in the preparation and ongoing management of a research study intended for HiREB submission.

Amendments

Any changes to the study protocol, investigator brochure, consent form, study instruments, and/or recruitment materials must be detailed on an Amendment form. Additionally, any changes to the LPI, PI, Co-investigator(s) and/or study coordinator must also be reported to the HiREB using an Amendment form.

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Annual Renewal

A detailed progress report must be submitted every year to the HiREB 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 Ontario (CTO)

Clinical Trials Ontario (CTO) is an independent not-for-profit organization established with support from the Government of Ontario.  Their mandate is to work collaboratively with the clinical trials community, the public and strategic partners to improve Ontario’s clinical trials environment and attract clinical trial investment to the province, while supporting the highest ethical and quality standards.

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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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Conflict of Interest

A conflict of interest (COI) whether real, potential or perceived, arises when an individual in a position of trust has competing professional or personal interests.  Researchers and research staff should identify and manage COI to maintain the public confidence and trust and to maintain the independence and integrity of the research process.

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Faculty-only Course-based Ethics Applications

The HiREB SRC is offering course-based ethics approval for those courses which are designed to have students develop their research skills but the research activities do not fit the standard definition of research, since the results are not intended for publication or generalization.

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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 HiREB provides a mechanism for approval for the purpose of submission to granting agencies. This is not permission to begin research.

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Incidental Findings

Incidental Findings are unexpected discoveries made during a research study, but are not part of the research itself.

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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, or have affiliation with, either St. Joseph’s Healthcare Hamilton, Hamilton Health Sciences or McMaster University.

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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 Improvement

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

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Resource Signatures on General Research Applications

In the eREB electronic submission process we recognize obtaining resource signatures can be quite onerous.  We have prepared this resource signature document as a guideline.

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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 Data Safety Monitoring Board (DSMB)/Data Safety Committee (DSC) Reports must be forwarded to the HiREB as soon as hey are available.

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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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Students

In order to facilitate the work of the HiREB, the Student Research Committee (SRC), a subcommittee of the HiREB, reviews student research applications. When an application is submitted, the HiREB makes the determination as to which committee will review that application.

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Study Completion

It is the local principal investigator’s (LPI) responsibility to notify the HiREB using the Study Completion Report form when the study has been terminated, or if the study is cancelled after HiREB approval has been received.

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A Collaboration of

Disclaimer: The Hamilton Integrated Research Ethics Board (HiREB) represents the institutions of Hamilton Health Sciences, St. Joseph’s Healthcare Hamilton, Research St. Joseph's-Hamilton, and the Faculty of Health Sciences at McMaster University and operates in compliance with and is constituted in accordance with the requirements of: The Tri-Council Policy Statement on Ethical Conduct of Research Involving Humans; The International Conference on Harmonization of Good Clinical Practices; Part C Division 5 of the Food and Drug Regulations of Health Canada,  and the provisions of the Ontario Personal Health Information Protection Act 2004 and its applicable Regulations; For studies conducted at St. Joseph's Healthcare Hamilton, HiREB complies with the Health Ethics Guide of the Catholic Alliance of Canada